Johnson & Johnson

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

PT CAME TO VACCINATION CLINIC WITH HIS FATHER WHO SIGNED PREVACCINATION CHECK SHEET. THE CLINIC WAS HELD AT WHERE THE PATIENT WORKS. PATIENT IS 16 AND RECEIVED JOHNSON AND JOHNSON VACCINE IN ERROR DUE TO THE FACT HE IS NOT 18. WE HAVE CHECKED IN WITH PATIENT AND HIS FATHER 4/1/2021 BOTH HAD BODY ACHES, HEADACHE AND CHILLS. I CHECKED IN WITH BOTH THIS AM 4/2/2021 NEITHER ONE HAS ANY SYMPTOMS TODAY.

Mother of patient describes chills, fatigue, and kidney pain. Is being exclusively managed by PCP who has seen him multiple times. Given Jannsen at mass vaccination clinic by student nurse under preceptor supervision. Error not brought to attention of until 4/2/2021.

My son is ONLY 16 and should NOT have received the J&J vaccine at all. He was supposed to receive the Pfizer vaccine only.

Headache and high fever the night of 4/10/21. Symptoms persisted the morning of 4/11 but have improved. This vaccine has not been approved yet for patients under the age of 18.

On 12-04-2021, a 16-year-old young man was administered the Janssen vaccine, which is indicated for 18 years or older. The next day the patient presented symptoms of fatigue, fever and headache but today April 15, 202 the young man's mother indicates that he feels better.

PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; FEVER; DIFFICULTY PERFORMING EVERYDAY ACTIVITY; GENERAL SENSE OF CONFUSION; EXCRUCIATING HEADACHE; This spontaneous report received from a parent concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced general sense of confusion. On 10-APR-2021, the subject experienced excruciating headache. On 11-APR-2021, the subject experienced difficulty performing everyday activity. On an unspecified date, the subject experienced product administered to subject of inappropriate age, off label use, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general sense of confusion on 11-APR-2021, and the outcome of difficulty performing everyday activity, fever, excruciating headache, product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.

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.

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

Fever 100.6 - given tylenol Near fainting - mother called medical facility and spoke and was advised by a Triage nurse

FELT AWFUL; VOMITING/ THREW UP; DIZZY; HIGH FEVER; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; NAUSEA/ FELT LIKE THROW UP; This spontaneous report received from a patient concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced nausea/ felt like throw up. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced high fever. On 11-APR-2021 06:00, the subject experienced vomiting/ threw up. On 12-APR-2021, the subject experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting/ threw up, high fever, dizzy, felt awful, and nausea/ felt like throw up, and the outcome of inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

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.

SWEATING; DRY MOUTH; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; FEVER; This spontaneous report received from a patient concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sweating. On 31-MAR-2021, the subject experienced dry mouth. On 31-MAR-2021, the subject experienced inappropriate age at vaccine administration. On 31-MAR-2021, the subject experienced off label use. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from off label use, and the outcome of sweating, fever, dry mouth and inappropriate age at vaccine administration was not reported. This report was non-serious.

PATIENT HAD A MILD HEADACHE AND TEMP FOR 12 HOURS AFTER THE VACCINE. HE TREATED THE SYMPTOMS WITH IBUPROFEN AND NYQUIL AT NIGHT AND SAID THAT IT HELPED. THE SYMPTOMS RESOLVED WITHIN 12 HOURS.

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.

Patient received Johnson and Johnson vaccine at age 17 (underage since it is for 18 and older). Patient reported feeling a little feverish and had body aches later that night after receiving the vaccine. The symptoms only lasted that day and the patient fully recovered the next day.

Extreme tiredness, headache, chills, fever. Lasted from 11:30pm until 7am the following day. He?s feeling better now.

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

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

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

Janssen COVID-19 Vaccine EUA Fever of 101.7 at 10 am on 3/14/2021. Started with chills at 3:00 am on 3/14/2021

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

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

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

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

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.

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.

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

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.

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.

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

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.

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

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

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.

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

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

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.

We gave patient the vaccine and advised him to wait for the CDC recommended 15 minutes observation time. He decided to leave after just a few minutes, despite his dad (who was with him) questioning the decision and suggesting he stay 15 minutes. I was then told by a member of management through our walkie-talkie system that they needed me at the front register immediately because someone passed out after getting a vaccine. I was there within the minute with my vaccine emergency bag. Upon arriving, the patient was already awake, talking, and sitting in a chair. He also was profusely sweating. He stated he's never experienced anything like this before. He said he normally has low blood pressure. He starting drinking some water. When I checked his blood pressure it was so low the machine gave an error message. Throughout this time, the patient progressively was feeling better and eventually wound up laughing and smiling. Him and his father said that he would be ok and that he was feeling himself. I told him to sit for a bit more before leaving and stay as long as he wants. I called him later that evening to check on him and had to leave a voicemail. His father called back 2 days later and said he's been fine.

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

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

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.

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

Patient began having chills, fevers and sweats within 12 hours of receiving the vaccine. 2 days later he had severe chest pain prompting him to present to the hospital.

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

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

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

Day 1 (March 7) 102.7 fever, severe body aches, headache. Resolved within 24 hours Day 6 (March 13) full body hives. Resolved with benadryl within 24 hours

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

Pt exhibited vasovagal s/s immediately after COVID injection. Stated he felt "light headed", was excessivel ydiaphoretic, and pale. Was sitting in the chair. Limbs were limp, but was able to move them. Remained conscious and able to answer questions, but stated he remained ligh theaded. Given water and able to drink. BP low-80/60. Pt assisted to cot to supine position. Stated he felt better and color returned. BP increased to what pt stated is baseline-92/44. After about 10 minutes, pt stated s/s resolved and able to sit up and then stand without difficulty or any s/s. Ambulated to waiting area where he remained for the rest of his 30 minute observation period.

NOT EATING; LETHARGIC; HIGH FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced high fever. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced not eating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargic, high fever and not eating was not reported. This report was non-serious.

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

This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, diarrhea, headache, chills, pressure in ears and injection site pain was not reported. This report was non-serious.

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

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.

The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and achiness. This report was non-serious. This report was associated with product quality complaint: 90000175989. The suspected product quality complaint has been confirmed to be voided(did not meet PQC criteria) based on the PQC evaluation/investigation performed.

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.

He has had the following symptoms from the 4/12/2021 till present time: constant headache and fatigue. Intermittent low fever (99F). On 4/21/2021, his primary care doctor recommended that we take him to Emergency Room because she was concerned about thrombosis as side effects from the vaccine. His legs had some red patches on the back of the ankles area. At ER, doctor did blood test for blood clot and result was negative. He got an IV injection less headache.

Patient received the J&J Covid-19 vaccine then fainted approximately 5 minutes later. Patient came to immediately and was conscious by the time the pharmacist reached the patient. Patient was ok other than having a sore head from when he fell. We provided the patient water and continued to monitor for an additional amount of time for a total of 30 minutes. Patient denied needing anything else such as juice. Patient was okay after and when asked if there was anyone that he could contact to drive with, he said he was okay to drive after.

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

Patient felt light headed and dizzy and passed out briefly following administration of vaccine. Patient had history of passing out during vaccination and blood draws. Patient felt sweaty and turned white. His color returned after a minute, I talked to his mother who was there during the incident. Did not eat or drink the morning of vaccine. I checked his pulse and blood pressure and it was 129/72 and pulse of 78. We gave him some water and orange juice. He felt much better. Then his mom bought him some muffins. He sat and ate for about 30 minutes and left feeling back to normal.

tested positive after completing 2 weeks after 1 dose COVID vaccine series; reporting symptoms of fatigue/sore throat/headache

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.

