Johnson & Johnson

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later.

Worst chills I?ve ever had during first night. Muscle soreness at injection site. Fever. Fatigue. Slight cough and tight lungs.

Difficulty breathing (short and shallow breathes), vomiting, increased heart rate, nausea, dizziness, numbness in extremities, headache and weakness and tiredness. Symptoms arose approximately 8 hours after vaccination (between midnight and 1 AM, 4/9/21) and persisted until approximately 5 AM, coinciding with sleeplessness. Throughout the entirety of the next day nausea, headache, and weakness persisted. After 36 hours, mostly bedridden, and 12 hours of sleep the following night symptoms have dissipated as of 10 AM 4/10/21.

Janssen COVID-19 Vaccine EUA. When I was going to bed, I had very bad chills, leg cramps, shortness of breath, and a pounding headache. my vision was a little blurry at times too.

I got fever, severe pain in the body from the tip of the head to the toes, without exception. All this for 4 days. In this same period snot and gag, throat felt a bit clogged and I did force myself to breathe the first day. Headache, tiredness, a little diarrhea only for 2 days.

5 MINUTES AFTER GETTING THE VACCINATION, PATIENT FAINTED WHILE SITTING IN THE CHAIR AND WAS GASPING FOR AIR FOR A FEW SECONDS BUT CAME TO RIGHT AWAYS AND SEEMED ALERT. PATIENT REPORTED EXTREME NAUSEA AND WAS SWEATING PROFUSELY. EMS was contacted and patient was taken to the hospital. A lot of tests were ran and it was concluded that patient vasovagled and was released from the hospital.

BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT ARM; This spontaneous report received from a patient concerned a 26 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

15:50pm ?patient was injected Janssen-J&J COVID-19 vaccine to Lt. deltoid muscle ? 25gauge-1? safety syringe used w/o difficulty. Side effects/adverse reactions explained to client, verbal acknowledgement and consent obtained. Written consent signed prior to injection. 16:20pm ? Patient was carried to clinic area by 3 fellow patient. He presented obtunded, grey pallor, face noted to be profusely diaphoretic with gasping attempts at respiration. P-110. Unable to respond to verbal commands, unable to speak or open eyes. Brisk taps to his face and calling his name elicited a slight optic response by visible attempt to open his eyes. At this time, he was observed to grimace, grab his throat and jerk himself upright, proceeded to projectile vomit a moderate amount of clear fluid. Immediately slumped off chair and was limp and non-responsive to commands. EpiPen Auto Inject administered-0.15mg Epinephrine to Lt. anterior quadriceps. Pulse-126, gasping during respiratory attempts. Skin frigid to touch. 16:22pm- B/P-150/101- P-58 per portable wrist B/P monitor. Respirations -22-rapid and shallow, appearing to hyperventilate. He attempted, but unable to follow instructions for calming and deeper breaths at this time. Fellow seamen and the 2nd Officer, carried him to the ship ?hospital? area accompanied by me RN, monitoring continued. Patient responded rapidly to administered Epinephrine. 16:23pm-B/P-148/108-P-68-per monitor-R-20 - Responsive to name, LOC x3, visible muscle twitching and tremors. Remains diaphoretic, pallid, and skin is cold to touch. Speech is slurred and weak, client continues to be lethargic and slow to verbal responses. C/O of ?bad HA?. 16:30pm- two-500mg Paracetamol tablets PO with H20 administered by 2nd Officer for increasing HA pain per patient request. Lights dimmed in room. Clear soup and a coke ordered for patient due to suspected hypoglycemia based on reported pt. hx of limited caloric intake in the past 12 hours. Attempting to locate a glucose meter on ship at this time. 16:38pm ? B/P-139/87-P-69-per monitor-R-20- C/O severe HA and feeling weak. C/O muscles twitching in extremities. Visible twitching noted. Reassurance provided. 16:43pm- B/P-139/87-P-69-R-20 ? Pt. fed clear broth soup and 12oz Coke PO without difficulty. Resting quietly. Appears to be tired, with continued slow responses to questions and weak speech. Pt. continues to be concerned about his exaggerated leg muscle twitching. Reassurance provided and informed of effects of epinephrine. 16:52pm ? B/P-133/86-P-65-per monitor-R-18- Personnel informed of need to transport by EMS to the Hospital for extended monitoring and evaluation by Physician per CDC adverse response to COVID-19 vaccination Protocol. Report given to personnel ? Technical Superintendent- who began transport requests through EMS services. Report to RN Supervisor. 17:07pm- B/P-126/83-P-85 per monitor-R-18- Monitoring pt. at BS. VSS. C/O severe HA and feeling ?weird?. Exhibiting pain with HA despite previous Paracetamol PO by squeezing his head and stating it hurts. Continues to be pale, mucus membranes pale, lower extremity muscle twitching is annoying him. Patient states he is feeling better after receiving food and liquids. OX3. Assisted to BR by fellow patient. Pt. reports urination w/o difficulty. 17:20pm ? Report given to EMS personnel. Transported from ship. Assisted Ambulatory by EMS and fellow personnel to stretcher at gangplank, and into ambulance.

Pt w/o medical hx/drug allergies presents with syncope in observation area s/p J&J injection. Patient stood up with dizziness and loss consciousness with head injury on counter. (Estimated 10 Seconds KO). Upon arousal pt presents tachypnea, pin-point pupils, hand contractions, one episode of vomiting, loss of memory. Orientated to name/dob although does not know location or recollection of receiving vaccine. EMS called responding to seen. Initial VS: BP: 86/55, O2: 96%, HR 81. Paramedics responding on scene EKG/BS checked patient taken to . Pt stabilized and transported with AMR paramedics to .

Day of-Within 5 minutes I went unconscious. I was sweating profusely and my vision began blurring I could feel my heart rate and had haggard breathing. After I came by to I had extreme light sensitivity and nausea. After 1 week-Still experience fever, chills, muscle ache, headaches, nausea, fatigue, winded easily, and hot flashes. 2 weeks- Still experience excessive fatigue, nausea, hot flashes, persistent mild to moderate headaches with occasional overwhelming migraine, light-headed, dizzy, loss of coordination and balance. 3 weeks-Same as 2 weeks out.

Fatigue, chills, slight fever headache- within first 24 hours Nodule felt on right temple area- 8 days after vaccine Headaches on both temples- 8 days after vaccine Slight blurry vision left eye- 1-2 weeks after vaccine Headaches left temple- 2-4 weeks after vaccine Left sided chest pain with difficulty taking deep breath lasting 2-3 days- 3 weeks after vaccine

7/9/21 only - Sharp excruciating neck and back muscle pain requiring pain medication (one dose of Aleve) Onset within 48 hours (beginning 7/10/21): Hives Itching Diarrhea Respiratory/chest pain Difficulty breathing/chest tightness Dizziness/lightheadedness Anxiety attacks High blood pressure As of 7/17/21 I presented to the emergency room 3 times with acute anxiety from difficulty breathing. Per doctors recommendation, began taking maximum dose of over-the-counter Benadryl, symptoms did not subside. On my 3rd trip to the Emergency Room I was prescribed Prednisone (40mg daily) and continue taking 75-100mg Benadryl daily when symptoms worsen to manage the discomfort and sleep.

-Muscles Spasms (lasted about 15 minutes) -Fever -Chills (including chattering teeth) -Diarrhea -Vomiting -Sore Throat -Headache -Fatigue -Stomachache -Loss of appetite -Shortness of breath

Chest pains and shortness of breath started within an hour from vaccination. 3 hours after shot dizziness and chills began. The following day symptoms progressed and lasted all day. Severe dizziness, blurred vision, muscle aches, headaches, chills , shortness of breath, chest pains, sore throat, cough, fatigue, fever(up to 102.5).

Apart from headaches and general nausea I began to shake uncontrollably around 5pm which lasted about 15 min. Then later in the evening it happened again but this time it was hard to breathe because everything in my body was so tight. This lasted until I got into the shower with the temperature set as hot as I could.

Difficulty breathing. Fatigue. Intense pain all over. Fever. Extreme chills. Involuntary shaking. Headache. Dizziness. Lose of strength. Loss of appetite.

After the initial 15 min wait period I was feeling fine, so i left the pharmacy. About 5-10 min later my heart rate became very fast very quickly and it became more difficult to breathe. I was driving home at the time, had to pull over and wait a few minutes until the event subsided. I debated contacting medical help, but i began recovering and was able to continue driving. Since the event i have been feeling slightly fatigued and i have a slight feverish feeling, but in general have been able to rest and have not had a repeat occurrence. I received no medical attention or treatment.

Around 6 pm the same day I received the J&J shot I started to feel chilly and a little nausea. I went for a walk for about 40 mins started to feel worse. I had body aches throughout my back and chest and in both arms, was freezing. Tried to eat dinner but couldn?t, too much pain and increased nausea. Tried to lay down, but began having a fast heartbeat and fast/some difficulty breathing. The pain in my chest was the worst pain I?ve ever felt. Continued feeling horrible with a fever of 100.7, nausea, headache pains throughout chest back and arms, freezing, and my arms and legs felt like they were becoming numb. Could not stand, very dizzy, tried to sleep through it. I threw up around 11 and did so a couple more times after that. Was finally able to sleep and woke up feeling much better. Arm is still sore at the injection point.

04/08 15min after injection, got breath difficulty that lasts for 1hr 04/09 Intense fatigue, muscle ache and dizziness whole day 04/10 Symptoms cease to exist 04/12 Early in the morning: Left arm and hand numbness with ache , head numbness; Noon: getting better; Evening: left leg and feet numbness, face and head numbness; Night: head numbness and nausea, left arm and hand numbness 04/13 Head numbness, left arm and hand numbness, left leg numbness

Presented with 27 YO male, seated in a chair S/P receiving Johnson and Johnson COVID-19 vaccine. PT started to feel dizzy and started to become diaphoretic. PT does not speak English, upon translator?s arrival they advised this writer that PT was feeling dizzy, and short of breath. PT visibly diaphoretic and his skin color changing from normal to pale. PT pulse weak and thready, and PT hypotensive at 76/P. PT administered 50mg of Benadryl IM in his right deltoid, successful. PT pulse no longer palpable in the radial so PT placed in a supine position on the floor and PT legs elevated to a Trendelenburg position for his hypotension. PT administered 1mg Epinephrine 1:1,000 IM in the left deltoid, successful. Ambulance called for transport of the PT to the nearest hospital. PT blood pressure slowly starting to stabilize at 90/56. PT SPO2 reading 98% on room air with respirations 18 and regular with clear lung sounds. PT no longer having Shortness of breath or dizziness. PT no longer sweating and he is beginning to stabilize. Radial pulse palpable again and strong and regular at a rate of 76 bpm. PT blood pressure reading 110/76. Upon fire department arrival determined that the PT was stable enough to sit upright in the chair again. PT was assisted off the floor and to a seated position in a chair. PT vitals after seated position for 5-7 min, BP 120/82, pulse 86 strong and regular, RR 20 and clear equal bilateral lung sounds. PT has no other complaints at this time. PT has no allergies to medication, PT has a pollen allergy that he takes over the counter allergy medicines for. PT has no past medical history. Upon arrival of ambulance PT care relinquished to EMS with full report, PT care relinquished without incident or injury.

Severe headache, shortness of breath, stomach ache, diarrhea, minor leg pain, moderate all-body soreness. Symptoms have abated except for headache and shortness of breath. These have only reduced in severity.

Fever temp reaching height of 102.2F, extreme light headedness/mild vertigo, incredibly high heart rate, quickened breathing (no shortness of breath), body temp of extremities quickly changing, strong shivering, nausea. Mostly more severe instances of known side affects/symptoms.

Chest pain began ~8 hours after receiving vaccine. Pain increased over next week, present in waves with no noticeable cause. Aggravated by deep breaths. Diagnosed as likely pericarditis, supported by symptoms and EKG with elevated STs. Began treatment of 800mg Ibuprofen daily. Currently 15 days after vaccine, still showing symptoms after 3 days of treatment.

Patient felt nausea and could not breath so he stood up and took a breath. When he stood up he lost consciousness and fell. Patient hit his fore head and started having a seizure. The seizure lasted about 1-2 minutes before he regained consciousness. Patient was taken away by the EMS

After like two weeks, before going to bed, I started having SOB and then a full-on chaotic panic attack. Chest pain, stomach was visually twisted and hurt, felt like I had a knot in my throat and full on anxiety. It took about a week for it to start going away after one Urgent Care visit, two ER visits, and a PC visit who prescribed me with clonazepan and Prozac. When I took both of them two weeks later, my symptoms and pain finally got better, but I am still having SOB, a little fatigue, my joints hurt once in a while, digestive problems, weird chest feeling. At least the heart pains went away.

had an allergic reaction - resulted in severe swelling in area around right arm/abdomen - caused difficulty breathing - symptoms were improved by use of benadryl / ibuprofen / tylenol

Patient called pharmacy on 07/06/2021 around 550 pm to report that he is experiencing side effects from the Janssen shot he recieved on 07/03/2021. He said he started to experience side effects the following day after shot (7/4/2021 - specific time unknown) and they have not improved. He said he is experiencing muscle pain and muscle spasms in his neck, back and arms. Also experiencing shortness of breath, nausea and chest pain. I instructed patient to seek immediate medical care. He said he was going to go to ER.

Patient complained of throat tightness and dry mouth, pale. Heart rate- 88 Respirations-30. Epi given, Benedryl given 50 mg PO. Instructed CO's to watch patient closer with 5 min checks X 3 hours. Patient stated signs and symptoms had improved and vital signs stable.

About 40 mins after I felt my throat closing and felt like I couldn't breathe. Since then I have had several other instances of feeling similar (though none of them went to full anaphylaxis. I went to the ER Saturday and my PCP today, still for shortness of breath.

chest pain. Chest Pain since 0900, started while at rest, radiating across chest lasting a couple minutes, describes as aching, deep breath makes it worse, reports feeling warm; reports CP at this time; alleve taken around 0915.

