Johnson & Johnson

PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; FEVER; DIFFICULTY PERFORMING EVERYDAY ACTIVITY; GENERAL SENSE OF CONFUSION; EXCRUCIATING HEADACHE; This spontaneous report received from a parent 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: 203A21A 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 general sense of confusion. On 10-APR-2021, the subject experienced excruciating headache. On 11-APR-2021, the subject experienced difficulty performing everyday activity. On an unspecified date, the subject experienced product administered to subject of inappropriate age, off label use, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general sense of confusion on 11-APR-2021, and the outcome of difficulty performing everyday activity, fever, excruciating headache, product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.

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.

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

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

Body aches, headache, restlessness through the night, sore arm, weak legs, normal temperature, but feels very hot

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

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

Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Loss of conciousness for less than 1 minute-Medium, Additional Details: The patient lost conciousness within a minute of receiving vaccine. Rph notified and immediately ran to patient. Rph tapped on patients shoulder and asked \"are you okay\" and patient regained conciousness immediately. Patient was confused and did not realize he lost conciousness. Patient felt oaky after regaining conciousness, but Rph helped patient lay down and elevated feet. Vital signs were monitored and were normal.

Mild fever <100°, mild chills, severe exhaustion, severe body aches, fogginess. This lasted about 36 hours, with the exception of the left hand. The left hand experienced carpal tunnel and arthritis-like symptoms for 6 days longer than all other symptoms. It then went away on its own. To my knowledge, I hadn?t in any way performed stressful or repetitive behaviors leading up to the symptoms; I had been bedridden with the vaccine side-effects and was too exhausted to do much of anything.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Seizure-Severe, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was given COVID vaccine and moved to another chair to be observed. Upon sitting in other chair, he almost immediately went stiff, began convulsing, and then went unconscious. Patient came to, 911 was called, and patient was transported to ER.

Headache, Fatigue within an hour, 8 hours after Achiness all over, Chills, Fever, Racing Heartbeat, Headache comes and goes, sleepiness, then too hot can't sleep Took 2 Ibuprofen, 2 x 30 suedo-effedrin , ate bagel and cream cheese, 1/2 a banana 3x2000 D3 vitamin Trying to sleep now

The patient fainted after receiving the vaccine. It was app. 5 minutes after receiving the vaccine that the patient fell over from his chair in our waiting area. The pharmacist helped him back up and the patient stated he was just nervous/anxious. He was given water and started to feel better. After an additional 15 minute the patient left. No medications were given.

After vaccination, patient fainted and by the time got over to him he was alert. He was able to sit up and then was able to get into the chair. While in the chair he appeared to faint again ( looked like he was asleep in chair) and 911 was called. Patient states he had not eaten today and this was late afternoon. He also said he was nervous. EMS arrived and he agreed to go get checked out.

Pt received the vaccine & was advised to sit near the pharmacy for 15 min but pt preferred to walk around the store instead. heard mom yelling to call 911 & went to the aisle. Pt fainted while walking in the cooler aisle. Per mom he hit his head against a shelf. He does not recall hitting his head but said his neck was hurting. Pt was alert. Per pt & per mom pt gets anxious w/shots. 911 was called, pt stayed laying on the floor until EMS came to evaluate pt. EMS did not advise pt to go to hospital.

The patient passed out a couple of minutes after receiving the vaccine. I asked if he had had any reaction or problems to vaccines or shots before and him and his parents and him both said no. After he passed out they told me he was mildly autistic and had passed out at the doctors office when getting a shot and in biology class dealing with dissection. They repeatedly said it was just anxiety. After laying him down and elevating his feet he started feeling better. At no time did he display any breathing problems or any anaphylactic symptoms. And he did not hit anything when being laid down. I monitored him for 30 minutes and let them go after they said he was 100 percent feeling fine and he seemed like he was ok.

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.

Patient had an adverse reaction to the Janssen COVID vaccination. After vaccination, patient was told to wait 15 minutes in this chair and we would observe. I prepare their COVID card and went back out to give card and ask if the patient had any other questions. Patient was scared of shots, so some anxiety was expected, however after a few minutes while I was talking to the patient, I noticed he got stiff, and started to seize. His family was near by and we immediately put him onto the floor with head on a cushion and called EMS/911 CODE WHITE. He did not hit anything while seizing/convulsing. Once he laid down, within a few seconds, He stopped jerking, became conscious, and asked what happened. He lost consciousness and only remembered me talking to him about his questions about the vaccine. He was fully aware of his surroundings afterwards and said he never had a reaction like that to a shot before. Some anxiety, but not a seizure. EMS arrived shortly there after and he was taken to the hospital after inspection from EMS just to make sure everything was okay. We had to make a report to management per Store Policy. VAERS was reported

Waking up in the middle of night with terrible fiver (feeling extremely cold while in reality burning up). Headaches. Fatigue.

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!!!

STARTED FEELING WOOZY AND BECAME UNAWARE PT PLACED ON COT AND AMMONIA INHALANT USED. BECAME MORE ALERT AND FEELING BATTER

Patient had a vasovagal response and passed out about a minute after the actual injection of the vaccine. He was unresponsive, was twitching, urinated himself, and when he woke up was slightly confused.

103 DEGREE FEVER; COULD NOT SLEEP OR ANYTHING; This spontaneous report received from a consumer 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, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced could not sleep or anything. Treatment medications included: paracetamol. On 23-JUN-2021, the subject experienced 103 degree fever. Laboratory data included: Fever (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever on 24-JUN-2021, and the outcome of could not sleep or anything was not reported. This report was non-serious.

My son woke up at 1am and felt like hw was "burning up" and felt like "heart was beating out of his chest". Heart rate on running watch was in the 150s. Pt is a runner and typically resting HR is 52-55. Mom took temperature and it was 104.1. 1000mg of Tylenol was given. Temperature was checked 20min later and it was 104.8 and checked a little bit later and was 105.4. He didn't seem himself during this time. HR was still in 120s on HR rate watch, it was difficult to monitor it by had because it was going so fast. During this time I also monitored my temp (mom) and it was 98.1 to see if the thermometer was working appropriately. The temperature took 2 full hours to gradually come down to 98.9 and HR round 100. When the temp was down to 102.1 then he started talking clear and said he felt a little bit better.

After receiving a vaccine patient became disoriented fainted and exhibit muscle spasms. Treat it with Aromatic ammonia salt and water. Upon arrival of EMS patient got some glucose as well. Last report he was felling better, EMS took patient to the bus for check up. Unknown if patient went to the emergency room.

Starting 11 hours later, I got a bad headache, chills, my whole body aches, it hurts to move, I can?t sleep

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

I have had widespread soreness and pain over my entire body, I woke up at 3:30 AM and couldn't go back to sleep, I had light sensitivity, and a massive headache.

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

My heart rate is constantly high and won't slow down. It started at 1am, 3 hours after I fell asleep and had a fever of 100.3 and a headache and soreness. I couldn't fall back asleep the entire night.

While patient was waiting out the 15 min, he states he felt weird and went to let his father know. Upon getting up and leaving waiting area, pt. fainted but was quickly alert and able to speak. Patients father did state the patient has a needle aversion and has experienced this situation in the past.

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

When trying to fall asleep night of vaccine, had chills and soreness and struggled to fall asleep. Throughout night woke up many times with same symptoms. At 6:00 AM woke up for good with a 102 fever, migraine, soreness, chills, and no energy. At 8:00 AM the fever got up to 103°F. I then took Tylenol and the fever slowly started to subside but the migraine, soreness, and lack of energy stayed. As of Tuesday, two days after the vaccine, symptoms have gone away.

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.

Lightheadedness and headache about 8 hours after vaccination, restless sleep during the night. Next morning before taking a shower felt lightheaded and sick to stomach. After my shower I fainted and had an ankle contusion due to fall.

BODY ACHE; DIZZINESS; FEVER; HEADACHE; DIFFICULTY SLEEPING; 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 premature baby, and concurrent conditions included asthma, and very thin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:45 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced difficulty sleeping. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body ache, and the outcome of dizziness and difficulty sleeping was not reported. This report was non-serious.

on 4/9 He said he had flu like symptoms, and dizziness and pain to the point that he could not sleep(he said all of his teammates got sick) on 4/11 He had some much pain in left arm he could not play tennis. He had not been able to play tennis since its been two weeks on 4/17 He went to Urgent Care and they prescribed pain and anitinflammatories He still cannot play tennis

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 had a J&J vaccine at 1327. He reported that he was having trouble breathing around 1333. He reported that he felt hot and sweaty and lightheaded. He appeared distressed. We called 911, then we provided a client with a cold pack. His pulse was 47 bpm and his spO2 was 97%. He continued to state that he was lightheaded so we had him lay down on the ground and take deep breaths. EMS arrived they collected his vitals which were WNL. His blood glucose was 71. He was warm and moist to the touch. EMS stayed with the client until 1350 at which point he had sat up and sat in the chair. He said he was definitely not having trouble breathing anymore and was feeling better. Provided client with a juice box and water. Client stayed onsite until 1410 at which point he said he felt comfortable leaving. Client walked unassisted out of the clinic.