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

Flu like symptoms lasting for about 18 hours, beginning about 12 hours after injection. Fever, muscle aches, extremely tired, mild headache.

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.

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.

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

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.

Two minutes after administration of J&J COVID-19 vaccine, patient asked this nurse for water. "I feel dizzy." Patient diaphoretic & pale. Patient remained seated in chair. Felt this way for 15 minutes. Feet elevated, cold compress to neck, fan directed at patient. Patient never lost consciousness. Took cold water and pretzels. BP at 1457: 104/76. Symptoms totally resolved by 1500 hours. Patient reports history of vasovagalfainting with needles. Patient and mother reports a history of vasovagal fainting when getting blood work. All symptoms resolved within 15 minutes of vaccine administration. All symptoms resolved with juice, pretzels, cold pack to neck, and blowing fan on patient.

Two minutes after administration of J&J vaccine, patient asked this nurse for water and said, "I feel dizzy." Patient was diaphoretic and pale. Patient remained seated in chair. Felt this was for 15 minutes. His feet were elevated, cold compress to neck, fan directed at patient. Patient never lost consciousness. Took cold water and pretzels. BP at 14:57 was 104/76. Symptoms totally resolved by 1500. Patient and mother report a history of vasovagal fainting with previous blood work/exposure to needles.

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 received Janssen COVID vaccination on April 6, 2021. Pt had no symptoms initially after vaccination. Pt started coughing up blood and having episodes of dyspnea on April 25, 2021. Pt went to Urgent Care earlier in the day on May 11, 2021 - no medications were given, told he was fine. Pt then went to Medical Center and was found to be pale, diaphoretic, and tachycardic in triage. Pt vitals were temp: 36.6; pulse: 128; respirations: 22; BP: 161/129; SpO2: 97. Hospital medications: carvedilol 6.25mg PO BID, enoxaparin sodium 40mg SQ Q24h, azithromycin 500mg/sodium chloride 250mLs @ 250 mLs/hr IV Q24h, ceftriaxone sodium 2gm/sodium chloride 50mLs @ 100mLs/hr IV Q24h, lisinopril 2.5mg tablet PO QD, metoprolol tartrate 5mg IV Q5MP prn tachycardia. ER disposition: consult for admission Dx: hypertensive urgency, tachycardia, suspected COVID virus infection, bilateral pneumonia

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.

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.

as soon as needle went in patient's arm patient turned white and sweaty. never lost consciousness. pt said ears were ringing and that he couldnt see patient's mother wanted us to call squad. we did. they arrived shortly after. they determined it to be an allergic reaction and administered epi and gave pt IV fluids patient was stable enough to leave a little before 7 pm

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.

Staff notices patient was breathing deeply and slowly. Asked patient if he is feeling unwell. Patient states he feels lightheaded. Patient then became diaphoretic. Took patient to medical tent via wheelchair. Vital signs stable. Gave patient orange juice and water and applied a cold damp towel. Patient stopped sweating and states he no longer feels dizzy. Too BP sitting and standing. Stable both ways. Symptoms noted: paleness, sweating, fainting, lightheadedness,; Orientation x 3. Vital Signs: 12:47pm - bp 116/62, p 71, r 15, pulse ox 98; Vital signs: 12:53pm - bp 120/76, p 74, r 16, pulse ox 98; patient treated at vaccine location, stabilized and discharged to home, alert and oriented with no further complaints.

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

Developed clots in both right and left lungs. Wedge shaped infarction in left lung. Extreme headaches. Pulmonary emboli and plural infusion.

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

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 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.

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

Immediately post vaccine administration, patient experienced syncope (fainting). Eyes rolled back, sweating, lost consciousness. 15-20 seconds later regained consciousness as if nothing happened. Provided patient 4 glucose tablets and sat/spoke with him for an additional 15 minutes

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

Within 12 hours- Severe chills for 2 hours, then turned into fever of 102. Took motrin at 4 am (four hours after effects started.) Headache and achy. Fever continued for 20 hours. Took Nyquil that night. 5th day at 11pm, developed itchy rash on forearms, spreading to torso and shoulders. Started down back. Took benedryl and used caladryl lotion on rash. Tired for 4 days.

Body chills started at 11:00 pm day of vaccination, major headache started roughly 12:00 am day after vaccination. Chills ended roughly 9:00 am day after vaccination, Headache ended roughly 3:00 pm day after vaccination.

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.

Patient fainted 5 minutes after the administration of the vaccine, he could still talk and told me that he was having difficulty breathing so while 911 was on the way I injected one dose of Epinephrine 0.3 mg. He was also pale and sweating. I was making sure he had a pulse, when 911 arrived they assess him and his blood pressure was a little high. After maybe 15 minutes he was feeling better and he told us that he was afraid of needles. Honestly we do not know if he was very anxious or if he had a reaction to the injection since he mentioned his throat was closing.

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

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

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

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

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.

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

Pt received 1st dose Covid-19 Janssen vaccination. Pt stood up and stated that he felt dizzy and immediately began to fall to the floor. Staff caught patient as he was falling and lowered him to the floor. Pt remained conscious. Feet were raised and pt was verbal, states he didn't know what happened but he was okay. Pt alert, remained on the floor and drank juice. Pt helped up from the floor and became pale and diaphoretic, wheeled to the cot. VSS, cold compress applied to head and pt drank another juice. Pt lie on cot for approximately 5 minutes, stated again that he felt okay, observation team performed orthostatic VS. VS remained stable. Pt ambulated out of clinic with parents. VSS, A&O x4, GCS 15

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

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

Patient presented to the ED for evaluation of chest pain. About 24-48 hours after receiving vaccination he started having left sided chest pain that worsened over the next 3-4 days. The pain intensified and he also reports having low grade fevers.

103 DEGREE FEVER; COULD NOT SLEEP OR ANYTHING; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced could not sleep or anything. Treatment medications included: paracetamol. On 23-JUN-2021, the subject experienced 103 degree fever. Laboratory data included: Fever (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever on 24-JUN-2021, and the outcome of could not sleep or anything was not reported. This report was non-serious.

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

Patient passed out minutes after receiving vaccine for approximately 10 seconds, then became very drowsy, pale in color and began to sweat excessively.

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

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

S: Patient is a 19 y/o male c/o odd sensation over his legs and arms lightheaded while he is walking out of the vaccination tent after 5 minutes of getting vaccine. Reports having history of lightheaded none with injections an appendectomy 2 years ago otherwise no other history . He did not eat or drink this morning. He did vape before taking vaccine. Allergies: PCN, anesthesia hives post surgery O: 1st reading 10:53 vitals BP 120/80 HR 92 Oxygen sat 99 pain 0/10 resp. 18 2nd reading 10:56 120/80 Hr 95 oxygen saturation 99 3rd reading standing after 5 minutes 110/80 Pale. Shivering. Weather is cold outside. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for n

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

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

He had a 105 fever on Sunday morning March 14th and Monday morning March 15th both days woke up with 105 fever. Extremely high. Bad headache, chills and high fever. We used two different thermometers to check the reading.

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.

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.

Within 2 hours of shot on 3.30.21?: severe headache, 1:30 am-2am- body aches fever 103.1F, at 7am high fever 102.6, severe body; heart palpitation, 3.31.21- high fever, heart palpations, sever body aches, headache. 4.1.21: fever is 99.5.

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.

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

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

Fever for all of April 3rd, ending on the 4th Soreness throughout whole body April 3rd, ending on the 4th Fatigue Fatigue start after about an hour after injection on the 2nd and ended on the 4th

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

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

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

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.

VERY SICK; TEMPERATURE OF 102; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.. No concomitant medications were reported. On an unspecified date, the subject experienced temperature of 102, and very sick. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature of 102 and very sick was not reported. This report was non-serious.