Employee came at 1:30 to get vaccinated. Three to five minutes after administering the Johnson & Johnson vaccine, I asked the patient if he is feeling ok because he seemed nervous and sweaty. He responnded "yes, but I have a mental anxiety from vaccines, needls, doctors". one minute later he started complaining of pain in his left arm and feeling weak. . He then asked to sit on the floor and said that he can hardly breath, and lost vision. I administered Epipen injection to his left thigh while the store director was calling 911. He then complained about not being able to move his hand fingers. The ambulance came and took him to the ER. later in the day, his manager said that he spoke to hid family and they told him that he has been having anxiety from doctors, needls, and shots ever since he was little. He is feeling better now and the hospital will keep him for tomorrow.

Initial symptoms included fatigue, chills, fever, mild aches (quad, hip flexor), and mild headache. Required additional clothing due to chills without improved symptoms. Fever progressed to highest at 104 degrees. Required additional effort for moving in bed and short household distances. Progressed to extreme fatigue, mild nausea, and extreme dyspnea ("very deliberate breathing" "I felt like if I didn't concentrate on my breathing I would just stop breathing"). Noticed increased restlessness and increased discomfort. Took 400 mg ibuprofen and after ~30 minutes there was a gradual decrease in symptoms, particularly fever and dyspnea. Symptoms resolved after taking ibuprofen. 24 hours following initial symptoms onset, noted to have fever (101 degrees), achiness return, face was flush, and transient chills/sweats.

I (the patient) experienced severe symptoms about 10 hours after receiving the vaccine. The serious symptoms lasted for 24 hours after receiving the vaccine: Serious Symptoms: -Intense Chills/Hot flashes -Rapid heart rate (90bpm) -Difficulty breathing -Joint and muscle pain -Headache -Nausea/Diarhea -Dizziness -Unable to sleep Moderate symptoms lasted for 48hrs after receiving the vaccine: -headache -Muscle and Joint pain -Chills

Headache, fever 104 degrees, body and joint aches & pain. Nausea, Chills, diarrhea, painful urination, throat swelling, light touching of torso is very painful.

Extreme fever 6 hours following the shot. Fatigue lasted roughly 48 hours. Then Sunday 4/11, 5 days after receiving the shot, I've experienced shortness of breath. It felt like someone was sitting on my chest. This restriction has loosened since but still causes discomfort.

RAPID HEART RATE FOR 6-8HRS; DIFFICULTY BREATHING; HOT FLASHES; MUSCLE AND JOINT PAIN; UNABLE TO SLEEP; DIZZINESS; DIARRHEA; INTENSE CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 28 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced rapid heart rate for 6-8hrs. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced muscle and joint pain. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced dizziness. On 2021, the subject experienced diarrhea. On 2021, the subject experienced intense chills. On 2021, the subject experienced nausea. On 2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 90bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate for 6-8hrs, difficulty breathing, hot flashes, muscle and joint pain, unable to sleep, dizziness, diarrhea, intense chills, nausea, and headache on 2021. This report was non-serious.

Patient returned to site 30 mins after observation as he felt short of breath, difficulty swallowing and dry throat. Patient was evaluated by RN and EMS. No swelling noted. Vital signs obtained. Patient hydrated and was closely monitored. Patient was also evaluated by PA and PA. Patient was then had some complaints of left arm tingling. Patient provided with water to hydrate. Patient felt better after 30 mins. Patient instructed to contact PCP if any worsens Symptoms or if any medical emergency to call 911 or to ER. Patient also advised to report any symptoms using the VAERs online on card.

Systemic: Throat felt itchy, but he never had any swelling.-Medium, Systemic: Shakiness-Mild, Additional Details: Pt waited 15 minutes, left. Then felt throat tingling and tightness on his drive home. Came back to the pharmacy, drank some water, we opted to give him loratadine instead of benadryl since he had a 2+ hour back home. He stayed in the pharmacy for another hour and was able to drink water and eat a snack with no issues and wanted to continue on his trek home. He called us when he arrived home and was feeling fine.

A few hours after vaccination the fever started and muscle aches/chills also began. Around 10:00 P.M., pain in the right calf started and light pain in the left side of the chest with shortness of breath. Patient went to the ER and was hospitalized for 1 day.

Patient fainted after vaccine. and felt numbness in cheeks. 911 was called. Patient came to in 45-60 seconds and no longer complained of any breathing issues or of feeling faint. Vitals were WNL. 911 was cancelled and patient was advised to see primary physcian for follow up.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium

Pt reported "pins and needles" in chest and veins, itching, nausea, and feeling hot. Administered 20 mL of 12.5mg diphenhydramine 15-20 minutes post-admin. Pt reported he continued to feel worse, then vomited 5-10 minutes after administration of diphenhydramine. Checked BP after pt vomited, 160/100. He reports that his BP is usually not high. Advised for HR representative to call EMS. Update from HR representative states that pt reported swelling of throat upon arrival to hospital, but appears to be "settling down".

Severe shortness of breath during activities such as walking up or down stairs flat land long distance. Take a while to get my breath back. Inhaler don?t even help. Never experienced any of these issues until after the vaccine.

Patient reported sudden vision impairment, started palpating and had profuse sweating with shortness of breath; patient was administered one dose of Epipen; 911 initiated per protocol. By the time ambulance arrived, patient was already feeling better; for safety and evaluation , they took him to emergency.

Shortness of breath, chest tightness, pain in shoulder, neck, and lower back. Symptoms started on 6/22/2021. Went to ER on 6/24/2021. Diagnosed with pulmonary embolism (multiple clot in left lung). Labs and imagining done, now on medication.

vasovagal syncope or seizure? After receiving the drive-through vaccine, we drove into a parking space to sit and make sure I was ok. Within 5-10 minutes, I was sitting in the car and sending a text and with no warning whatsoever mid-text lost consciousness, profuse sweating, wheezing, lost color in my skin, was making unintelligible noises, and eventually woke up about a minute later but couldn't speak or comprehend those speaking to me (according to my wife who was terrified). I was not nervous, stressed, or scared of receiving a vaccine. I regained the ability to speak about a minute later and my wife had summoned the staff on the scene who instructed me to lie back and breathe without a mask. I drank some liquids. A nurse was called over and offered to take my vital signs but I decided I felt ok enough not to. Eventually my normal skin color and came back and sweating stopped after about 5 minutes. We sat for a few extra minutes and once I felt it was past me, my wife drove us home.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body. Patient was dizziness. He received an epinephrine shot in which he then layed on the floor and started calming down. Paramedics came and checked him out and found him to be alert and well. Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction.

At 9pm (3-13) I began feeling sore and cold with some shivering. Couldn't get warm in bed, continued to shake harder. Slept until 11:15pm and woke up to violent shivering, pounding headache, full body aches, sore skin, achey joints, nausea, swelling tongue and throat. Took 1 dose of nyquil and then tossed and turned all night, very little sleep, symptoms persisted into the next day, but shivering stopped in the night. By morning (3-14) registered a fever of 100.3 which persisted most of the day along with remaining lessening symptoms. By evening I was still very sore, bad headache, and very lethargic/fatigued. Next morning (3-15) low temp of 97.1 degrees, headache, fatigue, lightheaded. Still feel headachy and tired.

Monitored for 30 minutes after injection, no symptoms, released back to housing (cell). Approximately one hour later, presented to Health Care Unit with c/o itching, nasal congestion, watery eyes, lightheadedness, nausea, "hard time breathing". Very anxious. Administered 50 mg Benadryl IM without any relief. Patient was sent to local emergency department as precaution. Given epi SQ and additional Benadryl in the emergency department

Have had some chest pain for a few days and different breathing. Doesn?t feel like my normal breathing just feels more restrictive than normal.

I had extreme chest pain on the 24th of March. It really hurt to breathe and it felt like I had pressure on my chest. I went to the Emergency room and they did a chest x-ray and a Covid-19 both of which were negative. I went home and I returned to the ER because the chest pain became worse. The chest X-Ray the second day showed I had pneumonia. I was told that it could have been from the Covid-19 in December or if was community acquired. I was prescribed with antibiotics and discharged. I still feel some chest pain after about a week and I have already finished the full course of antibiotics. I've seen my Primary Care physician, my cardiologist and my Pulmonologist.

SLIGHT DIFFICULTY IN BREATHING; DRY COUGH; CHEST TIGHTNESS; ALMOST UNRESPONSIVE AT DINNER TABLE; HIGH LEVEL OF FATIGUE AND SLEPT ALL DAY; NAUSEA; HEADACHE; SLIGHT NUMBNESS TO FACE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery to left foot at late adolescent, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight numbness to face. On 30-MAR-2021, the subject experienced slight difficulty in breathing. On 30-MAR-2021, the subject experienced dry cough. On 30-MAR-2021, the subject experienced chest tightness. On 30-MAR-2021, the subject experienced almost unresponsive at dinner table. On 30-MAR-2021, the subject experienced high level of fatigue and slept all day. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from high level of fatigue and slept all day, dry cough, nausea, headache, chest tightness, slight difficulty in breathing, and almost unresponsive at dinner table, and the outcome of slight numbness to face was not reported. 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.

Presented with 28 YO male, seated in a chair S/P receiving the Johnson and Johnson COVID-19 vaccine. PT states he was feeling dizzy with shortness of breath. PT was given a bottle of water by RN for hydration. PT skin color starting to change from normal to a pale and PT started to become diaphoretic. Ambulance notified for transport to the closest facility. PT pulse 70 and strong and regular, BP 100/60 and respirations 20 strong and regular. PT denies any medical history or allergies at this time. No other interventions performed with PT due to ambulance arrival and PT care relinquished to EMS with full report, PT care relinquished without incident or injury.

Complete body/muscle lock up - Was rendered useless on hallway floor for 15 minutes while my body locked up with muscle spasms Extreme Migraine morning after - Continues to be an issue as the days go on - Not getting worse, but each day is a headache Extreme Muscle pain from left collar bone area to the left ear Minor/Medium pain behind my eyes every so often Shortness of breath at times with no strenuous activity prior

29yom with no significant medical history was diagnosed by CT with acute pulmonary embolism involving the branch vessel in the right lower lobe 14 days after receiving Johnson & Johnson vaccine. Symptoms of right pleuritic pain began 4 days prior to the diagnosis. Initiated therapy on oral anticoagulants.

I started having constant headache with slight breathlessness 5 days later. The breathlessness is better now but the headache is still there on the 8th day after vaccination.

SHORTNESS OF BREATH; EYES BURNING; EXTREME FATIGUE; HEADACHE (PRESSURE IN FOREHEAD) FOR THREE DAYS; TROUBLE LOOKING AT THINGS FOR A LONG TIME/PATIENT COULD NOT OPEN HIS EYES; This spontaneous report received from a patient concerned a 29 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-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 trouble looking at things for a long time/subject could not open his eyes. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced eyes burning. On 07-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced headache (pressure in forehead) for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes burning on APR-2021, had not recovered from extreme fatigue, shortness of breath, and headache (pressure in forehead) for three days, and the outcome of trouble looking at things for a long time/patient could not open his eyes was not reported. This report was non-serious.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe

I got the vaccine at 2pm. At 12am when I was asleep, I woke up shaking, crying, screaming, I couldn't breathe, I was very cold and hot at the same time. I was sweating too much. My wife at home tried to calm down, I took my blood pressure and it was 170-160. As a result of this we went to the hospital where they admitted me for more than 4 hours, while they controlled my tension and fever. The next day a large swelling appeared under my left arm, a gland or I don't know what it will be, but it is a very large swelling

Patient received vaccine at around 11am. After waiting around for a few minutes he stated he was light headed. I went over to observe and gave patient some water. He was starting to sweat and turned very pale. 1 minute later he passed out. I brought him to the floor from his chair and he starting shaking and 'seizing" for about 10-15 seconds. We used pressure on his chest to try to "snap" him out of it. After about 15 seconds of "seizing,not breathing normally and his left arm completely locked up" he came to and did not know where he was for about 2-3 minutes. After about that time he started to realize where he was and recognized his wife who was assisting. EMS was called and arrived shortly, He was lucid and knew where he was and started to feel normal again. EMS checked his vitals and they were normal. Patient refused to go to hospital and EMS released him to his wife. I checked on patient 4 hours later and he had no ill effects and stated he felt just like he did before receiving the vaccination.

Patient developed intermittent right-sided pleuritic chest pain about 10 days following vaccination as well as lower leg pain. Patient started taking aspirin and stopped smoking and pain in leg resolved but still had intermittent chest pain. Last couple weeks patient stopped taking aspirin and started smoking again and 2 days ago noticed an increase in pleuritic chest pain that brought him to the emergency department.

LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.

Fever to 101F for about 15 hours, site pain for about 24 hours, headache for about 15 hours, shortness of breath ongoing, took 400mg ibuprofen every four hours

1:22 AM: chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance 4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER. Patient received 500cc NS bolus IV. Labs findings unremarkable. INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging with Dx: reaction to COVID vaccine.

Joints began feeling achy and body felt tired within a few hours of vaccination. About 10 hours later body began to feel warm and then within an hour began uncontrollable shivers and aching in testicles followed shortly after by a throbbing headache and pain behind eyeballs. I put on extra clothing and jumped into bed as symptoms persisted. Later in the night I began sweating profusely and removed the clothing. The headache and pain behind the eyes persisted. I also began feeling nauseous and almost vomited when I went to the bathroom. My body was so tired and achy I could barely move. I tried to wake up for work but my headache and pain behind the eyes was so bad I went back to bed for another four hours. I did not have any appetite for the rest of the day. My headache subsided that afternoon and I went for a walk that night and my body still felt incredibly tired and achy. The pain behind my eyes persisted. The following day I felt somewhat better and could work. That night I went for a jog and my body felt extremely heavy, my joints ached, and I could not catch my breath. My symptoms continued to improve but I have had no sex drive for a week.