Aches and pains outside of arm 15 minutes afterwards. Subsided largely, but chills started and became more heightened after strenuous exercise later in the day. After 3 hours of sleep, awoke the next day with chest pain and difficulty moving. Heart rate (normally 60) spiked to 140 and could not see fit five seconds, had to call ambulance. Ambulance determined much of it was due to anxiety (multiple exams and significant work were due soon), and recommended medical supervision to ensure it did not escalate. Went to urgent care and was supervised until 1 pm, 24 hours after the vaccination, by which time symptoms had subsided

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.

Immediately after sitting down in the waiting area after receiving the shot, the pt reported feeling a strange pressure in their arm. Following this, the patient described the sensation of "blanking out". The pt fell off their chair and lacked alert conconciousness for roughly five seconds. When the pt came to, they appeared confused and twitchy, with wide eyes and an overall appearance of shock. Pt remained in their state for roughly a minute, before stating that they felt completely better. The pt had developed a sweaty back but didn't state that they felt overally hot. They didn't mention being in any pain. The local injection site appeared a bit red but nothing of significant note. Pt did bump their head on the side wall behind the chair, receiving a minor bruise. Pt was given some water to drink and was monitored for 30 minutes. They pt stated they felt fine. They had no past history of fainting with vaccines, thought pt claimed to have passed out like this before but only after suffering a head injury. After their wait, the pt was allowed to leave and assured us that they felt completely fine.

Patient fainted roughly 5 minutes after vaccine. He was nervous and stated he had fainted in the past from vaccines. He asked to have his partner with him during the shot and after to help prevent fainting. She was there when he asked to put his head down, then fainted. We moved him to floor. By the time we were able to get him to floor, he was waking.

Adverse Events: Lack of muscle strength, thought capacity, sore eyes, sore left elbow. less coherent thoughts, headache, woken up from sleep. starting at 0230 all lasting approx. 6 hours. Treatment: 3x ibuprofen tablets taken approx 4 hours in. all events completely faded by 1000.

The patient is a 19 yo male with pmh of anxiety d/o on clonazepam, who is also afraid of needles. He presented with his father to the site of vaccination and was very worried about the phobia to needles. He was nervous, about 4 minutes after vaccination he experienced lightheadness and near syncope, he was lie down flat on the floor and had legs elevated about 90 degrees, at this time the father was looking for water and when he came back he noticed that we were assising his son. He stayed for 15 mins there, VS: were stable 120/75 HR: 80 taken by the nurse. Denied any headaches, no palpitations and felt better, he just landed from California. Pt and dad refused EMS and wanted to leave home. Patient was stable a

Worst back pain ever felt. Horrible, lingering headache. Complete body pain and weakness. Could not sleep. Took acetaminophen at 6 am the morning after vaccine.

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.

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 pre-existing medical conditions included the patient had no medical conditions and had no known allergies.The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced high fever. On 12-JUN-2021, the subject experienced brain fogs. On 12-JUN-2021, the subject experienced lower back pain. On 13-JUN-2021, the subject experienced not acting normally. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 13-JUN-2021, and high fever on 12-JUN-2021, and had not recovered from brain fogs, and not acting normally. This report was non-serious. This report was associated with a product quality complaint: 90000182718. The suspected product quality complaint has been confirmed to be voided (does not meet pqc criteria). based on the PQC evaluation/investigation performed.

patient fell down but was unaware of doing so, he almost immediately was conscious again and went and sat down, he was sweating all over for about 15 minutes as well; he was given a bottle of water and was observed until the EMS arrived: after they arrived and checked him out he left without the EMS

I fainted while sitting in a chair about 3 minutes after receiving the dose. When I was woken up I was disoriented and had patchy vision as though due to low blood flow to my brain. I laid down on the floor with my feet in the air for several minutes to regain blood flow, then slowly got to my feet.

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.

chills, shaking, delirium I got progressively more cold and then i started shaking. when i got into bed i was thrashing around for hours.

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.

Immediately had a dull headache. About an hour and a half just didn't feel well and became very tired where he was dozing off. About 7:00 pm started to shake. This continued to get worse with severe jerking along with the uncontrollable shaking. Had a rapid resting heart rate over 142 and a fever at 102.4. Was incoherent, mumbling his words and not making any sense. Went to ER at 8:48 pm they did blood work, urine test and started an IV. They weren't sure what was going on and first accused of doing drugs then wanted to do a spinal tap. His father stopped that and again told them it was from the covid vaccine. They finally gave him a shot of Ketorolac 30mg and LORazepan 1 mg. They sent him home and told him to take tylenol for his fever. spontaneous shaking kept on until late 3/11, along with a fever. Friday 3/12 he is feeling better, fever has broke but not quite 100%.

Headache and fever started about 7 hours after vaccination. He took 200 mg Ibuprofen . He had difficulty sleeping . Had a fever of 100.2 at 7am.

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.

Tired slight h/a 3 hrs post. Took nap, better. About 8 pm went to bed. Now, h/a severe, photophobia, wants to go to hospital, afraid. Fever of 100.8. Can?t lay down, get comfortable

Chills. Lots of chills. Fever. Felt like I was hit by a train, only the night of getting the vaccine tho. Also was extremely tired and my head felt foggy, even the next day too.

Starting about 6 hours after the shot: lower back pain, headache, shaking 7 hours: additional pain in legs and upper back 8 hours: shortness of breath, dizziness became extreme 9 hours: extreme shortness of breath, vision going dark, continued dizziness and pain, feverish 10 hours: violently shaking, extreme back pain, continued worsening shortness of breath and dizziness 11 hours: extreme headache, anxiety worsened 12 hours: extreme dizziness causing inability to walk, extreme headache, extreme back pain 13 hours-on: pain calming a bit, headache continues, slight dizziness, continues feeling feverish

In 15 minute observation area, Passed out, fell off chair, had some shaking, difficult to rouse, hit head on floor and got a small cut, was taken on stretcher to private area, vitals taken every 10 minutes, released in 30 minutes. He still feels off, several hours later. Incident wasn?t documented at site.

Patient was administered Janssen COVID vaccine. Patient was fine immediately post administration in the IMZ room but witness stated he fell sideways (within a few minutes of receiving the vaccine) out of post-administration observation chair (which is in front of the pharmacy). Technician called code white and patient was immediately met with management and the pharmacy team. Patient was laying on his stomach on the floor, supporting himself upward with both hands/forearms. Patient had blood dripping from forehead and nose. Gauze was applied to laceration on forehead to help with bleeding and once patient was able to roll over on his back, an ice pack was applied to his forehead/nose area. Patient said he felt "pain" after the injection and then he felt light-headed. He remembered blacking out for a few seconds. Patient stated he felt "ok", then later stated he felt better but just had a bad headache. Patient stated he felt "it starting to hurt" and that it triggered his anxiety. Dad was in the store and arrived a few minutes later; dad said son/patient has a "fear of needles" and "he hasn't had anything to eat today in quite awhile". EMS arrived to examine patient and asked him if he needed to go to the ER; dad felt going to the ER was for the best since they had a 3 hour car ride home. Paramedics then transported patient to the ER and said he would likely need a stitch for the cut above his eyebrow.

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 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.

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

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'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.

11 hours: Headache, fever, chills, nausea, fatigue, inability to focus, general feeling of unwellness 20 hours: Fever breaks 24 hours: Fever returns. Other symptoms begin to lessen. 36 hours: Fever breaks. Other symptoms continue to diminish 48 hours: All symptoms gone, except for mild fatigue and inability to focus 60 hours: All symptoms gone

DIZZINESS (HEAD RUSH); BRAIN FOGGINESS; FELT HOT; FEVER; PULSING IN THE PLACE OF THE SHOT; This spontaneous report received from a consumer. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 08-APR-2021, treatment medications included: ibuprofen. On 08-APR-2021 18:00, the subject experienced dizziness (head rush). On 08-APR-2021 18:00, the subject experienced brain fogginess. On 08-APR-2021 18:00, the subject experienced felt hot. On 08-APR-2021 18:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness (head rush), pulsing in the place of the shot, brain fogginess, and felt hot. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

BODY ACHE; DID NOT SLEEP; FEELING SICK; HEADACHE; FEVER; This spontaneous report received from a vaccine facility 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: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced did not sleep. On 06-MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, fever, and feeling sick, and the outcome of did not sleep was not reported. This report was non-serious.

Patient was given vaccine and was told to wait in the monitoring area for 15 minutes post vaccination. Shortly after, the patient reported "feeling pale" and was told to remain seated. The patient then fell over from the chair and lost consciousness. We immediately called 911 and went to the patient's side with epinephrine. However, he recovered within seconds and was able to sit up and drink water. He reported feeling "pale [...], weird [...]" and said he felt like his "ears are sweating." He did not want epinephine and remained seated and responsive. When asked, he said he had never received any adverse reactions to any vaccines in the past. A pharmacist then cleaned and disinfected his right temple that was bleeding, which he seemed to have hit when he fell. He later reported feeling chest pain and slight difficulty breathing but did not want epinephrine at that time. Emergency services arrived about 20 minutes after and assessed the patient and removed him in a gurney.

