Johnson & Johnson

Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.

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.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient remembered sitting down in a chair for observation, then slumped forward while on his phone. He did not remember falling over and was alert and oriented right away. Emergency services were called as he sustained an injury during his fall.

Approximately 5-10 after vaccination, pt began to feel lightheaded, became diaphoretic and pale and felt like he was going to pass out. Pt was lowered to the floor and placed in trendelenburg position. Vitals stable. Pt reported fingers feeling number. EMS was called and pt was evaluated and released. Pt remained at clinic being monitored until he was completely back to baseline.

Patient is a 26 y.o. male who received the Janssen Covid-19 Vaccine, Ad26.COV2.S (PF) 0.5 mL IM Susp, Lot 1805020 on 3/12/2021. Vaccine administered at 1610 and reaction was immediate. The patient experienced the following reaction(s) during the immediate observation: pt presented chills and shivering upon administration of vaccination. Brief altered mental status and decrease in HR. Staff talked pt through symptoms. PT stated "I pass out after hang a shot." Also informed staff that he is a runner. 1621 VS- 100/62, P-56, R-99, noted pale, shivers, clammy hands and cold 1627 VS P-61, O2-100% 1629- BP 104/64 and shivers improving 1635- Stood patient up and moved him to chair in post vaccination area 1637 VS 102/64, P-61, O2 sat- 100%, R-22 1652- P-50, O2-99% 1659- P-47-56, O2 sat 100%, BP- 122/62- good color, shivers resolved HR Increased to 56. Pt is now stable and ambulating. Patient was treated/managed as follows: assessed vitals until wnl, wrapped patient and covered, cool damp cloth, offered therapeutic communication, cool water, and stayed with patient until he was able to ambulate. Left vaccination site accompanied by mother @ 1720. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. Education patient on how to seek primary provider or additional medical management if symptoms return.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient has history of fainting with IVs but never to vaccinations. He said he gets stomach aches with sugar derivatives. First BP taken was 107/93 with a low pulse. 5 minutes later it was 165/93 pulse 99. We called the paramedics and they came within 5 to 10 minutes. Patient stabilized after.

~3PM PATIENT RECEIVED COVID VACCINE AND WAITED AT COUNSEL WINDOW TO ASK RPH A QUESTION. WHILE WAITING PATIENT COLLAPSED TO FLOOR FACE FIRST WHICH WAS WITNESSED BY PHARMACIST. PHARMACIST IMMEDIATELY CALLED 911 AND TECHNICIAN AND TECHNICIAN WENT TO ASSIST THE PATIENT. PHARMACIST MAINTAINED LINE OF SIGHT ON PATIENT DURING 911 CALL. PATIENT REGAINED AWARENESS OF SURROUNDINGS ~1 MINUTE AFTER FALLING AND ASKED HOW HE FELL. PATIENT REMAINED SEATED ON FLOOR FOR ROUGHLY 10 MINUTES WHILE WAITING FOR PARAMEDICS TO ARRIVE AND WAS OBSERVED DURING THE ENTIRE TIME BY PHARMACIST AND TECHNICIANS. PATIENT DRANK SOME WATER DURING THIS TIME FROM A BOTTLE PROVIDED BY TECHNICIAN. PARAMEDICS CARED FOR PATIENT AND LEFT STORE ~15 MINUTES AFTER ARRIVAL.

within 5 minutes of getting vaccine patient was sitting in the post vaccination waiting area and fell to the floor hitting head. Staff responded immediately. He quickly became alert and talked to staff stating that he has a history of "passing out." HE was assisted to wheelchair per his request and staff contacted EMS. Unsure if seizure. He postured and fell to floor a second time hitting his head. He immediately awoke and recalled the event again. Staff remained with him on the floor until assisted out with EMS at 10:23. Alert and orientated. Wife returned to the clinic later in the day and stated that he did not go to hospital and refused treatment. He was at home.

Syncopy: elevated feet, cold compress, Powerade. Dizziness lasted approx 45 minutes. Refused any more treatment. Left on own.

Syncope: laid pt down, elevatated feet, cold pack, water. Approx 45 min later patient left pharmacy refusing any more care.

Immediately after standing up experienced ringing in the ears and faintness. Was helped back to nurse who laid me for 15 minutes for observation. When I laid down I became very flush and sweaty. Then at 12am experienced fever of 101, body aches, and sharp stabbing chest pain which has lasted 18 hours so far.

Headache, high fever, fast heartbeat, fatigue, muscle soreness in legs and elbows, dizziness, inability to sleep

around 10 pm started with chills and fatigue with a sore injection location. Around 11:30 pm he got light headed and passed out for 4 seconds. After awaking he doesn't remember the last 5 minutes. He laid down to go to sleep and was consistently hot and then cold. He does have a history of night terrors but they have remained dormant for about 2.5 years. Around 12 am he started having one of the worst night terrors I've seen. The following morning, April 2nd 2021, he was feeling incredibly sore and the injection spot was tender. He said "it feels like I got hit by a truck." Seems to be doing okay otherwise now.

Patient sustained a vasovagal syncope event approximately 3 to 4 minutes after their vaccination. Fell to ground sustaining abrasion to right cheek. Advised ER evaluation but patient refused. Observed for 30 minutes w/o sequelae and released at patient insistence. Spoke with patient by phone today and he notes that he feels well and has experienced no new, recurrent, or residual symptoms.

Pt fainted in chair while being observed post vaccination. Date: 3/23/2021 Problem: Dizziness, fainting Notes: Pt stated he began to feel dizzy and started to lose balance in his chair. VS taken BP 113/70 P102 O2 97 T 97.1 RR 18 BS 104. Continued to monitor pt. No signs of acute distress. Pt able to communicate appropriately. A/Ox4. No bleeding or redness at injection site. Water and granola bar provided to pt. Monitored for 30 minutes. VS remain stable, pt AxO4 and states he feels good. Pt left facility in good condition.

Date: 3/23/2021 Problem: Syncope Notes: Client requested a bottle of water upon returning with the water client noted to fall out of his chair. Staff was able to reach him before he hit the ground, guiding his head downward off setting some of the impact from the fall. Client states he does not remember the fall. He also states he has a history of fainting when he gives blood. AAOx3 T 97.4 P68 R18 BP 124/72 O2 97% RA Client monitored for an additional 30 minutes. States he feels fine after 30 mins. T98.0 P72 R20 BP 126/70 O2 98% RA. Client left facility AAOx3 via personal vehicle.

About 5 minutes after administering vaccine I found patient sitting in chair experiencing a seizure and was unresponsive for a couple of minutes. Patient was pale and had perfuse sweating. After a couple of minutes patient was able to speak and was coherent. We called paramedics and they checked hi out in ambulance. Patient was released and was ok

Passed out 18 hours after vaccine, very low heart rate and blood pressure. Called 911 for ambulance to give saline solution through IV. Was taking to the emergency room and discharged 6 hours later after receiving two bags of saline solution.

Patient slunk down and fainter very briefly, 10 seconds or so. When he came to, he was totally aware of his surroundings and answered all of our questions. We had called 911 in the mean time. EMt's checked him thoroughly. His apple watch showed his pulse dropped to 42. EMT's stayed for about 15 minutes, We gave him water and his wife stayed within reach of him. We escorted him to his car in one of our wheel chairs after about half hour.

Nausea after about 1 minute, fainting, low blood pressure lasting 15 minutes, cold chills lasting ~1 hour. Fever over 103F recorded ~11 hours after injection.

Patient came in for vaccine. After vaccination, I had patient sit in a chair in case of any adverse reactions. About 5 minutes after vaccination, another patient came over and said that was not feeling well. When going out to patient I noticed he was very pale and sweating. The patient then proceeded to pass out. I was able to hold the patients head and the other customer was able to hold his shoulders to make sure he did not fall out of the chair. The patient then got very stiff and proceeded to push back in his chair, after about 10 seconds he relaxed. The patient was passed out for about 3 mins, during that time I was able to remove his mask and hold his head. After gaining consciousness, I was able to make sure he was ok. We were able to give him some water and he stated he felt better. I asked the patient to stay for another half hour to monitor. After giving the patient another bottle of water, and having him sit he was able to get up and leave.

Only minor chills before bed, 11pm. Muscle aches, felt as tightness in IT bands, made remaining asleep difficult. Got up to use the bathroom around 5am. Upon finishing peeing while standing, I lost consciousness, falling. As a result of the fall, I fractured my cheek bone, cut open my ear, later requiring three stitches, and was concussed, resulting in a loss of memory. I was nonresponsive when my fiance found me immediately following the crash, and was rushed to the hospital via ambulance. Upon arrival to the hospital, my fever was found to be 102 F. As a result of the fall, I have a cheek bone fracture, three stiches in my ear, and a concussion.

Pt experienced vasovagal syncope within 15 minutes after vaccination. Supportive care provided and pt recovered without incidence.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After administration of vaccine, patient was still seated in the waiting area. I went back and checked on him after 5mins of waiting, then came back to the pharmacy. But heard a big bang shortly after. Some how, he had fallen out of his chair and bumped his head and neck on an end camp. He seemed a little confused, when I ran over, but was awake, a little sweaty and nauseated. EMS was called. They transported him to ER to have his head checked, since he bumped it.

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.

AFTER PT GOT COVID-19 JANSSEN VACINE HE IS WAITING IN WAITING AREA AND ALLOF SUDDEN HE PASS OUT FOR COUPLE SECONDS HIS WIFE WITH HIM AT THAT TIME WE GAVE WATER TO HIM AND OFFER JUICE AND EMERGENCY SERVICES BUT HE AND SHE REFUSE AND STATS THAT HE IS NOW ABSOULETLY FINE .

Pt with vasovagal response during observation period following injection administration. Symptom onset noted approx. 12 mins following injection.

Patient fainted from sitting position and hit forehead. Had symptoms of nausea, HA, and laid down for 15 minutes. Drank OJ, ate chips upon sitting and laid back down due to dizziness. Patient sat up, vomited, and continued symptoms of headache. Stayed in observation for an hour and felt better enough to go home with friend. Recommended patient visit medical provider if no improvement or worsening of symptoms.

Patient passed out after sitting about 5 minutes after the vaccine. He went stiff and out for less than 30 to 45 seconds. He came to and was alert and talking. EMTs arrived and he passed out again and started vomiting. They did take him in the ambulance.

While at recovery pt complained of dizziness, became pale and diaphoretic. Immediately sat pt on floor( refused to elevate feet). leaned against wall with ice pack to back of neck , water for hydration. no LOC no SOB no N/V. VS taken 130/72, HR 98 reg strong, resp 16 reg non labored, SopO2 97% Pt stated this happened before with tetanus shot a long time ago. Monitored 30 minutes. Provided reassurance pt stated I feel fine now. OKd to exit

patient experienced low BP (68/39) and passed out, fell off the chair and onto the floor, woke up on the floor within 30 seconds.

Symptoms: cool, pale, diaphoretic, Vitals: 110/70, RR 16 pulse 88 O2 96% Intervention/treatment: assessed vitals, gave patient juice & water Passenger switched to driver side to drive patient home

Within 12 hours of injection: Body aches, fever, severe chills ( convulsions ), headache, nausea, threw up three times, passed out.

The patient was nervous prior to vaccine and had a needle phobia. About 5 minutes post-vaccine, the patient stated he was not feeling well and feeling warm and sweaty. The pharmacy staff provided the patient with water and an ice pack. The patient stated he was feeling faint. The patient fainted for about 20 seconds and then became conscious again. The patient didn't have any injuries and didn't fall down. The patient was okay and he laid down and elevated his feet on a chair. He then stated that he has severe needle phobia and has fainted several times in the past with vaccine administration and blood draws. He had experienced this in the past. He was still slightly faint and requested that he be checked out. The EMT arrived and they took his vitals and checked him. By the time the EMT arrived, he was beginning to feel better and had sat up and drinking water. There were no further issues. The EMT stated he was good to head home. We followed up with patient and the patient was feeling good with no further issues.

nausea & dizziness; clammy, diaphoretic; pallor; TX - mask removal / air flow; increased air condition; car seat recline; cool cloth to forehead; emotional support; after 15 mins, returned to upright position after symptoms much improved - no further dizziness; given water; 1625-assisted to passenger seat by 2 . Wife drove off observation lot.

I received the J&J vaccine at 10:00am on March 18, 2021 at the Community Center. By about 5:00pm, I started to feel minor flu-like symptoms, but as the night progressed it got significantly worse. Around 8-9pm, I was bedridden with the worst chills/shaking I've ever experienced in my life. Around 9:30-10:00pm, I was filling water at my sink and projectile vomitted multiple times into the sink and could not make it to the bathroom. Subsequently, I ate a bagel and drank lots of water, knowing my vomitting could make me dehydrated. Throughout the night, I was awake and shaking, and drank and filled my water bottle repeatedly. At 8:00am, I was filling my water, and without my knowledge of awareness, fainted on my kitchen floor, dropping the Brita filter and likely hitting my head. My roommate heard the commotion and saw me passed out in our kitchen. He tried to wake me up and I phased in, but then subsequently phased out again 20-30 seconds later as I was trying to stand and likely hit my head again. My roommate eventually got me over to our couch and called EMTs. Upon their arrival, EMTs checked my pulse, which was fine, and saw an open laceration on the back of my head, so they took me to Hospital to access the Trauma Center. On the way, I threw up repeatedly and was very lightheaded. Upon my arrival at Hospital, I was checked for any neck bone breaks, given an IV, a CT scan, an EKG, and staples were placed in the back of my head to heal the laceration. After my release, I was bedridden for 2-3 days and required a daily nap during work (1-2) hours for the next 1 1/2 to 2 weeks. For a while, everything was fine, but recently during the first two weeks of April, it has become apparent that my head is foggy and reacts to changes in the weather, which leads me to believe that I likely banged my head pretty good when I fainted those two times.

BLOOD SUGAR WAS 9; BLOOD PRESSURE 132/95; NAUSEA; PAIN IN BACK OF HEAD; DIZZINESS; LOSS OF CONSCIOUSNESS; This spontaneous report received from a physician concerned a 26 year old male. The patient's weight was 245 pounds, and height was 172.7 centimeters. The patient had no known allergies and had no chronic medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient complained of dizziness, nausea and pain in back of his head. Once the nurse arrived at the cell, the patient was on the floor with loss of consciousness. He was placed on a stretcher following which he regained consciousness. His vitals signs (unspecified) were stable, blood sugar was 9 (unit not provided), blood pressure was 132/95 (unit not provided) and respiratory rate was at 18 (unit not provided) (NR: not provided for all tests). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on APR-2021, had not recovered from dizziness, nausea, and pain in back of head, and the outcome of blood sugar was 9 and blood pressure 132/95 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210420193- Covid-19 vaccine ad26.cov2.s-loss of consciousness. This event is considered unassessable. The event 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.

Started with pain in the abdomen and chest after sinusitis Flammable throat started The phlegm has already drained everything I had. Without sinusitis Only fever and sore throat Fever. sweating all night yet I'm using medicine for those sintomas

THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT HE HAD. HE STATED HIS CHEST FELT TIGHT. HIS EYE MAY HAVE ROLLED BACK NOT SURE AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER FOR FURTHER OBSERVATION

The patient wanted to go to the restroom after getting the vaccine. He said he felt a little nauseous and had a slight headache but felt ok to walk to the bathroom. After returning from the bathroom, the patient informed he gotten a little dizzy in the bathroom and passed out. His head was bleeding. Patient informed his head was hurting at hit sit, feeling nauseous, vision a bit blurry and did throw up a bit. He was able to state his name, address, DOB, and was cognizant. There was no signs of SOB or allergic reaction. The EMS was called and it was detected his BP was a little low. Patient did feel a little better but it was advised to go to the hospital to make sure he did not have a concussion. Patient was then escorted by EMS to the hospital.

Patient got vaccine and sat down for observation. He reports that after 1 minute, he was shakey, sleepy, and very tired. Then he felt like he fell asleep until the person checking him called at him. He had some vision and hearing impairment at the beginning, then after 10 minutes he was better. His arm was hot, he was sweating, his skin was turning white color. His mom came (she was shopping) and said the patient is usually an anxious person, so it was overwhelming to be at department store and getting the shot. After another 10 minutes, he was drinking water, his senses were back, he was fine.

Systemic: Seizure-Severe, Additional Details: within 5 minutes after administration, he collapsed, lost conciousness and had a seizure which lasted 30-40 seconds. we protected his head and laid him flat on ground and called 9-1-1. he maintained breathing and pulse throughout. when EMTs arrived he walked out with them for further evaluation.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a syncope event shortly after receiving Janssen Covid vaccine. Patient put feet up and laid back for additional 10 minutes after initial 15 minute observation. BP and Pulse were not significant (176/79 and 79). Patient recovered after 25 minutes and went home.

Patient received J&J covid vaccine on 4/7/2021. Patient presented to the ED on 5/3 for right arm swelling with redness. Patient was found to have proximal right upper extremity DVT extending to right subclavian vein along with bilateral PE in the ED. The provider noted the patient had no risk factors other than receiving the vaccine, requested a hematology/oncology consult for evaluation hypercoagulable , patient started on bivalirudin while HIT work-up completed plan to transfer to oral anticoagulation upon discharge.

I asked the patient how he felt after the injection and he said that he felt a little lightheaded and nauseous. He said he had a little too much to drink last night because his buddies were moving West. I asked him to lay on the floor but he refused. He said, "I just want to sit for a while". Within minutes the patient turned pale and started twitching. I asked another pharmacist to help to move him to the ground. 911 was called while patient was on the ground lying sideways because I was afraid that he may choke on his vomit. In a few minutes, patient sat up and asked for a bucket to throw up in. The Fire department came and took his blood pressure (BP120/?) and asked him some questions. They his blood pressure was good and advised him not to drive home. They helped him to get back on the chair. He stayed in the vaccination booth for us to keep an eye out until his friend showed up to take him home (30 minutes later). We had a male associate escort him out because he said he was still nauseous.

7 May 2021 0900 hours - Vaccine received 0945 hours - Mild paresthesia experienced throughout left side of body (arm, leg, back, shoulder, neck) 1100 hours - Onset of mild headache 1630 hours - Experienced fatigue and lightheadedness 1800 hours - fever of approximately 103 degrees, chills, shivering, body aches, and moderate headache 1900 hours - Individual's face and extremities became cold and discolored: hands and lips of purple hue. Individual also experienced muscle spasms and cramping in back and legs. 1800 - 2300 hours - Aforementioned symptoms persisted in cyclical fashion. At one brief point, individual experienced dull pain in testes. 2300 hours - Continued fever with nausea, painful headache, and body aches. Individual unable to sleep due to headache. 7 May 2021-8 May 2021 2300 - 1100 hours - Aforementioned symptoms persisted. 1100 hours - Fever and headache subsided, but body aches persisted. Individual did not treat symptoms with OTC medication

2:05pm Post vaccination witnessed client pass out for about 30 sec., then becomes conscious responding to verbal / tactile stimuli w/ full orientation. During transport to medical monitoring witnessed another unconscious episode x 30 sec, noted color pale, skin cool/ clammy, again becomes conscious verbalizing and responding appropriately to questions. Vital assessment: BP 122/44 P85 O2 sat 99%RA; Upon several attempts to sit up during medical monitoring reports increased dizziness, remains aaox3 at this time. Plan for transport to ER for further evaluation/ treatment, for unresolved vasovagal episodes.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient went unresponsive approximately 30 seconds after vaccine administration, was unresponsive for a total of 30 seconds, his neck and face were flush, pupils were dilated and his eyes wandered. He woke up confused.

Administered vaccine in left arm at 11:46 AM . about 11:48 patient said he felt lightheaded. I got up to get patient a Gatorade and he began to snore. I realized he had passed out . I held his arm and said his name he immediately jerked awake and did not know where he was or what he was doing. He drank some Gatorade and ate a couple of chocolate kisses. He began to have cold sweats that lasted a few minutes. I sat with him in counseling room for 15 minutes and then he sat in waiting room until he felt better. He did not feel that he needed further attention or medical assistance.

About 2 minutes after injection patient became pale and he verbally says he is feeling dizzy. I quickly grabbed an ice pack and placed it behind his neck to keep him awake. He started leaning forward and told me he is loosing his vision. He leaned forward and I had to support his chest with my arm all the while trying to talk to him. He dropped his phone and wallet on the floor. He seemed to be loosing conciousness. I had an epinephrine 0.3 mg in my hand but because he was speaking I did not inject him. After about 20 seconds he started gaining his vision back but he said his vision is still fuzzy. After about 2 minutes he felt better so I asked him to position himself at the blood pressure machine. It was 86/65. He does not take any medications or has any health issues. After 10 minutes he took blood pressure again and it was around 129/91. He used the restaurant during the 10 m inute break.

SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-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: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. 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).

Shortly after (4 days) receiving the vaccine I began to experience leg pain and minor cramping, in addition to mild general pain. This continued for about 1 week. I still have occasional pain, particularly in the legs, made worse by exercise (lighter exercise than would normally cause pan). I have also been experiencing hypertension that, to my knowledge, did not exist prior to receiving the vaccine. This has persisted since first measured 5 days after the vaccine until today, more than a month after receiving it.

Pt got J&J vaccine around 1:25pm. After shot administered, while talking to me, patient suddenly slumped over into my arms and eyes rolled back and lost consciousness for about 10 seconds and he was making some gurgling noise. Some excretions came out of his nose and he came to and was able to lie on floor to elevate his feet, but still was very dizzy. First responders showed up and his vitals were WNLs, but pt continued to look pale and struggle to come to upright position for another 15-20 min. Pt's friend showed up to pick him up and he was able to walk out to the car without issue.

PALPITATIONS; HEADACHE; FEVER 102 F; This spontaneous report received from a patient concerned a 26 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced palpitations. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever 102 f, and palpitations. This report was non-serious.

Gave patient vaccine at 9:55 AM. Patient was instructed to hang out seated in the pharmacy department for 15 minutes. Patient was feeling fine and proceeded to head to customer service counter in store where he lost consciousness falling forward hitting his face on the counter, and then fell back hitting the back of his head on the floor.

2:01P PT RECEIVED VACCINE. 2:02P PT MOVED TO LOBBY AND SAT AT BP MACHINE. STATED HE FELT DIZZY AND LOST CONSCIOUSNESS AND FELL TO THE FLOOR. REGAINED CONSCIOUSNESS BY 2:04P ASKING WHAT HAPPENED, STATED HIS WRIST HURTS. ACKNOWLEDGED HE ALWAYS FAINTS WITH VACCINES/NEEDLES. BY 2:08PM PT REPORTED FEELING BACK TO BASELINE BESIDES HIS WRIST. EMS ARRIVED BY 2:18PM. WHEN GETTING HIM TO SIT UP HE FELT DIZZY AGAIN AND LIED BACK DOWN. WAS ABLE TO SIT THEN STAND BY 2:25PM. DUE TO THE DIZZINESS AND FAINT FEELING LASTING GREATER THAN 10 MINS, EMS RECOMMENDED AMBULENCE TRANSPORT TO HOSPITAL. PATIENT REFUSED STATING HE FELT EXACTLY AS HE HAD IN THE PAST WHEN HE HAD FAINTED PREVIOUSLY FROM VACCINES. NO REDNESS/ITCHING/SWELLING/PAIN AT SITE OF INJECTION. DECLINED TRANSPORTATION TO HOSPITAL. ONLY COMPLAINT WAS WRIST PAIN WHICH WAS A RESULT OF FALLING.

The patient fainted shortly after receiving his vaccination. He claimed to have a history of fainting after blood draws. He was fully recovered shortly after.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was very nervous/anxious upon arrival. Shortly after the vaccine was given he became unresponsive and unconcious. 911 was called. Patient became responsive minutes later. Patient became unconcious for a second time while EMT was present. Patient was taken to the hospital.

few minutes after the patient had the vaccine, he felt dizzy, start sweating, his face and lips looked pale. we gave him water and snack, then he felt fine. this just last 5 minures.

Patient experienced vagal reaction to the vaccine. He states that this is due to the fear of needles.

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.

Medical evaluator reports: profuse sweating, delayed response, near syncopal. EMS reports: Pt feeling dizzy with Blurred vision after receiving shot.

Patient reported dizziness, nauseous and had syncope. EMS was called, vitals were checked, patient refused hospital services and was stable after 10 minutes. Patient received hydration and left at 1pm.

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.

Approximately 60 to 90 seconds after administering vaccine to patient, the patient experienced a vasovagal syncope episode. The patient briefly lost consciousness. The pharmacist was able to catch the patient as he lost consciousness and prevent him from falling and further injuring himself. The patient was then moved to a mat on the floor to rest and recover. The patient regained consciousness as he was being moved to a mat on the floor. The patient then maintained consciousness and recovered fully from the event after approximately 20 minutes. The patient was monitored for 30 minutes prior to leaving the pharmacy. He also had a family member (his father) who accompanied him to the appointment and was the patient's driver to and from the pharmacy for his vaccination.

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.

Patient recieved Covid vaccination from our intern and 10 seconds later reported feeling dizzy and unwell. Pt sat down immediately in consult room but then fainted and fell out of the chair and landed face first on the floor and experienced seizing motions. Patient was out for 30 seconds to a 1 minute. The patient came to and reported feeling better, wanted to sit up and wanted water. A water bottle was provided for the patient. 911/paramedics were called and 3-5 minutes later the patient fainted with seizing motions again but was supported and did not fall out of chair again. shortly after the second fall, paramedics arrived and took over. patient ate 4.5 hours prior to vaccination and also reported never fainting before after or while getting a vaccine.

Status post receiving J&J on left deltoid. Patient stated he has a fear of blood prior to receiving the vaccine. Patient went to the observation area and was noted to have a syncopal episode witnessed by RN. Patient was noted to be pale and diaphoretic. Patient was lowered to the ground by two (2) RNs. RN held c-spine while lowering patient to the floor. He was nonresponsive for approximately 30 seconds. No injuries were noted. After being lowered to the ground in supine position, patient was A/Ox4. Vital signs were assessed as follows: O2 was 98%. HR was 65. Temperature was 98.1. BP was 116/75. Respirations were 16. Patient stated he has a history of a similar incident that happened 7 years ago when he cut his finger he "passed out." EMS was called at 1425 and arrived at 1430 and assisted him into a chair. Upon checking his blood sugar, patient immediately had a second syncopal episode/LOC while EMS was on scene. Patient was again lowered to the ground in supine position. EMS performed a 12 lead EKG and transferred him to a stretcher. Patient A/O x4 prior to EMS departure. EMS left with the patient at 1445.

Patient was seated for 10 minutes post vaccination, then suddenly turned pale and passed out. Patientas laying on floor on his stomach with seizure-like muscle contractions for a minute, then stood up abruptly. Patient was seated in chair again and reported feeling unwell, woozy and nauseous. EMS was called and evaluated patient. Patient declined further medical treatment or transport to hospital.

Within about 30-60 seconds of vaccine administration, patient became lightheaded and experienced loss of consciousness. He was sitting in a chair at the time and was prevented from falling. He was moved into the supine position on a cot with feet elevated and rapidly regained consciousness. Over the course of several minutes, his condition improved and he experienced a complete recovery.

Patient came into pharmacy for scheduled vaccine appointment. They stated they were nervous about needles but that they wanted to get vaccine today. Patient was able to have a normal conversation about travel plans while I administered vaccine. Right after administration I turned to get band aid and patient fainted out of chair. His companion and I got him seated again right after and he resumed normal behavior. I gave patient cold compress and observed him for about 20 minutes.

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 .

patient received Janssen vaccine around 10:37am . After receiving the vaccine, patient is sitting on the chair and waiting for observation. After a couple minutes later, he fainted and fell off the chair and laid on the floor. He was sweeting but alert. Patient stay in the pharmacy for about 30-40 minutes for observation . He was fine after all

The patient calmly walked out to seating area and sat down after receiving vaccine. The patient did state that he "did not like needles". After a few minutes the patient went pale, started sweating, then lost consciousness for about a minute. During that time patient was unresponsive. No vitals were taken. I ran to get an Epipen and by the time I came back the patient was alert and responsive albeit a little shaky. Patient was given water, a small Cliff bar, and an orange soda. After about half an hour, the patient stated he was fine and left.

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.

Pt. tol vaccine well and was moved to observation room. He was given water and apple juice--both of which he quickly finished. Appx. 3 minutes after vaccination, pt reported feeling dizzy. 1 minute later, became diaphoretic and reported losing his vision. CNP was called in and pt. was moved to a lying position in our recuperation area. As he was being lowered, pt fainted. After 5 seconds, he became cogent and said he felt fine. Cool cloths were applied. He remained lying for about 20 minutes before sitting in a chair for another 10-15 minutes. He finished 2 bottles of water and 2 boxes of juice in this time period. Pt. left with friend feeling better. He was instructed to continue drinking water.

Patient has a history of dizziness with shots, so they elected to get the Johnson and Johnson shot so that they would only need one shot. Patient received the vaccine in the counseling area, and the shot itself went as usual. About 15-45 seconds after the shot the patient stated that they began to feel dizzy. The patient then tried to lower himself to the floor. As soon as he started, he lost consciousness and fell forward out of his chair. He got some carpet burn in the area surrounding his eye. About a dime sized area above and a quarter sized area below. His head also mildly bumped against the wall. As soon as he passed out, 911 was called as a precaution. He was responsive within the minute, stating he was fine. He lost consciousness soon after for about 30 seconds before becoming responsive again. He was able to hold a conversation upon awakening. Patient states this is normal for him to experience. He has some discomfort with the carpet burns but reported no pain from bumping the top of the head. We offered some Neosporin for the carpet burns but patient stated that medication smells can sometimes make him dizzy, so we did not use any. We did provide him with some bandages for the area. I advised him to wash the area with soap and water at home. We kept him in the pharmacy for a half hour keeping conversation with him to make sure he was all right. He was able to stand on his own without issue after 25 minutes, he did not have any issues with dizziness at this point. After the wait and with patient being back to baseline, they wanted to get home and proceeded to go home. Before they left, I did verify that he was not the one driving home. Ii advised them to seek any medical attention if he has any further such issues. Patient came back after about 45 minutes asking what to use to clean wound. I recommended Neosporin, we did provide patient with both Neosporin and rubbing alcohol.

