Johnson & Johnson

Dose given outside of approved age range. Otherwise, having common side effects - fever 101.1, hot/cold flashes, headache, fatigue, dizzy spells.

PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; GENERALIZED WEAKNESS; ACHY; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 16 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies or drug abuse/illicit drug usage. patient denied history of reactions to vaccines. 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 12-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 21:00, the subject experienced achy. On 12-APR-2021 21:00, the subject experienced generalized weakness. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, generalized weakness, fever, chills, and sweating, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.

Pediatric patient presented to Covid vaccination clinic for scheduled second dose of Pfizer. Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine. Patient had headache and feeling of pressure when breathing for five days after vaccination. Came to doctor's office on 6/24 for evaluation of symptoms and to be checked due to receiving Janssen vaccine. Still with headache and feeling of pressure with breathing. No chest pain. He has felt tired and like he doesn't want to do much. Exam normal. Oxygen sat 92%. Reassurance provided.

Patient experienced fever, chills, and leg cramping on the first night after receiving the vaccination. Symptoms subsided by the next day and only soreness in the arm was experienced.

seizure about 2 hours after event, per mother also with increase in salivation and groaning. Benadryl has helped, is being monitored

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

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

Patient received vaccine in the AM of 3/16/21. Patient was in his usual state of health when he went to bed the evening of 3/16/21. He ate dinner normally and his PD was started as usual. There were no overnight complications with his PD and he got up shortly before 8 AM. Mom reports the dialysate from his bag was clear and normal and none of his dwell was retained. She heard a loud thud from the bathroom around 8 AM and the patient was found by his mother having generalized convulsions (bilateral upper and lower extremities) and he appeared to be foaming at the mouth. He did not respond to her and she called 911. The seizure stopped by the time EMS arrived and his initial GCS was 12, and 15 by the time they started transport. He had another seizure en route around 9:30 AM and was given 2.5 mg versed and required bagging. Patient was loaded with Keppra and now has been on maintenance Keppra. Patient has not suffered any additional seizures and is currently undergoing an extensive workup by inpatient neurology team. Vaccine adverse effect currently remains on the differential for inciting event leading to seizure however additional labs are pending to rule out other causes (eg. viruses causing PML). Patient was also diagnosed with multifocal pneumonia and started on antibiotics at time of admission.

The NP gave him my vaccine and him mine. No symptoms at time. Headache and seizures, black eye from falling, slow brain. Function

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient reported sweating, chills, feeling lightheaded/dizzy with visual disturbance (blurry, narrowed vission) for about 20 minutes post vaccination. Blood pressure taken 15 minutes after vaccination 105/68. Monitored patient for 30 minutes post. Symtpoms resolved significantly after drinking some fluids and patient left with Father. Followed up with patient next day and patient reported feeling feverish/chills not taking any medication to manage.

High fever started 6 hours after injection along with shaking/chills. Intense headache as well. 1,000mg Tylenol brought fever down to about 103.6. After talking with doctor, placed in cold shower and also gave 400mg advil. He calmed down and fell asleep for 7 hours. Woke and no fever but achy and tired for remainder of the day. Woke up the following day (so about 36 hours later) and felt much better. All is fine now.

The night after taking the vaccine, I woke up shaking relatively violently. I was very warm but shaking quite a bit, and this went on for about an hour. The following morning I woke up with a severe headache.

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.

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

8 hrs after the vaccination my son experienced violent shaking and rigor, extreme discomfort because of the muscle cramps. Headache, high fever (102F), nasal congestion, nasal discharge and generalized body pain. He took multiple Tylenol and Motrin however the fever did not decrease for many hours and low grade fever (100F) continued into the next day. He had pain on the entire left side of the body. He felt increased sensitivity to touch and even the shower water was hurting. The fever and body pain stayed till the next day evening and needed round the clock Tylenols and Motrins to feel better. He inly felt better 2 days after the vaccination.

As of today, 4/3/21, 72 hours post vaccine, still experiencing sore arm, headache that won't go away despite taking ibuprofen, hard to breathe - weight on chest.

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

Slightly sore arm upon vaccination. Went to bed and woke up with other arm feeling sore, cold sweat, and headache. Tylenol relieved headache but pain still slightly present.

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.

Perfectly healthy, fit, thin 18 year old young man with no allergies and no previous reactions to vaccines or medications... immediately upon receiving J&J injection his eyes rolled back into his head and he was unconscious for two to three minutes, then in and out of consciousness for another eight to ten minutes. He convulsed for around ten seconds after about two minutes of being unconscious. Four to five healthcare workers attended to him, asking him to "stay with us." They called an ambulance, and the medics monitored him for awhile. Heart rate dropped to 34 bpm, clothing drenched with perspiration. Blood sugar was slightly low, although he had eaten a late brunch of two fried eggs, sourdough toast and fruit salad. The last thing he remembers is a cold sensation shooting down his arm and into his left hand. He tried to talk to say he wasn't feeling well, but he couldn't form the words, so he raised his arm and then fainted. He felt generally unwell the rest of the day, and today he is still not fully recovered.

After a few hours, developed a low grade headache and some soreness at the injection site. About two hours later I started getting extremely cold, despite the temperature in the mid-high 70s. I covered up under blankets. I began feeling very tired and a general sick feeling. After about an hour and a half of progressively worse chills and cold sweat, I began to get very very hot and removed all blankets and eventually clothes. I took my temperature, which was at 102 f. At this point I drank some water and Gatorade and waited for it to pass. I also noticed that my Apple Watch heart rate detection was saying my heart rate was in the high 90s to low 100s despite me just laying in bed. This was alarming because my typical resting heart rate is in the low 60s. About two hours later I felt well enough to at least brush my teeth, but upon standing up was greeted with an extreme feeling of weakness and dizziness and it was hard to keep myself up right. I eventually was able to fall asleep, and upon waking up, felt better, but still not great. My heart rate was more normal at this point, I no longer had chills or a fever, but still had a headache and soreness across my body, worst at the injection site.

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

TERRIBLE MIGRAINE HEADACHE; This spontaneous report received from a consumer 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced terrible migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible migraine headache. This report was non-serious.

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

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

My son felt a tingling sensation in his arms and legs for 24 hours after he received the J and J vaccine. He was up all night due to the comfortable feeling. He was back to normal after 24 hours, but it was a very odd reaction.

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

Pt. had a syncopal episode as well as one twitching episode reported by patient's mother immediately after vaccine was administered.

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

VOMITING/EMESIS; SHAKES; LEGS NUMB; FEVER; WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a physician concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and seizure, and concurrent conditions included attention deficit hyperactivity disorder, intermittent asthma, migraines, psoriasis, and penicillin allergy, and other pre-existing medical conditions included currently not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported,1 total administered on 08-APR-2021 at 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 around 19:30, the patient experienced vomiting, had fever, shakes and complained of numb legs and was unable to feel them. He was instructed by his physician to go to the nearest Emergency room (ER). The patient visited emergency room or department and physician office for treatment of the events. He went to ER but was unable to walk at that time and was carried in. The patient was evaluated, had normal chest X-ray (CXR), temperature up to 104, had emesis, underwent rapid covid test which was negative. He was given intravenous (IV) fluids, Zofran, Tylenol and was discharged home. It was reported that the patient was doing better but with continued tiredness, weakness, his legs were feeling better, temperature was down, coherent and was tolerating fluids. Laboratory data included: Body temperature (NR: not provided) 104, COVID-19 antigen test (NR: not provided) Negative, and CXR (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/emesis, fever, shakes, and legs numb, had not recovered from weakness, and tiredness, and the outcome of unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420466-covid-19 vaccine ad26.cov2.s-vomiting/emesis, shakes, legs numb, unable to walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210420466-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.

CHILLS; HORRIBLE HEADACHE; RIGHT ARM IS SORE; FEVER; 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 seasonal allergies, attention deficit disorder, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced horrible headache. On 11-MAR-2021, the subject experienced right arm is sore. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever, horrible headache, and right arm is sore. This report was non-serious.

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

RED HANDS; CHILLS; FEELING WEAK; FEVER OF 103; This spontaneous report received from a patient 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, and batch number: 043821A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced red hands. On 30-APR-2021, the subject experienced chills. On 30-APR-2021, the subject experienced feeling weak. On 30-APR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red hands, chills, feeling weak, and fever of 103 on 02-MAY-2021. This report was non-serious.

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

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

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

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.

Patient stated that at 3am the following day he was cold, sweating and weak. He got up and fell on the floor twice and passed out twice. The whole episode lasted 5 to 10 minutes. The rest of the day he was tired, but not to the extent of the 3am episode.

Patient received the vaccine and while sitting down within one minute he fainted and fell on the floor. He remained on the floor until paramedics arrived. Paramedics took his vitals and observed him for a period of time. They said it was fine for him to leave with someone else to drive him. While waiting for family to arrive the patient began to have a seizure. Paramedics returned and this time they took the patient for further care.

Initially after first dose of Janssen Covid vaccine patient was initially on guerney but states he felt fine and was then assisted to a chair. Four minutes after vaccine, patient was sitting in chair and was observed to slump in chair and was then assisted to the floor. Patient had syncopal episode. Immediately ammonia was placed under his nose and patient aroused. Patient is cool and clammy. Cold ice pack applied to back of head and neck. Vital signs taken pulse 80, respirations 20, blood pressure 126/79, and 02 sat 100%. Patient is alert and oriented x4 and states "this always happens." Oxygen applied at 4 liters per minute via simple mask. Patient assisted slowly to a sitting position. Tolerated well. Patient assisted to gurney by Nurses. Vital signs rechecked, blood pressure is 132/65, pulse 69, 02 sat is 99% on room air. Patient transferred to nurse treatment room via gurney in stable condition with nurse assistance. Report given to Nurse.

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

Suddenly felt dizzy and loss of hearing, sweaty and arms and legs felt tingly. He turned pale. We laid him down and placed ice pack on his forehead and neck. BP initially was 84/50 repeat in 10 min was 105/54. He felt better after 10 min. Felt back to normal at 30 min when he was released to his mother

Patient had facial pressure and some throat tightness. His VS were normal and he was transported to the ER.

Towards the end of the night my arm started getting sore. I couldn't get out the bed the next day because of the body pain and super sore arm.

Upon standing post-vaccination, patient fell into the floor, eyes rolled back into his head, and was convulsing. Upon regaining his whereabouts, patient stated he did not recall anything that had happened. He had impaired vision, tinnitus, and was ashen in color. I was able to get the patient into a chair and he experienced two more episodes within 5 minutes. 911 was called. Patient requested water and it was provided. Paramedics arrived and conducted multiple tests (blood glucose, blood oxygen, blood pressure, heart monitoring). Patient refused referral to the local hospital and left the pharmacy within 30-45 minutes after the incident without any further problems.

Patient received vaccine and fainted several minutes after receiving dose. When patient retained consciousness he was having difficulty speaking and was having difficulty breathing and kept repeating that he couldn?t breath, a dose of epinephrine through an Epi pen was administered 911 was called the patients vitals were checked and he chose not to leave in an ambulance and left

5 minutes post vaccine, patient reported pain in arm and shortly after warmth/ flushing. Pt was warm to touch. Water, diphenhydramine, ice packs were administered to the patient. BP 77/44, HR 66. Ambulance called for assistance. BP came up to 103/60 then 132/66 within 15 minutes and ambulance arrival. Ambulance team evaluated and advised patient to not drive. Next day follow up with mother- Mother reported son to be fine and was at track practice. She described minor Headache and lethargy resolved with ibuprofen. Son went to track practice at school.

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.

Patient fainted approximately 30 seconds after vaccine. Eyes closed and patient did not respond for approximately 30 seconds but still had pulse. When patient's eyes opened he stated his vision was slightly blurred; also pale and sweating. After elevating feet and providing ice packs patient began to feel better. Blood pressure and pulse stable 30 minutes following. Patient felt fatigued but otherwise back to normal when leaving pharmacy.

Patient was told to have a seat in the waiting room for 15 minutes after vaccination. Against medical advice, he left immediately. Employee called the pharmacy and informed us patient was in the bathroom feeling like he was going to throw up, his vision was going black and he was tingling. Our pharmacist brought an epi-pen to the bathroom immediately, however, patient had left the building before pharmacist could evaluate him.

about 5 minutes after patient received shot , he came to pharmacy counter to say he felt light headed, as I ( the pharmacist) headed out to have him sit down, dropped to a sitting position on the floor, I was able to get him up to a chair and was fanning him and we got him some water. he the passed out and his lead lobbed backwards, I got behind him so he did not hit his head and he went into a mini seizure which only lasted about 5 seconds and then he came out of, he was in sweats and we called 911. He declined to go to hospital and his mom came and picked him up

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

After giving patient Janssen vaccine around 12.40pm he started shaking and lost consciousness for less than a minute, we called 911 but patient's parents were on the phone with them already, so we cancelled our call, his blood pressure was 97/57 and heart rate 47, we laid him on the floor and elevated his feet, when paramedics arrived he was feeling better and his vitals were stable. Patient's father( who is a doctor and was present at the moment) did not want the paramedics to take him to the hospital.

On Wed May 19 at approx 11:45 am my son was given the Johnson and Johnson vaccine as he was due to go to work on June 1st however patient had a seizure as a reaction to vaccine he was taken to vaccine site ER by ambulance where he had a second seizure around 3:55 pm he was released from ER after several hours and was told to follow up with PC within 2-3 days. As a result of reaction my son was disqualified from going to work on 6/1, due to seizure -this changed his whole life plans. To add his drivers license was medically suspended as well. Which we are now working having to submit medical test results in order clear him of having medical conditions.

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

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

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

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

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

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

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

Within 1 minute of receiving vaccine, patient experienced seizure. Called 911 and got patient safe and stable while waiting for EMS.

Patient received the vaccine on June 14th and experienced a seizure like event which the administrator attributed to prior Covid 19 diagnosis from January. No further events until June 27 after travelling all day /dehydration to another locale when he experienced a grand mal type seizure. The healthcare facility attributed to dehydration as all vitals normal/alert and after IV / hydration discharged. No further symptoms/events until travelling back to his home locale on July 2 when a similar event resulted in his being transported to a hospital. Vitals normal, Labs normal, CT without contrast normal, no indication of thrombosis and discharged to return to his home locale on July 3rd. Scheduled to see doctor.

LUMP AT INJECTION SITE ON LEFT ARM; HOT FLASHES; FEVER; FATIGUE/FEELING DRAINED; HEADACHE; This spontaneous report received from a patient concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced hot flashes. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced fatigue/feeling drained. On 03-APR-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced lump at injection site on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, and fatigue/feeling drained on 05-APR-2021, and fever, and headache on 04-APR-2021, and had not recovered from lump at injection site on left arm. This report was non-serious.