Patient was feeling faint, had shallow breath, headache, and nausea. Patient was given a snack (at 10:51) and patient started feeling less sick and headache was gone by 10:56. Patient was given water (at 10:58) and started to feel more alert.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: pt's blood pressure 77/43, threw up

Patient complained of right lower leg pain with shortness of breath and headache starting on 04/12. He was seen in the medical office for complaints along with malaise, fatigue and muscle pain. Patient was diagnosed with acute vital syndrome

Patient c/o dizziness, palpitations, SOB. VS within normal limits blood pressure 100/60, pulse 71, 97-99% Oxygen saturation. Diaphoretic, responsive with GCS 15. Denies existing health conditions, medications, or allergies. Given 1 bottle of water. Patient asked to walk with nurse. After walking 15-20 feet, patient said "whoa" and nurse grabbed patient and lowered him to the ground. Patient was placed supine and bag placed behind his head. Nurse unable to palpate carotid pulse and patient completely unresponsive. Nurse instructed to call 911 at this time. Patient positioned for CPR and opened his eyes. Stated "I fell asleep while I was walking." Patient instructed to lie still and informed 911 had been called. At this time, RN positioned patient's legs upward to increase blood flow to chest and head. This nurse repeated blood pressure at this time 96/62. Nurse obtained heartrate 71-75 and oxygen saturation 98%. Denied pain. Stated he used a push mower in his yard this morning. Patient diaphoretic and chilled. Assisted into seated position to drink orange sports drink and a second bottle of water. Upon EMS arrival approximately 4 minutes after call, paramedics examined patient and took over his care. They measured a blood glucose level of 134. Nurses assisted patient into ambulance for paramedics to run an EKG. Patient later returned to his personal vehicle and remained on site for about an hour. He called his brother-in-law to assist him home. Nurses on site checked on patient every 10-15 minutes until his family member arrived.

I received the vaccine on Wednesday, April 7th. I was told I had an anaphylactic reaction at the time of injection: I started sweating upon receiving the vaccine, my blood pressure dropped, and I almost passed out. I was monitored for 30 mins before being sent home. Other than some fatigue, I was fine the rest of the day. On Thursday, April 8th, I was tired but felt fine otherwise. Friday and Saturday, April 9th and 10th, I felt like I was back to normal and even did some light exercise. On Sunday morning, April 10th, the left side of my body (side of injection) went numb, I had extreme vertigo, shortness of breath, and blotches that appeared in random places. It didn't look like hives, but rather looked like strips of red. I didn't feel like I was having an allergic reaction, but something did not feel right. I consider myself a pretty healthy guy with a healthy lifestyle. I did not feel the need to go to the ER quite yet, but I did have a friend come over to monitor me. My friend did some acupuncture which helped resolve the numbness and dizziness and some of the blotches, and also mentioned concerns regarding blood circulation and potential clotting issues she thought I was having.

Fever for 2 days and I?m having fatigue feeling everyday till my vaccine date sometimes little shortness of breath. Have leg pain. These feelings and pains occur different days. Just took Tylenol no other medicines so far.

the next morning (4/9/21) i had a very bad headache and my lower bad hurt so bad i could barely move, extremely tired. slept most of the day. this continued until Monday. Monday my back was better and headache was better but very tired. Starting Monday night and continuing currently my chest has a sharp pain and i lose my breathe very quickly doing any kind of strenuous activity. Headache and fatigue have continued since then also.

Patient reported having abdominal pain and shortness of breathe for two days. Patient was assessed over the phone by P.A. and it was recommended for patient to call 911 or go to the nearest emergency room to be assessed further. Patient refused to go to ER on 4/20/21 patient verbalized that he would go on 4/21/2021.

FEVER; WEAKNESS; DIZZINESS; DIFFICULTY BREATHING; VOMITING; HEART RATE INCREASED; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included renal insufficiency. 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 14-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm at approx 13:45 -14:15. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced heart rate increased. On 15-MAR-2021 04:30, the subject experienced dizziness. On 15-MAR-2021 04:30, the subject experienced weakness. On 15-MAR-2021 04:30, the subject experienced difficulty breathing. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. 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, weakness, difficulty breathing, vomiting, and heart rate increased. This report was non-serious.

Body aches, joint pain, sore throat, fever, vomiting diarrhea, chest pain, starting several days before admission. Possible acute myopericarditis

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe

At approximately 7:15 pm on 5/7/21 administered a COVID19 (Janssen) vaccine to the patient. Immediately the patient began to complain of feeling "sick" and slumping forward in chair. immediately lowered patient to the ground and placed in a supine position. Called 911 and waited outside for EMS to arrive. Patient remained conscious and pulse was noted as strong but breathing was shallow and rapid. Pt was encouraged to focus on breathing but began to complain of muscle tightness in the hands and back. at approximately 7:25 EMS arrived and were able to calm patient using breathing exercises. EMS attributed the incident to an panic disorder which was reported to have occurred once before approximately 10 years prior when receiving a flu vaccine. The patient denied ambulatory care to the hospital for further evaluation.

The night/next morning after receiving the vaccine I was awoken by a racing heart rate that I measured at a resting heart rate of 200 bpm. After 5 minutes of trying to assess what was happening, I recognized that my heart rate was not slowing down. I woke my wife because I was worried and had difficulty breathing. It continued to be in the 180-190's, I called an ambulance. On the way to the hospital my resting heart rate was 180. After I got to the hospital they ran blood work, a CT scan and a chest x-ray. I was in the hospital until 10 am. My heart rate steadily fell to about 110 beats per minute after 9 hours in the hospital. They released me because my tests had come back normal. Upon being released, I came home, had lots of fluids and rest. After 1 week, my heart rate went back up to 160's. My chest started to feel tight again and I had difficulty breathing again. I called my PCP emergency number and they advised me to go back to the ER at 10 am on 05/15/2021. They did another EKG, a D-Dimer and I received saline. My heart rate dropped to 120 and they released me. I was given an all clear from all tests performed. Sunday-Wed that week, I had a slightly elevated resting heart rate, have had difficulty getting a full breath, general stomach pains and I had felt fatigued. Thurs-Sat, my resting heart rate returned to normal (60 bpm) minimal difficulty breathing, but continued pressure in my abdomen and chest. Saturday I fell asleep because I was having a migraine. I woke up at 10 pm and the cycle started again. My heart rate went back up into the 160's. I called the emergency line for my PCP and was told to go back to the ER (05/22/2021). They performed a chest x-ray, an EKG and some blood work. My resting heart rate went to 90 bpm around 3 am and was sent back home. The rest of Sunday, I had difficulty getting a full breath and my resting heart was higher than usual. I had an echocardiogram on Wednesday and it came back normal. I wore a heart monitor for 24 hours, but I have not received the results yet from my doctor. I have never experienced any sort of cardiac episode in my life.

urticarial rash w/ dermatographia, chest pain, SOB. started about 8 days after shot improving on steroids ECG abnormal w/ neg troponins x2. CTA of chest neg for clot or pneumonia was recently started on Buspar and wellbutrin 4 days prior to getting vaccine

1140 Medical Technologist from HCF calling to report that a patient who received the J&J covid vaccine in March now tests positive for Covid 19. Patient started having a cough and shortness of breath on June 1st. Arrived at the hospital June 4th. Diagnosis : Covid pneumonia. Patient is improving on 3 liters of oxygen via nasal cannula. Meds: albuteral, decadron, apap , zofran, Remdesivir . Patient has history of being overweight , diabetic , and hypertensive.

Body aches/soreness, migraine, shortness of breath. Patient felt like he had COVID again for 12hrs (he had COVID previously, and all the symptoms from the vaccine were the same).

About 12 days following vaccination, patient developed chest pain and shortness of breath. He went to the ED and was found to have multiple bilateral pulmonary emboli with signs of right heart strain. It is not clear if the vaccine was the cause of the embolism, but there are no other provoking factors that could be identified. He has been started on anticoagulants with improvement in symptoms, but he has persistent dyspnea with exertion.

I had a cough and congestion in my lungs. An ongoing cough and an ongoing congestion for a few weeks. I noticed the cough and congestion on 06/07/2021. I still have it now, it's just lingering, and it's not as severe as it was.

Woke up March 9th and had trouble breathing. Fell well short of getting full breaths, chest hurt. Took aspirin and slept for 6 hours. Felt about the same through the evening. Next day, still having trouble getting full breaths but less pain.

a 31 year old man who received the COVID-19 vaccine on March 27, 2021 in the Public Health Department parking lot. Upon arrival and check in, the patient declined any comorbidities and health history but did state that he was nervous. After administration of the vaccine by NP, the patient lowered himself to the ground, from a sitting position, and had a 60 second tonic clonic seizure. Seizure precautions such as turning the patient on his side, supporting his head, and calling EMS were taken during the seizure. After 60 seconds, the patient came to and asked what happened. PPHD staff oriented the patient to what had happened, to which he proceeded to say ?oh that is normal for me when I get anxious.? With the help of PPHD staff and his wife, the patient was brought to a sitting position and given a granola bar and water to his request. According to clinic lead RN, ?his skin was normal in appearance for race, ethnicity, and age. He was mildly diaphoretic. He verbalized feelings of anxiety and worry surrounding the vaccine.? As EMS arrived on the scene and began assessing vital signs the patients anxiety appeared to increase; he became less verbal, closed his eyes, and his breathing pattern became shallow. The patient then had a second seizure at this time lasting approximately 25 seconds. When the patient came to he immediately verbalized, ?I?m good, I?m good, I?m fine?. He was slow to respond to verbal cues, but persistently refused transport to the local acute care hospital for further evaluation. He rested on the ground in supine position for approximately 25 minutes, with his partner and EMS at his side. Upon further evaluation of the patient and his wife, it was determined that the patient has a history of seizure activities when he is nervous and that he was ?expecting? this to happen. The patient continued to decline medical care and transportation to the hospital. The patient left in medically stable condition with his wife operating the vehicle.

achiness and fatigue followed by chest pain/pressure and extreme shortness of breath. Pt also experiencing urinary retention and pain when urinating

10 after I received the Janssen Covid-19 vaccine, I admitted myself to the emergency room with severe chest pain and very difficult time breathing. They ran CT scans and found multiple blood clots in both lungs, pulmonary embolism. They put me on blood thinners and transferred me to another hospital. There they monitored me for a couple days and released me with a prescription for blood thinners.

9 hours after receiving the vaccine, around 5:00 PM on 3/21/2021, I experienced a fever, nausea, headache, soreness in muscles/joints, and chills. The next morning, these symptoms had all gone away. A couple of days after the vaccination, I believe on 3/23/2021, I began experiencing unexplained back pain and shortness of breath. This pain was severe at time and I still have a dull pain in my back as of today, 4/15/2021.

Received shot on Wednesday, woke up on Saturday with chest pain when taking deep breaths. Continued to be in pain for most of the day while breathing

My wife and I were driving home and while I was driving I started experiencing a pain in my chest and started experiencing a shortness of breath. We pulled of the freeway and I walked around for a few minutes trying to catch my breath but I was unable to. My wife started to drive and I as I sat in the passenger seat I started getting the chills and all the muscles in my body were shaking. When we got to town I told my wife we needed to go to the ER because I was not feeling well. That is where they did some tests and hooked me up to an IV.

The afternoon after I got the shot I went for a jog. When I returned, I got intense chills and a fever of 103 degrees along with some flu like symptoms. I had a slight headache. Ibuprofen helped but the next day I had similar symptoms, but they went away by the end of the day. On the third day I felt a little better, so I went for a run. I had some shortness of breath and it was difficult to breathe when I was running. I normally run 4 miles daily. The shortness of breath was present for a week after that and also started to happen intermittently even at rest. One week after the shot I saw a doctor and they did some testing but did not find anything definitive. Six weeks after the shot I went to the ER and they diagnosed with Thrombocytopenia. At this point it has been seven weeks the shortness of breath has improved, and I haven't experienced it for a few days.

Pt called call center reported taken J&J on 04/08/21. C/o SOB and Palpitation. Advised pt to go to nearest ED, pt agreed and verbalized understanding.

Patient received COVID 19 vaccine through work at the company in the location on 05/05/2021. 14:45. Said he didn't feel "right" immediately. Waited the 15 minutes without sxs of allergic reaction and went home. On arrival home felt dizzy and laid down. Had initial ED visit that night and again on morning of 05/09/2021. Full body hives, itching, facial swelling, throat swelling.

I began having strange heart palpitations in the late afternoon, 5 days after receiving the vaccine. On the morning of the 6th day, I had an elevated heart rate, chest tightness and shortness of breath. It was difficult to have a conversation without having to constantly stop to take a deep breath, to ?catch up.? My lungs felt like they had substantially less capacity with a deep breath than before the symptoms presented. I had extreme fatigue, joint and muscle pain. On the 7th day, I woke up with the same symptoms, and decided to go back to bed due to continues extreme fatigue. After waking up, I felt somewhat better, until later in the evening, when all the aforementioned symptoms came back. The following morning (8th day) I felt much better, and decided to go on a mountain bike ride to see how my heart and breathing felt. I noticed some decreased cardiovascular performance, but not as bad as the previous days. Later that evening, the shortness of breath and elevated heart rate came back. On the 9th day, the elevated heart rate was noticeably better, and the shortness of breath was still present, but not as bad as before. My blood pressure remained elevated and I have been unable to get it below 135/80 range. Same issues on the 10th day. Today, on the 11th day, I attempted to go run and found that my cardiovascular conditioning was the worst I have ever experienced in my life, without exaggeration. I had difficulty with a pace and duration that I would normally complete with ease before being vaccinated. I had to cut it short, as I was having difficulty breathing and my lungs were burning. I hope that these symptoms subside and are not permanent. I was hesitant to get the vaccine for a very long time, but decided to do it based of off removal of the mask mandates for vaccinated personnel. If I could go back knowing I would feel this way, I would never have allowed this vaccine to be injected in my body. I am a healthy, athletic 31 year old male, and now I feel like I am in the worst shape of my life. I feel awful.