SLIGHT DIZZINESS, THEN FAINTED, UNCONCIOUS FOR A FEW MINUTES, MOTHER ASKED US TO CALL 911 - REGAINED CONSCIOUSNESS AFTER 3-4 MINUTES, PALE BUT AFTER IS FINE,

Patient fainted after about 5 to 10 minutes never stopped breathing emt checked patient out and he left of his own accord stating he was fine now

approx 10 hours after shot, he felt chills, body aches and then sudden onset of nausea and then woke up next to his desk. uncertain length of time of LOC. next day feeling tired and achy but better

After receiving the Johnson & Johnson vaccination at approx 0855 the patient told the vaccinating nurse that he was "feeling dizzy." Pt then fainted and was lowered to the floor and positioned on his side; he was pale and diaphoretic initially but resolved before he was sat up. He then opened his eyes and stated that he was "feeling ok." Patient then confirmed that he has fainted twice before while receiving bloodwork or vaccines. Pt refused emergency services. Pt advised to call 911 or seek medical attention for any concerns after leaving facility. Pt verbalized understanding. Pt vital signs are as follows BP 136/58, R 18, P 84, O2 sats 98% on room air. Pt alert and denies any pain or discomfort. Denies any further concerns. Pt left facility at 0900.

elevated temperature of 99.3, some shivering soreness through upper back, shoulders, and neck with a bit of stiffness all mild

PATIENT FAINTED ABOUT FIVE MINUTES AFTER GETTING THE VACCINE. HE CAME TO AFTER ABOUT 30 SECONDS . CALLED PARAMEDICS AND HE WAS ATTENDED TO. HE DID NOT HAVE ANY OTHER REACTION. PT MENTIONED THAT HE HAD NOT HAD ANY FOOD SINCE MORNING AND HAS HISTORY OF SYNCOPE AFTER BLOOD DRAW.

Patient noted to have unsteady gait - experienced syncopal episode. Placed in supine position, with BP 82/40 (pulse 46). Blood glucose 112. Given 500 mL normal saline. Sent to Medical center.

Client complained of feeling dizzy and light headed after receiving the vaccine, He reports an allergy to Bananas which causes anaphylaxis. He does not carry an Epi Pen. Vasovagal event with no syncope. Blood pressure 87/41 pulse 78 with 02 saturation 96%. Se4cond set of vitals in 5 minutes was blood pressure 116/70 with pulse 75 and o2 saturation 98% . Released by Dr after second vitals by EMS on site. Advised to seek medical attention later if needed. Client stated understanding.

Syncope possible seizure about 5 minutes after vaccine. Vitals stable. Refused transport to ED. Mother drove him home.

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).

Patient became lightheaded 10 minutes after getting vaccination and wanted to go to the restroom. Was advised to wait but he got up and did faint. Epipen was administered and patient refused any further treatment. After further discussion patient disclosed was nice Saturday afternoon and had a few beers before coming in.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild

THE PATIENT PASSED OUT A FEW MINUTES AFTER RECEIVING THE VACCINE. HE FELL OUT OF HIS CHAIR AND WAS FULLY CONSCIOUS WHEN I CAME TO HIS SIDE A FEW SECONDS LATER. WE HAD THE PATIENT STAY LAYING DOWN AND HE SAID HE FELT COMPLETELY FINE. THE PATIENT DID NOT WANT US TO CALL AN AMBULANCE. AFTER A FEW MINUTES, WE TOOK THE PATIENT TO OUR PRIVATE CONSULATION ROOM AND CONTINUED TO MONITOR HIM FOR AT LEAST 30 MINUTES. THE PATIENT'S MOM ARRIVED AT THE STORE, WE EXPLAINED THE SITUATION, AND THEY LEFT TOGETHER. WE CALLED THE PATIENT A FEW HOURS LATER AND HE WAS DOING FINE.

Approximately 5 minutes after vaccine patient felt lightheaded. Pharmacist immediately checked on patient who was beginning to become incoherent. He had a mild seizure and ems was called. Patient was sweating and pale. He remained onsite with EMS and later left with a family memeber.

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.

Immediately following injection the patient stated he was going to pass out. He lost consciousness for approximately 30 seconds. He was confused and disoriented for a few minutes. Radial pulse was present and regular at 66, O2 sat was 96% on room air, BP was 118/77. Skin was warm and diaphoretic. He was monitored for 30 minutes in Observation area. He refused offer of EMS transport, When he left the clinic he was alert and oriented with no complaints.

Client seen face down on floor. At first, client seemed like he could be convulsing so 911 was called immediately. 2 PHNs and one safety officer came to be with the client and assess. Client suddenly woke up after being on the ground for approximately 5-10 seconds. Client was awake and able to talk. Client?s legs were elevated on a chair. Per safety officer, client hit left forehead on ground. Dr. came over to assess the client. Vital signs taken. BP=152/71, HR=72, 99=O2. Client explained that he had yogurt and honey along with coffee that morning for breakfast. Client explained that he has feeling lightheaded at first when walking back to observation area, he sat down, and then he suddenly woke up on the ground. Client did not want offered ice pack for his forehead. Dr. gave the OK to cancel EMS after assessment of client. Client given juice, fruit strips, and water. Client moved carefully to chair with armrests and seen sitting with roommate, which he came to the clinic with. Rechecked client again around 1045. BP=127/79, HR=68, and O2=98%. Client said his head was feeling OK, but neck felt like it was tweaked but said a hot shower would likely help. Client said he did not need an ice pack. Dr. reassessed the client saying he was good to go. Before client left, he was given additional fruit strips and juice. Client walked out of clinic with roommate.

Side effects started at 630pm same day of vaccine Started with muscle aches, then severe chills and fever of 101°F. At 5am the following day a fainting spell occured after awakening in severe hot flash with fever of 100°F. Lost consciousness for about a minute. Continued with chills and fever for about another 3 hours. Awoke next day with headache for about 2 hours then felt better and continued on normal. Treated with tylenol

On 04/04/21, around 11 AM, the customer walked in for his COVID vaccine appointment. After registering for the vaccine , the patient sat in the designated area and one of our immunizing technicians administered the vaccine while I was observing and I left the immunization area while my technician was finishing up cleaning. When the patient asked the immunizing technician a question about side effects, she offered him to talk to the pharmacist at the consultation window. While I was assisting the next customer, I heard a loud sound and saw the customer collapsing on the floor. I ran outside and checked his pulse, and asked to call 911. He was conscious and breathing. I went inside the pharmacy to get EpiPen and informed the customer that I will be administering EpiPen, but he denied it. In the meantime, the immunizing technician was already on hold with 911 and informed that they are on the way. The customers in the waiting area also kept him engaged and were watching him if he is alert. The store manager on duty was also in the pharmacy area. I came inside the pharmacy and offered the patient a chair to sit in. Paramedics arrived in a few minutes to transport him to the hospital. The patient came back to the pharmacy around 2:30PM to collect his immunization card and when I inquired about how he is doing, the patient informed me that he is feeling more better and the ER determined that there was no allergic reaction to the vaccine but the patient most likely stood up too quickly after the vaccine was administered.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccine was administered, patient lost consciousness

Diziness, Sweating, Visual disturbance, Heavy arm, Pale, Hearing disturbance (hearing voices), Nauseated

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.

vasovagal episode / syncope with subsequent fall to ground, striking head. lightheaded, clammy, loss of vision prior to episode. Brought to Emergency Department, discharged to home in stable condition within 5 hours.

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.

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.

4/07/21 12:40 PM B/P 140/78 Pulse 71, 12:56 PM B/P 144/72 Pulse 69. Chief Complaint loss of consciousness. No history of diabetes mellitus or seizure disorder, loss of consciousness with seizure like activity, not post ictal, recovered in less than 5 minute, then alert and oriented per EMT notes. EMS called and transferred to Hospital.

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.

Dizziness with HA with intermittent mid-sternal burning CP x 3 days; room is spinning; CP lasts few seconds, nothing makes/worse better; Denies any CP at this time; non-radiating; 325mg Tylenol at 0515. CHIEF COMPLAINT & HPI: 27 yo M with fatigue, bodyaches, chills, headache, and gastritis after covid vaccine on tuesday. no numbness or weakness. Pt endorses peripheral vertigo. no nausea/vomiting. no anginal chest pain. no cough/SOB.

Patient received Janssen COVID19 vaccine at 9:30am. Upon receiving vaccine he sat down on chair to wait for 15 minutes post-vaccination. Just minutes after sitting down patient lost consciousness, fell from chair, and hit his head on a nearby countertop in room. He fell on his side on floor, EMS were called, and ice pack was placed on his head while awaiting EMS arrival.

I gave the vaccine around 6:20pm after counseling on possible adverse reactions and going over the patient's questions. I then asked them to wait 15min. Within 5-10mins the patient got up and came back to our counter saying he thinks he's having a reaction. I pulled him back into our vaccination area and had him sit down and explain what he was feeling to me. He looked pale and told me he felt dizzy, sweaty, shaky, & nauseous. He wanted me to grab him a bag incase he puked. I grabbed a bag as well as water and Benadryl. I asked if he was having any issues breathing or if it felt like his tongue was swollen at all. He said no issues breathing and tongue felt fine. He started to feel better within about 10-15 minutes after onset. He did not puke and his color returned. I had him wait an additional 10-15 minutes after that to make sure we were recovered. I asked him if there was anything else going on and he mentioned that he hadn't slept well the night before and that he had barely eaten today. He also mentioned he can get anxiety. I told him all of those factors could certainly contribute to what he just experienced but that I would be reporting this on to be safe.

Chills, Muscle aches throughout my body, Elevated Heartrate (~115bpm while laying down trying to sleep-recorded on fitbit), could not sleep due to symptoms persisting through the night. Took tylenol in the morning and symptoms faded soon after. Took another dose of tylenol in the afternoon when symptoms seemed to be returning. Symptoms did not return afterwards

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.

PASSED OUT; FALL OVER; COLD; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old white, not Hispanic or Latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that day after vaccination on 11-APR-2021 in early morning, the patient had chills and fever. The patient went down to get some unspecified medications and he passed out for roughly 5 minutes and fell over. The patient had headache at the time of this report. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, cold, chills, and fever on 11-APR-2021, had not recovered from headache, and the outcome of fall over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421495 - covid-19 vaccine ad26.cov2.s- Passed out. 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).

12 hours after vaccination, had a fever, chills, increased heart rate (roughly 50 bpm higher than normal), headache, pain in chest. This lasted roughly 12 hours through the night and into the morning

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: this patient has had similar events with all vaccines administered in the past. he has even had a similar event at work recently due to a cut on his hand.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: IMMEDIATELY UPON INJECT THE PT FAINTED. I GOT HIM ON THE FLOOR AND ELEVATED HIS FEET. CHECKED HIS PULSE AND BREATHING. GAVE HIM WATER. HIS MOTHER KEPT CALLING HIS NAME. WHEN HE SAID HE WAS FINE. HE SAT DOWN THEN FAINTED AGAIN. 911 WAS CALLED. EMT ARRIVED AND TOOK CARE OF HIM. HIS MOTHER DROVE HIM HOME. MOTHER STATED HE DOES THIS EVERY TIME HE GETS A SHOT

On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.

27yo male vaccinated with Janssen covid vaccine. Within minutes of standing up from vaccination in the vaccine booth, stated he was dizzy. I sat him down immediately, he was having trouble staying awake eyes glossing over, speech very slow. I turned to push the door open into the main pharmacy to call for help and have them dial 911, grabbed epinephrine and ammonia salts as well. When I turned back he had slumped in his chair. As I took the step back towards him, he spontaneously started to sit up and speak. Was diaphoretic, still slow speech eyes glossy. I supported him as best I could. His HR was 42, i lifted his legs up unto to a chair in quazi trandelenburg position. He stated that made him feel alot better. I stayed with him until EMTS arrived. He got himself onto they stretcher and they took him out of the store.

Patient received vaccination. While he was sitting for 15 minute post-observation he notified us that he was feeling dizzy. He also became pale and started sweating. We had patient put his head between his knees, gave him some water, and a cool, moist towel. After a few minutes patient felt much better and got his color back. He never fainted or lost consciousness.

DIZZY, SYNCOPE, DIAPHORETIC, PALE, BS: 62, ATE SMALL MEAL EARLY AM,SEEN BY PARAMEDICS, VSS, PROVIDED GATORADE AND FOOD, SX IMPROVED, REFUSED TRANSPORT, AMA SIGNED.

FELT FAINT, DIAPHORETIC, PALE, SYNCOPE FOR 15 SEC, WOKE UP, PROVIDED DRINK AND SNACK, SYMPTOMS RESOLVED, REFUSED TRANSPORT.

PATIENT FAINTED 10 MINUTES AFTER ADMINISTRATION OF COVID VACCCINE. CALLED 911. EMS CAME TO PHARMACY AND EVALUATED PATIENT. PATIENT WAS NOT BROUGHT TO HOSPITAL AT THIS TIME.

Found to have myocarditis with troponin of 8 after presenting with three days of chest discomfort following the vaccine. Normal echocardiogram.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted and had seizures like symptoms along with cramps. Patient fainted for less than a minute. Was breathing and talking soon afterwards. 911 was called.

CHEST COLD; FEELING SICK; FEVER; PRESSURE IN CHEST; COUGHING ON AND OFF; DIZZINESS; NOT FEELING GREAT; SORE ARM; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported,1 total administered administered on 03-MAY-2021, 17:00 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, after 30 to 50 minutes of vaccination, the patient started feeling not sober, dizzy, not feeling great and sore arm. On 04-MAY-2021, (Tuesday), the patient woke up feeling really sick, feeling feverish then felt better during the afternoon (around 5 pm). The patient felt like he had a chest cold, he was clearing his throat more often, feels a kind of pressure in his chest (but no shortness of breath) and was coughing on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling sick, and fever on 04-MAY-2021, had not recovered from cough, and pressure in chest, and the outcome of sore arm, chest cold and feeling bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210509097 (same reporter).; Sender's Comments: V0;20210509350-covid-19 vaccine ad26.cov2.s-Chest Cold. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

I was feeling fine drove hope happy about getting the vaccine. When I got home after 20 mins exp uncontrollable shivering and teeth chattering(appeared comial). I took an Advil went to sleep, got back up middle of the night with 103 fever, high heart rate, full body, sweats sustained for the better part of next day. I continued to rotate Advil and Tylenol for high grade fever lasted 1 day and low grade day after.I was wearing Fitbit 105 beats per min abnormal I'm usually 50 beats per min. I contacted my doctor dint go in due to Covid regulations was advised to continue monitoring heart rate.

Patient recieved J&J COVID vaccine, after 1 minute was transitioned to the 15 minute waiting area. Upon arriving at the chair, patient fainted and fell to the floor, patient was out for approximately 20 seconds and came to. I then asked the patient if he hurt or felt injured, assessed his alerteness he was alert and oriented x 3. He transitioned to chair under own power and was speaking with me, his eyes then rolled back in his head for approximately 10 seconds went out again. At this time we called the ambulance, they came to assess patient, patient refused transport to hosptial and left under his own power.

About 8 minutes after injection, patient comes to consultation window to ask question unrelated to vaccine. Upon walking away, he gets light-headed and starts to fall. He half catches himself on immunization booth nearby. He sits in chair in booth. I check on him. He says he is ok. He is a little pale and sweating a little. A few minutes later he says he is fine and wants to leave. he agrees to stay longer. A little later after other store team members have checked on him, I check on him again. He says he is fine and then leaves.

Patient said that he sometime faint when receiving a vaccination, but proceed with the Janssen Covid-19 shot at 9:50a. Then, had a syncope episode at 9:52a. EMS at Amazon was called to tend to the patient while 911 was called. Patient left with the ambulance service.

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

Patient had a syncope event post vaccination, was caught by nurse before hitting floor. 911 was called and was assessed by the paramedics and the patient and was cleared to go home. Additional set of vitals -done and were WNL and patient was finally released and sent home. No further action taken

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: First BP reading was 108/49 pulse 45 at 4:08pm and second reading was 122/77 pulse 76. Patient experienced profused sweating, dizziness, and hypotension. After hydrating and laying down he gradually felt better.

patient took vaccine went over to post vaccination area and fainted. Patient immediately woke up in cold sweats. Sat for 30 minutes and felt better.

After injection, patient jolted and eyes fluttered. He seemed to be having a seizure like reaction. He then slumped to side and head hit side of wall since we had chair with side rails positioned against wall. He lost conscious for maybe 30 seconds and then eyes opened. I asked if he was OK and the first thing he asked for was water. He said he felt light headed and dizzy. I had my intern who was working grab him water from the deli and had him sit and rest. He started sweating and asked for paper towels. I grabbed him a couple of towels so he can wipe his face. I continued to check on him while doing my work. He seemed fine after that. After 30 minutes, I checked his blood pressure. It read 100/63. I continued to monitor him and he left after that. He did have friend with him the entire time who helped him.

5 min after shot. Warming sensation spread from arm across my entire body. Felt nauseous and blacked out. Passed out face first on the floor. No fear of needles. I have records of getting previous flu vaccines without passing out. I have been experiencing hot flashes, nausea and fatigue for 6 days now.

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.

Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt dizzy/like he was going ot faint after vaccine. sat with him for a few mins (held head between legs) and checked his vitals. all were good. pt was very anxious because he was diagnosed with afib recently and felt like his heart was being fast (vitals normal) - had us call an ambulance. they came and did vitals as well and more specific cardiac readings and everything was normal. they left and pt went home fine.

At approximately 6:47pm we gave a Janssen COVID vaccine to the patient. After a few minutes the patient became noticeably sweaty with pallor. I talked with him and he said he was dizzy as well. He stated that it is due to anxiety. I checked his blood pressure and it was 124/94 with a pulse of 83. We gave him a cold pack to use on his wrists and neck. We watched the patient for any worsening of symptoms. After a while the patient stated he now felt fine with no symptoms and left with no issues.

Patient stood up and walked over to register and said he didn't feel so well. I came around the pharmacy and he was fainting as I got to him. Technician called paramedics, store manager was called and when I asked him his name and if he knew where he was he said yes. We sat him up per his request. When he was well enough we sat him on a chair, I took his blood pressure and we got him water. He was on the phone with his dad who is a physician and dad said it sounded like a syncope and asked we give him gator aid. Paramedics arrived and they took his vitals and ran some tests.

Diffuse urticarial rash involving right axilla and over bilateral shoulders, developed intense chest pressure and squeezing, heart racing and when those symptoms resolved pt. became very weak. Of note pt. stated was lightheaded for 15 mins after receiving the vaccine

patient had post vaccine reaction to the Janssen vaccine. he lost consciousness without warning, his upper extremities were fixed and postured towards his chest. He contracted. He was LOC for an estimate of 15 seconds duration. He reported feeling nothing preluding to the LOC. He was fearful and agitated upon arousal. EMS alerted and patient workup done by EMS. Unknown whether patient refuses or consented to Hospital Observation.

Patient was nervous before getting vaccine. Within a few minutes after getting injection, he became very pale and clammy and asked for cold liquid. He consented to receive a Juicey Juice juice box and sat down with some cold wet napkins on his neck. He said he felt like passing out and we led him into our vaccine room where he lay on the floor for about 5 minutes. He then wanted to sit up. He felt much better and sat in our waiting room again for 10 more minutes. He left without further incident, having never lost consciousness.

Patient has history of fainting with needles. Patient started to feel lightheaded then fainted about 5 minutes after receiving the vaccine.

SEIZURE; DIAPHORESIS; PALE; NAUSEOUS; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient had no drug abuse or illicit drug usage. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 31-OCT-2021) frequency 1 total, dose was not reported, administered to left arm on 03-JUN-2021 at 14:37 p.m. for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, events occurred within 3 minutes post-vaccination- seizure, diaphoresis. After seizure-like activity, patient was nauseated and pale. The reporter began cool compress, BP monitoring (Blood pressure measurement) result not reported, called EMS (emergency medical services), and gave water and snacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, diaphoresis, pale, and nauseous on 03-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210607494-Covid-19 vaccine ad26.cov2.s-Seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Since my shot I have not been able to feel muscles all over my body. There is little to know sensation unless I press as hard as I can. Lymphnodes have been in pain and swollen since the first or second day after the shot. Headaches on and off for a month now. And my anxiety has been like I'm in fight or flight mode all of my waking moments. Even when I'm falling asleep. I will wake up with panic attacks. My muscles can't take talking on the phone for longer than 5 minutes before I have to switch to my other arm because the previous arm is "dead" in the muscles and couldn't do it any longer. Blood pressure was in the 180-190's / the high 80's and sometimes even 90 being my bottom BP number. It has since gone down because of meditation.

27 year old male with nka no known PMHx vaccinated with Janson vaccine on left deltoid @5:50 while on the waiting area @5:53pm patient was seating on the chair and suddenly fell dizzy patient fell on the floor hitting his face as a result of the impact patient broke his nose, with area of echimosis extending around the right orbit. 2-3 seconds after patient recovered consciousness and revised with no intervention needed... All vitals were stable.... Ambulance was offered for the patient and he refused stating this is regular for him every time he is "stick with a needle". Patient went home asymptomatic apart from tenderness and pain in the area. Next day Follow up calls were intended, but phone was never picked.

Patient stood up after vaccination and asked for water. The Pharmacist was getting water and he passed out. She went over with emergency kit and helped patient off the floor. He had a pulse and was breathing the entire time. She did not have to administer any medications. She called 911 and paramedics were here within minutes. He told the pharmacist after the shot that he passes out with shots , even though he put no on the form. Patient was fine and denied to go to hospital.

PT received the Janssen covid vaccination, after about 5 mins the pt fainted and then regained consciousness. Pt had hit his face on the floor, 911 was called to the pharmacy. 911 indicated not to give anything to the pt to eat or drink. Event occurred around 12:50/12:55. When EMS arrived a few minutes later and pt blood pressure was 125/81 , pt was feeling lightheaded and sweating profusely. Patient was also given an ice pack for his face, EMS took the pt to medical facility for further follow up

<10minutes s/p vaccine administration of Janssen COVID19, patient stated he was feeling faint. He was visually pale in the face, slightly slumped. No reports of trouble breathing/swelling/rash/hives. instructed patient to lay down if needed. Drank water. He started to feel better after 15 minutes; however, patient stayed 30 minutes till leaving pharmacy.

Patient was very dehydrated, lost consciousness a few times, lowered blood pressure. Blood pressure was taken, medical respondence was contacted, and they came and took care of the patient.

On June 19, 2021 I woke up around 6:00 a.m. having extreme chest pains. I went to the Emergency Room to be treated. They did an EKG, blood work, and an ultrasound of my heart. My EKG was negative for a heart attack, but my blood work was positive because of my Troponins were elevated. They gave me some aspirin and the chest pain went away. I was admitted into the hospital where I stayed until the end of the day on June 21, 2021. On June 20, 2021 they continued to watch my vitals, took tons of blood for blood cultures and for pretty much every virus you can get along with urine samples as well. All of the test for any virus and the blood cultures were negative. The urinalysis and urine culture were negative as well. Once all test came back negative, the cardiologist ordered a Heart cath. The heart cath was performed on June 21, 2021 and there was no blockage in any of my arteries and everything was clear so I was discharged that afternoon from the hospital. I was diagnosed with Myocarditis or Pericarditis. The doctor prescribed me 25MG Captopril to take 3 times daily and 25 MG Metoprolol Tartrate to take 2 times daily. I have only experienced any other affects a few times since being released which was a burning sensation in my check. I spoke with the doctor and they told me it could be indigestion or heart burn.

SEIZURE; PASSED OUT; POSTURE CONTRACTED; DIAPHORETIC/ SUPER SWEATY; CONFUSED; AFRAID; IT WAS LIKE A DREAM; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included chest burning, and concurrent conditions included seasonal allergy and non-alcoholic user and other pre-existing medical conditions included no previous medical history or conditions, no family history of seizures/epilepsy, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no family history of any disease (relevant to vaccination) or allergy, no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no drug abuse or brain surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On unspecified date in JUN-2021, Reporter stated that the patient had his head backwards, the patient posture contracted, passed out in the observe area, which was tight and small area. Reported did not see that patient fall to ground. Reporter assumes that patient must have had a fall to get from the chair to the ground when she was able to see. Reporter stated that the seizure was about 15 seconds, eyes rolled back, blank stare, eyeballs twitching, full blown seizure. Reporter stated that when patient came back, he was super sweaty, diaphoretic, and only remembers that his chest was burning prior to vaccine. Reporter mentioned that patient did not know that he passed out. Reporter stated that patient said it was like a dream and do not know how long he was out and stated that he just said his chest was burning. Reporter mentioned that the guy was afraid and did not know what happened. Patient was confused upon waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, passed out and it was like a dream and the outcome of posture contracted, diaphoretic/super sweaty, confused and afraid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210667371-Covid 19 vaccine-Seizure, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient 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.

Pt reports fainted in chair while waiting the 15 minutes after receiving the JJ vaccine and states hurt his right shoulder when he fell.

No more than 60 seconds or so after vaccine was administered, patient stopped responding verbally then his head tilted backwards (seemed to be vasovagal response). Held patient's head upright so that he did not hit his head on wall and applied ice pack to the back of his neck. Patient twitched, sneezed, then muscles tensed and then relaxed. He came to not 45 seconds after initially losing consciousness. Patient was very pale and sweaty. He asked for water and sat for 5 minutes or so. Patient said he was then feeling a bit lightheaded so we gave some orange juice. 5 more minutes passed and he said he was feeling much better. Patient described feeling very dizzy and not being able to hear clearly before losing consciousness

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.

Broke into cold sweats when I went to the bathroom. Went back and sat in the chair and blacked out. Eyes rolled into the back of my head. Stiffened up and rolled out of the chair. Then I slowly came out of the black out.

fever, headache, chills, body aches, burning eyes followed by nausea and burning chest when taking deep breaths

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.

07:40 patient reported to mother that he was "lightheaded and dim vision" then mother witnessed syncope. Nurse assessed patient LOC but breathing was recorded at approximately 1 minute with pallor, cool, and clammy skin. ED was notified of patient transport. Vitals were obtained BP - unobtainable, HR - 44 faint and thready, Resp -10. Patient regained consciousness and informed nurse that he had "white coat syndrome and history of fainting with blood drawn and doctor visits" he apologized for not notifying nurse prior to vaccination. 07:43 patient has second witnessed syncopal episode after reporting "dim vision", patient was lowered to floor with assistance from 3 nurses and bystanders. Vitals obtained - BP - 117/76, HR - 46 Resp - 12. LOC lasted 30 seconds, patient was pallor, skin was cool and clammy. Patient regained consciousness and was alert and oriented x 3. 07:48 patient was assisted to sitting position and then assisted to W/C and escorted to the ED with a nurse, CNA and family for examination and further treatment. Upon leaving patient had pink color, skin was warm, but diaphoretic. Pt entered ED at 07:55 VS BP - 141/83 MAP - 102 HR - 66 RR- 20 SPO2- 96% Temp - 97.9. Pt was observed in ED for an hour and was provided food and liquids after report of not eating or drinking since previous night.

I started to get uncontrollable shakes the night of my vaccine for 10-15 minutes. I had chills for about an hour afterwards and a sleepless night. The next morning I woke up with a headache and was achy/sore throughout my body. While I was eating I passed out without any signs. I was unconscious and do not remember the episode. Once I was alert, I felt nauseas and was heading to the restroom when I passed out again and was unconscious. I do not remember the episodes. There were no signs of passing out before I did either time.

--- 3/20/2021 10:39 AM --- Member received COVID-19 Vaccination, while completing 15min wait post vaccination wait period member lost consciousness, fell to ground on Left side, denies head pain, no edema/brusing noted, not tender to palpation on exam, VS Stable, assisted to exam room and supine position with LE Elevated, Abrasion on L hand, member declined dressing. Completed 20 min wait in exam room, assisted to sitting and standing position with no lightheadedness or dizziness noted, able to ambulate 50 plus feet independently. Member home in Private vehicle.

PATIENT WAS SITTING IN OBSERVATION AREA WHEN HE BECAME DIAPHORETIC AND PALLOR, STATED HE FELT HOT AND FLUSHED. PT WAS FAINT BUT DID NOT LOOSE CONSCIOUSNESS. HOWEVER PATIENT WAS LOWERED TO THE GROUND, CLOTHES LOOSED. PT WAS MONITORED FOR AN ADDITIONAL 30 MINUTES WHERE SYMPTOMS RESOLVED PATIENT WAS THEN RELEASED HOME TO SELF CARE

Body Ache starting 9 hours after. Main concern, I fainted while walking from the bathroom and split my eyebrow open. Could?ve been much worse but is a bad side effect. This occurred about 16 hours after vaccine

pt was extremely anxious about getting the vaccine. pt was fine during the administration. 5 minutes after pt sat in the observation area he felt light headed and clammy . we eased him down to the floor before he passed out. We them put ice packs around his neck and hand. he came too and after resting for 15 minutes in a supine postion he had some water and seemed to feel better and left on his on accord.

The patient passed out after receiving the vaccine. The patient received one dose of ammonium as the second time he passed out his eyes rolled back in his head. He has a history of fainting with vaccines. An ambulance was declined by the patient and the female who came with him. He was instructed to wait for 30 minutes at the pharmacy . A phone number was obtained to check on him later on.

PATIENT HAD TINGELING IN VACCINATED ARM, THEN HE LOST CONSCIOUSNESS BRIEFLY, BLOOD PRESSURE WAS ELEVATED BRIEFLY , SWEATING, PALE , 911 WAS CALLED AND HE WAS TAKEN VIA AMBULENCE TO ER FOR EVALUATION

Immediately after shot I felt a slightly elevated heart beat and 5 minutes later I blacked out and tensed up according to a witness. My back was also sore from whatever happened while unconscious. I never had an adverse effect with a vaccine before. After I came around I felt tingling in my arms and hands for 5-10 minutes. Back pain subsided shortly after. No other side effects

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient fained and regained consciousness very quickly. patient refused 911. Nurse and pharmacist checked on patient periodically. pt was under monitoring for 30 minutes and reported feeling well after drinking orange juice and some crackers.

?Janssen COVID-19 Vaccine EUA" About 3 minutes after administration was experiencing lightheadedness, dizziness, and blurred vision. Turned very pale and heart rate dropped to 47. About 8 hours after administration body aches and body temperature began to rise.

approximately 15 minutes after vaccination patient had elevated blood pressure, pulse,. He appeared very flushed, pale and sweating profusely. He was complaining of chest tightness, dizziness, ringing in ears, nausea. Continued to monitor blood pressure and pulse, after approximately 5-10 minutes heart rate, pulse and appearance back to normal. Patient stated at this point he was feeling back to normal.

The patient had symptoms of light-headedness, diaphoresis, and was pale approximately 8 minutes after administration. No signs or symptoms of anaphylaxis were identified so the patient was observed and monitored. The patient then became unconscious for approximately 10-15 seconds with small jerking movements identified during this time. 911 was called and the patient was monitored until EMS arrived. Epinephrine was prepared and ready during this whole time but was not administered because the patient didn't show symptoms of anaphylaxis (trouble breathing or talking, trouble swallowing, hives, flushing etc). The time from vaccine administration to EMS arrival was approximately 20-25 minutes. The patient was able to talk and communicate clearly the entire time except during the brief unconscious period.