After Janssen vaccine shot, patient was asked to sit and wait for 15 minutes. During the wait time patient was walking around and felt fine. About 10 minutes later patient looked a little pale. Told him to sit down and gave some water and a power bar. Patient had a seizure and past out for a few second. Patient regain consciousness and we lay him down on the ground. Breathing was normal. We called 911 and when EMT checked his vitals, his blood pressure was low. Patient was then taken to hospital for further monitoring.

Attendee received dose Johnson and Johnson vaccine at 11:40 in the left arm. Lot# 205A21A. Attendee was directed to observation area. Within 30 seconds attendee voiced complaints of lightheadedness, hot/cold feelings, escorted first aid to lie down on the cot. Skin was pale, cool, and clammy, rapid, shallow breathing. 11:43 – Alert and oriented, skin now warm and dry. HR: 62 BP: 120/90 RR: 20 O2Sat%: 99 11:48 – 911 called 11:50 -No voiced complaints- skin warm and dry. HR: 90 BP: 122/84 RR: 20 O2Sat%: 99 11:55 -No voiced complaints- skin warm and dry. HR: 72 BP: 120/84 RR: 14 O2Sat%: 100

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

felt faint, slurry, pale. patient was placed flat on back with feet elevated. injected Epipen. called 911.

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

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

1432hr Pt fell to the ground c/o shortness of breath & dizziness. Dose of J+J vaccine given about 15 minutes prior. B/P 70/50 HR 84 SPO2 100% on R.A., Lungs clear bilateral. Pt complained of tingling in both hands & feet. Pt refused epi but agreed to Benadryl 50MG po Liquid. Benadryl Administered at 1435hrs no improvement, pt feeling more short of breath & Numbness in Lt arm, 1 dose of epi administered at 1440. Pt had no improvement, pt complained of numbness now in right arm. At 1445 a 2nd epi pen was administered. 1447 pt stated he was feeling better. VS taken BP 100/60 R.24 HR 80 SPO2 97% RA. Lungs Clear bilateral. EMS arrived @1448. Pt stable and was transported to the hospital.

Patient received Janssen vaccine via IM into left arm at 519PM. This RN was called to patient side at 525PM due to patient feeling faint. RN and RN already at patient side. Patient was noted to be sitting in chair slumped over and diaphoretic. Patient not responding to questions or speaking. EMS called to scene. Cot immediately moved over next to patient and patient picked up via 3 person lift and laid onto cot. Patient eyes open and looking around with symmetrical chest rise and no appearance of difficulty breathing, patient pale and diaphoretic - vital signs at 529PM = manual BP 110/56, HR 48, SpO2 95% on room air. At 1732 patient became more coherent, GCS 15, alert and oriented x 4, patient remained diaphoretic and pink/pallor noted to skin. Vital signs at 1734 = manual BP 108/54, HR 77, and SpO2 99% on room air. EMS arrived on scene at approximately 545PM. EMS evaluated patient who remains alert and oriented x 4, GCS 15, and is now pink warm and dry. EMS allowed patient to go home after signing necessary paperwork on their end. Patient observed self-ambulating out of vaccination site with cousin at side.

After receiving the vaccine, patient became diaphoretic, lips were turning blue and patient seemed very weak. Vital signs were taken and oxygen administered. Patient was transferred to a stretcher and taken to the ED for observation. He was given some juice and crackers and went home. Patient's mom was present throughout all of the event and desired to take the patient home.

Palpitations and elevated heart rate began evening of 3/29/2021. At 10:30 pm experiencing chills and took tylenol. By 3:30 am on 3/30/2021, weakness, chills with fever of 102-103 and heart rate of 132. Given fluids. At 6:30 am, fever still up and heart rate still high(120+). Took tylenol and went to ER.

INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen. On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115. Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.

At 1628, RRT was called for a 19 y/o M with c/o dizziness and lightheadness. At first appearance, he was diaphoretic, pale, shaky, cool, and clammy. Head-to-toe assessment completed and all WNL than what was previously mentioned. Vitals: BP: 110/58, HR: 72, RR: 20. Has asthma, NKA, no medications/herbal supplements/vitamins taken that day. This was his 1st dose of Pfizer. Response team gave him icepacks to put on his neck and arms and client stated he felt better. His mother arrived and client and response team informed her of situation. Client declined paramedic/EMT assistance. Over monitoring/evaluation period, client?s condition improved. Skin color returned, no more diaphoresis, skin was warm. Client left facility at 1640, accompanied by mother. Mother drove client home.

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.

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

My arm was sore yesterday after I got the shot. Today (the second day) I have migraine and my body is sore like when I had the flu a long time ago.

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

About 5 minutes after the patient was vaccinated, he felt weak and faint. His pupils dilated and he began to profusely sweat. He then blacked out for about 15-20 seconds. By the time EMS arrived within 10 minutes , he was coherent and felt fully recovered.

Pain in left arm just below site of injection. 101 degree fever with dehydration, severe lightheadedness, and headache that lasted till morning. General feeling of weakness and exhaustion that lasted till evening the next day.

Patient fainted a few minutes after the vaccination. Slumped over in chair. Woke up within about 10 seconds. Was pale and very shaky. Recovered over the course of 15-20 minutes.

Janssen COVID-19 Vaccine EUA. Last night I was very warm, had a terrible headache, felt tired/dissociated and my entire body ached. I went to bed around midnight and woke up at 5 with terrible chills, body aches and a headache and couldn't stop shaking and couldn't fall back asleep for about an hour. I woke up around 10 drenched in sweat and had a bad headache, body aches and a 101 fever. I took ibuprofen last night, around 8 this morning at 5 and this morning at 10 and felt slight symptom relief but still have a fever.

Patient experienced syncope, flushing/sweating, and dizziness, likely vasovagal response. Patient fell, fall braced by healthcare provider, did not hit head. BP 96/46, HR 49, R16. Given water and crackers, stabilized within 30 minutes, BP 124/49 P52, stable and released from vaccination site

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.

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

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

Immediately after receiving vaccine, while waiting in observation area, patient started to feel "weak in the knees" and "tingling" in legs. patient admits history of dizziness in the past with blood draws. No prior history of allergies. No history of COVID, Last meal/snack/drink 24 hours prior. Patient was advised to lay supine- also given snacks/water. Symptoms resolved with rest. BP 133/75, Pulse 66.

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.

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

Patient stood up after the vaccine and became flush, pale, he briefly loss consciousness about 10 seconds and then jerked awake. He remembered the incident. Did not hit his head. He drank a bottle of gatorade and was monitored for an hour before leaving. He felt fine at discharge per patient.

At almost 10 hours after receiving my covid vaccine I experienced extreme chills and weakness. I had a tough time moving throughout my room and could barely get up from bed. It felt similar to having a severe fever. However, these symptoms diminished throughout the night and I only felt a slight weakness going into the next day. The severity of these symptoms decreased throughout the day but remained in the background for a while.

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.

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

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...

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

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

HEART PALPATIONS (FELT LIKE HEART WAS GOING TO BURST); FEELING JITTERY; POSSIBLE SWEATING; CHILLS; FEVER; 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On an unspecified date, the subject experienced heart palpations (felt like heart was going to burst), feeling jittery, possible sweating, chills, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpations (felt like heart was going to burst), possible sweating, chills, and fever, and had not recovered from feeling jittery. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

SKIN FEELS SENSITIVE/TINGLING; SKIN FEELS SENSITIVE/TINGLING; FEELS LIGHTHEADED; HEADACHE; FEVER 102 DEGREES; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 125 pounds, and height was 67 inches. The patient's concurrent conditions included non smoker, abstains from alcohol, and penicillin allergy, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced skin feels sensitive/tingling. On 08-APR-2021, the subject experienced feels lightheaded. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever 102 degrees. On 08-APR-2021, the subject experienced skin feels sensitive/tingling. Laboratory data included: Body temperature (NR: not provided) 102 deg, and COVID-19 virus test negative (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, skin feels sensitive/tingling, feels lightheaded, fever 102 degrees, and skin feels sensitive/tingling. This report was non-serious.

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

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

The day after felt normal aches and tired. On Tuesday my calves and right leg started to hurt. I woke up on Wed felt as if right leg was numb and begin to had headache. i left work went to ER had Blood Work, Ultrasound (right leg). I went home on Sunday I don't take my Claritin felt fine. On that Monday 4/19 I did take Claritin my right leg started back hurting. Since Tues 4/20 I haven't taken allergy medication my right leg doesn't feel weird.

initial arm soreness, followed by extreme fever of 103.9 on set hour 8 and lasting for 12+ hours. Roughly hour 28 extreme lung pressure, new bruising and patching red dots on palms of hands. A phone call was made to a Covid help line and determined an ER visit was needed ASAP. ER visit determined an extremely elevated INR, but chest xray was clear. Toradol injection given after it was determined it was an inflammatory response to the vaccine centered in the tissue/muscles between the ribs.

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

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.

1432hr Pt fell to the ground c/o shortness of breath & dizziness. Dose of J+J vaccine given about 15 minutes prior. B/P 70/50 HR 84 SPO2 100% on R.A., Lungs clear bilateral. Pt complained of tingling in both hands & feet. Pt refused epi but agreed to Benadryl 50MG po Liquid. Benadryl Administered at 1435hrs no improvement, pt feeling more short of breath & Numbness in Lt arm, 1 dose of epi administered at 1440. Pt had no improvement, pt complained of numbness now in right arm. At 1445 a 2nd epi pen was administered. 1447 pt stated he was feeling better. VS taken BP 100/60 R.24 HR 80 SPO2 97% RA. Lungs Clear bilateral. EMS arrived @1448. Pt stable and was transported to the hospital.

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT STATED HE'S AFRAID OF NEEDLES.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient experienced syncopal episode within 10 minutes after immunization. He was standing at the time, and fell into the floor. He was not injured. 911 was called out of precation. His vital signs were good. Patient left store on his own accord after being checked by EMT.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt. fainted a few minutes after he received the vaccine ~12:30pm. The pharmacist and family members attended to him until 911 emergency responders arrived. When he woke up, he told them he had not eaten, or had anything to drink all day. He also stated he had fainted in the past when receiving previous vaccinations. He declined to be brought to the hospital, and went home w/ his family. Pharmacist checked up on him at the end of the day and he stated he was feeling fine.

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

FLU-LIKE SYMPTOMS; PAIN IN ARM; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: diclofenac sodium. On 09-APR-2021, the subject experienced flu-like symptoms. On 09-APR-2021, the subject experienced pain in arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, and the outcome of nausea, headache and flu-like symptoms was not reported. This report was non-serious.

CLIENT HAD A VASOVAGAL RESPONSE IMMEDIATELY AFTER GIVING HIS VACCINE. CLIENT BECAME CLAMMY, FAINT, DIZZY, AND VERY PALE AFTER THE INJECTION. CLIENT RECOVERED AFTER 30 MINUTES, WITH WATER AND ELIVATION OF THE FEET AND REST.

Within minutes of getting the Janssen covid-19 vaccine, patient began to feel dizzy/light headed and warm. Patient lost consciousness a few times over 10 minutes stretch monitored pt. for 30 additional minutes

Starting within two minutes of receiving Janssen vaccine patient became pale in color, clammy, and started exhibiting seizure like activity (jerking). Patient fell out of his chair and onto the floor. Patient does not remember incident, stated he only remembers looking at his phone then becoming alert again to people surrounding him. Patient was assessed by pharmacist immediately and EMS was called at 9:35 am. Vitals were taken by pharmacist at 9:37 am. Patient was re-assessed upon arrival of EMS.

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

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

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

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

A FEW DAYS AFTER ADMIN OF VACCINE PT COMPLAINT OF SORE ARM. TINGLING OF LEFT ARM. WENT TO DR. HE RECOMMENDED OTC ADVIL

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

Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: delayed but quick onset of feeling of warmth-Severe, Additional Details: Patient came to me 5/13/21 to describe that later in the day, after receiving the Janssen vaccine, pt was driving and had a sudden feeling of body warmth and vertigo. Patient further described chest tightness and difficulty breathing, as well as all over body pain. He reported that he was able to safely get to where he was going and the next day had more "expected" grogginess and aches.

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

Patient seated in waiting area for 15 minute observation. Notified per staff that patient was not feeling well. Patient reported that he "passed out" while seated. Pt diaphretic and pale. VS obtained and blood pressure 98/60. No baseline blood pressure to compare. Pt given Orange Juice x 2 with improvement. Blood pressure retaken and 110/72. Pt with complaint of tingling in fingers , but stated that that was not new. RN sat with patient until patient felt better. Offered to call Paramedic to evaluate patient, but patient declined. Patient reported that he felt better and was going to sit for a few minutes longer and drive home. Patient did admit to fear of shots prior to receiving vaccine.

Client had an episode of dizziness , presyncope immediately after receiving his vaccine. Denied shortness of breath or chest pain . He reported tingling in his hands. He had not had breakfast prior to arrival . He was offered water . His symptoms resolved within 15 minutes and he was able to leave after his symptoms were resolved.

Patient reported feeling dizziness, his vision went black and he lost hearing within 5 minutes of receiving the vaccine. He was sweating and felt cold and tingling. Patient states the tingling started in his feet and worked its way up his entire body. Paramedics were called.

Janssen COVID-19 Vaccine EUA: patient reports within one hour after receiving vaccine developing muscle twitching in upper extremity on the same side as immunization. Since that time patient noted symmetrical bilateral mostly lower extremity muscle twitching that is worse at night. Patient has been trying over-the-counter vitamin D and magnesium with minor relief but not resolution. No symptoms of neuropathy or myelopathy documented on physical exam and vital signs within normal ranges. Prescribed tizanidine and cyclobenzaprine as needed.

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

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.

Pt was sitting in observation chair after his vaccination--a little slumped over and twitching as if he were having a seizure. He did not respond to me calling his name. Pt gained consciousness and was a little frightened, not understanding the situation or remembering where he was at. He felt a little better after some water. About 4 minutes later, he said he was losing his vision and seeing flashes of light. He was told to lie on the floor with his feet up. Within a few minutes, he said he was feeling a lot more like normal.

HPI This is a 19-year-old male that presents for complaint of witnessed seizure-like activity. He arrives by EMS. Patient is currently awake alert and oriented ×3. Today, he was out on the golf course with friends. It was a normal day and he returned home. When he got home, he was complaining of a headache to his mother. She gave him Motrin. Mother then heard a noise from the other room and found the patient on the floor unresponsive, displaying tonic-clonic activity, and eye rolling into the back of the head. This lasted for 4-5 minutes per mother. EMS arrived on scene he was postictal. Patient is never had this happen before. He denies any illicit substance, alcohol or medication use. Review of Systems Constitutional: Negative for chills, fatigue and fever. HENT: Negative for facial swelling and trouble swallowing. Respiratory: Negative for cough, shortness of breath and wheezing. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Positive for seizures and syncope. Negative for weakness, light-headedness and headaches. Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.

Immediately following administration of the vaccine, the patient reported lightheadedness, tinnitus, and paresthesia of extremities. Patient experienced these symptoms within 15 seconds of vaccine administration. Symptoms persisted for approximately 15 minutes.

