Johnson & Johnson

FELT AWFUL; VOMITING/ THREW UP; DIZZY; HIGH FEVER; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; NAUSEA/ FELT LIKE THROW UP; This spontaneous report received from a patient concerned a 16 year old male. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced nausea/ felt like throw up. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced high fever. On 11-APR-2021 06:00, the subject experienced vomiting/ threw up. On 12-APR-2021, the subject experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting/ threw up, high fever, dizzy, felt awful, and nausea/ felt like throw up, and the outcome of inappropriate age at vaccine administration and off label use 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.

inappropriate age for vaccine. Janssen not approved for under 18. Pt experienced nausea/vomiting evening of vaccine

Pt was 17.83 yrs of age at time of vaccine administration; not 18 years. Pt was choosen to prevent a wasted dose; pt also employee of pharmacy as a delivery driver. Pt's father also employee of pharmacy who had a heart transplant last year. Pt had nausea about 12 hours after shot; only lasted about 12 hours. By 24 hours after shot no remaining issues other than pain at injection site.

Patient is a 18 y.o. male who received the Janssen Covid vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: Pt reports nausea and diaphoretic Patient was treated/managed as follows: 1:27pm: BP: 136/88 HR:112 RR: 18 O2: 98% 1:37pm: BP: 144/94 HR: 107 RR: 18 O2: 97% Pt given gatoorade and reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by site lead.

flu symptoms. Pt received J&J vaccine this morning 0900. At 1400, started having a HA, chills, dizziness, chest pain cramps, and n/v. History: Pt had J&J COVID-19 vaccine this morning and after noon, pt started developing chills, non-thunderclap headache, felt light-headed like passing out while standing, having to sit down, sweating, with N/V x 2, here for eval. Also had muscle aches, in chest, thigh, and other parts of muscles, not isolated to chest. Felt not quite 100% when pt woke up this morning but otherwise didn't have any other symptoms before the vaccine and denies recent sick contact, recent travel, recent illness/surgery/procedures/abx use, diarrhea, rash, COVID-19 hotspot visit, sore throat, ear pain

Pt received the J&J COVID-19 vaccine on 3/14/2021 followed by chills, abdominal pain, headaches and fatigue started the night of the vaccine injection. Pain controlled with Tylenol prn. Improvement to symptoms today, 2 days later

Roughly 40 mins after shot, case was working, noted his face was hot, hand were cold and he felt lightheaded and nauseated.

Later in evening after vaccine administration: fever, chills, headache, nausea/vomting, body aches, exhaustion, facial swelling, rash on face and head. Unaable to sleep all night

The day the vaccine around 8pm Patient had chills and fever 100 degrees. Around midnight he started vomiting, had chills, fever 101, headache, body aches, extreme fatigue, racing heart 140 bpm. I called ER and told them symptoms. They said to bring him in. We arrived at ER at 1am. At ER they gave EKG, Tylenol, Toradol injection and IV fluids. They also gave him covid19 test. He started to feel better and he was sent home at 5am. Two days later he had rash going down his left arm where he received the vaccine. It was gone the next day.

Began with chills & fatigue, progressed to diarrhea. Then body aches, fever, chills, nausea, vomiting, ...lasted about 3 hours. Then fatigue, headache, chills which lasted about 18 hours. Treated with Tylenol 500mg after vomit and during headache feeling.

Feeling weak and tired, nauseas, faint like, and continuous vomitting for an hour and a half immediately after receiving the shot, heavy breathing.

Janssen COVID-19 Vaccine EUA I had a fever, headaches, nausea, fatigue, soreness on injection site, and loss of appetite.

7 minutes after vaccine was administered pt started reporting severe nausea. Face was extremely red. Pt did not report nausea until 15 minutes after. Administered 50 mg of benadry PO. Patient also started drinking gingerale. An hour later pt is doing a lot better. Nausea subsided redness as well.

Within 4 hours of vaccine and lasting 12-24 hours: Injection site pain, then severe chills followed by fever (99.9 degrees F), nausea, vomiting, joint aches/pain, shivering, loss of appetite, difficulty sleeping, GI pain, headache, severe light and sound sensitivity, fatigue; At 24-48 hours, headache, joint aches, fatigue, light sensitivity, decreased appetite, increased pulse; 48-72 hours - 2 pound weight loss, joint aches in major joints, fatigue, unable to perform physical work >72 hours - feeling better, but tired

Post vaccination syncopal episode about 30 sec, upon arousal vomited several times, color pale, diaphoretic; Medical monitoring w/vital assessment: BP 98/62 P66 O2 sat 97% RA; rest w/ improvement of symptoms and no additional complaints reported. Released from facility w/ parent-mother.

Patient had the injection, reported that is wasn't bad and then within a few minutes when in the waiting area, he reported feeling very light headed, nauseous, and lost his vision and hearing was fuzzy. He was cold and clammy. He never lost consciousness. It took him a couple minutes to "come back" to alertness and feel better. Severe headache, chills starting and began asthma symptoms (wheezing) at 11;30pm the night of the injection.. 2 extra strength Tylenol did not help. He was very cold and the headache did not let up after several hours. Eventually he had a bout of sweats and he reports he was soaked. In the morning, at 8 am the headache was still severe...was sensitive to noise, light and touch. He was given 2 extra strength Tylenol at 8 and then 2 Advil at 10am, which finally began to reduce symptoms. He was not hungry, felt weak, and finally by late night he was feeling better. In the morning on Saturday he awoke with a swollen left eye and blood shot in that eye.

103 degree fever, headache, nausea, chills. Couldn't sleep. Started around 8:30pm, lasted until ibuprofen was taken around 4am.

Started with shaking body then began pain in waist, toe and ankle joints, knuckles/fingers wrists. Then hands because numb as I started to lay in bed. Then numbness in feet, toes, hands, face, nose, chest and severe stiffness to the point I could not move.

Nauseous, chills, headache, soreness, arm soreness. Still felt ill the next day but recovered after one day and was able to resume normal activity.

Extreme dizziness, lightheaded, and profusely sweating moments after receiving the vaccine in waiting room. Nausea & headaches continued through the following morning.

STOMACH PAIN; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stomach pain was not reported. This report was non-serious.

Patient reports with low grade fever and complaints of headache, chills, abdominal pan, weakness and joint pain.

NOT EATING; LETHARGIC; HIGH FEVER; This spontaneous report received from a parent concerned an 18 year old male. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced high fever. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced not eating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic, high fever and not eating was not reported. This report was non-serious.

Received the J&J COVID vaccine at a state-run site. Chills and fever on day 1 post-vaccine. Vomiting and epigastric abdominal pain on day 3 post-vaccine. Continues with decreased appetite. Symptomatic care only at this time.

This spontaneous report received from a parent concerned an 18 year old male. 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: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, diarrhea, headache, chills, pressure in ears and injection site pain was not reported. This report was non-serious.

LYMPH NODES UNDER RIGHT ARM WORSENING AND GETTING SPREADING; STIFFNESS; Nausea; FELT JUNK; SHOULDER SORE; This spontaneous report received from a patient concerned an 18 year old male. The patient's weight was 170 pounds, and height was 71 inches. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known allergies and non drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for vaccination prophylactic. The batch number was not provided and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt junk. On 07-APR-2021, the subject experienced shoulder sore. On 07-APR-2021 15:30, the subject experienced stiffness. On 07-APR-2021 15:30, the subject experienced nausea. On 08-APR-2021, the subject experienced lymph nodes under right arm worsening and getting spreading. On 10-APR-2021, treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt junk, had not recovered from lymph nodes under right arm worsening and getting spreading, and the outcome of nausea, stiffness and shoulder sore was not reported. This report was non-serious.

VOMITING/EMESIS; SHAKES; LEGS NUMB; FEVER; WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a physician concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and seizure, and concurrent conditions included attention deficit hyperactivity disorder, intermittent asthma, migraines, psoriasis, and penicillin allergy, and other pre-existing medical conditions included currently not on any medications. 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 08-APR-2021 at 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 around 19:30, the patient experienced vomiting, had fever, shakes and complained of numb legs and was unable to feel them. He was instructed by his physician to go to the nearest Emergency room (ER). The patient visited emergency room or department and physician office for treatment of the events. He went to ER but was unable to walk at that time and was carried in. The patient was evaluated, had normal chest X-ray (CXR), temperature up to 104, had emesis, underwent rapid covid test which was negative. He was given intravenous (IV) fluids, Zofran, Tylenol and was discharged home. It was reported that the patient was doing better but with continued tiredness, weakness, his legs were feeling better, temperature was down, coherent and was tolerating fluids. Laboratory data included: Body temperature (NR: not provided) 104, COVID-19 antigen test (NR: not provided) Negative, and CXR (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/emesis, fever, shakes, and legs numb, had not recovered from weakness, and tiredness, and the outcome of unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420466-covid-19 vaccine ad26.cov2.s-vomiting/emesis, shakes, legs numb, unable to walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210420466-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.

within 4-5 hours fever spiked to 103; body was shaking, a sensation of pins and needles in arms and legs; abdominal cramping and vomiting. Fever reduced after administration of Tylenol to 102.3; fever persisted for 24hrs (@ 102.3); vomiting and cramping ceased after 12hrs.

Patient became pale, sweaty, nauseous and was not wanting to talk with staff. Patient was slumped over so it was difficult to get an accurate BP reading. At approximately 5:30 pm, the patient took a few sips of water. See the following timeline: 5:08 pm--cold pack applied to back of neck 5:13 pm--BP65/38 5:16 pm--BP 82/48 5:18 pm--BP 78/55 5:23 pm--BP errored 5:25 pm--BP 85/55 5:30 pm--BP 87/62 5:40 pm--BP 81/58 5:48 pm--BP 91/54 5:54 pm--BP 100/75 Patient left with brother and father. Tried to call patient at 7:30 pm, but left a voicemail.

In about a minute, ears "closed off", quickly became dizzy, feeling like going to "pass out". Some nausea. Indicated he had never experienced this with any other injections.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: DURING SYNCOPE EPISODE, PATIENT STATED HE "COULDN'T SEE". VISION RETURNED AFTER LESS THAN 1 MINUTE. PATIENT WAS UNCONCIOUS FOR LESS THAN 30 SECONDS. AFTER LAYING DOWN FOR 1 MINUTE, I RETURNED PATIENT TO CHAIR AND MONITORED BLOOD PRESSURE. PATIENT WAS HYPOTENSIVE FOR 20 MINUTES. PATIENT BECAME HEMODYANMICALLY STABLE AFTER 20 MINUTES USING 4 SEPERATE READINGS 5 MINUTES APART EACH. PATIENT'S FATHER ACCOMPANIED PATIENT AND OPTED TO TAKE HIM HOME AFTER HE WAS STABLE.

Woke up feeling warm, nauseous, feverish, had a headache. Went to the bathroom and felt dizzy, blacked out and fainted approximately 12 hours after vaccine.

Patient vomited a few minutes after receiving the Janssen Covid 19 vaccine. He rested for 30 minutes and felt fine then. No SOB, or difficult breathing.

Adverse reaction started at approximately 1030pm about 8 hours after receiving the vaccine. I started to shake and took my temperature to find that I had 104.6 fever and took Tylenol 1000mg and tried to go to sleep. About 30 minutes later at 11pm I vomited so I went to talk to my parents. They took my temperature and it spiked to 106.7 knowing I had already taken Tylenol they grabbed ice packs and wrapped them in a towel and placed them under my armpits and behind my neck they also placed a damp cloth on my forehead and monitored my fever. At around 1145 my fever started to come down slowly to 104.2. Around 130am I ate a few crackers and took ibuprofen 600mg and the fever still slowly dropped at around 2am my fever was still at 102.4 at this time my parents went to bed knowing that my body needed to continue to fight the fever. At 530am my father checked my temperature and it was normal.

18 y/o male received J&J vaccine. Five minutes after being vaccinated, pt complained of nausea. Patient presented with pale skin, diaphoretic, and incontinence of bladder in the observation area. Pt lost consciousness for 15 seconds in the car. After 15 sec, pt regained consciousness and was able to walk and talk. EMT brought the patient into the observation tent to lay on the cot. EMT obtained 4 sets of vitals and completed orthostatic vitals. Last set of vitals are: 10:15am: BP 103/60, Pulse: 74, Respiration 18 and O2 98% on room air. Blood Glucose level was 106. Pt returned back to normal state after 15 minutes in observation. Pt was no longer diaphoretic, pale, or nauseous. Pt is stable, alert, and oriented x4. Pt is walking and talking independently. No EMS services needed. Pt was instructed to follow up with the nearest ER, if symptoms return or worsen. Pt left with his mother, who is the driver.

Patient received vaccination and immediately felt uneasy (nauseous, lightheaded). The patient leaned over and became quiet and was not responding to questions. Patient then leaned back up and went stiff and had symptoms similar to that of a seizure (arms and legs went stiff and was unresponsive to questions) for about 30-60 seconds (at this time the paramedics had already been called). Patient then regained control and felt awful (a 5 on a scale of 1-10) and then felt even more nauseous and had to spit up into a trash can. Patient was given a water bottle to help them relax and cool off because patient felt warm. Paramedics arrived and checked blood pressure and pulse but found everything within normal ranges except for a slightly low blood pressure. The paramedics did nothing else except offer a scan of the patient's heart in their ambulance which he was then rolled out on a stretcher.

11:08 Text from client's mom: allergic reaction, throat swelling and hives all over. Client took Benadryl. Instructed to go to ER and ask them to complete a VAERS form. The mom texted back,: he took some Benadryl and it was about 30 minutes and he could feel things staring to go down and he feels a ton better, so I think we are OK. At 1:02 PM I texted her "How is he doing?" Her reply: "Much Better." At 5:11 PM Client's mom called and said patient was having chest congestion, swelling in his throat and sick to his stomach and nausea. I instructed her once again to get him to the ER . Client took Benadryl once again and also went to the ER. At 6:36 PM Client's mom let me know they were giving him an epinephrine shot and a steroid shot. she also texted: Dr. has never seen this kind of reaction. 6/3/2021 9:30 AM Client "so much better, thank goodness. 6/8/2021 Client himself stated he was fine. No additional problems

BODY ACHE; VOMITING; NAUSEA; FEVER; This spontaneous report received from a parent concerned an 18 year old male. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced body ache. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced nausea. On 05-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, nausea, and fever on 06-JUN-2021. This report was non-serious.

Nausea, vomiting, dizziness, pale color, low heart rate and blood pressure Tx: cold packs, laying pt down

CHILLS; HEADACHES; FEVER; FATIGUE; BODY ACHES; LOSS OF APPETITE; SORE ARM; This spontaneous report received from a parent concerned an 18 year old male. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced body aches. On 13-JUN-2021, the subject experienced loss of appetite. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced headaches. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of chills, fever, headaches, body aches, loss of appetite and fatigue was not reported. This report was non-serious.

Approximately 2-3 minutes after vaccine administration patient began having a seizure (convulsing/uncontrolled movements, random eye movements, unresponsive but conscious) in observation area chair. The paramedics were called immediately. The seizure lasted about a minute. The father was insistent that he get up and walk around. After 2-3 minutes he returned to his seat. Pharmacist attempted to take blood pressure reading. During blood pressure check the patient complained of fatigue and nausea and then began having another seizure. This also lasted about 1 minute. About 2 minutes later the paramedics arrived and took patient to ER.

Patient had slight queasiness/stomach discomfort and slight blurry vision before administration of vaccine. Both intensified within a couple minutes after vaccination, and 5 minutes after administration patient fainted/lost consciousness. He regained consciousness 10 seconds later and was ambulatory afterwards. Patient exhibited no difficulty of breath or cognitive impairment. Pharmacist had patient sit and drink water for a half-hour afterwards with observation. Patient left store on own ability and left afterwards.

In order in which they occurred: Fatigue, chills, fever, body aches, headache, and vomiting. Treatment included cooling packs and ibuprofen, and when I was finally able to sleep I woke up with just exhaustion the next day.

My son said his arm hurt badly, he then said he needed to go to the bathroom because he needed to vomit. Then he asked for water, then oxygen and then he said he was going to pass out. He reached for my hand and then he was ?gone? like the nurses surrounding us said. He was unconscious, his eyes were open but he wouldn?t speak and he wasn?t there, not breathing no pulse. They came and took his pulse and it was very low, if I can recall correctly it was 94? over 54? ?they brought him back with an ice pack on his neck, shoulders and lifting his legs. He explained afterwards he felt like a weird sensation in his arm, the. It went up his brain, like electricity? ?and then went towards his ears and that?s when he said he can?t remember, started dreaming everything was black and came back to me saying: ?no, wake up? ? Wake come now??and he realized he had indeed passed out. They said it was common for young healthy boys to have this side effect, faint. I still feel I need to report this. It scared the life out of me, he was gone for seconds, seemed way too long!!!

A few minutes after injection the patient reported feeling nauseous. Had patient sit back down where he then passed out. Checked for pulse and breathing asked patient if he could respond to me. Within 15 second patient was able to respond to me. After about a minute patient color came back and was able to open eyes and look at me. Patient then complained of not be able to feel his hands and feet which feeling came back after a few minutes. However patient still complained of feeling pins and needles in his fingers. After 20 to 30 minutes patient reported feeling ok and was released under parents care.

2 mins after receiving the vaccine he became dizzy and nauseous. Then later loss conscious, hands were clenched and was unresponsive for 45 seconds. Fever and slight headache currently.

I woke up very nauseous and woozy. I walked into my sisters room and fell down due to weakness. Expericed the following: Fever - 101.2, Chills, Nauseau, Sore Throat , Soreness, Acid Reflux, Headache. Went to the ER because the soreness of my throat was extreme and did not fit the normal side effects. The outcome was to take Tylenol for the fever and headache. To follow up with doctor.

Pt reported history of anxiety with needles prior to vaccine administration. Pt reported nausea, dizziness and headache about 5 minutes after receiving the vaccine. He was visibly sweating on exam. Ice packs were given (forehead/neck); initial BP was 152/92mmHg. pt was observed for an additional 10 minutes after moving into his air conditioned car; his repeat BP was 124/86mmHg. Pt reported feeling better and cooler prior to being released.

Patient said he couldn't hear. He felt dizzy, nauseas, and was sweating. Blood pressure was taken it was low. Gave patient water to drink. Took blood pressure repeatedly. Gave patient something to eat (said he hadn't eaten & that could be cause of nausea). Patient's blood pressure went back up to normal. Patient felt fine before he left. I had patient sit longer than the 15 minutes, it was at least 30 minutes.

Patient immediately reported the shot hurt more than usual shot and that he was feeling dizzy (he described it as "the spins"). He stated getting warm to the touch and started sweating profusely. About 4-5 minutes after the shot he said he was nauseous. About a minute later he threw up. He said that throwing up helped a little. RPh asked if he wanted some orange juice. He said he did and he took a few sips. He continued to feel warm to the touch and was sweating quite a bit. He also was quite pale. RPh continued to monitor him, providing cool compresses to forehead and back of neck and continued to have him sip on orange juice (drank about 20 ounces aver 30 minutes). He reported feeling better at 10:45am (about 30 minutes after shot.) RPh kept him for observation for another 15 minutes at which time he felt good enough to go home. Girlfriend drove him home. RPh called to check on patient at 6pm. Girlfriend reported he was doing ok and hadn't had any other reactions. He had just been sleeping all day.

Patient received J&J COVID 19 vaccine and proceeded to waiting area for required 15 minutes with his family. After a couple minutes, he starting getting dizzy, pale, nauseated and lost consciousness briefly. 911 was called and patient was transported to a hospital due to low blood pressure.

Temperature of 103.6 - Vomiting, Lower abdomen pain, Cold Sore outbreak on 7/27 at eyes, nose, mouth Complaint of ear ache. Cold sore eruption increase to around both eyes, under nose, bottom lip. Bottom lip swollen, eyes puffy

Patient presented about 5 minutes post vaccination with dizziness and nausea. Patient maintained consciousness and did vomit slightly. After about 15 minutes the patient did feel better and left the pharmacy.

Headache presented soon after dose. Tiredness presented soon after dose. Headache worsened through night. 99.9° fever presented ~8 hours after vaccine. Intermittent coughing presented ~10 hours after vaccine. 103.5° fever presented ~10 hours after vaccine. Intense chills presented ~10 hours after vaccine. Nausea presented ~12 hours after vaccine.

Pt states taking Johnson at Johnson vaccine at 1000 with headache x5 hours with chills/sweating, with N and being light headed starting 1600. Denies taking medication.

19 y/o M AD USMC with Hx G6PD Def was brought in by ambulance with complaints of abdomen discomfort, chills, fever, dysphagia/dysphasia, nausea and headaches following administration of Janssen vaccine 7-8 hours prior. Evaluation significant for edema/inflammation of the oropharynx, abdomen tenderness, down-trending BP, fever (>102 F), tachycardia (>115), despite the fluid resuscitation IV, Epinephrine, steriods, Antipyretic and diphenhydramine. Vital signs and symptoms significantly improved 2.5 hours into the treatment. Over the evening care, member had a unremarkable observation. Vital signs maintained stable in the morning and he was discharged with appropriate therapies and follow up instructions.

INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. 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 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen. On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115. Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.

Patient reported running a fever last night after getting vaccinated yesterday afternoon. She did not have any rashes on her face till she threw up this afternoon and then she stated that she had rashes all over her face and it was itchy. I advised her to take some antihistamine and she had cetirizine 10mg at home and she took one tablet. And then I advised her to go to the ER.