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

Patient vaccinated by nurse and nurse reported patients eyes rolled back, patient appeared diaphoretic and pale Patient seen by medical team, vitals were stable, patient provided water and stated symptoms resolved Patient refused medical transport and signed AMA form

On 04/07/21, 28 yo presented to clinic for immunization. Pt's documented allergies include codeine (rxn: rash; severity: low) since 02/06/2018. Pt had no previously documented encounters. Pt was seen at another institution on 02/06/18 for Generalized Anxiety Disorder and was prescribed sertraline 25 mg PO daily. Unknown if pt continues on this medication. On 04/07/21 at 1141, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; Exp: 6/21/2021; NDC #59676-580-15). Immediately after injection, pt became lightheaded, dizzy, diaphoretic and "felt like his vision was closing in". Vitals assessed at 1145 were BP: 94/55, P: 42, O2 sats: 98%. Pt placed in Trendelenburg position with vitals BP: 116/75, HR: 43, O2 sats: 98%. Pt denied any chest pain, shortness of breath, throat swelling, skin itching or hives. Pt reported no previous reactions to vaccines and no h/o anaphylaxis. Pt did report a similar event during a previous blood draw. Pt remained in Trendelenburg x 10 minutes. At 1159, pt was repositioned to sitting with BP: 120/80, HR: 48. Pt reported a low baseline HR. After a total observation of ~20 minutes, pt was reassessed by MD and permitted to leave. Event noted as "Symptoms are most consistent with a vasovagal reaction after J&J Covid vaccine."

Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild

about 5 minutes after vaccine, patient became pale, hot, sweaty, nauseous and lightheaded. He vomited once.

In case of starting the vaccination at 11:45am it went fine and once again I have have no medicine allergies. My adverse effects were the following throwing up, pain in the upper Portion of my neck and slight pain in my chest , and fever with chills grandually getting worse throughout the day. By 9:00pm - midnight I couldn?t even sleep or close my eyes to sleep because the pain was unbarring that I had to call my family for mental support. I eventually fell asleep because of exhaustion, and Sunday I couldn?t even get out of bed my body was so worn out from the shot and the night. I stayed home all day and slept . I still have pains in my neck and coughing becomes my issue.

These were the symptoms I was feeling: - Arm pain - Chills - Fever - Headache - Muscle Spasms - Rigidity - Facial Numbness - Chest Pain Treatment: - Went to emergency room after facial numbness and chest pain. Muscles in both arms were extremely tight and no control of my fingers as it was painful to extend them beyond a fist. Could barely walk and stand for more than 20 seconds as well. - Took tylenol and benadryl before going to hospital but had little to no effect. - Arrived at the hospital at 9:30 with severe pain throughout my body and the effects subsided by 12:30am.

Syncope during observation time approximately 5min after receiving the injection. Unconsciousness for 10-15 seconds then returned to observation chair. until paramedics arrived. He was cleared to leave on his on recognizance. He remained seated for 1 to 2 hours then left the store.

Pt received vaccine and counseled on side effects. Told to remain seated for 15 minutes. Pt got up after 15 minutes and said he was sok but got dizzy/passed out 30 feet away. Pt hit head on his way down and vomited when he sat up. Pt remained nausea and felt faint. Paramedics were called.

At 4:15 pm the Covid-Janssen vaccine was given to the left deltoid and the patient was told to sit down for 15 minutes. When the patient got up after 2-3 minutes, patient became disorientated, sat down, and shortly fainted thereafter. The patient was brought into a nearby room, away from a busy thoroughfare and laid down. The patient regained consciousness soon after. Symptoms included: sweaty, palpitations and low blood pressure. After resting for 15-30 minutes he was able to walk out.

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.

entered clinic with red bull energy drink, spouse reported Patient drank a soda earlier, skin appeared pale, reported he did not do well with vaccines as a child in the past, still wanted to proceed with vaccine. Had seizure for 2 mins, family reported past history of fainting. EMS attended, responded to questions appropriately, fainted a second time, monitored, pt was released home with spouse

Extensive RLE and DVT, Xarelto initiated on 4/7/21 revealed the clinical finding. Patient in good condition.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: while observing the patient after administering the vaccine, he temporarily fainted. He came to immediately and felt better within the following 5 minutes.

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.

ED NOTE is as follows...from 4/21/21 @ 21:47 a 28 y.o. male who to the emergency room with reports of a headache for the last 48 hours. He reports this as being one of the worst headaches he has ever had. He was seen at urgent care and given Toradol, Zofran and Benadryl and still rates his pain an 8 out of 10. He does feel pressure behind his eyes. And reports vomiting in the parking lot at urgent care. He denies abdominal pain back pain, neck pain, shortness of breath, chest pain, numbness or tingling or any other worsening concerns. Reports that he did receive a recent Johnson & Johnson vaccination. Patient states he does vape. He occasionally drinks alcohol he denies any illicit drugs. Patient denies any head trauma. Diagnosis management comments: This is a 28-year-old male arrives to the emergency room with reported migraine headache for the last 48 hours. He did report that he was go to urgent care in which he received a migraine cocktail of Zofran, Benadryl and Toradol. Patient reported that his headache was not resolved so urgent care sent him on for further evaluation. Patient upon arrival had a negative neurological exam however he did report that he had pressure behind his eyes. Was unable to see any papilledema on funduscopic exam. Check patient's pressures bilaterally and they were 21 and 18. Patient did report to me that this was the worst headache of his life. I did administer IV fluids here as well as Tylenol and morphine. Patient did report some improvement. Patient did report in his past medical history had a recent Johnson & Johnson vaccination. A CBC and CMP was obtained. Did have thrombocytopenia with a count of 66. Since my exam was PERRL with normal extraocular movements. He had no eye redness or eye pain. Of low concerns for any iritis or uveitis. Patient's patient CT of his head did show a abnormal CT that had a dense appearing superior sagittal sinus that was representing a venous thrombosis. Radiologist did recommend a MRI MRV. An MRI and MRV was ordered. Patient MRI MRv did show findings are consistent with a venous thrombosis involving the right jugular right transverse sinus and superior sagittal sinus there is also a patchy edematous change within the subcortical white matter areas bilaterally and symmetrically. There was no CVA. With patient's reported migraine headache. Reported blurred vision, low platelets, recent vaccination I do believe patient has vaccine induced thrombotic thrombocytopenia. With this finding I did converse with my overseeing physician Calls were made out to neurology and then a call out did prefer to have patient started on IVIG at 1 g/kg daily for 2 days and blood thinner Xarelto 15 mg p.o. twice daily. These orders were initiated. Internal med services was consulted and with conversations of family, internal med services out possible transfer that an interventionalists could be available if patient needed it. Report was given at 2100 upon my end of shift.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt experienced syncopal episode in store, resolved and left after 30 minute stay

Patient disclosed that he has passed out before from vaccination. He sat on the floor after vaccinated and even told me just before he fainted that he was going to pass out. He was out for maybe 15 seconds. No injuries. Monitored his blood pressure for approximately 15 minutes. Patient reported he was fine but had him wait another 15 minutes before leaving.

Patient fainted 4 minutes after vaccine given. Patient was able to talk but described "eyes in back of head". Blood pressure reading taken 132/76 pulse 72 then 128/82 pulse 85.Patient was responsive to our questions sitting on floor for 5 minutes. We then we observed him for and additional 15 minutes in our waiting area before he left.

At 1550, RRT activated when client (28 y/o M) at the vaccination table after getting the shot started getting pale, slow to respond to stimuli, and in and out of consciousness for about 1-2 minutes. Vaccinated at 1549 on the R arm, with no previous medical history, no allergies, and not taking any medication. BP ? 82/42, HR ? 79, RR ? 18, Pain ? 0/0, O2 Sat ? 93% RA. Head to toe assessment completed. During monitoring period, client?s condition improved. Stated ?I pass out every time I get a shot or seeing blood;? ?this is normal for me.? After 5 minutes, stated feeling better and ?back to normal.? EMS arrived at the scene, but by that time, client is already well. Client declined to be transported to the ER. At the end of the monitoring period, client was not experiencing what was experienced initially. Client stated not to retake his BP as it causes him to be anxious all over again. Client remained in the post-vaccination area an extra 15 minutes. He left the vaccination clinic at 1625 ambulatory and in stable condition.

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

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 experienced vasovagal syncope approximately 5 minutes following vaccination. Patient regained consciousness but was standing at time of incident and has a cut above eye after falling. He was taken by EMS to attend to the cut.

FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; 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 not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

28 y/o male experienced a syncopal episode approximately 10 min following janssen vaccine left deltoid. He suffered an abrasion to outer left pattela. He struck to left side of his head on the floor. No signs of abrasion or swelling that area. approximately 3 minutes after syncope, he vomited. x3 h= His pupils

After getting vaccine and during the 15 minute wait, he became light-headed and started sweating profusely. He became pale and lips were white. Helped to lie down on matt, with feet in chair, and cool cloth applied to neck. Blood pressure was 100/64 and pulse was 64. After about 2 minutes, he said he felt better than when he first came in. I asked him if he had ever had this happen before and he said yes when he had blood drawn a few years ago. He was helped to sit up in a chair. He no longer had any light-headedness and his color was returning to normal. His lips were now pink. He was given a granola bar and water to drink. After staying for 20 minutes longer he left. He was called the next day by me and he said he had not had any light-headedness after he left.

I saw him through the window and patient was felling little dizzy so I step outside of pharmacy to patient waiting area and ask him how he was feeling . He couldn't speak English and had the sister translate to ask him how he was feeling and the sister said he was nervous and feeling dizzy . I checked his heart rate and berating, notice his heart rate was high . He was having a anxiety attack and palpitation . we called 911 and also I gave a bottle of water to him , he drank some water and started feeling better ,then ems came and they took over from there.

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.

5/17/21 Patient given Janssen vaccine at 1859. 1905 : patient had an episode of syncope. BP:90/55, pulse: 50 1906: patient awake , alert and oriented.x4 1910: BP: 114/71, pulse 57. Alert and oriented x4 Patient reports a history of syncope and fear of needles. 1930: patient reports doing well. Vital signs stable, alert and oriented x4

Pt received janssen vaccine, within 5 minutes pt was seated in waiting area and fainted very briefly and fell to the ground. Fell slowly and did not hit head. 911 was called. With the help of pt's mother, pt placed on his side, appeared pale, slow to response, generalized weakness. Within 1 to 2 minutes pt become more responsive, was placed on his back and raised his feet up on a chair. An ice pack was applied to pt's forehead and was monitored until EMTs arrived and care was transitioned to paramedics. Pt was assessed and taken with paramedics to be evaluated.

Almost immediately after injection was given, patient complained of chest pain, light-headedness and sweating. He admitted to a previous history with past vaccinations although inconsistently. Chest pain resolved, per patient. Patient transported by wheelchair to paramedic area with brief loss of consciousness, spontaneously resolved. Patient able to transfer from wheelchair to cot, reporting improvement when lying down. Paramedic and EMT monitored vitals, paramedic advised transport to hospital to rule out cardiac event, patient consented. Tranported to Hospital

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".

Syncope. Patient felt dizzy initially after receiving vaccine, moments later (within 1 to 2 minutes) the patient loss consciousness and started sliding out of chair as patients wife caught him and sat him down on the floor. Patient regained consciousness just as we were coming out to assist (within 5 to 10 seconds). We had him remain on the floor for a couple minutes before we sat him back in his chair and we watched him for an additional 15 minutes (30 minutes total). Also questioned and monitored patient, evaluating for any signs of anaphylaxis/allergy type symptoms as he recovered.

ABOUT 10 SECONDS AFTER TIME OF INJECTION, PATIENT LOST CONSCIOUNSESS AND PASSED OUT AND SLUMPED OVER. AFTER ABOUT 20 SECONDS, HE CAME REGAINED CONSCIOUSNESS AND WAS SHAKING FOR ABOUT 3 SECONDS OR SO. PATIENT WAS VISIBLY NERVOUS AND CLAMY TO THE TOUCH. PATIENT WAS ABLE TO COMMUNICATE WITH US WHILE EMS WAS CHECKING VITAL SIGNS.

Patient was sitting for 15 minute observation period when he started convulsing and fainted. He again started convulsing and then he came to, was nauseas and dizzy and pale.

Patient was overwhelmingly nervous about needles. After injection, he felt faint, he became unresponsive, his head fell back and he was sliding down the chair. In moments he came to, and wanted to lie on floor, we moved him to the floor. Paramedics were called. He was pale and sweating on the floor. He stated his neck was stiff and face was tingling. Paramedics came and evaluated him. The patient chose not to go to the hospital. This was approximately over a 30 minute period.

5 minutes after initial injection I became increasingly lightheaded, nauseous, dizzy, disoriented, and fatigued. 10 minutes after initial injection I experienced a short fainting event in passenger seat of vehicle. Immediately after regaining composure I began sweating profusely and became very pale/flushed color in face at which point I exited the vehicle and flagged EMS to assist me. EMS monitored blood pressure and blood saturation before releasing me on my own recognizance approximately 25 minutes later. Tingling sensation felt in left arm after fainting approximately 10 minuets after initial injection. Next 48 hours after injection I experienced severe body chills, body aches, headache, nausea, loss of appetite, and night sweats. 72 hours after injection I am close to fully recovered but still experience fatigue and night sweats.

c/o of severe nausea and dizziness. pale and diaphoretic. patient assisted to exam room - able to ambulate independently. pt worked night shift in a factory had not slept or eaten prior. vital signs with in normal limits. pt wearing multiple layers of clothing - hoodie and long sleeve shirt removed pt remained in flannel pants and shirt. ice pack provided , water, juice, and food. returned to baseline. denies any s/s of sob, itchiness or tightness in chest. color returned and no longer diaphoretic. reports feeling "normal again". pt monitored an additional 30 mins VS repeated and spouse was present and accompanied them home. informed to take hoodie back off and keep hydrating. pt left facility in stable condition w/ written instructions on when to call for help and what is an emergency.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel. Pt got up immediately and sat back on the chair. Pt was pale but allert and responsive. After drinking some water and extended observation time, pt was able to walk away. EMT was called but pt refused service.

shortly after vaccine , patient fainted and fell off his chair; got a large bimp on forehead, emt arrived and patient left with rescue

Patient received vaccine - waited 15 minutes seated and then had fainted when exiting store. Elevated patients legs and rested on floor for 15 minutes and patient then exited store upon recovery

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.

fever, chills, syncope, unconscious. starting 5-10mins after vaccine received. s/s experienced for about 30min following vaccination emergency services contacted

CHEST PAIN; VOMITING; NAUSEOUS; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 11:28 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced chest pain. On 14-JUN-2021, the subject experienced vomiting. On 14-JUN-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous, and chest pain. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure for Non Serious cases.

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.

I started feeling intense chest pain a couple of days after vaccination. I went to the ER for the pain. Later I was referred to a cardiologist where they conducted additional testing. They found inflammation. I cant do any strenuous activity and they have to do further testing on my heart, which is interfering with my job. I'm still having the chest pain.

Patient felt dizzy immediately after administration of vaccine. I had him stay in the chair and after about 1 minute he blacked out for 5 to 10 seconds then awoke. He said he felt like he had been dreaming for an hour, he was no longer dizzy. I had him sit for another 20 minutes. He indicated he felt fine and he left. A follow up call 3 days later he said he was ok and had no further issues.

ACUTE MYOCARDITIS; This spontaneous report was received from literature: Myocarditis Temporally Associated with COVID-19 Vaccination. Rosner et al.: Myocarditis after COVID-19 Vaccination. This report concerned a 28 year old male. The patient's height, and weight were not reported. The patient had no history of prior covid19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 an unspecified date (3-7 days post vaccination), the patient was hospitalized for acute myocarditis-like illness. The patient also experienced acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I. The patient was hemodynamically stable and had no pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. The patient hospitalized for 2 days and symptoms resolved by hospital discharge. Treatment medication included beta-blocker, unspecified anti-inflammatory medication, aspirin, angiotensin converting Enzyme-Inhibitor(ACE-I) and clopidogrel (2 doses, stopped on discharge). Laboratory data (dates unspecified) included: ANA (NR: not provided) Negative, Blood pressure (NR: not provided) 145/82 mmHg, Body temperature (NR: not provided) 37 C, C-reactive protein (NR: not provided) 1.3 mg/dL, Cardiac MRI (NR: not provided) LVEF-50% (no regional wall motion abnormalities), Cardiac troponin I (NR: not provided) mean peak = 15.77ng/mL, median peak = 12.01ng/mL, Chest X-ray (NR: not provided) No acute pulmonary disease, Coronary angiograph (NR: not provided) No evidence of CAD, Echocardiogram (NR: not provided) LVEF-50%, LVIDd-4.8cm, IVS-1.0cm, RWMA-Mild global HKN, Electrocardiogram ST-T change (NR: not provided) 1mm ST elevation in II, V5-V6, Erythrocyte sedimentation rate (NR: not provided) 8 mm/h, Heart rate (NR: not provided) 70 bpm, PCR (NR: not provided) Negative, Respiratory viral panel (NR: not provided) Testing not obtained, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and WBC (NR: not provided) 8.08 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocarditis. This case was reported to the vaccine adverse event reporting system (VAERS) and the CDC. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210650174- covid-19 vaccine ad26.cov2.s-Acute Myocarditis, . 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).

1616- Patient received injection and immediately fell forward from chair and struck plastic chair with right forehead while falling to floor. Staff called for help. 1617- Patient lying on side, not responding to voice or tactile stimulation for 30-60 seconds. Patient spontaneously opened eyes, sat up, and asked 'where...what'. Pulse ox placed on patient HR 50, O2 sat 99% on RA. Code team arrived. BP 86/45 HR 50. Patient pale, diaphoretic. MD advised lowering head between knees. COld pack placed on back of neck. Pt offered juice, patient drinking juice. Patient with small closed laceration above right eyebrow. 1620 HR decreased to 48. This NP advised patient to lay down, feet elevated. Band-aid placed on laceration. MAE, Ice pack placed on forehead. Patient reports mild pain on forehead that increases when pressure placed on forehead. 1622- A&O x4, pale. BP 109/67 HR 58, O2 sat 100%. Patient consented to notifying spouse of his condition. Staff member sent outside to notify spouse. 1627- A&Ox 4, skin pink, BP 114/75, HR 54, 02 sat 98%.. Patient offered more juice. Denies dizziness, reports mild HA. Dsg to forehead clean, dry and intact. Spouse and children at patients side. Patient interacting. Spouse reports patient "didn't eat much and was very nervous". 1632- A&Ox4, skin pink, dry. BP 119/79, HR 55, O2 sat 100%.. Discussed plan with patient to gradually have patient sit up and that we advise following up at urgent care today. Worked with staff to find urgent care. Spouse states she will drive patient. 1634- A&Ox4, skin pink, warm, and dry. Patient sitting up. BP 120/76, HR 61, O2 sat 98%. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. 1640- A&Ox4 skin pink, warm, and dry. Patient sitting up. BP 108/73, HR 65, O2 sat 98%. 1646 HR 62. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. Patient wanting to stand up. Patient assisted to feet, denies dizziness, gait steady. Standing BP 123/70, HR 54, O2 sat 99%. 1650- transported via wc to private vehicle. Patient ambulated and seated in car without c/o. Address for Urgent Care provided to patient's spouse. Patient and spouse state understanding of recommendation for further follow up at urgent care.

Site: Pain at Injection Site-Mild, Additional Details: Pt received vaccine at 4:02 pm, started to feel faint at 405 pm( became pale and diaphoretic per). Called for NP help from in next room. Provided pt with ice packs. BP 100/62. Provided coca cola after patient stated he had not eaten since morning. Patient started to get color in face. BP re-check at 4:22 pm was 110/80. Pt was able to ambulate to waiting room at 4:35 pm. Pt & mom left waiting room feeling better at 5 :05pm

increased glucose levels, treated with insulin. Patient suspected DKA and went to E.R. Patient experienced vomiting and dehydration

Patient felt hot, fainted, and fell out of chair. He regained consciousness and was helped up while EMS arrived. The patient was assessed and given water and a snack. He informed the pharmacist on duty that his neck and head were a little sore from the fall but that he was feeling better.. After speaking to EMS he stayed for about 20 minutes then left.

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.

Fainted during the mandatory 15 minute evaluation period post vaccination. Sat with patient who returned to and refused medical transport and color returned was with wife who will watch him today. Recommended a meal with rapid, intermediate, and long acting carbohydrates. Reported once started drinking water again he felt better. Monitored patient for additional 20 minutes to observe. Stood up without assistance but was carefully monitored. Then left with wife for lunch since hungry.

pt received vaccine and went to waiting area. 5 minutes after in the waiting area, pt had a self reported panic attack/fainting spell. pt did not fully lose consciousness. pt has a history of panic attacks/fainting spells, especially with needle sticks. Paramedics assisted on scene but pt was not transported to hospital. pt left under his own power

Patient began to feel cold and clammy, and lose color in his skin. He temporarily lost consciousness for about 2 minutes. I monitored his pulse and respiration and he began to feel better after about 5 minutes. He remained seated for 10 more minutes and left under his own power.

While patient was being observed after receiving Johnson and Johnson vaccine he complained of nausea and requested evaluation by EMS. Upon evaluation by EMS patient was noted to have low heart rate of 35 bpm. EMS administered Atropine and transported resident to local hospital.

Anxious following vaccine with vasovagal response but no syncope. Reclined in car seat with pulse of 67 Blood pressure of 92/49 and oxygen saturation of 97%. EMS and Dr on site. Client felt better quickly and was released. Advised to seek medical attention later if needed. Client stated understanding.

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.

Severe dizziness, unable to stand for almost 4 hours. Ended up collapsing due to dizziness and momentary loss of consciousness due to fall and dizziness

Patient reported at 1210 feeling lightheaded, vision blurred, had syncopal episode and fell from chair hitting L temporal region of head. LOC approx 1 min. VS at 1219 were 134/78 and HR 61, SP02 97%; all while sitting. patient was assessed by nurse and reported a hx of passing out with blood draws. VS at 1225 BP 135/70 and HR 72. Left returned to normal.

patient fainted after vaccine while sitting outside pharmacy in post-vaccine waiting area. He regained consciousness quickly and was pale. He was given cold pack and blood pressure checked 12:18pm (104/59, pulse 48). Patient said he has not fainted from vaccination before, but has fainted after bloodwork. Blood pressure rechecked 12:40pm (112/69, pulse 53), he said he felt normal again, did not want any additional assistance, and left.

NKA from patient. Patient in at 1553 and out at 1608. Hx of chronic rhinitis and asthma. Patient presented with vitals of 163/105, HR 67, SP02 94% (sitting). VS at check out were 145/88, HR 64. Patient reported with hunger, flushed, diaphoretic, and pale. there was no SOB or dizziness reported. Patient provided juice and snack. Patient returned to normal and released.

Patient fainted after vaccination. He regained consciousness very quickly, but was pale. I gave him an ice pack and checked his blood pressure at 12;18PM (104/57 pulse 48). Patient stated he has not fainted for a vaccination before, but has fainted for bloodwork in the past. Blood pressure rechecked at 12:40pm (112/69, pulse 53), Patient no longer pale and he said he felt back to normal. He did not want any additional assistance.

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.

Male patient took Janssen vaccine and approximately 1 hour or so later was feeling chest tightness where it exacerbated to the point of needing emergency care. Patient was taken to E.R., but do not have outcome as of yet

Woke up at 1:30 AM with sudden severe panic attack with heart rate at 160+, acute panic symtpoms including elevated heart rate & blood pressure lasted about 6 hours, ongoing anxiety throughout the next 24 hours treated with proscribed benzodiazepines. 102 degree fever without medication, 99 with steady usage of over the counter ibuprofen. Violent shaking and chills, severe muscle aches, extreme fatigue, couldn't walk up stairs without assistance. Sporadic dizzy spells, similar to the "Brain zaps" of SSRI withdrawal. Began to subside 36 hours post injection, with lingering symptoms still present 52 hours post injection.

Patient received vaccine at 2:20 PM and showed no symptoms initially. His wife was having syncopal symptoms and he helped care for her while paramedics were on their way. After they arrived he experienced lightheadedness and blurry vision. He was evaluated by they team and they determined the cause to be vasovagal syncope. He recovered and declined transport. He left on his own accord after 40 minutes feeling back to normal.

UPON RECEIVING THE IMMUNIZATION, PATIENT REPORTED FEELING LIGHT HEADED. HE WAS GIVEN WATER AND REMAINED SEATED. AFTER A COUPLE MINUTES HE BEGAN TO PERSPIRE AND WAS PALE. ROUGHLY 5-7 MINUTES AFTER RECEIVING THE VACCINE, THE PAINTED FAINTED AND DID NOT RESPOND TO HIS NAME FOR 90 SECONDS. HE DID ALSO HAVE SOME BRIEF SHAKING MOVEMENTS OF HIS ARMS. UPON WAKING UP, THE PATIENT REMAINED SWEATY AND PALE. HE WAS ASSESSED IN THE PHARMACY (LOCATED IN A HOSPITAL) BY AN EMERGENCY ROOM PHYSICIAN AND WAS CLEARED TO LEAVE WHEN HE WAS COMFORTABLE.

Patient became very pale, reported feeling dizzy and having blurry vision after immunization, patient was given a cold pack to apply to neck and gradually felt better, patient remained at pharmacy for 30 minutes for monitoring

Pt passed out, fell to floor and hit right side of head. Tachycardia 250 pulse, vagal response low 80's at end of event. EMT called pt refused to go to hospital.

mostl likely vasovagal syncope. patient fainted and woke up very quickly disoriented. was sweaty for about 10 minutes. He was given reeses candy bar and water and monitored for an additional 15 minutes after his beginning time. was released about 40 minutes after his vaccine/reaction.

On the night of the vaccine: Fever of 101.5. and headache(6/10). Morning after vaccine: Fever 100.5, headache (6/10), pallor, diaphoretic, nausea. Stood up and then passed out for approximately 2 minutes, hitting his head on the wall. Regained consciousness on his own.

Within 5 minutes of administration, patient began to experience some nausea and alerted pharmacy staff. The pharmacist gave patient trash can and began monitoring patient condition. Patient stated has anxiety and has experienced this before. Patient was pale at this time. After 10 minutes from vaccination, patient began to get sweaty. pharmacist gave patient an ice pack for forehead and helped patient to the floor. Patient sat on floor and remained conscious. After several minutes on the floor. patient's color returned and he stated was feeling much better. Patient returned to his chair at this time (about 15 mins post vaccination). Patients condition continued to improve from there on. Patient waited at the pharamcy for 30 more minutes to ensure syncope event had past and no other issues arose. Patient left after 45 minutes stating they feel normal.

At approximately 4 pm, I gave the patient a Janssen covid-19 vaccination. I asked the patient to sit for 15 minutes for observation. About 10 minutes later I was notified someone wasn't doing well. I went to the patient and he was hunched down and looked pale and he stated he was very dizzy. I asked him if he had trouble breathing and he stated he had not. He appeared like he was about to pass out, I was asking him questions about his state and he wasn't being coherent. I told him I was going to give an EpiPen and call 911. I gave him the EpiPen in his outer thigh. EMS came 5 minutes later. A few hours later I got a call from a close by asking if I had given him a Benadryl because he was feeling drowsy. I asked his status and the nurse stated he was doing fine.

High fever reaching 103.8° F. Between 7pm and 12am, my fever ranged from 100-103.8° F Elevated resting heart rate of 90-130 beats per minute. My normal is 62-75 bpm. While I was sleeping, my heart rate ranged from 93-113 bpm (according to Apple Watch). Extreme headache Inability to sleep Chills and shakes Extreme fatigue Light headed and unable to speak clearly I don?t know if this was life threatening; I know it was likely my immune system responding but these side effects were extreme. I almost called an ambulance. I?ve never felt pain like that before in my head. My heart felt like it was racing all night and my brain felt like it was going to expand out of my skull. The head pain, heart rate, and rapid breathing was keeping me up. I tried to sleep 7pm?12am which was the worst of it. By the middle of the night, it seemed that the fever subsided and my resting heart rate was more in the 90-100 range (still 15-30% high). The next day, I have a moderate headache that feels like after pain from the night before. Fever subsided. Heart rate is slightly high at 80-100 bpm. I managed to sleep in the whole morning. I had to take off from work today in order to rest.

Approximately two minutes after patient receiving the vaccine shot complained of lightheaded and had self-limited systemic hypotension. Symptom and blood pressures resolved within 15 minutes. Patient later referred he had a similar episode when he donated blood in the past. Patient previous leaving the vaccination clinic recover himself completely denied any constitutional symptom including chest pain, headaches, nauseas or vomiting and vital signs were within normal limits.

Patient reported feeling dizzy and experiencing a pre-syncopal episode Patient seen by medical team , given water and stated symptoms later improved Patient refused medical transport and signed AMA form

Headache almost immediately, chest tightness starting maybe 2 hours later and persisting until present time, roughly 30 hours post-vaccine.

Fainted/fell unconscious in chair immediately after injection. Out for 20 seconds or so. Reportedly stiff as a board and twitchy. No significant history of fainting.

Nausea, Lightheadedness and Syncope 5 minutes after receiving Janssen Covid Vaccine. Given epinephrine at the facility, transported to ER by ambulance. Pt discharged in stable condition after 3 hours of monitoring.

Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.

Patient fainted from sitting on chair, felt nauseous, dizzy, and lightheaded 5 minutes after receiving vaccine. Felt dizzy for an additional 15 minutes and laid supine. Patient drank juice, ate a salty snack, and sat up. Continued to feel lightheaded, laid down for additional 15 minutes. Patient vomited, complains of headache and nausea. Symptoms continued for an additional 45 minutes before patient felt comfortable to leave with friend.

Flushed, Sweating, decrease drastically in HR, and almost passing out. Treatment with icepack on nape of neck, cold water and frequent HR checks with observation. Time allotted for patient to return to normal state was 34 minutes.

Passed out for approximately 10-15 sec, this has happened in the past with vaccine/blood draw. Stayed seated in chair, snack provided, feeling better. PB 84/50, PO2 95%, HR 77.

615pm went to sleep, 9pm woke up with headache that was moderate to severe, chills and racing heart later on my blood pressure went up to hypertension levels..my temp was 103.8, the back of my shot arm was ice cold, took 1 ibuprofen, 909pm 102.4 temp took 2nd ibuprofen, BP 155/82 @ 1059pm, 129/78@11pm. Racing heart between 121-111@1058pm. 99% oxygen. 1201pm 2 Tylenol rapid release, 101.2 temp heart racing 108-109, symptoms unchanged, 1232am 142/86, 100.8 temp 99% oxygen Symptoms mild. 122/83, 101-102 heart still racing melatonin taken..100.1 temp, 1:52 am 94-95 , 99.2 temp, 6:24 sleeping 70-71 heart rate 96.1 temp

Patient had symptoms of vasovagal syncope 10 - 30 seconds after receiving the shot. Felt dizzy, hot, and passed out. EMS was called and patient stayed an hour on site and received water. Patients girlfriend reported this had happened before with other vaccines.