I got my Covid vaccine on Wednesday, 5/5/21. That night I experienced the typical side effects (Chills, Aches, Pains, Soreness in the injection site on my right arm). By Thursday afternoon I was feeling significantly better. However, on Friday evening I started to feel a tightness and pressure in my chest and left arm and neck. The chest pain felt like I was having a heart attack but my heart rate was mostly normal. I felt shortness of breath where I couldn't get a good deep breath in and I was also nauseous and had no appetite. At times I felt lightheaded and weak. These symptoms continued over the next couple days. On Monday 5/10/21 I decided to got to the ER to get checkout since I was still having chest pains and tightness. They ran a series of tests and concluded that I was just experiencing typical aches and pains from the vaccine. My symptoms continued for another full week and at times the shortness of breath and chest pains felt really severe. By the following week I was starting to feel a little better on and off. I got my appetite back and and I was able to start exercising again. After about 2 full weeks after receiving the vaccine most of chest pain and pressure + shortness of breath has disappeared and I feel better.

a week after receiving the vaccine, I developed shortness of breath and a dry cough. it has been over 2 months with the shortness of breath and coughing without improvement

Received the J&J vaccine in May 20. Started experiencing leg muscle and back pain June 1, 2021. Progressively got worse over the following weeks. On June 15 I woke up with a new pain in my leg. Went to urgent care and had a D-Dimer test that came out very high. I was sent to ER where they discovered one clot in each leg and two in my lungs via ultra sound and ct scan. I was immediately hooked up to herapin blood thinner through an IV. I was released the following afternoon with Eliquis blood thinner tablets.

2 minutes after injection, proceeded to completely black out- the nurse at the time described it as if I was gasping for air, in somewhat of a convulsion. She then proceeded to administer to use an epi-pen, which in turn immediately relieved my symptoms. Paramedics were called, vitals were checked - was eventually able to leave the facility and return home.

Employee had shortness of breath, diarrhea, vomiting, fatigue and hypoxia and was taken by ambulance on 7/17/21 where he was given IV fluids and sent home. He returned to Emergency Room on 7/22/21 due to excessive thirst, frequent urination, blurred vision, and nausea. Employee was hyperglycemic with a blood sugar of 600. IV fluids given.

48 Hours after severe headache, muscle and joint aches low grade fever. Chest pressure and throat tightness occurred, cough associated and phlegm, low energy and upper back pain. Symptoms increasing gradually. Spouse is not experiencing same symptoms after 24 hours

Patient reported vertigo, nausea, vomiting, difficulty breathing, perfuse sweating, disoriented for approximately 45mins to 1hr

Approx 5 minutes post-immunization patient reported momentarily blacking out and dizziness. Patient was instructed to sit back down and was given a cold compress to apply to back of neck. Patient reported visual disturbances and shortness of breath. Patient was instructed to lay down with his feet elevated. Patient reported some numbness in left arm and hand (arm that vaccine was received in). Patient remained laying down with feet elevated for approx 10 minutes until he began to feel better. Patient then moved to sitting position on chair, with feet resting on second chair, where he remained until he began to feel back to normal. Patient was monitored for additional 15 minutes before patient left. Patient was feeling normal when he left the pharmacy area.

Patient is employee's son. Employee reported that he woke up at 3 a.m. c/o difficulty breathing, face and lips swollen. They gave dose of Benadryl and he seemed comfortable. Visit to Urgent Care in the morning, they administered a steroid shot. By Thursday afternoon, unusual looking rash all over. Visit 4/9/21 to PCP advising good possibility that it is delayed reaction to vaccine, since patient has not had anything different to eat or have contact with.

Heart racing/pounding, fatigue, muscle soreness, slight shortness of breath, chills lasting for six hours

On the first night after receiving the shot I woke up 1 hour after falling asleep with extreme chills. I had to get up and did not sleep again that night. I also experienced a slight difficulty in taking deep breaths. All of my muscles were sore and continue to be so 36 hours later, though that is improving. I did get normal sleep the following night.

I got out of work went home, started having sharp pains in my chest, and on my arm, I got worried nothing like this has happened before with the chest pain, I was already having back pain, shortness of breath, and headaches

4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl 4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl. 4/9/21 Visit to PCP Doctor, swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches. 4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.

Shortness of breath that began Wednesday night (date of vaccine). Hx of COPD. Albuterol inhaler given and chest xray obtained. Pt d/c'd to home in stable condition

On 03-04-2021 I started to experience respiratory problems, my nose was clogged up with mucus, had some difficulty breathing and was having like an asthma attack. I do not suffer from asthma prior to this vaccine. I experienced headaches, fatigue, congestion, my ears were plugged and I also developed a rash on my arms and I also noticed a lymph node in my neck that I did not have prior to the vaccine. When I went to see my doctor my symptoms were not as prominent and the lymph node in my neck is decreasing in size.

Inmate reports a red rash to bilateral legs and shortness of breath starting on 5/15/2021. The rash went from ankle to knee. Was not itchy. Rash has improved. Shortness of breath lasted 24 hours and is no longer present.

Heart attack - Sudden onset chest pressure, shortness of breath, bilateral arm numbness. Found to have clot in LAD requiring stent. No cardiac risk factors.

At around 4 am when he came to bed, he lay down and started convulsing. It was like he had an extreme chill but his body was so tensed up and he could not control his muscles or his breathing. He kept convulsing and was unable to control it for about 20 minutes. He asked if he was having a seizure but he was cognitively aware with no trouble speaking and so I told him it was not. His muscles hurt but I assume that was from the prolonged tensing of them. Later that afternoon he complained that his whole body was sore- arm, back, etc. He also has a headache and sore throat. Things to note- he has been running low on sleep (about 3-4 hours a night) for about 5 days leading up to the vaccine date.

Headache, severe muscle aches and cramping, difficulty breathing. Effects lasted 6 days before subsiding.

Was diagnosed with pleurisy. Intense sharp chest pain while inhaling and exhaling. Have had it for one week, it has improved but is still painful.

Client contacted NJCRI on 3/11/21 complaining that on 3/10/21 at 10 pm he began feeling tire, achy throat and this morning 3/11/21 at 8 am began with profuse diarrhea, shortness of breath and heart palpitations. BP taken by patient at home 164/90 and pulse of 140 bpm while nurse triaged on the phone.

Pain in injection site and hand, with little difficulty to breathe. that night start feel chili, wake up with fatigue, body ache, headache and fever at 102 degree.

DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious

Sudden onset of shortness in breath No other symptoms preceding or following the impact Self medicated (using Seroflo 250 Salmeterol and Fluticasone inhaler) - got relief 30 minutes after taking this inhaler and went to bed. No symptoms the following day, as if nothing happened.

As soon as I woke up, I read the Janssen pause news from my bed. I got up to go to the bathroom and upon finishing, I felt my heart rate skyrocket and felt faint. I immediately went back to the bed where I lost consciousness. My wife said my eyes were open and my body was rigid. I came too within a minute of that and was breathing heavy and sweating and very fatigued. My wife had called 911 as I was coming back to consciousness. The EMTs checked my vitals and all was normal. They asked if I wanted to go to the hospital, and I said no. My back was extremely sore all day, and I developed small red spots around my eyes. I went to my doctor later that day and told them about it. They took my blood for tests, which I have not heard back about, and they did not conclude anything, but did set me up with an appointment for an MRI of my head, given my past history.

Experienced, numbness and tingling in left arm that progressed into general pain in Joints. After 2 weeks pain occurred in left chest area and was diagnosed on 4/27/2021 as Pluerisy. Treatment with Methylprednisolone and rest.

PT REPORTED TO ED WITH C/O SOB/DYSPNEA, CHEST PAIN, PROBLEMS WITH INSPIRATION AND FATIQUE-TACHYCARDIA HR 119- BILATERAL LEG PAIN SINCE 4/26/21

He got his vaccine, then he waited for the 15 minutes, and went back home. That day he had a headache, but nothing serious or concerning. It has been a whole weak and nothing major changed. Since yesterday he has what they described in the beginning, depression in the left side of his heart, shortness of breath and rapid heart beat. He has not called his doctor or gone to the ER. He now has BP monitor and it has been morning, while on the phone he did his BP and it was 147/102. This is a little bit lower than it has been. Oxygen level right now is 98, BPM 97.

I woke up the next morning with an extreme headache that would not resolve for the entire day despite taking migraine medication. I felt achy and tired as well. The next day 5/29 I had extreme nausea, muscle pain, chills, shortness of breath/tiredness and a flare up of psoriatic arthritis and psoriasis activity as well as diarrhea. Today 6/1 I have a flare in PSA symptoms and diarrhea still.

A few minutes after receiving the vaccine the patient felt faint, started sweating profusely and was breathing heavily. I attended to him with cold cloths and helped him to lie on the floor. While this was taking place emergency number was called. After lying on the floor the patient started to feel a bit better and stated that he has fainted before when giving blood. He flet good enough to sit in the chair again after a couple of minutes and I monitored him until paramedics arrived. By the time the paramedics arrived the patient felt better and his blood pressure was 120/80 as measured by the paramedics. The patient's brother arrived to drive him home as he chose not to go with the paramedics. The patient was instructed to get medical attention if the symptoms happened again.

No treatment has been received. Anxiety with very elevated heart rate and shortness of breath. Almost like panic attacks. Those happen regularly that didn't happen before. The really bad one (episode) happened once. But I'm still getting them at a moderate level about 2 or 3 times a week. I went to ER other than that I've ridden it out when it happens. I went to ER on May 29th. I have scheduled a mental health therapist appt.

103.5 Fever, chills, convulsions, nerve pain radiating into elbow, hand and left pinky and ring fingers, numbness and tingling in left pinky and ring fingers, vomiting, chest tightness and mild asthmatic reaction, joint pain, muscle soreness.

2 hours after receiving the vaccine I began to feel hot and cold flashes and a flush feeling as if I was going to faint. I went to the emergency room. The ER doctor did blood work, took my blood pressure (a little high at first) and EKG. Doctor said everything appeared to be fine. After I left the hospital I started feeling mild shortness of breath and tightness in my chest which has not stopped as of this writing. I also have moderate pain in the upper middle part of my back by the vertebrate.

Pt had J and J vaccine at outside facility on 3/14. by 3/14 evening, had fever, sweats, bodyaches which he thought was vaccine related since 3/15, some ST w/ dry cough, fatigue, sweats overnight some mild sob when laying down by 3/18: Headaches, fatigue, SOB

Felt nauseous and out of breathe right away. Fainted and hit head on pavement within 15 minutes of shot. Admitted into ER with concussion and found bleeding in brain within 3 hours of shot.

Fever, chills to sweats, dizzy, really fast small breaths, full body aches, extreme fatigue, strong headache. This started at 7:30 pm on April 9. Most Side affects went away by morning when I woke up at 5:30 am, except for sore body and slight headache. Felt much better at 11:30 am with still sore body and even smaller head ache

Fever of 101 for a few hours, severe aches and pains all over and especially in joints, severe headache, mild vertigo / dizziness, severe chills, difficulty breathing.

Started experiencing extreme chest pains (stabbing feeling) between my lower right breast and upper rib cage on Saturday afternoon, especially when trying to take a big inhale. I went to the emergency room the next day after pain meds (ibprofen) did not help, and they did an EKG and X-Ray and they said it was a muscle strain. I went home and alternated between 3000 MGs of Tylenol every 24 hours, 2400 MGs of Ibuprofen, 8 hours of 4% lidocaine patch and then off for 8 hours + and a heating pad when the patch was off. The pain in my chest got worse and worse on Mon and Tue (started having spasms in the chest that caused extreme sharp shooting pain down my back up into my head) so went back into the ER Tues night. They

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received vaccine, went out to sit on chair in waiting area. Leaned over and passed out, pharmacist ran out to patient, bystander helped lower patient to ground, all the while the patient was breathing very heavily, sounded seizure like or that he was gasping for breath. Asked tech to call 911. While being lowered to ground patient regained consciousness. Mother came around the corner and stated patient has history of reacting this way to vaccines, neither pt nor mom told us this before.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Pt received shot, went to monitoring area, sat, leaned to right and passed out, pharmacist ran out, made sounds like gasping for breath/eyes rolled back/not responsive but breathing, asked tech to call 911, had bystander help lower to ground, pt regained consciousness, mother came around and said he has a history of doing this/phobia of vaccines, no one informed us

Patient was advised to remain in observation area for 30 minutes due to history of breathing difficulty with sulfa antibiotics in past. Shortly after being vaccinated the patient presented to our service window stating he did not feel well and was immediately escorted by the pharmacist to our administration area to have a seat. He stated he felt light headed, flushed (though not visibly), felt like his heart was racing, and was not having diffuculty breathing but felt like he couldn't catch his breath and stated he thought he was having a panic attack. He had stated before vaccination that he had not had a vaccine since his routing childhood schedule, his whole family had already had doses, and he had been putting it off because he was nervous. He insisted he needed some fresh air several times and was escorted outside by the pharmacist (with emergency supplies and a cell phone and within shouting distance of the pharmacy) for continued obsevation and was given water when requested. After a few minutes he stated he felt much better and the symptoms had resoved. He was directly observed outside per his request for the remainder of his waiting period and had no further symptoms. He was instructed to call the pharmacy right away if he had any additional symptoms after leaving.