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

ALMOST PASSED OUT; SKIN LOOKED WHITE AND PALE; MILD PAIN IN STOMACH; LEG HURTS; CHILLS (FEELING COLD AND SHIVERING); FEELING UNWELL; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed, and other pre-existing medical conditions included patient had no other health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced almost passed out. On 02-JUN-2021, the subject experienced skin looked and pale. On 02-JUN-2021, the subject experienced mild pain in stomach. On 02-JUN-2021, the subject experienced leg hurts. On 02-JUN-2021, the subject experienced chills (feeling cold and shivering). On 02-JUN-2021, the subject experienced feeling unwell. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low platelet count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from almost passed out, had not recovered from skin looked white and pale, leg hurts, and chills (feeling cold and shivering), and the outcome of mild pain in stomach and feeling unwell was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

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

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

19 YRS OLD MALE. NO KNOWN MEDICAL HISTORY. SEVERE HEADACHE, FACIAL DROOP, TINGLING SENSATION ALL OVER HIS BODY. CHEST PAIN, SOB, BLOOD WENT UP. SINUS TACHYCARDIA.

PATIENT FEEL SHAKING AND PASSED OUT FOR FEW SECONDS, FACE AND LIPS GOR PALE. CAME BACK NORMAL AFTER HAVING SOME WATER. CALLED 911 AND EMR SERVICE CAME IN 4 MINS ,WHO CHECKED HIM, FOUND ALL PULSE , BLOOD PRESSURE NORMAL ON ARRIVAL. HE WAS FEELING OKAY BY THEN AND REFUSED TREATMENT FURTHER AND REFUSED TO GO HOSPITAL

Patient was clammy, getting tunnel vision, and hearing was "tightening". Blood pressure was 101/56. this happened roughly 5 minutes after administration

High temp fever (102.5), body aches, headache, possible loss of consciousness (momentarily- unverified - I wasn't there) temp responded to acetaminophen/cold compresses but lasted thru night. In AM temp down to <=101 for another 12 hours, slept all day After 18 hours, temp resolved (still achy for another 12 hours) NO chills, NO nausea, only mild injection site swelling Note - the pharmacy suggested I create this report because of the possible loss of consciousness (was non-responsive to sibling when arrived home)

After I administered the vaccine the patient's pupils became dilated right after I finished injecting vaccine. On my question whether he was doing ok he answered yes, then stood up and walked out of the immunization room. While walking he walked directly into the end cap of the aisle. I rushed to him and with another customer and his mom was able to handle to make him sit on a chair. I kept talking to him while tried to keep him alert waiting for EMT. Another customer turned out to be EMT healthcare professional so he was helping me to keep the patient alert as he was losing his conscience, and we tried by any means to prevent this to happen. I pour a cold water on the back of his neck and put on the fan. His pulse was slow as well as his blood pressure as his whole body became very pale and cold to touch. However, he was alert as he was able to answer questions of how old he was, what type of education he was about to get and at what location he was pursuing his career. So, it was sort of a "zombie" state of mind which scared me the most. I have been practicing as a Pharmacist for six years as well as immunize people according to NYS Department of Health authorization and I never ever saw such a reaction before.

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

Patient received dose of vaccine. About 2 minutes later he started coughing. A minute later he started to hunch over in his chair. I went over to make sure if he fainted that he would not fall. He described numbing and tingling in both arms and face. He was having difficulty seeing complaining of seeing white. We took his Bp it was 116/70 and pulse of 63. Ge appeared pale and white. We called for ems, and by the time EMS arrived he was feeling better his color had returned in his face. Patient was able to walk and leave store under his own power and didn't need to be transported.

Attendee received dose of the Johnson & Johnson vaccine at 12:40 in the left arm. Lot# 205A21A. Attendee was directed to observation area. At 12:45 the attendee started to fall out of his chair, but was kept from falling by 2 nurses and another attendee, who was his brother. He was assisted to the cot after vital signs were taken and his legs were elevated. Cold packs applied. Attendee's skin was cool and clammy. Stated that he felt really hot. Eyes were open during the event and attendee stated that he remembers everything. HR: 50 BP: 110/60 RR: 12 O2Sat%: 99 12:57 - Laying down on the cot. Gave him some water. He reported that he had not had anything to eat or drink prior to the vaccination. Stated that he was feeling better. No longer cold, clammy, or feeling hot. HR: 67 BP: 120/80 RR: Not obtained O2Sat%: 99 Temp: 96.5 13:08 – Sitting up in a chair. Asymptomatic. Attendee's mother had come into site from her car. HR: 58 BP: 110/60 RR: 16 O2Sat%: 100 13:12 – Attendee wanted to go home, so the Care Practitioner educated him and his family on home discharge/adverse reaction instructions and attendee was discharged to home with his brother and mother. Recommended to call medical provider to advise that he had this reaction. Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.

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

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

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

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.

The Patient got the Janssen shot and Passed out several minuets later. After coming to He was provided a bottle of water. He drank the water and said that he mainly just felt really hot. We asked that he stay in the store an additional 30 minuets, his mother was with him and kept a constant eye on him with the pharmacist checking in in 5 minuet increments. Patient was feeling better and left, at the end of the additional 30 minuet waiting period.

Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: left arm numbness prior to becoming unresponsive

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

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

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

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

fever, sweats, chills, headache, body aches, loss of feeling in limbs. Took 500mg of Tylenol once every 4 hours.

20 y/o national guard male, presented to ER with weakness and fatigue, on exam was tachycardic, febrile and had chills. EKG showed sinus tachycardia, EKG with sinus tachycardia with RBBB, Echo normal. Troponin mildly elevated at 0.11, admitted for serial troponins and telemetry, released later in the morning.

Besides arm pain that went to my pinky, I was fine. Later that night, I started to get chills and was really cold. The next day, I developed a fever of 100.2 and was really cold. For about a week, I would be fine during the day and would get really tired by the evening and extremely cold. I also started feeling tightness in my chest about 2 days after I got the vaccine. I contacted my doctor and she told me to take Tylenol and Albuterol.

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

Came in for his Janssen COVID-19 vaccine and reported no allergies. Within 5 minutes of vaccination he briefly passed out. He was back up on his feet and reported feeling normal within 30 seconds. About 5 minutes later he began to have slurred speech, excessive perspiration and reported feeling warm. An ambulance was called and arrived within less that 5 minutes and took over care.

Patient fainted about 1 to 2 min after getting vaccine. Patient felt very hot and was given an ice pack and began to sweat. After about 10 min patient was helped to a sitting position.

About 3 mins after Janssen vaccine was given, pt was very white and faintish. I rushed out of pharmacy and had a tech call 911. As I was running to him pt started slipping out of his chair, as a women, who I later found out was his mother and I helped keep pt in chair as he fainted and then seized for about 2 seconds and then gained consciousness. Upon awakening pt said , what just happened?" The mother answered "oh you just had a little seizure, you're fine." To my surprise, I asked the mother is this has happened before and she said yes when he sees needles/get shots. I told them the ambulance was on it's why and the mother asked "why?!" I told her because your son just fainted/had a seizure and we want to make sure he is ok. The pt refused to go to the hospital. I did go back out there and mentioned to them that it is very important to answer questions truthfully any time they are asked as they failed to honestly answer our questions about ever feeling faint after receiving a vaccine. His blood pressure normalized and once the paramedics left so did they.

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

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

COLD; FEELING COLD; ARM PAIN; CHILLS; FEVER OF 101.3; 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 past medical history included 3 strokes, and concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced feeling cold. On 03-APR-2021, the subject experienced cold. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever of 101.3. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.3 on 04-APR-2021, was recovering from feeling cold, and had not recovered from cold, chills, and arm pain. This report was non-serious.

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

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

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

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

At 7:00 PM I noticed a feeling of slight prickling in my arms, legs, and neck. I thought nothing of this until around 7:30 where I began to have extreme chills and a headache. Around 9:00, I tried to get some water and I was too dizzy to walk at any normal pace. I took my temperature and it read at 101.9F. I proceeded to take ibuprofen, drink lots of water (about 80 oz that night), and go to sleep as best as I could.

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

Janssen COVID-19 Vaccine EUA 4/11/2021 1-3:30 AM: Chills, muscle spasms 4/12/2021 10 AM: Fever 4/12/2021 11:30 AM: Lightheadedness, muffled/impaired hearing, fainted

Experienced syncopal episode; ground level fall; PHN witnessed from vaccination station and provided assistance along with NP on-site. Recipient was lying on side and assisted to supine position; assessed skin pallor, bilateral hands cool to the touch; denied SOB, denied chest pain; no swelling noted; alert & conversing; stated "I can't hear from my right ear"; d/t fall skull examined and small raised area noted with no skin break. Spanish interpreter utilized.911 called. Denied any h/o of allergies or medical condition; remained alert until arrival of emergency responders. BP taken supine WNL; informed by responders hypotensive standing. Reported hearing returned back to normal. Recipient was taken to local ER for further evaluation. Patient returned to mobile vaccine site after discharge from ED to discuss vaccine and stated ER physician indicated episode was possibly d/t vaccine.

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.

At 10 pm pt. started feeling unwell so he went to lie down. About 10 minutes later he had chills, body aches and was shaking. After a couple of hours he started feeling hot and flushed but did not have a fever. He had body aches and a headache. At 4am he went to the bathroom and started feeling faint so he tried to go back to his bed but fainted in the bathroom. His Mom helped him back to his bedroom, he had no injuries just a headache at that time. He stayed in bed until approx. 5pm when he felt better. No other injuries, or doctor visits.

The patient had a needle phobia and was very anxious prior to the vaccine. Once the patient received the vaccine, he waited in the waiting area for 15 minutes post-vaccine. About 5 minutes after the vaccine, he notified the pharmacy staff that he wasn't feeling well and he was feeling faint. The pharmacy staff provided him with a glass of water and was monitoring him. He said he felt like he fainted and wasn't feeling well. He said he felt warm and sweaty. The pharmacy staff provided him with an ice pack. He then notified the pharmacy staff that he urinated in his chair while waiting post-vaccine. He wanted to be checked out and wanted us to call 911 . The patient began to feel better after about 20 minutes. The EMT arrived and checked the patient. Even though, the patient was feeling better, the EMT recommended the patient be checked further anyways. He was brought to the Triage center and was there for about 1 hour, according to the patient, and was feeling better. He said he felt slightly fatigued that day and the following day, but other than that he was feeling back to normal and no issues. He stated he has severe needle phobia and has experienced these fainting spells and anxiousness in the past. We followed up with the patient and he provided this information to us. He stated he was feeling good and back to normal. He had no further questions or concerns. We told him to follow up with us if questions or concerns came up.

Fever of 103.3, chills, shakes, body pain, headache that lasted three days. On the 12th of april, itching over all of body. Doctor treated with Hydroxyzine.

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

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

Patient's mother called today and stated that he had a seizure this afternoon at 1:35 PM. She stated that she and her husband are both nurses. She happened to be off today and was home with her son. She stated that the seizure was like a Grand Mal seizure that lasted approximately 5 minutes. She stated that he has had a diabetic seizure before when his blood glucose levels were low. She stated his blood glucose was 71. She said this was different, he had no residual after effects. He was not incontinent of bowel or bladder and he woke up quickly afterwards. About an hour after the seizure he ate and only complained of a headache. She gave him ibuprofen 600 mg and he put an ice pack on his head. She said he is better. She stated that she is a nurse and this really scared her, since it was so different than any other seizure he has ever had. She was thankful she was home. She call his primary healthcare provider and she did not feel he needed to be seen.

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

Left arm pain onset following vaccination/injection, but persistent for 3 weeks. States pain to deltoid area with moving arm/shoulders, but no shoulder pain. Full rom to shoulder joint. No redness or swelling, no induration or pain to deltoid area with palpation

Starting exactly 9 hours after injection, a headache set in, very high fever causing shivering, felt weak. Fever and shivering and weakness continued for the next 24 hours. Extreme headache continued for the next two days.

Systemic: Fainting / Unresponsive-Severe, Systemic: Very pale upon awakening, sweaty, feeling "hot"-Severe

ACHY; SWEATING; ARM PAIN; CHILLS; HEADACHE; This spontaneous report received from a parent concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced achy. On 2021, the subject experienced sweating. On 2021, the subject experienced arm pain. On 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, achy, arm pain, headache and sweating was not reported. This report was non-serious.

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

PATIENT OBSERVED TO HAVE POSSIBLE SEIZURE ACTIVITY IN CHAIR. PATIENT BROUGHT TO THE FLOOR AND LASTED ABOUT 1 MINUTE. PATIENT HAD CONTRACTED ARMS, HUNCHED OVER, PALE, DIAPHORETIC, AND VERBALLY UNRESPONSIVE. 911 DISPATCHED AND ARRIVED WITHIN FEW MINUTES. PATIENT DID NOT RECALL EVENT ONCE VITALS STABILIZED AND WAS TRANSPORTED TO NEAREST HOSPITAL.

pt presents to the ED for "cold sweats, fever, headaches and soreness, and eye pain" that began yesterday after receiving the J&J COVID vaccine, has not attempted to take tylenol or motrin for fever and headaches

Patient displayed syncope and observed contracting arms (those who witness expressed seizure like activity lasting less than one minute). Patient was pale and diaphoretic with a glazed over look. Vitals were taken and patient was transported to hospital for evaluation.

Fever, Chills, Headache, arm soreness all on the night of vaccination, all lasting for about a day except the fever. The fever stayed over 100F and lasted until May 4th, 7 days after I received the vaccine. I would take acetaminophen , which helped for only a few hours at a time, but the fever never subsided until the following week.

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

I felt lightheaded a few hours after receiving the vaccine. Around 5-6 hours after the vaccine I was running a high temperature, felt tingling in my thighs, and having a big headache every time I stood up. Persisted for day of vaccination and next day before passing.

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

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

pt had vasovagal syncope, dizzy, passed out, sweating, hot and cold. 911 was called. Put ice on pt's neck, spoke to pt to keep awake, blood pressure taken, EMS took all vitals and blood sugar and EKG all normal. pt allowed to leave pharmacy with ride home from girlfriend. followed up with pt 1 hour later by phone, pt is feeling ok but tired.

Approximately 10 minutes after receiving vaccination, patient became pale, faint, with slowed speech and responses. Patient was mildly sweating. Pulse was 80 and BP was 90/40 upon first checking. 911 was called and pt became more responsive (BP elevated to 115/60) while waiting for EMTs to arrive. Patient recovered by the time EMTs arrived, he was assessed by responders and denied going to hospital. Patient's significant other was present to provide transportation home.

Syncope - patient experienced lightheadedness, sweating, paleness, blurred vision and cold extremities. I reassure patient that he will be okay and this is the body's response to pain/anxiety. I also provided patient with water and make sure he was seated so he does not fall. His vision return to normal after 5 minutes or so and he started recovering within 15 minutes.