Patient was observed to have a syncope episode lasting less than a minute after receiving vaccination. Patient was placed from the chair is was sitting onto the floor and legs elevated. 911 was called patient was oriented X3 and did not want Ems to come. We had patient stayed in pharmacy for about 30 more mins. Patient left pharmacy and described he was feeling okay and had no further adverse reactions. Patient describes that he generally pass out after giving blood or dealing with needles.

Patient developed severe bloody nose 5 days after administration of vaccine. It did eventually stop on it's own. He also had moderate headache and cold sx starting 5 days after vaccination.

The patient was found lying on the floor face down at 2:40am. He was responsive and able to sit up. Reported dizziness and chills. Was visibly shaking while staff were talking with him. Was sent to the ER for evaluation.

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.

Patient had a syncope episode along with urinary incomitance shortly after receiving the Janssen vaccine. Pt was sitting in the medical monitor area when the event happened. Pt was unconscious for less than a minute and EMS was called. EMS evaluated pt, he was pale but fully verbal and functioning. vitals were stable, BP 110/69, HR 74, 02 97. Pt refused transport but was monitored at the site by doctor for an hr before being released. Pt was instructed to go to UC/ER if he had another episode or new s/s and follow up with his primary care provider. The following day, the patient's primary care provider tried multiple times to reach out and follow up with pt. Pt did not respond to his PCP.

7 PM (4.5 hours after J & J shot) - Chills begin, both calf muscle in legs starting to shake. I move to my bed. 7:30 PM - In bed, dressed in sweatshirt, wool socks, etc., a a couple blankets wrapped around me, space heater turned to 80 degrees, shaking uncontrollably from being so cold (mostly hands and feet), mild headache begins in middle back of head. 8:00 PM - still freezing, temperature was at 98.7. most of body is aching 9:00 PM - chills and body ache starting to slow down, temperature at 100.3 9:30 PM - still have chills, space heater still on and i was still wrapped in a bunch of clothing/blankets. temp at 100.5 and i drank 6 oz water. 10 PM - chills going away, heat/blankets/clothing still on, temp at 101. body aches mostly only in left and right calf. Rest of night until around 4 A.M. was me tossing and turning being restless. My heart rate was ~130 BPM throughout the entire night according to my smart watch. I was checking my temperature constantly with an infrared thermometer and it was between 101-102.5. I probably drank ~24 oz of water throughout the night. It felt like each time i fell asleep, i would wake up no more than 30 min later and each time i woke up it felt like i had been asleep for 5 hours. At a few moments it felt like i was hallucinating seeing little boxes around my head.. At no point during the episode did i take any advil/tyenol/etc. Only drank water. Woke up around noon the next day, I felt extremely groggy, still had a headache and my temperature was back to ~98. I ate for the first time that day around 1 P.M. and had a few advil which helped with my headache.

Patient was looking pale a minute after the shot, I asked how he was doing, he responded by saying he felt very dizzy. I asked him to take slow deep breaths, gave him some water. About after 1 more minute he passed out (very unresponsive but still breathing, pupils very dilated) pulse was slow but still palpable. Tried ammonium smelling salts, that did not bring patient around. Called 911. Tried patting patient and talking to patient to bring them back to consciousness. After about a minute or two patient was able to respond to me. He knew his name and date of birth and where he was. Asked him to wait for ambulance to check vitals. Patient said he still felt very dizzy. Kept his head down and eyes closed. Once EMS arrived they checked his vitals, determined BP was low (they did not tell me a number). They monitored patient's vitals for 10-15 minutes. BP did not "bounce back" per EMS so they took him to the hospital for IV drip possibly.

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.

Patient experienced epistaxis the morning after the vaccine, and has continued to have mild-moderate headaches. To note, patient?s baseline is typically: - Roughly 1 nosebleed every ~4 years - Mild headaches 2-3 times per week

HEART RATE OF 111-121; BLOOD PRESSURE OF 155/81; O2 SATURATION OF 99 %; CHILLS; HEADACHE; FEVER SPIKED 103.8; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart rate of 111-121. On 09-APR-2021, the subject experienced blood pressure of 155/81. On 09-APR-2021, the subject experienced o2 saturation of 99 %. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever spiked 103.8. Laboratory data included: Blood pressure (NR: not provided) 155/81 (unit not provided), 129/78 (unit not provided), Body temperature (NR: not provided) 101.8 to 102.8 (unit not provided), 103.8 (unit not provided), Heart rate (NR: not provided) 111-121 (unit not provided), and O2 saturation (NR: not provided) 99 %. On 09-APR-2021 21:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever spiked 103.8, and the outcome of chills, headache, heart rate of 111-121, blood pressure of 155/81 and o2 saturation of 99 % was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Syncopal episode after receiving vaccine. Regained consciousness, but had persistent dizziness. IV established with 250cc bolus. Positive orthostatic. EKG with possible RBBB. Additional 250 cc NS, transport to ER via ambulance.

CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; 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 concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Patient passed out during 15 minute wait time and began to have a seizure after receiving the J&J vaccine. Seizure last about 5-10 seconds. Pt was turned to his side and remained in the same position until EMS arrived. He was conscious after the seizure and was responding and speaking full sentences. EMS was on the line until they arrived in person. Medical EMS personnel were called and responded. They advised pt had a history of seizures. Pt refused to go to the hospital with EMS. EMS cleared pt to continue regular activities. Event time approximately 3:00-3:20pm.

DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable. On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. 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).

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

Patient lost conscious. Feet elevated, 0.3 ml Amonia inhalant provided. Pt regain consciousness after receiving respiratory stimulant. Powerade drink given ,paramedic staff assess patient. After 5 minutes ,Patient stated" feeling better" family menber came to tent and took patient home.

Upon arrival, patient noted laying down on floor with feet elevated. Patient noted pale, sweaty and clammy. Patient awake, alert and oriented x3. Patient states that he started feeling light headed immediately after receiving his vaccine. Bp 143/95 P 70 T 97.7 O2 99% on room air and Blood glucose 114. Patient states that he had breakfast around 8am and fruit as a snack at 1030am. Vitals reassessed Bp 137/88 P 80. Patient states that he is feeling much better. Patient able to sit up without feeling dizzy or weak. Bp 126/91 Hr 83 Patient had granola bar and water. Patient had to rest an additional 30mins. will continue to monitor O2 remains @99% on room air. Patient states that he feels great. Vitals reassessed Bp 130/80 Hr 78 O2 99% on room air. Patient left facility in stable condition.

Patient had fainted, pharmacist used ammonia salt to wake pt up and pharmacist had called 911. Patient was fine when he left.

Fever beginning at 7 pm of 101-102 F, racing heart beat, headache, swollen temples, insomnia due to racing heart beat, chills, fatigue

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT FAINTED AFTER RECEIVING VACCINE AND INJURED THEIR CHIN, PATIENT WAS SITTING DOWN AND WAS ABLE TO FEEL BETTER AFTER GIVEN WATER AND REST ON BENCH

Patient fainted for 1 to 2mins after receiving the vaccination. This happened 5 to 6 mins after the injection. The patient was sitting down, so I approached to see if it was an allergic reaction or not. I checked for breathing and had another patient call 911. Patient woke back up while we had the 911 operator on the phone. He asked for some water and he felt light headed.

I started feeling fatigue and soreness in both of my legs and arms about a 5 after the vaccine. At day 7 I started to feel sharp, cramps, tingly sensation and numbness in different parts of my legs, arms feet and hands. I also had headaches and felt dizzy. Headaches went away by day 15, but the pain, tingly sensation and fatigue in my arms and legs still remain (tomorrow it?s going to be a month since I got my shot). It gets significantly worse when I walk and I feel very fatigued after walking for about 30 minutes. The pin has also appeared less frequently on other parts of my body, like my heart, my neck and around my rib area. Over the last two weeks my legs have also been getting itchy.

Patient received Janssen Covid-19 vaccination at 04:24pm on 05/07/2021 and was counselled to remain in the patient's waiting area per protocol. At approximately 04:32pm a patient in line to pick up their prescription alerted pharmacy staff that someone just slumped over in the chair. 911 was called immediately but pt. stated he did not need them as he did not want to pay and declined EpiPen which was made available to him. He verbalized that it might be "mental"?? and it usually happens to him when he "gets blood". He remained under observation and stated that he felt better. At approximately 04:54pm patient departed from the pharmacy area.

about 15 minutes after receiving the vaccine, the person that accompanied the patient yelled for help. She states his eyes rolled back and then slumped over and arms flailed a few times. The patient didn't know it had happened. He stated he felt dizzy and looked pale. We gave him a water bottle and after a few minutes he felt better.

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.

pt received the johnson and johnson shot at 3:00pm. He began passsing out and myself and his girlfriend helped him to the floor. I administered an epipen 0.3mg. Pt became awake immediately. 911 was called. bp 150/80 when EMT arrived.

WITHIN 5 MINUTES OF RECIEVING THE VACCINE THE PATIENT FAINTED. MYSELF AND ANOTHER PHARMACIST SAFELY GOT HIM TO THE GROUND. WE TOOK HIS BLOOD PRESSURE WHICH WAS FINE. WE BELIEVE IT WAS JUST FAINTING DUE TO GETTING A VACCINE. WE GAVE HIM WATER AND GATORADE AND WITHIN 10 MINUTES HE WAS BACK TO NORMAL.

Pt recv'd Covid-19 J&J vaccine. Aprox 5-10 minutes after shot pt passed out in wife's arms. Our Technician dialed 911. We assisted in lowering him to the ground. I elevated his feet slightly and he slowly came back. Pt stated he was slightly dizzy but felt fine for the most part. Ems arrived and took over care.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt sat down after receiving vaccine and felt faint within the next minute, slouched over in the chair and woke up on his back on the floor. pharmacist reported pt was sweating but alert immediately after this incident. pharmacist assisted pt and pt ambulated into clinic with assistance and was supine for 10 minutes and sitting for 10 additional minutes. BP 118/76, pulse 79, spo2 98% and heart rhythm regular. pt ambulated out of clinic without problems, all symptoms resolved.

VACCINE WAS ADMINISTERED PRIOR TO PATIENT LOSING CONSCIOUSNESS. CAME ROUND AFTER A FEW SECONDS. REPORTED DIZZINESS, DENIED SHORTNESS OF BREATH, OR SWELLING. 911 WAS CALLED. EMS ATTENDED TO PATIENT.

5 minutes after receiving vaccine, patient stated he didn't feel so good. Lost color in face and then fainted. Pt layed on floor for 5 minutes. A wet cloth was placed in forehead. Pt came back to feeling better then sat up on floor for a few minutes then sat in chair. Pt drank a bottle of water and called his brother for a ride.

Patient with PMH of Aspergers, ADD and obesity brought to ED in status epilepticus. Headaches and nausea/vomiting started day of vaccine and progressively worsened. Was observed to have 2-3 seizures before arriving to ED (possibly over a 2 hour period) on 5/18. Found to have Superior sagittal sinus thrombosis and thrombocyctopneia with elevated D-Dimer and PF4 and low fibrinogen. Patient suffered irreverisible brain injury. Decision made with family to withdraw care

PATIENT FAINTED IN THE OBSERVATION CHAIR ABOUT 10 MINUTES AFTER RECEIVING THE J & J COVID -19 VACCINE. HE FELL OUT OF THE CHAIR BUT WAS NOT SERIOUSLY INJURED, HE MAY HAVE BUMPED HIS MOUTH. THE PHARMACY TECHNICIAN IMMEDIATELY HELPED HIM UP BACK TO HIS CHAIR AND GAVE HIM A BOTTLE OF WATER. SHE ALSO CHECKED HIS BLOOD PRESSURE (NOW AT 136/94). I CALLED 911 BUT HE DECLINED ANY ADDITIONAL ASSISTANCE SO I TOLD THEM TO CANCEL. WE ASKED HIM TO WAIT AN ADDITIONAL 5-10 MINUTES AND HE WAS FINE. HE LEFT ON HIM OWN ACCORD. I TOLD HIM THAT HE MAY RECEIVE A CALL FROM US AS A FOLLOW UP TO THE EVENT.

Patient presented with a myopericarditis with elevated troponin, normal LV function, normal coronary arteries.

Systemic: see comments below-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient became faint, sweating, with decreased vision. He sat down on a chair, heart rate in 52-57/min, BP 100/56, rr 20, O2 sat 100%. Took about 10 minutes to fully recover, and all sympotms resolved, HR returned to 61-67/min. He declines EMS, says he will follow- up with PCP regarding drop of heart rate. His girlfriend picked him up and he went home.

Janssen COVID-19 Vaccine EUA Pt lost consciousness after vaccine while waiting the 15 minutes before leaving. Father notified us at that time that he loses consciousness after all his vaccines. Pt is now okay and has left with father.

Patient reports feeling tightness in chest immediately after vaccine on 5/26/21, and 2 days later experienced feeling an internal burning sensation without a fever. Patient went to emergency room on 5/26/21 and was discharged with no conclusive diagnosis.

Almost immediately after receiving the vaccine pt went rigid and was unresponsive. He came to within a minute. He was very panicked and stated he thought it was a dream. He was extremely pale and very sweaty. We gave him some water and an ice pack to cool down. We checked his blood pressure. He then lied down on the floor and we elevated his feet. He then stated he could not move his hands and his lips were tingly. We then gave him some liquid benadryl and continued checking his blood pressure and called EMS. They arrived and he left with them. I tried contacting him later without success. Will try again tomorrow.

Non-traumatic bruising. Petechiae in random areas of body. Denies history of bleeding disorders in self or family. PLT <3.

AFTER THE VACCINATION, PATIENT WALKED TO THE OBERSERVATION CHAIR AND HE FAINTED WHEN HE GOT TO THE WAITING STATION. PATIENT FELL AND HIT HIS HEAD, HE WAS UNCONSIOUS FOR ABOUT 10 SECONDS THEN WOKE UP AFTER BEING HELPED BY THE PHARMACIST AND LOCAL MEMBERS. HE WAS AWARE OF THE DATE, DAY, MONTH, AND WHERE HIS LOCATION. PT HAS NO DIFFICULTY IN BREATHING OR SPEAKING. HOWEVER, PATIENT HAD HIT HIS HEAD AND HE WAS TAKEN AWAY WITH THE PARAMETIC.

Gastrointestinal issues including severe nausea, diarrhea, and loose stools. Difficulty eating due to tightness of stomach and feeling full after only a few bites. Sharp chest pains, including racing heartbeat and pressure which induces coughing. Various sharp body pains, mostly in the chest and torso. Uncontrollable shaking, and a buzzing electric feeling throughout body. Flashing in eyes when closed. Head feels heavy with constant vertigo and brain fog. Muscle spasms all over and twitching in left index finger. Insomnia due to listed issues. Nystagmus and feeling of eyes vibrating.

March 11: fever, headache, pain fatigue, arms turned bright red for about 10 minutes March 12:fever, headache, fatigue, nausea March 13:fever, pain, fatigue March 14:fever, pain, chills, fatigue, nausea, vomiting March 15: fever, chills, headache, tinnitus March 16: fever March 17: March 18: fever March 19: fever March 24: fever March 25: fever Last week or so: chest pains, really high heart rate

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.

Sudden increase in PVCs; have noticed them once or twice before, but increased to 1/4-7 beats. Noticed first at 11:00am, and continued at the mentioned interval until the present moment. Headache present as of June 14 PM.

Patient filled out immunization consent form incorrectly, failing to mark yes for "have you ever fainted or felt dizzy after receiving an immunization." After receiving the vaccination, patient was sitting for the 15 minute observation and another patient noticed he tried getting up and walking and immediately fell down. He tried standing back up and the 2nd patient had to grab and hold the fainting patient until I was able to come help. Patient fainted for less than 10 seconds, as I cautiously helped lay him down on the floor. I checked for vitals, and elevated patient's legs, and gave him ice to help. Patient remained in laying position for 15 minutes, regained strength and sat up for another 15 minutes, in which time, he was given water to drink and a protein bar to eat. I also took patient's blood pressure, which was within normal limits (approx. 117/82, HR 86). Patient and his mother both left the pharmacy without further incident.

I asked the patient to take a sit for 15 minutes after administering COVID vaccine. Right around after 15 minutes, he came to the counsel window to let me know that he was not feeling good and he passed out. He became conscious right away as our staff members called his name to check if he was ok and called our store manager. We asked him if he was ok and gave him a bottle of water to drink. We asked him to call his family member to get a ride for the safety of the patient. I checked his status as he was waiting for a ride. After 30 minutes, he left our pharmacy with his family member. I called him for the follow up and left message to call us if he has any concerns.

PATIENT APPEARED LIGHTHEADED THEN SEEMED TO PASS OUT FOR 8 TO 10 SECONDS WITHIN 2 TO 3 MINUTES OF THE VACCINE BEING ADMINISTERED. HE CAME TO AND WAS ABLE TO SPEAK TO THE EMS STAFF WHEN THEY ARRIVED. PATIENT WAS TAKEN TO ER FOR EVALUATION.

Pt received JJ vaccination, and subsequently moved to the patient monitoring area. Approximately 2 minutes after waiting in the monitoring area pt states he experienced flushing, dizziness and clamminess then ?passed? out for approximately 20 seconds while in a seated position. Syncope was witness by patients girlfriend. RN didn?t witness pt syncope, but noted patient laying in the seat then immediately alerted me. Pt was recovering in a seated position when I arrived, with noted pt w/ diaphoresis with no associated respiratory distress. While I was collecting pts history said he didn?t want to talk about it anymore in an attempt to calm himself down, approximately 2-3 minutes later I witnessed pt have another syncopal episode which lasted 15-20 seconds while in seated position. Pt regained consciousness and I had an employee help me move pt to the floor for recovery. Pt displayed no signs of respiratory distress, denied chest pain and headache. Pt states syncope is his typical response after vaccinations or blood draws, last occurrence was 8 months ago during a blood draw. Pt states these syncopal episodes initially started in childhood and has gotten worse as he has gotten older, pts father also experiences these episodes. Pt declined EMS several times. Pt was monitored for 41 minutes, vitals taken twice while pt was in recovery on the floor, vitals were stable. I had pt lay supine on the floor for approximately 15 mins post syncopal episode. After recovering for 15 mins I had patient sit upright on the floor, reassessed him and repeated vitals which were stable, pt reported feeling well. After approximately 10 mins pt was helped up into a seat, vitals were stable and patient reported feeling well and having no complaints. I had pt stand and repeated vitals which continued to be stable and pt reported no complaints. Pt drove to the vaccination site in a rental care which he states he will leave parked close to vaccination site and initially states he?d walk. I recommended pt and girlfriend take a free ride home which the agreed to do. I personally walked the patient up the stairs which pt was able to do with no problem and no reported complaints. Pt was given strict ER precautions and given resources for primary care also. Pt stable at the time of discharge. Pt declined follow up. Pt stable at the time of discharge. Pt accompanied by with girlfriend, who will get pt home via ride.

The patient was administered the vaccine at 4 pm. About 20 minutes later, as he was sitting in the waiting area, he fell face first out of his chair and passed out (at minute 12 of his 15 minute wait period). The pharmacist went to tend to him and he came to within a few minutes. A frozen water bottle was place on the back of his neck as he continued to lay on the ground for about 5 minutes. He then moved into the chair a she was starting to feel a little better. At about 4:45 he left to go home on his own.

Patient was seated in the passenger seat of the car. We talked for a few minutes prior to administration and I actually administered a vaccine to the person in the driver's seat first. I walked over to give his shot and he then tells me he "doesn't do well with vaccines." He later told me he felt sick to his stomach after getting the shot and had a metallic smell similar to a bloody nose. About 1 minute after administering his vaccine, the patient's head went back, his muscles went very stiff, and he appeared to convulse. We called 9-1-1. His mom was sitting in the back seat and placed an ice cube on the back of his neck which seems to have pulled him out of it. During the episode, he reports "blacking out" without orientation to time or place. After the episode, he was dizzy and lightheaded for a few minutes. Soon there after he was jovial. I took his BP and HR about 5 minutes later BP 100/62 and HR 48. Paramedics also took vitals which were a bit higher than these. He reported having a small cereal bar for breakfast and 2 cups of coffee.

Pt received his single vaccination of Janssen, and fainted while waiting in waiting area after receiving his vaccination. Pt says he has a needle phobia, and was hesitant to get the vaccine. He had a muffin to eat earlier in the day, and nothing since. The tech, called me when she saw him fall. when I saw him, he was standing up. He sat back on his chair. I got his to rest with his head lowered. He appeared to be dizzy and cold and clammy. When I took his Blood Pressure, it was 95/46. He had a 1 cm cut below his right eyebrow. He did not want to go for stitches, because he hates needles. After resting up for about 30 minutes, he told me that he felt better, then left.

I was administered the Jansen & Jansen Vaccine and while in the waiting room, i had a reaction. I began to drift in and out of consciousness and the pharmacist administered an EpiPen and called the ambulance. The ambulance took me to the ER because of my symptoms, including low heart rate. the ER physicians ran multiple tests and EKG to make sure i was okay. they said it was a severe reaction to the Jansen Vaccine

Shortly after patient received vaccination, I was flagged by spouse as patient became nonresponsive and experienced acute loss of consciousness. No fall or external trauma. Consciousness regained however patient was A&O x 2/3 with pallor and incoherent speech. EMT was contacted and pt was assessed. Pt declined transport to hospital and was further monitored in pharmacy prior to departure.

Pt experienced vasovagal syncope 5 minutes after receiving the Janssen Covid 19 vaccine. Pt became cool, pale, and clammy, and lost consciousness briefly. During this time, pt was breathing (moving adequate tidal volume) and maintained a radial pulse. Pt regained consciousness about 1 minute later, and vital signs were obtained. Pt had a heart rate of 56, breathing at 16 times a minute, moving adequate tidal volume with clear lung sounds. Pt was satting at 96% on room air, and when asked questions appeared fully oriented to person, place, time, and event. Pt had a blood pressure if 124/82, and pupils were 2 (L) and 3 (R) mm, and fully reactive to light. Pt states his pupils are irregular in size

I been having high than normal blood pressure and weird pains around my heart and chest. Which lead to me going to the ER. No diagnosis but have a follow up 07/20/2021.

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.

pt passed out while sitting in waiting area after vaccination, hitting head on can display. Was unconscious for approx. 5-10 sec. Paramedics called and evaluated pt. Pt had not eaten today and had BG=65. BP normal x3. Pt was given water, OJ and a candy bar to elevate BG. Wife picked up pt per paramedics suggestion. Pt recovered and reports no injuries or other side effects

Patient got dizzy around 5 minutes after dose; and began shaking a bit 1 minute later and staring into distance. Sweaty, continued dizziness. responsive at 1 minute after side effects began. Patient drank some water as able, and reported ears were ringing. Ambulance was called and reported all vitals looked good and patient likely experience syncopal event rather than seizure.

Patient received the Janssen COVID -19 Vaccine at the end of a work day on Tuesday March 16, the next day before noon he was experiencing fever, headache and pain in the upper left side of his chest to the side by his left Axillary. He came home at 1:00 pm. Had a headache all evening, fever of 100 and the pain in his upper left side of his chest. At around 12:25 went downstairs to take an Aleve for his head ache, and pain. His pain was so severe in the left upper side that he could not even raise his arm. It was severe pain. He managed to take one pill and collapsed falling on the kitchen floor. We heard the commotion and found him unconscious and unresponsive, we called 9-1-1 and he started to have a Grand Mal Seizure. He has never had a seizure in his life.

Pt began to feel lightheaded. Stood up to call nurse then lost consciousness, falling to the ground, scraping his face on the concrete. Pt had facial abrasions. Was transported to Urgent Care.

Initial soreness at injection site in right arm, which largely faded within four hours of vaccination; Ongoing as of this writing since 11:30 a.m. on 03/30/2021: mild stomach nausea (started at 11:30 a.m. and still going at 02:00 p.m.; vague chest pain (feels mild and seems like what I would expect from anxiety or drinking too much caffeine--of which I have not consumed), which started at about 01:15 p.m. and still going at 02:00 p.m.; a brief headache that lasted about 20 minutes from 01:00-01:20 p.m.; and a few times I had trouble mentally and visually focusing on my work (I do not mean my vision was blurry, just that I felt somewhat distracted). No treatment sought at this time.

Dizziness occurring 10 minutes after vaccine given Fainting occurring 10 minutes after vaccine given Headache occurring 30 minutes after vaccine given Nausea occurring 30 minutes after vaccine given Vomiting occurring 1 hour after vaccine given

After receiving the Janssen Covid 19 vaccine, I proceeded to the waiting area and was instructed to wait 15 minutes before leaving the facility. Approximately 5 minutes after receiving the injection, I started to feel faint, lightheaded, nausea, and clammy. I informed a member of the staff and several medical personnel came to assist. They laid me down on a cot and checked my vitals. I started to feel better after laying down. The staff took my blood pressure and heart rate readings, which were relatively normal. But after sitting me up and taking my vitals again, my blood pressure and heart rate spiked. I was taken to Hospital in an ambulance; however, after waiting in the ER waiting room for about 2.5 hours, I left without seeing a doctor. During those 2.5 hours my original symptoms did not return, so I elected to leave.

Patient given 0.5ml dose of covid-19 vaccine by Janssen. Patient stated was scared of needles. He immediately stated he thought he was going to pass out. Patient passed for approximately 30 seconds and jerked/like a seizure then came back but still felt dizzy, passed out again and jerked came back but still felt bad, Patient stated he did not feel right was hot wanted to lie down on floor. 911 was called made patient comfortable until EMT's arrived and patient was taken to ambulance and released.

Administered shot, patient moved to post-vaccination seating area. Within 5 minutes he complained about lightheadedness and appeared pale. Patient was given water and a fan. Requested patient stay an extra 15 minutes until he was feeling better. Patient left after 40 minutes of sitting.

CPT administered Janssen COVID-19 vaccine to the pt 4/5. While sitting in the pharmacy area for his 15 minute observation period, he fainted. He said that he was texting on his phone and the next thing he knew, he was on the ground with people around him asking if he was ok. He stated that he was very sweaty, nauseous, and a little dizzy. We called a code white, provided the pt with a cold compress and elevated his feet. Pt did not want us to call 911. Pt did not have PCP and has not been to a doctor in about 5 years. He said he was very nervous getting the shot and is afraid of needles so that may have contributed. Pt stayed in the pharmacy area for about 45 minutes until he started to feel better and his mom came to get him. I tried calling pt again at 7:10pm to check in, but there was no answer and I could not leave a voicemail due to mailbox being full.

About 10-15 minutes following vaccination, patient turned very pale, was sweating, and feeling lightheaded and dizzy. (Patient mentioned he had a great fear of needles prior to vaccine administration) A nearby ARNP took his blood pressure and he read very low..he was advised to lay down and elevate his feet to improve his blood pressure. He felt better. 911 was called and fire department was dispatched just in case. Fire department came and assessed his vitals. Patient started feeling better and was eventually able to sit up. He sat for a few more minutes before he left the store.

03/11/2021 3:05 pm Patient observed in chair pale with stiffened body and eyes rolling on back of head. Patient initially unresponsive V/S 97.2 20,71, 96/50, O2 sat@ 98% on room air. Blood glucose monitored @ 105 mg 1d1. 911 called patient responsive to verbal and tactile stimulation. Legs elevate, patient stated that he only ate breakfast for the day water and snacks offered and consumed. BP rechecked 80/50 Legs remains elevated. Awaiting for 911 to arrive close monitored is in progress. 3:20 pm The Fire Department arrives and assesses the patient. 3:30 pm BP 110/70 Patient awake and verbally responsive. Patient lift facility with rescue via stretcher en route to the hospital.

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.

The patient was fine directly after administration and for the first few minutes. He started feeling lightheaded and then experienced a syncopal episode. Patients eyes were open wide and was not responding. Checked for pulse which was present. Called EMS. He start responding after 2-3 minutes and was unaware of what happened. A few minutes later he started feeling better. EMS checked patient and he was fine. He was not taken to the hospital.

Patient fainted within 15 seconds of receiving the vaccine. Pt came too within 30 seconds after fainting. Pateint was observed for approximately 45 minutes by the pharmacy staff and the local EMS , which was contacted less than 2 minutes after the patient had fainted. EMS checked patients BP and pulse and everything was normal. Patient refused to be transported to the local hospital and a family friend came and picked the patient up to take him home.

I had received the Janessen vaccine around 3:30pm. Around 1 am I woke up to shivering and chills. My head felt extremely pressurized inside. My eyes felt like they were being pushed out of their sockets. My body hurt. It hurt to move. My neck , knees, ankles and back were in shooting dull pain. It took everything I had to stand up. I couldn't get to sleep. I had a fever. I started to shiver. My thought raced. It began to hurt to breath. My lower chest is sore on the inside where the lungs meets the rib cage. I could not to go class or do any work. Was easily one of the worst nights of my life.

During 15 minute monitoring- this RN performed her routine check. The patient had approximately 12 minutes remaining on his timer, indicating that he had received his vaccine in the last 3-4 minutes. He stated that he was feeling lightheaded. This RN and clinic staff secured the vehicle- shutting off the truck and removing the keys. We reclined his seat back and applied a cold compress on his forehead. At this time, the patient presented with diaphoresis and increased pallor. O2 sat 98% on RA, B/P 130/60, pulse 118. Had patient drink approximately 240 cc of cold water. Patient driving his company truck. Employer notified. Employer to send staff to drive the patient and the truck back to his home/work siteContinued to monitor patient for the next 30 minutes. At the end of monitoring- color had returned to his face, diaphoresis had ceased, and he stated the he felt "much better". Patient assisted to the passenger side of the vehicle with assist x 2. Gait steady. Patient drank an additional 240 cc of cold water. Patient encourage to continue to hydrate, and to contact his physician with any concerns- 911 with any emergent concerns.

Systemic: Fainting / Unresponsive-Mild, Additional Details: patient was given J and J \r\nCOVID vaccine. patient was seated when patient fainted. patient came to right away and was instructed to lay flat and elevate feet. patient started fo feel better. bp 100/80. Pt was monitored for 30min. Further BP was also 100/80. Pt was instructed to take it easy tonight and leave early from target shift and to seek medical care if any further fainting or symptoms.

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 reported feeling a little dizzy and nauseated after being vaccinated with girlfriend Patient soon after had syncopal episode Patient appeared clammy and pale and diaphoretic Patient seen by medical team Blood pressure 91/45 and heart rate 61 Patient provided water and repeat BP was 109/61 Patient refused medical transport and signed ama form but will have girlfriend drive him to hospital

I developed extreme body aches and chills along with an extreme fever, and it progressed throughout the night until I was delirious. I fainted once trying to take medication (ibeprofen) in the bathroom. I never measured the fever because I was delirious and could hardly move due to pain. I have never felt so sick in my life and I am a healthy 30 year old with no other health issues. I am feeling better this morning but have lingering symptoms of chills and aches. I am reporting this because the intensity of the reaction seemed overwhelmingly extreme and scary for someone of my health and age.