Injection site: pain/tenderness General side effects: Nausea, weakness (full body), nearly fainting multiple times, headache, some confusion, dehydration, some difficulty breathing, tired even with rest, low fever

Patient was given the vaccine and a min or so after the vaccine was given called for help and then blacked out. Patient was having troubled breathing and turned pale. Patient was given and injection of Epinephrine 0.3 mg to the right leg and 911 was called. After being checked out by EMS the patient declined going to the hospital for further treatment

UNRESPONSIVE; DIFFICULTY BREATHING; DIAPHORETIC; BLOOD PRESSURE 70/34; LOW HEART RATE; This spontaneous report received from a patient concerned a 34 year old white and not Hispanic or Latino male. The patient's weight was 134 pounds, and height was 69 inches. The patient's concurrent conditions included alcoholic, and non smoker. The patient had no known drug allergies and had no past medical history. The 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: 207A21A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 26-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, after administration, the patient had a somewhat severe reaction with difficulty breathing and went unresponsive. The patient did not remember much. The Emergency Medical Services (EMS) were called and the pharmacist gave an epi pen shot to the patient. The patient was diaphoretic and unresponsive when they arrived. The EMS slowly monitored the patient and as epi kicked in and the patient came back to life. The patient's blood pressure was 70/34, and that, along with it his heart rate, started to rise. The whole process lasted 45 minutes. The EMS wanted to take him to hospital, but the patient refused. On 26-MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 70/34 mmHg, and Heart rate (NR: not provided) low. Treatment medications included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unresponsive on 26-MAY-2021, and the outcome of difficulty breathing, diaphoretic, blood pressure 70/34 and low heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607523-COVID-19 VACCINE AD26.COV2.S-Unresponsive, difficulty breathing, diaphoretic, blood pressure 70/34, low heart rate. 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).

Rec'd vaccine at 1500, reaction started at 1505- pt observed to be stiff posture, eyes rolled to back of head and unconscious. Pt transferred to a gurney and heard to be wheezing. Epi x1 given and 911 was called. Pt became arousable after a few minutes as ambulance arrived. Pt breathing improved and able to answer simple questions. Transferred to nearest hospital.

Symptoms included: Body aches Fatigue Chills Fever Headache Nausea Some diarrhea (mostly clear liquid) Runny nose clear Some congestion Difficulty breathing - arrhythmia from 11pm to 4am night after vaccine administered

High fever for 2 days -topped out at 104, muscle aches and pain, Chest pain and mild breathing issues, and extremely tired

JANSSEN COVID-19 VACCINE EUA 12PM Sore deltoid left side up the neck BY 2PM lightheadedness, dizziness, nausea, headache, fatigue BY 4PM Dry cough and chills, BY 6PM Muscle soreness on the entire left side of body By 10PM 101 fever, aching in every joint of body, trouble breathing By 2AM hot and feverish. All symptoms continued through Sunday, many abating by Monday. However, I am still fatigued, coughing, lightheaded, dizzy, and nauseous since then to even now 3/19/2021. Headache comes and goes and slight difficulties in breathing from the normal. COVID rapid result test came back Negative today from facility.

Fever of 100.6f Extreme full body muscle pain. Headache Shortness of breath. Shivering Labored breathing Chest pain Unable to eat or drink. Symptoms lasted from 10:30pm till 9 am the next morning. Extremely painful experience. Able to drink and eat again at 5pm 4/2/21

Fever of 101 by that evening, treated with Tylenol. 99 by the next morning. Severe body/joint ache. Headache. Severe Diarrhea. Difficulty breathing, treated with Albuterol inhaler. Still experiencing body aches and diarrhea 46 hours after vaccination.

Patient reports shortness of breath and chest pain 7 hours after vaccine. Patient stating he has had ongoing shortness of breath with any exertion. Chest tightness in left side with breath in. Stating breathing feels "heavier." Ongoing headaches. Symptoms starting 7 hours after vaccine. Headache intermittent. Reporting breathing intermittently feels heavier.

My son states that he started to experience SOB, HA, tachypnea with shallow breathing, chest pain and weakness with general malaise. Fatigue. Started at 2100 hrs with no relief with albuterol given at 1 am. Was taken to ER arriving at 3 am. Upon arrival was diphoretic, tachypnic, tachycardia with c/o HA, and difficulty in taking a deep breath. At 6 am was admitted to hospital for further observation. Chest X-ray and CAT scan of chest all negative. Remains on O2 via nasal cannula. Pulse ox I on arrival was 92%.

Patient experienced extended episode of syncope and temporary discontinuation of respiration approximately 8 minutes after vaccination.

Pt received first and only dose of Janssen J&J COVID vaccine on 4/5/2021. 2 weeks later, patient would have been considered to reach full immunity. On 4/21/2021, pt went to the ED with symptoms of COVID and tested positive via SARS-CoV-2 PCR. Pt was not ill enough to be admitted. "Symptoms include nonproductive cough, pleuritic chest pain, shortness of breath, arthralgias, myalgias, fever, vomiting, diarrhea."

FAINTED; HEARTRATE SLOWED; LOW BP; SHORTNESS OF BREATH; SWEATING FROM HEAD TO TOE; FATIGUE/TIREDNESS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy-poultry. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 13:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced dizziness, light headedness and fainted 10 minutes after at vaccination centre. It was not allergy reaction, he had low blood pressure (BP) and his heartrate slowed. The nurses elevated his legs, other nurse took vitals. He was covered in sweats from head to toe, they gave him Gatorade. He kept his head down and legs up and was monitored for his vitals. It was reported that he came around in 10 minutes, after fainting until BP and heart rate returned to normal. The nurses kept checking vital, at vaccination centre, then sent home, asked him to eat and drink. He also had shortness of breath on and off lasting for 3 hours at a time and also fatigue/tiredness. He had never fainted before so unusual behaviour. Laboratory data included: Blood pressure (NR: not provided) normal, Low, and Heart rate (NR: not provided) Normal, Slowed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, heartrate slowed, low BP, and sweating from head to toe on 07-APR-2021, and was recovering from shortness of breath, and fatigue/tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432065-covid-19 vaccine ad26.cov2.s-Fainted. 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).

During the evening around 6pm after I started developing symptoms consistent with the flu. Fever reached 104 around 8pm. Uncontrollable chills also were present. A severe headache followed. I took fever reducing meds immediately. Confusion and trouble breathing happened during the fever and chills period. An attempt to go to the hospital was unsuccessful because I lost consciousness while attempting to find phone/car keys. After I woke up, I felt less confused and could catch my breath, so I decided to take more fever reducing meds and see how I felt in a few hours - this was around 11pm. Around midnight my fever broke and the chills stopped, but the headache was at the worst it's been. The headache lasted the entire next day as well. I wanted to go to the doctor, but was physically unable to and had no one to alert. I do feel better today. I have some weak headaches that come and go, along with muscle aches, but I feel that they are minor enough.

DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.

Reporting a symptomatic positive COVID swab after the Janssen J & J vaccine administration on 3/18/21. Description of symptoms Loss of taste and smell Congested Cough Sore throat Shortness of breath-states he feels like he cannot draw out a full breath and feels short of breath even at rest Muscle fatigue

lightheadedness, fatigue, headaches, mood changes, shortness of breath, nausea, concentration issues, forgetfulness

The patient walked in to the pharmacy for a Janssen Covid vaccination along with family. Patient was advised post vaccination administration to sit in observation for 15 minutes but did not comply and as he was walking away from the pharmacy fainted. Parents reported he did not hit his head and pharmacy was alerted post fall of what had happened. We approached the patient as he was getting to his feet and we advised again for him to come back to pharmacy to sit in a chair for further observation. His parents told us he always has fainting issues post any vaccination or blood work (no prior issue reported to vaccinations on consent form). The patient continued to decline going back to pharmacy and as he walked fainted again, he was able to hold on to shopping cart which lessened severity of fall. Pharmacy staff advised him to remain on floor and after he regained consciousness he was able to answer accurately his name, where he was and what day of week it was. At that time a nurse not employed by Company was shopping near by and began to help care for the patient. The patient and his parents continued to decline calling an ambulance, and after several minutes sat against a wall. He was starting to sweat profusely and heart rate was rapid (approximately 145 bpm per nurse) so we had him remove his coat and provided a cool compress for his head and neck. He was breathing rapidly but was able to slow his respiration upon our direction. The patient did not seem to be improving and the nurse helping advised calling EMS which we did. The patient continued to lose consciousness for brief periods awaiting and during EMS aid. EMS ran the patients blood pressure, blood sugar nd ran an ECG prior to taking patient away to hospital (results unknown to pharmacy as we stayed in area to provide information on patient vaccination administration but had no active assistance care at that time.

Pt reports inability to swallow liquids or solids immediately after injection until seen in ED the following day, cough and shortness of breath 9 hours after vaccination. Also w/ fever.

Systemic: anxiety, nervousness, shortness of breath-Severe, Additional Details: patient presented to pharmacy next day following janssen covid vaccine. presented with shortness of breath, anxiety, nervousness, cough. patient states symptoms started around 2AM. Ambulance was called. EMT took patient to hospital

covid reaction- SOB, rashes. HPI:35-year-old male with chief complaint of cough and shortness of breath. Symptoms have been present since the beginning of May. He reports this started after receiving his coronavirus vaccine. he reports he gets short of breath with walking short distances as well as he is unable to lay flat as he wakes up coughing and having difficulty breathing. He denies any heart history.

Patient developed severe bilateral pneumonia with respiratory failure requiring ICU Admission. SARS CoV-2 RNA, RT- PCR tested positive

He received his Johnson & Johnson vaccine around 1500 today in his left arm. At 2300 today he started feeling fatigue. He was last seen normal by his wife at 1045. He had a syncopal episodes in the shower. His wife helped him down. EMS was activated. He was hyperventilating and complaining of nausea and was given 4 of Zofran. He is also complaining of chest pressure that radiates to the right side of his body. He is complaining of right sided numbness from his ear all the way down to his feet. He denies any focal weakness or neck pain. Denies any back pain or abdominal pain. Patient does not take any blood thinners. In route with EMS, patient another syncopal episode. For EMS patient was febrile to 100.9. Notes relative numbness involving RUE and RLL. All imaging, including brain MRI have come back reassuring. Fluctuating paresthesias on the right hemibody. Imaging studies are negative for acute stroke or other concerning findings. Neurological exam was normal on day of discharge but patient continued to report subjective sensory changes intermittently.

Body aches - 1800 hrs Chills - 2000 hrs Recorded body temp, oral, of 102.4 F at 2125 hrs Extra Strength Tylenol, 1000 mg, at 2130 hrs Recorded body temp, oral, of 103.2 F at 2245 hrs Recorded body temp, oral, of 104.2 F at 2315 hrs, Pulse 110 BPM Ibuprofen, 1200 mg, at 2316 hrs, immediate cold shower for 15 - 20 mins Recorded body temp, oral, of 102.3 F at 2350 hrs Monday March 8th Recorded body temp, oral, of 101.5 F at 0015 hrs Recorded body temp, oral, of 96.4 F at 0700 hrs Body felt sore until Wed 10th Breathing - can take full breaths, however, discomfort felt when breathing in and out. Feeling similar to minor burns, chemical or thermal, in upper respiratory tract. Pulse Ox - consistently 98 - 99 percent Pulse has returned to normal levels with RBPM at 68

Chills; headache; joint pains; muscle and body aches; fatigue/extremely weak (had to be helped to sit up); nausea; slight fever (~99.8 F); racing heart rate (93, normal resting for me is ~60); heavy breathing, though no difficulty breathing.

Started with fatigue on March 25. Increased fatigue, Nausea, stomach tighness, lack of appetite began on the 26th. By March 30th my heart start beating out of my chest and I felt like I was having a heart attack. I could barely breath. Went to get something to eat, walked half way and felt like I would fall on the ground, and returned to my room. Called my parents because I wasn't sure if I would wake up the next morning. My team leader gave me a ride to the emergency room. They drew my blood and it was dark and thick. They sent me home. Still feel fatigue.

Reason for Call DIFFICULTY BREATHING and COVID-19 Vaccine The wife called initially. However, she was able to speak with pt directly Trying to get a nebulizer machine since Monday, pt is covid positive since 3/19/21 Nebulizer Machine at home broke on Saturday wants another machine Airway oxygen prescription was sent, and wrong information was given and was sent to store and also to pharmacy when needs to go to Airway Oxygen in per wife Needed a neb machine for chronic asthma Pt took Symbicort inhaler at 0200 am Ventolin inhaler used as rescue only and states have not used it today Pt had johnson and johnson covid vaccine yesterday 3/31/2021 pt had chills, body aches, and fever No fever today was 98 while on the phone triaging pt Pt wants work note for yesterday, today, and tomorrow Pt not wanting to be seen in office today states are just going to sleep and be home and is already feeling better as compared to yesterday and last night after receiving the covid vaccine spoke with wife about airway oxygen prescription for nebulizer machine and pt's work excuse notes for yesterday, today, and tomorrow instructed the wife to call the office back in 2 hours if has not heard from PCP office

Day 1 (vaccination date 10Apr2021) - did not notice any symptoms other than soreness on left arm which was the injection site. Day 2 post vaccination (11Apr2021) - headache like symptoms where there was heavy pressure on the back of the skull (Occipital knob/bone and around the parietal bone), felt clammy and hot/sweaty, shortness of breath, and very fatigued and nauseous. Temperature seemed to fluctuate throughout the day around 100 degrees almost like a low grade fever. Day 3 two days post vaccine (12Apr2021) - headache like symptoms seem to have settled but still felt clammy / sweaty / hot. Day 4 (13Apr2021) Injection site in left arm is still swollen and sore. Shortness of breath still present.