No local effects beyond slight soreness Headache and extreme muscle ache had to take tylenol to be able to fall asleep Did not check for fever

Apx 10 minutes after vaccine administration, Patient became non-responsive, his eyes rolled back in his head, and appeared tonic. His mother said this has never happened to him before. When he recovered he was disorientated and complained of blurred vision. He later said he thought he fell asleep. It is unknown if this is related to the vaccine. We took his pulse (apx 50 bpm) and gave him water. We called 911 and the paramedics evaluated him in the ambulance.

After administration of vaccine, patient was sitting in chair for 15 minutes. Within 5 minutes of shot patient fell out of chair and hit head. Never seemed to loose consciousness but was disoriented and dizzy . Called EMS and before their arrival sat with the patioent in uprigjht position/applied cool towel to head and neck/ and monitored slow small sips of water. EMS arrived and took over vitals and while patient was alert, transported to hospital due to hitting head

Increased anxiety, leading to hospitalization. Hearing voices, from 5/25 - present. Shortness of breathe. Headaches. Brain fog and general confusion. Treatments included anti depressant Lexapro 10mg. Hydroxyzine 50mg 4 times daily. Abilify, 1mg daily.

Pt collapsed right after sitting down after receiving the vaccination. I went out and asked patient to stay on his back a nd raise his legs. He seemed confused and got up. As he appeared very unsteady and confused, I wrapped my arms around his torso so he would not fall. I asked him to lie down and he walked over to the chairs and sat down. I again asked that he lie down, but he stayed in the chair. He seemed lucid after a few minutes and asked for something cold water to drink. He was lucid at this point and took a small sip. He was sweating profusely and explained that he has had this reaction before to events and said it had happened when he witnessed a large gash on his brother's leg. I believe this was a situational reaction and not really related to the vaccination, as he had been vaccinated numerous times in the past. I had him wait 30 minutes and checked on him several times. He left on his own with a girl and another gentleman when the 30 minutes was over.

6/9/2021 The night of the shot he had chills and did not sleep well. 6/10/2021 He had a headache, so I asked him to come to my home to be monitored. By 12:30pm, he had fever, temp of 101.1 and back and knees hurting. No issues at the site of injection. We are calling doctor now.

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

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.

Following vaccine administration, pt claimed to feel a little "dizzy." had him lie down on the floor. he refused a yoga mat. mother requested to put some paper towel that was wet to cool his forhead. patient was very communicative and cognizant the entire time. had his feet elevated. observed him for 20 minutes. Checked pulse and it was 75. After sitting for approximately 15 minutes, he was able to sit up without problem. He was not dizzy and I observed no restriction in movement to indicate hypotension. While laying down he stated the inside of his mouth felt tingly which happens when he is nervous. At about the 15m mark, patient was able to drink fluids (mother purchased a drink from cafe) and felt immediately better. Prior to administration, hestated that he has never had a vaccine reaction. He did state following injection that he felt the needle. He tensed his arm muscle as I was about to vaccinate. He said he felt the needle which made him feel a little nervous. I asked to observe him for another 15 minutes, but mother wanted to take him home. Offered to get him a scooter, but patient and mother refused. Techincian offered to walk him to the door to make sure he was safe and had no issues walking while mother brought car around. He was under constant observation.

ANIXETY, FEVER, CHILLS, TROUBLE BREATHING, POSSIBLE SWELLING IN MOUTH/TONGUE ALL OCCURED VERY QUICKLY AFTER VACCINE.

Severe fever, throbbing headache, dizziness, mild hallucinations. Started about 9 hours after vaccination, fever diminished after about 2 hours. Other symptoms lasted most of the night.

Patient received Janssen vaccination in our shot room and was able to walk to the waiting area without assistance or complaint of feeling ill. Within 5 minutes the patient passed out as he tried to move to a chair closer to his father. He fell to the floor and lost consciousness. He almost immediately regained consciousness, however, was very confused and disoriented for a short time. 911 was called. I stayed with the patient, gave him water, and made sure he stayed on the floor until EMS arrived. They checked the patient out and concluded that he was ok to leave with his father. A trip to the hospital was not necessary. The patient has a small cut behind his left ear, but otherwise was ok.

High respiratory rate with shallow breaths, Rash on chest, Tachycardia, Altered Mental Status . The Patient that was suspected to have an adverse reaction. EKG displayed no abnormalities, IV was placed in patients L Arm and provided 1,000 ML of Normal Saline, and administered supplemental O2 via simple mask. An Epinephrine Auto Injector 0.3mg was also injected into the patients L thigh. Determination to transport to local treatment center was made by provider. Patient arrived at Medical Center approx. at 2245 and further evaluated there. Patient was then transferred to Level 3 Trauma facility to Hospital around 0100, 17 March. Admitted to the ICU for further evaluation. Update- Patient will be admitted until 18 Mar 2021. It was noted by Hospital Patient had a sever anaphylactic reaction.

Felt fine the first 6 hours, then around the 6.5 hour mark started feeling mild chills and muscle aches. Progressively got worse through the night into really bad chills, aches, feverish, sweaty, and woke up at 7am the following day with pounding headache, mild chills, and moderate achy muscles.

Within a minute of receiving the vaccine, patient slumped back in the chair, head back, eyes open. He was unresponsive and shaking in the chair. After about 20 seconds he came to and leaned forward but wasn't oriented to time and place. As I was talking to him, trying to assess his breathing, he slumped back in the chair and began shaking much more violently. I asked the store director to call EMS at that point, I took his mask off at that point to better assess his breathing. After about 15 seconds, he came to again. At that point, I had him lean forward with his elbows on his knees, and he didn't lose conciousness after that. I took his blood pressure (70/22) and pulse (52, light and hard to find). EMS arrived soon after and at that point patient felt much better. EMS decided not to transport the patient to the ER. They instructed patient to follow up with his provider. Patient left the vaccine area under his own power about half an hour later.

Patient received vaccination sitting down. Stood up to move out of the vaccination room went to be seated outside the door. Patient said he felt like he was about to faint and went to sit down and immediately started to slid out the chair once seated. Patient was out for no less than 15 seconds. Paramedics was called during the fainting. He was responsive and able to breath. Patient was kept on the floor in supine position. no difficulty in breathing and knew who he was and where he was located. No signs of distress just very pale and shaky. Paramedics arrived at scene and O2 stats and HR was normal BP was normal. Patient was taken to hospital for further test. Pharmacist called for follow up at 5:30 with fiancé and she stated that they had diagnosis of vasovagal syncope and that they were running more test. She stated that he was doing fine and that he seemed to be better. They were still in the ER at 5:30 pm.

Patient started hallucinating at 3:00am. He had a low grade fever which we thought might be the cause. Slept and appeared dizzy upon waking but alert. At 3:30 pm, he again started hallucinating.

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.

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.

Incredibly painful headaches which then turned into migraines. Chills Fever Dizziness Whole body aches Disorientation Stabbing pain at injection site

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.

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

My head collapsed in on itself. I could not see, move, or think. I was more incapacitated than I have ever been in my life. I believe I nearly blacked out. This lasted for about two minutes, then slowly cleared up.

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.

Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: patient experienced temporary blindness, sweating ,syncope- which is ultimately why we call the ambulance

The patient's weight was 135 kilograms, and height was 70 inches. The patient's past medical history included reported to only take "ADHD" medication at school" when needed, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on 13:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced feel off. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from achy, tired, and feverish, had not recovered from feel off, and the outcome of not feeling well was not reported. This report was non-serious.

Recieved Jannsen vaccine at 11:15 AM on March 23rd. Rash on hands, arms, feet, and legs appeared at 5:00 PM on May 3rd. It itched and burned and was difficult to sleep. No medication was taken, but by morning the rash was nearly gone and by midday it seemed to be gone. Around 5:00 PM, it started back again. I took Diphenhydramine because it appeared to be an allergic reaction. This helped me get to sleep. It was gone in the morning again, but started back in the evening again. This happened repeatedly for a total of 5 days.

HEAD HURTS; FIRE SHOT DOWN ARM TO ELBOW WHEN RECEIVED THE VACCINE; SORE AND ACHY FEELING/ SORENESS EVERYWHERE; FEELS LIKE CRAP; SENSITIVE TO LIGHT; FEVER OF 102.5; This spontaneous report received from a parent concerned a 21 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: 201A2119 or 201A211A) dose was not reported, administered on 08-APR-2021 10:50 on right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore and achy feeling/ soreness everywhere. On 08-APR-2021, the subject experienced feels like crap. On 08-APR-2021, the subject experienced sensitive to light. On 08-APR-2021, the subject experienced fever of 102.5. On 08-APR-2021, the subject experienced fire shot down arm to elbow when received the vaccine. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 08-APR-2021 17:30, the subject experienced head hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fire shot down arm to elbow when received the vaccine, was recovering from fever of 102.5, and sensitive to light, and had not recovered from sore and achy feeling/ soreness everywhere, feels like crap, and head hurts. This report was non-serious.