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.

bodyache. patient c/o body aches, chills, headache that started this morning. denies taking any OTC medications. patient recieved J&J vaccine yesterday

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

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.

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

FEELING DIZZY; CHILLS; HEAD PAIN; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021 20:00, the subject experienced feeling dizzy. On 03-APR-2021 20:00, the subject experienced chills. On 03-APR-2021 20:00, the subject experienced head pain. On 03-APR-2021 20:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, head pain, fever, and chills. This report was non-serious.

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

Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe

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

After vaccination pt became dizzy and diaphoretic, assisted to recumbent position with BLEs elevated, cold compress applied to forehead. No LOC, no head trauma. VS as follows: BP laying down 146/84, HR 88, sats 98% on RA. Pt given water and snacks. VS 5 mins later as follows: BP sitting up 142/81 HR 80, sats 98% on RA. Pt recovered within 10 mins and ambulated out of clinic in NAD.

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

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

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.

About 10 hours after receiving the vaccine, I had a fever. The fever only lasted about 4 hours after I took some Motrin.

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.

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

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

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,.

A two hour period of full body chills in a room temperature environment (even with full body clothing).

Approx 8 hours after vaccination (around 8:00 pm), patient complained of feeling tired and achy, and felt as though he had a fever although he did not. Approx 9 hours after vaccination (around 9:00 pm), he had 100.2* F fever, and took 1000 mg of acetaminophen. Approx 3 hours later (12:30 pm), his fever was 102* F, and he took another 1000 mg of acetaminophen. Approx 2 hours later (after 2:00 am), his fever apparently broke as he was sweating. Approx 3 hours after that (5:30 am), his temperature was 98.4* and he was more comfortable. 24 hours after vaccination, he is afebrile but still complains of malaise.

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.

Chills and fever the night of the shot which ended by the next morning. Strong headache the following day.

Around 7 minutes after administration patient started to look like he was having headache. My technician asked if he was doing ok and he replied "no." I then went out and asked what symptoms he was having. He said he was having headache, dizziness, and didn't feel well. I then stayed with him to monitor him, at which point his arms fell, I was able to lay him on the ground with an associates help without his head hitting the ground. Code white was called and store management came to the scene. Patient regained consciousness, remained on the ground for a few minutes and then said he wanted to sit up. We helped him into a chair, a few moments later, he lost consciousness again. We then laid the patient down one more time and the instore officer requested a squad. Patient was monitored until they arrived and took over.

A 19 y.o. male fainted about 15 seconds after being seated in the post IMZ waiting area. I had just walked away so didn't see it happen. I had him lie on the floor until he felt better. He was rubbing his head and thought he may have hit it on the floor. After 40 minutes he said that he felt ok and his head was not very sore. He declined to having us call for medical help.

high fever (102+), chills, severe headache, body aches... Tylenol, ice packs on head and neck... fever lasted about 12 hours, head and body aches lasted for two days.

Patient reports having fever and chills overnight. At approximately 6am he had a fainting episode followed by two other fainting episodes later in the morning. At approximately 3pm when I talked to him, he was still fatigued but feeling better.

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

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.

Low Fever 99.0-101.7 on going at 99.0 Chills/headache Arm Rash on the same arm others of where shot was injected Fatigue on going. Racing Heart.

Massive chest pain that seemed to originate in the lungs. Worse with each inhale. Began about 12 hours after the injection and lasted about 2 hours. Also severe headache, beginning hours after injection, that lasted about 48 hours. Could not attend classes the next day. These symptoms were accompanied by high fever, chills, body aches, which began with the headache and did not dissipate for about 48 hours.

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...

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.

severe headache (uncommon) the morning after. Went away after 600 mg. of Motrin + 1,000 mg. of Tylenol

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

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

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.

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

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

Urticarial rash that appeared 4 day after vaccine, no respiratory/gastrointestinal symptoms, rash improved when seen in office, had fevers on day of vaccine, rash does not blister, no bleeding or bruising.

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.

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.

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.

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

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

HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.

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

TACHYCARDIA (FAST HEART RATE 116); HIGH FEVER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, 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 tachycardia (fast heart rate 116). On 06-APR-2021, the subject experienced high fever. Laboratory data included: Heart rate (NR: not provided) 116. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, and tachycardia (fast heart rate 116). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Fever which steadily rose to 100.3 degrees F as night progressed, joined by severe shivers at 2:00AM (but no coldness) Fever lessened but remained for all of the following day, shivering ceased Fever was addressed on first night with wet paper towels on head and extremities, and a refrigerated water bottle Max recommended daily adult dosage of Tylenol taken by time fever dissipated

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

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.

Headache, achiness, fatigue 12-36 hours after vaccine was administered. Daily headache beginning 4/12/2021

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

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

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

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

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

pt states getting J&J yesterday at 1500 and at 2300 felt fever and chills upon waking noticed hives on arms pt denies N/V/D pt denies change in soap, detergent.

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

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

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

PT became lightheaded and diaphoretic approx. 6 minutes after receiving J&J dose .5ml. Pt found lying on couch initial BP 80/60 Pulse 50. Pt was placed supine with feet slightly elevated. BP came up to 110/70 with Pulse 50 after 5 minutes. Pt stated that they were feeling better. BP 120/70 Pulse 50 after 10 minutes lying down. PT sat up after 13 minutes BP 126/70 Pulse 50. PT stood up at the 15 after 15 minutes BP 120/70 Pulse 60. PT stated that he felt fine standing. PT released with friend feeling no ill effects.

Pt c/o headaches, feverish, bodyaches x2hrs. Pt received the J&J covid vaccine at 1330 today. Pt has not taken any meds. Denies additional s/s. Denies anybody in area with similar s/s.

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.

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.

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

Patient passed out for a few seconds 2-3 minutes after the vaccine. Complained of dizziness , sweating and unable to stand up. Patient's father, was with him at time of accident. His after caught him and prevented him from falling. Patient did not get hurt. Patient sat in front of vaccination room for about 20 minutes and left. I called to check on the patient the following morning at 9 AM and was told by patient father that patient is ok now.

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.

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

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.

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

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

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

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.

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.

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

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.

SHORTLY AFTER VACCINATION WITHIN MONITORING TIME, PATIENT ASKED IF IT WAS NORMAL "NOT TO FEEL WELL" POST VACCINATION. PATIENT WAS LEANING ON A COUNTER AT THE TIME. THEIR EYES ROLLED BACK, I BROKE THEIR FALL AND GRABBED THEM. AFTER SITTING THE PATIENT CAME TO WITHIN A FEW SECONDS AND THE PATIENT HAD NO RECOLLECTION OF WHAT HAD HAPPENED DURING OR LEADING UP TO THEIR SYNCOPE. I APPLIED A COLD COMPRESS ON THE BACK OF THE PATIENT'S NECK AND THEY QUICKLY RECOVERED. THEY HAD NOT RECIEVED ANY RECENT VACCINATIONS BUT TO THEIR KNOWLEDGE NEVER EXPERIENCED SYNCOPE.

Patient felt faint, said this happens to him when he gives blood and layed down on the floor. I asked him to put his knees up. after about five minutes he said he felt better and sat up in a chair but I looked at him and noted that he was sweating. He felt dizzy again and layed down a second time. I took his blood pressure at 3:40pm it was 144/92 57. I gave him some water. He said he felt better and left with his two friends at about 4:45pm

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

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

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)

Patient began sweating profusely approximately 5 minutes after vaccination. Also complained of lightheartedness. As per pt account he has fainted previously following vaccination. Patient was staying hydrated with water, and provided cookies to help in case blood sugar was low.

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

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.