On the evening of 4/8/2021 at around 8 pm I began experiencing an upset stomach (felt like I might throw up) and then shaking in my stomach started and I got a lot of chills and a headache. Then I spiked a very high fever and sweat like crazy. I was shaking like crazy and had to call a doctor on call twice. I had full body pain and was very sleepy. The fever and chills lasted a bit over 2 days but unfortunately the pain in my body had not gone away. Currently (4/14/2021) I have pain in all my joints and my neck and back and I noticed a rash around my right knee. I have felt very tired. I have felt some mild shortness of breath, which may be seasonal allergies (discussed with a nurse earlier, my oxygen levels are 98 percent today, so I am breathing fine, but there is a sensation of shortness of breath) . I have consulted my primary care office about the above and they are speaking to the doctor. I am trying to limit my exposure to any hospital setting until the 14 days (2 weeks) is up from the vaccine. Hopefully these symptoms will go away soon and hopefully none are related to a blood clot issue. We'll see if my doctor or you guys may recommend a future platelet test?

36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission.

Leg pain, pressure headaches and chest tightness resulting in ER visit 4/12. Attending physician noted no visible signs of clots. Occasional shortness of breath and brief bursts of dizziness and nausea (not necessarily together) persist, as do minor headaches.

Received J+J Covid vaccine on 4/3/21. Admitted on 4/19. Per admission note: Patient is a 36YO male with a history of HFrEF s/p heartware 12/17/14, ICM with embolic MI, CAD, chronic driveline infection, HTN, HLD, DM type II, SVT, obesity, gout who was sent to the hospital for bilateral PEs. Patient called our OP line on 04/17 complaining of fever of 102 and chills. He was instructed to go to local lab and get labs done. They drew basic labs as well as blood cultures. On Sunday, the patient reported his fever was gone and he felt better. Today, he was feeling SOB and presented to his PCP. They ordered a CTA which reportedly showed bilateral PEs. They sent him to the local ED who transferred him here. Of note, his INR has been supratherapeutic for several weeks and pharmacy has been adjusting his warfarin dosing. The patient tested COVID negative prior to transfer. The vaccine lot number information is not accessible to this reporter.

Headache, chills, feeling very tired, muscle aches, nausea. Woke up shaking very hard and couldn't breathe much, was able to get breathing under control and stop the shaking.

Patient received first J&J vaccine and within 5 minutes or so started seizing, shaking, breathing heavy and slumped over in the chair. He woke up quickly but could not remember what had happened. He reported tingling in his fingers and toes. EMS was called and evaluated him. He went home in stable condition.

I felt really sick the following day! I had COVID-19 prior to this so it felt like that again... 48 hours after I had chest pain and shortness of breath! I went to the hospital and my blood pressure was 166 over 99... blood tests came back ok for now

Chief Complaint Patient presents with o Shortness of Breath Chest Pain 36-year-old male without significant past medical history presents with concerns for vaccine reaction. The patient reports that he got the J&J vaccine yesterday, while at work today he developed some dizziness. He went home, while resting at home he developed some chest pressure, shortness of breath. He reports the symptoms have largely resolved at this time, he just feels mildly dyspneic at this time. No known fevers. No recent illness. Patient does report some anxiety related to the vaccine. Well-appearing 36-year-old male presents 1 day after J & J Covid vaccine. While he did experience some dizziness, dyspnea and chest pressures earlier, at this time the symptoms have resolved. He appears well, is breathing comfortably, stable vitals. Patient is PERC negative. Will check an EKG, but otherwise recommend symptomatic management at home. Differential diagnosis: Vaccine reaction, viral illness, arrhythmia Low concern for PE given that the patient is PERC negative EKG Interpretation: normal sinus rhythm, no ischemic changes ED Course and Disposition: Patient reassured and discharged home.

FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, 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 experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.

Pt. presented to hospital with worsening shortness of breath, dry cough, fatigue, loss of smell, and poor appetite for about 1 week on 04/06/21.

I received my vaccine this morning at 6:12AM and felt fine after. Around 7:45AM I started to feel slightly short of breathe, but figured it was just from the cold outside and my Asthma. The shortness of breathe feeling goes away. Later in the day sometime after 3 PM, I start to feel as if I am getting stuffy. I take a nap on the buss on my way home, and when I wake up I suddenly feel like I am freezing and have chills all throughout my body. I get home and jump in a hot shower to warm up, but it did not help. I then heat up some food to eat dinner, and I go to drink some soda, and I notice I have no taste. I figured the soda was flat, but even flat soda has some taste to it. I then drink a Cherry Gatorade, and still no taste. Now I check my temperature and it is at 101.4, and I have a slight cough.

1515-Vaccine administered-Employee was monitored for 15 min and returned to work. 1600- Employee developed hives, reported to occupational health and benadryl administered. APRN present in Occupational Health. Patient stated he felt that his throat was swelling. Epi-Pen was administered while an ambulance was called, employee was transported to ER.

Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.

Seven days after vaccine was administered Patient started having symptoms of difficulty breathing, rapid heart rate, and breaking out in a rash all over his torso and upper arms. His lips also got quite swollen. The rash eventually spread down both his legs. He was taken to the emergency room at Hospital, as he was visiting there at the time. He was given benadryl, and prednisone once his Covid test came back negative. Blood work, chest x-ray, CT scan of both stomach and chest, EKG and blood work all came back normal. His resting heart rate was 120 and above, and he required two liters of oxygen to stay in the mid 90's saturation level. He spent five days in the hospital before the rash was mostly faded on his torso and his lip swelling had come down. He was discharged on 3/24/21 with the advice to see his primary care physician, and to be monitored carefully for oxygen saturation and heart rate. The family could not think of anything he had eaten or come in contact with that would have caused any reaction. At this time we think it was a reaction to his Janssen vaccine based on all the tests at the hospital coming back normal.

He is a 37-year-old active male with no significant medical history. One week ago, on Friday, March 26, he received the Johnson and Johnson vaccine for Covid 19. That day he felt fine. The following day he had some muscle aches. Sunday he states he had some slight shortness of breath, only for that day. Then he had some fever and chills feeling. That resolved. The only symptoms that persisted was his muscle aching and tightness. Then yesterday, the day of his presentation to the ER, he noted some bilateral lower extremity edema which prompted his visit. He is feeling mostly fine except a bit of muscle tightness. BNP was 154. Chest x-ray showed pneumonitis. He received antibiotics. Echocardiogram was completed showing preliminary findings of small to moderate pericardial effusion and trace aortic insufficiency. Will treat with colchicine and ibuprofen.

Flu like symptoms, sluggish. Loss of appetite, mild chest pain, mild shortness of breath. chills, fever

hives, slight shortness of breath, feeling tired, no energy, sleepy starting from approximately 45 minutes after vaccine administration. pt instructed to take loratadine 20mg (2 10mg tabs), went to sleep for approximately 3 hours and woke up feeling fine

The patient received the vaccine, proceeded to the observation chair to wait for 15 minutes. The wife informed us: "He is having a reaction" we immediately went over to assess the situation. The patient was shallow breathing, unresponsive, low blood pressure, and very pale. The patient was slumped in the chair and then brought to the ground. An EpiPen was administered and 911 was called. The EMTs then came and did an assessment as the patient was able to then sit up. They took him to the hospital for further observation.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Additional Details: approx 90 min after receiving vaccine patient reported with very slight chest tightness that resolved shortly after. He then began experiencing chest tightness, but no difficulty breathing. Approx 2hrs and 15min after the dose his symptoms are now considered a normal (just slightly sooner than expected).

I had swelling of the face, and cold sore on my lips, did have a hard time the first day after 40 minute swelling of throat

Day of shot - extreme nausea. First night - no sleep due to waves of shivers/chills and then fever and overheating. Shortness of breathe Day after shot - fatigue; some flu-like symptoms Day 2 after shot - fatigue and shortness of breathe

Patient reports that within 2 hours of receiving Janssen vaccine, started with migraine-symptoms and dizziness; he had to stay out from work the next next day due to fatigue/dizziness/headaches/myalgias. Started with shortness of breath and asthma exacerbation symptoms on 4/1/21; saw PCP, on 4/2/21 for shortness of breath and asthma/allergy-like symptoms. He also reports that since the time of his vaccine his BP has been running slightly high around 140/85 and headaches have continued off and on. He was started on Budenoside inhaler by PCP and prednisone (patient does not recall dose). Came to see me at on-site clinic on 4/13/21 for continued headaches and concerns to blood pressure elevation persistence

SHORT OF BREATH; DIZZY; FEELING EXTREMELY SICK; FATIGUED; A HEADACHE; FEELING WEAK RIGHT AFTER VACCINATION; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 23-MAR-2021, the subject experienced feeling weak right after vaccination. On 25-MAR-2021, the subject experienced short of breath. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced feeling extremely sick. On 25-MAR-2021, the subject experienced fatigued. On 25-MAR-2021, the subject experienced a headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling weak right after vaccination, feeling extremely sick, fatigued, dizzy, a headache, and short of breath. This report was non-serious.

Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.

KIDNEY INFLAMMATION (RENAL DISORDER); LUNGS FILLED WITH FLUID; PANCREATIC PAIN; KIDNEY INFECTION; LEG PAIN; KIDNEY FAILURE; CAN'T MOVE; SEVERE BACK PAIN; KIDNEY PAIN; LOSS OF VOICE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received two weeks ago covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 22-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. On 05-APR-2021, the patient experienced kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation (renal disorder). He addressed that his lungs were filled with fluid and he lost his voice which was later improved in few days. The patient required urgent/emergency care visit, for events back pain, kidney pain, leg pain, can't move, loss of voice, kidney failure, and kidney infection. The patient was experiencing as if he was dying and failure in kidney and not be able to understand to compensate the situation. The patient family was concerned about him and due to vaccine he was not able to work or to do anything. Considering severity he was asking for the compensation for the vaccine effect on him. The patient asked for a call back as he was not able to talk and he was on bus so could have got disconnected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of voice on 24-MAR-2021, had not recovered from back pain, kidney pain, leg pain, can't move, kidney failure, and pancreatic pain, and the outcome of lungs filled with fluid and kidney inflammation (renal disorder) and kidney infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report involves a 37-year-old male patient who experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain the same day the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. Apporxiamtelly two weeks later he had kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation. Medical history, concomitant medications, and details of the events were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.

DIFFICULTY BREATHING; MENTAL CHANGES; RAPID HEART BEAT; FULL BODY PAIN; FEELING OF LEAD IN VEINS TOE NAILS TO HEAD; ANXIETY; BRAIN ZAPS; FEELING OF HEAT IN BRAIN; SEVERE PAIN; LEG PAIN; LEG FALLING ASLEEP; FEELING OF CHANGES IN NERVOUS SYSTEM; FEELING SPACEY; PALPITATIONS; DIFFICULTY SLEEPING; BURNING IN CHEST; LIGHTHEADED; FEELING LIKE GOING TO PASS OUT; PANIC ATTACK; EXTREME BONE PAIN; SUFFOCATING; SUFFERING AND TORTURE; FOOT FALLING ASLEEP; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcoholic user, and postural orthostatic tachycardia syndrome, and other pre-existing medical conditions included the patient had illicit drug use as a teenage. the patient was homeless from age of 14 to 22. the patient was sober as of 26-mar-2006, past 15 years was sober. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: CT scan (NR: not provided) not reported, Contrast media reaction (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, Echocardiogram (NR: not provided) not reported, Fibrin D dimer abnormal (NR: not provided) not reported, and Heart rate (NR: not provided) Increased. On MAR-2021, the subject experienced difficulty breathing. On MAR-2021, the subject experienced mental changes. On MAR-2021, the subject experienced rapid heart beat. On MAR-2021, the subject experienced full body pain. On MAR-2021, the subject experienced feeling of lead in veins toe nails to head. On MAR-2021, the subject experienced anxiety. On MAR-2021, the subject experienced brain zaps. On MAR-2021, the subject experienced feeling of heat in brain. On MAR-2021, the subject experienced severe pain. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced leg falling asleep. On MAR-2021, the subject experienced feeling of changes in nervous system. On MAR-2021, the subject experienced feeling spacey. On MAR-2021, the subject experienced palpitations. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced burning in chest. On MAR-2021, the subject experienced lightheaded. On MAR-2021, the subject experienced feeling like going to pass out. On MAR-2021, the subject experienced panic attack. On MAR-2021, the subject experienced extreme bone pain. On MAR-2021, the subject experienced suffocating. On MAR-2021, the subject experienced suffering and torture. On MAR-2021, the subject experienced foot falling asleep. On MAR-2021, the subject experienced postural orthostatic tachycardia syndrome. On APR-2021, Laboratory data included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart beat, difficulty breathing, full body pain, feeling of lead in veins toe nails to head, anxiety, brain zaps, feeling of heat in brain, severe pain, leg pain, leg falling asleep, feeling of changes in nervous system, feeling spacey, palpitations, difficulty sleeping, burning in chest, mental changes, extreme bone pain, suffocating, and suffering and torture, and the outcome of lightheaded, feeling like going to pass out, panic attack, foot falling asleep and postural orthostatic tachycardia syndrome was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: epipen given. called 911. but the patient was ok before they get to the store after giving epipen.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: About 5 minutes after the shot, the patient lost conciousness, fell face forward on the ground. Face appeared grey, was unresponsive, but was making grunting sounds. His body appeared to be shaking lightly, possible seizure, was not responsive. Oral benadryl was not possible at this point. Turned patient on back/side in order to adminster the epipen. Patient quickly became alert and responded. No injection site reaction. Paramedics arrived shortly to check vitals and transfer him

I experienced heart racing and my throat swelled up. Pain at the injection site. I also experienced chills, weakness sensation to my body no fever and body aches. To this day I still have the pain at the injection site, left arm and no chills. At times I feel my joint feel stiff and I am able to move a bit better.

