Johnson & Johnson

LOW GRADE FEVER; NECK SORENESS; DIZZINESS; FATIGUE; SHOULDER SORENESS; INDIVIDUAL 16 YEARS OF AGE RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 09-MAR-2021, the subject experienced off label use. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced neck soreness. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced shoulder soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, neck soreness, dizziness, fatigue, shoulder soreness, off label use and individual 16 years of age received vaccine was not reported. This report was non-serious.

Janssen COVID-19 Vaccine EUA Awful headache, fever over 102, slow, weak, muscle aches, injection site hurts a lot.

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

Developed dizziness in the afternoon after receiving the COVID-19 vaccine on 03/13/21. Developed myalgias & malaise on 03/14/15. On 03/15/15, he woke up with erythema and warmth of his ears. At 7 pm that evening, he developed facial swelling (forehead and cheeks) and erythema around his mouth.

Fever Chills Terrible muscle and joint pain that Tylenol did not help with Headache that Tylenol did not help with Mouth sores Tired Still feels sick 4 days after the shot

Fever of 103.3 that would not go down after taking Tylenol or ibuprofen. Set in 5 hours after vaccination and continues to persist 24 hours after vaccination. Muscle/body aches, fatigue, chills

Patient at Vaccination table, just received dose of vaccine when patient's arm went limp. Also developed generalized weakness. Mother stood in front of him and held his head with both hands. Patient then passed out with eyes rolling in back of head. Also had convulsions for a few seconds that mimicked seizure. Patient soon became alert. Vitals obtained with BP 92/52, HR 34, O2 96% on RA. Patient also diaphoretic to touch. EMS activated and arrived at 1:30pm. Placed in reclining wheelchair and taken to private area. Started to feel better after given cold water. Suggested ER due to having seizure first time. Declined ambulance but mother will take to ER in private car. Patient and mother left with no further incident.

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

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

Patient had fever/chills/sore muscles. Patient reports going to take shower to help with flu-like symptoms and fainting in the shower. Patient's parents helped patient and had him hydrate. He has recovered now, with a lingering Head Ache.

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

EXTREME BONE ACHES; EXTREME BODY ACHES; JOINT ACHES; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced extreme bone aches. On 09-APR-2021, the subject experienced extreme body aches. On 09-APR-2021, the subject experienced joint aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, extreme bone aches, extreme body aches, and joint aches. This report was non-serious.

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

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.

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.

At 12:45, AM, my son got chilled and began shaking uncontrollably. He began running a 103 fever,. The fever, would drop to 101 with Tylenol, but would spike as soon as it would wear off. He was very tired and slept most of today. Today, the fever is gone, but his back hurts and so does the injection site.

Within 8 hours, muscle weakness and joint looseness. By 14 hours, fever 102, severe kidney pain, entire body muscle and joint pain.

HAND AND WRIST SWELLING; PAIN IN JOINTS; VASCULITIS; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced vasculitis. On JUN-2021, the subject experienced pain in joints. On 02-JUN-2021, the subject experienced hand and wrist swelling. Treatment medications (dates unspecified) included: cefalexin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on MAY-2021, and had not recovered from vasculitis, hand and wrist swelling, and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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

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

Received Jansen COVID injection at approximately 11am 4/3/2021. Developed sore left arm, shoulder, and neck approximately 10 pm evening of 4/3/2021. Woke up 3:30am 4/4/2021 and informed parents he did not feel well-awake most of that night. Felt slightly better morning of 4/4/2021, but continued feeling feverish, pain in arms, shoulders, neck. Approximately 8pm Sunday night 4/4/21 he stated he felt it was hard to breath, chest pain, and his arms felt like they were on fire. Was taken to ER at Clinic. Blood pressure 149/98, temp 100.6 complain of feeling feverish and short of breath. EKG was taken which was abnormal and enzymes noted to be elevated. Transferred to main branch of Clinic approximately 4:30am 4/5/2021. Father states patient has inflammation around the heart. Had a cardiac catheterization today 4/6/2021-father states that was normal and patient was started on medication to reduce inflammation around his heart. Patients father states that patient was very drowsy from his catheterization and was fine with his father telling me the events as they occured. As I was speaking with patient father, patient was going down for a MRI of the heart. This information was conveyed to me by father and mother. Patient is a college student and was home for Easter break. Patient currently remains hospitalized in Clinic and father thought he would remain hospitalized until Thursday 4/8/2021 depending on test results and his response to treatment. Both parents state they are willing to be contacted for further information.

Total loss of taste on the tongue. The (very few) taste buds in the other areas of the mouth remained minimally functional. For a point of reference, I can barely taste anything when I swish mouthwash around in my mouth. Pre-existing minimal chest pain (related to history of vaping) flared up to an extreme extent the night of the day I was vaccinated. Hurt more than the joint pain or headache I also have (but those are common side effects).

This spontaneous report received from a patient concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 on Left arm at 16:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back pain and then upper back. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced shivering. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain and then upper back, feeling hot, shaking, chills, and shivering, had not recovered from sweating, and the outcome of really bad headache was not reported. This report was non-serious.