Janssen COVID-19 Vaccine EUA Dry throat and dry cough. Painful cough. Discomfort eating and drinking. Drinking lots of water and using a humidifier has not helped. First started experiencing around 8:00 AM, and has been ongoing sicne.

Fatigue, headache, nausea, muscle aches, fever, cold sweats; all symptoms lasted from 6pm on day of injection until Sunday morning

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Mild, Additional Details: na

Almost immediately after Johnson & Johnson Covid Vaccine was injected into patient, he passed ouit. He was in chair and his head went backwards with his eyes rolling back. called for help and I responded. Patient was coming to but proceeded to pass out 2 more times. Epi Pen was ready to inject if needed, but did not appear to be an allergic reaction. 911 and a code white were called. Blood pressure was taken and was low. Patient was warm and clamy. Ice was placed on his neck. Paramedics arrived and checked his vitals. Blood pressure had come back up. Pulse ox 99. blood sugar was normal. Paramedics told patient to hydrate and eat. Water was given to patient after paramedics cleared it. Patient eating in store and then checking in with Pharmacist. Patient will be called tonight at closing time.

headache,hard breath. patient c/o chills, headache when waking this morning. states recieved the J&J covid vaccine yesterday. denies N/V/D. HPI:19-year-old male with chief complaint of headache nausea and body aches. Symptoms started this morning. He received his J&J vaccine yesterday. He has not taken anything for the symptoms. He denies any vomiting and nausea is improving.

The patient experienced syncope, diaphoresis, nausea and vomiting. The patient was able to recover within 45 minutes and leave under his own power. The patient was coherent and not in any noted distress.

Patient called the day after recieving his vaccine reporting vomiting. He states that the evening after receiving his vaccine he started to feel like he was being "placed under laughing gas" then around 12 am experienced stomach pain and felt nauseous but did not throw up until 1am. Spoke with him at 1130 the day after receiving his vaccine and he feels "off" and has a headache but is no longer vomiting

Patient felt diaphoretic, nauseous and dizzy. States that felt side effects right after side effects. Vital signs taken and observed, vital signs stable throughout, placed supine, given juice. Patient left clinic after 30 minutes, no concerns.

Extreme fatigue, body aches / pains, severe headache, slight fever, nausea. Became noticeable around 10 hours after vaccine. 24 hours later symptoms mostly gone. After taking advil symptoms alleviated.

Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was feeling light headed when his girlfriend called me over. The patient explained that he was dizzy and may pass out. He lost conciousness for approvimately 10 seconds. He came to and we laid him on the floor where the Pharmacist monitored him. He felt better and leftm here feeling fine.

Dizziness, Nausea, chills, heat flashes, heart beat surged, felt like I was going to pass out. Constant coughing, and weak in the body.

Janssen COVID-19 Vaccine, arms and legs were fully numb and cold, chest and back were hot, fever, headache, could not look to the edge of my vision, could not hold down food or water, intense pain in the lower back, bad balance, chills, aches,.

On the day of the vaccine injection, I experienced a headache and muscle soreness. The next morning, I had a persisting headache, hot flashes, loss of appetite, and muscle ache.

Light fever, diarrhea, body aches, back pain, chest pain, headache, chills, vivid dreams, Lasted for 48 hours

7 days after receiving J & J vaccine, patient developed a severe headache at approximately 1am. He had periods of time that he couldn't recall. He experienced vertigo as well as nausea. He tried to text and it came out as a jumble of misspelled words and letters. He called me, his mother, and he was extremely hard to understand and couldn't say a complete sentence without using words that made no sense. Him being in college I was 1.5 hours away. We were able to contact a friend of his and she was able to go to his dorm room and they called the campus on call nurse line. After speaking with her she instructed them to call 911 because she thought he could possibly be having a stroke. Patient was transported by ambulance to ER.

Patient received Janssen Covid vaccine. He then becam diaphoretic, dizzy and nauseous. Patient went to restroom and was found sitting on the floor.

I woke up around 1 am so sick that I could not sleep. My head was throbbing with every single heart beat. I had a fever of 102 and was constantly switching between chills and sweating through my sheets. The room felt like it was spinning and I felt like I was going to puke. Lastly I started to get chest pain which was by far the most concerning part to me. I still have a headache and chills but the fever is gone, and I am recovering

Chills beginning approximately 9pm; fever and vomiting by approximately 12:30 am of the 8th of April, with vomiting continuing at approximately 1 1/2 hr intervals through till approximately 7:30 am. Was given water to sip while awake. Would sleep between vomiting. Still feverish until late morning (was given 500mg acetaminophen when vomiting seem to stop) During the night, he said that he felt like his heart was pounding. By late morning, he did begin to feel and look better. Sore arm continued from evening of shot til 11th of April

STOMACH PAIN AND VOMITING ON 4/15/21. POST VOMITING STOMACH FELT BETTER CHILLS AND WEAKNESS DAY AFTER VACCINE. RECOMMENDED TYLENOL/IBUPROFEN FOR PAIN OR FEVER AND HYDRATION.

About 5pm after the vaccine I developed a cramp in my left leg, felt really tired and the fever began. About 10pm the symptoms got worse so I took nyquil because I was feeling horrible. My fever elevted to 101 causing me to have a seizure. EMT transported me to the ER about 12midnight and I was given meds for nausea, pain and monitored and about 3:30am I was released. The next day I was really tired, fatigued and had a really bad headache but by that Wed all symptoms had subsided.

Vomiting x 2 days with decreased PO intake x 3 days after receiving J&J vaccine on 12Apr21; denies any blood in vomit/abd pain/diarrhea at this time. 1 episode vomiting today, reports comes on right after eating

WOKE UP SWEATING; BODY SORENESS; CHILLS; HEADACHE; FEVER; THREW UP ABOUT EIGHT TIMES; TROUBLE BREATHING; This spontaneous report received from a parent concerned a 19 year old male. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced threw up about eight times. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced body soreness. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced woke up sweating. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up about eight times, trouble breathing, chills, and fever on 11-APR-2021, and woke up sweating on 12-APR-2021, was recovering from body soreness, and had not recovered from headache. This report was non-serious.

DIZZINESS; FEELS LIKE GOING TO PASS OUT; LEG WEAKNESS; QUEASINESS; HEADACHE; NAUSEA; FEVER; CHILLS; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid 19 positive test in November 2020. 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 07-APR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feels like going to pass out. On 09-APR-2021, the subject experienced leg weakness. On 09-APR-2021, the subject experienced queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, chills, nausea, fever, and headache on 08-APR-2021, and had not recovered from dizziness, leg weakness, queasiness, and feels like going to pass out. This report was non-serious.

ABDOMINAL PAIN; HEADACHE; FEVER; CHILLS; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 115 pounds, and height was 64 inches. The patient's concurrent conditions included non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on APR-2021, and had not recovered from abdominal pain. This report was non-serious.

HEADACHE; FATIGUE; NAUSEA; FEVER OF 102F; TERRIBLE MUSCLE ACHES; This spontaneous report received from a consumer concerned a 19 year old male. 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: 41A21A, and batch number: 41A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 18:30, the subject experienced headache. On 09-APR-2021 18:30, the subject experienced fatigue. On 09-APR-2021 18:30, the subject experienced nausea. On 09-APR-2021 18:30, the subject experienced fever of 102f. On 09-APR-2021 18:30, the subject experienced terrible muscle aches. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fatigue, nausea, fever of 102f, and terrible muscle aches on 11-APR-2021 09:00. This report was non-serious.

Patient's neighbor called pharmacy sunday 5/2 at 4:30 pm stating he is experiencing fever, chills, nausea/vomiting. Advised for him to drink fluids to keep hydrated when able, take Tylenol. Patient does not have a regular doctor, advised to go to ER if symptoms continue to worsen.

FLU-LIKE SYMPTOMS; PAIN IN ARM; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-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: diclofenac sodium. On 09-APR-2021, the subject experienced flu-like symptoms. On 09-APR-2021, the subject experienced pain in arm. On 09-APR-2021, the subject experienced nausea. 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 pain in arm, and the outcome of nausea, headache and flu-like symptoms was not reported. This report was non-serious.

Severe arm pain/low swelling in arm area. Nausea. Pain near liver area. General fatigue. Mental cloudiness. Random bouts of tinnitus in both ears, switching off, never both ears at once. The arm pain and swelling in shot area lasted about two days, but the nausea, ;over pain, and fatigue continued for the better part of 4 days after the shot. The tinnitus only happened a couple times about 1-3 hours after the vaccination then ceased. I did not get this verified by a doctor, but I suspect my liver pain was related to an inflammation in the liver associated with the vaccine, as in the past, pain around my liver area has been associated with inflammation of my liver during minor flare ups.

Client received vaccine through a drive through clinic. He was in passenger side of car. His mother was driver. Immediately after receiving the J&J vaccine he reported pain in his arm after vaccination and then he developed nausea and dizziness . No syncope noted. Immediately upon start of symptoms, a EMT was on site and assessed client. He was provided with water and his symptoms resolved within 10 minutes of start of symptoms. Client stayed for his 15 minute observation time and was able to leave after the 15 minutes with his mother.

PATIENT'S MOM INFORMED US THAT PATIENT WAS "SCARED OF NEEDLES". PATIENT APPEARED CALM IN VACCINATION OFFICE AND DID WELL WHILE VACCINE WAS BEING ADMINISTERED. PATIENT SAID HE FELT GOOD, STOOD UP WITH NO ISSUES, AND WALKED TO OBSERVATION AREA TO TAKE A SEAT. FIVE OR SIX MINUTES ELAPSED AND I WAS CALLED OVER WHEN PATIENT WAS "GOING DOWN". I RAN OVER AND NOTICED THE PATIENT PALE, COLD, WITH CLAMMY SKIN. HIS EYES WERE ROLLING INTO THE BACK OF HIS HEAD AND HE WAS BARELY RESPONDING TO HIS NAME. PATIENT'S MOM WAS CALLING HIS NAME AND I RAN TO GET THE BP CUFF. COULD NOT GET A PULSE OR BP ON PATIENT, CALLED 911. PATIENT WAS RESPONSIVE BUT BARELY. PATIENT RESTED, SITTING, WITH ARMS ON TOP OF A GARBAGE PAIL BECAUSE THE THOUGHT HE WAS GOING TO VOMIT. MOM TOLD US THIS HAS HAPPENED TO HIM IN THE PAST WITH OTHER VACCINES. HE HAS "VACCINE ANXIETY". THE PATIENT WAS TAKEN ON A GURNEY BY EMS, WAS AWAKE AND RESPONSIVE. EMS TOOK CARE OF HIM IN PARKING LOT IN AMBULANCE AND WE SAW PATIENT HEAD HOME IN CAR WITH MOM.

pt fainted approx 2 minutes after vaccination while sitting in waiting area. 911 was called. Pt was placed supine and was unconscious for approx 60 seconds with involuntary movements of arms and upper body consistent to passing out (not seizure like in intensity). confused, clamy/nauseas upon awakening, remained supine for 2-3 minutes. upon sitting up pt became dizzy and laid down again. paramedics arrived began assessment. BP, EKG, BG all normal. pt reports not having eaten today, also reports congenital heart defect that was corrected surgically while an infant. Mother arrived and decision was made in conjunction with paramedics to take pt to hospital for further eval based on his symptoms of lightheadedness/nausea continuing.

19 year old male who presented to Medical Center with presumed syncope leading to an MVA. He was the restrained driver of a car that was involved in a rollover. He was admitted to the trauma service, had trauma and syncope workup initiated. Pt has had 2 prior episodes of syncope, once when seeing blood and the other after smelling a noxious odor, suspect vasovagal syncope. Pt reports not feeling well since receiving covid vaccine on 5/4, and had vomited x 2 the morning of the accident. Trauma evaluation revealed nasal bone fracture, remained of imaging negative. He will follow up with the trauma facial surgeon next week

After receiving vaccine, pt had vasovagal event and "fell out of" open car door, waking on ground. Intermittent vomiting x 30 min.

Fever of 101 started approximately 24 hours after injection. Severe nausea and vomiting starting approximately 96 hours after injection. Fever of 101 faded 10 days after injection.

pt received JJ vaccine yesterday, chills, bodyaches, fatigue, nausea, denies vomiting/dirahea, pt reports HA 9/10 frontal pressure, pt took tylenol 0400 with some relief

high fever- 102, tightness in chest, headache, cold & sweaty, tingling feeling, loss of appetite. He took 2 ibuprofen, was able to sleep through the night and felt much better the next day. 2 days later he felt like himself again.

NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.

Patient informed me prior to receiving vaccine that he gets nervous about shots and does not want to see the needle. After I administered the vaccine the patient was fine he started to feel nauseous and had to use the bathroom. Upon returning patient was given some watered and allowed to breath without his mask on. After sitting the 15 minute observation period patient was fine. He was just anxious and nervous. His father was with him. Patient was fine upon leaving the pharmacy.

ALMOST PASSED OUT; SKIN LOOKED WHITE AND PALE; MILD PAIN IN STOMACH; LEG HURTS; CHILLS (FEELING COLD AND SHIVERING); FEELING UNWELL; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed, and other pre-existing medical conditions included patient had no other health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced almost passed out. On 02-JUN-2021, the subject experienced skin looked and pale. On 02-JUN-2021, the subject experienced mild pain in stomach. On 02-JUN-2021, the subject experienced leg hurts. On 02-JUN-2021, the subject experienced chills (feeling cold and shivering). On 02-JUN-2021, the subject experienced feeling unwell. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low platelet count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from almost passed out, had not recovered from skin looked white and pale, leg hurts, and chills (feeling cold and shivering), and the outcome of mild pain in stomach and feeling unwell 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.

numbness/tingling in lower legs, fatigue, severe headache, eye pressure pain, nausea, hot/cold chills, low back and leg pain

CAN BARELY WALK; WEAKNESS; FELT LIKE THROWING UP; HEADACHE; BACK STARTED TO HURT (TERRIBLE PAIN IN LOWER BACK); SORE ARM; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 175 pounds, and height was 66 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies and 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: 1820095 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced back started to hurt (terrible pain in lower back). On 03-JUN-2021, the subject experienced weakness. On 03-JUN-2021, the subject experienced felt like throwing up. On 03-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced can barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from felt like throwing up, weakness, and back started to hurt (terrible pain in lower back), and the outcome of can barely walk was not reported. This report was non-serious.

Arm started aching shortly after vaccination, nausea. Loss of consciousness, diaphoretic. Moved to stretcher by staff- taken to medical screening for eval. Paramedic; Fire Dept. Recorded Lying B.P. 119/73 Pulse 63 SPO2=99% @15:14 B.P=107/58 HR:48 @15:17 Standing : B.P=127/72 HR=74 SPO2: 95

Severe headache, starting in the day of injection and continuing each day after injection; fever and vomiting on day 5 after injection; an episode of shortness of breath on Day 5.

19-year-old male presenting for evaluation due to ongoing nausea and vomiting. Patient says he has had vomiting for approximately 4 days. Admits to daily marijuana use secondary to IBS. He states that he was in the emergency department yesterday and told that he has a acute viral infection. States that he struggled to keep food or liquid down even after discharge home. Patient denies other illicit substance abuse. Patient discharged with ondansetron. Of note, patient Qtc >600ms before discharge.

On 7/06/21 patient received his first dose Janssen vaccine (LOT#: 207A21A EXP: 8/07/21) at 1332. Patient alerted EMT's at 1345. Patient stated that he felt nauseous, hot and sweaty. Patient was not responsive to verbal or physical stimuli for approximately 5 seconds at 1349. Patient gained consciousness quickly at 1350. EMT took patients vital signs at 1350. BP: 118/72, pulse: 46, O2: 99%. At 1352 patient stated that he was feeling better. Patient was moved to anti-gravity chair at 1352 by EMT's. EMT retook patients vital signs and reassessed patient at 1353. BP: 110/60, HR: 51, O2: 99%. Patient stated that he had eaten breakfast in the morning. Patient stated that he has no allergies. PHN offered patient EMS. Patient denied EMS at 1353. EMT reassessed and retook patient vitals signs at 1357. BP:116/60, HR: 61, O2: 98%. Patient stated that he no longer felt lightheaded, dizzy or nauseous. EMT reassessed and retook patient vital signs at 1402. BP: 110/66, HR: 51, O2: 99%. Patient stated that he was feeling better. EMT reassessed and retook patient vital signs at 1410. BP:116/58, HR: 48, O2: 97%. EMT reassessed and retook patient vital signs at 1416. Patient stated he was feeling better and denied EMS for a second time. BP: 116/60, HR: 54, O2: 96%. Patient was educated by EMT of worsening signs and symptoms that would warrant a trip the emergency room/urgent care. Patient verbalized understanding of education. Patient left vaccination site with a steady gait at 1421.

Sudden vomiting. Was sitting down feeling normal one minute, next minute in the bathroom vomiting for about 15 minutes.

Patient was feeling dizzy and nauseous after receiving vaccine. He did vomit once. The patient was monitored and given water. After about 10minutes he felt better. He stated he hadn't eaten and was nervous which he said may be why he felt sick after getting vaccinated.

Patient expressed having anxiety to getting vaccines. A few minutes after administering the vaccine the patient reported feeling like he was going to faint. His vision got blurry and he stated that he couldn't see and that he was nauseous. He also said his hands were tingling. He sat in the pharmacy counseling room. He was given water and orange juice. After a few minutes he started to feel better. He called his mother to come and pick him up. He was in the store for about 40 minutes and his symptoms had resolved by the time he left.

PATIENT CAME IN WITH HIS MOTHER, I ADDRESSED ALL CONCERNS AND QUESTIONS REGARDING JANSSEN VACCINE AND ALLERGIES PATIENT HAD. MOTHER STATED THAT THEY DISCUSSED WITH PCP ABOUT ALLERGIES AND VACCINE OPTIONS, MOTHER STATED SHE HAS HIS EPIPEN ON THEM INCASE OF EMERGENCY. VACCINE WAS GIVEN TO PATIENT, HE SAT DOWN AND WITHIN 10 MINUTES OR SO PATIENT LOSS CONSCIOUSNESS, BEGAN DROOLING, AND COULD NOT BE WOKEN UP AFTER REPEATED ATTEMPTS. EPIPEN 0.3MG (IM) WAS ADMINISTERED TO THIGH AND PATIENT REGAINED CONSCIOUSNESS. 911 WAS CALLED AND PARAMEDICS ARRIVED WITH 5-10 MINUTES. PATIENT VOMITED TWICE, AND WAS SWEATING PROFUSELY. ONCE AWOKEN, HE WAS AWARE OF HIS SURROUNDINGS, WHO I WAS AND HIS MOTHER, APOLOGIZED FOR THE INCIDENT. MOTHER AND SON THEN LEFT WITH PARAMEDICS TO HOSPITAL.

severe headache, 102 degree fever, abdominal pain, leg pain and sharp chest pain that occurred over night and then again in the afternoon on July 23.

Patient had Adverse reaction to vaccine. Felt light headed- seems to have been brought on my anxiety. Had some sweating and nausea. Gave patient water and Benadryl and told him to sit and relax. Patient started feeling much better and left within the hour.

High fever, extreme shaking and chills, nausea. I was pretty much immobile from 11pm-3am (until I was able to fall asleep) on the day of vaccination (3/8/21). This happened immediately after I showered with hot water. The next day (3/9/21) until around 8pm I had a high fever, chills (not as bad but still pretty bad), headache, nausea, fatigue, and extreme muscle/joint pain particularly in my back and arms. I was unable to work, go to school, or do homework the entire day. After 8pm, I was down to a 100.4 fever and slight chills with mild nausea and fatigue. Today (3/10/21), I have mild muscle pain in my back and near the injection site. I took 400mg of ibuprofen every 6-8 hours from 3:00pm 3/8/21 (day of injection) to present with mild effects on pain and fever levels. I?m an infrequent user of ibuprofen. If I didn?t have someone with me the first night after the vaccination (3/8/21) I would have gone to the hospital.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.