5 minutes after receiving vaccine , patient experienced sweating and dizziness, gave patient water and had patient keep head upright, patient was fine after 5 more minutes.

Irritated throat, congestion, and light cough began 6/24. Took Mucinex for symptoms. Went to walk-in appointment on 7/4 after symptoms had remained constant for more than a week. Nasal rapid test was negative for COVID, was prescribed cefUROXime for possible sinus infection. Currently on day 8 of 10 for antibiotics.

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

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

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

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

FLU LIKE SYMPTOMS; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUL-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms. This report was non-serious. This case, from the same reporter is linked to 20210757738.

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.

The symptoms are dizzy, headaches, and chills and it started around 4:00 a.m. 3/12/2021. I still feel dizziness occasionally every hour.

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.

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

chill,body ache. PT presents with chills, subjective fever up to 105 and bodyaches after getting J/J vaccine yesterday 0900. last 650mg tylenol 0600 today. reports feeling well prior to immunization. 20 yo otherwise healthy m c/o isolated fevers/chills/bodyaches x24hrs w/o other sx's; Pt specifies took oral temp last night around 2000 was 105 but went down to 102 w/otc tylenol; pt states last dose tylenol at 0600 this AM; Pt denies any ha, nvd, abd pain, cp, sob, dyspnea, cough, rashes, urinary sx's, lack of taste/smell

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

Night of 3/06/21 -headache -severe chills -high fever -body aches -fatigue Above symptoms disappeared on 3/09/21 3/09/21 -began tasting/smelling a very strange taste, almost like dog food, when eating most foods -taste either completely masked over the normal taste of the food or mixed with it -taste made it unbearable to eat certain foods that were my favorite foods before -foods that are affected -meats -flour based foods(tortillas, pancakes, cookies, etc.) -fried foods -foods that aren't affected -fruits -sweets/sugars -liquids(that I've tested such as tea, coffee, milk, water, flavored water, etc.) -this taste severely limits the foods that I can eat and is still present as of 3/16/21

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

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.

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

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.

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

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

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

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

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

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

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

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

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.

fever. PT presents with fever, bodyaches, nausea and chills with chest tightness and SOB x 11pm. reports received JJ vaccine 1700 yesterday. covid positive May 2020.

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

Fever, chills, mild body aches. Fever temperature at 4/8/2021 7:00 pm: 99.8F. Fever temperature at 4/9/2021 7:30 am: 99.8F-100.3F

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

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

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.

FEVER 101 F; FATIGUE; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced fever 101 Fahrenheit. On 06-APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever 101 Fahrenheit, and fatigue. This report was non-serious.

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

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

FEELING UNWELL; SICK; This spontaneous report received from a consumer 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sick. On 01-APR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and feeling unwell. This report was non-serious.

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

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.

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

SEVERE BODY ACHES TOO PAINFUL TO LAY DOWN ON BED; CHILLS; FEVER; VERY PAINFUL HEADACHE FELT LIKE BLOOD VESSELS IN HEAD WERE SQUEEZING HIS BRAIN; FATIGUE; PAIN AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe body aches too painful to lay down on bed. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very painful headache felt like blood vessels in head were squeezing his brain. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches too painful to lay down on bed, chills, fever, and very painful headache felt like blood vessels in head were squeezing his brain on 03-APR-2021, and was recovering from fatigue, and pain at injection site. 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

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.

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

Around approximately 9:30PM on April 10th, I started to experience chills that got progressively worse throughout the night. No amount of layers seemed to help. Approximately 30min later I began to have a fever and a rapid heart beat started which led to chest pains . The chest pains subsided throughout the night, but the fever and chills lasted to around 11:00 AM, April 11th. I also had a bad headache from approximately 7AM to 10AM. Theses symptoms stopped around 11:00AM April 11th. Around 12 hours later I started experiencing chills and a fever again, however, these symptoms were less severe than the night before and subsided throughout the night.

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.)

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.

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

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

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

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

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

The most severe headache I had ever experienced, as well as pain when I move my eyes around, lastly pain in the injection site for 4 days since

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.

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

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

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.

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

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

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

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

Body aches, fever, chills, headache. Came on approximately 4 hours after vaccination, subsided approximately 24 hours after vaccination.

SLEEPY; BP NORMAL; BAD CHILLS AND RIGOURS; FATIGUE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and 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 sleepy. On 06-APR-2021, the subject experienced bp normal. On 06-APR-2021, the subject experienced bad chills and rigours. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/84, Body temperature (NR: not provided) 103 F, and Oxygen saturation (NR: not provided) 100 %. On 06-APR-2021 23:00, treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, bad chills and rigours, and fatigue on 09-APR-2021, and bp normal, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420331.

FEVER; MORE THAN 1 SHOT; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autism .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 15:00, the subject experienced more than 1 shot. On 09-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and the outcome of more than 1 shot was not reported. This report was non-serious.

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

BODY ACHE; DID NOT SLEEP; FEELING SICK; HEADACHE; FEVER; This spontaneous report received from a vaccine facility concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced did not sleep. On 06-MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, fever, and feeling sick, and the outcome of did not sleep was not reported. This report was non-serious.

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

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

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.

J&J vaccine was received yesterday afternoon. Pt c/o headache, bodyache and n/d. HPI:20-year-old male with chief complaint of fever headache and body aches after receiving the Johnson & Johnson vaccine yesterday. He has not taken anything for his symptoms. He denies any belly pain nausea or vomiting.

Patient states he felt very tired and light headed and dizzy about 45 minutes after receiving the vaccination.

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

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

PT presents with global headache that awoke PT from sleep with sensation of pressure behind eyes bilaterally. denies visual changes. reports receiving JJ vaccine 10am.

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

Pt received J&J yesterday. Pt started having fever, bodyaches and chills. Pt was SOB last night, but not now.

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.

Incredible fever/chills and body aches that are greater than what any prior virus has ever felt like. Temperature cannot be controlled with Tylenol or ibuprofen and is staying above 103 despite all efforts.

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.

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.

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.

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

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.

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

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

Syncope reaction - IMMEDIATE REACTION. DROP IN BLOOD PRESSURE, FAINTNESS, PROFUSE SWEATING, BLURRED VISION, COLOR DRAINED FROM FACE, NEVER LOST CONSCIOUSNESS. WAS UNABLE TO GET BP DUE TO SMALL SIZE OF HIS ARMS. I HAD TROUBLE LOCATING THE PEDIATRIC CUFF. WHEN EMS ARRIVED THEY TOOK BP AND IT WAS 58/40. EMTS HUNG FLUIDS AND TOOK PT TO EMERGENCY DEPARTMENT. Pt called pharmacy at 8:30p reporting leaving emergency department feeling fine after fluids administered.

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

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

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

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.

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

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

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

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

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

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

AFTER PATIENT RECEIVED THE JANSSEN VACCINE, PATIENT WENT TO GO SIT DOWN FOR 15 MINUTES. ABOUT 1 MINUTE LATER, PATIENT FELT DIZZY, BLACKED OUT AND FELL ONTO THE GROUND FROM THE CHAIR. PATIENTS BROTHER WAS WITH HIM AT THE TIME AND PATIENT REGAINED CONSCIOUSNESS A FEW SECONDS LATER. PATIENT WAS SWEATING AND FELT WARM TO THE TOUCH. WE HELPED HIM BACK TO THE CHAIR AND I ASKED SEVERAL TIMES IF I CAN CALL EMS FOR HIM, PATIENT REFUSED MULTIPLE TIMES AND STATED HE FEELS A LOT BETTER AND WILL HAVE HIS GIRLFRIEND DRIVE HIM HOME. I HAD PATIENT SIT DOWN FOR ANOTHER 20 MINUTES BEFORE LETTING HIM GO HOME. I ADVISED PATIENT IF HE FEELS ANY SYMPTOMS AT ALL, WHILE AT HOME, TO CALL EMS IMMEDIATELY. PATIENT AND HIS BROTHER UNDERSTOOD AND THEY LEFT.