RESTLESS; LACK OF SLEEP; LACK OF MOTIVATION; FELT ROSY IN THE CHEEKS; FELT HOT; FEVER; BODY ACHES; DIZZINESS; WEAKNESS; INJECTION SITE PAIN; EXTREMELY FATIGUE AND TIRED, FELT REALLY WORN DOWN; FELT OFF; SENSITIVITY TO LIGHT; SENSITIVE TO SYMPTOMS OF A SEIZURE ONSET; CRAMPING STYLE PAIN THAT TRAVELLED UP AND INTO THE SHOULDER AND UP INTO THE NECK MUSCLE INTO THE BASE OF SKULL WRAPPING AROUND HEAD CAUSING A MIGRAINE; HARD AND HOT TO THE TOUCH GOLF BALL SIZES LUMP SLIGHTLY PROTRUDING; DISORIENTED; 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 epileptic. 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 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensitive to symptoms of a seizure onset. On 10-APR-2021, the subject experienced cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine. On 10-APR-2021, the subject experienced hard and hot to the touch golf ball sizes lump slightly protruding. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced felt off. On 10-APR-2021, the subject experienced sensitivity to light. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced extremely fatigue and tired, felt really worn down. On 11-APR-2021, the subject experienced felt hot. On 11-APR-2021, the subject experienced restless. On 11-APR-2021, the subject experienced lack of sleep. On 11-APR-2021, the subject experienced lack of motivation. On 11-APR-2021, the subject experienced felt rosy in the cheeks. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, weakness, disoriented, fever, felt hot, felt off, sensitivity to light, and felt rosy in the cheeks, and had not recovered from injection site pain, cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine, extremely fatigue and tired, felt really worn down, body aches, restless, lack of sleep, lack of motivation, sensitive to symptoms of a seizure onset, and hard and hot to the touch golf ball sizes lump slightly protruding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

4/12/21 Vaccination About 10 hours later, I had 102 fever for couple hours, chills, HA, muscle pain, weakness. 4/13 HA pain, muscle pain, muscle weakness, not chills no fever. Lasted 5 days after vaccine. Muscle twitching, weakness, HA. I couldn't work for 3 days. telemedicine consult that Friday; Tylenol but wait till Monday if the pain was still present. Was feeling better by Monday so I didn't take.

pt said he didnt feel like himself and had some dizziness 5 minutes following administration. 10 minutes following vacc. pt had some sweating/perspiration at his brow . 15 minutes post vacc pt began feeling better on a scale form 1-10 from peak of reaction pt states he was about an 8. I continued to check in on patient and eventually walked him through the store and released patient. pt was under observation for 1/2 hour following vacc. and left facility at a 10 ie how he was feeling compared to pre vacc state (10 when he walked in 10 when released from post vacc. observation

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.

Patient was given Janssen COVID-19 immunization via intramuscular route in the deltoid region of the left arm. Patient was fine following the vaccination and was instructed to sit for 15 minutes to be monitored. Approximately 5 minutes after patient was sitting, his body suddenly went straight and his eyes were open. He started to seizure for about 5 seconds and hit his head against the counter. He regained consciousness afterwards and was in distress. After calling EMS, they checked for his blood pressure, Pulse Ox, and blood sugar levels, which they considered stable. They asked the patient if he felt fine at that time, which he said yes. They told him to wait at the pharmacy until his Dad came to pick up him.

vaccine adm @ 12:35 pm 5/18/2021 ,first event occurred 12:37 pm (passed out/muscle weakness(slumping)/ when over has no memory of event total time 5-7 seconds, then alert some sweating. second event same as first occurred 5 minutes later( was given water after first event.) CALLED 911 ARRIVED 5-10 MINUTES AFTER SECOND EVENT. after exam bp/blood glucose/pules/O2 sat/all normal(per emt) patient walked out under own power

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.

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.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium

post vaccination about 3 or 4 mins pt sat on floor and stated was dizzy and feeling warm. Pt started sweating so i go him a compress. Within 20 mins pt felt ok to leave. Pt stated he was getting anxiety reading fill list of potential side effects from vaccine. Pt stated he didnt like needles and has not been to dentist bc of this in years.

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.

21 y/o male here with brother whom he witnessed having an adverse reaction. Male moved into treatment area with brother and started to have a panic attack/vasovagal response. Became lightheaded, dizzy and diaphoretic. Placed on EKG per EMS, stable normal sinus rhythm, heart rate 71, BP 120/73. Placed in supine position, AAOx4 neurologically intact. Waited about 30 minutes, stable. No complaints or any other issues at this time. Able to walk out with brother.

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.

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

Severe chills, fever, muscle numbness, headache, brain fog, aches. Muscle numbness lasted 48 hours; afterwards, brain fog and muscle discoordination lasting since. Slower reflexes, numbness at back of head experienced. Ongoing, minor; but feeling really off since. The muscle issue/random numbness occurs still

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.

Vaccine administered ~7:30pm on 7/21. Patient sat down in observation area to begin medical monitoring. Within 2 minutes patient described feeling sweaty and looked pale. As the nurse began to check on the patient's status, he began having a seizure for about 10-15 seconds. 911 was called. Patient came to and was somewhat disoriented but responsive and still pale. Police/EMS came and recommended he go to the hospital for evaluation. He refused and did not go in the ambulance. Patient indicated no history of seizures. Nurse followed up with patient 7/22 - he is feeling well and did go to the ED. Treating physician advised that it was a "psychological reaction" and "not life threatening." Patient reported feeling well otherwise and has a follow up appointment with his primary care provider.

After the administration of the vaccine, patient was asked to wait for 15 minutes. shortly after about 3-5 minutes patient lost consciousness and was on the ground. After about 10 seconds he became aware of his surrounding and was able to express to us that he had a severe panic attack and that he gets like that with shots. Paramedic was called to check him out and he was allowed to go home after they felt it was not a seizure.

Janssen COVID-19 Vaccine EUA Headache and body aches 10pm. High fever to 102 by 1pm with severe head and body aches, shivering, dizziness, unsteadiness. Tried drinking water, resting. Rapid heart beat at 120bpm. Couldn't sleep, so woke parent at 5:45a. Tylenol acquired from pharmacy and given at 6:30am. By 7:30a, fever under 101, HR 107 bpm. Severe headache and body aches persist. Injection site soreness and generally feeling awful. Continuing to hydrate with electrolyte water and plain water.

Significant fever 8 hours after administration. Hallucinating at night and high temperature. Fever broke after waking up the next morning.

I got the injection then went and sat down in a chair at the back of the room and started getting light-headed about 3 minutes after I sat down, so I called a nurse over. Then the inside of my chest started getting really hot and my vision started going white in both of my eyes, it took about 10 seconds for me to completely lose vision. Then I passed out, I have no idea how long I was out for but when I came too I had a sort of epileptic-type seizure but I do not know how long it lasted. I woke up completely disoriented, had no idea where I was at and had a severe cognitive dysfunction. I still have moments where I just can't follow or complete a thought or just kind of go blank.

Patient left pharmacy and passed out on the sidewalk. Unknown if vaccine or fall caused Nausea, Headache, Memory loss.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe.

At around 7PM the day of the J&J vaccine, I began to feel very fatigued and could tell that I was going to come down with a fever. I went to bed early that day around 10PM. Woke up around 1:30AM on the 4th. Felt terrible and took my temperature. It read 101.5. Got up to use restroom and when washing hands, everything started to go blurry, I thought i had just become lightheaded and that it would pass so i stood there leaning against the bathroom door.I ended up fainting and hitting my head on the cabinets. I was completely soaked in sweat. An hour later we drove to the ER to make sure everything as okay. IV was started, some test performed, and fever was gone by 5AM. Felt completely fine after going home and resting for a few hours.

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

The patient was standing in the immunization room with the pharmacist and while he waited for his father to receive his immunization. As they wrapped up and began to exit the room, the pharmacist noticed that he seemed confused and as if he was about to faint . The pharmacist got him to the nearest chair. He never lost consciousness, he was just dizzy. He was given water and his pulse was taken. The patient also reported at a later time he had just finished a long shift at work with little to eat or drink.

Patient passed out. Mother stated he gets panic attacks every time he has a needle stick. Patient was fine shortly after.