Fever, headache, body aches, sharp lower back pain, redness in lower legs (from knee down) - the way a sunburn would appear, loss of sensation on lower legs for a couple of hours. This all happened within 24 hours of receiving the vaccine.

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

Intense pain in the legs (was told to report this), similar to the flu. Similar, less intense lower back pain as well. Moderate headache which has lasted for multiple days so far. Initially had temperature swings (fever, then cold). Aceitometaphen was taken and wasn't effective. Ibuprofen was taken the following day to minimal effect as well. After two days, the lower back pain, and headache still remain...

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

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

DIZZINESS; FEELS LIKE GOING TO PASS OUT; LEG WEAKNESS; QUEASINESS; HEADACHE; NAUSEA; FEVER; CHILLS; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid 19 positive test in November 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feels like going to pass out. On 09-APR-2021, the subject experienced leg weakness. On 09-APR-2021, the subject experienced queasiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, chills, nausea, fever, and headache on 08-APR-2021, and had not recovered from dizziness, leg weakness, queasiness, and feels like going to pass out. This report was non-serious.

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

INCREASED BACK TO BACK HEAVY NOSE BLEEDS FROM BOTH NOSTRILS; ARM SORENESS; HEAVINESS IN ARM; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed and concurrent conditions included seasonal allergy to pollen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in arm. On 12-APR-2021, the subject experienced arm soreness. On 16-APR-2021, the subject experienced increased back to back heavy nose bleeds from both nostrils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 14-APR-2021, had not recovered from increased back to back heavy nose bleeds from both nostrils, and the outcome of heaviness in arm was not reported. This report was non-serious.

Started with a low fever 6 hours after vaccination, with slight muscle ache symptoms. About 4-5 hours later it evolved into a high fever (104 at peak), muscle aches on the whole body, and ringing in my right ear. The next day the symptoms were more mild, but still present (other than ringing in ear) with a lower fever, and the day after the symptoms were gone except for tenderness at injection site.

I had a numbness in my hands and sharp pains from my lower back to my feet. Soreness all over to where it hurt to move

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.

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.

My son woke up and complained to us of pain in shoulder where he got shot and pain in chest. Chest pain worse when inhaling or bending over. We had been telling him he sounded congested and ill for several days prior, but he denied feeling ill. Just thought he was groggy from waking up or having usual allergies. Sunday morning he told us ?I think you were right. I am sick. Told us about pains. Advised him to call advise nurse on insurance card. He was told to rest and take otc pain reliever. He rested but took no medication. By the next day his arm pain was gone and chest pain reduced to only on deep inhale.

PAINFUL ARMPITS; REDNESS IN ARMPITS; RASH UNDER BOTH ARMPITS; 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 patient had no known allergies. patient took 180mg of otc allergy medication. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced painful armpits. On 21-MAY-2021, the subject experienced redness in armpits. On 21-MAY-2021, the subject experienced rash under both armpits. On 22-MAY-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful armpits, and had not recovered from rash under both armpits, and redness in armpits. This report was non-serious.

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.

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

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

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.

On July 27, my leg buckled and I fell to the floor and couldn't move it. Hit my head and had to get 6 staples with mild concussion.

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.

H/A,neck pain. Pt ED EMS; received COVID vaccine this morning with syncopal event, possible head strike. state he was sittig in a chair and awoke on the floor. facility VS: HR48, SPO2 100% RA, A/Ox3. reports feeling better at this time. denies visual. emergency room there is no evidence for intracranial bleed or skull fracture. The patient had a rapid return to baseline. As well as laboratory evaluation was normal and he had an unremarkable EKG. At this time there is no emergent indications for referral or hospitalization.

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

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

Sinus tachycardia probably related to immunologic reaction to COVID-19 vaccination. He started experiencing tachypalpitations about 30 minutes after receiving Johnson & Johnson COVID-19 vaccine. He reports having associated low- grade fever, chills, and myalgias. He was noted to have elevated lactate levels which resolved on follow-up labs.

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

Fever: elevated temp of 38.5 Celsius, started at ~9 pm on 4/10 chills: even in state of overheatedness, still was shivering, started at ~9 pm on 4/10 headache: pain around temples, started at ~9 pm on 4/10 muscle pain: pain/constant contraction of butt muscles, started at ~9 pm on 4/10 tiredness: unable to stay awake to normal bedtime, started at ~9 pm on 4/10

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.

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

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

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

Got chills, muscle aches, headache, hives on day shot administered. 12 days later started seeing defined red and purple splotches, started on hands and palms, spread over my entire body over the next 2 days. Splotches were dark purple. Went to clinic, they were unsure of the cause. Waited a day and then went to another clinic where they thought it might be Coxsackievirus, except there were no sores in the mouth and the splotches were on the palms and pads of the feet. The splotches faded over the next 2 weeks, the last place they were visible were on the upper arm, torso and thighs.