Patient lost consciousness/blacked out and fell out of observation chair. Patient suffered a minor head injury including a laceration. 911 was called. Patient became alert and oriented as well as stopped the bleeding before paramedics arrived. After being assessed by the paramedics, he requested not to go to the hospital and to leave on his own. I requested the patient sit for another 15 minutes before leaving to which he obliged and thanked me before leaving.

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.

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 woke up in a very heavy sweat and got up to use the bathroom. I felt unsteady. After washing my hands, I turned to the towel and vaguely remember falling to the floor. When I came to, I was too weak to get up. I laid there for 5 minutes before struggling to sit. After some time I was able to weakly return to bed and drank some rehydration tablets. My best guess was I had been drinking water but not replenishing my electrolytes.

Deep vein thrombosis (DVT) of axillary vein of upper right extremity, sub clavain vein and pulmonary embolism of right and left lung. Treated with injected Lovenox.

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.

Extreme chills and high fever starting approximately 12 hours following vaccination. 14 hours after vaccination had high fever, profuse sweating, leading to heart palpitations and two syncope episodes resulting in hospitalization. CT scan and xrays, ekg and blood tests, all normal, sent home on fluids. 76 hours after vaccination presented axatia, slurred speech, confusion, dizziness, resulting in rehospitalization. MRI, EEG, EKG, blood, and urine tests all completed and normal. Sent home on steroid.

COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave. On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. 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).

Client was leaving the parking lot post vaccination waiting period when he felt lightheaded. Wife indicates that client passed out twice in the car. Client reports feeling dizzy and hot and he looks pale and sweaty. His BP is 60/40. Client does not have any other medical history and is not taking any medications currently. He is allergic to sulfa. EMS on site evaluated client and was determined that 911 needed to be called. EMS responded and client was transported to the hospital.

Seizure - I have never had a seizure before and there is no history of epilepsy in my family. I had the Janssen vaccine shot at around 5PM on Thursday and felt mostly fine on Friday. I had typical shot symptoms (tired and soreness near injection sight). On Friday night around 10:00, I was standing talking to one of my friends in the living room when I had a blackout seizure without any warning. The seizure only lasted about 30-45 seconds, and then I became conscious again. It took me about 5-10 minutes to become completely aware and able to stand up. I have never had a seizure before and have not had one since then. Later the following week, I did have a couple of hours where I felt extremely dizzy and lightheaded, but it went away without another seizure. This is also not typical for me.

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

Nosebleed occurring for about 5 minutes twice since receiving the immunization. Has never had a nosebleed prior to receiving the COVID-19 Janssen Vaccine.

Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body. Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots

MILD COLD SYMPTOMS; SORE ARM; WEAKNESS; FATIGUE; THIRD STAGE HBP; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry-unknown) dose was not reported, 1 total administered on 06-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After the vaccine administration he felt "kind of weak and tired" and had mild cold symptoms and his arm was little sore With weakness on 06-MAR-2021, patient visited to the dentist to get a cleaning, they took his vital signs in the office, and were not able to do a cleaning because the blood pressure was very high (196/150). They waited 10 minutes and took the Blood Pressure again, still 196/150. he always had low BP. then bought a blood pressure monitor and it was continuously very high and even higher than at the dentist.due to this patient scheduled a doctor appointment on 3/25 physician took Blood pressure and prescribed some lab test. He had another appointment on 4/1,that time blood work was good everything functioning well, physician not understand why the BP was so high. patient told he received vaccine recently. On 25-MAR-2021 He was diagnosed with stage 3 High Blood Pressure, then physician put him on blood pressure medication. he also report works out every day ,very healthy and never had medical condition before, never took any medication ,No family history of HBP or heart condition Laboratory data included: Blood pressure (NR: not provided) 196/150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from third stage high blood pressure, and the outcome of sore arm, mild cold symptoms, weakness and fatigue was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441025.; Sender's Comments: V0-20210436063-covid-19 vaccine ad26.cov2.s-Third stage high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient raised hand and noted to be pale. Was asked if okay and noted that eyes rolled back and became diaphoretic . Paramedics called. Patients legs lifted and ammonia applied. Patients color started improving and patient started speaking. Patient stated " I want to lay down". Patient was taken by paramedics on stretcher

BLOOD CLOT FROM NOSE; TEMPORARILY UNABLE TO WALK, RICKETY KNEES; BURNING LEG PAIN; JOINT PAIN/ SHOULDER PAIN; SHOULDER FEEL TIGHT; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker (occasional pot; rarely). The patient's grandfather died from blot clot under knee (thrombosis). The patient had no history of bloody nose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 (two days after vaccination) the patient experienced really bad burning leg pain for few days and his joints in shoulder and knees were affected two days after vaccination and he could not walk (temporarily unable to walk). The patient also experienced rickety knees. On the same day, the patient blew out a huge blood clot from his nose. On 2021, the patient's shoulder felt tight. At the time of this report, the patient's knees and shoulders were still feeling tight like there was hardly any cartilage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot from nose, and temporarily unable to walk, rickety knees, was recovering from joint pain/ shoulder pain, and the outcome of burning leg pain and shoulder feel tight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-blood clot from nose. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY

pt developed symptoms of left leg swelling on 4/22/21 with increased pain and fullness in lower leg. found at ER on unspecified date to have a acute DVT, started on Xarelto, and fu in clinic on later unspecified date - with cbc normal, cmp normal goal of 3months of AC and hematology consultation

During the observation period, pt was seen trying to take off his jacket, and proceeded to pass out and fall out of his chair. Pharmacist rushed to help him up and he complained of feeling very hot and sweating profusely. He did not have any swelling/itching of throat/facial area. Patient was provided cold water, and told to remain seated. Pt was asked questions such as name, what day it is, to establish if patient was alert and oriented. Patient complained of experiencing tunnel vision while passing out. He proceeded to pass out once more, while seated, this time the pharmacist was able to support him in his chair. After the water and rest, patient said he felt much better and his girlfriend came to escort him home. He stayed for about 30 minutes before leaving and staff made sure he was feeling alright.

30-second syncopal episode and urinary incontinence while seated--3 minutes after injection. Did not fall or hit head. Regained consciousness without intervention. BP, pulse and respirations wnl. Positive for diaphoresis. Negative for swelling and shortness of breath. Recovered in 20 minutes and was able to leave clinic site. Provided water and cookies. Employer activated their emergency response system.

About 5 minutes after receiving the vaccine patient approached the pharmacy and said he wasn't feeling well. I asked him if he would like some water and he accepted. He returned to the chair in front of the pharmacy and sipped on the water. He looked like he was pale and breathing more slowly. I went out front to check on him and his breathing appeared labored, he was sweating profusely and he said he felt lightheaded and his hands were tingling. I told him to relax and take some breaths. His hands were very shaky and I took him BP (94/61 and HR 54). At this point I had my technician call 911. Between the time the paramedics arrived he went unresponsive for approx 20-30 seconds. I yelled his name and slapped his leg. No response. I checked for a pulse and if he was breathing. He did have a pulse and was breathing. After coming to the paramedics arrived and took him to the hospital for evalution.

He felt dizzy and passed out for about a minute. Paramedics observed him for an hour, checked BP and pulse frequently. He said he has a history of syncope after any injection or needle stick. He was escorted out to his ride, said he's fine.

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

Pt had near syncopal episode following vaccine. Pt states "he has fainted around needles in the past" Vitals taken, hypotensive, reassessed pt after 5 minutes to find vitals WNL. Refused transport to hospital

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

Friday, I received the shot at 3:30pm. I got home around 5:00pm and I started to not feel not feel well at all around 8:00pm. I woke up Saturday feeling dizzy and weak just like the night before. Saturday evening I let my dog out and when I turned around to go inside I fainted and feel on my face.

LOST OF CONSCIOUSNESS WITHIN MINUTES OF VACCINATION; SWEATING; HIGH BP 214/157 WITH "LO" PULSE; REMAINED BREATHING THE ENTIRE TIME WHILE WAITING FOR 911; GIVEN COLD COMPRESS TO THE NECK; REGAINED CONSCIOUSNESS BEFORE EMT'S ARRIVE AND COHERENT

Patient fainted after injection. He stated he has a history of fainting with any vaccine, not because of vaccine but because of fear of needles. Patient laid on floor until he felt better then moved to a chair outside the imz room to continue monitoring. He fainted again and was moved back to imz room. He laid on the floor for about 10 minutes until he felt better then moved back to chair outside room. Remained there for 20 minutes and felt he was fine to leave.

Syncope. Pt sustained abrasion to right forehead. BP 140/90 initially, 120/80 when released form recovery area.

COUPLE OF MINUTES AFTER RECEIVING THE VACCINE PATIENT GOT UP AND WALK UP TO THE REGISTER. DURING CONVERSATION WITH PHARMACIST PATIENT REMOVED HIS MASK AND SAID SOMETHING WHICH PHARMACIST DIDN'T HEAR OR UNDERSTAND. PATIENT FAINTED AND FELL ON THE FLOOR. AFTER FEW MINUTES PATIENT WAS ABLE TO MOVE AROUND AND COMMUNICATE. PARAMEDIC WAS CALLED AND TAKEN TO THE EMERGENCY ROOM FOR FURTHUR EVALUATION. ACCORDING TO NURSE AT ER PATIENT WAS FINE AND DISCHARGED AFTER COUPLE OF HOURS OBSERVATION. TRY CONTACTING PATIENT MULTIPLE TIMES VIA PHONE AND EMAIL BUT UNABLE TO COMMUNICATE WITH PATIENT AS OF NOW.

Symptoms began on 05/01/21 with fever, rapid heart rate, headache, chest pains, disorientation, nauseous and dizzy spells. I have kept a log of symptoms of when they occur, the time they occur and what the symptom is.

PT WAS SEATED, WAITING FOR 15 MINUTE MONITORING PERIOD POST VACCINE ADMINISTRATION. FELT DIZZY. REMAINED SEATED BUT PASSED OUT FOR A FEW SECONDS. CALLED 911. CAME TO, WAS ABLE TO TALK AND BREATHE BUT WAS SWEATY AND DIZZY AND PALE. SAT ON FLOOR SO HE WOULDN'T SLIDE OFF CHAIR IN CASE HAPPENED AGAIN. PARAMEDICS CAME, MONITORED BP, BLOOD SUGAR, EKG. HE HAD LOW BP BUT IT CAME BACK TO NORMAL IN FEW MINUTES. PARAMEDICS DETERMINED HE WAS OK TO GO HOME, DIDN'T NEED TO GO TO HOSPITAL

The patient experienced vasovagal syncope a few minutes following vaccine administration. Patient became alert seconds after fainting and made a full recovery.

Roughly 5-10 minutes after receiving the vaccine, patient fainted and began seizing for about 30 seconds. 911 was called, but patient came too and denied ambulance. Patient then vomited a couple minutes after. Patient reported he had not eaten anything and he was given orange juice and water. Patient waited another 30 minutes and reported feeling better. denied any further medical treatment.

The patient received their vaccination and before my immunizing technician could apply his bandaid he fell straight back while seated in his chair. She was able to catch his fall and lie him on the ground. I went into the immunization room to assist immediately and he was apologizing for scaring. I asked him to lie there for a few minutes and take some deep breaths. He was talking and aware of his surroundings. I asked him about his medication history which was null. I asked him if he had been nervous and he said he didn't think so. She said that he did mention he did not like needles. He had not eaten since the morning (a bagel) and it was late in the afternoon. After a few minutes I asked him if he would like to sit up so I could see how he was doing. Management arrived and observed while I went to get a cold cloth for his neck/face. Management asked him if he would like to sit in a chair. He sat in a chair and before I came back after just a few minutes, he had slumped over to the side with his eyes rolling back. Management was concerned so they immediately called 911. fire department and EMS arrived. They tested his blood pressure, etc and said they believed he had just passed out. They asked him if he wanted to go to the hospital. He declined. He called a family member to pick him up who arrived about 45 minutes after his vaccination. He was walking around and coherent when he left.

Patient passed out after having the Johnson and Johnson vaccine. It occurred about 20 minute after the vaccine. Causing him to crash into another car. The patient loss consciousness and the EMT came to the site.

Pt received the Janseen vaccine and two-three minutes later the patient fainted and regained consciousness intermittently as they were waiting for the 30 min post vaccine observation. Code white as called and was by the patient to make sure they did not fall out of the chair. EMS responded and took over as they called 911 to have the patient checked out. The ems confirmed the patient was stable and the patient did not need to be put in the ambulance. Pt was given orange juice and an ice pack. Pt was checked on before they left and they were ok.

pt felt faint, blanking out, pale color to face, seemed unresponsive at one point, he stated he was not feeling good and that he needed help. I sat pt down, lifted his legs onto a chair, got alcohol for pt to smell, got water for pt to sip, got a fan to circulate air around him, removed his mask and called 911. rescue came and pt left on his own. after 10 minutes pt was feeling better and color and responses confirmed he was better.

I woke up in the middle of night to use the bathroom and I don't remember what I was feeling, but I kept telling my self to just finish peeing and I woke up on the ground, I was pretty out of it, it took a couple minutes to get out of it I had a couple of buries, I felt stages of light headed for a few days it felt like I was giving blood. The next day I felt off, I didn't think I was safe to drive, I did feel better but still off and on Tuesday I felt drained.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness in about 20 seconds after lying him on his back with leg elevated.

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.

Patient felt weak and collapsed for 1 second, patient felt better quickly. Called 911 and paramedics checked vitals and left after five minutes. Patient stayed for 10 more minutes and felt fine and left.

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

9:50- Patient was sitting in chair talking to girlfriend. Per girlfriend patient's head started to tilt back, and then he fell on his right side. Patient had a vasovagal response X 10 seconds. EMT and NP rushed to patient, immediately assessing patient, hooked him up to EKG, took vitals and blood sugar. When patient woke up he was A&OX3, patient stated he did not eat anything for the day. Vitals: 140/88, pulse 67, 100% O2, BG 101. 1000: 12 LEAD EKG was performed, patient is in SINUS RHYTHM. Another set of vitals were taken. 115/70, 91 pulse, 100% O2. Patient was given cereal bar and orange juice. 1010: Third set of vitals 123/71, pulse 74, 100% O2 1030: Patient stated he was well. Patient was able to walk to car with girlfriend. Did not request any further medical intervention.

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt dizzy, lightheaded and then began seeing spots and proceeded to faint about 5 minutes after receiving vaccine. He attributes it to getting worked up just before vaccine.

Shortly after administering vaccine, patient nearly fainted. Patient was sweating, pale, and BP was low. Patient advised he was nervous and only had a smoothie for breakfast. Gave patient water and protein bar. Monitored patients symptom and BP which normalized shortly after consuming water/food. Let patient leave after 30 minutes post incident after confirming patient had been feeling okay 15 minutes.

About 2 minutes after administering the vaccine to the patient, the patients fiance notice that the patient began to roll his eyes and slump over. Upon accessing the patient I notice that the patient was unresponsive to my calls, at which point I motion for my technician to call for emergency; then I proceeded to try to move the patient from the chair to the floor with the aid of his fiance. The patient became responsive a second before we go him to the floor and he seemed responsive and was breathing pretty well. The patient was unresponsive for about 35 second at which point his eyes were rolled backwards, his head was sweating profusely as well as his muscles seemed to become very rigid. Thankfully within 5 minutes emergency personal was at the scene and they took his blood pressure and heart rate with both values being on the lower end. The patient objected to going to the hospital, at which point they offered to roll him outside for him to get fresh air and observes him before leaving with his fiance

Delayed slowed down time nauseous heart racing chest pains muscle aches joint pains anxiety stress none functional went to a urgent care and hospital no help CT scans x rays shakes fevers at night going on almost 2 weeks unable to work keep focus body shuts down

Patient received the COVID vaccine (Janssen, lot #205A21A use by 08/07/2021) at 1101. Pharmacist vaccinated the client at 1101 and as she was talking to him after administering the vaccine, the client began to slouch to the side in the chair. The client's eyes were closed when RN ran to station and EMT both assisted the client to the ground. The client loss consciousness for approximately 20 seconds and had no head trauma. The client's legs were elevated immediately by being place on a chair after he was placed supine on the floor. and his face mask was removed. The client regained consciousness at 1102 and was A & O x 4. The client was pale and denied shortness of breath, difficulty breathing, chest pain, dizziness, or difficulty swallowing. EMT took vitals at 110 BP: 115/75, HR: 46, RR:20, oxygen saturation: 98%, the client's color returned, skin was pink and warm. Client stated," I feel like I just took a nap, I feel good." The client reported nearly fainting in the past with getting his tattoo and fainting with the removal of stitches. The client was given Gatorade and was offered Pringles, the client denied the Pringles but did have a few sips of Gatorade. The client did not eat breakfast prior to being vaccinated. Denied having any known drug allergies, currently taking any medications, or having any chronic medical conditions. The client was placed in a supine position and then slowly placed in a sitting upright position. Denied any lightheadedness, dizziness, changes in vision, chest pain, or shortness of breath. EMT took vital signs at 1108, HR- 122/82, HR-54, RR-18, oxygen saturation- 99%. The patient then ambulated to the anti-gravity chair with assistance, by EMT and PM. The client placed his face mask back on and was offered a granola bar. The client stated," I'm tracking my macros and I need to check my app." The client then at the granola bar. EMT took vitals at 1113, BP- 122/80, HR-57, RR-18, oxygen saturation-97%. The client denied any oral trauma, head trauma, or incontinence. A final set of vitals were taken at 1121 EMT BP-120/80, HR-54, RR-16, oxygen saturation: 98%, the client stated, " My heart rate is usually in the 40's, I play Rugby." RN advised the client to follow-up with his primary care provider and educated the client about agency and emergency room precautions. The client was advised by RN to have his friend drive him home, him and his friend verbalized understanding. The client's friend was observed in the observation area after receiving COVID vaccine. The client left the site at 1202 with his friend, and had a steady and even gait.

30yo Male client reported dizziness and had a syncopal episode after receiving Janssen vaccine. LOC returned without assist. Client alert and oriented post syncope. BP 100/60 Client reported not eating for over 12hrs Gatorade given to client No EMS called Client ambulatory upon leave

Lightheadedness about 2 minutes following injection. Faintness and then loss of consciousness resulting in a fall.

Patinet received his Janssen Covid Vaccine today. He was fine in the immunization room and he went to the waiting area. Patient lost conciousness and fell on his partner. He regained conciousness in few seconds. He said he was feeling really lightheaded before he fell down. He had Syncope (Dizziness, and Loss of Consciousness for few seconds). He mentioned he did not drink much water today before the appt. We had him wait for 30 mins and he was fine when he left. Member of managements came to do an incident report and then he left. His partner was with him all the time.

Approximately 5 minutes after patient received vaccination, the patient passed out. He was standing outside the pharmacy and fell down. Family member cried for help. 911 called. Once I got to patient, he was responsive. Had patient sit up till paramedics arrived. Patient did not go to ER. Tried to call patient 2 days later to see how he was, but no answer. Did not leave message.

BP 115/64 (BP Location: RA-RIGHT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult) | Pulse 52 | Resp 16 | SpO2 100% Location of event Vaccine Center Description of Event: Pt reported not feeling ok. Was sitting in chair and began to slump back into chair. Reports having blacked out for a moment. Interventions: Transferred to gurney, given water, juice, assessed, vitals taken. Medications administered: None Response to interventions and/or medications given: Improvement to baseline Disposition:Home Treatment

30y M w/no PMH s/p COVID-19 J&J vaccine <5min exhibited syncopal episode while seated, resulting in ground level fall from chair witnessed by relative associated w/prodrome of mild flushing and upward nystagmus, but w/no significant head trauma. On exam noted to be contracted in extension, nonverbal and with fixed gaze which resolved w/in 1-2min with nl return of mental status. Pt's knees were slowly bent and the spine lightly placed in flexion, with slow transition to chair and finally legs elevated; no further complaints/events encountered.

after about 10 minutes patient went weak and muscles went into tetani for a brief time .911 was called .Patient recovered well in a sitting position bu then some minutes later p[resented with syncopy. He was placed on floor with legs raised and did recover some time later. The para medics put up a drip and took him away . Patient does not return my calls to find out status

gave pt Janssen shot at about 3:05 pm 7/6/21. after 5 minutes pt asked for water. Staff saw that the pt was pale and alerted me to that. Pt told me he was feeling dizzy. Had pt put his head down to his knees while I questioned him about other symptoms. Pt reported no nausea, no feeling of fullness, no itching, no headache, no other signs/symptoms. Dizziness abated after pt had his head down for 2-3 minutes. BP taken at 3:13 pm was 133/106 pulse 59. Explained to pt that I needed to continue observing him for signs of adverse rxn for a total of 30 minutes though he indicated that he was feeling better. pt agreed. Let pt go after the 30 minutes was up. counseled pt to mention the dizziness if ever he needs a Janssen "booster" in the future.

After I finished a light jog, I felt a pulse type feeling near my heart. It dropped my too my knees, but I did it lose consciousness. Early on that same day I felt light headed,?but nothing serious.

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 experienced normal side effects. Aches, fever, headache, chills, fever for about 5 days. They subsided, but I still don?t have an appetite, and I keep coughing up mucous, some with what looks like blood streaks, like a blood vessel, and blood spots when I blow my nose. And my lungs feel heavy. And it?s almost impossible to breathe deeply with coughing. Although I can go a few hours without coughing. The blood is very rare but it has happened several times in the past 4-5 days. It could have to do with my vaping, but it isn?t normal, only since being vaccined.

Administered vaccine at 1:33 PM into RD Deltoid patient fainted at 1:36 PM after administration of Vaccine. Nurse practitioner assessed patient Vitals Taken 1:36 PM Blood Pressure: 112/80mmhg Pulse: 62 Sp02: 100%. Observed patient for additional 15 Minutes per provider. Vital retaken at 2:10 PM Blood pressure: 90/60mmhg Pulse: 63 Spo2: 100% . Per provider okay to release home . Notified if symptoms worsen go to nearest emergency room and/or contact his Primary Care, if needed. patient verbalized understanding and agreed (Note: per patient he has a history of Fainting (syncope) due to needle phobia)

Immediately upon administering the vaccine, the patient loss consciousness. I was able to catch him. He was unresponsive for approximately 5 minutes. His eyes rolled back in his head and he made seizure like motions. By the time EMS arrived he was responsive.

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.

APPROXIMATELY 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED TO THE PATIENT, THE PATIENT BEGAN SWEATING AND FEELING LIGHTHEADED/DIZZY AND WAS THIRSTY AND APPEARED PALE IN COLOR. THE PATIENT WAS GIVEN 50MG OF LIQUID DIPHENHYDRAMINE BY MOUTH AND BEGAN TO HAVE IMPROVEMENT IN SYMPTOMS APPROXIMATELY 5 MINUTES LATER. THE PATIENT WAS OBSERVED FOR 30 MINUTES AFTER, AND WAS GIVEN WATER TO SIP.

3/7/21 - The day of the vaccination, minimal adverse side effects encountered. Minor soreness at the injection site, as well as general tiredness. 3/8/21 - Day after vaccination - mild soreness in arm, shoulder. Tiredness. 3/9/21 - Day - moderate soreness and pain experienced in the injection arm, shoulder, and back. Body aches, chest aches. Occasional waves of discomfort, similar to nausea but without stomach discomfort. Overall tiredness. Occasional mild headaches. No noticeable fever. Total 1000mg paracetamol taken throughout the day. 3/9/21 - Night - unable to sleep soundly due to moderate pain and aches in upper body, lots of discomfort. 1 dose of Nyquil liquid taken to reduce pain and aid sleep. 3/10/21 - Most pain has gone away, just some mild soreness remains. Still some overall tiredness. 3/11/21 - Side effects appear to have subsided by this day.

Injection was around noon, felt fine until dinnertime At around 5pm I started feeling a little groggy, lack of appetite By 7 pm I was experiencing moderate chills and shakes and tingling fingers and tongue, shakes subsided around 830p 9pm I went to sleep, 11pm woke up disoriented having been tossing and turning, elevated heart rate (approx 120 bpm) and temp (101.5) which lasted until around 12:30 am Resolved with symptoms of pressure headache until mid morning, made it difficult to sleep Treatment was ice and water, cold compress, hot shower, then in the morning two tylenol Day2 only effects seem to be those lingering from the night before (tired from lack of sleep, muscle soreness from shakes) The main fear was the high heart rate which was only listed in my side effects packet as something to look out for shortly after the injection as sign of an allergy, not something that would come on later

Vaccine given at approximately 11:10. Patient states "light headed". Noted to be diaphoretic and pale. Vitals taken. Patient placed on floor with 2 assist. Dr. on site. Patient recovered quickly with color (skin) improvement. He was moved by wheelchair and brought to the clinic's first aid room. Patients vitals obtained and within normal limits. No further issues noted. Patient left clinic for home in the care of his wife.

immediate syncope, hypotension, and bradycardia after vaccine. refused hospital transfer resolved with observation

Fatigue 2-3 hours after vaccination. Sweating/elevated heart rate about 11 hours after vaccine. Severe Headache 11 hours after vaccination.

Patient became diaphoretic and light headed following vaccine. Skin pale and Bp 108/60 with pulse 68. No respiratory distress noted. Patient transported to cot via wheelchair where they were monitored for 60 minutes. Bp improved to 118/60 before leaving.

After the vaccine observation period, the patient stood up and passed out. This has happened before when he has had blood work completed in the past.

Patient states he felt a "head rush" and then lost consciousness and fell out of his observation chair to the floor. Immediately had return of consciousness and sat up and returned to the chair. Observed and released to family and instructed patient to be taken to local Urgent care for evaluation. No obvious injuries from the fall. Patient reported his back teeth felt jagged. VS were stable

Fainting, dizziness, blurred vision, sweating, feeling clammy, blood pressure dropping and sugar dropping.

Pt presents with syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to left deltoid. Pt was in his vehicle when he started to feel lightheaded and had +LOC. His girlfriend who was sitting next to him states that he was unconscious for about 15 seconds before regaining consciousness. He had no head injury or other trauma. On immediate evaluation he is conscious and endorses diaphoresis and lightheadedness. He states that he has had similar episodes of syncope in the past following vaccinations. He denies medical problems, medications, or any Hx of allergies. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. Following evaluation by EMS, Pt refused medical transport and signed out AMA. Pt felt improved and was driven home by his girlfriend.

Patient was talking to a friend about five minutes after receiving the vaccine and suddenly passed out and fell to the floor. He was awake again in about a minute. The patient was sweating, pale and a little disoriented for a couple minutes but started improving steadily until he was feeling his normal self again. The EMS was called but the patient declined being taken to the hospital as he felt much better by the time they arrived.

He got his vaccine and was waiting when he felt dizzy and his color turned pale. Gave him water to drink and call 911. Paramedics came and checked his vitals. He felt better within 20 minutes

He felt dizzy and became pale. Gave him water to drink and called 911. Paramedics checked him and he recovered in about 20 minutes.

Fever, skin pain nausea. Very low blood pressure. The fever last for 6 hours and the episode of blood pressure was in the next morning.

About 3 hours after the shot, I experienced severe painful PVCs that then turned into a tachycardia of over 180 bpm while I was driving.

Passed out within 5 minutes of receiving the vaccine. Dizziness, skin pale, b/p 80/48. Transported to Hospital for treatment.

Fever, headache, body aches, light headedness and nausea causing me to pass out while trying to walk to the bathroom. Upon standing up from the laying down position, I got lightheaded, started profusely sweating, became nauseous and ultimately lost consciousness. When I regained my consciousness, there was a loud ringing in my ears and my hands were numb. I took some Tylenol, laid down and it subsided shortly after. I did not experience any symptoms as severe as this at any point again.

The patient fainted post vaccination. He did not come to immediately and EMS was called as a precaution and the patient was assessed and found to be fine. The patient states this is common for him.

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

Roughly 12 hours post receiving the J&J vaccine, I woke up with a nose bleed. I haven't had a nose bleed in the last 10 years. No nasal trauma or dryness/ exposure to dry or cold weather. applied pressure to the bridge of my nose, cleaned my nose out, and woke up in the morning with additional dried blood in my nose. this has happened two nights in a row now.

Patient is 31 year old male who came in today to get his Janssen Covid-19 vaccine. He came with his wife and father-in-law. He verbalized ahead of time that he has a history of fainting due to his fear of needles. He does not have any allergic reaction to vaccine components. After reviewing his PQCF and possible side effects of the vaccine, patient verbally consented to get vaccinated. I administered the vaccine into the deltoid muscle of his right arm. I gave him an ice pack. Right after the vaccine was administered patient said he felt fine. He relocated from the immunization booth to a Post Vaccine waiting chair with his wife by his side. He fainted into his wifes's arms for about 30 seconds. His father-in-law helped place him on his back on the floor and we raised his legs up on a chair. Patient came to immediately when placed on supine position and said he just needed to rest. We called Code White and assistant manager came to the scene. Patient was conscious and verbalized that he was feeling fine but should just rest. Patient continued to use ice pack and rested for about 30 minutes.

Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after only about 2 minutes in chair. he came to immediately, was surprised, he sat in observation area for 25min as he recovered.

About 30 seconds after the shot, became faint, dizzy, and ears started to lose hearing and became fuzzy. Sat down and drank some water, vitals showed lowered BP. Recovered after 15-30 minutes and some water.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: about 1-3 mins after patient received vaccine said he felt dizzy and lightheaded then he passed out and hit his head on table and floor. patient came back conscious quickly and i helped him get to his feet and back to a seated position. an ambulance was called immediately. they checked him out and he refused ride to hospital.

Patient received the vaccine and fainted shortly thereafter. He became very sweaty and came to in a couple of minutes. Paramedics attended to him and deemed it necessary to take him to Medical Center for further evaluation due to irregular heart rate.

Weakness, Dizziness, server headache, chest pain, Blood pressure went down to 90/52 . I'm going to see primary care physician Monday.

patient fainted right after he was give his vaccine, he seemed very stiff. It took 2 minutes for hi to regain conscious. he mentioned that he sometimes faints when he gets injected by a needle. he was observed for 30 minutes offered water, and left the pharmacy in good shape

Patient passed out in sitting position 5 minutes after receiving vaccine, opened ammonia salts at 1:40pm, but patient became unresponsive by 1:48, administered EpiPen in right thigh. EMS contacted - HR of 54, BP too low to calculate. MD/hospital referral.

Patient received I IM injection of Johnson and Johnson vaccine. Patient went pale in the skin and felt lightheaded and unwell. Nurse supported patient and laid patient down on the cot next to table. Emergency response / Code Green on site vital signs stable patient recovering. Five minutes post incident patient walked to observation no immediate life threatening signs or symptoms. Patient refused additional medical support and transport.

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.

Patient was in attendance at the JANSSEN vaccination clinic on 4/9/21. After vaccination while he was in the observation area, PT experienced a syncopal episode and hit his head on the window sill next to where he was sitting. Staff responded and assessed PT and decided to initiate a MET call. There was concern that the patient may have experienced a seizure. Patient was taken to the Emergency Department. Patient was ultimately admitted on 4/9/21 with new onset of a. fib. He was discharged on 4/11/21. While hospitalized, the patient received IV cardizem

Patient appeared to be fainted for 1-2 seconds. After having water and snack, he became ok. Patient was asked to wait for 45 minutes. Family members said that he did not have breakfast and he is scared of seeing needles or blood.