Headache, muscle ache which lasted all night starting in earnest around 10 PM, shoulder ache began at around 8PM, spreading to the whole body at the aforementioned time, nausea started around 12AM. 2 Ibuprofen 200mg were taken for pain with little to no effect. The next morning I awoke with no symptoms.

vaccine reaction. Headache, bodyaches, nausea and fever since last night. Has not take any meds for those symptoms. Had a J&J vaccine yesterday. HPI:20-year-old male with chief complaint of vaccine reaction. he received his Johnson & Johnson coronavirus vaccine yesterday. He reports starting last night he began to have headache bodyache fevers chills and nausea.he could not sleep well due to the symptoms. He has not taken anything for the symptoms.

numbness in lt hand. PT received J&J COVAX yesterday, came to ER today for work note to miss work today. Pt reports nausea and malaise, numbness to L pinky finger and lateral portion of hand. No other numbness/paresthesias/weakness. 20 yo otherwise healthy m c/o acute onset of numbness/tingling to L 4th and 5th fingers <24hrs perceived onset s/p J&J covid shot in L arm yesterday; Pt denies any pain, fevers/ns/chills, redness/warmth/swelling of fingers or at imms site on L shoulder, prior hx of similar sx's

ED COURSE & MEDICAL DECISION MAKING Patient is a 20 y.o. male who presents emergency department for evaluation of fevers, chills, nausea, and shortness of breath. Symptoms occurred approximately 3 to 4 hours after his Covid vaccination today. He has not felt symptomatic for symptoms related to COVID-19 prior to his vaccination. Nausea was noted without vomiting and he was given Zofran prior to arrival. No objective evidence of anaphylaxis or angioedema was noted at urgent care nor was this noted on physical examination. He does have a fever on arrival with Tylenol taken a little more then an hour prior to arrival. Chest x-ray negative for findings of COVID-19. There was no evidence of pneumonia. His blood counts were otherwise reasonable though he did have relative lymphopenia that can be described in COVID-19 infection. Metabolic profile was otherwise benign. Differential diagnosis of his fever include the possibility of a vaccine reaction though the timing is rather quick for this reaction. Certainly this remains in his differential. His he has history of asthma and felt short of breath he was given Solu-Medrol. He was given Toradol with improvement of symptoms as well as IV fluid. With differential diagnostic considerations that he may have Covid, he was swabbed and tested at bedside. With his well appearance he was ambulatory in the emergency department. He was discharged stable condition with recommendations for Tylenol and ibuprofen in the short-term. Procedures MDM CHIEF COMPLAINT Fever and Chills HPI The history is provided by the patient, medical records and the EMS personnel. Patient is a 20 y.o. male who presents emergency department with fevers, nausea, and shortness of breath. He has generally not felt well over the course of the last 8 hours after receiving his first Covid vaccination this morning at 9 AM. Fevers have been noted. He took Tylenol with 2 tablets an hour prior to arrival. He has had shortness of breath with a history of asthma. He denies productive cough, or chest pain. He denies abdominal pain, or diarrhea. He denies dysuria or frequency or hematuria. Seasonal allergies are noted without significant medication allergies. He denies a sensation of throat closing. He denies tongue or lip swelling. He was seen in urgent care and sent to the emergency department for further evaluation.

Janseen-Covid 19- EUA Shortly after pt got Janseen vaccination he felt a sudden in onset of dizziness with possible syncopal episode. Pt states he has very poor intake decrease oral intake with increase of nicotine. pt states he has had this happen after getting a shot before. 911 was activated and ama signed with fire department.

Fever, Headaches, Shivers, Nausea, Fatigue. Fever started 8 hours after I received the vaccine and excruciating headaches followed. The night after I received the vaccine, I had long shivers and cold sweat. The next day, headaches continued alongside nausea and fatigue.

pt's mother called stating he went to hospital er for dehydration on friday was given iv fluids and zofran, nausea and vomiting continued and was brought back to hospital on sunday where he is now, ct scan done and awaiting gastro consult

Pt. passed out, diaphoretic and nauseated. Pt fell to floor hit left side of head. Pt given water and snack then recovered went home with mother

Patient reported feeling nauseated and went to bathroom, patient felt dizzy and appeared diaphoretic Patient found by staff and seen by medical team, vitals were stable, and patient stated symptoms improved and provided snack and water Patient refused medical transport and signed AMA form Patient driven home by grandmother

Started with headache, full body aches, then chills, nausea, loss of appetite, then 101.1°F fever (after taking 300mg Tylenol). Generally fatigue, depressed mood & irritation

Patient became lightheaded with blurred vision, pale, and nauseous within 5 minutes of administration of the vaccine. Called ambulence, EMT's performed vitals. Patient was given water to drink and refused transport to the hospital. Symptoms resolved between 30-45 minutes post vaccination.

Chills difficulty breathing loss of consciousness altered mental status fainting fever fatigue gastrointestinal pain

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Mild, Systemic: Weakness-Medium

COVID VACCINE BY JANSSEN LOT# 1808982 EXP JUNE 23/2021 IN ADDITION TO REGULAR SIDE EFFECTS - PAIN AT INJECTION SITE, FEELING UNWELL, HOT AND COLD CHILDS, TIRED, NAUSEA - THE PTNT ALSO HAS CHEST PAIN AND VOMITING. PHARMACIST ADVISED PTNT TO GO TO ER - PTNT WAS RELEASED UNCER FATHER CARE. ADVERSE EFFECTS AND SYMTPONS IMPROVED AND WERE GONE BY DAY 5.

Patient was waiting in chair about 5 minutes after the vaccine when I heard him say he didn't feel too good. His skin color was pale and when I went up to see how he was he bent over and vomited. After he vomited he said he felt a lot better. I asked him to remain seated and asked for my tech in the pharmacy to call 911, but he then said no and that he was feeling better. He said he felt clammy just before he vomited. I asked him to stay seated and got him some cold water. He remained in the waiting area another 15 minutes after to make sure no further problems. After 15 minutes he was feeling fine and I reassessed and his color returned to his skin and I noticed some redness around inner portion of both thighs, but he said that was from his eczema and that it was there already. Allowed him to leave at 1:15pm and told him to seek medical attention right away if he felt any issues regarding trouble breathing. I called him an hour later to check up on him at 1:30pm and he was feeling fine. He thanked me over the phone.

I got the shot on Friday, 4/9/2021 at about 930 am. I had a severe migraine the night of and severe body aching to where I was just laying in bed crying. Saturday, 4/10/2021 I felt okay. Sunday 4/11/2021 I felt perfect and thought I was okay. This morning, Monday 4/12/2021 I woke up at 4am in a puddle of sweat, and started puking at 530am. I puked at least every hour multiple times. My whole body felt as if it was vibrating, or falling asleep (the worst feeling I've ever had.)

It is now the next day, and I feel significantly better. I have pain at the injection site, some muscle fatigue, a little bit of a depleted appetite, tiredness in my eyes and head (likely due to lack of quality sleep), and a bit of sweating, but my pain has reduced to maybe a 2/10 or 1/10 (i.e., not even uncomfortable). I did end up getting decent sleep between 2 AM and 12 PM with only a few interruptions of family members checking on me. The only notable pain that is worrying me is abnormal soreness in my right wrist that is not the result of overuse, overextension, etc., although I was able to take care of that pain with another 3 Advil pills. I am considering scheduling a doctor's appointment, as I know the J&J vaccine got recalled today for blood clots. My assumption is that because I am a healthy 20-year-old, my immune system overreacted to the vaccine, but I want to check to make sure that it doesn't cause any additional health problems.

Pt was sitting in the waiting room approximately 5 minutes after receiving the vaccine, when he said "I'm not feeling well. I feel dizzy. I feel like I'm going to pass out". We assisted him to a room and he laid down flat. I also gave him an ice pack for his head. Pt also c/o nausea at this point. After 20 minutes, pt felt better and discharged from the clinic accompanied by his father.

Fever, Nausea, headache, muscle ache, fatigue all occurred about 12 hours after I received the vaccine. I took Tylenol and used an ice pack on my head to help the fever subside. After about 20 minutes I began to feel better and was able to then lay down and rest a little more comfortably.

Fri 4/9/2021- Immediately upon receipt of vaccine, reported prickliness of soft palate and ?heaviness in throat?. Was observed for ~ one hour due to these symptoms q 10 assessments of vital signs, all of which remained normal at each measurement (100/60, o2 sat 97-99%, RR 12/min, HR 66). Provided with water to drink. Later that day (fri 4/9) ? c/o of headache, tiredness, chills, low gr temp (100.5). No resp c/o. no body aches. Sat- 4/10- slept most of day. Drank fluids (water, soup), nml urine. Began advil 400 mg bid-tid. When awake, c/o Persistent headache, Sun 4/11- c/o persistent headache, now with pain behind his eyes, and photophobia. No blurred vision. Denied sinus pain, nasal d/c or any visual changes. Applied cold spoons to his eyes with minimal relief. No sinus, nasal, or visual c/o. Continued motrin 200 mg po bid-tid. Mon 4/12- vaccine symptoms abating, eating normally, still tired and with HA (unchanged) and eye pain (unchanged). Noted eye worse when looking t upper and lower extreme corners of visual fields. No sinus, nasal, or visual c/o, EOM intact but w/ pain when looking at superior and lateral fields (r&L). (said this optic complaint was true all along, but only at this point was able to describe it). Tues 4/13- Because of the unusualness of complaint and the "J&J Pause", patient given given 1 adult aspirin & evaluated by (optometrist). Exam (including dilation) Nml optometric exam ( normal visual fields, visual acuity, color vision, eye pressures (14 bilateral); normal range of extra ocular movements, though pain reproduced at the extreme corners of the visual field; normal vessels and discs; NO evidence of optic neuritis)

CHILLS; FEVER; HEADACHE; MUSCLE ACHE; NAUSEA; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from chills, headache, muscle ache, and nausea. This report was non-serious.

Pt reports chills, vomiting and SOB. Having muscle pain, dizziness and headache starting at 20:00 last night. Pt had Johnson and Johnson covid vaccine yesterday. APAP last at 0330 IBU last at 2200.

Janssen Covid 19 vaccine given at onsite employer vaccine clinic As documented on: 1025 client c/o bilateral itching upper arm and slight headache 5/10. Itchy and HA began after 15 min observation period. Denies SOB, no wheezing noted. no hives or rash noted. 1027 50mg of Benadryl administered for itching. BP 122/70 , HR 88 @ 1045 1058 142/72 RUA, HR 82. Continued to c/o itching, no hives or rash visible. Reports slight improvement in HA, rating 5/10 pain level. Reports slight drowsiness, A&Ox3. 1110 Continued intermittent itching. Reporting worsening HA 7/10 frontal area. states he is unsure if HA has worsened because he is thinking about not itching. Mild nausea reported. 1124 BP148/82 HR 86, Reports continued mild nausea, upper extremity itching. Patient went home at 1128am.

Pt's mother called, and stated that her son in autistic so she was calling on his behalf. She stated that her son has been experiencing some adverse reactions since receiving his Janssen Covid vaccine on 4/3/21. She states the the first three days he experienced sleepiness, pain, and flu like symptoms; which she treated with Tylenol. Over the course of the next couple of days the symptoms have gotten progressively worse, now including stomach pain, disorientation, body aches, and unusual behaviors. She states that the symptoms are intermitted, may stop for a day or two then returns. She states her son does not have a fever. She states that her son did not have a primary care physician and had not been seen regarding his condition yet. Instructed her to follow up with a doctor, urgent care, or emergency room since she described symptoms to be worsening.

I was throwing up all night and I felt sick for the entire day after my shot. I had very bad cold sweats as well

Shortness of breath, difficulty swallowing (current) Fever, joint pain, tiredness (former: ended on 4/25/21)

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Fainting / Unresponsive-Mild

patient c/o dizziness, nausea, chills, congestion. denies stomach pain. states recieved J&J vaccine this morning symptoms started after receiving shot.

SHORTNESS OF BREATH; NUMBNESS TO BOTH HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced nausea. On an unspecified date, the subject experienced shortness of breath, numbness to both hands, chills, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105.0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and the outcome of headache, nausea, numbness to both hands and shortness of breath was not reported. This report was non-serious.

PT presents with n/v/d and "Acid reflux" x 1 day with onset of rash to R hip and L ribs. reports itching to site of rash. received JJ vaccine x 2 days ago. denies taking any medication today.

Patient came to received his Covid-19 shot. After the shot, he was instructed to wait 15 minutes nearby for observation. The patient was standing up reading the EUA given to him, felt dizzy, and fell to the ground. This happened approximately 5 minutes after the shot. He was able to get up by himself and sit down to a chair, where he requested water. He proceeded to vomited as he was sitting down.

Fever of 102.4, chills, soreness at injection site, throwing up, nausea, head ache, uncontrollable shaking, stuffy nose.

PATIENT EXPERIENCED VASOVAGAL RESPONSE ~2 MINUTES AFTER VACCINATION. UNCONSCIOUS FOR 20 SECONDS. LETHARGIC AND VOMITING OCCURRED UPON WAKING. EMS WAS CALLED, CHECKED PULSE AND BLOOD PRESSURE. PROVIDED EMESIS BASIN AND COLD CLOTHS. AFTER EMS EVALUATION PATIENT WAS APPROPRIATELY RESPONDING AND LEFT WITH FAMILY.

PT states getting J/J vaccine on tuesday, states lightheadedness and nausea today with headache and fever yesterday. 20-year-old male who reported to the emergency room with symptoms consistent with resolving side effects of coronavirus vaccine and/or mild dehydration. Patient's nausea resolved after 4 mg of Zofran and he subjectively felt better after 1 L of normal saline hydration.

patient reports that he passed out before coming to ED, states felt nauseas. states received J&J vaccine yesterday, started having chills, nausea last night. denies V/D/fever.

slight abdominal discomfort x3 days ER 5/20/21 with admission appendectomy 5/21 /21 Right Bundle Branch Block on EKG (no prior ekg abnormalities)

Symptoms: Paleness, Nausea, Sweating, Lightheadedness, low blood pressure; orientation x3. Vitals: 10:25am - b/p 98/60, p 72, r 16 10:35am- b/p 108/70, p 72, r 18; 10: 40AM - B/P 108/72, P 64, R 18, NO PULSE OX available. Patient was noted to be hanging his head and pale 5 min after receiving the vaccine. Pt states this "happens all the time" when receiving immunizations and was expected. Father has similar reaction with blood draws and vaccines. Patient was placed on floor in supine position with feet elevated on chair. BP improved, color returned to face. Stated feeling dizzy, diaphoretic and nauseous. Pt given water to sip. Declined foot, had not eaten yet today. VSS, alert and oriented throughout eventually up in chair and then standing with no complaints. Discharged ambulatory from monitoring area accompanied by father. Encouraged to drink fluids liberally and avoid strenuous exercise/activity today. Disposition: Alert , color returned, subjectively states feeling fine, ambulated with steady gait. Discharged with dad.

Didn?t start noticing any possible symptoms unless later that night after receiving the vaccine. Around 930 pm I started experiencing a lot of nausea and what seems to be a migraine. Migraine lasted all through the night along with muscle spasm/aches in my hips and legs. Migraine and muscle aches carried into the following morning of 06/09/21. I have taken ibuprofen to help deal with the migraine and muscle aches.

got J&J vaccine yesterday around 0800. c/o nausea, chills, headache and bodyache per pt. Denies blurry vision or dizziness. Eating and drinking normally per pt. Last dose of Tylenol was 0800.

disorientation, light headedness, extensive soreness, severe shortness of breath, severe feebleness, tiredness, hallucinations, fever, chills, migraine, severe chest pain, loss of appetite, dehydration, minor physical exertion made me short of breath and have an elevated heartrate

got J&J vaccine yesterday around 0800. c/o nausea, chills, headache and bodyache per pt. Denies blurry vision or dizziness. Eating and drinking normally per pt. Last dose of Tylenol was 0800.

pt felt dizzy and vomited immediately after vaccine administered, no hives/itching or trouble breathing, no loss of consciousness, pt said this reaction happens after every vaccination they have ever had

Client reported feeling nauseous and lightheaded during the 15 minute waiting period after receiving his vaccine. Client's vital signs taken at 1530 and were BP 118/78, P 86, O2 98% and R 16. Client was given some water and animal crackers. Client was encouraged to drink fluids and stay hydrated. Client continued to report feeling "queezy" and lightheaded. Blood pressure was reassessed at 1605 and was 138/86. PHN encouraged client to rest and stay hydrated and if his symptoms did not improve or resolve he should be seen in the walk in or by a medical provider. Client verbalized understanding. Client left clinic with a friend who was giving him a ride. On 6/18/2021 at 1012 PHN placed call to client to see how client was feeling today. Call went straight to voicemail. PHN requested call back.

This spontaneous report received from a patient via a company representative concerned a 20 year old male. 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: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. 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 got lightheaded and dizzy 30 to 60 seconds after getting immunization. Blurred vision, pale, nausea. Had stay seated leaning back and gave OJ and water, observed for about 30 minutes. Pt walked away after rest and fluids.

10pm after taking the vaccine started getting headaches and nausea he was in alot of pain from the headaches. 911 was called After the he experienced diarrhea and swollen lymph nodes in his neck

Chills and fever that night, cold sweat, nausea, dizziness throughout night. Some muscle weakness. Fever of 102, likely was higher last night.

flu symptoms. Pt received Covid J&J vaccine at 0920. At 2100ish stared to have ha/blurry vision/body aches, cough, chills, nausea. History: pt received J&J COVID-19 vaccine this morning and after 2100 or so tonight, pt developed body ache, nausea, non-thunderclap headache, and cough, here for eval. Denies any symptoms prior to vaccination and went to the area once over the weekend in the past 2 weeks and no recent travel/COVID-19 hotspot visit, no sick contact, and denies also ear pain, sore throat, runny nose, SOB, focal abdominal pain, vomit/diarrhea, rash, prior co-morbidities, use of any meds.

palpitation. PT brought in by EMS for nausea and chest tightness starting an hour after the J/J shot at 1000. States taking tylenol this am but nothing recent. Pain is described as intermittent tightness to the center of chest without radiation. States intermittent shortness of breath. PT speaks in full and complete sentences. MDM: 21-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with moderate tachycardia and otherwise reassuring vitals. Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for sepsis or severe bacterial infection. No dry mucous membranes or tachycardia to suggest clinically significant dehydration. No exam findings to suggest strep, epiglottitis, RPA/PTA, or AOM. EKG nonischemic with no dysrhythmia, sinus tachycardia evident. Given Toradol, Zofran and IV fluid in the ER with improvement of symptoms and tachycardia. PO tolerant in ER. Plan for discharge with Tylenol/motrin PRN for fever/pain, and PCP follow-up. Discussed findings with patient/caregiver. Plan for discharge as above. Patient/caregiver verbalized understanding and agreement with plan. All questions were answered to satisfaction of patient/caregiver. Written and verbal discharge instructions were given to the patient, including strict ER return precautions. Patient was discharged in stable condition. Voice-recognition software was used in the documentation of this note and may contain minor grammatical errors/typos. CONSULTS: NA DIAGNOSIS: Vaccine reaction DISPOSITION: Discharge home acute intraabdo

headache,nausea. Headache, bodyache, nausea and chills since this morning. Had J&J shot yesterday. HPI:21-year-old male chief complaint of chills, headache fever and nausea. He reports symptoms started in the evening after getting his Johnson & Johnson coronavirus vaccine. He took Tylenol yesterday which helped but he has not taken anything today. 21-year-old male WITH CHIEF COMPLAINT OF FEVERS CHILLS AND HEADACHE. oN ARRIVAL PATIENT IS AFEBRILE nontoxic and in no acute distress. Heart regular rate and rhythm. Patient with no focal neurologic deficits. Plan to treat supportively vaccine reaction. Patient in agreement with plan.

Began symptoms almost 6 hours after receiving vaccine. Had a fever for 4-5 hours. Moderate nausea - could not eat anything to relieve the feeling. Mild dizziness. After sleeping through the night, woke with a terrible headache. Mild nausea and slight dizziness continued for hours, as of 5:30 PM on 3/25/21, still not feeling 100%.

fever. patient c/o fever, weakness, nausea that started today after recieving J&J vaccine. states took 800mg motrin prior to arrival. History: pt s/p J&J COVID-19 vaccine at noon today here with fever, chills, occipital/neck headache, body ache, transient bilateral upper arm paresthesia, since this evening, s/p 3 pills of ibuprofen at 2200, here for eval. Takes no other meds and denies vomit/diarrhea/rash, sick contact, recent visit to COVID-19 hotspot, or co-morbidities in the past.

Experienced soreness at injection site, body aches, fever, headache, and nausea. By the next day all symptoms were gone besides soreness at injection site

Immediately upon vaccination patient described feeling 'light headed,' patient was encouraged to remain seated and put his head between legs. After approx 1 minute patient leaned to his right side, so we decided to place him on the floor. Patient alternated between supine and right side. Patient reported feeling nauseas, so he was given an emesis bag. No vomiting occurred, but there was a fair amount of sputum he expelled. He denied any shortness of breath, heart palpitations, or chest tightness. 911 was called after the patient's mother requested we do so. EMS responders evaluated patient, and by the time they were done evaluating (approx 30min later) patient was sitting and talking without any further symptoms/complaints. Patient was offered transport for further evaluation via EMS, both patient and his mother declined. Patient stayed at pharmacy for several minutes (approx 15) after EMS left.

Fever at 1100pm 3/31/21, muscle soreness from the start of injection, a little nauseous around 1100pm 3/31/21.

Over the last 36 hours: 102.8 degree fever, nausea, repeated vomiting, chills, body aches, other severe flu like symptoms.

Client experienced less than 5 second syncopal episode within 5 minutes of vaccination. Client reported lightheadedness, nausea, and was visibly diaphoretic. Staff helped client down to a crash mat and elevated legs. Client remained conscious and responsive, but continued feeling dizzy, nausea, and persistent shivering. Paramedics contacted, evaluated and client moved to ambulance for remainder of monitoring period. Client recovered.