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

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

HORRIBLE BACK PAIN (WITH A PAIN SCALE OF 7.5 OUT OF 10); SWOLLEN POUCH ON LEFT LOWER BACK APPROXIMATELY FOUR INCHES DIAMETER AND THREE INCHES HEIGHT DIAGNOSED AS LYMPHATIC ISSUE DUE TO VACCINE; FEVER OF MORE OR LESS 100 F; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight was 150 pounds, and height was 190 centimeters. The patient's pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced horrible back pain (with a pain scale of 7.5 out of 10). On 24-MAY-2021, the subject experienced swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine. On 24-MAY-2021, the subject experienced fever of more or less 100 f. Laboratory data included: Body temperature (NR: not provided) more or less 100 F. Treatment medications included: paracetamol. On 25-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine on MAY-2021, and was recovering from horrible back pain (with a pain scale of 7.5 out of 10), and fever of more or less 100 f. This report was non-serious. This case, from the same reporter is linked to 20210557778.

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

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.

CHEST PAIN; COUGH; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a parent 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 (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced fatigue. On 14-JUN-2021, the subject experienced muscle aches. On 14-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced chest pain. On 15-JUN-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest pain, cough, fatigue, and muscle aches, and the outcome of fever was not reported. This report was non-serious.

20 year old, male patient came in for his appointment for Janssen COVID vaccine. Patient filled out the vaccine questionnaire, and we discussed patient questions and common side effects. Patient did not state any adverse reaction to previous vaccine or fainting history on the vaccine questionnaire. Patient was given vaccine in left arm. Shortly after receiving vaccine, patient states, "uh-oh it's happening again." I asked patient what was happening and he stated, "this happened to me when I got a blood draw. I fainted." I told patient to take some deep breaths, patient started to stare off to the ceiling and his pupils were dilated and his head fell back in the chair towards the ceiling. His legs body became stiff and he lost consciousness in the chair. I called for help and she came to assist me in the immunization room. I ran to get him a water while the pharmacy called for 911. He regained consciousness quickly, within a minute. Emergency response came quickly and attended to him and took his blood pressure and vitals. He was able to drink water and respond to all questions. He refused to be taken to the hospital and did not think he needed any additional medical attention. He was advised to follow up with his primary care physician. He was advised to sit and stay and get a ride home, which he did. An incident report and VAERS report will be reported today.

Patient came to counter approximately 5 minutes after receiving vaccine stating he felt like he may pass out. He was instructed to have a seat in the waiting room and the pharmacist was notified. Pharmacist immediately went to the waiting room to check on the patient and observed the patient drop his paperwork and lean back in the chair and his eyes rolled back. Within 30 seconds he sat up and began talking to me. He was able to tell me about feeling light headed and sitting down. We gave him water and he immediately began to feel better. He stayed in the store with supervision for approximately one hour before going home.

BACK PAIN; SWEATS (SOAKED BED SHEETS); FEVER TO 103F; FATIGUED; This spontaneous report received from a parent 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: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the subject experienced sweats (soaked bed sheets). On 23-JUL-2021, the subject experienced fever to 103f. On 23-JUL-2021, the subject experienced fatigued. Laboratory data included: Body temperature (NR: not provided) 103 F. On 24-JUL-2021, the subject experienced back pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, sweats (soaked bed sheets), fever to 103f, and fatigued on 25-JUL-2021. This report was non-serious.

About 9 hours after receiving the vaccine (around 2am) I had a fever, chills, headache, sore arm, and muscle soreness. I fell back asleep and when I woke up the fever had broken and the chills had improved but the soreness and headache remained. I took Tylenol in the afternoon and that helped the symptoms but by the time I had gone to bed the chills had returned but not a fever. When I woke up in the middle of the night (night 2) the chills had stopped and I woke up with a moderate headache and sweating profusely. After falling asleep and awaking in the morning I felt much better with the exception of a minor headache.

Experienced extreme chills starting at 4 pm and through the evening/night. At about 3 am I started getting very sore in the left injection arm and throughout my back/shoulders.

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

After 11 hours of getting the vaccine I believe I experienced a sleep seizure. I woke up abruptly, shaking uncontrollably with absolutely no control over myself. Since then I've only experienced the normal side effects, muscle fatigue, headaches etc.

Following administration of vaccine client complained of blurry vision, a heavy arm and that he felt his heart rate was pounding out of his chest. EMS and Dr on site. Pulse 58, Blood pressure 104/65 and 100% 02 saturation. Client was reclined in his car seat until he started feeling better. He reported reactions to previous vaccines but no elaboration. Released by Dr and advised to seek medical attention later if needed. Client verbalized understanding.

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.

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

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

Medium pain and soreness in left arm at injection site immediately after, 30 min later heavy soreness in entire left arm down past elbow -8 hours later moderate headache - 1 hour after above splitting headache - 20 minutes later extreme chills chittering teeth and coldness - then after 20 minutes heat feeling overtook body - splitting headache continues

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

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

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

- Chills accompanied by uncontrollable shaking, lasting approximately an hour. - Muscle soreness, ongoing - Fatigue, ongoing - Fever, ongoing

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

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.