Patient received vaccine through pharmacy at employer vaccination event. Presented to clinic on 04/13/2021 and noted to have imaging confirmed "There is occlusive superficial clot starting the upper lateral right thigh and extending distally through the mid to distal lateral calf. This appears to be within a superficial varicosity. Findings are consistent with extensive superficial thrombophlebitis of a varicose vein of the right lower extremity."

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

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 the shot in left shoulder. Was browsing phone for about 30 seconds to a minute. Felt a rising sensation in the esophagus. Felt as though nausea was impending. Sensation rose into skull in "crawling waves". Skull felt heavy. Interpreted the sensation as disorientation. Asked pharmacist if dizziness was normal with the vaccine. Woke up a few seconds later picking myself up off the floor.

15min after receiving the vaccine I felt chills on the right side of my body and muscle soreness in arm spreading up to right side of neck. 10hrs after receiving the vaccine I developed a headache that lasted for 72hrs and wasn't relieved by Tylenol. I began running a fever of 101F, muscle and joint aches, chills, sweating that soaked by bedding that lasted for 48hrs. Four days after the injection, I noticed my legs from knee down were swollen for 36hrs. I also experienced by heartbeat racing for 48hrs that began 10hrs after the injection.

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.

Client awoke with chest pain and visited local ER for suspect M.I. Transferred to Hospital for angioplasty, related to thrombosis in R) coronary artery. Treated for 3 days and released to home with 3 months of follow-up cardiac rehab. Scheduled to return back to work as an auto mechanic on 4/26/2021.

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.

PERICARDITIS; MYALGIA; This spontaneous report received from a physician concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) with unspecified dose 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021 the patient had experienced fever, myalgia. On 20-APR-2021 the patient diagnosed with pericarditis, chest discomfort and was hospitalized, patient had reported these symptoms to health care professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, fever, chest discomfort, and myalgia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210448217-COVID-19 VACCINE AD26.COV2.S-Pericarditis. 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).

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Vitals : BP 130/87 HR 69 BS 103. EMT arrived to evaluate pt. Pt refused hospital care. Pharmacy had pt wait 30 minutes before leaving. EMT confirmed pt ok to stand, walk, drive, and state date/location/president.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting/ responsive-Medium, Additional Details: Pt fainted due to vaccine. Was responsive 1 minute after fainting. Woke up and stayed prone on ground until EMS arrival.

dizzy, sweating, clammy skin, light headed about 5 minutes after getting vaccine, lasted less than 10 min, he got a ride home just to be safe

Patient reported feeling light headed approximately 8 minutes after receiving the vaccine, then fainted. Patient came to 2-3 minutes later. Patient was provided water and orange juice, as he had mentioned he had only had a very small breakfast (one poptart). Patient says he has not fainted post-vaccination before, but has fainted before after getting his blood drawn.

after about 5-6 minutes, he started feeling weird, then started to get pale and sweating, didn't pass out but did vomit. took a ride to er with the ambulance, came back to let me know he was ok and thank me.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild

"Patient who had recently been vaccinated approached me and stated that he did not feel well." "Complaining of weakness and dizziness after COVID Vaccine." "Pale and notably diaphoretic" "Vital signs assessed and found to be bradycardia and hypotensive in seated position. EKG completed and transport to medical facility via medic ambulance." 11:43 BP 90/31, HR48 (weak, regular), RR 16 normal and SpO2 98% room air. 11:46 BP 86/39, HR52, SpO2 98% 11:55 BP 125/68, HR73, SpO2 100% 12lead performed to show brady-sinus with no indications of heartblock. IV fluids, 100mL LR via 20g in LAC.

imeediately after vaccination, patient lost conciousness, had a period of muscular jerks similar to seizure, for about 30 seconds. After that, could respond (had no memory) but was generally not lucid for another 90 seconds. At that point, the patient could respond, wanted to lie down, started sweating profusely, and after about 5-10 minutes was generally recovered. Patient stated that they have had previous issues while giving blood.

Approximately 10 minutes after receiving the Janssen vaccine the patient walked up to the pharmacy counter and asked a technician if it was normal to feel clammy after the vaccine. Immediately after the patient passed out.

Horrendous chills, terrible back and joint pain, uncontrollable shivering and muscle spasms, intense nightsweats, fever, extreme headache, Soreness in chest/heart area. All 1000x worse than Covid which I had in December. Would have gone to the hospital if I didn?t know I had the vaccine.

Patient started feeling lightheaded about 2- 3 mins of vaccine administration. Patient moved from the chair to the floor because he felt like he was going to pass out. Patient passed out for about 30 seconds, slight twitching during episode and then came through. He was a bit disoriented but alert, we had him stick around until his wife came and picked him up.

patient became light-headed after immunization and fainted, falling off of the chair. Emergency services were called and he was determined to be okay.

DIZZY, PASSED OUT IN HIS SEAT, MOVED TO COT, REMAINED UNRESPONSIVE FOR 30-45 SECS, INCONTINENT OF URINE. EMS CAME, BP 137/72, HR 56, PROVIDED GATORADE AND SNACKS, SYMPTOMS RESOLVED, REFUSED TRANSPORT.

Patient fainted about 10 minutes after vaccine administered. Came to within a couple of minutes and vitals were stable upon examination by EMT's within about 15 minutes.

5/23/2021-Pt received J&J vaccine at pharmacy today approx one hour prior to arriving to the ER, passed out after receiving the vaccine in the room at the pharmacy. Pharmacist was in the room with pt and he had no injuries/did not fall. After leaving pharmacy he passed out again in the car and was shaking per pts wife, then started vomiting. He arrived to the ER c/o feeling 'like crap." vitals with normal bp, temp, RR , hr 69. given 1 Liter normal saline. he was observed in the ER and discharged home to recover.

Immediately after the patient received the Janssen Covid-19 vaccine, the patient closed his eyes and became unresponsive for less than 10 seconds. Patient then opened his eyes and was conscious again. Patient stated that he always has this type of reaction every time he receives a vaccine. He did not disclose this information because he did not think it would happen since he had not received any vaccines for the last 3 year.s.

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.

Patient stated feeling dizzy and nauseas, patient presented with red hives along right side of the neck, PT also presented as diaphoretic and pale. PTs lung sounds were clear and patients air way remained open. vitals were SPo2: 97% HR: 85 BP: 145/90

PATIENT RECIVED VACCINE AND PASSED OUT WITHIN 5 MINUTES AND REGAINED CONSCIOUSNESS, EMTs responded and patient was released, patient's alternative domestic number listed above

Patient fainted almost immediately after needle was withdrawn and bandage was applied. Patient reports always fainting with any shot he gets. Was out for about 3-5 seconds, then came to, and no other issues afterwards.

Patient was given the vaccine at 10:40am. He was being monitored and at 10:53am, stood up and immediately passed out falling face first. He came about immediately and refused medical attention but has a large swollen area on his forehead.

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.

RUE DVT in brachial vein at site of injection. Patient complained of RUE pain and swelling on 4/28. That evening the team ordered a RUE venous duplex. The venous duplex noted a DVT in the proximal aspect of one of the two brachial veins. He was vaccinated during an inpatient psychiatric hospitalization. He was evaluated by the medical team on 4/29 and noted to be in stable condition. On discharge he was prescribed xarelto 15 mg BID with food for 21 days with instruction to follow up with PCP in 1-2 weeks. After 21 days of therapy plan was to switch to xarelto 20 mg daily with food until 7/22/21 for a total of 3 months of therapy. The adverse event did not prolong his hospitalization.

After administration patient was sitting in post vaccination chair and was passing in and out, sweating very much, pale, high blood pressure, and experienced dizziness and tunnel vision. after about 30 mins patient was feeling much better.

Patient and his girlfriend came in for a COVID vaccine and received it in our vaccination room. Patient was consulted on possible side effects of the vaccine and was instructed to wait for 15 minutes before leaving the area. - A couple minutes after receiving the vaccine we heard the patients girlfriend cry out for help. - We went to assist the patient immediately and the patient was slumped over on his side with his girlfriend holding him up. - Patient did not hit the floor or hit any part of his body. - We asked the patient if he was ok, and he was disoriented and looked pale. - The girlfriend told us that he has fainted in the past after getting suck with needles. - Patient started to come to and said he was hot. We gave him Pedialyte to drink and aimed the fan on him. - I asked the patient a series of questions to determine what his condition was. - Patient did not feel any allergic reaction coming on, did not have difficulty breathing, did not feel tightness in his throat area. - Patient stated that he felt hot, and felt his blood pressure drop, and was light headed. - Patient was instructed to sit and stay in the area and we would observe him before he could leave the area. - Patient was within visual sight and every few minutes we would check on him to see if he was feeling better. - Overtime patient's color started to return to normal, patient became more responsive to conversation, and no longer complained of being hot or light headed. - After about 20 minutes or so, patient said he was felling much better and was ready to leave the area and get lunch in the food court. - Patient and his girlfriend was instructed to report back if was feeling lightheaded or faint before leaving the store.

On Saturday, I woke up to my right arm - at injection site area - was itching. I woke up to numerous nose bleeds. I'm not prone to nose bleeds. Also - consistent since Saturday, Diarrhea; muscles aches; fatigue; vomiting. Problems with keeping liquid and food down now - just started a couple of days ago. Dr called me on Friday -I was doing okay; On Monday - he called again and I wasn't doing well. Have spoken to my doctor each day. And now (since two days ago) it feels like my skin is tearing apart and burning and that the inside of my bones are on fire. At the same time, I couldn't keep food and liquid down anymore. Autonomic immune system is in fight response since Saturday. Haven't been able to get out of bed for last two days. Diarrhea has worsened. - Have been taking Zofran - nausea med for the last two days. To subdue the vomiting. Have a new medication that I am starting today to subdue the diarrhea - can't remember what it's called. Trying to make sure it doesn't go into an autonomic crisis. Only Telemed visits so far - video appts. Have had several fevers doing this time - currently at 100 but went up to 103. I have gone to low grade too and means I have not been doing well at all - on Saturday to Sunday. (Went to high grade - Mon, Tuesday, Wednesday).

within a minute patient felt nervous ..faint, two minutes later he started to sweat, but talkative and I took blood pressure at 1:32 it read 69/41 67 a few minutes later he looked less pale and his demeanor improved I re took the blood pressure at 1:38 and it read 112/85 91 he continued to improve and at 1:45 he stood up said he felt normal, stayed for a few more minutes then went home

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: fell on forehead after fainting-Mild, Additional Details: pt fainted and fell on his forehead causing his forehead to bleed

Administered vaccine to patient and not long after patient stated he wasn't feeling well and fainted. Had technician call 911. Paramedics came and accessed patient. Patient was asked if he wanted to go to the hospital and he refused. Currently patient has recovered and called for a ride home

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported hx of previous fainting with other vaccines and within 2 minutes of receiving this vaccine if fainted and quickly came to. We continued to monitor him for 30 additional minutes with no further complications.

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.

Vaccine given, pt seemed fine and walked from vaccine room to waiting room and he was asked to wait 15 minutes. A few minutes later pt began sweating and feeling dizzy. He tried to lie down on the floor, but passed out. He hit his face and got a bloody nose, scrape on his cheek and swollen lip. He came right to and notified us of what happened. He stated he had only eaten applesauce for breakfast. We gave him some water and crackers. He started feeling better. We had him sit in the waiting room for a while, probably about 30-45 minutes. He stated that he felt fine. We offered medical assistance, calling 911, or calling to have someone pick him up, but he refused all. At that point, he said he felt much better and was ready to leave. He said he felt fine to drive home. His mom was meeting him there.

One minute after vaccination patient began to develop urticaria on his upper anterior chest. Patient complained of dry mouth and throat and "not feeling well". Patient was given 50mg of PO benadryl. Rash on chest resolved but swelling began in face around eyes, and blanchable redness developed on forehead and patient complained of itching scalp and nausea. 24 mg of methylprednisolone and 8mg of Zofran was administered. Patient maintaining a normotensive state throughout events, hr in the 70s and oxygen saturation 96%. at 0910 patient had returned a normal state, no signs of swelling or difficulty breathing. Fire team was called for evaluation and patient was observed for one hour. No return of symptoms.

Patient experienced a syncopal event. Patient was lowered to the floor, legs were elevated, and vital signs were monitored. Provided ice packs and fluids. Patient returned to a sitting position, and then standing position. Patient was monitored for an additional 30 minutes after event.

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.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: patient bp was recorded as 85/75mmhg at the time patient felt light headednes. rechecked again after 15 minutes and pt felt better and bp recorded-120/79mmhg

Immediately after immunization administered, pt became unresponsive. Remained conscious entire time, but very light headed. Pt was warm, sweating, clammy. After 5min, epinephrine was administered. Pt became more conscious after 5-10min of epinephrine dose. Pt. stayed in immunization area for approximately 70min after event. Wife contacted. Wife arrived 60min later. Pt left under wife care. Pt did not drive home. Pt was given water, and a soft drink after 30min. Contacted pt early evening. Pt reported feeling fine. No further symptoms.

Patient with a history of vasovagal reactions first experienced shakiness and diaphoresis and thenhad a brief (<30 seconds) loss of consciousness but without loss of postural tone about 2-3 minutes after the injection. BP-148/82 P-86 O2- 99% Monitored, offered fluids, recovered fully and was discharged home.

Vasovagal reaction. Lightheadedness, pale, clammy. Resolved with lying down in passenger seat, elevating legs, juice/water/crackers, and additional monitoring time Advised to go to ED if symptoms arise later in the day or call PCP

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

Migraine, dizziness, vomited, fever of about(101.7), extensive sweating and elevated heart rate. Lasted for 6 hours.

Patient stated feeling lightheaded and palpitations Patient provided with food and water, stated symptoms resolved Patient seen by medical team, refused medical transport and signed AMA form

Patient received COVID Janssen injection, saw blood and had a vagal response to which he passed out and was lowered to ground. Did not hit head. Laid supine with legs elevated, profuse sweating, ice packs to chest, water given. After a few minutes assisted to sitting position and then assisted to standing position with no s/s reported. Assisted to monitoring area for continued monitoring.

Patient awoke early Wednesday morning feeling very feverish and had tightness in his lungs. He did not have a thermometer to take his temp, but felt feverish. His symptoms have eased some as of his call into the pharmacy around noon.

Patient recieved vaccine and was moved to observation area. Patient suddenly lost conciousness and fell from chair to the ground. Pt regained conciousness within 30 seconds. Patient was alert and orient upon regaining conciousness. Patient verbalized he was having no trouble breathing and vitals were taken. Patient vital signs were within normal ranges. Patient verbalized that his left arm hurt and fingers were numb on that side. Patient was taken to urgent care clinic and evaluated by physician. Patient signed an AMA form and was released from hospital. Patient encouraged to follow up with primary care doctor.

After vaccination, patient got very pale, nauseous, chills, and sweating. He felt as though he may pass out. We elevated his feet and had him remain seated for 15 minutes. After 15 minutes, patient felt better, but still shaky, We continued to monitor for 30 minutes.

Following vaccination, patient experienced paleness, Sweating, chills, nausea, and felt nearly loss of consciousness. We elevated patient's feet, and after about 15 minutes patient began to feel better. We then provided water. We continued to monitor for 30 minutes post vaccination

Patient recieved dose at 3:32pm and went to sit out front for the 15 minutes at 3:36pm another patient that was waiting thier 15min came to get us because he noticed he was turning white. I went to check on him and he was yellowish in color and barely able to speak to me. I asked another pharmacist to get me a cold pack and water. By the time we got the cold pack and water, he was not speaking, but eyes were open. I called 911 and the other pharmacist fanned him and placed the cold pack on his head and neck. He started talking within minutes and we waited for ambulance to come just to check him out. He was ablet to verify his name and where he was and EMSA came at 3:50pm. He left to their truck and said he was okay just felt shaky and clammy, but he could hear everyone talking to him.

32yrold patient with PMH including anxiety presented on 4/7/21 at office for J&J COVID 19 vaccine. Administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1350. After receiving vaccine, patient felt lightheaded and sweaty. At 1358, BP 81/49, HR 37, 93% RA. Patient endorsed previous reactions during immunizations previously. Other symptoms denied and no history of anaphylaxis. Patient placed in Trendelenburg position with resolution of symptoms. BP while in Trendelenburg position, 1010/58, HR 66, 98% RA. Minutes later while in sitting position, VS remained stable and BP 125/89, HR 87. Provider assessed patient and noted vasovagal reaction following vaccination. No syncope. All symptoms resolved. Patient discharged home in stable condition.

Patient had an episode of fainting about 10 mins after vaccine administration. after regaining consciousness he had rolling eyes and seizure and 2nd episode of fainting. The fainting episodes were for few seconds (30-45 sec). Patients feet were elevated and paramedics were called. while waiting for the paramedics we had patient drink water and orange juice as he was on diet and had taken only 300 calories per patient. Used cold compress on his face and neck, patient was comprehending well afterwards. paramedics arrived and examined the patients vital and asked if he would like to go to the hospital even though patient seemed fine. Patient denied going to the hospital and paramedics left afterwards. patient waited for 30 minutes afterwards and then left. we called the patient later and he was doing fine.

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 started fainting a few minutes after the Janssen vaccine was injected. Patient started fainting in while he was seated. He wasn't very responsive but his eyes were open. Patient stated that he has a panic attack to the injection of the needle and has had similar reactions in the past from other injections.

2-3 Minutes after receiving the vaccine, the patient was seated in the waiting area for his 15 minute wait time. We heard a crash and the yell of his wife and 3 children. Found the patient laying on his back on the ground. Patient was breathing, but non responsive to tapping and shouting. 911 was called. Patient regained consciousness after about 15-30 seconds. He complained of being hot, thirsty, having to go to the bathroom and feeling out of it. He appeared pale. We did record a BP of 95/57. He remained conscious until EMT's arrived. He was attended to and taken to the ER by emergency personal.

Approximately 2 minutes after the patient received the vaccine, the patient had other questions and while talking about the vaccine, the patient's eyes rolled back and he experienced a vasovagal reaction (syncope). Although he was sitting in a chair, his head fell to the left and his forehead bumped the table. The patient's legs were elevated and his upper body was laid back. Ammonia inhalant was crushed and immediately placed under the patient's nose. The patient came back to consciousness approximately 30 seconds after passing out. Patient was asked what symptoms he felt leading up to passing out. He said that he suddenly felt dizzy and does not remember much after. Patient states that he did not eat breakfast prior to receiving the vaccine and has a history of not doing well with needles or vaccines. He states that he now feels completely fine, however, the patient was advised to stay 30 minutes for monitoring, and once he felt comfortable standing up, a nurse walked with him to the observation area. Patient was provided an ice pack for his forehead. Observation nurse was notified of the adverse event and is now monitoring the patient.

Patient was waiting in chair about 2 minutes after he received his covid shot, said he felt dizzy. Tried to assist him but he had fainted and hit his head.

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

fainting and patient fell on ground (hitting forehead), 911 was called; the patient came around in 10 seconds or so. Patient said they felt a little nauseous but then dizzy and things went dark. We kept them laying down on the floor with knees up, took their BP (127/72) and waited for medics to come. Medics arrived within 10 minutes to evaluate the patient, offered to take them to the hospital, patient declined and they released them to take it easy and call them/go to hospital if they felt faint again.

Patient collapsed/experienced syncopy 5 to 7 minutes after receiving the covid vaccine in the pharmacy sitting area , he was walking along the aisle the store and collapsed/fell face down. An ambulance was called and patient was taken to the hospital

Pt. became diaphoretic and had a syncopal episode. Pt. was caught by staff and lowered to the ground. Pt. was assessed by EMS and stated to them that he "always passes out when he get a shot." Pt. refused transport or treatment. Pt. left the vaccination site under his own power.

I typically faint when getting shots or blood drawn. I did faint about 10 seconds after the initial shot injection. I was conscious throughout but was not able to speak clearly or control my body even though I could hear everything going on around me. After 30 minutes, I was feeling back to normal. The remainder of the day I felt drowsy and a little out of it. At 12:15am I began to get severe chills and shakes. This lasted throughout the night but was the worst from about 12:15-1:00am. I woke up at 4am with a fever and sweating. My entire body was stiff and in pain with aches specifically in my arms and legs. Very sore pain in my left deltoid where the shot was injected and is still slightly sensitive. It felt like my veins were stiff and in pain and it hurt to move. I had what I can describe as flu like symptoms (i.e. my teeth hurt, my body ached, fever, shakes, body stiffness and overall tiredness and weakness). These all lasted until about 6:30am at the worst and were relieved over the next few hours. I started to feel back to normal around 3pm later that day. That was April 11th. Last night, April 12th, I had trouble sleeping because my left arm was in pain from my elbow to fingers. It was a lingering pain that went away by this morning and is mostly gone now (morning April 13th).

General muscle ache Dizziness Chills Very severe headache blew out my nostrils this morning and clotted blood came out

Nausea (24 hours), chills (24 hours), sore throat (1.5 weeks, ongoing), thick bloody mucus (1.5 weeks, ongoing), dry cough (1.5 weeks, ongoing), loss of voice (1.5 weeks, ongoing)

Immediate loss of consciousness. I lost color in my face (pale white) I experienced chills and cold. My hands were shaking for about 4 hours following. From the fall, I developed right shoulder pain, right hip pain, jaw pain, right eye pain, right chest pain, right back pain, and a black eye. All symptoms have lasted a week.A I also had fever for about a day, along with generally feeling weak/unwell.A I

(URGENT) MULTIPLE - severe, sharp shooting pain up from left side of neck to upper chest. - Lasted 3 weeks and still will come every now and then. - 2 day neck stiffness (normal) - complete immune system break down: Lost partial taste in tongue, developed oral thrush that was resistant to diflucan and nystatin. - 2 day stint with allergies (Sneezing, stuffy nose, no yellow mucus or fever) - Periodic headaches - swelling of tongue - fatigue lasted weeks. - easily bruising or bleeding under skin after getting minor scratches. Never healed properly (As in disappear) -glossy watery, red eyes with swollen nasolacrimal duct (inside pink corner of eye. Puffy and red.)

I opted for the J&J variant and received it on Monday at 1:00 PM, mere hours before they pulled distribution of it on the national level. I started feeling flu like fatigue, body aches, and a headache 8 hours post injection. I ran a 101+ fever Monday night and got less than 4 hours sleep due to fever and fairly intense muscle aches. On Tuesday morning the headache, fever and muscle aches persisted till the late evening accompanied by general fatigue. By 9:00 on Tuesday night I was feeling significant improvement and slept well Tuesday night with minor night sweats on and off. Wednesday morning I felt 80% back to normal. No fever, minor headache only evident when standing up quickly or sudden head movement, and continued muscles aches body wide specifically in the neck and chest as well as injection site muscle soreness. These symptoms continue to persist into Thursday at the same or perhaps slightly elevated levels. Friday 4/15 symptoms persist with generalized soreness, fatigue, headache, injection site soreness. Not his typical self.

TIGHTNESS IN THE CHEST; MIGRAINE HEADACHES WHEN STANDS UP FROM BED; PAIN IN THE ARM; This spontaneous report received from a consumer concerned a 32 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tightness in the chest. On APR-2021, the subject experienced migraine headaches when stands up from bed. On APR-2021, the subject experienced pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the arm, tightness in the chest and migraine headaches when stands up from bed was not reported. This report was non-serious.

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

I experienced a sudden onset of symptoms approximately 7 hours post-vaccination. Symptoms started with severe chills, elevated heart rate, fever (~102), and progressed into muscle and joint soreness, severe migraine with sensitivity to light, and strong fatigue, coupled with insomnia. The symptoms were severe enough that I considered going to the hospital, but ultimately did not. Fever, chills, and elevated heart rate subsided by the next morning (~12 hours after onset), but muscle soreness, migraine, and fatigue lasted for another 12-24 hours, along with a loss of appetite. I am an otherwise healthy, male adult with no outstanding medical conditions whatsoever. This was one of the most severe immune responses I have ever had, including actual illnesses. I have received other vaccinations in the past and never had any response nearly as severe. I was significantly concerned for my overall health during the height of the vaccine response, and I wanted to report this to ensure that is aware of these types of responses, and can help prepare others by informing them adequately of the types of responses to expect from the vaccine. This response very much took me by surprise in terms of severity -- I had to call out of work at a critical time.

0 mins: Discomfort in arm flowing from injection site to the rest of the body 2-4 mins: Light-headedness 5-10 mins: About 2 minutes after sitting down at the 30-min waiting area, I began to feel more light-headed while checking my phone, though I don't remember it, I fainted and hit my head on the gym floor ~15 mins: I am awake and feel extremely foggy and have low blood-pressure and heart rate ~25 mins: I am told to sit back up in the chair ~26 mins: I start feeling light-headed again and lose consciousness again and am told that I had a seizure for 20 seconds before coming back again

BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Covid-19 vaccine JJ: 32 y.o. male w/ no PMH presenting 2 weeks after receiving his Johnson & Johnson COVID vaccine after having severe L calf pain found to have thrombocytopenia. From H&P on 4/21, Patient reports that he had both fevers and aches after his vaccine (4/8/2021). Several days later developed low back pain radiating into his left leg which he initially attributed to sciatica. However, several days later, he went for a 6 mile hike, and felt that his left leg was hurting more. He went to PCP, where he received a blood test and was found to have a platelet count in the low 60s. This was initially thought to be a lab error, but he noticed that his left leg was swollen, somewhat red, and appeared that his blood vessels were swollen. This swelling resolves when he is lying down, and is worsened when he is standing. He received an US to r/o DVT, which was negative. However, after his repeat platelet count demonstrated thrombocytopenia, he was sent to the ED. He denies any recent leg trauma, though he has broken his leg before nearly 15 years ago. He denies weakness or issues going to the bathroom. Denies chest pain or shortness of breath. Denies chills, fevers, but did wake up last 2 nights drenched in sweat. He also reports a petechial rash on his legs. As of 4/22, medical team suspects Vaccine-induced thrombocytopenic purpura (VITT). VITT requires 1) thrombocytopenia, 2) documented clot, 3) positive PF4 Ab, and 4) recent AstraZeneca or J&J vaccine. He meets criteria 1, 3, and 4. He has clinical signs of DVT but does not have a documented clot. Patient has L calf tenderness and prominent pooling of blood and vein engorgement of the L leg when he stands up. Possible that he had a DVT or multiple that cleared and now he has post-thrombotic syndrome. This is consistent with the pooling of blood with gravity and relief of symptoms with elevation. As he has had 2 negative US for DVT, unlikely that he has an unresolved DVT. abdominal and head CT are neg for thrombosis.

Syncopal episode with spontaneous recovery. Second syncopal episode associated with 15 seconds of asystole on cardiac monitor.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Numbness, tingling in hands/ mouth/ tongue. History of similar reactions with other vaccinations per patient. Patient has a phobia with needles.

Can feel increased heart rate at times and harder beating. Started day of vaccine and has continued to today, nearly 2 months later. My watch has data on heart rate variability and has seen a statistically significant increase variability since the date of the shot. The feeling can come and go. It can persist for hours at a time in a noticeable At its worst it can stop me from an activity for up to a minute of intense heart rate and chest pounding feeling. Does not totally seem to be related to physical exertion.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Within 10 minutes of administration patient became very overheated and passed out. I provided and ice pack and cold water to help revive the patient. I monitored the blood pressure which was elevated at 126/93 at the time of the event. I monitored him as he revived and his blood pressure came down to 110/68 then normalized at 118/81. He reported feeling nauseas before he lost consciousness. Conciousness was lost for a matter of seconds. Patient also reported numbness/tingling in both arms.

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium

loss of consciousness two times, light headed and dizzy. Throat felt uncomfortable but not swelling or closing

After receiving vaccine patient was about to sit in observation chair, he started seizing and fainting. Hit his nose and had nose bleed. He was having panic attack due to injection. Called 911. We made him comfortable and then in 5 minutes he started to faint. Ex-Ems was next to him, he started asking him questions and make sure he was awake. Within 5 minutes EMS arrived and they took over, checked all his vitals and found out patient did not eat or drink for whole day and had phobia with needles. Patient refused to go to hospital. Per EMS recommendation patient had drink and a bagel. Patient's relative came and took him home.

Culminated in myocardial infarction. Chest pains started next day and leg pains. By April 23, I had severe chest pains and had to see medical at work. On April 30, 2021 was at emergency department for heart attack symptoms. Was transferred for myocardial infarction. Test results show myocardial infarction, coronary spontaneous arterial dissection, and blood clot.

Patient had vasovagal syncope reaction to a Janssen Covid 19 vaccine. Patient was waiting in a chair in the pharmacy's waiting area where he fainted a few minutes after receiving his vaccine. The pharmacist rushed to assist the patient while staff called EMS. Patient recovered and was aware of where he was and what happened. Patient was pale and sweating. Patient was given a few sips of water and concentrated on deep breathing. Shortly after this, patient fainted again while waiting on ambulance. Patient was lucid and conscious when paramedics arrived. The paramedics checked patient vitals and took patient away by ambulance.

Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient came to pharmacy for Covid vaccine. He said he once fainted after giving blood and has a fear of needles. He was given his vaccine and after 10 minutes he felt nauseated and fainted. The patient awoke within 30 seconds but then vomited. EMS was called to make sure the pt was okay. After another 30 minutes of rest the patient was able to leave the pharmacy.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Tingling of Lips and Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

I felt faint and dizzy, as though I was about to faint. I was unable to think clearly. After arriving at the ER, my symptoms graduated to achy muscles, pounding headache, neck aching, odd throat sensation, etc.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccination, the patient became lethargic and slow to respond. Immunizing technician immediately called the RPh over to assess the patient. RPh instructed technician to grab blood pressure (BP) cuff and bottled water. BP did not register on cuff, the patient's pulse was 54. After a brief unresponsive episode, the patient became responsive & drank water. Then became sweaty and unresponsive 2 more times. RPh monitored for 30 minutes and will check in on 5/8/2021.

Patient received the Janssen vaccine on 5/7/21, he experienced flu like symptoms (fever, chills) at midnight on Friday. His symptoms went away on Sunday morning. Since then he has experienced nose bleeds multiple times a day since Sunday morning. This has been happening every day for approximately 5 minutes total per day (multiple instances). He stated that his past medical history only consists of poor circulation. Pt has already contacted his primary care physician.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt fainted-Medium, Systemic: Flushed / Sweating-Medium

Patient began sweating profusely approximately 10 minutes after his vaccine. He went to his parent's car and asked his father to turn on the air conditioning as he was hot. he then passed out in the back seat of the car. His mother came inside and asked for assistance. I grabbed an epi-pen and ran outside to the car. Patient was breathing and had a pulse rate of 64. He aroused shortly after I began asking him if he could hear me and asked if he could tell me his name. He was pale (notably his lips were quite pale) and confused. He could not say his name but could nod appropriately to questions when asked. We immediately called EMS for assistance. They arrived within 4-5 minutes and transported the patient to hospital.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient became unresponsive/faiting while sitting in the chair.