Pt received his vaccine and returned to the waiting room. Within 5 minutes he slumped to the floor, he lost consciousness and had a brief seizure lasting less than 30 seconds There was a sheriff deputy in the waiting area that asked him his name, year, president and where he was. He was able to answer all questions, but was still shaking. We called 911 and EMTs were here within 2 minutes and took over. After assessing him and taking his vitals they decided to transport him to Hospital.

I administered the vaccine and asked patient to move to the waiting area for his 15 minute observation period. He moved out to the chair and sat down about 2 minutes later his abdomen started to move back and forth a few times and then he started to have what appeared to be a seizure. It was very short (20 seconds), he remained in the chair. His mom and I moved him to the floor with his help. He then mentioned that he forgot to take his seizure medication last night and was feeling very nervous about the vaccine.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient nodded off into a faint when I went to get him a snack, he remained in his chair but dropped his water. Patient said he was feeling sweaty and seeing black. He rested with head down & on the floor. Had some water and a snack. Side effects lasted 5-6 min, patient remained in pharmacy for an additional 15 min without any further events.

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.

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

Systemic: Dizziness/Lightheadness-Mild, Systemic: Fainting/Unresponsive-Mild, Systemic: Weakness-Mild.

This spontaneous report received from a patient via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

after giving the vaccine the patients arms and head jerked around and then he fainted. all in about 60 seconds. he was able to breathe after gaining consciousness

3:30 pm Received the vaccine 3:40 pm Lost vision, gained a loud ringing in the ears, hands went numb, and passed out for over a minute 3:45 pm Vision was regained, hands were still numb and I could not hear due to the loud ringing in the ears 3:55 pm All Symptoms subsided, went to urgent care and I checked out

Several minutes after receiving vaccine, patient became unconscious and appeared to have seizure like symptoms. After 1 or 2 minutes, patient retained consciousness and felt ok. Paramedics were called but his mother picked him up to take to emergency room.

LETHARGIC; FELT PAIN IN HIS ARM INSTANTLY; HEADACHE; PAIN BEHIND EYES WHEN LOOKING LEFT AND RIGHT/STRAIGHT; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced pain behind eyes when looking left and right/straight. On 02-JUL-2021, the subject experienced felt pain in his arm instantly. On 02-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and felt pain in his arm instantly on JUL-2021, and headache on 04-JUL-2021, and had not recovered from pain behind eyes when looking left and right/straight. This report was non-serious. This case, from the same reporter is linked.

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.

Body aches, migraines. These symptoms started about 8 hours after the vaccine was recieved and lasted about 16 hours.

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.

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

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.

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

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

The patient started heading towards the pharmacists from the observation area stating that he felt dizzy. We grabbed a chair and had him sit down. Almost immediately he collapsed to the floor before we could grab him. He fell face first onto the floor. He moaned and shook. With the assistance of a medic and police office, he was rolled onto his back and his feet were elevated. He started to regain consciousness. EMTs were called to assess him after his head hit the floor. He was monitored by EMTs for 30 minutes. He refused to go to the hospital and was instructed to call 911 if he had additional symptoms.

Adverse event(s): Hives/red swollen skin(arms, legs, abdomen, back), fever, swelling of lips, fast heartbeat, high blood pressure, dizziness, weakness, headache Treatment: Prescribed Medrol (Pak) 4mg tablets, OTC antihistamine Zyrtec daily x 2 weeks, Benadryl at night Outcome: N/A. side effects have been reduced, occasional flare of hives.

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

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

pt states he had the normal side affects on the first day after taking the vax but today 4/8/2021 when he woke up he had chills and his entire body feels numb. Including his face, both arms, torso, both legs and both feet.

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

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

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

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

Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt said he was feeling tingling in arms and legs

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

With in 5 minutes, Patient went from usual reddish complexion to pale, white. Complained of extreme dizziness, and that his sight was ?fuzzy?. Remained this way for approximately 10 minutes. Had him remain sitting and place head between knees. After 15 minute observation, he had regained some color, was able to stand, and left the pharmacy. He has a very sore arm today(4/10/2021), stated he is tired and feels feverish.

Approximately 1 minute after administering the vaccine the patient fainted. Within 15 seconds the patient was awake and oriented. His last memory before fainting was experiencing pain in his arm after the injection . The patient was monitored for at least 20 minutes and given some water and a protein bar. .When questioned whether he often faints, he said the only other time he had fainted was in the past when he was experiencing stomach pain. He appeared to be doing very well when he left the pharmacy with a friend.

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.

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

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.

Pt received injection and immediately upon standing, pt lost consciousness and fell face first to the ground. Pt noted to have hands to side and was shaking. Pt turned to supine position and mask removed. Pt noted to have moderate amount of blood to mouth and lips. Visible damage to two front teeth observed as well as possible laceration to lip.

Unknown if the vaccine has any correlation to event. Patient was found unresponsive and not breathing on 4/11/21 @ approximately 3:45 PM outside on the grounds of the campus. A rented scoter was next to him. There was no sign of trauma. 9-1-1 was called and CPR initiated by passerby (there were no witnesses). He remained unresponsive and was intubated when the paramedics arrived. He was transported to hospital where he was pronounced dead.

Intense headache, fatigue, chills, body aches beginning the morning after vaccination. These symptoms have persisted for 48 hours after vaccination. On Monday, April 12th at 2:45PM, I experience a full-body fainting and collapse onto the floor when attempting to stand upright.

Covid Symptoms: Chills, Body Aches, Fever, Sweating while cold. Slept for 14 hours. Symptoms lasted from 8pm-4pm the next day.

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

Feeling very cold followed by very hot along with weakness, paresthesia. BP was initially in the 170s and his temp. was >99.

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.

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

FEELING COLD; CHILLS; 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 concurrent conditions included seasonal allergies. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:57 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and feeling cold. This report was non-serious.

21 y.o. male with no significant PMHx who received the Johnson and Johnson vaccine 4/10/21 found to have extensive LLE DVT (extending above inguinal ligament). Pt was transferred to OSF for catheter directed thrombolysis. He was given 10 mg Eliquis prior to transfer. Pt reports acute onset of LLE pain the evening of 4/16 with progressive pain over the weekend and development of LLE edema/redness 4/18. Left leg mildly more edematous than right. Foot pink/warm, sensorimotor intact. No skin discoloration. Pt denies recent surgery, prolonged immobility or known family history of clotting disorders.

-Fatigue, headache, fever, dizziness, burning sensation in head 4/9/2021 ~2AM-6PM -Fatigue 4/9/2021-4/20/21 -Fatigue, dizziness, fever, headache, dry eyes, shortness of breath 4/17/2021 5PM-12AM -Heart palpitations, fatigue, dizziness, fever, headache, dry eyes, shortness of breath 4/18/2021 3PM-4/19/2021 12AM (was hospitalized) -Resting heart-rate upon arrival to hospital was ~105

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

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.

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.

RESTLESS; LACK OF SLEEP; LACK OF MOTIVATION; FELT ROSY IN THE CHEEKS; FELT HOT; FEVER; BODY ACHES; DIZZINESS; WEAKNESS; INJECTION SITE PAIN; EXTREMELY FATIGUE AND TIRED, FELT REALLY WORN DOWN; FELT OFF; SENSITIVITY TO LIGHT; SENSITIVE TO SYMPTOMS OF A SEIZURE ONSET; CRAMPING STYLE PAIN THAT TRAVELLED UP AND INTO THE SHOULDER AND UP INTO THE NECK MUSCLE INTO THE BASE OF SKULL WRAPPING AROUND HEAD CAUSING A MIGRAINE; HARD AND HOT TO THE TOUCH GOLF BALL SIZES LUMP SLIGHTLY PROTRUDING; DISORIENTED; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensitive to symptoms of a seizure onset. On 10-APR-2021, the subject experienced cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine. On 10-APR-2021, the subject experienced hard and hot to the touch golf ball sizes lump slightly protruding. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced felt off. On 10-APR-2021, the subject experienced sensitivity to light. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced extremely fatigue and tired, felt really worn down. On 11-APR-2021, the subject experienced felt hot. On 11-APR-2021, the subject experienced restless. On 11-APR-2021, the subject experienced lack of sleep. On 11-APR-2021, the subject experienced lack of motivation. On 11-APR-2021, the subject experienced felt rosy in the cheeks. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, weakness, disoriented, fever, felt hot, felt off, sensitivity to light, and felt rosy in the cheeks, and had not recovered from injection site pain, cramping style pain that travelled up and into the shoulder and up into the neck muscle into the base of skull wrapping around head causing a migraine, extremely fatigue and tired, felt really worn down, body aches, restless, lack of sleep, lack of motivation, sensitive to symptoms of a seizure onset, and hard and hot to the touch golf ball sizes lump slightly protruding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: he fell

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Got shot 2:09pm pt had vision loss, sweating, low bp after recieving shot. 1st bp: 120/50 pulse 51 at 2:23pm, 2nd bp: 97/56 pulse 52 at 2:34pm, 3rd bp:97/47 pulse 54 at 2:48pm. advised pt to not drivr had friend leave with him at 2:50pm

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

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Collapsed about 1 minute after receiving shot for about 30 seconds. Called 911 and paramedics arrived. He was able to walk out without assitance.

Pain in the arm of injection(at site and when moving arm), migraine/headache, forehead feels hot, exhaustion, runny nose.

patient was in the observation area when his family told us that the felt dizzy. i got to his side and asked if he was doing ok but did not get a response. he was sitting on a chair with eye opened but not responding. so we called 911. then a few seconds later , he said i could hear you but was not able to see. then he said he felt hot so we gave him some water. Now dispatcher on the phone told us no water and have him lay on the floor. by now he had started to feel a lot better. then the parametic team came and took over . His vitals, blood sugar and EKG were all normal. then patient was offered to go to hospital for evaluation but he refused

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.

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

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

Patient felt faint shortly after immunization during 15 minute observation. Upon first presentation, patient was clammy, sweating and lightheaded. EMS was notified and patient verbalized feeling better after drinking fluids. EMS came and evaluated the patient further.

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.

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

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

Patient - received the Johnson & Johnson vaccination (Lot # 1808609) on 05/22/2021 at 1131 in the left arm. Upon walking to observation patient fell, it was observed that he hit the back of his head by nurse at nursing station #4, nurse immediately cradled patient?s head and turned patient on his side for safety. Patient was assessed for open wounds, hematoma and bleeding. Negative findings. EMS called by RN Patient assessed RN. Patient is a 21-year-old with no past medical history per patient?s grandfather. Patient is laying on the floor, with eyes wide open, not verbally responsive, and unable to follow commands. Patient was pale and diaphoretic. Patient is awake, but not oriented to time and place. Patient also does not recall having breakfast, but his grandfather stated that he did have eggs earlier this morning. Vital signs as follow: Time 1134: BP 147/78, pulse 43, 98% room air, temp 97.1 Time 1138: BP 147/82, pulse 47, 98% room air, patient started to become response asking questions. Patient denies any lightheadedness or dizziness, he only felt a burning sensation on the back of his head. Patient?s grandfather at his side. Patient?s wallet, vaccination card and glasses given to patient?s grandfather. Time 1142: BP 125/79, pulse 64, 98% room air Privacy screen in place for confidentiality from other patients. Awaiting EMS. Incident aware 1144 EMS arrived. 1146 Patient placed in wheelchair and left the building with EMS. Patient was awake and alert upon leaving the building.

Pt w/ hx of allergy to penicillins - swelling that required hospitalization. Pt presents w/ facial rash/hives, dizziness. p/t c/o tingling/numbness BLA LE, RUE. BP 164/92, HR 116, RR 16 -- > 160/94, 116, 16. 911 called and the patient was taken to the Emergency Room ~30mins post vaccination.

Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: sore throat-Severe, Systemic: Weakness-Severe, Additional Details: Pt has been having these symptoms since he has received the J&J vaccine. Pt's mother called the pharmacy 4 days after he has gotten the vaccine, stating pt's symptoms are worse. Recommended to take him to the hospital for a check-up. Tried calling the patient but lost follow-up.

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

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

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

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

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

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

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

Client received the COVID vaccine Janssen Lot#205A21A at 1:29 PM. RN was alerted by the client's family prior to vaccination that the client has a history of "fainting" with injections. RN recommended vaccination on the cot in the observation area to decrease risk of syncope. The client and his parents refused vaccination in the observation area and his mother stated "if he can look at his phone he'll be fine." The client received the vaccination at the table and ambulated to the observation area. RN was alerted by the client's parents at 1:39 and responded. EMT also responded at this time. The client was not verbally responsive to RN and EMT and his posture was tense sitting in the chair. RN elevated the client's legs on a metal chair. The client's posture relaxed and subsequently the client regained responsiveness. No injury was sustained. The client then stated that he was dizzy and lightheaded. He denied SOB, throat tightening, and itching. . Client was AOx4. Vitals obtained by EMT were as follows: BP 132/88 and HR 64 regular rate and rhythm. RN noted pallor on the client's face. At 1:42PM the client stated he was "a little bit dizzy" denied any other s/s of an allergic reaction. The client was offered water and began drinking it. No medications administered. Client denied any chronic conditions or medications and no known allergies. He began eating some goldfish at 1:45 PM. RN provided education to client and his parents regarding s/s of anaphylaxis, when to seek EMS, to follow up with PCP regarding syncope event, and V-safe. The client and his parents voiced understanding of this. Vitals obtained by EMT at 1:50 were BP 122/90, HR 72, RR 20. Repeat vitals obtained at 2:00PM were BP 122/86, HR 64, and RR 16. The client departed the vaccination site at 2:05 with his parents unassisted with a steady gait. The client's parents drove him home.

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

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

Patient was experiencing symptoms after 10 minutes of receiving J&J vaccine. He passed out for 5 minutes without any verbal response; with signs of seizure. He has a history of the same reaction with another vaccine. He got epinephrine 0.3mg IM Lot OFM625 Exp. Nov. 22. The ambulance was called and the patient's care was transferred to the paramedic. The patient was transferred to the ER.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After administration of Jansen vaccine in less than one minute, patiet had a syncopal episode. He recovered within few minutes. Vital sigs within normal range. He stated he had not eaten or drink anything since night before. 911 was called.

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.

NERVE PAIN (SHOOTING PAIN IN BOTH LEGS, BOTH ARMS AND IN BETWEEN SHOULDERS AND UPPER BACK); CONSTANT TINGLING SENSATION; DISCOMFORT WHEN WALKING (ALMOST FELL DOWN ONCE); BRAIN FEELS DIZZY (LIGHTHEADEDNESS); MINOR ADVERSE EVENTS; 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 past medical history included back pain (nerve pain), and marijuana abuse, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with gabapentin for back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced minor adverse events. On 07-JUL-2021, the subject experienced nerve pain (shooting pain in both legs, both arms and in between shoulders and upper back). On 07-JUL-2021, the subject experienced constant tingling sensation. On 07-JUL-2021, the subject experienced discomfort when walking (almost fell down once). On 07-JUL-2021, the subject experienced brain feels dizzy (lightheadedness). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor adverse events on 02-JUL-2021, and had not recovered from nerve pain (shooting pain in both legs, both arms and in between shoulders and upper back), constant tingling sensation, discomfort when walking (almost fell down once), and brain feels dizzy (lightheadedness). This report was non-serious.