Pt received vaccine. Immediately upon standing, pt lost consciousness and fell face first to the ground. Pt noted to have arms down to side and was stiff and shaking lying on his abdomen. Pt turned to supine position and mask removed. Pt noted to have obvious damage to two front teeth and blood to mouth and lip. Possible laceration to lip.

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

By 6 pm fever, shakes, chills, severe pain in lower back. Could not walk, laid in bed, Fever broke at 4 am next day . No energy, exhausted the next day.

Breakthrough COVID case: patient received J&J vaccine on 3/6/2021. experienced fever, chills, myalgias, fatigue for 12-48 hours. Patient developed mild upper respiratory symptoms on 4/13/2021 and tested positive for COVID via PCR testing on 4/14/2021.

SEVERE BACK PAIN; PAIN ALL OVER; MALAISE; WEAK; CHILLS; HEADACHE; WEIGHT LOST; 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: 1888979 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced weight lost. On 04-APR-2021, the subject experienced pain all over. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced weak. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced severe back pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from severe back pain on APR-2021, was recovering from headache, and weight lost, and had not recovered from chills, malaise, pain all over, and weak. This report was non-serious. This parent/child case is linked.; Sender's Comments: V0-Medical assessment comment is not required as per standard operating procedures.

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.

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

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

7 weeks after receiving the vaccine patient complains of pain on the arm that goes all the way down to the arm. There is stiffness and can feel some muscle knots.

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.

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

patient received vaccine , looked at his arm , and started to freeze up, almost passing out , eyes rolled back and we got him to the floor and he came around saying he could move his arms (both) and his fingers were seizing up, we got ice packs, hewas clammy, but breathing fine , and hew was speaking and complaining about his inability to move. no issues breathing , we called 911

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

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

LEG PAIN; HEADACHE; DIZZINESS; NECK PAIN; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 130 pounds, and height was 68 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse or illicit drug usage. medical history the family had a history of vein issues, and the mother had blood clots before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced neck pain. On 11-JUN-2021, the subject experienced fever. On 12-JUN-2021, the subject experienced dizziness. On 12-JUN-2021, the subject experienced headache. On 13-JUN-2021, the subject experienced leg pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-JUN-2021, and had not recovered from dizziness, headache, leg pain, and neck pain. 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

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.

Arm that got injection is very sore. Muscle aches, headache, and fever of 99.8. Started about 12 hours after injection. Tylenol helps with symptoms.

Starting the night of vaccination and ending in the afternoon the day after: Headache, body/muscle ache, pain at injection site, fatigue, chills, low fever

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

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

Prolonged mono-like illness x >3 weeks. I saw patient on 3/19/21 for ongoing symptoms including severe fatigue, headaches, back pain, chills. The patient had history of EBV infection a couple years prior, and he noted it felt very similar to that bout of Mono

Headache, Mildly elevated, fever 100.4 at home afebrile in office, fatigue, left deltoid soreness experienced the day after vaccine which was received at 11:30 on 3/31/21.

Left deltoid pain day after injection, continued with paresthesia's to left arm. attempted to exercise to alleviate pain, symptoms persisted. he was seen today. left deltoid appeared normal on exam, no erythema, no swelling, distal pulses intact. normal rom, strength 5/5. DTR's to left +2/0-4. prescribed ibuprofen 800mg TID x 7 days. Return to clinic in 1 week for follow up, sooner if worse.

Pain at site immediately - arm very sore after, very tired upon awakening in AM at 8:00 AM and throughout the day, chills muscle aches and slight headache - no fever. 2 regular strength tylenol at 10:00 AM and then 2 regular strength tylenol at 4 PM. Giving 2 regular strength tylenol at 10:00 PM because the other doses worked.

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

Onset lower lip swelling 14 hours after vaccine. Urticarial rash 18 hours after vaccine. No respiratory associated S&S. Treated with Allegra and Zytrec with improved S&S. Also had fever 100.5 with HA, myalgia and fatigue.

Jannsen COVID-19 Vaccine EUA Had a high fever, worst pain I?ve ever felt. Was up until 5 am shaking and in serious pain. Lower back hurt really bad and my legs were sore. Hurt so bad it motivated me to fill out this form.

12 hours after receiving vaccine I got sharp pains in back and legs. Burning sensation all over body. I was walking across my room and passed out waking up on the floor. Muscle cramps and tightness followed this. I could not move my muscles for roughly 12 hours. After 24 hours from receiving vaccine these extreme symptoms seemed to fade and I was left with fatigue, soreness and fever as expected. This lasted for the next 3 days

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

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.

Flu-like symptoms starting the night after the injection and continuing for about 24 hours. Achiness throughout the body, fever, tiredness, headache. Used ibuprofen during the 24 hours to treat the flu-like symptoms. Also experiencing random sharp pains in various muscles, sometimes in the arms but mostly the legs. This has been ongoing, not every day but most days since the injection.