Fever 3pm- overnight Fatigue/aches, etc Some nausea after eating miso soup Next morning all good, fever and fatigue again around 3pm

bodyache,headache,sore throat. PT states getting the J/J vaccine at 1300 yesterday with body ache, fever, sore throat, and headache starting at 1900, states taking tylenol (500mg) at 1900 with no relief. HISTORY OF PRESENT ILLNESS: 21 yo M p/w fatigue, body aches, subjective fever, sore throat, headache nausea after receiving J&J COVAX yesterday at 1300. Acute onset of symptoms, constant, mild muscle aches. Nausea without vomiting. Denies recent illness, cough, vision changes, chest pain, dyspnea, weakness/numbness.

bodyache,fever,chills. PT states getting J/J vaccine this am with fever, chills, and body ache starting afterwards. HISTORY OF PRESENT ILLNESS: 21 yo M p/w fatigue, body aches, subjective fever, nausea after receiving J&J COVAX earlier today. Acute onset of symptoms, constant, mild muscle aches. Nausea without vomiting. Denies recent illness, headache, vision changes, chest pain, dyspnea, weakness/numbness. MDM: 21 yo M presents with vaccine reaction. Stable on arrival, afebrile with reassuring vitals. Patient well-appearing on exam with no respiratory difficulty or other exam abnormalities. Given tylenol/toradol/zofran/IV fluids with improvement of symptoms. Plan for discharge with tylenol/motrin/zofran, and primary care follow-up in 7-10 days. Discussed findings with patient/caregiver. Plan for discharge as above. Patient/caregiver verbalized understanding and agreement with plan. All questions were answered to satisfaction of patient/caregiver. Written and verbal discharge instructions were given to the patient, including strict ER return precautions. Patient was discharged in stable condition

The patient began experiencing nausea and light-headedness around 11:00 P.M. on the 6th of April. Three hours later, he reported lower back pain that steadily increased in severity over the course of several hours. Throughout that same night, severe headaches and impaired kidney capacity (i.e. constant need to urinate about every hour) kept him from sleeping longer than two or three hours. Come morning of the 7th (roughly 8:30 A.M.), he took a single capsule of ibuprofen and performed various lower back stretches in addition to walking around the house. During this time, he experienced a gradual decrease in symptoms and was able to eat a small meal. The patient returned to bed two hours after taking the medication and slept without any further interruptions.

Within fifteen seconds after injection, patient became very diaphoretic and stated he was very hot. Full body sweating, along with chills, mild body ache, and abdominal pain. Patient given water to drink and vital signs measured. Pt moved to a cooler environment and was given relaxation techniques.. After five minutes of deep breathing sweating stopped, abdominal pain resolved, and patient was able to walk to the observation section of the clinic. D/C'd home to self care. Given further instructions in the event symptoms returned.

At 2 am 4/8/2021 started with mild headache, went to bed. At 3 am headache was migraine strength and was having full body aches (except for arms), extreme lower back and lower abdominal pain (he said it must be like what women experience in labor or during their menstrual cycle). He got up and took temperature (normal) and blood ox (100 %SpO2 on two fingers). He got a wet rag for eyes and tried to fall asleep. He said he felt hot with cover on and cold with cover off. At 5:50 am his father gave him two Motrin (400mg total), applesauce and a ice pack for his head and back. I checked on him thru-out day and he seemed restless. He woke up at 3 pm on 4/8/2021 said headache and major back pain/abdominal pains were gone. He still feels slightly achy, but fine otherwise. as of 8:24 pm.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Syncope, light head, blurry vision.

vaccine reaction,headache,chills. PT presents with bodyaches, chills and HA x 0200. reports nausea denies vomiting and diarrhea. received JJ vaccine yesterday.

5 minutes post vaccination client had vision changes, lightheadedness, mild nausea, sweating. Symptoms resolved after 10 minutes. Client's treatment was elevating legs, applying cold packs to neck and staying close to client and not allowing client to leave until he was 100% normal per client's report of normal.

Patient felt light-headed, sweaty and nauseous. Gave him a cold compress to the face. Sat for 15-20 minutes and felt better after a while and left the store.

fever 102.9 bilateral arm pain severe lower right abdominal pain feels unwell IV hidration, advil, tylenol, ultrasound abdominal, CT scan, were given. Patient is better except for continued temperature of 100.4 in the evenings.

Low grade fever, restlessness all over (jittery), feeling cold/chills, body aches (especially lower back), stomachache, loss of appetite, headache.

He started feeling funny, his pulse starting racing, the vein in his right arm (the shot arm) started pulsing rapidly. He then had chills, fever of 101.2. His pulse stayed at 95-100 beats per minute for 2 hours. I spoke to a nurse friend of mine who told me to give him Tylenol and Benadryl. His pulse went down to 80 beats per minute. His fever went higher during the night but eventually broke. Next morning he was still running a low grade fever and took Tylenol the rest of day. He also had diarrhea on 2nd day and exhaustion. 3rd day feeling better but still tired. No fever or diarrhea today.

1. Vasovagal syncope almost immediately after vaccination, little to no warning of oncoming syncope 2. Extremely fast acting fever (temperature went from 98.6 to 100.5 in roughly 30 minutes) followed by nausea, pounding headache, and body aches/chills. Remedied by alternating very high doses of ibuprofen (800mg) and acetaminophen (1000mg or 1g) every two to three hours. This did not ever bring down the fever below 100 degrees. 3. Blurred vision around 29 hours after vaccine - advised to go to ER by triage nurse. ER doctor determined not to worry about, likely due to headache but not 100% sure.

Minutes after receiving the vaccine, the patient started feeling dizzy and had blurred vision. He also started vomiting after drinking water. The patient recovered quickly after the arrival of the EMS and didn't require any medical assistance.

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.

Janssen COVID-19 Vaccine EUA Following the shot was the expected soreness. Then pain throughout my arms like pins and needles began about 8 hours later. I self treated with Tylenol. After going to bed, I woke at 5am nauseous and in pain. I was freezing even though I would normally be fine. I was shaking which made the pain in all of my limbs and back hurt more. The day following the injection, the pain and nausea didn't go away. It hurt to pick up and hold things. It is now two days after injection and I keep fighting nausea after eating. I keep stretching and it barely keeps the soreness in my arm at bay. I can feel my hands starting to cramp just from typing this even though I would normally be fine.

Chills, nausea, intense headache, 39.45 Celsius fever, it started at 4 and didn?t go away until I took ibuprofen at 10pm and eventually fell as sleep at 11

Approximately 8 hours after the administration of the vaccine, patient began to experience aching muscles. Overnight, patient experienced fever, chills, aches, and persistent vomiting. The following day, patient continued to experience aches, tiredness, and chills. Symptoms resolved approximately 48 hours post-vaccine. Patient states they have never felt so terrible in their life and will not be getting additional covid-19 booster shots, etc.

4/8/21: Vaccine Received - 6:oopm By 9:00pm, patient begins suffering from intense headache, hearing loss in both ears, and blurred vision. For the ears, it was as if someone had taken ear plugs and coated the ear drum with them, making it hard to hear. Headache was treated with an ice pack on the temple for immediate site relief. Began to feel tired and worn out while in bed, loss of vision begins to occur as well. Body aches begin. 4/9/21: Patient is woken up from intense body spams throughout the entire body. Once awake, the entire body was spasming, causing the patient to be unable to control his body, and all extremities. After sipping some water for about an hour, the spasms subsided in all areas of the body except for the legs and shoulders. 4:00pm patient begins to feel extremely nauseous, begins having increased bowel movements including rapid diarrhea, and extreme stomach cramping. Deep body aches and pain continue. 4/10/21: 10am: patients body begins to become covered in hives all across his skin, inside his mouth, under his feet, and in his hair. Hives continued to grow, with no reddening of the skin however. This was treated with Benadryl for the remainder of the day; hives subsiding around 6:15pm. Dehydration also occurred, and hospital treatment for IV saline bag was soon to be utilized had the patient not been able to rehydrate himself. Body aches continue

The adverse events that occurred after this vaccination include the following: Severe headache, vision issues (i.e., loss of clarity, focus), muscle aches/cramps, chills, stomach/abdominal discomfort, upset stomach, loss of taste, loss of smell, sore throat, swelling of lymph nodes (underarms, groin region, and behind the ears), tiredness / loss of energy, and nasal congestion. The most adverse event, a headache, led to some dizziness, loss of clarity/focus (vision), and pain behind the eyes. The only treatment taken to lessen the severity of these events were acetaminophen and ibuprofen. The adverse events still occurring today are (as of now 04/14) include: stomach discomfort, muscle aches/pains, and discomfort under the arms (armpit area) near lymph nodes.

24 HOURS AFTER THE VACCINE HE BEGAN HAVING HIGH FEVER, AND VOMITING. HIS FEVERS BECAME HIGH TO 103.7, HAD DIFFICULTY BREATHING, PRESENTED TO THE LOCAL ER, AND HOSPITALIZED. CT SCAN SHOWED NO PULMONARY EMBOLISM, BUT HAD SIGNS OF PNEUMONIA. COVID-19 TEST WAS NEGATIVE. He was hypoxic, requiring oxygen.

Pt received vaccine at 1130 on 4/10. Per report of others reported feeling fine at 2300 4/10. Went to bed. Awoke at approx 0100 4/11, reported not feeling well, vomited, returned to bed. Found by housemate at appox 2100 4/11 unresponsive. Declared deceased with rigor mortis by EMS. Pt in custody of the coroner for autopsy.

12 hours after vaccine I got chills, fever, nausea. Felt better next day with just fatigue and lightheadedness. Tuesday after the vaccine I got diarrhea with constipation along side the fatigue. Those symptoms lasted throughout Thursday. Friday night after the vaccine I got small haves around my head, neck, and upper back that would not away after an hour or two. That continued throughout Saturday and midday trough Sunday. Sunday I had shortness of breath after moving some water bottle cases around and lightheadedness along with the small hives at around 2pm I went to the ER to get checked out. Doctors said it was a reaction caused by the vaccine. They gave me Benadryl for the reaction and injected me with a "Steroid" to the my upper buttock. I don't remember the name of what they injected with me. It is now Monday April 19th a day after the ER and I feel much better. The Benadryl made the hives go away.

Experienced sensation of cold and shivering around 8:30 PM on the day of vaccination (April 10). Went to bed at about 9:30 PM and fell asleep. Woke up around 11:40 PM and threw up. Ran fever of 102.2 F. To lower fever, took "nimesulida" (Spanish), kept ice bag on head and sprayed alcohol on feet. Fever lowered around 1:00 AM. Slept the rest of the night. Felt tired and with a slight headache, similar to that of a sinus infection, coming and going throughout the next day (April 11), so stayed in bed. Symptoms were gone by the night. No more symptoms starting on April 12 and after that date.

Patient starting feeling very sweaty, nauseous, light headed, dizzy almost immediately after sitting in the post vaccination chair. I had already instructed him to sit on the floor if he started feeling faint as he stated previous fainting episodes as a kid. He sat on the floor, then laid on the floor. I brought him a garbage can in case he got sick, an ice pack, wet paper towels, and a bottle of water. After 5 minutes or so the color came back to his face and he started feeling much better. He then sat back in the chair, then stood up and stated he was feeling back to normal. I asked him to stay standing an extra minute just to make sure he was good, then he left with the woman who was with him during the vaccine.

after pt got janssen vaccine he suffer blurred vision, ear ringing, light headache, vomiting, dizziness and sweating for short time

Once vaccine was administered patient started having chills, numbness in hands, weak, and nausea. Our BP machine could not register BP, once EMS arrived they took BP of 90/64. We had patient sit for 45 minutes until he felt better and BP can up.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient had a history of seizures from 2012-2015 but is no longer on medication of any sort. About 5-7 min after vaccine was given he had seizure like activity. He had cold sweats, low blood pressure, and was very pale. He complained of dizziness, nausea, tingling in hands, and blurred vision. 911 was called and he left with EMT

Technician administered vaccine according to standard protocol into patient's left deltoid. Patient has no allergies and was afebrile (96.7). Approximately 5 minutes post-vaccination patient's mother reported that the patient was feeling lightheaded, and shortly after the patient vomited. He stated he felt as though he had a fever coming on. The patient was given a bottle of water while EMS was called. EMS arrived to the scene shortly after the call and assessed the patient. Patient denied going to the hospital and left soon after. Patient reported to EMS that he was feeling anxious/nervous and this likely contributed to his adverse effects. No futher harm to patient.

Woke with headache, stomach cramps, nausea, fatigue, sore muscles, and twitching. Took cold shower, advil, and drank water. Still feeling off but slightly better at 7pm on 5/12/2021.

pt presents to the ED after receiving the J&j vaccine yesterday, pt endorses HA, chills, and nausea, pt has self treated with tylenol and ibuprofen which did not help symptoms.

Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: Patient had profuse sweating after COVID vaccine, accompanied by nausea and dizziness. After patient reported chest tightness, 911 was called. An ambulance arrived to monitor patient (blood pressure, vital signs, etc). Paramedics took over care, however patient began to improve quickly and was feeling better by the time they arrived.

I gave a 21yo male a Janssen vaccine approximately 508p on 5/15. Vaccination was routine and the patient walked to the observation chair. Around 520p, an acquaintance of the patient came up asking for a vomit bag. I went out to the observation chair with a small trash can and paper bag and at 522p the patient stated he felt dizzy and vomited. My technician stayed with the patient, and I went to the pharmacy to grab paper towels, a new mask, and a bottle of water. I came back and asked the patient how he was feeling (524p). He said that he felt much better after vomiting. I asked if he wanted a cold pack or water, and he took the bottle of water and denied the cold pack. I asked him to continue to stay for observation. At 537p, I went out to see how the patient was feeling. He stated he was feeling better and was no longer dizzy. At 538p (30 minutes after vaccination) the patient stated he felt comfortable to leave and continue shopping in the store with his acquaintance.

Patient had a bout of syncope without warning. He awoke less than 3 minutes later disoriented. He felt light-headed and nauseous for several minutes and vomited but produced nothing substantial. Patient was monitored for 30 minutes and felt tired and light-headed for most of that time. He recovered fully and left of his own accord.

minutes after receiving vaccine the seated patient complained of dizziness and nausea. pt was also in cold sweats and proceeded to vomit

PATIENT FELL TO THE FLOOR AND HAD A SEIZURE WHICH LASTED ABOUT 45 SECONDS. THIS WAS FOLLOWED BY VOMITING.

Patient is fainting right after getting the vaccine and lasts for 1 minute and then recovered back after tapping on the patient and then fainting second time and then recover from fainting. Then he said he felt nauseous and after giving some water he recovered gradually. EMS was dispatched to the scene and they checked on his blood pressure and pulse oxygen and was confirmed to be going back to normal. He refused to go to the hospital then EMS and police left the scene

PAIN IN THE REAR OF THE RIGHT RIB CAGE; SHARP PAIN; SORE THROAT; NAUSEA; LIGHT RINGING ON THE RIGHT EAR; LEFT EYE DRYNESS; SLIGHT NECK STIFFNESS; BOTH EYES SENSITIVITY TO LIGHT; LEFT EYE IRRITATION; SLIGHT PRESSURE-LIKE FEELING ON THE NECK; SLIGHT PRESSURE-LIKE FEELING ON THE CHEST; DROWSINESS; HOT FLASH ON CHEST AND NECK; TOP LEFT OF THE ARM (AND SHOULDER AREA) FELT LIGHTLY NUMB; DIARRHEA; NERVOUSNESS; ANXIETY; SLIGHT LEFT SIDED CHEST PAIN; VERY SORE ARMS; LOSS OF APPETITE; ARMS AND LEGS FELT HOT TO THE TOUCH; HANDS WERE CLAMMY; SHORTNESS OF BREATH (UPON ACTIVITY - BUT WHENEVER LYING DOWN OR SITTING, THERE IS NO SHORTNESS OF BREATH); SMALL "HIVES" APPEARED ON HIS BODY; UPSET STOMACH; STOMACH PAIN; LIGHT HEADEDNESS; FATIGUE; HEADACHE; FEVER; CHILLS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A - VHC 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 trouble sleeping. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.4 deg. On 12-APR-2021, the subject experienced light headedness. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced upset stomach. On 13-APR-2021, the subject experienced stomach pain. On 16-APR-2021, the subject experienced small "hives" appeared on his body. On 18-APR-2021, the subject experienced shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath). Treatment medications included: dexamethasone, and diphenhydramine hydrochloride. On 19-APR-2021, the subject experienced arms and legs felt hot to the touch. On 19-APR-2021, the subject experienced hands were clammy. On 19-APR-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) negative for fever. Treatment medications included: paracetamol. On 20-APR-2021, the subject experienced very sore arms. On 21-APR-2021, the subject experienced anxiety. On 21-APR-2021, the subject experienced slight left sided chest pain. Laboratory data included: Blood test (NR: not provided) no abnormality, Chest X-ray (NR: not provided) no abnormality, and EKG (NR: not provided) no abnormality. On 22-APR-2021, the subject experienced top left of the arm (and shoulder area) felt lightly numb. On 22-APR-2021, the subject experienced diarrhea. On 22-APR-2021, the subject experienced nervousness. On 23-APR-2021, the subject experienced hot flash on chest and neck. On 26-APR-2021, the subject experienced drowsiness. On 28-APR-2021, Laboratory data included: Body temperature (NR: not provided) no fever. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the neck. On 01-MAY-2021, the subject experienced slight pressure-like feeling on the chest. On 03-MAY-2021, the subject experienced left eye irritation. On 04-MAY-2021, the subject experienced both eyes sensitivity to light. On 08-MAY-2021, the subject experienced slight neck stiffness. On 09-MAY-2021, the subject experienced left eye dryness. On 14-MAY-2021, the subject experienced light ringing on the right ear. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced nausea. On 16-MAY-2021, treatment medications included: ibuprofen. On 17-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 18-MAY-2021, the subject experienced pain in the rear of the right rib cage; sharp pain. On 19-MAY-2021, treatment medications included: azelastine hydrochloride, cetirizine hydrochloride, and methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 12-APR-2021, headache on 18-MAY-2021, and nausea on MAY-2021, was recovering from loss of appetite, very sore arms, diarrhea, and sore throat, had not recovered from upset stomach, fatigue, light headedness, small "hives" appeared on his body, arms and legs felt hot to the touch, stomach pain, top left of the arm (and shoulder area) felt lightly numb, hot flash on chest and neck, slight pressure-like feeling on the neck, left eye dryness, both eyes sensitivity to light, nervousness, anxiety, light ringing on the right ear, slight pressure-like feeling on the chest, and left eye irritation, and the outcome of shortness of breath (upon activity - but whenever lying down or sitting, there is no shortness of breath), hands were clammy, pain in the rear of the right rib cage; sharp pain, trouble sleeping, slight left sided chest pain, drowsiness and slight neck stiffness was not reported. This report was non-serious.

Patient received Janssen COVID19 vaccine (LOT#201A21A) in his left arm at approximately 14:43 on 5/25/21. During the 15 minute observation period, he expressed "I don't feel well" and endorsed dizziness/ lightheadedness, slight tingling feeling in fingers, and nausea. Shortly thereafter at approximately 14:50, he started to slouch and appeared faint while sitting in a chair with eyes closed. He did not fall or hit any part of his body. He was easily aroused with a touch on his arm and responded to verbal questions immediately. He denied trouble breathing, chest pain, palpitations, headache, muscle weakness, vision changes, skin reactions, swelling. He was oriented x3 and not exhibiting verbal or swallowing problems. His vitals were normal- HR 80 bpm and BP 105/80 mmHg. He was offered a receptacle to vomit in if needed; however, he did not vomit. This initial reaction was consistent with potential vasovagal reaction/ near-syncope after vaccination. Patient was encouraged and instructed to sit on the floor to prevent injury in case of fall but he refused. Staff offered him water, a fan, and opened windows while monitoring. Later while waiting for a ride at around 15:10, he endorsed headache (first above his eyes and then toward the back of his head) and clarified this did not feel like a typical migraine that he has had before. Then at around 15:20 he endorsed vision changes in his right eye- he could not see a portion of vision out of that eye except peripheral vision and described not being able to see writing on the right side of a whiteboard in front of him in the room. Later he described a resolution of that gap in vision but then had blurry vision out of that eye. He denied any vision changes in the left eye. Due to alarming symptoms of vision changes and onset of headache, patient was recommended to go to ER for further observation and evaluation. He was not in urgent distress and patient did not wish for EMS to be called but agreed to go to ER when his emergency contact picked him up. Patient's emergency contact came to pick up patient at approximately 15:40 and was recommended to take him to the ER. Patient and emergency contact were amenable to this plan. He was able to stand up and walk to the car without issues.

DIFFICULTY BREATHING; PAIN ON SWALLOWING; MUSCULOSKELETAL PAIN; FEVER; HEADACHE/SWOLLEN HEAD FEELING; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced pain on swallowing. On MAY-2021, the subject experienced musculoskeletal pain. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache/swollen head feeling. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, headache/swollen head feeling, difficulty breathing, pain on swallowing, and musculoskeletal pain. This report was non-serious.

Patient received vaccine and within a couple of minutes, became completely pale, started sweating, and felt nauseous. Continued for 20-30 minutes and then started to resolve. Did not need additional assistance and came into store later on and was feeling better.

Janssen COVID-19 Vaccine EUA Fever, severe chills, nausea, vomiting, lower back pain. Went to Emergency Department because back pain was so severe and nausea/vomiting was ongoing. Received and IM dose of Toradol. Received oral Zofran prescription at discharge. Spent about 2 hours in ED.

Patient felt sweaty and nauseous right after shot was given. Vomited a little. Patient was given cold compress for neck and after 30 minutes felt fine. contacted patient 3 hours later and was still feeling fine.

c/o no appetite,nausea,fatigue, weak, cold sweat, epigstric pain, redness on both eyes with visual change sicne 21May2021(s/p J&J Vaccination).

After administration, patient did not report any reaction and was asked to wait 15 minutes for monitoring. A few minutes later, he started feeling lightheaded and called his father. His father notified me that he was "spazzing out/seizing" with his head jerking backwards "for a couple seconds". When I saw the patient, he was sitting and unresponsive to verbal and physical stimuli with his father patting his cheek. After a minute or so, the patient was able to respond, but his voice was faint. He reported having a "severe headache" and feeling "sweaty". He had no fever or difficulty breathing. Father said there was no anaphylaxis, and asked for a bucket since the patient felt very nauseous. I then called 911 for emergency services. When I returned to the patient after the call, the father said he was feeling much better and that the "color had returned". Patient was unwilling to stand, and remaining symptom(s) was headache. Emergency services came and checked blood pressure, which was normotensive (SBP 111). Father insisted ER visit was not necessary.