The patient (self) felt a soreness around the site of the injection begin immediately and grow throughout the day. The soreness continued to at least April 12 (at the time of this report). The soreness was immediate unlike a tetanus shot but the pain the following days was 2-3 times less that of a tetanus shot. By 4pm the same day, the patient felt fatigue and tired and had difficulty staying awake. Around 6pm the patient took 200 mg of ibuprofen by mouth because of a strong headache. At 7pm the patient was experiencing the following: headache, warm head to the touch, shivering/shaking, fatigue, mild aching. The patients pulse was consistent 100-104 bpm. The patients temperature at 8:30pm was 100.4 F. The patient then went to bed at 9pm. Patient had trouble falling asleep due to fever, shaking, aching. The patient slept intermittently until midnight. At midnight, the patient noticed the fever and shaking had ceased but the headache and aching were still strong. The aching was all over the body. The patients eyes hurt to move. The aching was constant and at times was throbbing. At 3am the patient could still not sleep well so he took 650 mg of Acetaminophen by mouth. The patient began to notice some relief approximately 30-60 min after. The patient fell asleep after the relief began and slept soundly til 9:15 am, April 11th. The patient awoke feeling much better. All side effects had stopped with the exception of a feeling of weakness and slight dizziness. The patient was able to carry on normally and took no more medications.

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 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.

My son Fell out at work after shot was given. He had a seizure, he lay unresponse on floor until medics were called. He noe has a blood clot in brain & has had 3 more seizures.Patient drives a fork lift & drives a truck he is nolonger able to do either.

COULD NOT SLEEP; ITCHY RASH ON HIS ARMS AND LEGS WHICH WAS SPREADING UP; BODY ACHES; 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 concurrent conditions included eosinophilic esophagitis. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced could not sleep. On 11-APR-2021, the subject experienced itchy rash on his arms and legs which was spreading up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash on his arms and legs which was spreading up, and the outcome of body aches and could not sleep was not reported. This report was non-serious.

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 couldn't concentrate and felt tired. He was sitting and leaned/fell forward. After a hew seconds he felt better but warm.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt had tunnel vison and lost his vision for a split second, he could not remmember me asking if he was okay. I gave his benadryl and checked bp that was 95/65, Encoraged pt to drink water and got a sucker for him. He was clammy and seemed worried. His bp started coming up within 5 minutes and was 105/80. His bp was 120/80 in 5min later, asked pt to get a ride and his wife came and got him. It had happened to him one time giving blood. pt had chills and ackes last night and is fatigued

immediately following the vaccination (within seconds) patients head dropped down. I said his name bc I thought he was looking down at first but he would not respond for about 20-30 seconds before he came to. He blacked out for that short amount of time he said everything suddenly went black. He was able to get to the floor with assistance once he came to and he laid down, he was sweating and pale. his BP was 138-78 pulse 88 about 10 minutes after the event. he had reported being nervous when he first arrived for his appointment. he also has severe food allergies but never had a reaction to a vaccine.

Pt received J&J yesterday. Pt c/o having fever/ha/unable to sleep. Pt is walking w/o issue. Pt VSS and NAD.

WITHIN 5 MINUTES OF ADMINISTERING VACCINE, PATIENT WAS SEATED AND COMPLAINED THAT HE COULD NOT BREATHE.. HE BEGAN TO PANIC AND BECAME INCREASINGLY ALARMED, CRYING AND WAS HOLDING ONTO HIS CHEST. HE WAS CONSCIOUS BUT DID NOT RESPOND TO ME WHEN I KEPT ASKING IF HE WAS OKAY. I CALLED 911 AND GRABBED THE EPI PEN IN ANTICIPATION OF ADMINISTERING IT. PATIENT WAS DROWSY, CLOSING EYES AND SUDDENLY OPENING THEM. NO SIGNS OF BLUE LIPS. WHEN PARAMEDICS ARRIVED, IT LOOKED LIKE PATIENT'S BOTTOM LIP STARTED SAGGING TO RIGHT SIDE AND WAS SWOLLEN. PATIENT WAS TAKEN TO LOCAL ER AND WAS GIVEN EPI AND BENADRYL IN ER DEPARTMENT.

Patient complaints of dizziness and anxiety which resolved over time. Patient was given water to hydrate. EMS evaluated patient. Patient felt better after hydration.

10 minutes following vaccine patient became confused, sweating, pale and dizzy, lasted 10-15 minutes and then resolved without treatment.

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.

HARD TO READ/CONCENTRATE; HEADACHE; DISCOMFORT WITH DIZZINESS; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.5 Degree Celsius, and Body temperature decreased (NR: not provided) 38 and 37.8 Degree Celsius. On 16-MAY-2021, the subject experienced discomfort with dizziness. On 16-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced hard to read/concentrate. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 16-MAY-2021, was recovering from headache, and discomfort with dizziness, and the outcome of hard to read/concentrate was not reported. This report was non-serious.

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.

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.

About 10 minutes after the vaccine, pt began to feel bad, vision went black, hearing was muffled/ringing, sweating and dizzy. Pts mom requested an ambulance. He drank a few sips of water and we put cool, damp cloths on his neck. We considered laying pt flat but he refused saying he was feeling better. His vision cleared, hearing returned , sweating stopped and by the time the fire department arrived he was just shaky. His vitals were all normal by then. He then said now that he thought about it, he flet like it was a panic attack and he almost passed out. i checked on pt again today and he stated that he is now fine.

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.

Patient complained of increasing heart rate and anxiety. Patient denied any symptoms/allergies. Nurse monitored and checked his vitals 2 times; did not show anything abnormal. At 9:30 - HR: 68. BP: 130/64. Room air: 99%. Resp: 19. At 10:10 - HR: 69. BP 110/64. Room air: 98% Resp: 17.

Patient was given the vaccine and seemed fine. He was talking and then just fell out of the chair and fainted. He was unconscious for about 15-20 seconds and came to. He was disoriented and complained of tingling in his hands. EMT was called non-emergency since the patient had regained consciousness. He still appeared disoriented for several minutes. Patient said he hadn't eaten since breakfast. He was given crackers and water. EMT arrived and took vitals. Patient appeared fine, just a bit shaky.

Starting about 12 hours after my vaccine, I started to feel fatigue and body aches. An hour after that I experienced intense chills and a sense of dread. I put a heater on myself with two layers of thick blankets, but it didn't help. My fingers and parts of my face started to tingle and go numb and I couldn't fall asleep in spite of me doing breathing exercises and lying down. Eventually the chills turned into a fever and my body temperature suddenly shot up. I didn't have a thermometer, but it was certainly over 100 degrees Fahrenheit. Despite my relief from the chills, I still couldn't sleep. I wasn't remarkably stressed/anxious, I just couldn't get to sleep. I'm not typically an insomniac, and upon speaking to others who received the same vaccine, they've also reported intense chills and an inability to fall asleep.

When I received the vaccine (Saturday) I was dizzy and my arm went numb immediately but after waiting 15 minutes I felt fine and everything was okay. The next morning (Sunday) I woke up with a fever, chills, sweats, and fatigue that lasted until about 24 hours after I received the vaccine. The following day (Monday) I felt completely fine and had no adverse symptoms or side effects. Tuesday was fine as well until about 2pm after I ate lunch, during a meeting my arm went numb as well as my legs and I had trouble concentrating and could not hold a conversation. Went home and slept until Wednesday morning. Today, Wednesday, I am still not feeling normal and am having trouble concentrating at work, low light seems to help. No numbness today but still feel dazed and not able to focus

Took vaccine at 3:05pm on 3/27/2021. At 11:30pm started symptoms of site pain injection in left arm. Also started to feel flu-like symptoms. On the 28th he had really bad flu-like symptoms and could not walk or move without muscle pain and weakness, overall malaise, arm hurt too much to move or touch, migraine, swelling in left arm at injection sight, slept 24 hours almost completely other than to urinate, fever of 102.3. The following day, 3/28/2021, still had same symptoms but not as severe and was able to drink some fluids. On 3/29/2021, he was able to eat and drink but slept a good portion of the 24hrs. On 3/30/2021, fever gone, can move around some, eating and drinking improved, flu-like symptoms mild. Still slept a lot.

Symptoms began 6 hours after shot abruptly. Fever of 104, heart rate over 120, blood pressure spikes, headache, trembling, severe body pains and shooting pain, dizziness, lightheaded essential, short of breathe. All symptoms persisted for over 12 hours, but the fever broke with aspirin, and Tylenol given by the Emergency Room at 4am the following morning. Pain was too great to walk or sleep until 8am after the fever broke. The following day I was still sick with a mild fever, headache, and tachycardia that wasn't as high.

4/3 immediately after vaccine had lightheaded, tingling. 4/4 fatigued and slept alot.4/5 started with palpitations, and heart racing often to 110. 4/6 bad enough to go to ER with normal EKG, monitoring, Chemistry and CBC, troponin and CXR. released and saw me 4/7 with symptoms all resolved.

Immediately after getting the vaccine, I was extremely fatigued and disoriented for the rest of that day (April 6th), to the point that I had to leave work. The following day (April 7th) I was still fatigued and was constantly out of breath, however I was able to work, albeit not to the best of my abilities.

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

PATIENT PASSED AT HOME, BEGAN TO SWEAT COLD AND FELT UNCONSCIOUS. THE PATIENT WAS COLD TO THE TOUCH, GOT UP A LITTLE DAZED, HE WAS COLD HIS PULSE WAS LOW, THE BLOOD PRESSURE WAS OK. THE COUPLE REPORT THAT LOOKED LIKE A TYPE OF SEIZURE WHAT HAPPENED.