Patient was administered the Janssen COVID vaccine at 403 pm. I returned back to the pharmacy to prep his partner's vaccine and when I came back at 405 pm, he was loopy with his head swaying. He wasn't responding to verbal communication by his spouse and me nor through touch as I shook his shoulder. He then lost consciousness and so I lifted his head to check for breathing and pulse which he had. I asked my technician to call 911, and asked my other tech to help me transition him to the floor so we can raise his legs to provide blood flow to his head. Mid-transition, he had a seizure. We brought him completely to the floor and just as I was about to turn him to his side, he regained consciousness. Pupils were dilated, breathing normal, pulse elevated. He also was able to speak immediately and confirmed feeling "okay". I then had my technician remain outside with him laying on the ground as I returned back inside the pharmacy to call management and my technician was still on the phone with EMS. Paramedics and management arrived within 10 minutes upon which patient was then taken to the hospital. Wife followed and we rescheduled her vaccine.

PT states headache/muscle ache/dizziness/chills (received J/J at today 1100). Denies dizziness at this time.

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

Patient developed flu-like symptoms the following day including headache, myalgias, fatigue and fever. This resolved after 24 hrs later. On Thursday night, he developed severe substernal chest pain that radiated to his back. Pain improved when he sat up. He presented to Hospital ED on Friday morning (6/11/21) with continued chest pain and found to have an elevated troponin at 0.561. Patient was admitted at the time for possible COVID-19 vaccine myo/pericarditis. His chest pain did resolve with Toradol IV and has been start on full-dose Aspirin. His troponin has continued to rise however and is now 2.150.

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

Pt received Johnson & Johnson vaccine on 6/12 @11:03 at the Vaccination Site. Patient started walking to observation area, reported feeling dizzy, lost consciousness, was assisted to the ground by staff at 11:05. When awakened, patient reported right elbow pain, headache, and was found to have a small amount of bleeding from his right ear. No preceding chest pain/palpitations/dyspnea, seizure activity, nor focal weakness. He was transported to the ED via EMS for further evaluation. In the ED patient reported previous history of syncopal episode with preceding dizziness several years ago but did not seek further evaluation. No nausea/vomiting. Evaluation revealed decreased hearing, drainage from ear, and right elbow tenderness. CT of head demonstrated right temporo-parietal bone fracture extending to skull base with blood within right mastoid air cells. Elbow x-ray showed no obvious fracture with right elbow contusion diagnosed. Trauma and neurosurgery further evaluated patient and recommended non-operative management of right temporal skull fracture extending into the auditory canal with no evidence of intracranial bleed nor depression. Hospital consulted and prescribed Ciprodex drops for 1 week with follow-up audiogram in 6 weeks. Patient to follow-up in trauma clinic or with PCP in 2-3 weeks. If hearing still muffled at follow-up, ENT will be consulted. Patient was discharge later in the evening on 6/12/2021.

22 year old male patient stood after vaccination, walked a short distance towards recovery area, and fell face forward to the ground, hitting his face on the floor. Provider turned patient to a supine position and noted eyes wide open, upper extremities stiffened, and unresponsive to verbal questions. Napkin saturated with alcohol solution held under patient's nares. Shortly thereafter, approximately 15 seconds after falling, patient began verbal communication. Patient was initially A&Ox1; remembered his name but could not remember the date, his location, the event, or getting the vaccine. Members of the team arrived to assist. EMS team arrived and continued assessment.

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.

10 min. after vaccine - small pang of soreness through left arm, went away after a couple of seconds 7:30 PM the same day - Grade 3 fever (102.9 degrees), intense chills, joint pain, minor headache, loss of taste and smell, coughing fits. Threw on lots of blankets, drank some water, and took two Tylenol pills. 10:30 PM the same day - while on Tylenol, fever dropped to 101.9. Kept taking Tylenol until I went to bed at around 1 AM. 9 AM on Sunday 3/7 - 101.2 w/out Tylenol, no chills or coughing, minor headache. Symptoms faded away over the course of the rest of the day. Back at 100% on Monday 3/8.

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

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

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.

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

Fatigue around 10 hours after initial vaccination. Radiating ache and joint pain from the injection site. After 12 hours, temperature reached 99.7 F. At 14 hours after vaccination, major aches and soreness, chills and fever rose to 101.2. By 1:00am fever had reached 103.0F (all temperatures taken with ear thermometer). I took 1000mg of Tylenol at that time, which greatly reduced the aches and pains. Woke up with a temp of 99.2, minor aches, almost all effects had subsided.

Experienced severe chills approximately 10 hours following vaccine, was shaking uncontrollably and could not properly function/move for about 10-15 minutes. Also experienced regular side effects such as stiff muscles, sore arm, and fever.

Severe Fever, body ache, headache 12 hours after shot. Muscle pain and lung tightness , congestion for week after shot was received

Muscle pain (back, legs, top of feet), headache, fever lasting 3 days, shortness of breath and fatigue lasting 10 days (as of today).