Sudden onset of high blood glucose (more than 500 mg/dL) about 2 weeks after vaccination with no family history of DM, no history of chronic illnesses and no other apparent risk factors!

Patient received a Johnson & Johnson vaccine today. Shortly afterwards while waiting in pharmacy area, we were alerted that the patient was unresponsive by his wife. Immediately responded to patient. Code white called and management responded. Tried to get him to wake up, he opened his eyes but immediately closed them again. I attempted to keep him alert and eyes open. This proceeded to go on for several minutes. Ice packs were placed on neck and wrists. Feet elevated. Once patient was alert and oriented, water was provided and patient was instructed to take small sips. Patient was kept in pharmacy area for additional 15 minutes once he was back to normal. Patient stated that when he passed out, he felt tired, couldn't see or hear.

Pt received vaccine sat down in recovery complained of "feeling woozy". Pt became diaphoretic, pale, had near syncable episode. no LOC, Alert to verbal. brought to recovery to lie down and elevate feet. Put ice pack to back of neck and forehead. no shortness of breath. Left deltoid site benign no redness, no swelling. MD assessed summized as vaso vagal episode. VS taken 108/80, hr 60, reg strong, resps 16 reg non labored. father at side, stated "this happened when he had blood drawn" Changed to monitor for 30 min, gave water to hydrate. pt stated he felt much better after lying down 10 min. Provided reassurance paleness and diaphoresis subsided. OK'd to exit after 30 min. Exited with father.

Patient family shouted to nurse , upon nurse arrival patient was already unconscious and ammonia quickly placed under the patient nose . Patient was stuffed and started having sudden body and limb jerks movement that involved the arms, head and neck. Shortly after patient regained consciousness follow by a small period of confusion . Paramedic arrives at the scene and patient was placed on the lateral position ,oxygen was provided and continued to be monitored by the paramedic.

Patient fainted after vaccination while he was seated during the 15 minute observation window. Patient quickly recovered (less than 1 minute) but was feeling cold and clammy. Patient was given water to rehydrate and stay seated for observation; Pt did not require EMS to be called as he recovered quickly on his own. Patient left with his friends when he recovered. A follow-up phone call to the patient was made a few hours after vaccination and patient was doing well. Patient instructed to rest up and contact MD if needed.

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

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium

Patient had rapid heart beat that occurred on and off of approximately 10-15 minute intervals over the course of 40 minutes. His face also felt warm at the temple area. His blood pressure was elevated when taken by EMT services but pulse was normal. EMT was called and he was given the option to go to the hospital which he did as precaution.

7 minutes after the injection of my Janssen injection for COVID-19, a heat enveloped my body from deep in my chest and I went pale (according to the objective findings of my nurse) and I began to feel lightheaded and almost became syncopal. I was asked to remain there for 30-minutes, and began to feel better shortly thereafter. The next several days, the lightheadedness came and went in waves, which became stronger and stronger. Two days post-injection, I developed severe joint pain where I'd otherwise previously had none - for instance, my low back ached with 7/10 pain which only went away after the first week. I had thoracic spinal pain which radiated to my chest, and by day 3 I was having serial panic attacks (which I don't have), such that I visited the local emergency department to rule out sinister cardiorespiratory sequelae. I was discharged with a ddx of GERD, though I do not believe this to be true. Since then, I have largely recovered, however the lightheaded spells have dissipated only a little but are largely still plaguing me. Thankfully, the panic attacks have decreased to the point of almost being gone altogether.

PATIENT RECEIVED J&J COVID VACCINE AT 11:15AM ON 5/29/21. WHILE WAITING FOR 15 MINUTES PERIOD AFTER VACCINATION, HE WAS FAINTING AND SAT DOWN ON THE FLOOR IN FRONT OF PHARMACY AT 11:20AM. PATIENT WAS SHAKING. HIS BODY TEMPERTURE TURNED COLD. HIS SKIN TURNED PALE.

Dispatch was called by Team 1 lead. Run #2021-00032724. "Janssen Covid-19 Vaccine EUA." Pt received his single dose of Janssen IM Shot in the lt. deltoid. pt., who was a 32 y/o M had a 20 second witnessed syncopal event with no traumatic event pre/post syncopal. pt. did not complain of any symptom other than a bit of minor dizziness. Event was witnessed by observation personel in observation approximately 10 min. post shot. Escondido Fire RA133 arrived on scene and transported pt. to Palomar ER. No treatment was rendered on scene. Palomar ER was contacted by Fire Dept.

Patient lost consciousness approximately 5 minutes post vaccination with Janssen COVID-19 vaccine. He was sitting in the observation area and fell out of his chair. Patient fell onto his side, and when he regained consciousness he said he didn't feel any pain or headache. Patient recovered consciousness in less than 1 minute and recovered completely in approximately 12 minutes. He laid on the floor for about 7 minutes, and then sat on the floor for another 5 minutes before feeling well enough to stand. Patient had a small patch of skin scraped off his right knee and right elbow, but declined bandaids. Patient did accept a small bottle of water and a bag of pretzels.

pt had syncopal episode for about 1 min. pt diaphoretic. recovered well with rest, cold pack to back of neck and time.

Patient experienced syncope approximately 5 minutes after receiving vaccine. Patient fell from chair. Patient came to immediately. Patient was rolled over, placed flat on ground with legs elevated. Was immediately examined by PA. Blood pressures were taken approximately every 5 to 10 minutes over the next 30 to 45 minutes. Average BP was 130/90 Pulse 81. No significant visual injuries were noted. Patient returned home unadded. Follow up phone call was made the next morning, patient reported no significant issues and was feeling fine.

APPROXIMATELY 4 MINUTES AFTER ADMINISTRATION, PATIENT REQUESTED TO LAY ON THE FLOOR DUE TO DIZZINESS AND BEING HOT. I ACCOMPIONED HIM TO THE FLOOR, AS PATIENT LAYED DOWN, HE LOST CONSIOUSNESS, EYES ROLLED TO BACK OF HEAD,SWEATING AND UNRESPONSIVE TO MY VOICE OR TOUCH. DEEP SNORE. 60-90 SECONDS, LIFTED HEAD, THEN SLIGHTLY BUMPED BACK OF HIS HEAD. AS PATIENT WOKE UP, HE ASKED WHAT HAPPENED. INSISTED AND REPEATED HE WAS ALRIGHT. I KEPT HIM ON THE FLOOR FOR APPROXIMATLY 7 MINUTES UNTIL FIRST RESPONDERS ARRIVED. THEY SAT HIM IN THE CHAIR, ASKED SEVERAL QUESTIONS AND TOOK VITAL SIGNS, AND EXAMINED BACK OF HEAD. HE SIGNED OFF WITH THE AMBULANCE ATTENDANTS AND REFUSED TO GO WITH THEM. HIS MOTHER ARRIVED AND STAYED WITH HIM FOR ANOTHER 7-10MINUTES. PATIENT LEFT WITH FAMILY MEMBER, SIGNED OFF AT THE REGISTER .

On the morning of Monday April 19, 2021, 1 1/2 days from receiving the Johnson & Johnson shot, I walked upstairs after coming down for breakfast and felt something off with my heart and I felt my heartbeat and noticed that I was in AFib. My heart had an irregular heart beat. I was taken by ambulance to the hospital where they had to shock my heart to get it back to a normal rhythm. They were able to get it back to a normal rhythm with one shock. Since then I have still noticed more heart palpitations, but have been alright since. I am a healthy 32 year old (now 33), with no health issues.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated he has history of vasovagal syncope. EMS was called. Patient was fine after 30 minutes

Immediately after a whole blood donation, as I was walking from the donation chair to the waiting area I felt nauseous and lightheaded. Upon sitting in the waiting area I put my head down on a table and my vision began going dark. I was able to make eye contact with a phlebotomist who asked if I was okay, to which I could only shake my head ?no?. They rushed to me with ice packs and moved me back to the donation chair so I could sit in a recliner position. As I started to feel less faint they gave me apple juice, Oreos, and gordettos. I felt better within 30 minutes. The phlebotomist thought the reaction may have been due to a poor meal beforehand, which consisted of two litelife veggie dogs on white buns with ketchup, veggie chips, and cookies.

Pt received the vaccination at approximately 4:25pm on 6/21/2021. Pharmacist went over potential side effects before administration. Pharmacist administered the vaccine, filled out his paperwork, and then stood up. Pt stood up. Pharmacist started to ask him to wait in the pharmacy waiting area for 15 minutes so we could make sure that he did not have a reaction. Before the pharmacist could finish, the Patient started to sway. He leaned against the wall, started to bend over, hit his head on the wall, and passed out. The pharmacist called for help from the other staff. Pt's legs were lifted up so that his feet were resting on the chair. He had hit the bridge of his nose against the wall/side of door. His nose was swelling up, turning black and blue, and was starting to bleed. After about 15 seconds, the patient came around. He was able to answer questions coherently. He stated that he did not need an ambulance. Pharmacist retrieved a couple of ice packs for him and put his coat under his head. Patient remained lying down for approximately 30 minutes before he stood up. When he stood up, he did not sway and seemed stable. Pt declined the pharmacy staff to contact someone to drive him home.

Patient experienced syncope and sweating a few minutes after vaccination. He recovered immediately and experienced no further symptoms for the remainder of the observation period.

I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now, fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time. BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile, weight lifting gets me extremely tired now, now its not as bad, can work out longer. In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now but when I work out I still get tired where I have to stop, sit, or nap.

During the post vaccine observation period, patient had a sync opal episode and fell off a charge face down on the floor. He was turned over he came to immediately and was oriented to place, person, time ,and ,situation . He was noted to be diaphoretic. He reported to staff that he usually passes out after a vaccination and had not had eaten. He was observed for an additional 45 mins before leaving the site of the vaccination.

Heart Palpitations starting on the 28th of May. Chest pain starting on the 3rd of June. And a sick feeling that I have described as a flu or hangover feeling starting on the 5th of June. All of those palpitations and chest pains have continued at present. Sick feeling lasted until the 30th of June. On about midnight of 22nd of June - I felt extremely faint and went to Hospital ER. Nothing out of the ordinary was found in all the testing for ER and at the urgent. No treatment other than the IV Saline at ER visit.

Patient received their COVID vaccine in the pharmacy waiting area and went to the pharmacy register to pay for an item after receiving the vaccine. The patient fainted or passed out at the register. The patient fell backwards and collapsed. The patient recovered almost immediately after passing out. We called 911 and had the paramedics come take a look at the patient. While waiting for the paramedics we had the patient sit in a chair and wait. We gave the patient orange juice to drink since the patient was a diabetic and he said he felt a lot better after drinking the orange juice. He was treated by the paramedics onsite but didn't go with them and left the store on his own.

Patient appeared to have a vasovagal response after having the vaccine. He became nauseous and clammy and pale. He began to seize and passed out. EMT evaluated him and found his vitals were stable, as well as, his blood sugar. He felt better and refused transport for further evaluation. No other incidents occurred.

About 4 weeks after my J&J vaccine I noticed blurred vision along with (what I can best describe as) ?neon colored eye floaters?; followed by an intense headache that lead to violent vomiting; after that day stopped; but headache, muscle ache (at base of skull and neck /shoulder area), mental fog / inability to focus, mild to intense vertigo all continue to today. A week after chest pain started occurring.

Got on an airplane that evening, while on plane, Severe sweating, chills, blood pressure drop and feeling faint. Fever of 101.9 at 10:15pm. Acetaminophen seems to improve symptoms well.

Client begin to feel numbness and tingling to right hand and fingers shortly after receiving vaccine. While being assessed by this nurse, client experienced syncope episode for approximately 10 seconds and was immediately alert and oriented to self, person, place and time after syncope episode. Client became clammy and diaphoretic. 911 was called and client was assisted to triage area for further assessment. BP 164/96, HR 74. Client was cleared per EMT, able to walk out of clinic withou assistance and drive self home.

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.

Patient is a 33 y/o male c/o having dizziness and nausea while he is sitting after 5 minutes of getting vaccine. vitals BP 100/60 HR 66 Oxygen sat 95 pain 0/10 resp. 18 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Vasovagal synciope Reasurrance given. Monitor. Patient standing walking around after 30 mintues. Refuses to call parents reports he feels much better.

Patient went into a vasovagal response with sweating about 8 minutes after the shot. patient came back to consciousness after 7 seconds after pharmacist checked pulse made sure the patient was upright and used applied tension technique. Patient was then given fluids and lime soda that helped the patient come back to total consciousness. We continued to monitor patient for an extra 30 minutes and called family to pick him to ensure that he does not drive. Moreover, I recommended that the patient does not go snowboarding as he was thinking of heading to the mountains today.

Passed out 5-10 seconds after injection. Passed out a 2nd time after waking up the first time. Blood pressure & heart rate dropped.

I sat down for 15 min and felt fine for the rest of the day. The hives started about 30 mins after I had dinner. It started on my shoulders and back, so I took a Benadryl, which was expired. So, I went to get some more and took a second dose around midnight. I won't up with none, but they were back around noon. That happened for a few days with it happening around lunch and dinner. On Tues, they started spreading more, so I went to the doctor. There was no swelling of the tongue. They lessened over the next couple of days. As of today, I have a small amount of itching, but nothing bad. I've also been taking Claritin since yesterday. I have not seen any the same size as before, but I notice that they seem to be worse at night. I took my BP a few times and it was high at those times, but it went back to normal the next day. I will be seeing an allergist in the near future.

Hypertension was first noticed a little over a week after the vaccine. Hit a high almost 2 weeks after. Had to go to the emergency room after testing at 183/122. Now with high dosage medications, it's still high averaging 170/110! With no known catalyst.

Numbness in left arm and face, overheating, fainting, Medical personal fist on site noticed shaking due to Seizure.

Janssen COVID-19 Vaccine EUA First day after getting the shot I got a feeling of being very tired throughout the day I did not feel like to do anything. Also my arm was very very sore. Even moving it slightly a bit would hurt. The second day is when things got way worse I could not really sleep that well throughout the night because I noticed I had body aches in my legs and my back. Throughout that day I also felt like I had a fever in the morning I took my temperature and had a 100 fever. At night time I took my temperature and it went up to 102, with still a bad headache, chills, and body aches throughout my legs mostly. I also felt some palpitations. When I went to bed I was sweating very prefusively all night that I had to change my shirt. On the third day I felt a lot better, still with a slight headache no fever, and still feeling like im sweating on and off.

Patient became distressed within 1 minute of injection. Became sweaty and hot. Pulse became elevated to 120 bpm. After 20 minutes all symptoms returned to baseline.

Patient was recommended to wait for 15 minutes to monitor for any adverse reactions. Within 15 minutes patient has reactions of nausea, dizziness, paleness of face. We advised patient to sit down and elevated his feet. We gave patient some water. In a few minutes patient was doing better, after 15 more minutes patient was able to go home. No medications given.

April 5th sore arm 11:30pm fever of 100.2 on tylenol. Took advil at 3am. Still had fever and sweating. April 6th felt tired and achy. The night of April 7th at 1am had severe chest pain, felt like heart attack. Went to urgent care at 5:55pm April 7th. Had ekg done and was diagnosed with pericarditis. Was treated with ib prophen 800mg 3x a day for one week. Follow up appointment with primary care April 15th.

Pt received vaccine; then stated that he felt nauseated, dizzy, and had increased anxiety due to his fear of needles. While sitting in observation he passed out momentarily while sitting in his chair. He awoken quickly and was assisted to a wheelchair for one on one observation. Pt states this has happened before and he always quickly awakens. Water given. Pt observed for 30 minutes and left in stable condition.

It was a drive thru shot facility. They gave me a shot in my left arm and asked me to pull around to park. I parked my vehicle and didn?t feel well so I switched seats with my girl friend. As soon as I got into the passenger seat I was out. She said My eyes rolled back in my head and I started shaking and eyes at this point she said where going up down and side to side . She ran for help and after about 1-2 minutes I woke up. I thought I passed out so I instantly put my feet on the dash of my car and the pharmacist gave me water and chocolate milk. He then checked my heart rate it seemed good and after 20 minutes he let us go home.

UPON ADMINISTRATION OF THE VACCINE, THE PATIENT FELT FAINT. THE PATIENT STARTED SWEATING PERFUSELY FROM HEAD TO TOE. THE PATIENT LOST CONSCIOUSNESS MULTIPLE TIMES FOR A BRIEF PERIOD OF TIME. PATIENT WAS NAUSEATED AND ATTEMTED TO VOMIT BUT COULD NOT. EMS WAS CALLED AND CAME TO ASSIST. THE CARE OF THE PATIENT WAS THEN TURNED OVER TO THE EMERGENCY MEDICAL SERVICES . BY THE TIME EMS ARRIVED, THE PATIENT STATED THAT HE WAS FEELING MUCH BETTER. EMS EVALUATED THE PATIENT AND AFTER APPROXIMATELY 15 TO 20 MINUTES THE PATIENT WAS ABLE TO LEAVE ON HIS OWN WITH ASSISTANCE FROM HIS WIFE.

After vaccine he reported being nauseous and dizzy. He got very pale and about 5 minutes after the vaccine he passed out. He came back after about a minute. EMT was called to check patient. Vitals were stable.

Injection +8 hours: strong headache, full body sensitivity, body fatigue, flush neck and face, full body chills, full body shivering. +9 hours: hands pale, thumb capillary refill L: no refill, R: 6 seconds. HR98 +10 hours: Temp: 101.4, thumb capillary refill L:2 R:2. Eyes bloodshot, headache over eyes/temples +11 hours: Temp 102.5, HR 109, SpO2 95 +12 hours: full body chills transition to full body slight flush/damp. Headache pulsing behind/above eyes and temples. +18 hours: Temp 100.2, HR 87, SpO2 99, headache continues.

Client experienced syncope with in seconds of receiving vaccine. Assisted to wheelchair. Brought to EMS Observation area. Vitals monitored. Client recovered and left site in stable condition.

Severe shaking. Admitted to ED for 180/90 blood pressure and rapid heartbeat (>120). Screened for potential pulmonary embolism and blood clots

Around 5-10 minutes after the injection, patient began to feel faint. Patient turned pale and diaphoretic and passed out. Patient was lethargic and confused when coming back. Patient then began to remember where he was and started to feel better for about 2 minutes. Patient then fainted again and was able to regain consciousness with tactile and verbal stimulation. Medics were called for the patient. Patient's blood pressure was 80/55. When medics arrived, the patient had started to feel better and refused ER treatment. Medics left patient without doing vitals or assessments. Patient stayed at the vaccine clinic for another hour and then left after feeling better.

Jansen COVID-19 Vaccine EUA Since vax on Friday April 9th: - extremely lightheaded, fuzzy, dizzy and disoriented, would describe similar to vertigo - fever on off, less frequent Sunday and Monday (today April 12) - racing heart (fri night after vax, resting heart rate over night at 70+, normal RHR 48) - anxiety

Patient he has a history of feeling faint after having blood drawn. Shortly after administration of the covid vaccination, the patient fainted. He had been seated. 911 was called. The patient revived quickly. Emergency personnel consulted with him. Patient remained at the pharmacy and left independently once he felt better.

After administration of Janssen vaccine 0.5mL, pt reported arm was hurting and he began moving arm. CMA noticed that continued to shake arm after 5 minutes but patient was alert and oriented x 3. CMA thought the way he was shaking his arm seemed irregular so she advised pt he would be taken to an observation area for further observation. Half way to the observation area, pt reported to CMA that he was seeing spots and felt like he was going to get sick. CMA called for help. Patient experienced a syncopal event just as he made it to the chair. Several staff was helping to support patient. Legs were lifted to another chair. Patient was not responsive for a short time, very diaphoretic, breathing regular and unlabored. Patients eyes then rolled upward toward the ceiling and patient's entire body began shaking uncontrollably while staff managed to keep patient from falling to floor from the chair. Once patient was conscious, he was able to state his name but reported he was very confused and could not think clearly. He was able to sit upright. In the meantime while patient was shaking uncontrollably, staff sought urgent care provider to come and see patient. Patient was then taken over to the urgent care side of the building to evaluate and treat patient.

33yr old patient with unknown PMH and allergies, presented to office for COVID-19 injection on 4/10. CMA administered JANSSEN COVID19 VACC (LOT # 207A21A, exp 6/23/21) IM to patient's right deltoid at 0841. Immediately following injection, patient's arm began to shake which continued past 5min. Patient endorsed seeing black spots, then nausea. Patient denied shortness of breath, difficulty swallowing, chest pain or other symptoms. Patient noted to be pale, diaphoretic, and fainted upon sitting down. Reporter observed patient shaking. Patient admitted to urgent care for further follow up. At 0904, BP 136/82, HR 79, 98% RA. At 0947, BP 93/61. Patient given NS 500mL bolus IV. At 1025, patient denied dizziness, weakne At 1025, patient denied dizziness, weakness, or nausea. Patient changed to sitting position with mild nausea. VS remained stable. At 1035, patient ambulating without issues. Patient discharged home in stable condition. Patient noted he had not eaten prior to injection. Urgent care provider indicated per physical exam consistent with vasovagal reaction to vaccine. POC = 142, given crackers and water x 2.

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.

Noticed headache bottom left back of head before bed. Woke up at 2:30am with right leg fully asleep. Attempted to wake leg up, lost equilibrium, stumbled, lost hearing, couldn't put words together to tell wife what was going on and ended up on the floor to regain composure. Had difficulty putting on clothes to go to hospital. Went to ER, had severe diarrhea there, they did blood work and EKG, sent me home saying maybe I feinted. Had high blood pressure at ER, 150/86. Felt weak and 'off' sense the event, felt tightness in chest and odd limb pain past 72 hours. Woke up at 3:30am on 4/15 with left arm asleep, went back to bed fine. Never had these symptoms before.

I am experiences pain in both my legs, in the calf musscle of both legs and palpatations int he calf muscle.

PATIENT SAID THAT VACCINE BURNED AFTER ADMINISTRATION. HE GOT REALLY HOT AND NEEDED TO REMOVE HIS MASK TO BREATH. I ESCORTED HIM TO A SEAT NEXT TO HIS WIFE AND HE FAINTED. HE REGAINED CONCIOUSNESS AFTER 1 MINUTE. GOT HIM A COLD CLOTH FOR HIS HEAD AND A GLASS OF WATER. ABOUT 15-20 MINUTES LATER HE FAINTED AGAIN. HE REGAINED CONCIOUSNESS AFTER 30 SECONDS. EMS FINALLY ARRIVED AFTER 2 CALLS TO THEM. EMS CHECKED HIS VITALS AND PREFORMED AN EXAMINATION. HE DECLINED TO BE TAKEN TO THE HOSPITAL. AFTER ABOUT 2HRS HE LEFT ON HIS OWN POWER

I received the vaccine Saturday 4/10/21 at 9 am. By 8 pm of the same day I had fever, chills, headache and body aches. For about 30 minutes I saw a white spot on the peripheral view of my left eye. By Monday, I felt dizzy and bottom right part of my chest hurt when taking deep breaths. The dizziness and chest pain lasted all week, still feel feel it today 4-18. My doctors office told me vertigo was a common side effect. On Thursday 4-15 every time I bent down and tried to get up, my right leg hurt as if I had exercised. At the moment I haven?t gone into work since Monday 4/12 since my job requires a lot of physical work. I have mostly been home resting but don?t feel ready to go back to work. If someone calls can it be a Spanish speaking person please.

Severe thrombocytopenia (Platlet Count of 18) HPI: 33 y.o. male with no PMH coming in now w/ progressive thrombocytopenia to 18. He received the J&J covid vaccine on 4/8 and felt well afterwards. Last Friday (4/16) he began to experience constitutional symptoms (fever to 100.4, chills, night sweats feeling drenched, decreased appetite) so decided to get his labs drawn as an outpatient for further evaluation. Symptoms progressed until Tuesday, when they began to subside slightly. At that point, his labs resulted and were notable for thrombocytopenia. He got his labs redrawn the day before admission and it was noted that his thrombocytopenia was worsening, so he was directed to the ED for further evaluation. Patient seen by hematology, started on dexamethasone 40 mg PO daily as well as IVIG treatment x2. MRV of brain without evidence of dural venous sinus thrombosis ***PATIENT CURRENTLY HOSPITALIZED***

4/15/21 woke up with severe pain in left upper thigh. Fatigue and headache began a few hours later. Needed to leave work. Early evening a rash developed in the left thigh and left foot swollen size of balloon and bright red. Went to the ER 10:30PM, admitted from ER on 4/16/21 for possible deep vein thrombosis and cellulitis of left leg. Shortly after admission, unable to obtain venous access, central line inserted for IV fluids and IV vancomycin and Zosyn. Foot swelling increased up to below knee with bright red skin color. No open wound noted on extremity. Ultrasound did not find a thrombosis but enlarged lymph nodes. 6 days later leg still swollen and red, repeat doppler ultrasound negative, but report stated could not compress to complete test due to severe swelling. He was also tachycardic and hypertensive during admission. Infectious disease doctor consulted and confirmed severe cellulitis but it was written in discharge summary the covid vaccine can not be ruled out as a cause of the infection and admission. Lasix was initiated to decrease swelling in lower extremity. He was on SQ heparin 3 times a day during the admission. He was discharged on Doxycycline and Augmentin. After discharge saw primary care physician who palpated large lymph nodes in neck. Mild headache persists. Ultrasound of neck to be completed on 4/27/21. Started on Tizanidine for pain.

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.

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was dripping sweat, very pale. blood pressure never dropped below 120/100 per OMRON meter, pulse stayed around 60. he was given water and recovered in about 5 minutes. He stayed for 30 minutes further observation, then left feeling very normal

After one week I suffered a TIA and have to be hospitalized From April 11 to April 15. After I was discharged I went back to the hospital April 18 with a second TIA. I was hospitalized from the 18 to the 21. Both times at same facility.

Patient received vaccine at 545pm. Administration noted as normal per pharmacist (rph), pt walked to waiting area chair. Approximately 7 minutes later pt asked for water. Pharmacist brought water to pt and asked if he was feeling okay. Pt stated he was having trouble hearing the rph. Rph walked back to pharmacy and continued to observe patient. approx 2 min later, pt passed out from seated position. rph did not see fall. both technician and rph ran out to pt. pt face down and water bottle spilled. assistant store manager reported as well. pt came to immediately and sat up on floor. He attempted to stand to sit in chair, but rph asked him to remain on floor. rph went to get emergency kit while tech observed patient. rph came back with instant ice pack. First pack did not activate but second pack did and had patient hold to his head as there was a visible red spot. Patient continued to be observed and was texting on phone during observation. Patient came up to pharmacist at 6:15 to ask to leave and Rph asked if pharmacy representative to could walk him to his car. Patient denied and Rph asked him to wait additional 5 minutes for observation. After 5 minutes, patient left. Today I called patient. He said he is feeling better and still has mild pain and a headache today.

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

BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-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 fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.

Patient presented w/ loss of consciousness on 4/26. Initial workup negative. Pt then had a witnessed seizure requiring intubation for airway protection. After extubation on 4/29, patient was noted to have profound leg weakness out of proportion to brief intubation. Infectious and neurologic workup negative for transverse myelitis. Thought to be possibly auto-immune Guillain-Barre like peripheral neuropathy. Started on plasma exchange with immediate good response.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: called 911 but patient recovered before paramedix arrived

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Additional Details: Wife of patient had called the pharmacy hours after patient had recieved his J&J vaccine to inform us of this symptoms a few hours when arrving at home. He experienced fainting, chills, fever, and pain and took a tylenol and symptoms started to subside and has been currently been resting in bed. Wife says they will continue to take tylenol around the clock if needed and will seek medical attention is symptoms worsen.

I received the vaccine on 4/2/21. I started feeling tightness, soreness and throbbing pain in my right calf on 4/28/21. On 5/4/21 the pain was unbearable and there was swelling in my calf/ankle. On 5/5/21 I got an ultrasound that confirmed I have a DVT blood clot in my right calf and I got blood work done that confirmed everything was normal with my health (liver function, platelet counts...). I was prescribed Xarelto 15mg and began taking Xarelto on 5/8/21.

About 2 minutes after vaccination patient was feeling light headed, pale, sweaty, clampy. It lasted about a minute or 2 then he stated that he was starting to feel better. He stayed in the store about 30 minutes ( or until he was comfortable leaving on his own).

A few minutes after administration the patient went to leave the room where he got his vaccine. He stood up turned to ask another question about the vaccine and then fainted. He was out for about 15 seconds. He awoke disoriented and sweaty. I gave him water and some glucose tablets. He said he felt fine after that. i have called to follow with him and he says he fells fine

Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe

Patient nearly fainted shortly after receiving the vaccine. He turned pale and his head dropped. EMS was called to the scene. The pharmacist gave the patient some water and he came around before EMS got there. EMS checked the patient and determined his vitals were okay. Patient did not need to be transported to the hospital. Patient did not have any known allergies. Patient did not know how they would react to the vaccine as they did not have insurance and did not usually get vaccines or routine blood work.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg. It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). 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).

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: he was fainted right after the shot. my tech called 911 and i stayed with him. after 1 minute he was responding but still needed medical attention. i waited with him until paramedics come.

Patient was instructed to wait 15 minutes before leaving the pharmacy. During the 15 minutes, a team member on the store floor witnessed the patient faint and hit the floor. Within 30 seconds, the patient regained consciousness and got up and sat back in the chair. 911 was called and EMS arrived within 10 minutes to evaluate the patient. EMS determined that all his vitals were normal and allowed the patient to leave the pharmacy.

Patient developed pain in the left lower leg about 8 days post vaccine, progressively worsening over time, with associated swelling and spread of discomfort to the thigh. Presented to urgent care on 5/23/2021 and was felt to have findings suspicious for deep vein thrombosis. See item 19 for details on test results.

I have blood clots in my left leg and some that have spread to my lungs. Pain started on May 19th shortly after waking up. At this time I can put no weight on my left leg. I went to an urgent care on May 23rd. I received an ultrasound and CT Scan.

I started to have blood coming out of my butt in the morning a week after the shot. The blood was enough to fill up my toilet but it only happens in the morning when I first wake up.

patient was feeling dizzy and head hurt about 5 minutes after administration. He took his bloop pressure which was high 160/98. I kept monitoring the patient and had slight rash on chest which went away and after 5 minutes time . Then started to feel itchy but no rash appeared. after about 20 minutes didn't feel better so gave 25mg benadryl capsule and called 911. EMS took patient to the hospital because patient said tongue felt heavy.

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.