Approx 3 min after receiving the vaccine, (Patient) suffered a seizure. He experienced cold sweats, rapid heart rate, and blacked out. His eyes moved rapidly side to side. The seizure lasted approx 10 seconds. Pt. was lucid and able to answer basic questions when he came through. We took him to the hospital for additional evaluation. He received a CAT scan and blood work. Those results are pending

Pt suffered a seizure approx. 10mins after receiving their vaccine. Recovered quickly and refused any additional treatment

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

Hives breakout all over face and arms - I've been taking Benadryl but still present, swelling on eyelids so I could barely open eyes - Been taking benadryl, Fever of 105.3 degrees - Been taking tylenol for 2 days but still have fever, Sore arm and body aches, Overall weakness feeling

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.

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

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

3pm - trembling and extreme cold and fatigue. 5pm in addition to the above, 102.2 fever and sweating. 7pm - in addition to the above, headache 9pm - headache Saturday 3/20/21 Headache remains. But the fever subsided, as did the trembling.

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.

Patient passed out and began seizing within 5 minutes of vaccine administration sitting down on chair. Tonic, clonic motions for 5 seconds. No foaming at the mouth. Patient was taken off chair, held on the ground until seizure ended. Patient gained consciousness after a minute. Given water, snacks, air and EMS was called. EMS assessed situation, and allowed patient's girlfriend to pick him up from site and drive back home.

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.

Patient became dizzy and in and out of consciousness. Patient was then taken to a private room where he had a 10 second seizure with no reported hx of epilepsy or other medical conditions (according to the patient) Needed EMS transport off site. This occurred at a mass vaccination site and patient was transported off facility grounds. Resolved at clinic level, not monetary reimbursement.

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

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

Patient was given the Janssen covid vaccine and after he had sat down in the waiting are he fainted. time was 12:39 pm Friday, 4/9/21. We called EMS and code white at that time. Patient was unresponsive for a few seconds but woke up quickly. When we asked about any reactions to previous vaccine patient stated he had no reactions. After talking to him once he was feeling better, he did mention that this has happened in the past when his blood sugar was low. We gave cool compress and patient refused services from EMS. We also offered water and store management offered orange juice. We also advised him to stay for an additional 30 minutes for observation.

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

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

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

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

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

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.

SEVERE BODY SHAKES; VOMITING; CHILLS; NAUSEA; FEVER; FEELING HOT; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 23:00, the subject experienced severe body shakes. On 06-APR-2021 23:00, the subject experienced vomiting. On 06-APR-2021 23:00, the subject experienced chills. On 06-APR-2021 23:00, the subject experienced nausea. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes, and chills on 07-APR-2021 02:00, and had not recovered from fever, nausea, feeling hot, and vomiting. This report was non-serious.

PATIENT REPORTED BEING LIGHT HEADED AND WARM AFTER RECIVING SHOT. PT DRANK SOME ORANGE JUICE AND WAS RECOVERED BEFORE LEAVING THE PAHRMACY. PT DECLINDED MEDICAL ATTACNTION.

Patient called the pharmacy on Monday, 4/12 to report an adverse reaction through the night on Friday, April 9 into Saturday, April 10. Patient reported had been taking ibuprofen following administration of Janssen vaccine on Friday at 9 AM. On Friday evening, patient reported that body temperature began to rise, going as high as 102.5 degrees F. Patient reported going to bed, then awakening early Saturday morning with a feeling of shortness of breath, intense pain in his left side that he described as "knives" in his chest, numbness in hands and legs, as well as body aches. He stated his jaw was locked up and he had bit his tongue. Patient's father called 9-1-1, paramedics arrived and were able to stabilize the patient at home. Patient stated his BP was elevated, however HR and 02 saturation was within normal limits. Patient reported to pharmacy on Monday, 4/12 and stated symptoms have resolved other than mild fever.

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

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

Patient fainted while sitting in chair. Started sweating profusely, felt clammy and cold. Elevated legs, checked pulse and pulse oximeter. Was awake and talking within a couple minutes. Gave him cold water and crackers and he was feeling much better. Paramedics arrived and confirmed all was good.

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

Patient was sitting in the waiting area after his vaccine. Within 5-10 mins of his vaccine he recalls suddenly feeling warm then he was observed convulsing in his chair. He fell over to the side, hit a metal bin, then fell forward onto the floor, hitting his head. It took him a few seconds to regain consciousness. Pharmacist 1 called 911 and pharmacist 2 attended to patient until EMS arrived. EMS reported he was very pale and blood pressure was low. Patient declined transport to the hospital.

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

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

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

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.

BODY ACHES; SHAKING; NEUROLOGICAL SYMPTOMS; HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to antibiotic, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced shaking. On 06-APR-2021, the subject experienced neurological symptoms. On 06-APR-2021, the subject experienced headache. On 06-APR-2021 17:00, treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shaking, neurological symptoms, and headache on 06-APR-2021. This report was non-serious.

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

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

DIFFICULTY IN MOVING RIGHT ARM; NUMBNESS IN ARM; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced difficulty in moving right arm. On APR-2021, the subject experienced numbness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty in moving right arm and numbness in arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Patient had known fear of needles and despite mitigation strategies, once he knew the vaccine was administered, he began to feel weak and look pale. He lost consciousness twice but only for a few seconds and then he "came to." I helped along with the mother to lay him down to prevent injury. Patient was alert, breathing, and responding, but still appeared pale, "clamy" shaky and sweaty. Code was followed with store management responding, ambulance arrived to take care of patient within minutes.

Patient was visibly nervous prior to receiving the vaccine. About 5 minutes after administration (during the 15 minute watch period), patient appeared to be slumped over in the chair. He had eyes closed and seemed to be shaking slightly. Pharmacist and tech grabbed the emergency kit and laid patient on the floor. After a few more seconds the patient woke up and was able to respond to questions. He was very pale, sweaty, reported feeling clammy and dizzy. Patient claimed he had not eaten since the morning. We gave him some water and a pb&j sandwich. Patient stated he felt better and he just gets very nervous around needles. The patient sat with us for another 30 minutes until his grandmother and cousin were able to come pick him up from the pharmacy.

Woke up the next morning feeling weak, with full body aches, and sensitivity to coldness. I may have had a slight fever. These symptoms were gone by 2-3pm.

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

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

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.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: A few minutes after administration, pt was lightheaded and dizzy and reported possibly fainting for a very brief moment. Pt was pale and sweating and reported being short of breath briefly. Pt was hypotensive but blood pressure and heart rate normalized after 10 to 15 minutes after pt lied down and propped up feet in addition to drinking water and juice. Pt reported feeling "normal" after resting for about 30 minutes.

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

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient asked for water, I told him to put his head down in between his knees and asked my tech to get him water. Patient fainted and fell out of the chair onto the floor. Unresponsive for about 15 seconds, felt pulse. Blood pressure was 120/75, pulse 55. Had him lay with feet propped on chair until he was feeling normal and then had him sit, drink water, and stay 30 minutes. Said he felt fine after, called to check in on him tonight at closing and he said feeling fine.

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted after receiving Johnson and Johnson covid vaccine. He asked for water, I told him to put his head inbetween his legs which he did and then he fainted and fell out of his chair onto the ground. He came to after about 15 seconds. Blood pressure 120/75 pulse 55. Had him stay for 30 minutes after. Followed up tonight he said feeling fine.

Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fell as he passed out called 911 paramedics checked out patient

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

FEVERISH AND FEVER LIKE SYMPTOMS; SHAKING; SWEATING; FELT COLD; POUNDING HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included prothrombin gene mutation - increased risk for blood clot (predisposition), amoxicillin allergy, occasional alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) .5 ml, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced feverish and fever like symptoms. On 03-MAY-2021, the subject experienced shaking. On 03-MAY-2021, the subject experienced sweating. On 03-MAY-2021, the subject experienced felt cold. On 03-MAY-2021, the subject experienced pounding headache. On 03-MAY-2021, the subject experienced felt tired. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish and fever like symptoms, shaking, sweating, felt cold, pounding headache, and felt tired on 04-MAY-2021. This report was non-serious.

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

Patient had uneventful immunization at tiime of injection. Upon waiitng in 15 minute waiitng area, began to feel dizzy and "tingly" Gave patient water, monitored pulse, applie cool rag. Pharmacist stayed with patient all the time. After 30 minutes, patient said dizziness subsided and was able to stand without assistance and able to leave with parents who were in the store at the time

Pt fainted after ~2-3 minutes of sitting on a bench. Moved to the floor and resting against hard surface. Pt was warm and sweating. Came back to in about 1 min. BP was normal. Gave water and food. Pt is resting until ride comes to pick him up.

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt witness previous pt receive vaccine and was nervous, we offered to reschedule him, but he insisted on getting the vaccine anyways

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

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: About 2 minutes after receiving the vaccine the patient was complaing about being hot (flushed) with sweating. Patient asked for a glass of water. When getting the patient water my technician said she saw the patients eyes roll to the back of his head and that he was going to pass out. I went out to the patient and helped him to the ground and had him lay flat on his back with his feet elevated. After 3-4 minutes the patient was feeling better. Patient never lost consciousness.

PT states he got the j&j vaccine at 0930 today. He states he experienced chills, body aches, head ache and numbness in his hands. PT denies taking any medication.

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

Patient became pale, clammy and light headed for 1-2 minutes while sitting being monitored. Patient given wet cloth to forehead and water to drink. Patient's symptoms resolved in 3- 5 minutes with additional 15 minutes of monitoring after the first 15 minutes.

patient was dizzy, sweaty, skin color pale. He wanted to lie down and not would not respond to calls or touches. After about a minute he became responsive with normal skin color. Vital signs normal a

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

Within 60-90 seconds after receiving J&J vaccine, patient became lightheaded, sat down, then subsequently passed out. Then had 2-3 jerking motions similar to seizure activity. Was lowered to the floor and called a CODE ASSIST. patient was not registered at the time, but was in a hospital. No previous reaction to injections. Patient taken to ED for workup. Patient diaphoretic and bradycardic at 36. given IV fluids and performed EKG. was later discharged from ED

patient's friend's alerted me that he was feeling dizzy about 2:10pm. I went over to patient just as he was passing out. small muscle jerk was noted. I obtained assistance to place patient on the floor. He regained consciousness before we could put him on the floor. He was out only 5-10 seconds. he was given some water and proceeded to sit for 20 more minutes. Patient was feeling fine. He did state he had fainted receiving flu shot previously. Patient walked home and called to inform us he made it home safely and was feeling fine. He was instructed to hydrate and take it easy for the day. He refused offer to call the squad

FEVER; ANAPHYLACTIC REACTION (PASSING OUT/ COULD NOT BREATH/ SWOLLEN LIPS AND FACE); LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma (as a child), non-alcoholic, and cigarettes smoker. The patient experienced drug allergy when treated with Tamiflu (oseltamivir phosphate). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown, NDC number: 59676-0580-15) dose was not reported, 1 total administered on 14-MAY-2021 at 10:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, as soon as the patient got the shot (within the 15 minutes of wait at the pharmacy), he had an anaphylactic reaction. It was further reported that he could not breath, his lips and face started to swell and then he passed out. The patient was taken to ER (emergency room) and his doctor gave him EpiPen (epinephrine) shot, Medrol (methylprednisolone), Benadryl (diphenhydramine hydrochloride) and IV (intravenous) fluids. The patient's lips were drooping to the right side of his face even after taking the medications. The patient stayed at the ER for 6 or 7 hours then was sent back to home on the same day. On 15-APR-2021 (reported as Saturday), the patient had fever. On 16-MAY-2021 (reported as yesterday from the date of reporting), the patient was much better, and his drooping lips was there a little bit but not as bad. The reporter did not have patient's vaccination card (for lot number or expiration date). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction (passing out/ could not breath/ swollen lips and face) on MAY-2021, and was recovering from fever, and lips were drooping to the right side of face. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210532244-COVID-19 VACCINE AD26.COV2.S-ANAPHYLACTIC REACTION. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210532244-COVID-19 VACCINE AD26.COV2.S-LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE. 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).

Approximately 5 minutes after receiving vaccination patient fell out of chair onto floor and was breathing but unresponsive to pharmacist. Patient opened eyes and was fully alert with in a couple of minutes of passing out. Patient waited for another 30 minutes, had someone come pick him up, and stated he felt fine.

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

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

pt started feeling dizzy and blurry vision a few minutes after vaccination. Dr observing instructed him to rest on the floor. BP low, felt cold hands. His BP increased and he stopped feeling dizzy/blurred vision a few minutes after laying on the floor w feet elevated on chair. Police detail called resucue team, but patient was feeling normal by the time paramedics arrived. Was able to stand up and sat under observation for several more minutes before leaving clinic.

chills, hot flashes that have persisted for more than 2 days, extremely hot/sweaty, constant headache/soreness at injection site.

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

Patient seemed to be having a seizure within minutes of vaccine. Head tilted back, arms started shaking in patients lap, Patient was unresponsive and seemed to stop breathing momentarily. Patient seemed to recover within 5 minutes and was able to answer paramedic questions once they arrived. Declined further treatment or to go to hospital

AFTER PATIENT RECEIVED THE VACCINATION, HE SAT DOWN IN THE WAITING AREA. AFTER APPROXIMATELY 1 MINUTE THERE WAS A NOISE AND I NOTICED THAT HE WAS SLUMPED TO THE RIGHT SIDE AND STARTED TO CONVULSE. I RAN OUT TO THE PATIENT AND ENSURED THAT HE DID NOT FALL AND HELD HIM IN PLACE UNTIL HE STARTED TO COME TO. AFTER ABOUT 30 SECONDS THE PATIENT STARTED TO BECOME AWARE AND COULD HEAR ME TALKING BUT WAS STATING HE COULD NOT SEE. AFTER ABOUT 30 SECONDS HIS SIGHT RETURNED. DURING THE TIME THAT I WAS FIRST WITH THE PATIENT, THE STORE MANAGER CALLED 911 AND THE EMS WAS ON SITE AFTER APPROXIMATELY 5 MINUTES. I HAD THE CUSTOMER SIT DOWN AND GAVE HIM WATER UNTIL THE PARAMEDIC ARRIVED. THEY TOOK A HISTORY OF THE PATIENT AND AFTER A FEW MINUTES TOOK HIM BY AMBULANCE TO THE LOCAL HOSPITAL FOR ADDITIONAL OBSERVATION.

after 1 min pt experienced blacked out - rph reported pt being in shock grabbing chest and shaking arms. loss consciousness but regained in a few minutes - called 911 pt received help -pt states anxious about getting vaccine - pts father took the patient to the hospital

LEFT UPPER ARM HURTING; SLIGHT AND POUNDING HEADACHE; This spontaneous report received from a patient concerned a 22 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: 17676, and batch number: 17676) dose was not reported, administered on 28-MAY-2021 15:50:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced left upper arm hurting. On 28-MAY-2021, the subject experienced slight and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight and pounding headache, and left upper arm hurting. This report was non-serious.