URINATION DIFFICULTY; DIFFICULTY HAVING BOWEL MOVEMENTS; NIGHT SWEATS; ACHES AND PAIN IN JOINTS; ACHES AND PAIN IN LEGS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 170 pounds, and height was 60 inches. The patient's concurrent conditions included smokes marijuana, alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced night sweats. On 04-APR-2021, the subject experienced aches and pain in joints. On 04-APR-2021, the subject experienced aches and pain in legs. On 04-APR-2021, the subject experienced severe headache. On 05-APR-2021, the subject experienced urination difficulty. On 05-APR-2021, the subject experienced difficulty having bowel movements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and severe headache on 09-APR-2021, and had not recovered from aches and pain in legs, difficulty having bowel movements, urination difficulty, and aches and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

NECK PAIN VERY TENDER TO TOUCH; SHOULDER PAIN VERY TENDER TO TOUCH; LOW GRADE FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-MAY-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced low grade fever. On 07-MAY-2021, the subject experienced injection site pain. On 08-MAY-2021, the subject experienced neck pain very tender to touch. On 08-MAY-2021, the subject experienced shoulder pain very tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and injection site pain on 08-MAY-2021, and had not recovered from shoulder pain very tender to touch, and neck pain very tender to touch. This report was non-serious.

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

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

Full body muscle aches developed in the evening of the day the vaccine was received. The next day, full body aches persisted. A low fever and moderate headache also occurred. The following day (2 nights after vaccination), a nosebleed occurred along with general drowsiness and a minor headache.

7 hours after vaccine severe chills, high fever (104.1F), severe headache, severe joint pain in legs. After 12 hours and 400mg Ibuprofen every 4 hour, fever down to 101.8F headache less severe, leg pain still significant.

Aching intermittent Left-sided CP x 2-3 hours, started while sitting today, radiates to Lt shoulder, deep breath makes worse; J&J COVAX yesterday.23 yo m presents with chest pain that radiates to lt shoulder, chills last night. J&J COVAX yesterday

MUSCLE PAIN; FEVER; HEADACHE; EYES HURT; RED EYES; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced eyes hurt. On MAY-2021, the subject experienced red eyes. On 22-MAY-2021, the subject experienced muscle pain. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, headache, and muscle pain, and the outcome of eyes hurt and red eyes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545645.

Severe headache, severe muscle pain, loss of taste, severe skin sensitivity on whole body, sleepiness, lethargic, sharp eye pains

Patient became extremely faint immediately after the injection. Patient began to shake, got really hot, then really cold and felt as if he were going to pass out. Also said that his arm hurt & felt stiff at the injection site. This feeling he described lasted about 15 minutes, then he began to start feeling a little bit better. We gave him some water and had him sit for as long as he needed. Patient sat for total of 30 minutes, then left of his on accord.

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.

About 5 minutes after vaccination the patients body became stiff for about a minute, also went pale and lips turned white. Had patient lie down and rest for about 10-15 minutes. He also ate a protein bar. Color in face/lips returned to normal. Had patient remain in pharmacy for another 15 minutes for further observation, no other adverse effects. Although the patient stated never having an adverse effect to any other vaccines on the pre-vaccination questionaire; after recovering he asked "did I go stiff?", when told yes he said "that happened once before when I had a vaccine".

Please note patient did not receive vaccine at this organization. Submitting to VAERS following ED visit and admission. 23 y.o. male with no previous past medical history presented 6/10 with complaints of dizziness, presyncope and syncopal episodes. Initial fainting episode was in January 2021 upon receiving sutures the laceration on his his right index finger. At the time he reports that although he passed out he did not really lose consciousness as he was aware of his surroundings. Things seem to go fine for a while until the day after he received his J &J vaccine in April 28, 2021. Reports having the usual post vaccine symptoms such as myalgias and malaise but the following day while at the barbershop he reports having another syncopal episode. He reports a prodromal phase that includes shortness of breath, numbness of the lips and a generalized warm feeling. During this episode he denied any loss of consciousness, as he was able to unlock his phone and respond to the people around him. He denies any myoclonic movements or jerks. He denies any postictal symptoms. Patient has been seen in the ED 3 times within the last week. On 6/10/2021 while at the base clinic, he reports feeling like he was about to pass out and was brought to the emergency department for further evaluation. He denies any nausea, vomiting, headaches. He endorses some chest pain when he lays down flat that is relieved by leaning forward. He denies any recent illness. Denies any new medications or changes to his diet or hydration status. The day prior to admission, his ED visit for weakness and presyncope occurred shortly after PT eval at the base. He felt very lightheaded and he attributes that to not eating and drinking prior to the PT eval. Work-up in the ED included EKG which showed ST elevation in leads V3 and V4 in a biphasic pattern. CT chest which showed no PE or consolidation pneumonia or pleural effusion. CMP was remarkable for potassium of 3.4 serum bicarbonate of 21. CBC was normal. CK was slightly elevated at 913. Troponin was negative. Lactic acid was 1.9. UA with no concern for infectious process. UDS was negative. Due to EKG findings reported above, patient was discussed with cardiologist who recommended that patient be admitted for observation. Upon further discussion with patient, it was clear that his chest discomfort improved when leaning forward, and his EKG was consistent with diffuse ST elevation. With a clinical diagnosis of acute idiopathic pericarditis, patient was initiated on colchicine 0.6 mg twice daily and ibuprofen 800 mg 3 times daily. He is to continue his colchicine therapy for 3 months and his ibuprofen therapy for 1 to 2 weeks with a gradual de-escalation of that ibuprofen by 200 mg/week. He has follow-up with cardiology scheduled. Cardiology mentioned in their notes that they would obtain an echocardiogram to rule out structural heart disease and recommended a 2-week event monitor upon discharge with a 3-week follow-up with tilt table testing and exercise stress testing. Cardiology had high suspicion for possible vasovagal. Echocardiogram was unremarkable without pericardial effusion.