FEVER; NAUSEA; SICK ALL NIGHT; VOMITING; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no significant medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced sick all night. On 30-MAY-2021, the subject experienced vomiting. On 30-MAY-2021, the subject experienced nausea. On 31-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, sick all night, nausea, and vomiting. This report was non-serious.

Frequent and severe vomiting, hourly from 0100-0400, resulting in mild dehydration, resolved without intervention

STIFFNESS IN BACK OF NECK; LITTLE NAUSEA; ACHE IN THE BACK OF NECK; SHIVERS; FEVER; HEAVY HEADACHES/ SLIGHT HEADACHE TO THE FRONT SIDE OF HEAD; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included a bit of anxiety problems, seasonal allergies, allergies to dog and cat, marijuana smoker, and non-alcohol user. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced ache in the back of neck. On 28-MAY-2021, the subject experienced shivers. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced heavy headaches/ slight headache to the front side of head. On 29-MAY-2021, the subject experienced stiffness in back of neck. On 29-MAY-2021, the subject experienced little nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from ache in the back of neck, shivers, fever, and little nausea on 29-MAY-2021, and had not recovered from heavy headaches/ slight headache to the front side of head, and stiffness in back of neck. This report was non-serious.

Vaccine given at 3:35pm. Asked him how he was feeling at 3:40pm. Patient replied "not too good." Patients was visibly pale and sweaty, but did not lose consciousness. He was able to walk back into the consultation room for BP monitoring. BP was 105/45 P 54. Patient admitted to a fear of needles and a history of anxiety. Also said he had not eaten today. BP measured again at 3:45pm --106/55 P 58. Gave patient a pack of peanut butter crackers and a water and rechecked BP at 4:00pm--104/57 P 65. Patient did not know the name of his regular doctor, so we called a clinic in town that he went to in May 2020 for a baseline BP reading. NP clinic reported that his BP at last visit was 120/72. BP at 4:10pm had dropped back to 99/46 P 62. Declined EMS service, but I did make him call a family member to come get him since he had driven himself. Advised family to keep an eye on him and to take to ER if he declines. Patient stated that he felt better, but was hungry. Released to family at 4:20pm.

Next morning after receiving vaccine, there was tightness in upper chest that migrated to the left side near the heart. It persisted for about 3 weeks and then I started having stomach problems. About a month after I started having headaches and started having difficulty breathing.

RN to J&J vaccine about 3-5 min after delivery. Assuming Vasovagal response. His brother reports that patient was sitting there and his eyes rolled back in his head and he fell off his chair and hit his head/right eye. Employee got out there and he was a bit combative and saying "whats going on, whats going on". I asked him to sit down and employee called 911. We put pressure on his eye area to stop the bleeding. He was sweating, shakey, pale, and nauseous. Paramedics arrived quickly and eventually took him away on a strecher. Update: mom came back a couple of hours later to thank us and let us know that he is home and resting. He did get 3 stiches by his eye and the reason they took him via strecher was because his blood pressure was staying so low while they were here.

Twelve hours after vaccine, he developed severely sore arm, shoulders and down back. This was followed by severe vomiting, to which he lost two pounds in 4 hours. Arriving at the ER at 5:45 AM, he had horrible stomach pain, (we could see his stomach move), nausea, vomiting. His hands, arms and face became fuzzy then numb. He was given multiple medications to ease symptoms, along with IV. He had tests of blood, urine and a CAT scan. This was followed by morphine. Discharge around noon on 7-8-21

HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. 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, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain, severe vomiting, soreness all day, hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea, severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Near fainting episode. Pt did not lose consciousness but blacked out (visual disturbances, tinnitus/temporary hearing loss, nausea) occurred within 2-3 minutes of administration. First attempt to read BP was low (~80/60). Pt is an athlete, so I waited until after water was consumed to take BP again. 2nd reading was ~106/65. Pt felt better after drinking water and after sitting for 15 minutes under observation.

flu symptoms. PT states they recived the J&J covid vaccine today at 0830 today and started to experience flu like symptoms around 1330. pt states he had chills, body ache,fatigue, headache, fever, nausea and vomiting. pt took 2 ibuprofen at 1400, and Motrin at1830. History: Pt had J&J COVID-19 vaccine this morning and started having after 1300 mild non-thunderclap headache, fever, body ache, nausea, fatigue, joint aches in multiple joints, and vomited twice in the evening, here for eval. Lives off-post but denies recent sick contact or COVID-19 hotspot visits. Also no sore throat, cough, diarrhea, rash, use of any meds other than motrin today, prior co-morbidities.

ringing in the ears, nausea, numbness in extremities BP: 124/62 HR: 70 Sp02: 98% Seen and cleared by EMS

Patient experienced nausea, vomiting, puffy eyes, itchy eyes, fever, chills, and abdominal pain. Patient was treated with Benadryl and Odansetron 8mg. Patient symptoms have sense stabilized and progressively resolving.

Starting a few hours after my vaccination, I?ve experienced The following: chills, fever, headache, muscle soreness all over my body, nausea, nearly uncontrollable shaking last night, extreme dizziness, and my body has felt heavy. It was worst as I was going to bed (midnight), and it woke me up at 5:30 am today. My fever may have broken, but I am still in pain and dizzy.

PT PRESENTED DIAPHORETIC WITH NAUSEA, NEAR-SYNCOPAL EPISODE O2 SAT - 97 BP - 132/72 RESP. RATE - 18 GCS - 15

Janssen COVID-19 Vaccine EUA Soreness immediately after injection. Chills, dizziness, ringing in ears, nausea lasting from about 9pm to 3am.

He mentioned feeling lightheaded in the car & severe arm pain at the injection site. 5 minutes later experienced cramping sensation in his facial cheeks on both sides. Within 10 more min encountered numbness in his face & his arms began to have sensation of, "dead weight" along w/nausea & unable to move rt. hand. VERY lightheaded all along. We had to travel due to limited supply. His symptoms mimiced a stroke; however, it was determined that it was a severe nuerological reaction & not a stroke. After arrival at the hospital his face felt fully numb & he was unable to smile, like normal. Lower extremities were fine. 102.5 fever next a.m. w/headaches, fatigure and aches that week.

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

NAUSEA; MIGRAINE/HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 22 year old male. 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: 0431A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 05-APR-2021, and had not recovered from nausea, and migraine/headache. This report was non-serious.

It started with extreme fatigue and an extreme headache. The headache caused patient to have an extreme light tolerance causing them to wear sunglasses indoors with the shades drawn three hours after injection. As time progressed the patient began to become nauseous and contract a bone shaking chill. By 5 P.m. the patient was dry heaving and having trouble consuming liquid and solids then around 8:30 the patient vomited for 10 minutes. After that the next day the patients headache continued and they were extreme weak and fatigued.

Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Confusion-Mild, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium

patient fainted; light headed, dizzy, sweaty and nauseous for about 5 minutes watched patient closely, used ice pack, gave water .patient was fine after

Fever, headache, fatigue, vomiting since day after shot--on fourth day and still in bed, exhausted. Has lost five pounds.

SEVERE BODY SHAKES; VOMITING; CHILLS; NAUSEA; FEVER; FEELING HOT; This spontaneous report received from a consumer concerned a 22 year old male. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 23:00, the subject experienced severe body shakes. On 06-APR-2021 23:00, the subject experienced vomiting. On 06-APR-2021 23:00, the subject experienced chills. On 06-APR-2021 23:00, the subject experienced nausea. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes, and chills on 07-APR-2021 02:00, and had not recovered from fever, nausea, feeling hot, and vomiting. This report was non-serious.

Just couple hours after the shot, I was throwing up and had really bad stomach pain. I haven't been able to go No#2 and can't keep any food or liquid down. Constant throwing up and feel very weak.

I first started developing chills and a mild fever about eleven or twelve hours after taking the vaccine. My entire body felt like burning and a headache came up not long after the fever. I could barely fall asleep at night due to body ache and excessive sweating. The headache and body pain persisted till the next morning, and as of I am writing this response now, I feel extremely weak and I have no appetite at all.

Janssen COVID-19 Vaccine EUA. The vaccine was given at 10:45 AM. At 4:00 PM I began feeling nauseous. At 9:00 or 10:00 PM I began feeling both muscle and joint pain on my upper body which made it somewhat difficult to sleep. After one or two hours of sleep at 1:00 AM I woke up with a fever, headache, and worse muscle and joint pain (upper body only). When I woke up I was sweating profusely that the bed was lightly wet and extremely hot from all the heat my body was letting go. An ice pack can relieve the headache and fever. However, I was still not able to sleep. At 4:00 AM I made the decision to consume 800 mg of ibuprofen and it took 20 minutes for my headache and fever to go away. Yet, after being able to sleep for 30 minutes, I woke up again to the same headache and fever. Around 10:00 AM the symptoms were partly gone and was finally able to get sleep after a long night.

I took a nap after around an hour of receiving my shot at around 1:40pm. Once I awoke at around 6pm, I had irritated eyes, extreme nausea, extreme dizziness, insatiably low body temperature, extreme shivers, migraine because of my head uncontrollably shaking, and dry mouth. I felt like I was in 20 degree weather and nothing I could do would heat my body up. My body grew so tired from the uncontrollable shaking that I could not get out of bed to get my phone to call 911. Every symptom I was experiencing was not mild and was to the level of extreme. This lasted until around 9am. I have been slowly recovering since then (currently almost 9pm) and feel only 70% back to normal.

c/o subjective fever, chills, H/A, sweating, rhinorrhea, and nausea since receiving COVID vaccine Wednesday evening around 1800. Symptoms have improved, per pt, but have not subsided completely. Has tylenol and ibuprofen at home but has not taken it. HPI: 22yo AD M presents to ED for above symptoms that began shortly after receiving the J&J COVID vaccine 3 days ago. He has no focal neuro symptoms, no LE swelling, no pleurisy or dyspnea. No URI/LRI symptoms. No rash. L deltoid vaccination site. Pt has generalized malaise after vaccine. No red flags for HA, no acute abdominal symptoms/signs, unlikely PE or DVT, unlikely CVA. Unlikely anaphylaxis. F/u and return precautions discussed. Stable for D/C.

Sores in mouth starting about 36 hours after the vaccine. Some sores lasted a few hours. Others, especially those towards the back of the throat have persisted and caused pain.

vomiting. presents with chill, HA, vomiting over 10hrs since got COVID vaccine. can't take fluid down. denies took meds at home. HPI:22-year-old male with chief complaint of vomiting headache and body aches. He received the J&J vaccine yesterday. He reports around 2 AM he woke up with persistent vomiting. He was unable to even keep down liquids. He denies any abdominal pain. He denies any fevers or chills.

ON 4/7 PATIENT RECEIVED A JANSSEN COVID VACCINE AT OUR PHARMACY. THURSDAY AND FRIDAY HE HAD NORMAL REACTIONS TO A VACCINE (LOW GRADE FEVER, SORE ARM, HEADACHE). BY SATURDAY HE HAD A HIGHER FEVER AND WAS NAUSEATED. ON MONDAY HE STARTED WITH VOMITING AND SEVERE CHEST PAIN. PT WAS ADMITTED TO HOSPITAL ON TUESDAY WITH HIGH TROPONIN AND FLUID ON THE LUNGS. THEY ARE RUNNIGN MORE TESTS TODAY (WEDNESDAY). MOM CALLED ME TO REPORT.

NAUSEA; FEVER; SORE ARM; CHILLS; FATIGUE; BRUISE; This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and had not recovered from sore arm, fatigue, chills, nausea, and bruise. This report was non-serious.

Before the vaccine, I was able to and hold down food. After words, my throat was irritated and I kept throwing up due to that feeling. It's been going on for close to over a month and I'm currently taking Acid Reflux medication, Vomiting and Nausea medication after going to the a gastroenterologist to which they didn't find anything doing an endoscopy that occurred on April 12th, 2021. Still waiting on the biopsy. With medication, current only symptom is painful stool (due to medication most likely) and after eating, burning in the throat (most likely due to acid reflux type symptoms). Only able to eat a certain amount before throwing up again.

STOMACH PAIN; NAUSEA; CHILLS; HEADACHE; FELT FEVERISH; SWOLLEN THROAT/COULD NOT MOVE WATER; ITCHY THROAT; This spontaneous report received from a physician concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, concurrent conditions included severe allergy to food, and mild asthma, and the patient had no allergic reaction to any other vaccinations or injections. 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 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included epinephrine for severe allergy to food. On APR-2021, after 3-4 hours post vaccination the patient experienced mild headache. About 8 hours post vaccination, the patient's headache became severe (reported as severity 10/10 by patient) and patient felt feverish and chill but no temperature was measured. The patient took 2 tablet of Tylenol and 1 tablet of Advil before went to the emergency room (ER) around 10 hours post vaccination. The patient received unspecified drug intravenously (IV) and oral Benadryl. Around 11 hours post vaccination, patient discharged from the ER. On the way home, the patient felt his throat itch and swollen and could not move water down to throat. The patients symptoms of swollen throat significantly relieved when he got home (10 minute walk from ER to the front door and a short car ride by his friend) and he went to bed without using his epipen. Next day, patient felt mild headache after waking up and no other symptoms. At day three, APR-2021, he only felt very mild headache in the back of his head and severity was about 1% of that degree of the most severe time of day one. On 13-APR-2021, the patient felt stomach pain, nausea and headache. Severity was mild for all events. On same day, he went to ER for blood tests. All tests (including platelet count and clotting) were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt feverish, swollen throat, and itchy throat on APR-2021, and headache, stomach pain, and nausea on 13-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210421214-covid-19 vaccine ad26.cov2.s-Chills, Headache, Felt feverish. This event(s) is labeled per RSI and is therefore considered potentially related.

POSSIBLE INFECTION DUE TO LOW IMMUNITY; CAUGHT ANOTHER VIRUS; CONSTIPATION; FELT VERY BAD; NAUSEA; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and other pre-existing medical conditions included no known drug allergies and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient felt very bad, had some constipation followed by nausea and it continued until 12-APR-2021. On 13-APR-2021, the patient felt better, then On 15-APR-2021, the patient got admitted to the hospital for possible infection due to low immunity and caught another virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constipation, felt very bad, and nausea on 13-APR-2021, and the outcome of possible infection due to low immunity, caught another virus was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210431111-Covid-19 vaccine ad26.cov2.s-Possible infection due to low immunity and caught another virus. These events are considered unassessable. The events has 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.

Patient fainted within 5 minutes after receiving the Janssen vaccine. He then appeared to be experiencing a seizure lasting no more than a minute. No history of fainting or seizure. EMS was called and arrived within about 10 minutes, and patient appeared to experience another seizure and he vomited. EMS then transported the patient to the hospital.

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

APPROX. 5 MINUTES AFTER INJECTION, PATIENT REPORTED FEELING LIGHTHEADED, DIZZY, AND NAUSEOUS. HE BECAME PALE, DIAPHORETIC, AND VOMITTED FOR A FEW MINUTES. PATIENT HAD CHILLS AND WAS WEAK. PT HAD A FULL SET OF VITALS TAKEN (WITHIN NORMAL FOR AGE), MONITORED, AND GIVEN WATER TO SWISH AND SPIT. AFTER 30 MINUTES, THE VITALS REMAINED STABLE AND WAS ABLE TO TOLERATE SMALL SIPS OF WATER. COLOR RETURNED TO NORMAL AND PATIENT WAS ABLE TO STAND AND NOT FEEL DIZZY. HE REMAINED AT THE CLINIC FOR AN ADDITIONAL 30 MINUTES UNTIL HE FELT COMFORTABLE TO DRIVE.

5 minutes after injection patient exhibited diaphoresis, nausea, vomiting, chills. Routine patient care and water was given.

Pt received Johnson and Johnson vaccine at about 145 pm. About 10 - 15 minutes later the pt was feeling light headed, nauseous, sweaty, and felt like he was going to faint. I attended to the patient, laid him on the ground bein case he fainted (which he did not), put his feet up, and asked him how he was feeling. The pt stated he felt better after laying down for a couple minutes and sat back up in his chair. I gave the pt the pt water and Gatorade and told the pt he would need to hang out for about 15 minutes longer. Pt stated he felt fine and 100% and requested to leave.

Sore right arm shortly after the shot. Arm is still slightly sore as of completing this form. Lost of appetite, chills, sweating, and mild fever starting 12 hours after the shot. Took Ibuprofen shortly after the symptoms showed up. Symptoms lasted for 7 hours.

Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Medium, Additional Details: patient fainted shortly after receiving covid-19 vaccine. pts legs were propped and he gained conciousness fairly soon. paramedics were called, they checked on pt and found all vitals to be normal. pt was given option to go to hospital but declined. he sat in chair for another 30 mins and then felt strong enough to walk. he walked a few times around pharmacy and then felt comfortable going home with mother.

Patient became light headed and had a syncope reaction and fainted, and came to attention immediately as we approached him. He then vomited 10 minutes post syncope reaction.

After patient received vaccine, another patient shouted that he needed help. Came back out of pharmacy to find patient passed out but he came to quickly. He was very pale, sweating and complaining of nausea. Got patient ice packs, water and Gatorade and after about 20 minutes patient was feeling well enough to leave with his father.

Pt passed out in chair about a minute or so after administration of vaccine. He brought along his girlfriend who was in the consultation room with him. Prior to administration, pt informed me that he was afraid of needles. After administration, we discussed the type of needle that was used (vanish point syringe) and the mechanism of how it works. He seemd anxious so I advised that it was ok for them to sit in the room for a few minutes instead of getting up to wait in the lobby, I left the door open for them. I walked back into the pharmacy and his girlfriend alerted me that he had passed out. He regained conscious within a few seconds. I advised he sit with his head between his legs, as he mentioned feeling light headed, feeling hot and sweaty. he threw up a little into the trash. pt sat in room for at least 30 minutes until he felt better. was given a few cups of water while sitting. did not leave until he felt comfortable and no longer light headed. pt mentioned that his last vaccine was about 2 years ago and the same response occured then.

After receiving the vaccine, the patient stated that he felt light-headed, and was sweating profusely. He vomited. His blood pressure was 118/82 mmHg, pulse 81 bpm, and respirations 16 bpm. He said he felt like his throat was closing, so we gave him liquid diphenhydramine. At this point, we called 911. The patient was alert and talking the whole time. The patient went with EMS. The patient came back later after being released from the hospital and said that he didn't have an allergic reaction, but he had vasovagal syndrome.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient said he was not feeling well. When I responded to him he said he did not feel good. I told him to put his head between his knees, but before he could do it, he became non-responsive. He remained seated as I shook him gently asking if he was ok, his eyes were open. When he became responsive, he said he must have fallen asleep. He said he felt nauseated. He was sweating. We called 911. The paramedics came and checked vital signs. His BP was 110/68, blood glucose was 107.Pt left on his own.

Myocarditis with elevated cardiac biomarkers and decreased EF. Patient had chest pain on admission along with nausea, vomiting and diarrhea.

I had all the possible side affects at once and lower back pains which started to bother my kidneys and I ended up going to the hospital and they treated me for dehydration because I lost so much fluid because of vomiting and sweat, They gave me tramadol and Zofran

At 1624, RRT activated when client (22 y/o M) tensed up (as in a panic attack) immediately after getting the J&J shot. He was complaining of feeling dizzy, nauseated, and clammy. LOC intact and client was talkative all throughout the incident. Noted that he is usually anxious every time he gets a shot. Vaccinated on the R arm. Support provided, and VS taken: BP ? 130/78, RR ? 18, HR ? 74, Pain ? 0/10. Head to toe assessment completed. No PMH, not on any medication. Within 3 minutes, client felt much better and remained that way until leaving the vaccination clinic ambulatory and in stable condition at 1652 with mom and girlfriend.

22y/o AD male c/o Chest Pain since 4am today, Mid-sternal radiates to back. PT states Shivers/chills and anxious. PT is in Quarantine right now recieved J&J vaccine last night at 2300.

Immediately within 1 minute started feeling nausea, cold sweats, and light headed. Crackers, water, and a cold pack were given in the EMS room for treatment. Approximately a few minutes after treatment, patient started feeling much better.

12 hours after receiving vaccination I woke up with severe cold chills, heart burn, and body aches. I took Tums, Pepto, and other prescriptions to try and alleviate those pains. None of those worked so around 5:30- 6pm (4/25/2021), I went to ER. When I went in they took blood work, a urine sample, and then gave me Iv fluids, and other medications. The Dr. confirmed that I was dehydrated, and I had a normal reaction to the shot. I was in the ER for about 2-3 hours, and then they let me to go home. I went to work the next day.

5 minutes after vaccine administration, the patient felt light-headed, dizzy, nauseas, sweaty, and went pale.

Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine started around 11 am that lasted until the next morning after which a dull headache lasting till Friday, 102.3 fever, EXTREMELY painful body aches, metallic taste in mouth, thirst that could not be quenched, dizziness, blurred vision, confusing, nausea.