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.

Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe

Increase heart rate. Started 5/5/21 at about 6:45PM and continued through the rest of the day. Leading up to the hear rate increasing I was fine and just enjoying my day. No drugs or alcohol or did not do any exercise that day. Felt uncomfortable and with some anxiety I visited a urgent care facility. The visit was about 45 minutes and left. As I am writing this, my heart rate is still a bit above normal but doing better.

Patient admitted to being nervous prior to administration and said he did not like needles. Patient was consulted about what to expect, side effects, and asked if he had any additional questions prior to receiving vaccination. Patient declined and said he wanted to have the vaccine administered. Patient sat down in the designated waiting area. Approximately 2-5 minutes later patient blacked out and his body weight caused the chair he was sitting in to flip over, thus landing on the floor. EMS was called. Patient came to about 30-60 seconds later. Patient was disoriented, sweaty, pale, and shaky. Blood pressure was taken with a result of 143/95. EMS arrived and evaluated the patient. Patient admitted to having nothing to eat or drink today and being very anxious previous to getting the vaccine. There were no signs of an allergic reaction. Patient's blood pressure was checked about 20 minutes later and was returning towards normal. Patient declined transport to the hospital, but mother was called to come pick him up. Patient was advised to get something to eat soon and to rest and be observed for the next 24 hours.

c/o increased anxiety/panic attack. Syncopal feeling after Covid-19 Vaccine. Refused transport to ER

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.

Patient received vaccination. Walked to observation area and fell to the floor. Remembers feeling anxious and warm and also reports history of high blood pressure and anxiety. Patient alert and orientated in EMS room on exam. Reports not eating. Blood pressure 130/90, O2 97% and pulse 65. No history of seizures. Possibly hit his head. Pupils equal and reactive. Refused an ice pack and refused any further medical care including EMS. Will follow up with primary care provider. Water and snack provided.

High fever for 24 hours, extreme fatigue for 48 hours. Severe fatigue and malaise and difficulty breathing and concentrating and dizziness ever since symptoms began to kick in, 9 days ago.

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

Started bad fever at 7:30. Bad body aches, had to lay down, and sweating. Slept early and all night, sweated through my shirt and sheets all night. Fever and body aches subsided in the morning, but still don't feel right and couldn't exercise. Brain fog came on about 4:00 after 11:00 am shot. Very difficult to concentrate and do work, found myself walking into rooms and forgetting why. Brain fog is still there today while body aches have subsided, very challenging to focus or work on computer and just feel slow and dumb.

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.

It started off with a burning sensation in my throat that work it way down to my Adams apple. I started having chest pains and felt like I was being stabbed with a knife. On a scale to 1-10 the pain was a sharp 5.

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.

Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Pt fainted about 5 minutes after injection for less than 1 min. Did not require EMS call. Pt sat for 20 minutes before leaving and drank water. Slight headache also reported. Pt states this has happened about 10 years post vaccination - most likely panic attack, not a fan of needles.

After getting a vaccine, patient was advised to sit for 15 more minutes. As soon as he left the immunizing room, he fainted for couple of seconds. Then regained consciousness but had shaky hands, SOB, and in tears. He was provided with water and asked he may take off the mask if breathing is difficult. Taking the mask ease the breathing a little, but still SOB. Gave him a brown paper bag to breath into and as him to take deep breath in & out. He did that few times, then regained his normal breathing. Saw him looking down to his phone, which I told him to lift his head up to his eyelevel to decrease the dizziness. Was situated for about at least 30 minutes, then he said he was feeling better and he wants to leave as his friend is outside to pick him up and left.

About 8 hours after receiving the Jansen COVID-19 dose, the site around the injection point began to few sore and my entire body began to feel sore, especially at the joints. Furthermore, my heart rate became elevated and beat erratically. These symptoms continued for about 12 hours. I could not sleep overnight as I ached all over and my heart rate was rapid. The next morning, I began to feel much better. My heart rate began returning to normal, though my heart area still felt somewhat sore. By about 36 hours after receiving the dose, all of my side effects were minimal. By about 48 hours after receiving the dose, I had virtually no more side effects.

Inability to take a full breath. Asthma inhalers, including steroidal ones do nothing for the first time ever. Condition persisted past 2 weeks, so visited ER. ER prescribed strong steroids as x-rays came back clean. Feeling better but not good.

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.

Janssen COVID-19 Vaccine EUA At 11 PM the night of the vaccine (Saturday), extremely bad chills, fever and weakness set in almost immediately. I could not get my body to warm up and was borderline too weak to walk. Very bad headache and nausea set in as well. After several hours the chills turned to intermittent sweating/cold and I could not keep a consistent body temp, nor sleep that night. The next morning (Sunday) I had very bad aches and soreness, along with chills/fever and headaches that could be managed fine with around the clock acetaminophen. Around 8 PM that night, most of these flu like symptoms subsided. The following morning (Monday), still very exhausted despite a full 10 hours sleep. Tiredness and weakness lasted through the day. Tuesday morning until around 3 PM i still experienced drowsiness and was unable to gain strength for anything more than typical day to day tasks (could not workout). Wednesday morning, felt normal but while exercising experienced shortness of breath almost immediately as well as chest/lung pain easily. Come Thursday I feel 90% normal.

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.

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 received Janssen COVID-19 vaccine at 123pm on 3/25/2021. Patient directed to observation area and fell backwards out of chair at 127pm on 3/25/2021. After falling backwards out of chair patient had a full body stiffening episode and was noted to be bleeding from his head. Bleeding controlled with gauze held by an RN. Patient initially GCS 13 and unable to answer questions appropriately, manual blood pressure 118/60 HR 50 SpO2 89% on room air, patient pale and dry. Patients legs raised by RN and pressure to laceration on top of forehead continued to be held by RN. After 5-7 minutes patient GCS increased to 15 and he was alert and oriented x 4, manual blood pressure 114/60 HR 62 SpO2 97% on room air, patient pink warm and dry. Fire arrived on scene at 147pm and Ambulance shortly after. Fire and Ambulance given report by RN on site while other RN on site continued holding pressure to laceration on forehead with gauze.

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

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was being monitored after their immunization when started to feel dizzy. Patient fainted and fell out of chair to the floor where we responded to him and called EMS. Patient was still breathing and became coherent as he was rolled onto his back. EMS confirmed he was ok to not go to the hospital so patient opted out.

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

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.

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.

PATIENT FELT SWEATING AND ANXIETY IN 5 MINS , DIDN'T WAIT AFTER VACCINE DROVE HOME THEN HIS FINGERS WERE LOCKED, WENT TO HOSPITAL WAITED FOR 3 HOURS THEN EKG WAS DONE , HOSPITAL FOUND NOTHING WRONG AND WAS RELEASED. PATIENT IS DOING OK NOW

MILD FEVER; FEELING OF DEATH; BODY ACHES; HARD TO WALK; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 12:30 to Left Arm as prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling of death. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 104 F. Treatment medications included: ibuprofen. On 05-APR-2021 19:30, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 100-102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, hard to walk, and mild fever, and the outcome of feeling of death was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Janssen COVID-19 Vaccine EUA Starting on 4/11/21 at around 12:00 pm I started to have a numbness on both sides of my face. It felt as though there were pins and needles throughout my face. I would say that it was a 4/10 in terms of intensity. At first I thought maybe it was due to drinking coffee without food or other water (I don't regularly drink coffee but I have never had these symptoms from coffee before). However, even after eating food and drinking a sugary drink around 4:00 pm, the pins and needles remained. The symptoms began to subside at 6 pm or 7 pm. The only other normal symptoms that I had were feeling tired on 4/8/21 and 4/9/21. Also, on 4/9/21 I had very slight muscle soreness throughout my body. I have also had difficulty concentrating which may or may not be related.

On Monday 4/12/21, 5 days after taking the J&J vaccine, I had an extremely itchy and painful full body rash. It was big red bumps like mosquito bites all over my body including legs, back, arms, chest, stomach, etc..I could not sleep all night due to the pain and itch and had to constantly apply cortisone cream as well as ice to make the pain bearable. The rash went away almost completely the following morning but then returned again the following night. I have never had any prior allergies or skin conditions and worry that this may become a recurring event since it has now happened for 2 nights. I did hear that a rash at the injection site was a possible side effect from the covid vaccines but this was way worse as it was all over my entire body.

RESTLESS SLEEP; This spontaneous report received from a parent 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: Unknown, batch number: [043A71A], [043A21A] OR [043AZ1A] expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced restless sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restless sleep on APR-2021. This report was non-serious.

Chills, elevated heart rate, racing thoughts, shortness of breath, sleeplessness; I remained awake until around 8AM the following morning.