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

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

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

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

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

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

Patient 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.

Blurriness in the left eye and muscle fatigue continuing for more than 2 weeks after the vaccine. Reduced muscle recovery after physical activities, even 2 weeks after the vaccine.

24yr AD male that presents on 28Mar2021 with left arm pain and concern that it may be related to the Johnson&Johnson COVID-19 vaccine that he received on 17MAR2021. He describes 2 days of post vaccine fatigue/chills/myalgias that resolved with rest. On day 3 post-vaccination, he states he had a circumferential rash from bilateral feet to upper thigh that lasted approximately 24hrs. The rash resolved without intervention. He states that he has had new onset left arm pain (side of injection) that started in his left hand 7 days after his shot and begin radiating up the arm into the neck over the next 4 days. He has been lifting weights but denies any changes in workout habits or a perceived injury. Pain is 6-7/10 per patient but has difficulty articulating the quality of the pain. He has no associated weakness/numbness/paresthesias. He denies any rash to the left arm. He has not utilized any medications for the pain. He does not have any functional limitations of the LUE. He was discharged to follow up with his PCM.

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

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

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

Patient had an initial response 2 days after the vaccine, with general malaise, dry mouth, headache and itching hands as well as local discomfort at the injection site that seemed to resolve spontaneously. On April 3rd he had non-specific changes in his hands that he attributed to cold weather that led to discomfort when running them under warm water. By monday APril 5th he was having worsening sensitivity in his hands and feet to heat, touch and experienced numbness. he also began to have difficulty walking. He went to the ER April 6th and was discharged April 7th after undergoing MRI of the brain and spinal cord, labs and lumbar puncture, with a presumptive diagnosis of early Guillain-barre Syndrome. His symptoms continued to worse, loss of gait was more pronounced as well as loss of balance and new off sensations in his tongue. He was admitted to the hospital, continued to undergo diagnostic workout. Results from tests on APril 6th came back positive for Anti nuclear antibodies and high protein in his CSF. He was treated with 3 days of infused Immunoglobolin therapy and was discharged on April 11th with a diagnosis of likely GBS. His symptoms continue to worsen slightly, but with less day to day decline

Patient had a brief syncopal episode w/flushing followed by muscle contractions. 911 was called. Blood Pressure 94/43. O2 sat was 98% on room air. Per patient, vision got blurry and then went black. Tingling in bilateral hands. Paramedics arrived and assessed patient. Per paramedics request patient was to wait another 20 minutes before leaving. 10:34am patient is alert & oriented x4. Walking and feeling back to baseline. patient was then walked to his vehicle and was informed that if he began to feel that way again, to call 911 immediately. from time of vaccination to time patient left was a total of 42 minutes.

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.

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

Prior to receiving vaccine patient was normal healthy 24 year-old male, with no underlying health conditions. Pain and Swelling in Groin area/Testicular Pain (on 4/12/2021). Started as discomfort at 9:00 a.m. and gradually worsened during the day. By midnight pain was sever, no position would give relief. Pain intensified to causing loud painful screams. Took 600 mg of Ibuprofen waited 20 minutes with no relief. Taken to local hospital ER, Emergency Department, Upon release from ER- recommended to see Urology Specialist. As of 4/14/2021 patient is still taking Ibuprofen for discomfort. Pain has lessened and is not as intense but is still present.

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

pt says he developed a severe headache and back pain. He took ibuprofen for his symptoms which seemed to help. He says the headache and back pain will come and go.. He says the pain is moderate. When he takes ibuprofen medicine for this the pain will subside but then come right back after a couple of hours. Pt will contact his PCP.

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.

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.

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

BACK PAIN; SHORTNESS OF BREATH; CHEST TIGHTNESS; EXHAUSTED/VERY TIRED; HEADACHE; CHILLS; FEVER; DIZZINESS; 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 depression, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included desvenlafaxine for depression. On 20-MAY-2021, the subject experienced dizziness. On 20-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Between 100.3 -102.7. Treatment medications included: acetylsalicylic acid/chlorphenamine maleate/phenylpropanolamine hydrochloride. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced back pain. On 22-MAY-2021, the subject experienced exhausted. On 22-MAY-2021, the subject experienced shortness of breath. On 22-MAY-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness on 22-MAY-2021, and fever on 21-MAY-2021, had not recovered from headache, back pain, exhausted, shortness of breath, and chest tightness, and the outcome of chills was not reported. This report was non-serious.

Began experiencing pain (6/10) in the center backside area of my neck. Headache was (4/10) and enveloped my entire head. Fever was ~101 (can not recall exact temperature); went between being overly hot and sweating to chills and shivering . It all appeared to fade away around the same time ~27 hours after vaccination (5/12/2021) between 6-7pm.