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

pt mom reports on Tuesday morning. PT HAS FEVER, SWELLING OF LEGS, SHORTNESS OF BREATHE, NO BLOOD FLOW IN EXTREMETIES. PT REPORTS FEELING NUMBNESS IF EXTREMETIES. CANT SEE OUT OF HIS RIGHT EYE, REFERRED TO hospital.

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.

FREQUENTLY HOT FACE AND HOT MOVES TO FEET; FEELS LOUSY; MOVING SUBJECTIVE FEVER; HOT AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 22 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced frequently hot face and hot moves to feet, feels lousy, moving subjective fever, and hot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moving subjective fever, hot at injection site, frequently hot face and hot moves to feet and feels lousy was not reported. This report was non-serious.

Assumed Vaso-Vagal Syncope, patient was nervous about receiving an injection. Immediately after removal of the syringe, the patient leaned backwards. He stated that he felt dizzy. He started to jerk his head backwards (911 called) and then his head fell forward, unresponsive. At his time, we used an ammonia inhalant close to the nose. He started to move and we brought him to the floor supine with a pillow at his feet and then his head. Soon, he was able to sit up and we brought him water to drink. He was subsequently cleared by the EMT to go home.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has fear of neddles and he passes out during vaccination and blood drawn. Patient faint out/ unreponsive for 30 seconds then he was responsive and fully orianted. Pt did not have any confusion after being responsive. Pharmacy staff called 911 by the time paramedics came, patient was responsive and fully oriented. Patient refuse to go to hospital. He was able to go to home after 30 minutes.

Patient was given the vaccination and asked to remain in the consultation area for 15 mins. The pharmacy student that administered the vaccination walked turned to walk away when he heard bumping on the wall of the room. He turned to see the patient with his head back and eyes wide open. He returned to the room and called the patient's name with no response. The patient at this point had his eyes shut and seemed to slump in the chair. His breathing was labored and then seemed to stop. His pulse was still felt. The patient was unconscious and seemed to be seizing. An Epipen administered in the right thigh. The patient seemed to twitch and immediately regained consciousness. At this point the EMT arrived and took over. The patient seemed unaware of the events and was fully recovered.

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

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 Fainted approximately five minutes after vaccination. Patient was waiting in post vaccination observation area. He fell from the chair and was discovered face down. After rolling patient to his side, the pharmacist tapped patient back until he was responsive. After hydrating and staying on the floor for 5 minutes, patient fully recovered and spent another 10 minutes in a chair with arms until he insisted on leaving.

WHOLE BODY NUMBNESS; SLUGGISHNESS; MUSCLE SPASMS IN BACK AND NECK IN BOTH THE BACK AND FRONT AND UP AND DOWN ALSO; SEVERE CRAMPING TO BOTH UPPER EXTREMITIES, ESPECIALLY HANDS, WRISTS, FINGERS; UNABLE TO MOVE WHOLE BODY; FEELING UNWELL; GENERALIZED WEAKNESS; BEAT UP, WASHED OUT FEELING; FEVER UPTO 100F-104.5F; THE PATIENT WAS IN TEARS; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's past medical history included covid-19, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced whole body numbness. On 22-JUN-2021, the subject experienced sluggishness. On 22-JUN-2021, the subject experienced muscle spasms in back and neck in both the back and front and up and down also. On 22-JUN-2021, the subject experienced severe cramping to both upper extremities, especially hands, wrists, fingers. On 22-JUN-2021, the subject experienced unable to move whole body. On 22-JUN-2021, the subject experienced feeling unwell. On 22-JUN-2021, the subject experienced generalized weakness. On 22-JUN-2021, the subject experienced beat up, washed out feeling. On 22-JUN-2021, the subject experienced fever upto 100f-104.5f. On 22-JUN-2021, the subject experienced the subject was in tears. Laboratory data included: Body temperature (NR: not provided) 104.5 F, 103 F, 102 F. On 23-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body numbness, severe cramping to both upper extremities, especially hands, wrists, fingers, and unable to move whole body on 22-JUN-2021, was recovering from fever upto 100f-104.5f, muscle spasms in back and neck in both the back and front and up and down also, beat up, washed out feeling, feeling unwell, and the patient was in tears, and the outcome of sluggishness and generalized weakness was not reported. This report was non-serious.

Pt received vaccine, then within 1-2 minutes began having an apparent seizure . The symptoms were mild & pt recovered in less than 30 seconds. He was pale & clammy, but not other significant symptoms. After drinking water, cold compress applied to back of neck & a lollipop, the patient was back to his usual self. Pt reported he had not eaten prior to vaccine, and he had experienced similar symptoms when giving blood.

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt sycope most likely due to fear of needles. ems called and evaluated pt. pt declined visit to hospital. pt released after ems eval.

after receiving injection, pt. sat in chair @ about 0918 pt. fell to ground, noted having tonic clonic seizure like activity lasting about 15 seconds, pt. .placed on his side. After about 15 seconds, pt. became arousable, awake alert and oriented, noted to have "chipped tooth" and slight bleeding in his mouth. Pt. states has hx. of syncopal episodes after receiving injections. Denies any history of seizures. Team alert was called and Pt. was taken to ED for further evaluation

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.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a vasovagal response after COVID-19 Vaccine. He was monitored in clinic for over 30 minutes and completely recovered from incident prior to disposition home.

Patient felt very warm and tingle for about 10 minutes. This feel causes him to lose consciousness for approximately 10 seconds. He return to state of full consciousness. He stated he was okay, "just fell asleep for a second." Blood pressure reading was 115 / 55 about 3 minutes after event occurred. Monitored patient for full 30 minutes. He stated he felt fine after 30 minutes were up.

Id say approximately 60 seconds after administration of the vaccine, I started to become the most lightheaded I've ever felt, like I was really about to pass out. I felt a very extreme pins and needles feeling in both my hands and my feet, and my vision began to fade. After about 30 seconds of that and beginning to panic, I stood up and knocked on the doctors door and asked for water and told him how I was feeling. After about a few minutes of sitting and drinking Gatorade my vision returned fully and I began feeling stronger again. Since then I only feel a slight pain around the injection site.

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

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

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.

23 yr old male sat on chair post Janssen vaccine and complained of light headedness approximately 1 minute afterward, patient called for assistance and onsite Paramedic (1) arrived by his side immediately. Patient became pale and clammy and as onsite Paramedic (2) approached patient sustained syncopal episode while seated on chair. Patient remained in seated position. Patient awoke and only recalled feeling "dizzy and lightheaded." Patient denied any medical history, allergies or medications. Patient denied shortness of breath, chest pain headache or pain. AOx4 EMS arrived. Care provided.

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

Drop of body temperature even wearing layers of clothes and bedsheets, drop in body temperature caused me to have uncontrollable shaking. The hyperactivity of having the uncontrollable body shaking accelerated my heart palpitations and felt intense pain in my chest. This reaction lasted for about an hour and felt like I needed to go to emergency care.

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.

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

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

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

10 hours after shot, I developed chills, fever, and migraines with hot and cold flashes after the chills subsided.

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

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.

PATIENT DESCRIBED SUDDEN TEMPERATURE ELEVATION AND SWEATING. TEMPERATURE RECORDED WAS 97.6 WITH INFRARED THERMOMETER. PATIENT WAS GIVEN TWO DOSES OF ACETAMINOPHIN 325 MG TABLETS AND TWO DOSES OF DIPHENHYDRAMINE 25 MG CAPSULES. PATIENT STATED TINGLING IN THE HANDS OF BOTH ARMS. PATIENT WAS GIVEN WATER AND ASKED TO REMAIN SEATED FOR 30 MINUTES FOR FURTHER EVALUATION. PATIENT DECLINED OFFER TO CALL EMERGENCY CONTACT. AFTER 30 MINUTE EVALUATION, PATIENT STATED THEY WERE FEELING NORMAL AND DROVE HOME. FOLLOW UP CALL MADE ONE HOUR LATER AND PATIENT WAS AT HOME AND FEELING GOOD

After the patient received the vaccine, he sat down in a chair for observation and less than 5-10minutes he slumped and dropped to the floor. the patient is able to respond to questions and felt very weak. he felt very thirsty and we gave him water drink. he slowly recovered while partially lying in the floor and being supported. when medics came in he was already able to sit in the chair and refused to go with the ambulance. he rested more and finally went out of the pharmacy.

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

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

Patient received J&J IMZ at 9:45 am. After receiving dose was sitting in waiting area for 10 minutes. Patient then lost consciousness and fell off chair. Patient bump head on floor and had mild case of tonic clonic seizure for approximately 6 seconds. Patient came regained consciousness within 1to 2 minutes.911 was called in and EMTS arrived for assistants. Taking patient out in stretcher. Patient did not have any alerts or allergies noted on PQCF form to alert of any issue

Patient passed out shortly after receiving the vaccine. He lost consciousness for a minute and seemed to be twitching in his eyes and his mouth. He regained consciousness after a few minutes and we monitored him for 30+ minutes. We referred him to urgent care to be monitored further.

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

RN saw seizure activity for 30-45 approximately 3 minutes after receiving the Janssen Vaccine. Pt had an arched back and slid down in his chair. LOC occurred during the seizure event. Approximately, 10 minutes after the event (1:56pm), the patient was A&Ox3 and PERRLA. Called EMS to advise. They arrived at 2:15pm, checked in on the pt and decided not to transport. No further action was necessary. Patient went home under his own power.

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.

Dizziness right after and felt a numb feeling - felt like he could not hear - sweaty . Feeling better now - was initially very hypotensive but better after laying down. Feeling better now after sitting again

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

Patient was given the Janssen vaccine on 4/08/2021 at 4:25pm. Patient reported feeling faint, dizzy and hears ringing in his ears less than a minute after. Had the patient laying back on chair against wall with feet elevated. Patient turned pale and started to break out in cold sweats. No signs of swelling or redness around the injection area. Patient did not report any itching or swelling in throat/tongue. After 2 to 3 minutes from time that vaccine was given, patient started to recover, no longer feeling faint nor sweating. Over the course of the next 30 minutes, the patient?s condition stabilized with pulse returning to 80 beats per minute. Patient reported feeling fully recovered at 5:00pm.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient fainted minutes after receiving the dose. He was sweating and disorientated after passing out. Recovered with iced tea and some crackers. Took about 30 minutes before he was comfortable standing again. He has never previously reacted to a vaccine before

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

At 8 pm that night, I had aches and a 100 degree fever. By 2 am the following morning, I had a 102.7 fever, aches, arm soreness, shortness of breath, headaches, and chills. By 8 am, fever was down to 100, still had headache. By 2 pm, fever was 99, and by 7 pm fever and headaches were gone.

Janssen COVID-19 Vaccine: Vaccine administered by pharmacy staff at 1320, patient was observed for 15 minutes without complaint or concern. Upon check-out he stated he was "starting to feel sweaty". He denied dizziness, difficulty breathing, chest pain or other concerns. Systolic blood pressure was 76/40 (manual), heart rate 70. He remained awake, alert, skin pale, clammy, & cool. Sweat noted on forehead, in no acute distress. He was transferred to supine position and given cold water. BP increased to 124/82, heart rate 88, pulse ox 98%. He verbalized he felt much better, stated he began to have concerns about a reaction when he began to feel sweaty. He was unsure if it was anxiety or a reaction to the vaccine as the feelings began to escalate. He has no history of similar reactions but "doesn't like shots". He has no medical history, takes no medications/supplements and is otherwise "healthy". He ate lunch prior to appointment. Additional BP readings remained within normal limits, skin warm/dry, back to baseline. Observed for an additional 45 minutes and returned to work. Discharge vitals: 116/84, 90, 98%, 16.

8 hours after vaccination, became very lethargic, weak and got a fever of 103.2 degrees Fahrenheit. Was getting the chills followed by hot flashes. Woke up next morning (today) still with a 100.7 degrees Fahrenheit fever. Took Tylenol when symptoms started to occur.

AFTER RECEIVING THE IMMUNIZATION, PATIENT SLOWLY MOVED FROM THE CHAIR TO THE CORNER OF WALL AND SAID HE FELT FAINT. HE BECAME UNSCONSCIOUS FOR A FEW SECONDS AND WHEN HE BECAME ALERT, BEGAN CONVULSING. WE CALLED THE PARAMEDICS. WHEN THEY ARRIVED, THE PATIENT REFUSED TREATMENT.

Severe body aches, bad headache, bad chills, lack of energy. I woke up at 4:30am the morning after receiving the vaccine needing to use the restroom, but I could barely get out of bed because of my severe body aches and lack of energy. When I did manage to get out of bed, I struggled to even stand up. I took 800mg of ibuprofen at that time (around 4:30am) for the pain, which helped. I spent more than the first half of my day in bed under layers of blankets until about 3:00pm, where I finally felt good enough to get out of bed. I didn?t feel the body aches completely go away until the morning of the 8th, 3 days after receiving the vaccine.

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

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

AFTER PATIENT RECEIVED THE DOSE OF COVID VACCINE JOHNSON AND JOHNSON HE WAITED FOR 15 MINUTES AND WHEN HE STOOD UP, HE COLLAPSED BUT HE WAS CONSCIOUS, WE HELPED HIM AND PUT HIM BACK ON A CHAIR AND HE PASSED OUT FOR 3 TO 5 SECONDS AFTER THAT HE STARTED FEELING BETTER BUT STILL VERY COLD AND PALE. WE ASKED HIM TO WAIT FOR OTHER 30 MINUTES AND AFTER THAT HE FELT OK.

4/11 vaccination 12:46 12:51 They had us go sit in observation. I felt fine and all of a sudden I felt dizzy and felt near syncope, sweaty. I raised my hand. 2 EMT monitored my HR and BP; both high. Gave me some water, cold compress. Symptoms went away. I went to bed Sunday night, woke up at 230am to chills, shaking, sweats, feverish. That lasted thru till 8/9am and all day Monday I was pretty fatigued. Tuesday symptoms I was pretty much back to normal. I contacted my PCM with recent J&J news. My platelet numbers were normal (blood work done a few weeks before vaccine). Monitored by endocrinologist

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

BODY ACHES; MIGRAINE; SLIGHT FEVER; FATIGUE; This spontaneous report received from a parent 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: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) less than 102F. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced slight fever. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 09-APR-2021, was recovering from slight fever, and had not recovered from fatigue, and body aches. This report was non-serious.

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.

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

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

CAN HEAR OWN HEART BEAT IN EARS; BODY ACHES SORENESS; CHILLS; NOT STRONG WEAK; HEADACHE; .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: Unknown) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced can hear own heart beat in ears. On 27-APR-2021, the subject experienced body aches soreness. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced not strong weak. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, not strong weak, body aches soreness and can hear own heart beat in ears was not reported. This report was non-serious.