PATIENT BROUGHT TO ED DEPARTMENT: HISTORY LIMITED TO PATIENT MENTAL STATUS CHANGES. PATIENT PRESENTS TO THE ED AFTER BEING FOUND ROLLING AROUND ON GROUND OUTSIDE OF APT. COMPLEX. SEVERAL HOURS INTO PATIENT STAY, HE BEGAN DROOLING. PATIENT HAD A RIGHT-SIDED FACIAL DROOP. CT ANGIOGRAM ORDERED WHICH SHOWED A THROMBUS IN THE LEFT MCA. VACCINATION OF JANSSEN VACCINE APPROX. 1 WEEK PRIOR TO PRESENTING PER PATIENTS MOTHER. UNKNOWN WHERE HE RECEIVED VACCINATION. PATIENT DIAGNOSED WITH ACUTE CVA

Inmate reported myalgias overnight after J & J vaccination. Altered mental team in AM. Upon arrival to inmate's cell, he was breathing heavily, shaking, and unable to walk. He was unable to state his name fully or recall his registration number.

Systemic: Bell's Palsy-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: OTHER-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild

Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches. I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.

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.

Patient reported being dizzy, tired, confused since day after vaccination. Someone said he looked clammy and flushed at work today so he was sent home to rest.

Patient received J&J vaccine at 4:09pm on 5/11/2021. Within 3 to 4 minutes patient's girlfriend stated that the pt was having difficulty seeing. Pt evaluated and he described complete loss of vision (lasting approximately 10 seconds) that returned. Pt was seated and was instructed to move to floor and lean against wall. Pt described numbness and tingling in both legs that resolved within 5 to 10 minutes. Pt stated he was anxious, shaking was observed, and he was hot and sweating. Vasovagal episode with loss of consciousness was immediate assessment. BP was 98/62 within 20 minutes of AE. 911 was called and EMS evalauted pt. Pt did not go to hospital AMA per EMS and pt stated he felt better. Patient was contacted on 5/12/21 at 3:25pm and he stated "I'm all good no further issues. I got a fever 8 hours after the shot. Other than that I'm all good". Inquired about temperature and pt stated "I do not have a thermometer". Pt instructed to contact primary care but he has not seen them in 2 year (She is primary care). Pt then instructed to contact cardiologist that he sees for his heart palpitations and heart rate control. Patient is prescribed metoprolol for this and he missed a dose the night of 5/9/21, took dose night of 5/10/21, and had shot on 5/11/21. Patient's physician office was called and information reported to her.

CHILLS; FATIGUE/TIRED; HEADACHE; SHORTNESS OF BREATH; FALLS ASLEEP FOR SEVERAL HOURS AT A TIME; TROUBLE WALKING; This spontaneous report received from a parent concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergic to peanuts and tree nuts, non alcohol user, and non smoker.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced falls asleep for several hours at a time. On APR-2021, the subject experienced trouble walking. On 05-APR-2021, the subject experienced shortness of breath. On 05-APR-2021, the subject experienced fatigue/tired. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced chills. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided. On 12-MAY-2021, Laboratory data included: Pulmonary function test (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, had not recovered from fatigue/tired, and shortness of breath, and the outcome of headache, trouble walking and falls asleep for several hours at a time was not reported. This report was non-serious.

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

First felt pressure on right side of head on Tuesday May 4th. Took Vaccine on Sunday May 9th. Experienced fever, chills, and dizziness until Tuesday May 11th. Noticed head pressure increase and spread to left side of head and top side of head on Thursday May 13th. Noticed head pressure spread to back of head on Friday May 14th. Pressure and tenderness on all sides of head, with pulsating superficial veins make it difficult to sleep, as pain increases in conjunction with amount of time resting head on pillow. ER doc persribed fioricet on Wednesday May 19th. Felt tingling and numbness down left side of body in reaction to it on Friday, May 21st. Visited ER on May 21st, and received migraine cocktail. Helped relieve pain so that I could lay my head down to rest, but did not stop pulsating throbbing of superficial head veins. May 24th, neurologist prescribes steroids for pain and inflammation, and sleep medication so I could sleep. Sleep noticeably improved. Still testing out 50mg dose of steroids. Steroids noticeably do nothing for pulsating throbbing superficial veins. *Note: I worry this vaccine may have exacerbated the headache I was feeling prior to my vaccination, or that the vaccination was fine, and what I am experiencing now is merely a extension of the headache I was feeling prior to vaccination.

patient fainted within minutes of getting the vaccine. they reported they were afraid of needles and was advised to take a seat in the waiting ares. patient fainted breifly, were sweating. emergency services was called immediately and they questioned the patient and determined it was just the result of anxiety from the fear of needles. patient was okayd to leave the facility by emt at around 3.50 pm. (within about 20 mins from starting of incidient) patient then left the facility without any other issues. follow will be done by rph in a few days. there were no signs of an allergic reaction or history of one

fever, sweating, headache, cough, bloody nose, congestion, fatigue, difficulty eating, muscle weakness, slept for over 24 hours in total two days after vaccine

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 .

Red blotchy skin, hives, blood pressure very high, trouble breathing, panic feeling, itchy everywhere to point of pain

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.

103 Fever and 115 resting heart rate in evening of the day of the vaccination. 2 days later I developed reactions upon consuming food and drink (besides water). Feeling of throat closing and itchiness in the cheek and jaw area of the face indicating an allergic reaction. Symptoms are still prevalent as of today 6/24/21. I have a feeling that something is stuck in my throat/throat closing after eating most foods and consuming hard alcohol and beer. Coffee doesn?t seem to be a factor, as I originally thought the reaction was acid reflux/digestion related. Sometimes the reactions are severe enough to make breathing difficult. I have no history with food allergies and no preexisting medical conditions. My father also had the same reaction following his Janssen vaccination. He reports that he no longer has this symptom.

patient received vaccine 1330at Bakers 300 , 30 minutes later arm numbness 1400 1800 severe itching, 1900 altered mental status given Bendaryl 50 mg and Solumedrol 125 mg IV PTA by EMS squad 1925 arrived ED stroke alert activated - per neurology no stroke 2010 Compazine 5mg , ativan 0.5 mg and LR 1000mL IV r/o migraine

Assessment: Full body diaphoresis, pale in color, extreme anxiety, rapid HR (120) and low BP (80's-90's /50-60s). Tx: cool washcloth to forehead, removal of mask, head down, fluids (oral) and snacks. Call to EMS. Patient refused transport to hospital for IV fluids. Outcome: Stayed on sight for 1.5 hours. VS returned to normal. Still pale upon exit, but A/O x4 with no other complications.

Patient reported feeling dizzy, nervous and diaphoretic Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form Patient?s symptoms improved and will be driven home by mother

Patient received injection and the pharmacist stayed for a few minutes to talk to him and make sure he was ok before leaving patient in the waiting area. About 5 minutes later pharmacist was notified that the patient was feeling dizzy. As the pharmacist approached the waiting area, the patient and fainted and fell out of his chair. The pharmacist helped the patient sit up and he immediately regained his consciousness. The patient was assisted by being given a pillow and ice pack. He was monitored for over 30 minutes before leaving the clinic after recovering. Patient claims to have fear of needles and had not eaten lunch prior to receiving vaccine but had never passed out before, but was states that they were very anxious.

Jansen Covid-19 Vaccine EUA, 0130 restless, insomnia, severe chills, sweating, heart racing, approx 0510. woke up mother stating ?did not feel well & was going to pass out, anxious, heart racing, 0520. collapsed in bathroom, grazing head against the bathtub, loss of consciousness, profuse sweating, 911 called. approx. 3-4 minutes of loss of consciousness, waking, but lethargic, confused, EMT assessment on scene, started IV fluids, transported to hospital - additional IV fluids, CT scan of head, EKG, CXR, labs, given zoltan, pepcid, toradol, monitored for 2-3 hours. Reported from physician that ?all tests were normal?. Discharged from hospital, ate few bites of food, coherent but reports no memory of events beyond waking up mother. Sleeping comfortably

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.

High fever, muscle aches, chills, headache, couldn't sleep, sore throat. One of the most intense 6 hours of my life. The symptoms started at 1.30am and lasted until 8am. Still feeling tired and beat up, it's like I got hit by a semi-truck.

I experienced all of the listed side effects (except, I didn't have an actual fever, I felt like I had a fever, but my temperature was normal). The chills and muscle pain were extremely intense 6 hours after I received my vaccine. I could not stop shivering, or get warm enough. That would be followed by a feeling that I was too warm and I would begin sweating profusely. I also experienced a few additional side effects I could not find listed: I felt especially sensitive to stimuli as if normal sensations were heightened (e.g. hot water in a shower felt painful, running fingers through my hair felt like I was having my hair pulled, I kept my eyes squinted because the sunlight through the windows felt too bright.) I was extremely irritable and became extremely frustrated easily. I mean frustrated to an embarrassing degree over small things that didn't matter. It was inconsistent with my day-to-day temperament. It felt like an adrenaline rush came in response to the most minor of inconveniences.

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

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.