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

About 11 days after receiving the shot, I started experiencing chest tightness/pain. The pain persisted for four days and I went to urgent care. Urgent Care referred me to ER to screen for blood clots. After returning from ER, I started feeling sharp pains in multiple places all over my body?hands, fingers, toes, feet, calves, shins, forearms, back. Chest pain also continued. The chest pain has subsided, but I still experience shooting pains in arms, legs, hands, feet, toes, fingers, and occasionally my back. Pain is a 3-4/10 on average, but persistent. Some days are better than others. Some days the pain is mostly in a forearm (sometimes both) and the next day it's in a leg (sometimes both). Some pain seems to be in/along muscles, some in/along bones. It sort of feels like there's a small electrical storm in my body. Movement does not seem to have any effect on the pain.

About a week after vaccine started exp chest pain and difficulty breathing, After the two week mark of those side effects I started exp joint pain, little fatigue, redness and swelling of both knees.This was causing difficulty for me to stand.As of today I'm still exp symptoms taking Ibuprofen causing stomach pains stopped and physician recommended Tylenol.

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

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

6.5 hours after receiving vaccine began to feel muscle soreness throughout body especially in legs. 7 hours after receiving vaccine had 104 degree fever and chills which was reduced with acetaminophen. Throughout the following day, had a low grade fever of ~101 when not using acetaminophen and tiredness. Two days after receiving the vaccine, all side effect besides tiredness have subsided.

I had a fever that ranged from 99.3 to 100.8. I also had muscle aches, including pain at the injection site. I also was very fatigued. The side effects started approximately 12 hours after receiving the vaccine and were done approximately 24 hours after starting. The exception is the pain at the injection side which continued for an additional 12 hours.

Woke up at 4:00am the next morning with fever, muscle aches over whole body, soreness at injection site, headache, sore throat. Starved the fever for a few hours and took Tylenol. I had broken the fever by 7:30am that morning and only minor body aches persist.

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.

reported started to feel dizzy after receiving vaccine. Thought it was nerves, tried to walk to chair for monitoring. Observed by clinic staff fainted on way to chair. Medical Doctor who was vaccinating on premises responded to incident immediately and patient came too right away. Patient is reporting butt feels sore, head and shoulders are fine. Place where shot was given feels sore.

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.

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.

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

I had chills and muscle aches which lasted about 24 hours starting about 9 hours after receiving the vaccine. I just rested the next day and wore more layers to feel warm. No additional medication aside from my prescription of 3mg of melatonin at bedtime was taken. Symptoms were gone after awakening from a full night sleep, roughly 43 hours after vaccination.

Monday around 11:30pm started experiencing headaches, fever, muscle cramps, and body aches. Next morning the headache and body aches persisted through the day. Only taken 1 benadryl, 4 loratadine. Wednesday night taking a shower started feeling some discomfort on the left side of my neck. Today 4/15/2021 still bothers. Feel like a swollen muscle or ganglion.

pt had transient fatique and myalgias on 4/8 post vaccination. adm 4/15 with chest tightness and palpitations; found to have suspected polymorphic VT/wide complex tachycardia and pericarditis. otherwise healthy young adult with no med hx. CTA neg for PE. given amiodarone. echo normal LVF. troponins normal arrhythmia resolved to be discharge today

BACK ACHE; LETHARGY; MINOR CHILLS; This spontaneous report received from a patient via a company representative concerned a 25 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced back ache. On 10-APR-2021, the subject experienced lethargy. On 10-APR-2021, the subject experienced minor chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back ache, lethargy, and minor chills. This report was non-serious.

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

HEADACHE; LOWER BACK PAIN; PAIN IN GROIN AREA; LEG PAIN; This spontaneous report received from a patient concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced lower back pain. On MAY-2021, the subject experienced pain in groin area. On MAY-2021, the subject experienced leg pain. Laboratory data included: Pain scale (NR: not provided) 7/8 out of 10. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 07-MAY-2021, and the outcome of leg pain, lower back pain and pain in groin area was not reported. This report was non-serious.

Vaccinated roughly around 4pm on 5/19/21. a few hours later had painful cramp that made his arm draw in for about 30 minutes. that relaxed and since then he has had numbnes and weakness in the right hand. I believe brachial neuritis.

On May 19 2021 and 8 hours later I could not move or use my right hand. Pain, numbness, weakness still occurring a week later. Went to family doctor on Friday May 21 2021 and she diagnosed me with Brachial plexopathy from receiving the vaccine. Sent me to neurologist.

I had the expected side effects for about two days after the vaccine. A week later I started to have pain and tightness in my jaw. I waited about a week and the pain seemed to be spreading into my face. I started to have a headache after that and consulted my doctor. The headache and pressure in my sinuses and cheeks has been persisting for eight weeks. It happens intermittently and some days it seems to come on later in the day. The tightness in my jaw has gone away and it is a nagging headache now. When I run it seems to be a slight tightness in my sinuses. I have been using some Allergy medication and they only hep a little.

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

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

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