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.

CHEST PAIN; COUGH; FATIGUE; MUSCLE ACHES; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced fatigue. On 14-JUN-2021, the subject experienced muscle aches. On 14-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced chest pain. On 15-JUN-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chest pain, cough, fatigue, and muscle aches, and the outcome of fever was not reported. This report was non-serious.

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

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

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

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.

The J and J vaccine was administered at University to students and my son on 4/9/21 at 11am. Seven hours after receiving the injection (6pm) my son came home from work with a temperature of 101.7F and body aches. On Saturday 4/10/21 my son was still running a temperature of 99.1F at noon, 100.9F at 5pm. On Sunday morning 4/11/21 his temperature was gone, but he continued to feel tired the next few days.

Patient received the Janssen COVID-19 vaccine and fainted while walking back to the chair in the waiting area. Pharmacist was walking behind him and asked if he was feeling ok, but he stopped and said no he felt light headed. Then he fell backwards into the pharmacist's arms. Pharmacist laid him down on the ground on his left side. He quickly regained consciousness, but remained on the ground for 10-15 minutes (until he regained color in his face and stopped sweating). His mother was present and right there for the entire incident. Then he sat up in the chair for an additional 10-15 minutes before leaving with his mother. There was no injury and patient did not want further medical treatment.

Patient reported feeling near syncope and sat down in his vehicle at 09:17. Patient had previously had Janssen COVID-19 vaccination on his right deltoid via intramuscular injection at 09:11. Patient was found awake, alert and oriented to person, time, place and event however was sluggish in response. Patient was observed pale, skin was dry to touch. Vital signs were obtained and patient was monitored every 5 minutes during incident. Patient reported progressively feeling better during interaction however patient stated that initially he experienced dizziness, a ?white-out, like a flash bang? to his vision, and feeling of near syncope. Patient stated not having any food intake that morning and to have previously used marijuana over night. Patient was offered EMS services on his behalf but patient stated he felt better after 15 minutes of monitoring and was well enough to drive home on his own. Patient was educated to stay hydrated and to have meals to compensate for his incident and informed to call 911 if his condition worsen or continued.

FATIGUE; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 at 11:30 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, the subject experienced fatigue. On 23-JUL-2021, the subject experienced headache. On 23-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headache, and fever. This report was non-serious.

BACK PAIN; SWEATS (SOAKED BED SHEETS); FEVER TO 103F; FATIGUED; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the subject experienced sweats (soaked bed sheets). On 23-JUL-2021, the subject experienced fever to 103f. On 23-JUL-2021, the subject experienced fatigued. Laboratory data included: Body temperature (NR: not provided) 103 F. On 24-JUL-2021, the subject experienced back pain. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, sweats (soaked bed sheets), fever to 103f, and fatigued on 25-JUL-2021. This report was non-serious.

Patient got Janssen vaccinc , 5 minutes later his sister told us he was getting head ache ..got him water , headache he stated was getting worse throbbing pain, gave ice pack. as he was drinking bottle water , pt started leaning over as if sick, noticed blood coming from right nasal and he was actually about to pass out.got him sitting up while sister sat with him on phone with mother. Called 911 .pt was soaked with perspiration.He told EMT his vision was blurry but slowly coming back. After EMT assessed him he was starting to feel better and started walking and his oxygen was back up. Mom met with EMT later.

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

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

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

When injected, felt the burn of the vaccine. A few minutes later started sweating, dizzy, blurred vision, ears ringing and sound start fading.

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

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

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.

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

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

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

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

DIAPHORETIC, HYPOTENSIVE 95/45, BRADYCARDIC 45, PRESYNCOPE LAYED ON STRETCHER, DRANK WATER, SYMPTOMS RESOLVED. OPTED TO GO HOME ONCE SYMPTOMS RESOLVED

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

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

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

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

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

headaches that have stayed for more than 12 hours, fainted at pharmacy minutes after receiving vaccine, blurry vision for around 8 minutes, dehydrated before fainting, a little difficulty breathing

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

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

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

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

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

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.

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.

Developed a fever the night following receiving the shot of 101.7 degrees Fahrenheit. Fever did not dissipate until the evening of the next day (Tuesday). Came down with a headache Wednesday afternoon that is still persistent to the present.

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.

Within minutes of receiving vaccine , patient became diaphoretic and had a vasovagal episode. Patient returned to baseline and was sent home with mother.

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

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

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.

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

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

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.

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

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

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

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

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

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

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

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

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

developed at 103 degree fever, chills and fatigue. took until early Sunday 4/11/21 to break fever. used Tylenol and ibuprofen and cool ice packs. also just rested r/t to fatigue.

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

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.

On 3/31 the patient received Jenssen Covid vaccine at 9:30 am. At 9:39 patient complained of N/V and lightheadedness. 9:40 BP 110/90 Pulse 104. Blood pressure faint. Patient pale and diaphoretic. His mother is with him. 9:43 BP 150/82 9:55 BP 142/74 Ate a granola bar and juice pack. Sitting at the edge of the cot. Skin cool and dry. Alert and oriented 10:10 BP 142/98 Remains sitting. Reports "feeling OK". Patient was DC'd with parent to home. Numerous attempts to contact via phone for follow up. Have not received a call back.

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

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

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.

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

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.

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

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

ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a 21 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced aches. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and aches. This report was non-serious.

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.

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

RIGHT SIDED CHEST PAIN, NOT EXCRUCIATING, BUT LASTING 90-120 MINUTES; TENSION IN CHEST; CHILLS; FEVER; This spontaneous report received from a patient 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: 1808978, and 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 chills. On 06-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced right sided chest pain, not excruciating, but lasting 90-120 minutes. On 07-APR-2021, the subject experienced tension in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right sided chest pain, not excruciating, but lasting 90-120 minutes, fever, tension in chest, and chills. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

-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.

DIFFICULTY BREATHING/HARD TIME BREATHING; COUGHING; CHEST PAIN; WHEEZING; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's past medical history included untreated pneumonia during childhood, and concurrent conditions included lungs not in great shape, no alcohol use, and no smoking, and other pre-existing medical conditions included the patient had not known any drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced wheezing. On 30-MAR-2021, the subject experienced difficulty breathing/hard time breathing. On 30-MAR-2021, the subject experienced coughing. On 30-MAR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing/hard time breathing, wheezing, coughing, and chest pain. This report was non-serious.

BODY ACHES; TIRED; 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 b+ blood type. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced body aches. On 04-APR-2021, the subject experienced tired. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tired on 04-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210451256, 20210451243, 20210451285 and 20210452044.

Patient without medical history, allergies, or medications, arrived with sister for Johnson and Johnson vaccine. Patient received vaccine and then became lightheaded, so the RN called for a medical response. NP and RN responded and found patient lethargic but answering questions appropriately, sitting in a chair. Patient was able to tell me his name, DOB, and what he had for lunch. Patient was moved over to nearby cot and while there experienced a 15 second syncopal event while supine. Patient was hypotensive and diaphoretic. Patient became responsive after 15 seconds and was able to tell us his name. Patient was able to sit up and drink juice, have a granola bar, and inform us that he has experienced this reaction to a flu vaccine and while having blood drawn. Medical team was called to evaluate the patient. The patient refused transport and signed out.