Pt. fainted while vaccine was in arm. I called a CODE 100 and put a cold water bottle on the patient's neck. Pt. came to within seconds. Pt. came to profusely sweating, pale, and feeling dizzy. We took his BP and kept monitoring it for 45 minutes after we had him lay down. His BP continued to rise and was normal. Pt. was nervous before vaccine administration (shaking). After event, Pt. stated this has happened in the past with donating blood. Pt.'s girlfriend picked him up, so he did not drive home.

About 3 hours after getting the vaccine I started to feel short of breath. About 5 hours after that I got chills that made me shake all over because I got a fever of 103. Then 2 hours later my heart started to beat very rapidly and got up to 126 beats per minute, my heart was also not only beating vast but very very hard. Then throughout the night and all of the next day, I had pain in my chest on the left side and also pain in my rib area on the left side. The pain lasted for over 24 hours and because of that I went to the emergency room. It turned out they didn't find anything life threatening at the emergency room but all the pain I had was very scary and very uncomfortable. It was a terrible experience and because of it, I am telling people not to get the Johnson and Johnson vaccine.

After a few hours I know it is more common symptoms such as pain at the injection site, headache, fever, all over body soreness. I also noticed short-term memory loss and mood changes from feeling of Happy and sad and angry from around 5:00 p.m. to 8:00 p.m. and the feeling of complete uselessness and regretting getting the vaccine to the point I wanted to cry saying oh I made a mistake. Almost as if my body was trying to tell me this was a mistake. Throughout the evening the all over muscle soreness and headache and fever seem to be getting worse I even woke up in the middle of night between 2:00 and 3:00 a.m. and took Tylenol PM to help go back to bed. Started feeling better later in the afternoon on April 2nd. Almost if everything went away and back to normal. I have noticed that I have been having more head pain (I normally have none) than normal since receiving the vaccine.

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.

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.

3 weeks after getting the vaccine on 3/26 I started to feel a slight numbness in my fingers. Wasn?t very noticeable and had some bad allergies that day so I chalked it up to that. About a week passes and it only slightly starts to get worse, and i can feel it in my feet as well. I was confused so I started asking about it around my work eventually it had started to affect my walking and it was clear something was wrong, I felt like I had lost balance in my legs and I was losing sense in my fingers. I stopped going to work and went to a doctor on 4/15.

PT appear to have a Focal Seizure and syncope ensue. PT hit his head but no abrasion. Pt awake and alert. Reported feeling tightness in chest and anxious before passing out. Rescue Team contacted ; PT refuse transfer. Vitals in all normal range; BP:120/70 HR:98 Spo2: 97-98. Pt monitor longer in oberservation by Nurse and Rescue Team REFUSE Transport vitals taken before leaving site. Vitals before leaving site: BP:122/77 HR:90 Spo2 97-99.Pt was able to be ambulatory and leave site

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Weakness-Mild, Additional Details: patient was nervous and was hesistant about needles just prior to vaccination. as soon as the vaccinnation was done, patient became tense and seizure like activity for ~10 seconds, then he became coherent and was sweating/ pale/ feverish. Gave the patient water, ice packs, and offered to call 911 once he was coherent. Patient refused and then called friend to take him home.

Started running fever and chills about 2 am, fever was 103.5 took Tylenol for fever and chills, slept most of the next day and that night again started running fever which was only 100. Also took Tylenol.

-brain fog starting about an hr since vaccine administered -random spurts of dizziness/lightheadedness with varying lengths of time

FEELS HORRIBLE; SEVERE FLU LIKE SYMPTOMS; ALMOST PASSED OUT; 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 work out. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced severe flu like symptoms. On 12-MAY-2021, the subject experienced almost passed out. On 13-MAY-2021, the subject experienced feels horrible. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feels horrible, and the outcome of severe flu like symptoms and almost passed out was not reported. This report was non-serious.

Patient DOB: 10/23/1995. Received his single dose Janssen vaccine (LOT#: 205A21A EXP: 6/23/21) at 1054 on 5/22/21. Patient alerted EMT that he needed to lay down 1100. EMT walked patient to the cot. Patient laid down on the cot. EMT took patients vital signs at 1105. BP: 160/118, pulse: 62, O2: 96%. Patient stated that he was feeling anxious. Patient was asked to stay an extra 30 minutes for observation. Patient was given a snack and water. EMT retook vital signs and reassessed patient at 1120. BP: 110/70, pulse: 72, O2: 97%. Patient stated that he was feeling better. EMT retook vital signs and reassessed patient at 1130. BP: 118/75, pulse: 63, O2: 97%. Patient stated he was feeling better. Patient completed observation time. Patient was educated on worsening signs and symptoms of vaccine and when to call EMS or seek emergency/ urgent care. Patient verbalized understanding of education. Patient completed his observation time. Patient walked out of vaccination site unassisted and with a steady gait at 1135.

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.

Despite taking proper medications and having adequate sleep, my husband had a sudden influx of seizures (over a dozen) starting a few hours after getting the vaccine. His seizures are more convulsatory in nature than normal and take longer to recover from than his average seizures.

Chest pain, lung heaviness, pressure behind eyes and in head, weakness, fatigue, joint pain, dry mouth, feeling of passing out.

Last week Monday - June 14 I worked 1pm-9pm. My opening pharmacist left around I'd say 2pm, or 2:15pm~ish and hadn't witnessed the incident. So somewhere around that approximate time I was inside the pharmacy working on a back computer by drive thru and I heard someone yell for help in the waiting area. It was the kind of help you just know means something really drastic has just occurred. I quickly entered the waiting area via the pharmacy consultation door and saw patient face down between two chairs and his nose had a consistent drip of blood that was apparent on the floor. My technician who was in the consultation room told me he had received a Johnson and Johnson Covid vaccine probably within 5 minutes of the incident. With the combination of that information and the visualization of an active bleed, I made eye contact with another staff member inside the pharmacy at will call and told him to call 911 which he turned around immediately and did. The man was alone, but the woman who yelled for help was also calling 911 I believe. At this point I'd say approximately every 3 seconds, a new drop of blood would emerge. There were a couple people nearby including the customer and I asked everyone to stay back a little, I surveyed the scene and it appeared to be safe and I approached patient as I tried to verbally get a response of some sort. I asked if he could hear me, if he knew where he was and what happened, both with no response. The bystander recommended turning him on his side but with the unknown cause of the bleed and the recent vaccination I didn't know if it could be CNS or spinal related and since we were on the phone with EMS, we could get their recommendation of whether to move him or not. Within 15-30 seconds probably, he started regaining consciousness and he was scared at first and rightfully so. He jolted up and back and looked at me like, "why am I face down in my own blood (and probably in a lot of pain i'm sure)", and it scared me a little to be honest. I told him what we had observed, and I saw the bridge of his nose stuck out beyond what was normal but I'm not sure what normal is to him..?? I saw two small lacerations on the side of his nose and a pair of glasses on the floor. I couldn't determine if they were broken or not but surmised, he must have fainted and fallen off the chair and landed on his glasses which cut and may have even broken his nose. Or maybe the ground broke his nose. Either way it looked bad. There were several store team members around at this point (those listed in this report), and the patient was given paper towels for the bleeding and bottled water. There was a store use wheelchair we put him in when he was ready and wheeled him into the consultation room where he could be monitored until EMS arrived. While speaking with the patient before EMS arrived, he rendered all the following information: Never had a reaction to a vaccine before Never had any knowledge of high or low BP issues Doesn't recall ever feeling lightheaded or dizzy upon quickly erecting Might have low blood sugar issues Reasonings for the above response: Hadn't eaten that day yet before his shot and was feeling a little anxious about it Last time he gave blood he hadn't eaten breakfast and passed out after that This was the only other fainting history mentioned He did say it was within the last 6 months EMS arrived within another 2-3 minutes I'd say at which time we had already began the cleaning process. We blocked off the area to other customers, we halted the vaccination process until the issue was resolved, I printed the Biohazard Spill procedures, we obtained the bio-hazard spill kit, and proceeded to clean with all the PPE and sanitization materials included within the kit. After the entire process was completed the store team even ran the cleaner over the area to go above and beyond. The patient refused the ride to the hospital via ambulance due to costs and signed a medical waiver I believe..??

At 1142, patient reported minimal chest discomfort to nurse Patient reported the chest discomfort started at approximately 1130 and stated "it comes and goes". Patient reported he took deep breathes and walked after it started. Patient reported history of anxiety attacks and similar episodes in March 2021. At 1150, Nurse assessed patient vitals: blood pressure 148/92 mmHg, pulse 78 beats/minute, and SpO2 98%. Patient offered 911. Patient refused 911. Patient reported he was nervous before getting the vaccine and stated "I know it's all mental". At 1205, nurse assessed patient vitals: blood pressure 140/98 mmHg, pulse 82 beats/minute, and SpO2 98%. At 1212, nurse assessed patient vitals: blood pressure 142/90 mmHg, pulse 76 beats/minute, and SpO2 99%. Patient reported he wanted to leave. Nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on V-safe, and to follow up with primary care provider. At approximately 1220, patient left facility with unlabored respirations and steady gait.

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.

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.