Within 2 minutes of getting vaccine, patient said he felt 'light, sweaty and like he was going to throw up.' Staff attended to him and he almost immediately slumped over and was unresponsive. While being moved to the floor, he stiffened and arched his back and had urinary incontinence. Seizure like activity lasted less than 30 seconds. EMS was called at 1347 and arrived at ~1355. At 1345, 128/80, HR 63, 02 sat 97%; at 1350 BP 122/80, HR 73, RR 18, 02 sat 98%. Pt was alert by 1350 and remained alert while he was evaluated by EMS. EMS offered pt evaluation at hospital and pt declied. He said he would f/u with Doctor. Roommate was called and provided transportation home for pt. Pt was called 3 hrs later and he said he was doing well.

Full LOC, fell from post vax chair (approx 2.5 ft) onto the cement floor, striking head upon landing. Patient regained consciousness ~30 seconds after syncopal episode. Patient reporting posterior head pain and stomach pain. Negative DCAPBTLS. Patient provided with ice pack to apply to head. vitals at 05:17 PM were BP: 100 over 60 HR: 88 BGL: 88 RR: 14 Patient refused an ambulance to be called and signed that he did not wish to go to the hospital. Advised to contact PMD should further symptoms occur.

patient received J & J vaccine at 1050 am patient was talking with nurse and suddenly stiffened his body with clenching fists curled upward to chest. He had bright red skin color, and could not speak. this lasted 10 seconds at most. Afterward the patient was sitting in chair had turned very pale and did not realize what had happened. one of the other nurses asked him if he knew where he was, he stated "In the Hospital", the nurse repeated that he was not in hospital, that he was at the health department getting a Covid shot. He stated "oh yeah.. I forgot," patient stated he was going to be sick, patient grabbed garbage can that was sitting next to him Patient was hooked up to oximetry, reading was 99% on RA, attempted Blood pressure 3 times but was unable to attain a reading, patient was holding garbage can tightly. patient had emesis 3x's that was clear in color, cold packs were placed on the nape of the neck and under armpit, patient was sweating and white in color. patient stated he had blurred vision, and noted that he was unconscious for approx. 25-30 seconds. 911 was called at 10:57. Nursing supervisor was notified at 10:58. Patient stated that he had nothing to eat today, and his mother stated that he had been anxious about getting the vaccine and that she made her son get it. Epinephrine was available but not given. no issues with breathing. EMS came in did a quick evaluation and transported patient to the hospital. Mother was with patient during the entire incident.

Day 1: Chills, full body aches and cramps, headache, loss of apatite, nausea, dizziness, fatigue. Day 2: Full body aches, headache, loss of appetite, fatigue, dizziness. Day 3: Fatigue, Localized aches.

A few hours after I got the shot I had flu-like symptoms. Headache, fever, nausea, chills, and vomiting. About 12 hours later my flu-like symptoms went away but my headache turned into a migraine. I have no history of migraines. I have been taking ibuprofen and tylenol but it has not been working. I currently still have the Migraine 48 hours after the shot.

Fever starting later that night that resolved by morning, headache, dizziness, loss of appetite continuing for the next day

On going symptoms : chills body ache head ache nauseous it?s been just under a year since i recovered from covid 19

12:00 AM: Sore Muscles, Nausea 04:30 AM: Vomiting, Fever (107.4 °F). No treatment provided. Symptoms resolved naturally by 13:00 (1PM) 03/12/21.

Janssen COVID-19 Vaccine EUA Headache, nausea, extreme exhaustion, muscle/body aches, fever, dizziness, sensitivity to light and sound (headache), skin sensitive to touch, loss of appetite. Vaccine was administered at 10:38 AM. Symptoms began 10:00 PM 3/10/21. The worst of it was 8 AM to 6 PM 3/11/21. Some lingering mild headaches until 3/13/21.

fever,nausea,headache. PT states getting the J/J vaccine this am 1000 with shortness of breathe, nausea, and headache starting around 13/1400. PT states taking 500mg tylenol around 1.5 hours ago. DATA: 23-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with moderate tachycardia and otherwise reassuring vitals. Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for DATA: Med/Allg: denies PMH/PSH: denies ROS HEENT: no eye pain, no sore throat, no ear pain CV: no chest pain, no palpitations Pulm: no shortness of breath, no cough Abd: no abdominal pain, no N/V/D MSK: no joint pain, no joint swelling, no back pain PE Gen: A&Ox4, NAD, non-toxic appearing HEENT: no pharyngitis, no AOM/OE, no PTA/RPA/Ludwig's, no cervical adenopathy CV: S1/S2 RRR without MRG, cap refill <2 seconds all extr Pulm: CTA all fields, no dyspnea on exam Abd: no focal Abd TTP, no peritoneal signs, no CVA tenderness MSK moving all extremities without limitation, no gross deformities, no joint swelling or tenderness Neuro: CN 2-12 and cerebellar grossly intact Skin: maculopapular lesions on Bilat lower legs c/w contact dermatitis. Lab: none indicated Rad: none indicated

Felt fine after the shot all day. Around midnight (between March 19/20) began to have cold chills and headache. Woke up periodically through the night for stomach queasiness + sweating heavily

On 3/12/21 day of injection The patient got the Johnson & Johnson Covid vaccine this afternoon around 1400, after which he noted a red, itchy rash on his chest, back, and bilateral upper extremities. He also notes a dry mouth and mild throat swelling, but denies shortness of breath, vomiting, lightheadedness, chest pain. He took benadryl about an hour after getting the vaccine without any improvement.. He states that amoxicillin is the only medication to which has had an allergic reaction. On 3/12/21 He was s treated with Vistaril 50 mg, Deltasone 50 mg, and epinephrine 0.3 mL. The medications relieve most of his symptoms for 2 hours before it returned along with having developed a sore throat and sensation of swelling to his throat. On 3/13/21 at 0139am patient returned to ED for further evaluation. Patient remedicated with benadryl, epinephrine and was given pepcid. On 3/14/21 at 1430 patient again seen in ED for further evaluation with worsening rash. patient that last night he had a severe allergic reaction and self administered epinephrine at 0440. This morning he woke up with a worsening rash that he describes as burning. He reports a sensation of throat swelling. He has had 3 episodes of diarrhea, but no nausea or vomiting. Yesterday, patient states that his heart was "racing" but denies any chest pain. He states that every time his rash is treated, it returns and is worse in severity

After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.

Head ache Arm ache Slight fever Joint pain Slight stomach ache Fatigue Lack of appetite Cough Shallow breathing

Patient passed out shortly after given vaccine. Immediately regained conscious but felt nauseous and sweaty. Monitored the patient for thirty minutes and gave a cool compress. After the 30 minutes he felt well enough to leave the pharmacy. After two hour patient had eaten and felt completely fine.

12:17, RN and another nurse reported that patient complained of nausea. Nurse placed patient in the lying position in the foldable cot and assessed patient's VS: SpO2 97% RA, BP 150/60, T 97.9, HR 68, RR 20. Patient was awake and alert. At 12:26 pm.. Both nurse educator were notified and 911 was called as advised by nurse. Two other nurses continued to assist patient. Nurse allowed patient to sit up and drank water. Patient stated he was feeling better without any other issues. 12:30 pm, nurse rechecked VS: T 98.3, RR 20, BP 140/62, HR 72, O2 Sat 99% RA. Patient remained to be awake and alert. 12:50pm, Fire Dept arrived. Patient signed the document not to receive further treatment and to the hospital. Patient also stated he did not have any friend and family to drive him home. Patient stated he needed to urinate and was escorted to the bathroom without any issues. Patient was able to ambulate with steady gait. Patient then left the facility.

Headache, body aches, fever, vomit and nausea, fatigue, sinus pressure. Treatment: extra strength tylenol, sleep, fluids (water/Gatorade)

Immediate feeling of mild nausea after receiving the vaccine When going to bed a more intense feeling of nausea and mild body pain Next morning, the same feeling a nausea, a more intense body pain and a slight fever Around 10 AM the next morning - a VERY intense headache and high fever (~102) with intense nausea and body pain that almost resulted in a trip to the hospital Rested and got fluids throughout the rest of the day and fever began to break around 5 PM. After this ate dinner and was asleep by 7 PM. Next morning felt better and had no remaining side effects.

pale, nausea, vomiting and sweating. patient stated, "needles/shot make him nervous, as well as he has not eaten any food today" He also drank an energy drink this morning

Pt is 23 YOM at vaccination site, status post Johnson and Johnson vaccination, pt states he has a hx of fear of needles where he has ?passed out in past? from other medical procedures, pt states he returned to chair after receiving vaccine and began to feel light headed and dizzy, where he then fell to ground off chair, pt believes he may have syncopized however is unsure because he ?woke up right away?. Pt skin initially pale and clammy, but quickly had color return to face and extremities. Pt can recall events in entirety, is alert and oriented x4 and states negative head/neck/back pain, negative blurred vision, negative vomiting but + nausea/dizziness, which resolved after approx 3 minutes, initial systolic BP in 90?s but improved to 130 once seated, pt states eating full breakfast, with BGL of 106 mg/dL, pt initially denied transport to hospital but after brief period of time began to feel dizzy again and agreed to transport, due to reoccurrence of SBP in 90?s, IV placed in RAC 1:1 with NSL given KVO, pt 3 lead sinus rhythm without ectopy, upon arrival of ambulance full report given to EMT who assumed care of patient

Approximately 12 hours after vaccination, awoke with severe trembling and nausea. Fainted twice. Fever of 100F. Nausea lasted approximately 30 minutes, trembling lasted about 45 minutes. Important to note that I previously had COVID-19 60-70 days prior to vaccination. The symptoms from the vaccine were significantly worse; however, they appear to have lasted for a much shorter period.

Extreme chills followed by vomiting every 30 minutes and a rotating headache. Lasted for one day. Then just an upset stomach. Went to ER. They said possible stomach ulcers due to vomiting.

Pt received the vaccine sat in our waiting area and then passed out a couple minutes after receiving the vaccine. He came to in a minute or so. We called 911 and the paramedics came and took him to the local hospital. Per his report he had not had anything to eat that day and when he came to he felt nauseated and clammy.

Pt received J&J vaccine at 0900 on Monday. Pt had ha and bodyaches on Monday night. Tuesday went to clinic for HA and bodyaches and was given tylenol. Pt woke up on Wednesday with a nose bleed and stomach ache. CHIEF COMPLAINT & HPI: 23 yo M here with epigastric pain, nausea, shortness of breath, fever, chills, since receiving the covid vaccine several days ago.

Chills, body aches, nausea and headache since he got J&J vaccine on 12Apr2021. Denies fever, chest pain or difficult breathing. Took some ibuprofen/tylenol @1700 yesterday with relief. CHIEF COMPLAINT & HPI: 23 yo M here with fever/chills/nausea/headache after getting his covid vaccine several days ago. no rash/numbness/weakness/chest pain. no abd pain.

LITTLE WARM TO TOUCH; PAIN GOING DOWN AFTER RESTING; SORENESS ON INJECTION SITE; SEVERE STOMACH ACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol sometimes, and non-smoker, and other pre-existing medical conditions included the patient have no known drug allergies and there was 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, batch number: 203A21A, 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 severe stomach ache. On an unspecified date, the subject experienced little warm to touch, pain going down after resting, and soreness on injection site. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, and the outcome of little warm to touch, soreness on injection site and pain going down after resting was not reported. This report was non-serious.

Pt became nauseated following vaccination, patient vomited. Pt diaphoretic, face flushed, vitals checked, cool cloth placed on back of neck

VOMITING; ACHINESS; CHILLS; FEVER; HEADACHE/SEVERE PAIN IN TEMPLES; This spontaneous report received from a consumer concerned a 23 year old male. 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, and batch number: 40Z1AZ1A expiry: not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache/severe pain in temples. Laboratory data included: Body temperature (NR: not provided) no fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, achiness, chills, fever, and headache/severe pain in temples on 06-APR-2021 13:00. This report was non-serious.

A WEEK AFTER GIVING THE JOHNSON AND JOHNSON VACCINE PATIENT BEGAN TO PRESENT SYMPTOMS OF ANXIETY, INCOHERENT SPEECH, HALLUCINATION, INSOMNIA AND NO APPETITE.

THE FIRST TWO DAYS AFTER THE VACCINE PATIENT HAD FEVER AND THEN HE COULDN'T SLEEP FOR ALMOST THREE DAYS IN A ROW, HE LOST THE APPETITE, HE DIDN'T EAT, HE WAS ANXIOUS AND STARTED TO SAY INCOHERENT THINGS, THE THUMB OF HIS HAND DOES NOT STOP SHAKING AND HIS FEET WOULD NOT STOP SHAKING, HE HAD A BREATHING PROBLEM AND HE START MAKING A GESTURE AS IF HE HAD FACIAL PARALYSIS, HIS TONGUE WAS STICKING OUT OF HIS MOUTH AND HIS FACIAL GESTURE WAS AS IF HE HAD A THROMBOSIS ATTACK, THEN HE GOT AGGRESSIVE AND HE KICKED HIS FATHER IN CHEST AND WHEN THE AMBULANCE CAME AND TOOK HIM TO THE HOSPITAL HE ALMOST COULDN'T WALK.

No side effects until 12 hours after with fever, chills, soreness, nausea, and fast heartbeat throughout the following day.

Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: patient fainted for several seconds, when he came to, he was shaky and sweating. then vomited several times. completely recovered

Patient had the vaccine and was doing well for 13 minutes then became nauseous and had feelings of throwing up. patient then fainted briefly but regained consciousness after 30 seconds. Was laying down on floor for 10 mins and was clammy, sweating and low blood pressure 116/68 but high pulse 90. Patient states was very anxious after with frequent respirations. Patient then was helped up to the chair and sat for 1 hour with blood pressure taken every 15 minutes. Blood pressure was taken before leaving 128/71 before leaving attended by caregiver. Patient states didn't eat and was working outside for 2 hours before getting vaccine. Patient was advised to seek medical attention if condition worsened and was amendable to that suggestion.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient was laid flat to avoid fainting and recovered within 15 minutes

BODY PAIN; NAUSEA; FATIGUE; SLIGHT COUGH; CHILLS; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced elevated heart rate. On 08-MAY-2021, the subject experienced slight cough. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 140, 100. On 08-MAY-2021 03:00, the subject experienced body pain. On 08-MAY-2021 03:00, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient was recovering from elevated heart rate, and had not recovered from nausea, body pain, slight cough, fatigue, and chills. This report was non-serious.

VOMITING; PAINFUL HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 23 year old male. 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced painful headache. On 11-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 11-MAY-2021, was recovering from fever, and had not recovered from painful headache. This report was non-serious.

I got th eJassen COVID-19 Vaccine EUA at 10:50am. When the needle was removed, blood ran down my arm. That has never happened, but it might have been the nurse. I had nausea for a few minutes afterwards, but I think that was due to the blood. I didn't feel like eating after the shot. Hours later, around 5pm or so, I started to feel hypersensitive and weak. I also started to have a fever that went up to 102.2 farenheit before decided to take ibuprofen. I had shakes, a heartbeat of 146, and a headache. It lasted all through the night and into the next day. Around 11:20am, whenever I moved my head, I would feel pain in my head. By the end of this day, I started to feel more like myself. By the start of the third day, all I had was pain in my left arm from the shot. It was strange that the pain got worse from Day 1 to Day 3, but that might be from how the vaccine was given and the blood that ran down my arm at that time. Another thing is my appetite has gone down a lot. I don't want to eat and when I do, I just want to stop. It's been a couple days, so I'm hoping my appetite will come back.

3:00 AM- Woke up with a headache, eyes hurting 3:30 AM- Alarm goes off for Saturday work, found self couldn't keep my balance, felt hot 3:38 AM- Temp read 104° F, drank 8 Ounce of water and some Gatorade, called in sick for work and laid back down. 3:40 AM- Vomiting, sweating, knees aching and felt weak and dehydrated. 7:13 AM- Arived at IU, got some meds to help with headaches and keeping fluids down

Patient is complaining of fatigue, generalized body ache, fever, sore throat, nausea, vomiting, diarrhea.

So it happened later when I got home, but I suffered from extreme body and muscle pain, heavy fatigue, severe naseua, a fever at about 100 degrees Fahrenheit, and severe migraines. This continued till about 8 am the next morning when my fever finally broke, and the other symptoms have gradually lessened over the period of today.

I had excessive vomiting for 5 hours couldn't keep anything down, had difficulty swallowing, lethargic, incoherent, felt dehydrated. Went to the ER around 2:00 pm. Did several test.

7 hours after injection high fever 104.8F. Severe chills and body aches; severe headache. Fever of 103-104;5 lasted approximately 12 hours and was over 103F with 400 mg Ibuprofen (every 4 hours) and 1000 mg Tylenol (every 4 hours). approximately 20 hours after injection faint, very dizzy and dry heaves/nausea. 24 hours after injection fever of 102.5F with the ibuprofen and tylenol, body aches and chills but not as severe. Headache improving.

approximately 13min post vaccination patient fell to the ground, medic went over and then checked for injuries. Within minutes patient was answering questions and was oriented to person, place and time. Patient then started vomited, vomited for about 2 minutes stated he then felt better. Dad came and medic recommended that we call 911 and have the paramedics take him to the hospital - Dad agreed.

Patient became syncopal within seconds of receiving the shot. Passed out for about 10 seconds. Felt dizzy and nauseous after. Lay pt down on cot, elevated feet. BP supine 110/68 P 66 R 16. Postural drop when seated, lay back down. After about 20 minutes pt maintained pressure when seated and standing, dizziness subsided. Pt declined further treatment or transport and friend drove him home. Advised to call 911 if began to feel worse.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: after receiving the J&J vaccine on 6/5/21 about 1.5 minutes after administration the patient hit his head against the wall and was unconscious. the patient started to mildly seize and lips started turning cyanotic and the patient urinated himself. The whole episode lasting about 45 seconds. When the patient came to he informed me that was epileptic. I kept the patient in the supine position until the paramedics arrived on the scene shortly after.

SHORTNESS OF BREATH-A LITTLE; CHEST PAIN; CHILLS; NAUSEA; FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-JUL-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced shortness of breath-a little. On 07-JUL-2021, the subject experienced chest pain. On 07-JUL-2021, the subject experienced chills. On 07-JUL-2021, the subject experienced nausea. On 07-JUL-2021, the subject experienced fever. On 07-JUL-2021, the subject experienced muscle pain. On 08-JUL-2021, Laboratory data included: Chest X-ray (NR: not provided) Not reported, and EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, chills, muscle pain, shortness of breath-a little, and chest pain. This report was non-serious.

The patient had syncope a few minutes after the injection. They were unconcious for approximately a minute before regaining conciousness. They told me that right after the shot, they had a few moments of nausea which went away quickly. They then had a 'high-like' sensation before losing conceousness. After regaining conciusness, they had no further symptoms until the next day (today). They are feeling drowsy, achy bones, and headache. They said they would contact me if they experienced further symptoms.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient recovered after surpine positing for 15 minutes and water

Caller is pt's mother; not sure if fever and diarrhea are r/t vaccine or hx of Crohn's disease as he had a low grade temp of 99 at home yesterday prior to receiving vaccine.

Immediate muscular pain and soreness at injection site Delayed muscle soreness in back, legs, and arms. Chills Headache/Sinus Pressure Nausea/dizziness

vomit. Patient presents with N/V, body aches, achy lower back pain, fever, weakness, and int SOB. 24-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with appropriate tachycardia and otherwise reassuring vitals. Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for sepsis or severe bacterial infection. No dry mucous membranes or tachycardia to suggest clinically. 24-year-old male presents with constitutional symptoms after COVID vaccine reaction.. Stable on arrival, mildly febrile with appropriate tachycardia and otherwise reassuring vitals. Patient well-appearing on exam with no productive cough, hypoxia, abnormal lung sounds, or respiratory distress to suggest pneumonia. No urinary symptoms or abdominal pain to suggest UTI or other acute intraabdominal process. No AMS, neuro symptoms, meningismus, or rash to suggest meningitis/encephalitis. Non-toxic appearance; low concern for sepsis or severe bacterial infection. No dry mucous membranes or tachycardia to suggest clinically significant dehydration. No exam findings to suggest strep, epiglottitis, RPA/PTA, or AOM. Given Toradol, Zofran and IV fluid in the ER with improvement. PO tolerant in ER. Plan for discharge with Tylenol/motrin PRN for fever/pain, and PCP follow-up. Discussed findings with patient/caregiver. Plan for discharge as above. Patient/caregiver verbalized understanding and agreement with plan. All questions were answered to satisfaction of patient/caregiver. Written and verbal discharge instructions were given to the patient, including strict ER return precautions. Patient was discharged in stable condition. Voice-recognition software was used in the documentation of this note and may contain minor grammatical errors/typos. Additional information for Item 19:

Confusion, Headache, Myalgia, Arthralgia, Fever, Chills Narrative: Johnson and Johnson vaccine - Only upper body body aches and joints, bad headache with light sensitivity, nauseous, feeling a little disoriented - don't feel irrational but just foggy, forgetful--got home and left car running in driveway, fever 99.7, chills; taking Tylenol, but did not at first because she was told to wait at least 12 hours before taking anything.

I experienced slight nausea the night I received the vaccine. The following morning was miserable. I had a fever of 101 all day long, a headache, my body was aching from head to toe, extreme lethargy, and occasional bouts of extreme nausea as well as throwing up twice. As of the following day (March 18), almost two days since receiving the shot, I feel pretty much completely normal again aside from a slight headache and some pain at the injection site still. I experienced some pretty bad side effects that only really lasted a day.

Reported nausea with bloody emesis x 1 on 3-18-21 at 2247 . sent to Emergency Room for rule out of GI bleed. Diagnosis of nausea and vomiting from ED physician.