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

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

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

Patient got vaccine and sat down. He felt tired, his vision and hearing was impaired, and his skin turned white. He was still talking to us and somewhat alert but felt very tired and lightheaded. After continuing to talk to him for about 5 minutes, he started feeling better and his skin color recovered. He was able to drink water and his senses came back. He kept sitting and staff member watched him longer till he was able to get up .

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

Approximately two minutes after receiving vaccination patient fainted. He came to consciousness within one minute of fainting where he was sweaty. He did not seem disoriented and stated that the injection site radiated and had pain for a moment prior to his fainting.

Patient developed COVID symptoms 01MAY2021 (coughing, chest pain, fever, difficulty breathing) and was placed in observation by medics and physician. During initial evaluation vitals: temperature 102.7 °F, SpO2 95%, RR: 14, BP 132/90 and HR 115. The morning of 02MAY2021, patient had worsening difficulty breathing, lower oxygen saturations (88-92%) and sent to local hospital where he was admitted and found to have rapid antigen COVID test and confirmed with COVID PCR test. Patient was fully vaccinated as he received the vaccination 29MAR2021. Patient received antibiotics, 10L oxygen with non-rebreather mask, fluids and steroids.

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

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

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

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.

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

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

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

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.

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

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

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.

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

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

Patient received 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.

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

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

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

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

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.

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

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

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

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

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

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

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

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

Fever, headache, chills and difficult breathing since he got the JASSEN 2days ago. Took ibuprofen 400mg @1300.

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

Patient went to wait outside after 15 minute observation period. Came back inside at 1500 for family member. 1505 Started complaining of itchy throat, forehead, dry mouth/throat while sitting in observation. Nurse practitioner was called at 1507 and assessed patient. EMT was called at 1510. First set of vitals sitting position 136/93 99% O2 82 HR RR16. 1515 vitals 119/83 98% O2 HR 85 RR 16. 1515 NP performed physical assessment. NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. Checked integumentary system for rashes. None noted. Provider does not believe allergy is related to vaccine. 1516 Patient feels dry mouth and throat has subsided. Patient continued to be monitored for 15 minutes. 1530 NP reassessed patient. NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. NP cleared patient to go home. Patient left with family members.

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.

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

FEVER; FEELING VERY TIRED; This spontaneous report received from a patient via a company representative concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) POSITIVE. On 16-JUL-2021, the subject experienced fever. On 16-JUL-2021, the subject experienced feeling very tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-JUL-2021, and had not recovered from feeling very tired. This report was non-serious.

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

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

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

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

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

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.

Hypersensitive skin covering my torso and scalp; from my belly, armpits, chest, etc. I can feel my clothes rubbing against me at the slightest movement. I also get occasional chills from my torso thanks to the sensitivity.

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

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

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

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

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

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

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

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

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

Patient was looking pale and getting sweaty and stated they may pass out. Patient was given apple juice, water, and crackers. Patient stated he was feeling better after eating the crackers and that he was up all night due to working third shift and didn't eat anything. Patient remained on site for 45 minutes (including the recommended 15 minutes after vaccine administration) until he felt well enough to drive home.

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

Extreme fatigue, headache, and chills. Temperature hovering just below 101 F. By far the most sever flu-like symptoms I've ever felt.

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

RED RASH UNDER BOTH EYES; CHILLS; FATIGUE; 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 alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. 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: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced red rash under both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue on 02-APR-2021, and had not recovered from red rash under both eyes. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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

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

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

Chest pain, tightness, shortness of breath, and coughing. Symptoms progressively cleared after a couple days. Pain started on Thursday the day after the vaccine, and continued until Saturday morning.

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

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

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

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

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.

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.

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.

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.

Approx 5 minutes post vaccine, patient lost consciousness but remained in chair. Patient was immediately given a cold compress to apply to back of neck and wrists. Patient regained consciousness but was very pale and was sweating profusely. Patient was able to hold a conversation but reported feeling very warm and sweating. After approx 5 minutes, patient began to feel normal. Patient's color returned to normal, stopped sweating and reported feeling normal. Patient was monitored for an additional 15 minutes before leaving.

Around 6:15 PM the day of the vaccine, began to experience chills and a headache. I also became very dehydrated quickly and started to rest. I woke up around 8:30PM the same day with a fever of 102.7F, but no longer had chills. The headache had gotten worse and I took Ibuprofen to help the fever and headache. I feel back asleep until 11:30PM the same day when I was feeling better and had come down from my fever. I slept the rest of the night and woke up feeling dehydrated still and tired. When looking at my Apple Watch, my heart rate jumped to 90-120 BPM when the symptoms started and stayed around there until when I woke up the next day. The symptoms ran their course and I did not have any other events until April 13th, 3 days after the vaccine when I developed a dry cough.

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.

Headache beginning shorty after vaccination persisting rest of day. Intermittent headaches of greater severity on right/top right of head starting 42 hours after injection. Currently 75 hours post-injection and intermittent headaches persist. Moderate light/sound sensitivity.

Severe Headache starting approximately 9 hours after vaccine received. Lasted about 24 hours. Mild on and off headaches since.

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.

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.

Patient reports history of passing out with lab draws and one other time with injection. Within 30 seconds of vaccine, patient reported dizziness, narrrowed vision, and diaphoresis; he also appeared very pale. As we attempted to assist him to the floor, his eyes rolled back and he lost consciousness. Patient became alert within 10 seconds of losing consciousness. When safe, he was assisted to WC and taken to clinic where he was observed for a few hours. Patient discharged home with his mother when he was feeling better.

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.

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

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.

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

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.

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.

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.

Pt reports headache, fatigue and rash beginning 3 days after the injection. He notes the rash to his upper chest and back (maculo-papular), described as itchy and not radiating to other areas of the body. The rash has not gotten better or worse and remains today. He also notes "discoloration" (which was not seen on exam by this NP) to the right lower shin.

Prior to immunization the patient was extremely nervous and stated he did not like blood and was also nervous about potential side effects. The pharmacist addressed his concerns and proceeded with the immunization. While the patient was in the waiting area and decided to get up and walked over to report he was not feeling well and proceeded to faint. 911 was called and the patient refused treatment

Within 24 hours after receiving vaccine, patient developed fever 100. 4, body aches, chest tightness and shortness of breath with exertion

RIGHT SIDED HEADACHE AND LEFT TEMPLE PAIN; 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced right sided headache and left temple pain. Laboratory data included: Pain scale (NR: not provided) 5 to 6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right sided headache and left temple pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as 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.

BODY ACHE; FEVER; HEADACHE; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and body ache. This report was non-serious.

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

STOMACH PAIN; NAUSEA; CHILLS; HEADACHE; FELT FEVERISH; SWOLLEN THROAT/COULD NOT MOVE WATER; ITCHY THROAT; This spontaneous report received from a physician concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, concurrent conditions included severe allergy to food, and mild asthma, and the patient had no allergic reaction to any other vaccinations or injections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included epinephrine for severe allergy to food. On APR-2021, after 3-4 hours post vaccination the patient experienced mild headache. About 8 hours post vaccination, the patient's headache became severe (reported as severity 10/10 by patient) and patient felt feverish and chill but no temperature was measured. The patient took 2 tablet of Tylenol and 1 tablet of Advil before went to the emergency room (ER) around 10 hours post vaccination. The patient received unspecified drug intravenously (IV) and oral Benadryl. Around 11 hours post vaccination, patient discharged from the ER. On the way home, the patient felt his throat itch and swollen and could not move water down to throat. The patients symptoms of swollen throat significantly relieved when he got home (10 minute walk from ER to the front door and a short car ride by his friend) and he went to bed without using his epipen. Next day, patient felt mild headache after waking up and no other symptoms. At day three, APR-2021, he only felt very mild headache in the back of his head and severity was about 1% of that degree of the most severe time of day one. On 13-APR-2021, the patient felt stomach pain, nausea and headache. Severity was mild for all events. On same day, he went to ER for blood tests. All tests (including platelet count and clotting) were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt feverish, swollen throat, and itchy throat on APR-2021, and headache, stomach pain, and nausea on 13-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210421214-covid-19 vaccine ad26.cov2.s-Chills, Headache, Felt feverish. This event(s) is labeled per RSI and is therefore considered potentially related.