Patient in chair sitting position at time of vaccination, minutes later fell out of chair face forward and on carpet floor lying on left side breathing hard. Patient had rug burns on face. Patient lost consciousness for about 1 to 1 and a half minute patient snapped back immediately and slowly came back to being oriented. EMS arrived to check over patient, patient was nauseated and vomited. Patient complained of neck discomfort, EMS pressed on patients neck and EMS felt it was muscle related. Patient refused additional service from EMS. EMS advised patient to seek additional services from hospital if symptoms worsen.

SHORTLY AFTER RECEIVING VACCINE (APPROXIMATELY 1/2 MINUTE) PATIENT FAINTED. HE SLOWLY SLID OUT OF CHAIR AND I (PHARMACIST) CAUGHT HIM GOING DOWN AND HE LANDED ON HIS LEFT SIDE, ALMOST FACE DOWN. I SHOUTED OUT HIS NAME SEVERAL TIMES, ROLLED HIM ON HIS BACK, AND CHECKED FOR BREATHING. NO BREATH SOUNDS OR CHEST RISING, COULD NOT FIND A PULSE, AND THEN HIS EYES ROLLED UP AND BACK. A STORE CUSTOMER CALLED 911 AND I BEGAN COMPRESSIONS. AT COUNT 20 HE BEGAN TO MOVE AND TRIED TO TALK. STOPPED COMPRESSIONS, AND ROLLED PATIENT ON HIS LEFT SIDE. I WAS ABOUT TO CHECK BLOOD PRESSURE WHEN PARAMEDICS WALKED IN AND TOOK OVER. PARAMEDICS CHECKED VITALS, TEMPERATURE, BLOOD GLUCOSE AND RAN EKG. THEY SAID THEY COULD NOT SHARE RESULTSWITH ME, BUT STATED PATIENT REFUSED TO GO TO THE ER/HOSPITAL. AFTER ABOUT 30 MINUTES PATIENT WALKED OUT OF THE STORE ON HIS OWN.

At approxiamtely 1716 observation nurse reported 37 year old male with no known allergies complaining of throat tightness and ?weird feeling in throat? after receiving Janssen vaccine ( Lot # 204A21A). Patient assessed, no visual swelling noted on evaluation. Patient denies difficulty breathing or difficulty swallowing. Vitals stable BP 108/65, HR 67, RR 17, O2 Sats 98% on room air. Patient was alert and oriented and in no visible distress. 1720- EMS already on scene for a different call and was called for further evaluation of this patient as well . 1724 EMS assessed patient. Pt stable and refuses transport. Patient states he "feels ok?. Patient educated to seek medical attention for any difficulty breathing, difficulty swallowing or any concerning symptoms. Pt discharged in stable condition.

Patient b/c diaphoretic, pale w/ facial flushing w/in 3 min of injection. He then c/o feeling dizzy and nauseous. Vitals were stable other than his BP being slightly low at 97/58. After ~10 min he c/o feeling his throat getting a little tight, at which time he was injected w/ 0.3 mg of Epinephrine w/ an auto-injector. His throat started to feel better shortly after, but still felt sick. He was given Cetirizine 10mg along w/ Pepcid 10 mg , but avoided benadryl d/t h/o severe sedation and wanted to keep him alert during the observation period. After 2 hrs of observation, he was feeling much better and all vitals were normal. However, he still c/o some discomfort w/ his throat, so another 0.3mg of Epinephrine was injected using an auto injector. He continued to recover and after another 2 hrs of observation, he was allowed to go home w/ his wife for close monitoring. He was called 1 hr later and confirmed that he continue to do well. He was advised to take 25 mg of Benadryl before going to bed. He was seen the following day and was back to normal.

Received vaccine on 6/5/21, next morning at 7:00 am mother heard a loud noise and found PT face down lying half way in bathtub unresponsive, attempted to lift him observing his eyes were rolled back in head, was unconscious for approximately 1 min trying to lift him out, then he blacked out a second time hitting bathtub a second time. Lifted him out and placed on floor, he was unresponsive - called 911, he came to slightly after 3 minutes. Ambulance took him to ER and we stayed all day receiving fluids and chest XR (clear). We were discharged in the afternoon with the doctor saying he has a syncopy episode. At 4:00 PM PT was going to the bathroom and he stated he didn't feel good. I stood in front of him because he turned white and eye rolled up into his head and he blacked out and stopped breathing for approximately 2 minutes while I got him on floor and gave CPR. Called 911 and he began breathing again . Back in ambulance to hospital and we stayed in hospital for 2 days.

Right after the vaccine was administered, patient complained about dizziness, temporary blurred vision & loss of hearing. Patient became pale, hyperventilating and complaining of shortness of breath. Soon after, he passed out for 20 seconds. When he gained consciousness, he felt tingling and numbing on both hands.

*Throat tightness Treated w/ 0.3 ml of EPi *Chest tightness 25 mg of benedryl *warm sensation 10 mg of Decadron *Tingling taken to ER by EMS *Lightheadedness

24hrs after receiving the vaccine I had fatigue and sortness of breath, 72hrs after severe flu symptoms with a fever of 101.5 lasted 3 days, severe diarrhea and mild to moderate cramping in the stomach and just below for the last 4 days.

On Saturday 3/20 I experienced the usual symptoms that were noted. On Monday 3/22 I began to get very dizzy with a heart rate of 150bpm. My blood pressure went up to 210/138 which is extremely abnormal for me. I began to tremor uncontrollably. I thought it was an anxiety attack so I took my Xanax. .50mg. That did not work at all. I experienced nausea and stomach pain. I called 911 and was taken to the hospital where after 4 hours I started feeling better. Tuesday I continued to have tremors. Wednesday the rapid heart rate, stomach pain, and nausea returned. The rest of the week did not get any better. On Saturday 3/27 I slept all day long which again is not normal for me at all. At this point we are 1 full week into the vaccine administration. On Sunday 3/28 I bagan to have the same feeling as the prior Tuesday. Sweating, couldn't breath, heart rate hit 170 this time. BP was the same, tremors, stomach pain, nausea, dizzyness, and this time my Carbon Dioxide level dropped to 24. This morning 3/29 I woke up with extreme tremors. No dizzyness.

Patient felt "funny" a few minutes post vaccine but couldn't describe what that meant. Vital signs were stable and patient was observed for 55 minutes. 128/64, pulse 84 resp 24. Vaccine was given at 11:50, vitals at 12:20, left clinic at 12:45. At 5pm patient began wheezing and feeling short of breath. PCP ordered prednisone, Benadryl and Pepcid. Wheezing has improved some today. Today patient has fatigue, body aches and fever.

SLIGHT DIFFICULTY IN BREATHING; CHILLS; FATIGUE; HEADACHE; INTERMITTENT FEVER; MUSCLE PAIN (BACK AND JOINT PAIN); This spontaneous report received from a patient concerned a 38 year old. 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: 202A21A 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 slight difficulty in breathing. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced intermittent fever. On 10-APR-2021, the subject experienced muscle pain (back and joint pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight difficulty in breathing, chills, fatigue, headache, and intermittent fever on 11-APR-2021, and had not recovered from muscle pain (back and joint pain). This report was non-serious.

Left work early because Chills, sweating Fever, Headache, Muscle and body aches, Fatigue, Shortness of breath, Fast heartbeat, Blood pressure 150/86/98 at 4:10pm on April 11. Cyclobenzaprine 10mg at 5pm and slept under multiple blankets because I was cold and sweating. Woke up the next day fine just a sore arm.

pt developed a severe migraines and is still having them. He vomits every time he eats. He developed a rash on his chest, has shortness of breath, runny nose. Some confusion and brain fog. He went to ER in on 4/16/2021 for migraine headache and other symptoms. He was given a CT and a shot of Demerol and sent home to FU w/ neurologist. He continued having migraines so went back to ER on 4/18/2021. He had an EEG, ECG, and abnormal lab work. He was given another shot of Demerol, Phenergan and IV fluids. He was monitored for a few hours and released to FU w/ Neurologist.

After the initial "normal" side effects.. fever, fatigue, cold chills... I started having respiratory discomfort and shortness of breath. About a day or two later, I developed a chronic cough that is still currently persisting. After seeing my doctor on Sat 4/17, I was prescribed an Albuterol inhaler for asthma, which has been dormant for years. The coughing is continuous, and at times strong/violent. On the morning of Tues 4/20 I had coughed up a little bit of blood after the coughing had persisted for about 5 or 10 minutes. Asthma, chronic cough, and coughing up blood are not typical/documented side effects of received the Covid vaccine. My asthma has been dormant for years, and prior to this event, I have not had instances of chronic cough or coughing up blood.

Chills, Muscle Spasms, Shortness of Breath, Fever, Sweating, Joint Pain, Muscle Aches, Severe Headache. Symptoms resolved within 24hrs except headache and fatigue. Headaches continue and new symptoms have emerged. Acute severe head pain, dizziness, mental confusion, difficulty speaking and visual affects of stars, dark spots and difficulty focusing.

2 weeks of intense nausea, confusion, foggy, fatigue, motion sickness, headache, arm numbing, heart burn, short of breath, neck pain, shoulder pain. Neck pain and shoulder pain remain at 4 weeks post vaccine. Pain level 9 on a 1-10 scale.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: close to fainting several times-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Specifically tingling in Hands. Patient was very disoriented and appeared close to fainting a couple of times post vaccination. Was closely monitored for 30 minutes. He did not think it was due to being nervous, he was slightly nervous before the vaccine, but nothing of concern.

Patient received vaccine and immediately felt light-headed and faint. He turned white upon standing and sat back down. He continued to have labored breathing and starting sweating. We were monitoring him and he informed us that it was anxiety related. He couldn't move his hands and started blacking out. When EMT arrived he started to feel better. They were able to rule out an allergic reaction and it was most likely anxiety related. Patient refused to go to the hospital and was walked out by EMT to make sure he could drive home.

More than 30 days after receiving the Janssen vaccine, I tested positive for COVID-19. Symptoms began as runny nose, sneezing, and sinus pressure/burning on April 6, 2021. Tested for COVID-19 on April 11, 2021 (nasal swab, PCR test) after a family member tested positive. Symptoms worsened on April 12, 2021, including shortness of breath, chest pain, complete loss of taste and smell. Sought treatment for breathing difficulty at ER on April 13, 2021 (Vidant Medical Center and was instructed to rest at home. Sought treatment for breathing difficulty at PCP on April 14, 2021 ( Medical Center) and prescribed Prednisone. Symptoms worsened on April 15, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting. Sought treatment at ER on April 15, 2021 (Vidant Medical Center, Greenville, NC). Held for three days, treated with Remdesivir (3 doses) and supplemental oxygen. Discharged from hospital on April 18, 2021. Symptoms did not improve following discharge. Sought treatment for ongoing symptoms at ER on April 21, 2021, instructed to rest at home. Symptoms continued to worsen on April 24, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Sought treatment at ER on April 15, 2021, admitted to hospital on April 25, 2021 diagnosed with probable TIA. Treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Received a variety of tests and scans of head, neck, spine, chest, heart; none showed signs of any serious cardiac, vascular, or neurological problems. Transferred to in-patient rehabilitation on May 1, 2021 for physical and occupational therapy. Discharged from in-patient rehabilitation on May 6, 2021. Prescribed out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits.

patient stated he went to the hospital for blood clots. Says he went in last Tuesday or Wednesday for heavy breathing. Normal activity was making him very tired. Had COVID infection in March. The doctors cannot determine what other cause could have led to him having blood clots. Patient was released yesterday from being in since last Tuesday or Wednesday. Patient says he's having nose bleeds starting today. He was on the blood thinner shots but not sure of the name. Now he is on the pills (Eliquis) from pharmacy instead of the shot.