Janssen COVID-19 Vaccine EUA Roughly 1 hour after vaccination I started to experience nausea and fatigue. The fatigue continued for several hours until about 6-8 hours after vaccination. At that point I started to experience chills, muscle aches, and rash on my left arm (at injection site region) and over other parts of my body. Temperature at that time was still within normal range but close to 10 hours after I began to run a fever. Highest temperature at its peak was 100.3F. These symptoms continued into the night but began to considerably subside in the morning, close to 24 hours after vaccination. At this point, 26 hours after, I still feel mild muscle aches and a mild headache.

Patient passed out 5 minutes after receiving vaccine. 12 hours later the patient had severe chest pain and went to the ED. He received a ketorolac shot there and returned home. 36 hours later, red dots were noticed on the patients feet and ankles (appeared to be petechiae). No other s/sx of bleeding but extreme fatigue, nausea, head fogginess, etc. has been experienced over the past 4-5 days. Patient w/ no PMH of any significance.

Patient felt dizzy, warm, funny feeling in the stomach and turned pale. This happened 5 minutes after the administration of vaccine.

Starting 6hrs after injection 101 degree fever, coupled with headache, fatigue, and nausea. Most symptoms ceased after 24hrs after the injection. Small aches and Minor fatigued persisted for another 24 hours.

Body aches, tiredness, nausea for 24hrs after injection. General tiredness and slightly sore throat for 5 days after injection

Patient reported feeling sweaty, mildly nauseous, tingly in his hands and teeth/roof of mouth, flushing of the face and ears. Treatment included administering an ice pack for the patient's neck and a cool towel for the patient's forehead. Observed patient for 30 minutes, and he made a full recovery within 25 minutes of vaccine administration.

pt had a sore achy arm all of the way to his hand immediately after getting the vax. Later that day he became fatigued, extremely nauseated, had body aches, chills, profuse sweating, and headache. He took Tylenol 1000mg that night, the next morning and again twice the next day. The next day his eyes hurt, had headache, loss of appetite, fatigued with body aches and pain. On 4/3/2021 he still had a headache but the other symptoms were better and disappeared by the end of this day.

headache,body ache,chills. PT reports HA, bodyaches, chills and nausea x 0300 received JJ vaccine yesterday. has not taken tylenol or motrin.

The patient became unwell a few minutes after receiving the vaccine, he informed me he threw up, felt dizzy and sweaty. I gave him some water and a cookie. He said he felt better after consuming the cookie. I had him sit in a chair outside my counseling room and to knock if he continued to feel unwell. After 10 minutes, the patient said he was feeling much improved. I had the patient wait another 20 minutes before leaving. The patient left feeling normal again.

First nausea, then vomiting, fever and headache during the day, took 400mg ibprofin around 1PM. At night: chest pain, night sweats, continued nausea, fever and headache, took 500mg acetaminophen. Second day: headache and nausea continued, took 400mg ibprofin. Second night: extreme night sweats.

Chills, fever, headaches, muscle aches throughout entire body, muscle spasms, nausea, vomiting, diarrhea, fatigue, loss of appetite

Beginning 7 hours after inject, has increased in severity in the 4 hours since fatigue confusion dizziness lethargy soreness throughout body nausea fever i feel like shit dude

Worst headache I?ve ever had (8 out of 10 pain scale), could not sleep due to the headache, very lightheaded, entire body ached (could barely move), eyes hurt, highest fever temp 102.8, nausea (at times I thought that I may have to puke). These symptoms lasted all night, but felt better in the morning. These symptoms were like COVID but x5. When I had the COVID-19 virus, my symptoms were not as bad as yesterday?s adverse effects from the vaccine. At 3 AM, I was considering going to the hospital and I have never been hospitalized before. I could barely open my eyes since the headache was so bad.

Began feeling delirious around 7:00pm - uneasy and strange. Upon walking to the subway station, I felt overwhelmed with sudden depressive thoughts and anxiety. On the Subway, I had a very severe, and disturbing panic attack. My vision became blurred and distorted, my heart rate spiked, and I became nauseous and extremely frightened. I sat down to try to maintain a sense of calm - but got off the subway after a few stops and met with a friend whom I had texted, to take care of me. From the point on, I was very shaken and agitated, and have been since the event. I have never experienced anxiety, depression, or any such symptoms in my life before, nor was I nervous or anxious about having received the vaccine. The onset of the event was sudden, and seemingly out of nowhere, without real purpose, hence my conviction that it may have been spurred as a side effect from the vaccination. I went to Urgent Care Sunday morning, April 11th, the morning after the event. My resting pulse was 97 BPM (normally 52-54) - and my blood pressure much higher than normal - 175/110. The doctor insisted I go home "and relax". I still feel uneasy and shaken from the event.

4/10, 9:30 pm: chills, sensitivity, fatigue, arm pain at site of injection 4/11, 12:00am: dry heave followed by vomiting, extremely shakey, and fever. 12:52am: larger watery vomit, more shaking.

At roughly 4pm the day of vaccine I started to feel generally sore in my muscles. At around 7pm I started to become light headed, had a headache, and bad muscle pain. My fever at this point measured 102f. These negative effects increased over the next few hours until I fell on the floor and couldn't get up without help from my wife. I felt like I was going to pass out every five seconds, threw up twice, my muscles kept contracting and relaxing and were intensely painful. Around 12:30am Saturday morning we went to the emergency department. I needed a wheelchair to get around. The wait at emergency was too long, and by 3am we went back home. I was feeling slightly better, but still not great, and my fever had reduced. I rested on Saturday with less severe but still considerable symptoms, and took paracetamol. Now on Sunday I feel sick and a little sore and very tired, but mostly better.

Diarrhea, noticeably distended stomach, with severe stomach pain for about 2 days. treated with smooth muscle relaxer. Currently recovering.

24 y/o male received Janssen vaccine @ 3:45 pm, while in the post recovery area, @ 3:50, Patient began to become diaphoretic, c/op lightheadedness, nausea and feeling faint, was assisted by the recovery Nurse from the chair to sitting on the floor w/knees drawn toward his chest, initial vitals: 113/83, HR 53, sats 98% on RA, skin clammy to touch, respirations/deep breathing. AAox4, verbalizing freely, able to answer questions clearly. Repeat vitals @ 4:00pm: 113/83, HR 63, stats 99% on RA, continued to monitor, 4:05pm stated feeling was passing, no longer diaphoretic, stated feeling much better. Ongoing monitoring by the recovery Nurse. 4:18 repeat vitals: 110/70, 73 no longer in distress, stable, stated no further issues, ready for release, dc from recovery to self care.

patient fainted, then came to, had nausea, then vomited. Had patient sit and drink water afterwards ~30 minutes.

Starting 04/12/2021: Headache started at around 3pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Stuffy ears started at around 6:30pm; continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:16pm, 04/13/2021.Starting 04/12/2021: Fever started around 9pm, 04/12/2021 at 99.3 degrees fahrenheit ( oral temperature); at 11pm worsen to 102.5 degrees fahrenheit ( oral temperature); took 650 mg of acetaminophen (Tylenol) at 12am 04/13/2021; temperature went down to 101.5 degrees fahrenheit (oral temperature) which continued until the morning of 04/13/2021 when I woke up at around 9am after falling asleep at around 3am with temperature at 9:47am 98.5 degrees fahrenheit (oral temperature). Starting 04/12/2021: Body aches started at around 7pm and continued to worsen until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it significantly improving but still present as of the submission of this adverse event account at 3:40pm, 04/13/2021. Starting 04/12/2021: Nausea started around 9:00pm, 04/12/2021 continued to until the morning of 04/13/2021 when woke up at around 9am after falling asleep at around 3am with it subsiding.

after administering Janssen COVID Vaccine, patient felt light headed, rapid heart beat, sweating all over the body, cold, slouched over in chair, nausea, did not throw up, weak (could not make a strong fist), felt dehhydrated, general unwell, took about 10 to 15 minutes to get back to baseline for patient. I sat with patient in IMZ room until felt better...I asked if wanted EMS but shook head no...later in evening I saw patient in store pulling freight....gave water at their request

pt says he feels like has been hit by a train. He is very achy, chills, fatigue, hot with no fever, nauseated, light headiness, dizziness. Feeling of being drunk like his motor sensors are off. He has taken ibuprofen for his symptoms.

Vaccine administered at clinic. Pt is a 24yo male who received the J&J vaccine on 4/8/21. On Day 1 reported having mylagias, chills and pain at the site of injection. Symptoms resolved the next day and for two days had no other symptoms other than pain at the site of infection. He presents today, 4/13/21, with acute onset of shortness of breath this morning with cough as well as one episode of NBNB emesis at home. Rapid COVID test negative. no hypoxia, including ambulatory. exam and vitals reassuring.

(Saturday)When I came home after I received the vaccine I didn't really have anything to do, so I decided to take a nap and rest. I think after I woke up is when I started to feel the side effects. I can't remember exactly but I started feeling cold. I didn't think too much of it I just thought it was a cold day (which was quickly turning to night). Later that night I started feelinga bit dizzy and my head was hot but I still had chills. Since I had a had a blanket with me, and I think I was starting to feel what would become muscle aches, I just didn't want to move from the couch to my room. Feeling chills the rest of the night, I realized it was bad choice, since one of my family members left a window open. The cold air of the night really exacerbated my chills. Despite the cold I was still able to sleep, but the next day (Sunday) I did have a slight cough which I think was from experiencing the cold air of the night and not a side effect from the vaccine. (Sunday) This is when I really felt all the side effects. I felt weak, chills, headache, dizziness, muscle aches,(I'm not sure if I had a fever, I couldn't think clearly my head felt hot). I haven't had a hangover but I think that is what it would feel like to have one. I basically slept most of day Sunday ; This time in my room with 3 blankets (light blankets )and heat up (felt like 80°F under blankets). I was sweating under the blankets but it really helped warm me up and alleviate my chills. I woke up later that day to a call to help my sister with some work. I couldn't drive, felt weak and dehydrated(dark orange/yellow pee), but she insisted so she picked me up and scolded me for not eating anything all day(besides the side effects I mention, I think I may have also lost my appetite because I felt dizzy). I was still feeling my head aching after I woke up, still had muscle aches and a slight cough too. It was raining that day so I put on a winter coat with layers underneath to help with my chills. At her home she gave me a Gatorade (and water) which I think really helped since I was sweating a lot under the blankets when I fell asleep. She also gave me some home cooked meals she made. The combination of drinks, food, and familial concern really helped me recover. By Monday my cough was gone and the side effects had worn off to the point that I could go to work safely. My mother & father also received vaccine at the same time I got it. My father also experienced side effects but his started later with the most effects felt on Tuesday. My mother did not get any side effects.

J&J/Janssen COVID-19 Vaccine EUA Symptoms: Headache, Migraine, Nausea, Fever Had a headache the morning of when I was going to get vaccinated. The headache went away before the appointment (did not take any medication); however the headache returned about 10 minutes after I got vaccinated. A few hours later the headache converted to a migraine resulting in increased nausea. Overnight I developed a fever. Within 24 hours, all the symptoms were gone. At this time I have fully recovered from all side effects but am monitoring my heath to see if anything else comes up.

STOMACH ACHE; LOSS OF APPETITE; DIARRHEA; NAUSEA; NUMBNESS FROM HEAD TO LEGS ON LEFT SIDE; FEVER; PAIN IN KIDNEYS; This spontaneous report received from a patient concerned a 24 year old male. 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in kidneys. On MAR-2021, treatment medications included: paracetamol. On 31-MAR-2021, the subject experienced numbness from head to legs on left side. On 31-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced nausea. Additional treatment medications (dates unspecified) included: calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, loss of appetite, diarrhea, and nausea on APR-2021, numbness from head to legs on left side on 31-MAR-2021, and fever on 03-APR-2021, and the outcome of pain in kidneys was not reported. This report was non-serious.

24-year-old male patient with no past medical history received Johnson & Johnson Covid vaccine on April 7 presented to ED with abdominal pain and was found to have portal vein, splenic vein, superior mesenteric vein thrombosis. Patient was also found to be thrombocytopenic he was admitted to the stepdown unit placed on bivalirudin. Patient remains hospitalized at the time of this report.

Patient administered Janssen Covid vaccine at 0943AM on 5/1/21 by pharmacist on duty. Patient had no prior reactions to vaccines but did admit being needle adverse prior to administering vaccine. After administration patient sat in waiting area within direct view of pharmacist. No sooner than 2 minutes post administration patient spoke up to pharmacist assisting customer at consultation window about feeling nauseous, and vision fading. Patient comfortable being assisted in taking two steps to immunization room to lie flat on ground after removing outer jacket. Patient was visibly sweating profusely and described hands feeling cool, dizzy, and lacking peripheral vision slightly. Pharmacist remained in immunization room talking to patient for 10 minutes, patient never fully lost consciousness and within 10 minutes recovered from all visual disturbances. Patient moved to seated position within immunization room and accepted offer for juice box. Patient remained seated in immunization room for additional 10 minutes under supervision from pharmacist through window. Patient comfortable moving to waiting area again for additional 10 minutes, afterwards he described feeling still slightly nauseated but no other symptoms. He called his ride from the waiting area and told pharmacist he was recovered and comfortable leaving. Pharmacist agreed to call patient later in the day to check in again. Pharmacist left message at 5pm 5/1/21. Appropriate parties notified and VAERS completed.

After patient got vaccine a few minutes later he fainted while sitting in chair and fell to the floor. He came back quickly. He stated he started to fill hot before he fainted. He said he was now cold. Pt also said he was nauseated and felt clammy. WE eventually moved him to vaccination area to take blood pressure. While taking Blood pressure , he fainted again and was having seizure like symptoms(flailing arms, fit kicking and his head falling back) 911 was called.He came back quickly. He was monitored at scene by EMT. His blood glucose was 115 and initially they were only able to get systolic of 75. They removed him from pharmacy on stretcher and monitored him outside. His blood pressure was fine and they released him. He came back to the pharmacy and was fine

Woke up extremely nauseous at 4 in the morning the morning after and vomited multiple times. Still nauseous now. Otherwise, intense chills, weakness.

Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: Patient stated prior to the vaccine that he was very nervous and did not like needles. Less than 5 minutes after recieving the vaccine he stated he was not feeling well, I noticed that he had perspiration on his forehead. I gave him a small cup of water, he immediately vomited both the water and contents of his stomach. I gave him a bottle of water. He continued to sit near the pharmacy for roughly 45 minutes after which he stated he was feeling much better and left for home.

Started with a headache, nausea, body aches, chills which was expected. Ever since I have noticed a difference in my skin, I randomly have rashes, itching, if I get a scratch my skin swells

Pt states he was vaccinated with J&J at 1500 yesterday. Pt c/o difficulty breathing, ha, body aches, and n/v. Pt went to sick call which referred him to ED.Pt is able to drink water w/o issue.

A week and a half approximately after the initial vaccination of the J+J covid vaccine I started having a course of strange symptoms. Insomnia, inability to focus on things directly in front of me (a hand in front of my face would go out of focus automatically after a second), blurred vision, short term/long term memory loss, severe emotional issues, difficulty breathing, anxiety. Shortness of breath at a certain point was so bad I thought I was not going to make it. One very troublesome symptom that culminated after weeks of 4 hours of sleep was that my brain started feeling "funny". The best way to describe it was a brain "orgasm" which I have never experienced before. At the same time I experienced dry heaving for several minutes, and severe shortness of breath. After this experience my symptoms gradually improved over the next week or two. Prior to this it felt like my brain was not getting enough oxygen/blood, which could have been feeding my insomnia. When I would try to sleep, I would wake up at 4 am gasping for air, as I felt like my breathing was labored when sleeping. I could not focus on my computer screen to do my job at home. Large amounts of melatonin seemed to help my brain feel better and get some rest. I took hydroxyzine for unrelated reasons prior to the vaccine injection as needed, however not too often. During March I did not take it, as I had experienced disruptions in circadian rhythm due to the medication. I feel it is possible I had a blood clot that has been described in the news, although now there may be no way to know for sure. I talked with my primary care physician about this, and he did not think this was the case because I was male. However I have a BMI of 18.7 and some issues females have such as TMJ and inability gain weight/anorexia diagnosis when younger. I also was recently diagnosed with an only recently described actual medical issue called R-CPD, which is the complete inability to burp or belch. I felt like during the time when I experienced the side effects, that this condition was heightened (bloating/loss of appetite). I lost quite a bit of weight during March, I usually weigh 135-140, and was down to 115 at a certain point. I am now back up to 130. I now take sertraline at 1/4 pill dosage to treat the anxiety I experienced as a result of these symptoms as well as some other personal issues. I experienced severe side effects from the sertraline taking it at full dosage, and still experience some at 1/4 pill dosage.

Diarrhea started 1-2 hrs after vaccine 12 hrs after vaccine fever then 24 hrs shoulder pain chills fever 32 hrs after vaccine fever chills vomiting blood shortness of breath weakness

Patient approached pharmacy counter shortly after receiving vaccine looking very pale and clammy. Patient was trying to say something but fell over. He was conscious by the time I got to the other side of the counter but was stating he felt very nauseated like he was going to vomit. We got the patient to a sitting position and got him some cold water. Patient remained seated on the floor until his mother arrived and escorted him out about 15 minutes later.

Tightness in chest and slight difficulty breathing hours before event. Event was an episode on the toilet including vomiting, diarrhea, dizziness, sweating, slight tingling sensations, and temporary loss of vision (5-6 minutes). Dehydration and headache occurred after the event.

immediately after vaccine: pre-syncope symptoms (lightheaded, perspiring, felt cold). 15 minutes later pulse 60 bpm (normal for pt). 30 minutes post vaccination pt reported feeling normal. called pt 5/12 to check in and he reported normal fatigue, and having experienced nausea for 2 hours

Patient was sweating, dizzy and experienced pain on left side of stomach. 911 was called and patient was brought to the hospital.

Patient received the J&J vaccine on 5/18/21. 12 hours later, he developed nausea, vomiting, cough, weakness, headaches, sweats, and chills. On 5/19/21, he came to the emergency department. He received 1L of NS, ketorolac 30 mg, ondansetron 4 mg, and orphenadrine 60 mg.

Approximately 12 hours after receiving the vaccine, I woke up around 2:00 a.m. or so with extreme body aches, fatigue, headache, nausea, dizziness, and slight fever. Around 9:00 a.m. or so that same morning, I went to Emergency room because I was so sick I didn't know what to do. They said I was just having a reaction to the vaccine, and it should go away in a day or so. They gave me Ibuprofen and Tylenol and a shot of toradol. I was then discharged and went back to my living quarters. I had covid already back on January 20th 2021. But the vaccine was five times worse than the virus.

Swelling at injection site, fatigue, nausea, chills, hot flashes, mental fog, upset stomach and trouble with appetite for 2-3 days.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient was sitting in chair after vaccination and <5 minutes later, he started shaking, then faceplanted on the ground. He regained consciousness within 30 seconds. I elevated his feet and laid him on his back/gave water bottle. Observed for total of 30 minutes before allowing him to leave. he denied emergency services.

pt rec'd vaccine, waited 15 min in recovery stood up ad became lightheaded, dizzy, pale, diaphoretic no LOC near syncope, + nausea, no vomit. Ice pack to head and back of neck. refused to lie down. Gave water for hydration provided reassurance. Pt stated no nourishment taken in prior to vaccine. VS taken 122/80, HR 88 reg strong, resps 16 reg non labored, 94% O2 sat. L arm vaccine site benign. Monitored 30 min. at 9:50 pt stated, " I feel great can I go" Paleness and diaphoresis subsided. OK'd to exit with friend.

while in post vaccination observation, client thrust head back into the wall, while in a seated position. Became unconscious. Left arm tremor- observed. diaphoretic, skin warm to the touch, sweating. When client became alert and oriented, he was fearful of the situation and began to cry. stating he didn't know what happened, he was scared, and he was dizzy and didn't feel well. Patient given emesis bag, given water and Ice pack. He also reports no ability to alert anyone prior he had no physiological indicators of what was about to happen. He urinated himself. He then had the second emesis and EMS alerted and on site to assess patient .

He got his vaccine, he had the fever that evening. Overnight he started vomiting some brown gunk that looked like dried up blood from 1:00-2:00 AM. He did not have much of an appetite. This continued the following night around the same time. Then he started vomiting again the third day after the vaccine, and he vomited after work and was pretty much vomiting nonstop and started having difficulty in swallowing. Feeling fatigued. On Thursday morning at 2:00 AM he went to the ER on 4/29/21 and they prescribed him some anti-vomiting medication. That worked for about a day. On Friday he started spitting into a cup and spit about 3-5 cups of spit. On Saturday he went to the hospital on 5/1/21 and looked in his throat and said that he had some acidic burns from the vomiting and prescribed him Ondansetron 4 mg for the vomiting, which he did not take much of. They also prescribed him Diphenhydramine elixir to soothe his throat which he took every 6 hours which worked like wonders he said. He started to feel better after that point. He tested negative for COVID in the negative. He did have COVID in November of 2020, and he had vomiting at that time as well. He was sick with COVID for about a week. He did not have much of an appetite either. He also felt very fatigued and felt better following Thanksgiving and tested negative the Monday after Thanksgiving. The fatigue symptoms lasted about 3 weeks after he tested negative, so he was sick for about a month in total.