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

SYMPTOMS: HEADACHE, CHILLS CHEST AND ARM PAIN FEVER DIZZINESS TEMPORARY EVOLUTION: THE FEVER DOWN A LITTLE, IT IS NO LONGER HAVING CHILLS. STILL HAVE ARM AND HEAD PAIN

After 5 minutes of receiving IMZ, pt felt hot, light headed, dizzy, and sweaty, skin palor and clammy. After 10 to 15 minutes supine, pt felt better and was 100% normal after 30 minutes.

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

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

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

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

pt presents to the ED for migraines and blurred vision that began last night which he is concerned is a side effect from the J&J vaccine, pt received the vaccine on 5/3/21.

4/10 vaccination 4/11 1AM, I started to feel generally sluggish and tired, chills. 230 AM the chills came full blown. Extreme chills, shaking, elevated 115-120 BPM, SOB that lasted 2 hours. I called to the advise line with medical facility. They told me to take some Tylenol. I made sure it was ok to take my anxiety medication with the Tylenol. 2 hours later, the chills had stopped.

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

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

Angioedema; treated with and EpiPen, famotidine, and diphenhydramine; swelling and tingling are reducing

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

Shortly after receiving the vaccine patient felt light headed and removed mask. He then passed out falling forward in chair and hitting his head he then went into convulsions. Quickly came to and was able to walk out with EMS.

Patient reported arm soreness, few minutes later left leg starting to feel numb, shortness of breath. Then he reported tight throat and tongue swelling. Immediately called 911 and activated ems. Vitals: 0xygen 100%, bp 230/130, HR 80. Symptoms seem progressing so epinephrine 0.3 mg was administered at 11:30 a. EMS arrived 2-3 minutes later after epi was administered . Epi lot: OFM242, exp 11/01/2021. Patient left with EMS on gurney

Pt scheduled and appt for J&J vaccine and it was administered by LPN in his left arm. Pt waited in observation for 5 minutes and reported he felt dizzy. Pt loss consciousness while sitting in his chair. Nurse repeatedly called patients name with no response . Charge Nurse was called for assistance . Charge Nurse administered a sternal rub and patient woke up . Pt was able to state his name , DOB and location . Pt reported that he lost his vision , with a headache and everything was black. Laid patient in first aid area on a cot and took patients vitals which were WNL. After lying down for 15 min patients vision returned. Pt stated he walked 25 min in the sun to the vaccination clinic and only had 1 meal for the whole day. Pt was monitored for an additional 30 minutes , drank water and was provided some crackers. Pt refused EMS services and just wanted to lie down . medial director was notified immediately of the incident and felt comfortable releasing the patient to walk back home on his own . Patients Vitals were rechecked and within normal limits . Pt left after 45 minutes

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

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

Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted 5 miuntes after receiving the vaccine. Pt feels much better after getting water from the staff and getting rested for about 30 minutes. Pt said he does not need an ambulance, and he is doing ok

Patient received the Janssen vaccine. Less than 1 minute after receiving the vaccine, passed out and had seizure like activity for 10 sec. When he fell, his hit the right side of his head. When he came to, he knew where he was. Ambulance was called, he refused to go to the hospital. BP was 138/78 and pulse was in the 60's. Leading up to passing out, reported that he felt warm, then passed out. After waking up and coming to, he was feeling better.

Since vaccine has experienced numbness in same side arm. Starting with middle finger, now effects all fingers in right hand. General numbness throughout all day. When performing physical activity with right arm, numbness travels further down past hand. Started prescription of naproxen. Have a EMG scheduled to rule out potential Carpel tunnel/ nerve damage.

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.

Patient had reported previously losing consciousness after vaccination a few years prior. About one or two minutes after receiving the vaccine the patient lost consciousness and experienced mild convulsions lasting in total about 10 seconds. His mother was present and explained this was the same reaction he had experienced several years earlier with a previous vaccine. The patient regained consciousness and reported that he felt dizzy, but otherwise okay. He appeared clammy and asked for some water. I gave him a bottle of water, which he drank slowly. He reported to us feeling the same as he had after the previous vaccine reaction. As patient was conscious and speaking clearly, I watched him and asked him to wait until he felt comfortable to stand. At one point he asked to sit on the floor, but was eventually able to sit on the chair again, then move to another chair in our waiting area about 20 minutes post-vaccination. I asked him to wait for a total of 30 minutes or longer if he felt anything unusual. At 6:39 approached me and said her son was feeling normal and they would be leaving.

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

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Severe

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.

About 4 minutes after administering the vaccine patient was sitting down in the waiting area and stated that he was not feeling too good. I immediately went over to him, at which point I noticed he was sweating profusely and stated he felt a little light headed. Less than 1 minute afterwards, he stopped talking and his eyes began to roll back, at which point his upper body began to slide over to once side as if he was going to fall. I immediately caught him, motioned for someone to call emergency services and continued to call him name. He did not respond, was pale and blacked out for about 30 secs. He was still breathing thankfully. When he regain consciousness, he stated that he felt better but he felt some tingling sensation in his forearms bilaterally. Thankfully at this point emergency services were present and upon taking his vitals, realized that his HR and BP were significantly low for someone of his age.

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.

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

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

Patient immediately after getting the vaccine stated his arm was very sore. After he sat down to be observed for 15 minutes he started feeling like he was going to vomit and/or lose consciousness. He started sweating profusely and stated that both arms felt tingly and numb. I immediately gave him juice and applied a cold pack to his back. After a couple of mins he stated that he was feeling a little better. We called the ambulance and they arrived and took over his care. He was not transported to the hospital

23 YO male was given Janssen vaccine and started getting tired and leg shaking without respond for a few seconds 5 mins after he was given the vaccine. He was then responsive again and said he has blur vision and feeling hot in the ears. Ambulance was called when pharmacy staff noticed his reaction. He was awake and oriented x3 according to paramedics, bg 109, bp 77/57. He was then taken to the hospital via ambulance.

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

Patient lost consciousness and appeared to have a seizure immediately following vaccination. He came back around within 1 to 2 minutes. EMS was called and attended to him. Reported as a vasovagal reaction. Patient left with his mother.

Patient began to get dizzy, shaky and sweaty within 1 minute of vaccine. He was given orange juice and immediately started to get better. He declined medical care. He asked for cold water and continued to improve. In about 10 minutes he was able to walk over to Blood pressure machine and he measured 102/86. He was given 100 mg of Benadryl. He had a companion to drive him.

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.

Patient awoke at 2:30 am after getting vaccine with uncontrollable shaking. Went to ER and blood pressure was also high. Given Ativan to decrease shaking and calm patient. Diagnosed with allergic reaction to vaccine by ER staff.

Patient got dizziness and shaking. Patient was given gatorade, hershey kisses, and water. About 15 minutes later, he felt better and was able to walk out of the pharmacy.

I was laying in bed and felt a pins and needles pain in my legs it was worst in my left leg so I stood up to go to the bathroom and my legs wouldn?t move I ended up falling over and hit my head and sprained my foot

Patient was seen at the treatment center. Patient was receiving covid-19. Patient had gone to the bathroom, and was found in the bathroom floor; had twitching of leg and hands; After that patient appears to stare off into space repeatedly. Vital arPatient developed seizures after covid vaccine; also had repeated what appears to be absence seizure Vitals stable Called 911 for ER transfere stable

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

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

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

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:

After getting J&J covid vaccines the patient was having allergy reaction, difficulty breathing and warm. I gave the pt epipen and called 911, he had seizure For 3 minutes as well

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt did not report history of syncope after vaccination. only told me after event occured. pt said he felt dizzy and sat back down in the post-vaccination area chair. monitored for approximately 40 minutes and pt's appeared to be stable and mobile alert and oriented and asked to go home. followed up with patient at 4 pm and he reported that he was feeling much better and appreciated us reaching out to him

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.

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

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

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

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

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

pt received vaccine LA IM by certified administering pharmacy tech under supervision of pharmacist. About 10 min post IMZ pt started having trouble breathing, became clammy and unresponsive. PCSM was in the observation area at the time and administered one dose of EpiPen. Pt became responsive and EMS arrived. He refused to go to the hospital with EMS

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

Pt walked over and sat down in waiting area. Within 2 minutes he lost consciousness, fell out of his chair, hit his head on the floor. this lead to bleeding/ bump on left eyebrow. Pt was hot, sweaty, clammy, and pale. he laid on floor with feet raised for a few minutes. He felt better in about 15 minutes, parents arrived to drive him home.

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

The evening after my vaccination shot, I started to feel groggy and unwell. I then started to develop a fever. This morning on 4/12/21, I woke up to my right hand itching and burning. Within a half hour I started to experience the same burning and itching sensation on my hands.

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

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

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

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

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.

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.

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.

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

Hyper feeling on the first day, headaches migraines (5 total days unsure if any more) ,chills the next day,dizziness currently ongoing, soreness currently ongoing

Pt is a 24 year old male with hx of IBS and anxiety with reported swelling and pain to the left shin that just popped up prior to presenting to ER. Complained of pain on Lt shin that started while he was standing at the sink. Started stinging, looked down at shin, he stated it started swelling and stinging. Does not remember any injury, but is unsure. DX - Hematoma to the left lower extremity. BP 155/72 Temp-98.0 HR 77 R- 18

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

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

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

patient s/p J&J COVID vaccine on 4/9 at pharmacy. admitted on 4/26 with acute onset paralysis to BUE and BLE. MRI c/w transverse myelitis

(4/10/21)Day of shot: small headache and tired 4/13/21: had tingling/numb feeling in my lower half of my right leg and right arm and a bit on my left leg as well, lasted all day until i woke up the next day and the symptoms were no longer there 4/28/21: those tingling/ numb feeling came back but this time my right leg around my calf area would hurt when i would walk down/up the stairs( wouldn't hurt if i walked around the room unless i angled or moved my foot up) 4/29/21: still feel a bit of the tingling feeling a bit on my right hand but not as much s the day before

Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint fainted within 5 minutes of receiving the vaccine. 911 was called and responded but he had quickly come to. He felt better within 10 minutes but the paramedics examined him anyway. He left of his own accord.

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

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

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

During the observation period, the patient became lightheaded and dizzy. He complained of sweating and cold skin. The pharmacist immediately went to the aide of the patient. The patient was laid on the ground and we began to get a blood pressure reading. We also gave the patient cold pack to place on the skin. The patient never lost consciousness and was verbal and responding to pharmacist questions the entire time. We asked multiple times if he needed EMS and he each time told us he did not. His status continued to improve with deep breaths and cooling the skin. After 10-15 minutes he felt like he could sit up in the chair and did just fine and continued to recover. We kept watch over him.

AFTER THE PT RECEIVED THE VACCINE, HE CAME TO REGISTER TO SIGN FOR IT. THEN HE WAS TOLD TO SIT FOR 15 MINUTES TO MAKE SURE HE DOESNT HAVE ANY ALLERGIC OR ADVERSE REACTIONS. HE WAS LOOKING AROUND THE STORE WHEN HE ALL OF THE SUDDEN HAD SEIZURE AND FELL ON THE FLOOR. WE CALLED EMS RIGHT AWAY HOWEVER HE WOKE UP AND BOTH HIM AND HIS FRIEND TOLD US TO DISCONNECT WITH EMS. HIS FRIEND TOLD US THAT HE HAS EPILEPSY AND HE HAS EPISODES LIKE THIS TIME TO TIME. THE PT EXPERIENCED SOME CUTS ROUND HIS FORHEAD AND HIS (L )EYEBROW WHICH WE HELPED CLEAN UP WITH DISINFECTANT AND BANDAID. AFTER HE LEFT WITH HIS FREIND (WHO WAS THE DRIVER), WE FOLLOWED UP WITH HIM AND HIS FREIND AND THEY SAID HE IS DOING WELL.

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

Patient called and reported leg pain and numbness starting today. I advised patient to go to the emergency room as similar side effects were reported by other patients who had clots after receiving the Janssen vaccine.

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

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.

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

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

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient experienced symptoms for few minutes and was resolved within 20 minutes of injection

Severe migraine headache with visual changes, aura, right sided numbness of face and arm, followed by pain. never had this before. lasted over 24 hours and necessitated trip to urgent care; CT scan was considered, but symptoms resolved with sumitriptan; recovered completely and no further symptoms

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

Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT EXPERIENCED SYNCOPE (FAINTING) BUT REGAINED CONSCIOUSNESS WITHIN A FEW SECONDS. HE WAS CONFIRMED THAT HE IS GOOD TO GO HOME BY HIMSELF.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Severe, Additional Details: pt did not have reddness or pain at site, but fainted and had a seizure

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

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

About week after shot, became extremely weak , fatigued , and am showing signs of vestibular neuritis (vertigo , feeling as though I would pass out, blurred vision , head ache , ear pain)

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: TINGLING-Mild, Additional Details: HAD PATIENT PUT HIS HEAD IN BETWEEN HIS LEGS, GAVE WATER, CHOCOLATE AND A CLIFF BAR. PATIENT STILL WAS NOT FEELING BETTER SO HAD PATIENT LAY DOWN AND HAD LEGS ON CHAIR ABOVE HEAR LEVEL. GAVE PATIENT WATER AND STILL WAS NOT FEELING BETTER SO HAD PATIENT PUT LEGS DOWN ON GROUND. I GRABBED NURSE PRACTITIONER FROM CLINIC AND SHE CHECKED HIM OUT. VITALS WERE NORMAL ACCORDING TO NP. SHE ADVISED TO CALL 911 DUE TO TINGLING IN FINGERS AND NOT GETTING BETTER. WE CALLED AND PATIENT WENT WITH EMS.

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

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

LIGHT HEADEDNESS, THEN SEIZURE FOR ABOUT 10 SECONDS. WE CAUGHT PATIENT AND LIED HIM ON THE FLOOR AND TURNED PATIENT ON A SIDE, ARM WAS SWELLING AND TURNED ORANGE. PATIENT WAS CONCIOUS, EMT ARRIVED AND TOOK HIM TO THE HOSPITAL.

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

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

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

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.

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

Patient informed paramedic of arm tingling, paramedic informed patient that he will check back with him in a couple minutes. 5 minutes after, paramedic witnessed the patient having a seizure for 10 seconds. During seizure, patient hit car in front of him. Paramedic stated that patient had flexion and eyes rolled back. Patient came to and asked paramedic what happened. Patient does remember seizing. Patient went into ambulance and was given snacks due to blood sugar of 95. Patient states he is currently on a keto diet. Patient informed staff that someone will be picking him up and refused to go to hospital with EMT.