ANGIOGRAM PULMONARY ABNORMAL; SCAN WITH CONTRAST ABNORMAL; SARS-COV-2 TEST POSITIVE; FULL BLOOD COUNT NORMAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; ANGIOGRAM; ANGIOGRAM PULMONARY; BLOOD GASES; BLOOD MAGNESIUM; BLOOD PHOSPHORUS; BLOOD THYROID STIMULATING HORMONE; CHEST X-RAY; COMPUTERISED TOMOGRAM; COMPUTERISED TOMOGRAM HEAD; COMPUTERISED TOMOGRAM THORAX; ECHOCARDIOGRAM; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; GLYCOSYLATED HAEMOGLOBIN; MAGNETIC RESONANCE IMAGING HEAD; MAGNETIC RESONANCE IMAGING SPINAL; METABOLIC FUNCTION TEST; SCAN WITH CONTRAST; TROPONIN; LIPIDS; PULMONARY EMBOLISM; TRANSIENT ISCHAEMIC ATTACK; AGEUSIA; AMNESIA; ANOSMIA; BALANCE DISORDER; CHEST PAIN; COVID-19; DIZZINESS; DYSARTHRIA; DYSPNOEA; EXPOSURE TO SARS-COV-2; PRESYNCOPE; RHINORRHOEA; SNEEZING; PARANASAL SINUS DISCOMFORT; HYPOAESTHESIA; SPEECH DISORDER; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1347147), concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol. The patient had no known allergies. The patient had no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced pulmonary embolism, ageusia, amnesia, anosmia, balance disorder, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, dizziness, hypoaesthesia, angiogram, angiogram pulmonary, angiogram pulmonary abnormal, blood gases, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin D dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive and troponin. More than 30 days after receiving the Janssen vaccine (on 06-APR-2021) the patient tested positive for COVID-19 (Confirmed COVID-19 Infection) and was confirmed Clinical Vaccination Failure, the patient experienced symptoms runny nose, sneezing, and sinus pressure/burning. Laboratory data included: Angiogram (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Abnormal, Blood gases (NR: not provided) Not reported, Blood magnesium (NR: not provided) Not reported, Blood phosphorus (NR: not provided) Not reported, Blood thyroid stimulating hormone (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Not reported, Electroencephalogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported, Full blood count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) Not reported, Glycosylated haemoglobin (NR: not provided) Not reported, Lipids (NR: not provided) Not reported, Magnetic resonance imaging head (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Metabolic function test (NR: not provided) Not reported, SARS-CoV-2 antibody test (NR: not provided) Negative, SARS-CoV-2 test (NR: not provided) Positive, Scan with contrast (NR: not provided) Abnormal, Covid-19 virus test (NR: not provided) Positive and Troponin (NR: not provided) Not reported. On 11-APR-2021 tested for COVID-19 (nasal swab, PCR test) after a family member tested positive (confirmed covid-19 infection). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 13-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (NR: not provided) Not reported, and EKG (electrocardiogram) was normal. On 12-APR-2021 symptoms worsened including shortness of breath, chest pain, complete loss of taste and smell. On 13-APR-2021 the patient received sought treatment for breathing difficulty at ER (emergency room) and was instructed to rest at home. On 14-APR-2021 the patient received sought treatment for breathing difficulty at PCP (primary care physician) medical center and was prescribed prednisone. On 15-APR-2021 symptoms worsened including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting and patient received sought treatment at emergency room. The patient was held in hospital for three days and was treated with remdesivir (3 doses) and supplemental oxygen. Laboratory data included: CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, EKG (electrocardiogram) Normal, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, TSH (thyroid stimulating hormone) Not reported, Troponin I (NR: not provided) Not reported, and Urine analysis (NR: not provided) Not reported. On 16-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Computerised tomogram scan (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Lipids (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, Troponin I (NR: not provided) Not reported, and Vitamin D (NR: not provided) Not reported. On 17-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported, and Fibrin D dimer (NR: not provided) Not reported. On 18-APR-2021 the patient was discharged from hospital. The patient reports that the symptoms did not improve following discharge. On 18-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. On 21-APR-2021, the patient undergone sought treatment for ongoing symptoms and was instructed to rest at home. Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram thorax was found to be pulmonary embolism with contrast, EKG (electrocardiogram) Not reported, Estimated glomerular filtration rate (NR: not provided) Not reported, and Troponin I (NR: not provided) Not reported. On 24-APR-2021 the patient reports that the symptoms were continued to worsen including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Laboratory data included: Arterial blood gases (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, EKG (electrocardiogram) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Positive, and Troponin I (NR: not provided) Not reported. On 25-APR-2021 the patient received sought treatment at emergency room and admitted to hospital on the same day again, patient was diagnosed with probable TIA (transient ischaemic attack) and was treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Laboratory data included: CBC (complete blood count) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram neck (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Magnetic resonance imaging brain (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 26-APR-2021, Laboratory data included: CBC (complete blood count) Not reported, and Lipids (NR: not provided) Not reported. On 27-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and electroencephalogram (EEG) (NR: not provided) Not reported. On 28-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Fibrin D dimer (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Magnetic resonance imaging thoracic (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, and SARS-CoV-2 IgG antibody test (NR: not provided) Positive. On 30-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and SARS-CoV-2 PCR test (NR: not provided) Positive. On 01-MAY-2021 The patient was transferred to in-patient rehabilitation for physical and occupational therapy, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 03-MAY-2021, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 06-MAY-2021 patient was discharged from in-patient rehabilitation and was prescribed with out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits. The patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ageusia, amnesia, angiogram pulmonary abnormal, anosmia, balance disorder, blood gases, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, pulmonary embolism, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, transient ischaemic attack, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, angiogram, angiogram pulmonary, and scan with contrast, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000181966. The suspected product quality complaint has been confirmed to be not confirmed. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related, based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.; Sender's Comments: V1. The follow-up information in this version updates Product complaint investigation result. This updated information does not alter causality of previously reported events. 20210609990 -covid-19 vaccine ad26.cov2.s - Pulmonary embolism , transient ischaemic attack, Ageusia, amnesia, angiogram pulmonary abnormal, angiogram pulmonary , anosmia, balance disorder, blood gases, chest pain,dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, and angiogram. 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). 20210609990-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

My left sinus gradually swole shut and grew growths causing me not to be able to breath out of the left side of my nose.

Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital.

Patient began to feel short of breath, fatigue, with distal numbness/tingling to feet about 1 week after being vaccinated.

At 1500 started having chills, running a fever and was very shaky. Took Tylenol and rested. Around 2100 woke up feeling even worse and felt like heart was racing with frequent pauses (3-5 PVC's/minute). Following ER visit continued to feel tired, achy, and occasional SOB.

I'm self reporting this and didn't need emergency medical attention. About 20hrs after receiving the shot I started to run a low grade fever floating from 99.5-100.5F; I normally average around 97.5-98F. Thursday night/Friday morning I had the most prolonged fever break I've ever had; my entire bed was soaked. Fever was gone by Friday sunrise. Saturday I experienced a sever headache, stomach ache and in the evening shortness of breath. I felt extremely light headed. All symptoms cleared by Sunday. I just drank plenty of fluids and rested as much as possible.

This was one of the worst headaches I've ever had in my life. Migraine headaches run in my family so I'm no stranger to them, which is why it is particularly surprising. Along with the headache I had severe flu symptoms - body ache from head to toe, legs toward the end. Abdominal pain toward end. I was breathing heavily throughout, except for an hour or two of bad sleep. It was almost certainly a high fever, but I didn't measure. Chills, sweating. Complete misery. The extremely painful cycle lasted about 10 hours before it started to recede. I felt better close to 100% within 48 hours. I'm reporting this because I've realized that most people have "mild flu like symptoms" while my symptoms were extreme. If I had any other health issues (I don't) it seems obvious that it could have created a bigger problem. I didn't go to a hospital, but I should have, in hindsight.

Was at the grocery store and was having a hard time focusing. All of the colors were running together. I then fell backwards, and began having a seizure. Bystander said my eyes got huge and mouth and tongue turned blue as I couldn?t breathe. I had a seizure for about 5-8 minutes and was totally blacked out. During the seizure I lost control of my bladder and dislocated my jaw.

is a 39 yo M with no significant PMH. He presents for symptoms following Johnson and Johnson vaccine. PMH: none PSH: Right knee surgery, Lasik Family Hx: Denies any family history of HTN, clots, heart disease Patient received the Johnson and Johnson COVID-19 vaccine on 4/11/21, he began feeling tiered, headache and bilateral leg pain on 4/12/21. He had one dose of Tylenol 4/12/21. At around 4pm on 4/14/21 he reports that he had SOB, more bilateral leg pain, and dizziness. He states he went home and slept. Woke up Thursday and all his symptoms had resolved. Denies chest pain, numbness, tingling, swelling in his legs. Patient does endorse that he does have a stressful job working for airport and he had 3-4 cups of coffee daily. He also endorses that after the new of the side effects of the Johnson and Johnson vaccine appeared, he did notice he had more anxiety. Occupation: Works at airport, 12 hours shifts, on-call Social: no drinking, no drugs, smokes 1 cigarette per day for past 8 years

Monday, April 12th, around 2pm I started to develop extreme stomach pain, as well as noticed some shortness of breath or elevated heart rate. The stomach pain worsened after dinner. I assumed it was something I ate, which was the same thing I eat every day, and expected it was some type of gas that would resolve itself naturally. I went to bed in lots of pain. I didn't sleep well due to the issues and woke up still in pain in my mid stomach, mostly on the left side. I called the nurse who did an intake and advised that I go to the ER (Tuesday, April 13th)

I got the vaccine and chills, fever, nausea, diarrhea and dizziness. I was kind of our of breath and fatigue, I wasn't able to life anything and constantly out of breathe. It was hard for me to do anything, I had to rest all the time and take off of work. I was driving to work and had to keep pulling over because I felt dizzy. I ended up going to the Dr. and had test ran and they said I was extremely dehydrated and I didn't understand because I drink a lot of water. they hooked me up an IV and gave me fluids. They said I was Healthy just extremely dehydrated it. My injection site was kind of tender but nothing more. I'm still having issues. I'm just always thirsty no matter how much water I drink.

Chills and Fever the first day a few hours after injection along with Fatigue, Multi-day Headache, Slight Body Ache, and Injection Site Pain all for about 2 or 3 days. Some leg pain was noticed the 2nd or 3rd day. And I have experienced ear ringing randomly about a week and a half after vaccination. Those may or may not be related. Also I feel it important to note in March of 2020 (before testing was available) I experienced a very similar set of symptoms: fever, chills, fatigue, multi-day headache, body ache, 6 weeks of slight cough, leg pain, and a day a few weeks after the coughing started where I had shortness of breath. I wasn't tested back then as it was not available. But based on the symptoms I experienced, I truly believe I had COVID-19 last year prior to vaccination.

Three days and continuing since onset Fevers of above 100(Tylenol sometimes controls fever) 2 every 6 hours Muscle aches Extreme fatigue Dizziness Shivering /hot and cold flashes Loss of strength Mental confusion Coughing Shallow breathing Loss of taste and smell Loss of appetite Nausea Sensitive skin(pins and needles)

Three minutes after receiving a Janssen vaccine, patient was noted by this RN to be unresponsive in his chair located in the post vaccine observation area. The following observations were noted. His head was tilted back resting on the clinic trailer. Body positioned, slumped in the chair. His pupils were positioned back. Unresponsive to verbal or tactile stimuli. Respiration labored with an occasional agonal breath. Infrequent twitching of body noted. Patient was drooling, clear secretions. Pallor was noted on this patient's face. Time lapse for previous noted symptoms was one minute. Vital signs were assessed. Vital signs were normal. BP 120/60, left arm, manual assessment cuff. HR 56. RR 18. 02 saturation 97 % on room air. Blood glucose 97 mg./dl. 911 called for rescue. Patient gradually regained conscious. Patient vomited two times, small amount, clear secretions. Rescue arrived. Normal sinus rhythm. Patient was alert and oriented x 3. Refused transport to the hospital for evaluation. Home with family driving him home. Patient does not have a PCP. Patient encouraged to call 911 if symptoms return.

within minutes of vaccine administration - shortness of breath; difficulty breathing, sweating, bp 150/104 p 48 and 142/75 p 54; pt left on ambulance

The patient returned to the pharmacy shortly after receiving a Janssen COVID vaccine. He was sweating, pale, clammy, and breathing hard. We had him sit, helped him calm his breathing; I assessed for wheezing and swelling of the tongue, but he did not have those symptoms. The patient was able to speak and did not report dizziness or lose consciousness. Paramedics responded. I spoke with the patient this morning, and he reports no residual symptoms.

CHEST PAIN; SHORTNESS OF BREATH; VOMITING; BEDRIDDEN; FEELING OF SICKNESS; ARM SORENESS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced vomiting. On 21-MAY-2021, the subject experienced bedridden. On 21-MAY-2021, the subject experienced feeling of sickness. On 21-MAY-2021, the subject experienced arm soreness. On 21-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced headache. On 13-JUN-2021, the subject experienced shortness of breath. On 13-JUN-2021, the subject experienced chest pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, bedridden, and feeling of sickness on 24-MAY-2021, and arm soreness, had not recovered from nausea, and headache, and the outcome of shortness of breath and chest pain was not reported. This report was non-serious.

Night of the vaccination had a fever of 102., body aches, chills and fatigue one night tired for a couple of days then three weeks later three weeks after vaccination had a fever body aches, chills, fatigue lasted 9 days, 3rd short ness of breath, 5th day head aches,6th blistered and body swelling, face swelling lips, neck and antiphallic type. A week into the symptoms Tele visit was told to take Benadryl next day, Emergency room a week into the symptoms, after taking Benadryl and was not seeing relief. Right wrist blister and both arms and legs was swollen feet and ankle was swelling and over the weekend the swelling. 5lbs of water swelling. Cold sweats through the symptoms.

Two minutes after injection, patient stated he felt light headed. He started breathing heavily and turning red in the face while clenching his fists. Patient's eyes were open but he was unresponsive for 30-45 seconds. Patient then became responsive and started breathing normally and returned to normal facial color. He was then alert and feeling normal. Patient was given water and observed for 30 minutes. He walked out on his own with no problems. Was given our contact information and told to call with any issues.

I went to bed just fine on the night of the vaccine. Woke up two hours later with extreme shortness of breath, sweating and hot flashes. Symptoms eventually disappeared within 48 hours. But they returned on June 20th, though more mildly. Mainly whenever I puff my cigarette, I start feeling a lack of breath -- not being able to breath deeply and fully. If I keep puffing, I eventually start having hot flashes and chest pain. It's very bizarre, because I've been puffing 10+ years with no problems.

PATIENT PASSED OUT MOMENTARILY FOR NO MORE THAN 30 SECONDS WITHIN 5 MINUTES OF RECEIVING VACCINE DOSE. PATIENT SELF-REPORTED FEELING ONSET RIGHT BEFORE SYNCOPE OCCURRED. HE SLUMPED BACK IN HIS CHAIR (DID NOT FALL) AND ARMS DROPPED TO HIS SIDES. DURING SYNCOPE PATIENT HAD SHALLOW AND QUICK BREATHING AND TURNED PALE FOR ABOUT 15-20 SECONDS. BREATHING THEN NORMALIZED FOR 10 SECONDS AND PATIENT REGAINED SOME COLOR TO COMPLEXION. PATIENT FINALLY WOKE UP FEELING SLIGHTLY NAUSEOUS, DIAPHORETIC, AND STILL SLIGHTLY PALE. HE WAS PROVIDED WATER AND A GLUCOSE TABLET AND VITALS WERE TAKEN. HE DECLINED PARAMEDICS OR ANY EMERGENCY ASSISTANCE, AND LEFT THE FACILITY ON HIS OWN.