SEIZURE; VOMITING; DIAPHORESIS; TIRED; This spontaneous report received from a consumer concerned a 24 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 31-OCT-2021) dose was not reported, one total administered in Left arm on 03-JUN-2021 at 13.25 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021 (within 5 mins of the post-vaccination, 13.30), consumer reported that patient received the Janssen COVID-19 vaccine and began to seizure, of the post-vaccination and 20 mins later (13.45), patient vomited. Diaphoretic. EMS was called to assist the patient. Patient refused to go to ER (emergency room), but was given an ice pack. Patient was now fine, and was picked up to go home. Currently patient felt tired. The patient recovered from seizure, vomiting, and diaphoresis on 03-JUN-2021, and was recovering from tired. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210607415-covid-19 vaccine ad26.cov2.s -seizure. 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).

2 days after receiving the vaccine, I felt a severe pain in my chest/stomach area, centered just below my rib cage. It hurt when I was laying immobile, and it hurt even more when I moved. The pain lasted for approximately 4 days, by the third day I the pain had lessened considerably, and on the fourth it was only present when I was upright for extended periods of time.

client reported nausea after receiving 1st Janssen Covid vaccine. At 1540 RN assisted client who was pale and nauseous to sit down in observation room. Client reported he had just received Janssen Covid vaccine and was feeling nauseous. RN gave client emesis bag. PHN joined RN at 1543 with vital supplies. Upon arrival client sitting in chair, leaning forward holding emesis bag. Client appeared pale. Vitals: blood pressure 103/56, pulse 61, oxygen 96%. PHN and RN assisted client to transfer from chair to anti-gravity chair. Per client only had nausea. Declined headache, blurry vision, chest pain, shortness of breath. Per client had arrived to site and ate snack quickly prior to vaccine, last meal was breakfast. RN provided client water and juice at 1545. Per client no relevant medical history, medications and no known allergies. Vitals at 1548: blood pressure 135/75, pulse 59, oxygen 96%. Per client nausea improving, skin color improving. RN stayed with client remaining time in observation. Vitals at 1553: blood pressure 131/78, pulse 68, oxygen 97%. Per client all symptoms resolved, skin color normal for ethnicity. Vitals at 1603: blood pressure 136/79, pulse 58, oxygen 100%. No complaints. Client finished juice. Last vitals at 1613: blood pressure 140/81, pulse 56, oxygen 99%. Per client feeling fine, no nausea. Client left facility with steady gait at 1620.

Patient received the vaccine at approximately 10am on 6/21/21. Shortly after receiving the vaccine, he complained of a headache and arm pain. Patient was told to remain seated and was monitored by pharmacist and staff. After 20 minutes, he was still not feeling well. He was moved into a different observation area. Based on symptoms it appeared he was having a a vasovagal reaction. He did not want to lie down and elevate his feet. At approximately 1/2 hour, he became nauseous and threw up. We continued to monitor him. He still had a headache and said he felt off. He had no swelling in the face and was speaking without issue. No hives were noticed. Patient said he was having a hard time breathing- I suggested he remove his mask to get more fresh air. After removing the mask, he said it felt better to breathe. In total, patient was monitored for 3 hours. He did not lose conscience, exhibit facial swelling or hives. Patient went back to work for 1 hour then left to go home. Prior to receiving the shot, patient showed a lot of anxiety and was hesitant to get vaccine. In the end, he decided he wanted to get it. Per medical staff at his work, he does tend to be high stressed and anxious. I followed up with patient on 6/22/21. He stated that he was feeling a lot better. He did have redness at the injection site- I explained he could ice the area. He still had a headache= I instructed him he could take a pain reliever. He mentioned he had a purple spot on his back. I asked if he had any other spots and said he would have to check. I suggested he contact his PCP and make an appointment to be seen.

Patient received shot around 2:45pm. Around 2:48, patient started feeling nauseous, sweating, flushing in face. Gave patient bag incase of vomiting, applied two ice packs, one to back of neck, one to forehead. Around 2:52 patient said was feeling less nauseous, a little less flushing. Around 2:56 patient asked for a cool rag rather than ice packs, very little sweating, little redness in face, asked for water and felt better. Patient stated prior to immunization has problems like this with blood draws, however did not recall having this reaction before with vaccinations.

Janssen COVID-19 Vaccine EUA Beginning morning of 3/4/21. Nausea, extreme fatigue, body ache, severe headache, chills, fever, coughing. Beginning morning of 3/5/21. Nausea, body ache, mild headache, coughing, chills, mild fatigue

Body chills 8 hours after receiving vaccine. 2 hours after that, fever of 103 F and severe headache. Took 1000mg of ibuprofen. The next day fever was about 100F, headache was mild, slight nausea, tired feeling.

Woke up at 1:30 am with shivers and vomited. Felt dehydrated. Woke up one hour later sweating and vomited. Repeat back and forth cycle until 7am. Feeling much better now. Just achy.

Started feeling very tired as the evening went on. Went to bed around 10pm and woke up at 11pm with extreme chills and violently shaking, that shortly turned into feeling very warm showing sines of a fever along with nausea. Temperature seemed to normalize around 4 am and then a severe headache followed and has lasted all day. Slight chills started again approximately 24 hours after receiving the shot.

Begun feeling fatigued and weak when waking up in the morning, progressed into chills and feeling of faintness. Difficulty swallowing and some pain and shortness of breath when swallowing.

severe nausea, anorexia, epigastric pain. Symptoms lasted 10 hours are required 4L NS IV, 16mg zofran IV, 50mg phenergran IV

Patient experienced significant nausea and vomiting and 103 degree fever. Symptoms started about 4 hours after vaccination and built for the next 3 hours before patient went to the emergency room for treatment.

I received the Janssen vaccine on 3/19 at 8pm. 7 hours later ~3am I awoke to severe chills, climbing fever, and nausea. OTC fever reducers helped bring the fever down eventually. The entire day (3/20) my fever was on and off and nausea would also be present. Bouts of feeling well and bouts of fever. Had a minor fever when going to sleep that day and the fever was gone when waking up on 3/21. So ~24 hours of side effects.

Chills, fever, nausea/vommiting, fatigue, headache muscle pain. Symptoms lasting roughly 14 hours. Treated with Nyquil and Ibuprofen

15 (09:50) minutes post vaccination, pt approached healthcare staff and indicated eye itchiness and thickening in throat. Per pt, facial swelling was not present. Pt was observed closedly x 3 minutes, during which time pt indicated throat swelling was progressing. Diphenhydramine, 25 mg PO administered at 09:55. At 10:10 pt stated eye itchiness was worstening, and he was unable to swallow, could breathe comfortably thru his nose. At this time RN and MD decided to call for emergency support, and they arrived at approx 10:15. After initial assessment they determined the best course of action was to transfer to ER should airway management be needed Pt and EMS left facility at 10:25.

headache,vomiting. 25y/o male Had Covid vaccine today @0800, now PT has all the symptoms plus Lumbar pain. PT looks to be in a lot of discomfort, talks in breaks, lower back TTP.

Woke up at about 1:00 AM with a 102 degree F fever, cold sweats, shaking very hard, headache, dizzy, and nauseous. It was hard to walk. Temperature and affects started going away slowly by about 9-10 AM and just the headache remained, by about 12 PM all side affects mostly went away. My temperature is now 98 degrees F at 4:15 PM.

Gave the immunization and a few minutes later he started to feel dizzy, nauseated and was sweating. He said he felt like he was going to pass out. I laid him on the floor with his legs up and ice packs on his neck. He never lost consciousness and recovered quickly.

Thursday 4/8: 3:20pm: COVID injection given in right arm Friday 4/9: ~1:00 am: woke up shaking with chills and severely cold; had slight headache. Had insomnia all night. 6:00 am: woke up with bad headache, slight fever. 7:00 am: got out of bed and had vertigo and was running into walls trying to walk to my living room, along with the worst migraine I?ve ever had. Also had dizziness, nausea, chills, 100+degree fever, aches, skin sensitive to touch, and severe tinnitus. All of the veins were visibly popping out of my head. As the day went on, everything got worse. Any time I moved, my head would throb so bad that I thought I was going to have to go to the hospital. 3:45 pm: the headache started to finally go away. It would only hurt if I moved fast. At this point my fever was only slightly high, about 99 degrees. I was still unstable when I walked and dizzy. I went from being super cold, to being super hot and sweaty. And I was alternating between cold & hot and sweaty for the rest of the night. Was also having some memory issues, repeating things when I was having a conversation with someone over the phone. I was sweating all night when I was sleeping. Saturday 4/10: 7:00am: woke up with a slight headache; still out of it and dizzy. 8:00am: after being awake for about an hour or so, I looked in the mirror and my whole face (around the lips, cheeks, and jawline, and under the eyes) was really swollen and puffy. My face was even mis-colored. Under my eyes was purple and yellow, and my cheeks were white. Some confusion persisted throughout the day as well as dizziness.

Headache & fatigue - 6pm (3 hours after vaccine) Nausea, dizziness, body aches - 6am (15 hours after vaccine)

Approximately 5 minutes after vaccine patient was in 15 minute lot, car in park. Observer Called on emergency radio for RN with bag. RN noted patient was actively Seizing. the patient's wife was in the vehicle and confirmed the seizure. The patient was conscious within 2 minutes, vomited x 1 and stated he was stating to feel better. EMS was activated as son as the seizure was noted and took approximately 10 minutes to arrive. The patient was conciuos and walked to the ambulance and was transported to hospital

9 April 11:07am: got the vaccine 12:00: started feeling an underlying headache. 15:00pm: very fatigued, headache increased, slightly nauseous. 16:30pm: started feeling better, but still have an underlying headache. Appetite came back. 17:42pm: started feeling a fever develop. 23:30pm: temp. were normal 97?F. 10 April 03:30am: +102?F fever, body pain, Took one 500mg Tylenol, Stayed awake until 04:17 with elevate heart rate and it felt like my heart was pounding through my chest. Headache increased and I started to experience neck stiffness. 04:17: Temp 98.9?F. 04:39am: took another Tylenol 500mg and finally slept. 10:00am: woke up 11:31am: had breakfast and took Tylenol 500mg. Underlying headache, neck stiffness, light chills, ears are sensitive to sound. Elevated heart rate and increase blood pressure. Could feel my heart beating very strongly and intensely. 16:07pm: fever chills continued to be more severe. Latest temp is 102.2?F. Took another Tylenol 500mg. Heart rate is still elevated and beating very strongly. Headache and neck stiffness. 18:35pm: Temp 102.7 F. Heart, head and neck same as above. 18:42pm: temp 102.3 F. Heart, head and neck same as above. 19:30pm: Went to Urgent Care to seek medical assistance as my condition deteriorated. Received 975mg of Tylenol from Urgent Care unit. 20:00pm: Transferred to Hospital ER facility for further checks/tests. 21:20pm: Temperature gone done from fever levels. Still waiting for doctors to tend to my case. 22:05pm: Doctor came to see me and suggested an IV to hydrate me. 11 April 12:58am: Received the IV and pain medicine. 02:03am: IV completed, headache and neck stiffness reduced. Heart rate still very elevated and pounding strongly. 11:00am: Still had an underlying headache, dizziness and foggy mind.

It felt like I had contacted the virus all over again except worse than last time. Body aches, chills, fever, nausea, severe headache, fatigue, slight cough, balance and coordination problems, chest pains. Literally the only things I don?t have are the loss of taste and smell.

Symptoms began about 12 hours after the shot was administered. They lasted for about 22 hours. I received the shot Friday morning, by Friday evening the symptoms had appeared and worsened throughout the night and day on Saturday. By late evening(6-8) I began feeling much better. The symptoms included body aches, high fever, chills, nausea, hallucinations, dehydration, dizziness, loss of appetite, exhaustion, and a restless night of sleep.

PT presents with fever/chills and fatigue x 1900 reports received JJ vaccine 0945 yesterday. Patient is a 25 year old male who presents to ED with fever, weakness, nausea and body aches 12 hours after receiving the J&J vaccine. He has not taken any OTC medications. He is able to drink however. He denies any vomiting, no rash, no productive cough.

Symptoms: pale, nauseous & chills PMH: history of anxiety and allergy to sulfa Vitals: BP 120/63 RR 20 Pulse 50 O2 99% Intervention/treatment: assessed vitals, gave patient juice and water

Beginning about 7-1/2 hours after the shot, I began to feel lethargic and dizzy. Over the subsequent 12 hours feelings of fogginess, nausea, headache, chills, and sweating increased, peaking at about 3a.m., including a low fever. Symptoms then began to slowly subside until by around 4p.m. the next day I felt mostly normal.

PT reports HA, nausea, fatigue and chills x 1600 yesterday after receiving JJ vaccine. last 650mg tylenol 8pm. HPI: 25yo AD M presenting to ED for evaluation of above complaints that began yesterday after receiving the J&J COVID vaccine. The patient is having no dyspnea, no pleurisy, no cough or fever. The chest pressure is substernal without radiation, no palliating or provoking factors, not associated with N/V or diaphoresis. He has no family history of early MI, no ACS risk factors. No PE risk factors.

I began to have am intense headache, and a strange acute pain in my gut. It hurt a lot, I became extremely achy and feverish. I had a fever of about 103°. There wasn't much pain in my arm, only a little. Everything felt so so achy. By the next day at noon my symptoms were gone.

HEADACHE; SHORTNESS OF BREATH; NAUSEOUS; MUSCLE TENSE; SEVERE MIGRAINES; SWEATING; SHAKING; CHILLS; ELEVATED HEART RATE; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's weight was 200 pounds, and height was 66 inches. The patient's past medical history included childhood asthma, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known vaccine, food or drug allergies and no history of drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced elevated heart rate. On 19-MAR-2021, the subject experienced sweating. On 19-MAR-2021, the subject experienced shaking. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:00, the subject experienced severe migraines. On 20-MAR-2021, the subject experienced muscle tense. On 20-MAR-2021, the subject experienced nauseous. On 20-MAR-2021 02:00, the subject experienced shortness of breath. On 20-MAR-2021 07:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate, severe migraines, sweating, shaking, chills, headache, nauseous, and fever on 20-MAR-2021, was recovering from muscle tense, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V2: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

About 11 or 12 hours after receiving the vaccine, patient began a fever of 103.6 degrees and had severe chills. He also developed nausea and a headache. He then took his first Motrin(200 mg). The following morning his fever temperature was 99.5 and by noon it was normal again.

c/o chest tightness, headache, chills, cold, muscle ache, throwing up since had J&J vaccine. took Motrin last night and this morning, 0900 but no changes. denies sob, abd pain, dizziness.

Developed abdominal pain on 3/25/2021 and developed bilateral leg pain on 4/2/2021. Bloodwork and ultrasound of legs were normal. Advised to follow-up with PCP.

After receiving injection patient walked out of pharmacy and sat in chair in front of pharmacy. About 8 minutes or so later, patient fell back in the chair and passed out. I ran over and called the patient's name who came to, and he felt warm and sweaty. Patient was able to recall his name, the day of the week, and where he was. About 2 or 3 minutes later after coming out to the patient, he vomit into a trash can and then stated he felt much better.

SWEATING; VOMITING; TREMBLING; SEVERE MIGRANE; LIGHT HEADEDNESS; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced trembling. On 10-APR-2021, the subject experienced severe migrane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, trembling, severe migrane, light headedness, weakness, chills, and fever on 10-APR-2021. This report was non-serious.

Two weeks after I got the shot I got the following symptoms. Not sure if they are related or not to the vaccine. - left arm tingling - belly tingling - headache (persistent but mild) - diarrhea - felt like I was about to faint when walking

PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 year old male. 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 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 body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case

I received the J&J vaccine after 1 PM, on Tuesday, May 4th. Around 9PM that night (last night) I started experiencing chills and a dull, aching pain focused in my testicles, groin and lower abdomen.

Status post vaccination patient reported nausea, abdominal pain, and light headedness. Patient stated he went to car and was unsure whether he fainted or not as he felt weak. This occurred within a time frame of 20 minutes post vaccination. Vitals were checked and BP, temp, and pulse within normal range. Patient stated he was feeling much better and the event only lasted a short period of time. Patient was given a cold water bottle and observed at the pharmacy. Vitals were rechecked after another period of 15 minutes and were unremarkable. No medications were administered and no further medical attention required. Notably was a hot day (temperature in the 90s) and patient stated he had not eaten anything all day since cereal in the morning (vaccination administered at 5PM). Patient stated he was feeling much better.

Severe headache, vomiting, diarrhea, chills, fever, cold sweats No treatment for health professional Symptoms subsided after 10 hours

Patient received vaccine. He has a history of fainting/becoming light headed after vaccination. He began to feel light headed and decided to lay down. Patient was given water and an ice pack. Patient was nauseous, and sweating profusely. After ~5 minutes, patient began to feel better. He waited another 15 min in the pharmacy before leaving with a driver.

25-year-old male chief complaint of nausea vomiting headache fevers chills and bodyaches. On arrival vital signs stable. On exam abdomen soft nontender nondistended. Patient with no focal neurologic deficits no meningismus. suspect vaccine reaction. Patient givenZofran N ED with resolution of vomiting. Plan for discharge home with continued supportive care and follow-up with primary care physician.

Patient received vaccine and with in minutes, became very light headed, vomited and lost consciousness. Patient became alert but still had trouble hearing, seeing and speaking, and vomited several more times. Paramedics arrived and transported to hospital

ER care, spent 5-7 hours under treatment of lactic acid, saline IV, ivsoln IV and ceftriaxone vial after receiving multiple imaging tests, EKG, and other tests. He started feeling bad in the evening, went to sleep, and woke up around 11pm that night shaking uncontrollably, unable to see, had an extreme headache and was throwing up. His heart rate was close to 180 while sitting down and he could not stand up. Was taken to the ER and seen immediately. Afterwards for about 2 weeks he had bad chest pains and extreme shortness of breath. He could not exert himself at all.

At 12 Hours Post-Vaccination the following adverse effects were experienced for approximately 48 hours: Moderate Fever, Severe Fatigue, Moderate Chills, Moderate Body Aches, Mild Nausea, Mild Headache Onset 3 Days Post-Vaccination: Mouth and Tongue Ulcers

NECK ACHES; DIZZINESS; JOINT PAIN; HEADACHE; CHRONIC FATIGUE; NAUSEA; ACHINESS; FEVER; TIREDNESS/CHRONIC FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with cetirizine hydrochloride for drug used for unknown indication, and fluticasone propionate for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative, Diagnostic ultrasound (NR: not provided) Negative, Lung function tests (NR: not provided) Negative, and Mononucleosis heterophile test (NR: not provided) Negative. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness/chronic fatigue. On 15-APR-2021, the subject experienced neck aches. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced joint pain. On 15-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced chronic fatigue. On 15-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, tiredness/chronic fatigue, achiness, headache, neck aches, dizziness, joint pain, chronic fatigue and nausea was not reported. This report was non-serious.

Pt at vaccination table after receiving first dose Johnson and Johnson vaccine. Nurse states she left table to get the lot # and upon returning pt stiffened up, eyes rolled into back of head. 1425 staff assisted in lowering pt to the floor where he began to demonstrate convulsions lasting no more than 30 seconds. Nurses and EMS responded. Pupils dilated , skin pale and stated "am I okay? Hello." Nurse told pt what had happened. A&O and able to tolerate water. Pt states no past medical hx. BP 118/62, HR 62, O2 97% and POC 108. Pt sat up, stated feeling nauseous and started to vomit. Pt assisted to stretcher at 1440. Pt educated on going to hospital for further evaluation. At this time pt is refusing transport and wants to wait.

Pt passed out (slumped over in chair) was unconscious for maybe less than 10 seconds and twitching. He came to and was conscious and seemed to know what had happened. was pale, sweaty, weak, upset stomach and low blood pressure. was not feeling well for a good 15 to 20 minutes. felt better, was assessed by EMTs and declined hospital visit.. went home with 2 friends. did not drive.

HEADACHE ALMOST MIGRAINE; MOSTLY SLEEPING; LITTLE TIRED; VOMITING EVERY WHERE; This spontaneous report received from a parent concerned a 25 year old male. 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, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vomiting every where. On 03-JUL-2021, the subject experienced mostly sleeping. On 03-JUL-2021, the subject experienced little tired. On 04-JUL-2021, the subject experienced headache almost migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting every where on 04-JUL-2021, and headache almost migraine on JUL-2021, and was recovering from little tired, and mostly sleeping. This report was non-serious.

Patient complained of dizziness,nausea ,sweating and fever which lasted for about 2minutes(hot flashes). He was asked to sit down while EMS is being activated and the pharmacist kept an eye on him as he was recuperating EMS(911) was invited and they arrived about 3.11pm. By that time patient has recovered from those reactions and was waiting for EMS to arrive. EMS arrived and took his vitals and asked him how he is feeling. He acknowledged that he is fine and after a couple of minutes he stood up and walked away with the EMS staff

pt states the day he got the vax he was fatigued, nauseated, headaches, body aches and pain with high fever. These symptoms went away and then came back 2 days later and lasted about 2 1/2 weeks. He went to Urgent Care. He was going to be prescribed antibiotics but he didnt have insurance so was told to take over the counter pain relievers. He had an unexclusive Covid test.

CHEST PAIN; UNABLE TO SLEEP; FEELING NAUSEOUS; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included nuts allergy, seafood allergy, dog allergy, and cat allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUL-2021, the subject experienced chest pain. On 22-JUL-2021, the subject experienced unable to sleep. On 22-JUL-2021, the subject experienced feeling nauseous. On 22-JUL-2021, the subject experienced headache. On 22-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, unable to sleep, feeling nauseous, and fatigue on 23-JUL-2021, and had not recovered from headache. This report was non-serious.