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

Patient came to Pharmacy today for his J&J vaccine along with his wife who also received her vaccine as well. After I administered the vaccine, the patient got light headed and I asked him if he would like to lay down. Before he could respond, the patient collapsed off his chair hitting the side of the plastic trash bin in our patient care room. I caught him before he hit the ground. I asked if he could hear me after saying his name a few times, no response. I assessed his subjective vitals and could tell he stopped breathing. Called for Pharmacy resident to grab and administer an epi pen. Patient responded within 30 seconds of epi pen administration and started breathing again. Proceeded to call emergency services, first responders arrived within 5 minutes and administered IV fluids and oral ondansetron. Patient left with the ambulance and will follow up tomorrow to make sure everything is ok.

Patient was passing out right after 10 minutes later after the vaccine. He felt dizzy, weak, and his hands were numbed for as short time.. He felt like he was sweating and still feeling weak. EMS came to take care of him.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was sitting and than fainted 911 arrived and helped pt recover

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

PT REPORTED FEELING DIZZY AND WEAK KEPT PT WAS KEPT IN OBERSEVATION FOR ADDITIONAL 45MINS UNTIL HE FELT BETTER

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.

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

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

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

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

Patient began feeling dizzy and hot about 10 minutes after receiving vaccination. Notified staff, Dr assisted patient to floor with his feet elevated. VS done, juice and crackers given, Patient stated, "This happens all the time. I have anxiety about needles." Left clinic in no distress, no dizziness.

Janssen-COVID-19-EUA CAMVU-Run #2021005119 25 y/o male with a chief complaint of Dizziness/Weakness post vaccination. Symptoms subsided several minutes after onset. Onscene medic performed full assessment. Pt refused transport for futher eval, pt signed AMA.

Seen and released by EMS for "numbness to forehead" 02 saturation 99%. Pulse 60 Blood pressure 136/80

Patient complained of pain at injection site, weakness & joint stiffness. Temperature obtained 101.6.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt presented with a temperature of 99.1F after running from another pharmacy to our pharmacy. Shot was given at 1:10PM and within 5 minutes after pt's arrival time. Pt reported light headed, hard breathing and tingling in hands after 5 minutes of shot. Offered Epipen but pt refused. Continued to monitor pt, All adverse reactions were gone after 15 minutes. Pt was contacted after 24 hours and have no chief complaints except soreness at injection site.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

At the time of injection, I started to go numb everywhere in my body, feeling a tingling sensation that lasted 20-25 minutes. It was difficult to move my extremeties. The day after the vaccine, I had chills, body aches, a headache, and was very lethargic.

Fever started at around midnight. Couldn?t find thermometer so do not know exact temperature. Took 3 Tylenol at around 3:00 AM when it became clear I was not well. Fell asleep around 5:00 AM after Tylenol kicked in and got super hot instead of super cold. Woke up around 11:00 AM with no fever, but slightly achy. Aches went away by nighttime, and felt 100% the next morning, April 3rd.

Went downhill rapidly... Aprox 6 hours after shot was administered I was shaking uncontrollably (freezing sensation) fever 102.6 and commiting. Woke up this morning and felt better but still very much aches and pains and headache

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.

Systemic: Dizziness / Lightheadness-Severe, Systemic: blacked out immediately post vaccine administration (1-2 min)-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PT stated passing out post vaccine is normal / occurs (why he used nasal flu shot in 2020 and not injection). blacked out post vaccination, RPh held patient at head and shoulders in chair to prevent fall from chair or injury to neck when as when he blacked out he fell back in his chair. post black out we provided water and monitoring. PT stated during recovery light headed, tingling in fingers / numbness. vision impared (like post concussion when hit in head/face).

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

NEAR SYNCOPAL EPISODE PALE/WARM/DIAPHORETIC PT REGAINED SKIN TONE, NO OTHER PAIN DENIED HOSPITAL TRANSPORT

Fever, Chills, Bodyaches, Lightheaded after 1st vaccine. Generalized numbness that subsided after 2nd vaccine received 2 DAYS after 1st vaccine.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Mild, Additional Details: 12:20pm\r\n24/Male fainted after administration of Janssen vaccine. No other symptoms noted. Had patient sit on the floor and elevate legs. Assessed for anaphylaxis, epinephrine was not indicated.\r\n12:24pm BP 140/75 (unsure of patients baseline, no diagnosis of hypertension). Ambulance was called. When ambulance arrived patient felt better. May have just been nervous due to needle itself, not COVID vaccine. followed up with patient 4:20pm and he states he feels perfectly normal now.

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

Full body chills, fever, shaking/shivering uncontrollably. Full body aches. Followed by severe migraine the following day, continuing aches. Lasted the duration of the day, but no fever. By day 3, light headache, symptoms gone by end of day.

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.

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

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

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

SX: lightheaded, feeling faint, losing BP 110/70 color and clammy. TX: Food (crackers with chesses), water, stayed an additional 15 minutes. Patient felt better after 23 minutes and left in good spirits.

One week after receiving the Johnson & Johnson vaccine, several small bruises (6-8) appeared on the back of my left leg. Throughout the day, my leg developed a soreness that, after reading a 10 Feb 2021 story in the newspaper about COVID vaccine recipients developing immune thrombocytopenia caused me to seek medical treatment in the afternoon of 4/6/2020. I first visited an urgent care facility where my high blood pressure (130/98) combined with my slight lightheadedness, soreness in the leg and observes bruising were enough for the tending physician to recommend rushing to the ER for bloodwork to be performed immediately. I was admitted to the ER in the early evening with an elevated blood pressure (~150/111) and the bruising still prevalent. The tending nurse practitioner authorized a complete blood count (CBC) and discharged me an hour later when the results came back ?extremely close to normal,? noting that my platelet count of 194 was no immediate cause for concern. Since then, the bruising and soreness has subsided.

In the span of about 40 minutes following the shot, I had severe reactions. I initially felt really warm in my arm and my heart started to race for a bit. That subsided pretty quickly. Then I got really dizzy, lightheaded and warm and sweaty while waiting the 15 minutes. Then my vision started to blur and I felt tingly in both of my hands and both of my legs. According to others with me, I also went grey. I was given a cool cloth and fanned which helped with a lot of the issues. I also had my legs elevated and was given some slightly sugary food and drink to help the vaccine disperse better. Paramadics and amabulance arrived to assess me. I was improving by the time they arrived and was deemed stable, so I did not go to the hospital for this incident

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.

Fever that won't break for 3 days, chills, uncontrollable jerking, Horrible headache (couldn't lift head up), loss of taste (on day 2 only) (taste returned on day 3) day 3 soreness down the arm.

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

Spoke with patient today. He experienced severe flu like symptoms approximately 4 to 6 hours after the vaccination. He had a severe headache. fever of 104 along with chills that lasted 1 days followed by extreme heat Patient also expressed to me that he suffered from shortness of breath that lasted about 12 hours during time of high fever. followed by aches and pains lasting about 2 days.

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.

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

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

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

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

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

PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case

Patient received immunization. Was sitting in chair for observation and about 5 minutes after immunization was given he passed out. Was awake immediately but said he didn't remember passing out. Knew his name, date of birth, where he was. I watched him until paramedics arrived. He said he felt fine but was sweaty. Paramedics stated all his vitals were normal and he said he felt ok but he said he got really hot. Remained at the pharmacy until his friend could come and get him.

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

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was sitting on the bench waiting for his 15 minute interval. A few minutes after sitting there, he passed out & fell on the floor. Said he got dizzy & didn't remember falling: was able to talk & answer questions within a few seconds. He was exremely pale, sweaty but remained responsive & stayed on floor until EMS arrived. Unsure if he hit his head or injured during fall. EMS assessed as syncope & possible dehydration. BP didn't stabilize so he went to ER for fluids & was released.

on the patients PQCF every question was a no,pt showed no fears for needles or signs of aversion,afetr administeru=ing the vaccine pt was waiting for 15 mins sitted ,after 5 mins or more he stated that he could not see,he went blind momentarily, would not blink after a waved my hands across his eyes,we initiated a call to 911 and made him comfortable no other signs of syncope was observed ,he was very aware and calm,after acouple more minutes he regained his sight and at this time he broke out in sweat and was clammy, he felt a lot better with the fan on him and drank some water and ate some chocolate and after a couple more mins he was good to go home,checked up him again the next day and everything is normal

3:35pm Post vaccination reports sensation loss right arm and fingertips. Medical monitoring w/vital assessment: BP 113/78 P 66 O2 sat 99%, rest, and po hydration. Symptoms resolve, released from facility home w/self

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

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt fainted about 2 minutes after getting their COVID vaccine. We had him sit with his feet up. We checked blood pressure about 5 minutes after and found he was hypotensive (109/71). Called the ambulance was was released by them.

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.

Pt was lethargic, described blurred vision, tingling in both arms, sweaty, felt cold to the touch, BP at 7pm was 70/42, contacted EMS for help. EMS followed the pt home (came to pharmacy with his father), his BP had risen to 119/88 per call with father at 8:38pm. Father stated his symptoms had resolved and he was resting.

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

Systemic: Fainting / Unresponsive-Medium, Additional Details: lost conciousness during his 15 min wait (while he was sitting). Bumped his head. I immiediately got his legs elevated and put something under his head. He regained conciousness within a minute, but I had him remain on the ground. The pharmacy tech called 911 right away. EMT services arrived within 10 minutes, although patient was persistent about wanting to leave on his own as he stated he regularly passes out with needles and has in the past as well. Emt evaluated him and let him leave.

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.

SYNCOPE, PALE, COLD, UNRESPONSIVE X 30 SECS, ASSISTED TO FLOOR, WOKE UP, PARAMEDICS ON SITE, BP 141/72, HR 91, PROVIDED WATER, SX RESOLVED, NO TRANSPORT.

Administered about 3:30pm and sent to observation area. At roughly 4:40pm client started getting dizzy and closing eyes, color gone from skin with lips getting grayish-purple. At 4:45pm client was going in getting "clamy" skin, sweating some. I had him recline in a chair and administered 1 dose (0.3mg) epinephrine using an auto-injector pen and called for emergency services. At 4:50pm blood pressure was 125/80. Client still coherent. Had mentioned that he had not eaten that day so gave him some saltine crackers and juice. Color started to return and emergency services arrived to take over.

Shot was inserted into right arm just slightly below the shoulder and I still have long lasting pain in my arm that comes and goes.

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

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.

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

5 minutes after patient got his J$J vaccine he lost consciousness and fell down on the floor. The pharmacist(myself) run to him. Patient started to seize. I turned him to his side and tried to keep his mouth open in order for him to not bit his tongue. Meanwhile 911 was called. Patient had seized about 15-20 seconds, then suddenly he became calm and conscious. 911 dispatcher told us to keep him laid down on the floor till they get to the store. One of our coworker asked patient few questions to see if he remembered things. Paramedics came about 7 minutes later and took care of him. They let him go after evaluation. I called him later & he had recovered.

At approximately 8pm the day of the vaccination, I felt fatigued. I woke up the next morning feeling like I was definitely sick with the typical symptoms. I was resting all morning on the couch at the house I was dog sitting. At around 11:30am I took my daily Claritin and two ibuprofens. At around 12:15pm, I was getting my haircut and felt like I was going to pass out. I asked the hairstylist to grab water and something to cool me off. I didn't have much control of my body, ED was called, and paramedics showed up. About 5 minutes into the incident my arms and legs started tingling and felt like someone was trying to twist my skin. An IV was put into me and about 5 minutes later I snapped out of the episode.

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

CLIENT PRESENTED 10 MIN. AFTER INJECTION AND C/O SOB, FEELING HOT, SHAKEY, AND DIZZY. VS 4:15PM HR 90, RR 16, BP 164/82, O2 SAT 97%. CLIENT CONTINUED WITH ABOVE SX'S AND RN NOTED FACIAL FLUSHING AND SCLERA OU APPEARING BLOOD SHOT AND CLIENT C/O R ARM NUMBNESS. VS 4:20PM HR 90, RR 16, BP 154/84, O2 SAT 98%. 4:40PM HR 92, RR 16, BP 156/82 02 SAT 98%. 4:40PM HR 96, RR 30, BP 136/86, 02SAT 99%. CLIENT WAS TRANSFERRED VIA AMBULANCE TO MEDICAL CENTER. F/U CALL TO CLIENT 6/15/2021. CLIENT STATES HE FELT DIZZY FOR ONE HOUR AFTER ARRIVING IN ER. HE REPORTS BEING MONITORED UNTIL 10:00PM AT WHICH TIME HE WAS RELEASED AND FELT BACK TO NORMAL.

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.

MUSCLE TWITCH IN BOTH ARMS; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced muscle twitch in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitch in both arms on 2021. This report was non-serious.

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

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

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

Patient was feeling fine before the vaccine was administered. After administering vaccine, patient suddenly collapsed briefly from a sitting position to the ground. Patient wasn't responsive at first but then was able to verify his name and birth date. Blood pressure was taken and it was 93/60. Patient rested on the ground until his BP normalized and was given a cup of water.

Patient received the Jansen covid-19 vaccine today. he was fine when he received the vaccine but when he was sitting in the chair in the pharmacy lobby he fainted. I saw him fall out of chair and immediately ran out the door to assist him. He fell out of chair face down on the floor. When I reached him I rolled him over and spoke to him and he responded to me. I had him remain on the floor for several minutes before I had him sit in the chair. He bit his lip and there was a spot of blood and he hit his forehead on the floor. We called emergency number and emergency medical team arrived shortly and took his vital signs and they were normal. He was a little clammy and sweating a little. I gave him a bottle of cold water to drink while he was sitting. The emergency team checked him out and they ask him if he wanted to go to hospital and he declined going. The emergency medical team left and I had him wait a while longer. I had him call his mother to come and pick him up so he did not have to drive himself. His mother arrived about 20 minutes later and I went over with her what had happened. She took him home and I called to check on him after a few hours and he said he was doing fine. He also stated while talking with him that he had never passed out when getting other vaccines or the flu shots previously. He did state that he didn't like needles but was not afraid to get the vaccine.

After his vaccination, patient was waiting 15 minutes in waiting room. Patient knocked on door and said he didn't feel well. I closed door and turned to grab epi-pen and diphenhydramine. When I turned back around, patient fell on the floor and was unresponsive. I asked my technician to call 911. Patient regained consciousness in about 10 seconds and I told him an ambulance was coming. I observed his breathing to be normal. He sat up against the wall in a cold sweat and told me this has happened to him one time when he donated blood. The ambulance and paramedic arrived very promptly. They took him to the ambulance.

LOST CONSCIOUSNESS; COLD TO THE TOUCH; SWEATY; This spontaneous report received from a consumer concerned a 25 year old male. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 07-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, few minutes after the vaccination, the patient lost consciousness and regained it a minute later. The patient was also cold to the touch and sweaty. The patient had visited the doctor/healthcare professional office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness, cold to the touch, and sweaty on 07-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210718535- covid-19 vaccine ad26.cov2.s-Lost consciousness. This event(s) is considered un-assessable. 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).

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

INMEDIATELY AFTER VACCINATION, THE PATIENT DEVELOPED DIZZINESS, SWEATING, AND TREMORS. THE SYMPTOMS RESOLVED AFTER 30 MINUTES APPROXIMATELY.