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.

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.

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.

Upon check out, status post 15 minutes sitting in observation area, patient reported a headache. Patient describes a left-sided headache with 3/10 pain. Patient denies any other symptoms. Patient instructed to drink fluids, rest, and contact PCP if any worsening or current symptom, or in the case of any other/concerning symptoms.

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: 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: 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

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

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.

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

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.

Pt and his mother went to their car after vaccination. After about 5 minutes, mom beeped the horn, so myself and another nurse, RN., ran to the car. Once arriving there, pt was in the passenger seat, appearing pale, and mom said he was not feeling well. Reclined the seat fully had had him lay back. VSS. Never lost consciousness. Pt had not eaten nor drunk anything before his appt at 12:15 pm. Gave him some water and crackers with peanut butter. Within 5 minutes, pt's color returned and he stated he was feeling better. Mom was going to take him to get some lunch in a drive-thru. No further issues at this time.

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

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

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

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.

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: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium

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.

22 yo otherwise healthy m c/o general 'unwell' feelings w/ha, dizziness, mild diffuse body aches approx 24hrs after receiving j&j vaccine; Pt states has had similar reaction feelings after receiving influenza vaccine previously; Pt denies any fevers/ns/chills, rashes, cp, sob, dyspnea, abd pain/cramping/nvd.

PATIENT WAS PROFUSELY SWEATING IN HIS POST WAIT TIME AFTER VACCINE ADMINISTRATION. HE WAS WEARING A BEANIE AND HOODIE AND WAS ASKED TO REMOVE THOSE. ICE PACKS WERE APPLIED TO HIS WRISTS AND NECK AND HE FELT BETTER WITHIN A FEW MINUTES. INITIALLY HE STATED HE WAS A LITTLE DIZZY BUT UPON REMOVING HIS HOODIE THAT WENT AWAY. HIS BLOOD PRESSURE WAS NORMAL. HE FELT BETTER IN APPROX 5 MIN AND THE SWEATING STOPPED WITHIN 5 MIN UPON REMOVAL OF EXCESS CLOTHING AND ICE PACKS.

HA, bodyache and chills since he got a J&J 10am this morning. Also having some left side pain without urinary issues or trauma. Has not taken any meds. Denies chest pain, difficult breathing.

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

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

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

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

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

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

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

Sequence of Events re Incident * Patient made his appointment via on- line scheduler * Patient came in, filled out his paperwork, made no mention of previous vaccine issue on paperwork * I performed the usual screening of patient, and when I asked him about any previous reactions to immunizations he stated that he had an ?issue with a TdaP shot 4 years ago and passed out in doctor?s office for several minutes.? He stated the MD told him that ?he had several other issues with the shot so the MD said it was a ?bad batch??. * I made sure that the patient was comfortable about getting the Covid shot and he agreed that he was fine to get it. At that time the patient did not seem overly nervous about receiving the shot. * I administered the shot to the patient and he went directly to the seats next to the pharmacy. I asked him to stay there because he had a past issue with another vaccine. * Approximately 2-3 minutes later, the patient came back, looked troubled and said he didn?t feel well and was feeling the same way as the other shot. I brought him back into the pharmacy immunization room, sat him down and put his head between his knees. I did a quick check on him to be sure he was breathing OK and that there was no apparent allergic reaction. * After a minute I brought his head back up and put patient into regular seated position. At no point did he completely lose consciousness or faint. I asked him at that point if he wanted me to call an ambulance or a family member and he declined. He sat there in the chair for approximately 15 minutes- part of the time his head was in his hands, part of the time looking at his phone. He asked for a glass of water and I got him one (he had completely drank it by the time he left). I kept checking on him and it seemed like every time he saw me check on him he put down his phone and put his head in his hands again. He could have been embarrassed by the situation, unsure though. I tried to make him as comfortable as possible. * After 15-20 minutes I asked him if he wanted me to call someone and he said at that point he wasn?t sure he wanted to drive home so he would call his mother to pick him up, which he did. * I sat down with him for a couple of minutes and explained that this was called a vasovagal response and was quite common (I even empathized with him by explaining that I have the same response when I get blood drawn at the doctor?s office). He seemed to feel a little better after I explained it to him. * His mother came in 15 minutes later and I brought her back as well. She explained the same thing happened at the MD office 4 years ago and that it was the Meningitis shot, not Tdap. I explained to them going forward that it would probably be best to get his immunizations at the doctor?s office so that he could lay down after the shot and they agreed. * He and his mother then walked out of the immunization room and left the building. He left under his own power and without assistance from his mother. I gave him a business card and asked him to call me on Sunday to let me know that he was feeling ok.

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

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).

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

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

PT presents with HA, fever and bodyaches x last night reports receiving JJ vaccine 1000 yesterday. denies taking medication. denies known sick contacts.

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

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

PATIENT REPORTS LIGHTHEADEDNESS, DIAPHORESIS AFTER NEEDLE WAS WITHDRAWN. PATIENT WAS GIVEN A SNACK AND APPLE JUICE

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.

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.

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

Fever, chills, and aches started around 1AM the night of the vaccination. Shortly after coughing, wheezing, shortness of breath, and dizziness began and lasted until about 8AM. It was severe enough that I almost went to the ER. But my rescue inhaler was helping to control the coughing some. This was by far the worst ~8 hours of my life. I have never felt anything like it, and I had Covid earlier this spring and it was not nearly as bad.

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.

Patient had hx of feeling dizzy/passing out following vaccination as indicated on consent form. Patient began feeling dizzy and sweaty after administration, but during counseling. Patient passed out in chair and urinated. Patient was awoken and given water, then requested to wait while a family member could come to pick him up with a change of clothes. Patient felt well enough to leave with father approximately an hour after fainting.

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

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

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.

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

Patient started to not feel well about 2 minutes after injection, asked for water. I grabbed co-worker (my pharmacist as I am a student) and she stayed with him while I called 911. He passed out on here, came back to, EMTs arrived and he again passed out on them so they took him to ambulance on stretcher

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

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.

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.

Felt fatigue for 24 hours after shot - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration.

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.

Pt c/o sore throat, congested/stuffy nose, on/off slight sob while walking not severe not continuous and loss of taste. Pt concerned its due to possible s/e of covid 19 vaccine J&J that he got on 06/09/21 as all these sx started same day and not getting better still. Pt speech clear, comfortable. Also denies emergency sx at this time. Advised to monitor his sx . was scheduled to speak with urgent care provider for consultation.. Notified pt if any emergency sx arises call 911 or go to nearest ED.

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

Day 2 after getting the vaccine I went to the hospital over headache, tinnitus, chest pain and breathing problems. The pain never went away but it slowly got worse over time. 5-6 weeks and I am severely suffering from chest pain and shortness of breath. Airways feels very tight. Went to the doctors and got perscribed prednisone and an inhaler. I've never needed or used an inhaler before. I've never had breathing problems other than nasal congestion during flu season. Neither the prednisone or the inhaler help at all. The prednisone and inhaler do not help the breathing even a tiny bit and this is after using them for all 5 days that they were perscribed. Breathing never feels satisfying. I am constantly breathing deep breaths through the mouth for air but it never feels like I'm getting enough air. Whether it be stress, allergic reactions, or exercise, I have never had breathing problems like this before and I have not done anything else that could have brought these problems on.

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.

PT'S MOM CALLED ON 07/28 AND EXPLAINED PT HAS BEEN HAVING VERTIGO RIGHT AFTER GETTING VACCINE AND IT WORSENS AFTER LYING DOWN. SHE ALSO MENTIONED PT IS GETTING FATIGUE AND BODY ACHES

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

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

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.

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

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

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

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.

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

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

Full Body Chills - 3/15 - 3/16 Lightheadedness - 3/16 Fatigue/Tiredness 3/15 - 3/16 Elevated Heart Rate 3/15 - 3/16 (94 bpm resting avg as opposed to 68 bpm normal resting avg)

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

High fever, body aches, chills, and fatigue all at once. Took two Advil?s which decreased fever and chills. Still have fever, body aches, and fatigue.

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

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

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.

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

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.

Fever and chills starting at 2AM. Got moderately better by 7:30 AM. Called doctor at 9AM. Doctor stated that symptoms are common among all Covid vaccines and symptoms should disappear within 48-72 hours. Suggested taking tylenol, and keeping hydrated.

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

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

Starting around 6 pm I started having aches and chills. At about 11 pm, those chills and aches got more severe and I had a fever of 101 degrees for about two hours.

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.

I experienced tightness in my chest and mild, dull pain for fifteen minutes while I was lying in bed. I also experienced a low-grade fever lasting from approximately 6:00pm on April 3rd to 4:00pm on April 4th.

major pulsating headache, malaise, fatigue, fever like symptoms (increase in temperature) - 1 day injection site soreness - ongoing (2 days)

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

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.

Patient immediately started sweating, turned pale, complaining of dizziness and blurred vision. We observed him for approximately 30 minutes. Sweating stopped; coloring became better and normal vitals were seen before he left.

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

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

J&J COVID-19 Vaccine EUA Soreness and aches (around whole body), fatigue, headache, chills - Currently taking ibuprofen to address symptoms. Woke me up in the middle of the night (3:00 AM) and had considerable difficulty going back to sleep. Headache persists through the day, but aches and chills seem to fluctuate/come in waves. Currently at 24 hours from receiving injection at time of writing this report.

The patient was very anxious and hyperventilating before shot. Sat in car with father and passed out. He was sweaty, pale, but otherwise okay. Patient came to and was given orange juice and squad was called.

Patient reported feeling dizzy, lethargic, shortness of breath Patient seen by medical team, patient has low blood pressure and provided with iv fluid Ambulance called for medical transport to hospital

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

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

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

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.

Chills beginning at 11PM day of vaccination, woke up with a 101.5 fever, throbbing headache around 4am. Began experiencing fatigue around 10am, along with body aches.

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

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.

Patient lost consciousness during the 15 minute waiting period after receiving the vaccine. He was pale and sweating, and lacerated his nose as he fell to the to floor. It appears that he fainted.

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.

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.

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

HEADACHE; FEVER; 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: 202A21A, expiry: not reported) dose was not reported, administered on 07-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from fever. This report was non-serious.

Apart from the expected side effects (headache and chills, some soreness at injection site), I believe I'm experiencing tinnitus or a similar ringing in my ears. It appears to be concentrated in my left ear, although it's hard to tell. There's a consistent high-pitched tone that won't go away. I'm not entirely sure when it started (maybe 24-36 hours after receiving the vaccine), but it's gotten slightly worse since then and is more noticeable. I have not been able to go to the doctor yet.

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

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

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.

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

Seen Emergency Services on 4/15/21 Dr: Diagnosis with Vaccine reaction, initial encounter, near syncope, frontal headache, evaluated for possible vaccine reaction, received J&J vaccine 6 days ago, now headaches and episodes vision blacks out, pt does not have any thrombocytopenia, D- dimer negative, at this time does not feel needs CT of head, if s/s worsening or changes, return for imaging, supportive care at home, discharged home, tylenol or ibuprofen for headaches as needed, return if changes or worsening.

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

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

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

CHILLS; TEMPERATURE; This spontaneous report received from a parent concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included factor v. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and temperature 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.

right after vaccine(April 7): chills, dizziness day after vaccine(April 8):headache, sore throat, chills, shortness of breath, lightheadedness dizziness varying in intensity by day until today(April 9-22):shortness of breath, lightheadedness, dizziness

PAIN IN LEFT TESTICLE; HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 240 pounds, and height was 78 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) .5 ml, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced pain in left testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-APR-2021, and had not recovered from pain in left testicle. This report was non-serious.

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.

Patient presented with significant rigors eight hours following vaccination. Received Acetaminophen, Ketorolac, and Diphenhydramine and was given warm blankets with resolution of symptoms within two hours.

'Pt rec'd vaccine lying down on cot. pt stayed 3 min lying down talking to vaccinator. Pt Sat up on cot for 2 more min, gave water for hydration Pt Alert and orientated. Pt stated "I did better than I thought I would." moved to recovery chair. Pt AAO after sitting another minute stated" I think I need to lie down. " 5:35pm pt started to have syncoble episode. + LOC - SOB. Several people came to pt side. Caught pt to help to floor. pt regained consciousness after 10 sec, with verbal and sternal rub. Mother at side stated" this happens every time he gets a shot. " Pt immediately became pale, diaphoretic, warm and alert. Ice packs to back and front of neck. Elevated feet on chair. Medical MD responded. stated Vasovagal episode occurred. VS taken 5:37 pm 102/60, HR 48 weak, thready, resp 12 reg non labored SpO2 97%. After 15 min sat pt up on floor. Check head for any bumps. denied hitting head and denied any pain. No further episide of syncoble.2nd set VS taken 114/72, HR 78 reg, strong, resps 12 reg non labored. SpO2 97%. Paleness and diaphoresis subsided. pt stated I feel back to normal . Suggested to go to hospital to be checked out. Pt refused hospital. stated this happens all the time. Ok'd to exit after 30 min.

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

PHLEGM WITH BLOOD; COUGH; SORE THROAT; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced sore throat. On 17-APR-2021, the subject experienced phlegm with blood. On 17-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 15-APR-2021, and had not recovered from cough, and phlegm with blood. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

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

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

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

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

Patient 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.

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.

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

Elevated resting heart rate (102 bpm), accompanied by flu-like symptoms (moderate chills, fever, headache, lethargy)

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

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

Extreme fatigue starting around 10pm 4/5/2021 that has not resolved; shortness of breath with mild exertion starting 4/6/2021 that has not resolved.

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

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

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

Patient received shot from our technician and immediately began to lose conciseness. He never fully lost conciseness, but was very pale and began sweating. Patient was moved for the chair to the floor. He was given orange juice and 911 was called by the staff pharmacist. After about 10 - 15 minutes, patient began to return to normal color and sweating had stopped. First response arrived, checked vitals, and patient left with his mother, who was present throughout the event. Patient declined ambulance transport.

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

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

after receiving the vaccine pt felt sweaty and lightheaded and wanted to lay down, so the nurse directed and walked with pt to move him by the privacy area so he can lay there. while walking to the privacy area pt fell on the floor. when i examined the pt his body felt hot at touch and he stated that he was feeling dizzy. after few minutes the pt felt better and after waiting for 20 minutes pt stated he is feeling better again.

Patient reported feeling lightheaded and having a bad headache 45 minutes after receiving the vaccine. The patient was still in the pharmacy.

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

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

Pt. stated he felt a little dizzy and that is the last thing he remembers. Patient passed out and was found on the floor. Denies hitting head. Patient was diaphoretic blood sugar was taken and was 71 . Patient drank juice and ate crackers. Sugar was rechecked and was 101. BP 145/83 HR- 67. Patient was feeling much better and left.

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.