The patient was being monitored post vaccination. I noticed (RPh) that pt was leaning back in the chair and making a snoring noise. On closer inspection his eyes were closed, body limp, and head back. We tried to ask if he was ok and grabbed his arm and held him up. We were getting ready to place him on the ground and he regained consciousness. Patient said after vaccine he became drowsy and sweaty. Incidence lasted 2 minutes and he stayed at the pharmacy for at least 30 minutes post vaccine.

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

Started feeling tightness in my left arm and left side. Then, eventually, I had muscle spasms on my left side. They had to issue 2 CC of lidocaine in my left shoulder. My muscles were so painful that I couldn't drive or stand any type of vibrating sensations, and I was issued muscle relaxers My left arm will go numb frequently and I have trouble moving it. For a while, I couldn't sit up straight or work because of my arm. My blood pressure has also shot up significantly and is often over what is healthy for me

GIVEN INJECTION AROUND 12:50 pm, patient moved to waiting area, patient passed out around 12:55 and hit head on floor. Pt was conscious quicky, was sweaty, hot, dizzy before passing out. Applied cold rag to neck, fanned pt, eventually moved to chair. Asked if he needed ambulance, he refused. Feeling better within about 15 minutes and patient wanted to leave.

The first 15 minutes after the shot, I felt weak and a little dizzy. An hour later, I felt dizzier and my resting heartbeat was up to 75 bpm. My heart was racing and tingling, it felt like chills inside of my body. I became weaker and my heart jumped to 90 bpm. I became pale, disoriented, and my jaw tightened. I had no respiratory issues but I had a little troubling swallowing. I met with a Teladoc doctor who said that if I didn't get better by 6pm, to go to the ER. At 5:20, things calmed down and the reaction stopped. I felt very tired.

After 5 mins of getting the vaccine, pt had a syncope and/or seizure episode. Pt's eyes started to roll back and was only showing the white. His hands were flinching into fist and pt was unresponsive. This lasted about 20-30 secs. We called ED and got the operator on the phone. When we started to give the operator information, pt starts waking up. Pt's mom didn't want the ambulance to come since pt is now awake so we told the operator everything is fine now and hung up. Pt's forehead was sweaty and facial color was very pale. We gave pt some water to drink and asked pt to continue to sit there and relax. Pt has no idea of what happened he said he just remember one moment talking to his mom and the next moment she was holding him up. Pt sat there for a total of about 1 hour and he said he was fine so they left. We informed mom and pt to please go the UC or ER for follow up but they declined. They said they will have him rest and hopefully things will be OK soon. I checked his Blood pressure x 2 and both times they were good at around 128/87. Gave mom my pharmacy business card to call with any further questions or concerns

Patinet received his Janssen Covid Vaccine today. He was fine in the immunization room and he went to the waiting area. Patient lost conciousness and fell on his partner. We went to him when we heard from another customer. He said he was feeling really lightheaded and thirsty. He had Syncope (Paleness, excessive sweating, and Loss of Consciousness for few seconds). He mentioned he did not drink much water today before the appt and also worked outside in the sun. We had him wait for 30 mins and he was perfectly fine. Coach came to do an incident report and then he left. His partner was with him all the time.

Pt fainted in the observation area by the pharmacy. He was pale and trembling. We called 911 and the paramedics checked his BP, Blood sugar, and heart function. Everything was normal and paramedics let his wife pick him up and take him home. I spoke to pt around 8:15pm on 6/24 and he said he was feeling fine

blood clot in left leg, cramping and soreness, tender to the touch. currently taking Eliquis for the next 6 months

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: patient had vasovagal episode @ 3 minutes after receiving Janssen vaccine. Has a history of vasovagal with blood draw and injection.

pt fainted after being administering janssen covid vaccine. regained conscous within a few seconds and laid on the floor for about 30 minutes until he felt better.

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.

Vaccine was administered at approximately 5:57 P.M. At approximately 6:00 P.M., patient's companion alerted pharmacist that patient appeared to be unresponsive. Patient was slumped forward and momentarily unresponsive to verbal queues. Patient quickly (within seconds) became oriented and stated he felt hot and sweaty. Pharmacist called 911. Patient denied difficulty breathing and reported no swelling or difficulty swallowing. EMTs arrived within 10 minutes. EMTs determined that patient most likely experienced vasovagal syncopal episode. Patient was allowed to leave on his own accord by EMTs with instructions to seek medical attention if difficulty breathing developed. Duration of entire case was approximately 25 minutes.

Several minutes after vaccines patient became light headed, he then passed out for several minutes and became very stiff. When patient came to he was disoriented (didn't know where he was or who I was). Patient felt nauseous. Patients blood pressure was 81/50. Patient was taken to ED for further evaluation.

Presented 7/24/21 to the hospital with recurrent seizure and declining mental status after persistent headache for the several previous days. On imaging found to have extensive dural venous sinus thrombosis with hemorrhage. Treated with anticoagulation, anti-seizure medications, invasive mechanical ventilation, and transferred to alternate hospital for consideration of endovascular treatment.

Patient sat down in a chair to be monitored after his J&J vaccine and he immediately passed out and fell out of the chair. Suffered abrasions to left forehead, under left eye, bridge of nose, and under nose. Regained consciousness quickly. Sat back in the chair and passed out again. Eased him to the floor. He appeared to have some small seizure activity. 911 called. Patient regained consciousness, examined by EMTs. Patient refused to go to the ER. His father came to pick him up . He was up, walking, and said he felt well. He left the vaccine clinic at 2:15pm. I called patient on 7/16/21 to check on him. He said he is fine, and that he has a needle phobia.

Sweating, light headed, dizzy, nausea, emesis , pale in his car . After emesis he felt better and his color came back. Ambulance came to reassess. He felt fine. Parents came to pick him up and take his car home

Janssen COVID-19 Vaccine EUA 34 y.o. male with GERD who presents with syncope and question of PEA arrest. He went for COVID 19 J&J vaccine on 3/13/2021. A few minutes after getting the vaccine he started feeling nauseated. His lips became gray. He went unresponsive and was taken out of the car. He had agonal respirations. He had 90 seconds of chest compressions and returned to his normal state of health. He was seen in ED where labs were remarkable for mild hyperkalemia (serum potassium 5.5). Given worrisome syncope, chest compression he was admitted for observation. He did well overnight, No arrhythmias of telemetry and was discharged with Holter monitor.

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.

Reports dizziness, fainted for few minutes. history of same symptom with venipuncture. BP: 71/42; Repeat: 110/69 HR: 57 Sp02: 97% Refused to be transported to ER, refusal form signed. Seen and cleared by EMS

Patient reported to vaccinator before receiving vaccine that he normally passes out when he gets shots. After receiving shot, patient passed out for about 20 seconds and head fell back. Vaccinator called for assistance. Patient regained consciousness and stated, "I didn't even know where I was." Patient noted to be diaphoretic. He also had pulse rate of 42 and Bp of 98/48 which he reports as being normal for him as he is a runner. Patient stayed seated, vitals assessed, ice applied for sweating, and juice given. After 15 minutes, patient escorted in wheelchair to monitoring area where he remained in a cot for 20 minutes. Vitals reassessed with Bp 113/73 and pulse 49. Patient reported feeling well and able to ambulate steadily. Patient left at that time

Syncopal event approximately 1 minute after vaccine was administered. Woke up on floor to EMS. Sustained bump on left forehead with persisting headache but no follow-up care sought.

Patient fainted and hit his head. We called 911, elevated his feet, and have him an icepack for his head. The EMTs assessed him, and determined him to be okay, and had a friend come get him to drive him home.

Rapid heart rate 138bpm- 3:20 am. Stayed elevated all night Uncontrollable shacking- 12:30 am. Lasted 10-15 mins

Patient received vaccine and five minutes after injection he began to see dots, slowly progressed to the floor and passed out. Patient reports hitting his head. After recovering patient states he woke up with healthcare personnel making sure he was ok. He describes his experience as taking deep breaths, he felt chills, sweats and nausated. He refused further treatment.

Patient passed out about 5 minutes after receiving the Janssen vaccine. Patient recovered after a few minutes and applied ice pack to left side of face that hit the ground.

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.

Shortly after receiving vaccine, patient complained of fatigue and dizziness. Blood pressure was measured as 156/97 mmHg and pulse was 69 bpm. Patient stated he doesn't normally have high blood pressure. Patient also started sweat. Patient then declined any further treatment and was sent home with a ride (patient's mother-in-law).

I was feverish, felt nauseous, and then passed out twice. My partner called the doctor who advised us to go to the ER. At the ER I passed out again.

Initial night - headache, muscle aches, nausea, arm soreness, and fever. Intense shivering as well as feeling both too hot and too cold. Near inability to sleep. Second day - headache, muscle aches, weakness, fatigue, nausea, arm soreness, fever (101.3 oral), and elevated heart rate (resting pulse of 120 - my normal is 80-90). Sensitivity to temperature but milder than the previous night. Was able to sleep through the night. Third day - most symptoms have subsided or are mild. Mild headache.

Approximately 15 minutes after vaccination, patient?s wife said he wasn?t feeling well. I found him sitting up right but not very respondent. Said he was blacking out, he couldn?t see well. He was barely audible and sweating. 911 was called at 11:17am. Before EMS arrived he started to feel better and was conversing but waited for EMS. They arrived about 10 minutes later. He had a couple sips of water He was checked out. He said he hadn?t eaten all day and had never had a vaccine before. He walked out on his own with his wife

Minutes after receiving the injection (4pm) my blood pressure dropped and I lost consciousness. I recovered well enough to drive home within 15 minutes afterwards. That night (10pm) I began shivering, which escalated to periods of convulsions, to which a mouth guard was needed to prevent chipping teeth and/or biting my tongue. There was no fever present, and to subside the uncontrollable shivering I sat in a very hot shower until motor functions gradually returned. Periods of headaches, joint pains and sweating ensued for the remainder of the night. There were no other symptoms in the following days.

Patient passed out shortly after vaccination, patient fell to floor and hit his head, he was immediately attended to, patient had legs elevated and was monitored and evaluated for 45 minutes.

After vaccination, patient appeared to be slouched over in chair in observation area. Two bystanders approached him and held him to prevent him from falling from his chair. Patient was diaphoretic and eyes half-closed. Attempt was made to arouse patient by talking to him and rubbing chest. His head and body moved erratically for approx. 3 seconds. Patient was lowered to the floor. Nurse continued speaking to patient and rubbing his chest. He then opened his eyes and was startled. Patient abruptly sat up and said, ?what happened and where is my phone?? The nurse reassured him he was being taken care of and she asked if he knew where he was? Patient replied, ?I have no idea.? A paramedic approached and asked the patient if he knew his name. The patient correctly replied. The patient had no recollection of what had taken place, but did know where he was. Patient was then evaluated by the paramedics. All tests performed were normal and patient refused to be transported to hospital. Patient was driven home by his wife. Follow up phone call to patient yesterday evening with no answer. Follow up phone call to wife (listed as emergency contact), 4/7 at approx. 6 pm. Per wife, patient experiencing fatigue and still very pale. She said he just wasn?t himself. Patient was concerned that they did not know what to expect a week or two from now. I advised patient that if she had concerns, she needed to have patient evaluated in ER.

Patient given COVID J&J vaccine and within a minute complained of being dizzy/faint. While seated, patient fainted, eyes rolled, arms and hands clonic/tonic activity which caused him to fall from chair. Doctor was able to hold on to upper back of patient as both fell to the floor. Patient hit head on carpet with not traumatic injury. 911 was called and by time of paramedic arrival the patient was alert and oriented. Patient was assited to wheelchair and taken to ED for evaluation.

Patient passed out while in observation after receiving the vaccine. A passing customer noticed patient was in distress and asked for his wellfare. Patient returned back to consciousness and asked to have someone check on him. 911 was contacted and firefighter department advised not to give him water. He was not taken to the hospital.

Client felt light headed and dizzy approximately 3-5 minutes following vaccination. Loss of consciousness, fell from chair in observation area. Regained consciousness approximately 1 min. later. Assisted to cot with legs elevated. Vitals obtained by on-site EMS. Vitals: @ 1605 HR 53, Spo298%, BP 159/88 initially. Continued to monitor last vitals 143/80, HR 56, SPO2 98%. Client denies ongoing dizziness or feeling faint. Client able to sit, stand, and walk without symptoms. Client left site in stable condition.

Patient was asked to sit for 15 minutes after. Patient was sitting for about 2 minutes. rph technician, noticed that the patient appeared red, sweating, and about to fall over. Patient went outside and prevented patient from falling over. pharmacy called 911 about the patient, patient was not vomitting, patient was conscious (unconscious maybe about 20 seconds). 911 operator asked for the patient to wait for paramedics to arrive. patient was asked dob and he responded. paramedics took vitals and patient had normal readings. paramedics left afterwards. Then the patient left without any symptoms.

3 minutes after vaccination was given patient stood up and requested juice then fell down and fainted. About 15 seconds later the patient came to. EMS was contacted. Patient had his vitals checked, blood sugar taken. Patient reported to EMS that he was feeling anxious. Patient was asked by EMS questions in relation to time and place. Patient refused to have EMS take him in to the hospital for further tests. Patient was instructed to have a family member come in to take him home and advised him not to drive. Upon a follow up call 30 hours later patient reported he was bruised on his left shoulder, left hip and he had a puncture wound to his Jaw due to his fall. He reported he went to urgent care for follow up. they told him stitches would not be necessary for the puncture wound to his Jaw.

Pt fainted immediately after injection, regained consciousness after about 15 seconds. Reported feeling uneasy and weak for 20-30 minutes following injection. Provided supportive care with water. Pt was able to leave on his own after about 45 minutes.

Directly after giving the vaccine the patient fainted. Patient "came to" and paramedics were called. When they got here, he fainted again and they took him to the hospital.

Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.

Exact date and time of COVID vaccination unknown. Patient presented to Medical Center on 04/02/21 with left sided weakness and slurred speech. He reports receiving the COVID19 Janssen vaccine 15 days prior. Details of vaccination beyond patient report are unknown. Diagnosed with acute left cerebellar stroke, status post TPA on 04/02/2021. Extensive workup in hospital negative and unremarkable, including TEE, and hypercoagulable state so far negative. Follow up with hematologist as outpatient underway to evaluate for any possible coagulation disorders.

SLOWING DOWN; ARM WEAKNESS; FEVER; FATIGUE; ARM TINGLING; PALE HANDS; HOT FLASHES; DROOPY EYES; LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 13:30 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm tingling. On 07-APR-2021, the subject experienced pale hands. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced droopy eyes. On 07-APR-2021, the subject experienced low blood pressure. On 07-APR-2021, the subject experienced arm weakness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021 20:30, the subject experienced slowing down. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tingling on 07-APR-2021 19:30, and arm weakness, had not recovered from fever, fatigue, hot flashes, and droopy eyes, and the outcome of pale hands, low blood pressure and slowing down was not reported. This report was non-serious.

Diagnosed at ER with a transient ischemic attack. Right side went numb, struggled to speak and right side of face drooped

BLOOD CLOTS IN LEFT LUNG; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 34 year old male. The patient's weight was 175 pounds, height was 67 inches and Body mass index (NR: not provided) 27.4. The patient's concurrent conditions included non smoker, no personal or family history of clotting disorders and no recent trauma or travel. The patient was active and ran for 30 mins every day. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043AZ1A or 043A21A) frequency one total, dose was not reported, administered on 05-APR-2021 at 10:15 hours in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021 in the evening, the patient experienced "normal side effects", specifically tiredness and fever (temperature was not taken) and he took 2 Advil and went to bed. On 06-APR-2021 in the morning, he felt back to his normal baseline. On an unspecified date of APR-2021 (08-APR-2021 or 09-APR-2021), he felt pain and tightness in his chest and difficulty breathing. He noticed that he had to work harder to do his daily run. On 13-APR-2021, when the symptoms did not improve, he went to the emergency room. The patient had blood was taken (results not reported). A computerised tomography (CT) scan showed 2 blood clots in the left lung and duplex scans of both legs did not reveal a clot. A chest x-ray was done but results not provided. The patient's COVID-19 test was negative, and he was admitted to the hospital and treated with intravenous heparin. It was reported that no oxygen was given. On 14-APR-2021, he was discharged with Eliquis which he should continue for 6 months. On 16-APR-2021, the chest pain was gone, and his breathing was better in the morning but still difficult later in the day. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and feverish, and was recovering from blood clots in left lung. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 34 year-old overweight male (BMI 27.4) was hospitalized for 2 blood clots in his left lung 8 days after receiving vaccination with Janssen Covid-19 vaccine. He had no chronic medical conditions, was a nonsmoker, no personal or family history of clotting disorders, no recent trauma or travel, and exercised every day. On the evening of his vaccination, he felt tired and fever (temperature not taken) and took 2 ibuprofen and went to bed. The following morning, he felt back to normal. Two or three days later, he felt pain/tightness in his chest and difficulty breathing; he found it more difficult to perform his daily exercise. Eight days after vaccination, when his symptoms did not improve, he went to the emergency department where a CT scan showed 2 blood clots in his left lung. Covid-19 testing and duplex scans of his legs were negative. Blood tests were performed but results were unknown. He was hospitalized for 1 night, treated with IV heparin, and discharged the following day with apixaban. As of the time of this report, the chest pain had resolved and breathing was improved in the morning but still difficult later in the day. Based on the limited information (e.g. absence of blood test results), the relationship with Janssen Covid-19 vaccine is considered indeterminant.

I felt extreme fatigue and general malaise at 14:30. I took a Vicodin for my chronic back pain and lost consciousness at 15:00. I Went to bed and woke up at 16:25. 30 min later I slept again for about 90 min. Then I woke up and walked outside for some fresh air and got this extreme ice pick pain in the left side of my head for a few seconds. Then a few seconds later again. Now it just nags a bit behind my left eye and it feels a bit off in the left side of my brain. Bright lights hurt a bit. My back pain and Sciatica is also a lot higher than normal.

T+ 4 to 6 hours: mild fever, fatigue. T+ 1 days: mild fever continues, hot flashes begin, mostly at night interrupting sleep. T+ 2 days - 7 days: fever subsides, hot flashes increase in intensity significantly, continuing to interfere with sleep. Other possible androgenic symptoms begin to arise: change in body odor, sex drive, motivations, appetite. T+ 7 days till current: previous symptoms of days 2-7 continue, extremely gradual onset headache begins one night. Making sure to rule out hydration and electrolyte imbalance expecting headache to be gone in the morning after sleep, I found that it was only worse and that an interpolation of the two pain points from when I went to sleep and woke up would have created a almost imperceptibly gradual but linear increase between the two points. The headache was of a type I had never had before, located in the center of my head just barely dorsal to the spinal insertion. It felt deeper than any headache I had had before which usually occur in the frontal lobe/neocortex zone. I do not regularly suffer headaches getting maybe a couple per year. Once I recognized androgenic involvement and the headache were continuing I took myself to the ER where I was evaluated and despite presenting with continuous hypertension and the symptoms mentioned above, I could not get them to perform a estrogen test and they let me leave with hypertension without any investigation. I'm returning today to their urgent care facility to try again to get my estrogen levels checked. I had left a message on the phone line of VAERS prior to the original ER visit but had not heard back from anyone so I felt it was prudent to file a written report here.

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: 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

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.

CUSTOMER REPORTED FEELING LIGHTHEADED/DIZZY ABOUT 2 MIN AFTER INJECTION. HE SAT DOWN AND PUT HIS HEAD DOWN ON TABLE AND PASSED OUT FOR ABOUT 5 SECONDS, WOKE UP THEN PUT HEAD DOWN AGAIN AND PASSED OUT AGAIN FOR 5 SECONDS THEN WOKE UP AND SAID HE WAS FEELING NAUSEOUS THEN WE CALLED 911 . HE LAID ON FLOOR AND RAISED HIS LEGS AND HE WAS OK AFTER AND HE DID NOT WANT TO GO TO THE HOSPITAL

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.

Patient experienced light headedness, dizziness and passed out for about 2-3 seconds. Minor convulsions during unconsciousness.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

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 warned of previous vaso-vagal syncope. Patient was placed in supine position for vaccine administration and about 1 min afterward became anxious and passed out. He was unconscious for 10 sec and awoke, sweaty, weak. He was not confused, did not seize or lose bowel/bladder continince.

While waiting for 15-mins monitoring after getting Johnson&Johnson covid vaccine, he fainted and fell off the chair. Pharmacy staff rushed to his aid and he regained consciousness within a minute. He said he was feeling flushed and dizzy. He said he was having too much anxiety and has had fainting issue with vaccinations/MRI in the past. His blood pressure was low with high heart rate. We called 911 and paramedics came immediately. He was still unstable so the paramedics took him for further evaluation

Patient received the Janssen COVID vaccine then shortly after administration patient stated that their vision started to go blurry and the next thing their sight went dark, patient was seen falling out of chair head first after passing out.

Went into Afib at 3:00AM on 4-21-21. 911 was called. Diltiazem was administered IV. ER performed EKG and CT. I received Eliquis, Diltiazem and Lovenox. Released from ER at 9:00am still in Afib. Referred to cardiologist.

It has been 25 days since I took the AZ vaccine. Below are the side effects and significant blood test results: Day25: INR 1.29, CRP 4.8 Day 20 INR 1.05 In addition, I have been having an ongoing 37.3 fever since day 15 which goes back to normal 36.5 at night. Moreover i have been having light bruising on the arms and fee without any physical impact. my blood vessels / veins on hands, arms and legs are inflamed and cleary visible. i have been also having a feeling of tiredness and fatigue. Please advise on what I should do. Regards

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

Muscle aches, ocular pressure behind the eyes, chills, fever, soreness, gas and bloating, frequent urination, dizziness, faintness, difficulty moving, head ache, subocciptal pressure / muscle tightness, nausea.

After 5 minutes of patient getting the inmunization he felt lightheaded, dizzy, pale and nauseous. He was alert all the time and responding to our questions. His blood pressure was low 94/79. He mentioned he was fasting and spend long hours without food , including that he was anxious regarding the inmunization. He drank a sip of orange juice and we place him on the floor by his back and his feet elevated resting in a chair. After 15 minutes his blood pressure went to normal 126/87. He sit down for 30-35 minutes more. We offered to call 9-1-1 but he refused. I spoked with him by the phone 4 hours later and he responded he is good.

syncope right after vaccination, patient gained consciousness after few seconds. then he passed out again for few seconds, patient has phobia from needles , right after his second episode , he became extremely pale, started sweating heavily and his pupils dilated, the episode passed on its own, the paramedics still took him to the hospital to make sure he didn't hurt his head when he fell.

Patient received vaccine at approximately 10:55a.m. and started reacting at 10:57a.m. Patient stated that he started to feel like he was blacking out, alerted staff at the vaccination site. When staff got to patient he was incoherent and having body movements similar to a seizure, when staff spoke to patient he immediately responded as other staff went to get epi. Pulse was racing, breathing was normal, and patient able to communicate. Epi not administered, as soon as epi arrived to patient and 911 called at 10:58a.m. patient was talking normal, responding to questions, heart rate was returning. Staff stayed with patient to wait for EMS to arrive, police officer arrived pulse ox reading was 99% saturation, and heart rate of 59bpm. Applied oxygen with non-rebreather to help stabilize. Patient continued to improve, vision blurriness was the last symptom to fully return. Patient evaluated by EMS staff and released shortly after.

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.

Severe raised burning itching rash, severe headache, vision blurred, very tired fatigue, joint muscle pain, throat pain, mental fog slowness,severe pain at surgery site, increased tremor, pain in chest, itching keeps waking me up

Patient passed out for about 15 seconds about 3 to 5 minutes after receiving vaccine. pharmacy staff called EMS. Patient woke up after 15 seconds and was alert. He was given a bottle of water and stated that he was okay. He refused to go to hospital. Pharmacy followed up with him the next day and patient stated that he was completely back to normal health status.

Tremors, sweating, severe headache, vision flashes, pain in arm, fatigue, confusion, reduced consciousness, fainting, loss of balance, unable to ambulate or communicate, adrenal crisis, started in morning, treated at home with oral steroids for Addison's disease, doubled dosages for the next few days, pain and headache lasted beyond these symptoms.

Patient appeared to be pale and started sweating with complaint of nausea and expressed to use bathroom to vomit. Patient was escorted to the bathroom where he vomited a multiple times. Water was provided to the patient, and blood pressure was measured after 10 minutes. Blood pressure measure was 175/115; however, patient stated that it is always high, and he is feeling much better. Patient was monitored for 30 minutes, and he confirmed to feel safe to leave. Patient also reported his symptoms to V-Safe. He does not have an established PCP to follow up. Pharmacy information was provided to report any additional symptoms or complaints.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient found unresponsive to physical stimuli, staring up at ceiling, clammy pale skin, hypotensive (80/40), and Heart rate 49. EMS activated. Epinephrine given in Left thigh, patient responded. HR increased to 62bpm and Blood pressure 142/72 and 130/80. Patient stable and refused to leave store with EMS. Patient signed refusal to be transported via EMS and notified of importance of monitoring after Epinephrine administration. Patient verbalized understanding.

He had a stroke 25 days after getting the vaccine, before the stroke he was in a general state on not feeling good. He was also feeling bad a couple of days after the vaccine. After the stroke he is now paralyzed on his right side. He was in the hospital for over two weeks and is now in physical therapy to regain strength on his right side.

Immediate pain in the arm after the injection and it still hurts 4 days later. Every arm movement causes pain. About 8 hours after the injection, I could feel my heart rate rising. I tried to sleep and experienced disturbed sleep. At 3:00 am I woke up and felt terrible. I checked my blood pressure, and it was normal at 105/61, but my heart rate was 99. My resting heart rate is typically about 50. My heart rate doubling provided a terrible sensation. I could barely walk and shuffled around outside to get some fresh air. 3 hours later, my heart rate started coming back down but took a day to get back to normal. Even now, I have lost my appetite, am not eating much, and I just slept 16 hours. I have never experienced any vaccine such as this.

Tested Positive for Covid19 on 07/08/2021. Suspected Delta Variant Had Covid19 Symptoms, including headache, body pains, Severe lower back pain, Loss of smell, Low oxygen levels (83%), persistent cough, fatigue- Lasted 10days Recovered, but persistent cough, mild headaches and mild fatigue

Very nausea, pale, low BP (70/50), almost fainting - gave him water, sprite, and ice packs on neck - recovered in about 10 minutes

PATIENT RECEIVED VACCINATION AND WAS THEN ASKED TO SIT IN LOBBY. AFTER BEING SEATED PATIENT PASSED OUT AND FELL OUT OF CHAIR, HITTING HIS HEAD AND BITING HIS LIP IN THE PROCESS. 911 WAS CALLED AND EPI PEN WAS RETRIEVED. PATIENT CAME TO AND WAS PALE, SWEATY, AND HAD CLAMMY HANDS. PATIENT REPORTED NO DIFFICULTY IN BREATHING OR FEELING OF THROAT SWELLING SO EPI PEN WAS NOT ADMINISTERED. BP WAS CHECK AND WAS EXTREMELY ELEVATED. AMBULANCE ARRIVED A FEW MOMENTS LATER AND EMTS ASSESSED PATIENT. PATIENTS BP HAD RETURNED TO NORMAL RANGE, COLOR WAS IMPROVED AND HE WAS NO LONGER SWEATING. EMTS ASKED PATIENT IF HE WANTED TO BE TAKEN TO THE ER FOR FURTHER EVALUATION AND PATIENT REFUSED. PATIENT SAT IN THE PHARMACY FOR A FEW MORE MINUTES AND WAS THEN DRIVEN BACK TO WORK.

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

Patient had a syncopal episode post vaccination with brief unresponsiveness lasting about 5-10 seconds . At time of episode pallor and diaphoresis was noted and right after brief LOC he became AXOx3. The patient was placed in the Trendelenburg position while being evaluated by EMS:- Vitals: B/P 99/58 HR: 60 RR20 O2sat 98%. Blood glucose 132. Hospital transfer was recommended but the patient refused. Oral fluids were administered and repeat vitals showed improvement in BP to 104/68. Patient ambulated without assistance and reported a return to baseline. Signed to go home against medical advise. Encouraged to seek medical attention if symptoms returned and see PCP. Left in the company of his spouse

I developed a rash at the shot site that spread down my back and across my neck. My blood sugars have been high since Wednesday. I have been struggling to get them within range since then. I have an antihistamine cream that I?m applying and have had to adjust my insulin to improve my blood sugar levels.

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

following vaccine client complained of feeling dizzy and nervous. Per Dr he was experiencing a vasovagal event with no syncope. Blood pressure initially 83/43 then within 5 minutes 129/65. Pulse 54 then 79. 02 saturation 100%. juice given x 2 then released once symptoms resolved. EMS on site also.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received covid vaccine - while in waiting area, fainted suddenly and hit his head (rug burn on forehead). Got up and felt fine. Called EMS who then took patient away. Patient was alert when taken away. Previously has fainted when he's gotten blood drawn.

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

Vasovagal syncope 5 minutes post vaccination. Patient regained consciousness in chair in observation room 2 minutes after fainting. Vital signs at baseline: blood pressure 59/34, heart rate 44, respiration 22. Vital signs at patient discharge 40 minutes later: blood pressure 105/80, heart rate 74, respiration 18.

Patient was asked to sit for 15minutes after vaccination. After sitting, patient Walked approximately 15 feet and fainted onto concrete floor. Sustained head injury with laceration. Pt was alert and oriented. Was immediately attend to former EMS and nurse. Stated he had only eaten a banana that morning. Ambulance called and received head staples at the ER.

Patient felt light-headed, then became unresponsive. He moved both arms halfway up, and they both quivered simultaneously. I called for help. One nurse raised his legs & another put a pulse oximeter on patient & took his BP. Patient started responding to verbal cues. A nurse gave him Gatorade to start drinking. He was drenched in sweat from head to feet. The nurse continued to take his BP, which did hit 120/~70, but then dipped again. Once his BP & pulse stabilized, he was able to go home. Patient ate a full meal & a non-diet soda. He reported being exhausted ~4 pm. He fell asleep & rose once to urinate. Dr. at a Family Medicine practice checked his heart and lungs, and confirmed this did not appear to be an allergic reaction, but more likely was a vagovasal reaction. Patient started reacting ~10 minutes after the injection.

HPI: Patient is a 35 year old male who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid. Patient started to feel light headed and nauseous while walking to his car. About 20 minutes following vaccination, a vaccinator had walked passed his vehicle and noted that he was unconscious. Patient was still unconscious upon medical response team arrival and unresponsive to stimuli. Once the patient awoke about 30 seconds later, he continued to state that he was nauseated and ?did not feel good.? Patient was unaware that he had lost consciousness. He further disclosed that he had been working in the sun planting trees all day and had not consumed any food or beverage. He denied allergies to medication, food, and other vaccines. He relayed that he had passed out from vaccinations in the past as a child. He affirms lightheadedness and nausea. He denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, and vomiting. Exam (update as needed): GEN: Upon arrival, patient unconscious and not responsive to stimuli HEAD: NCAT EYES: pupils unreactive and mydriatic ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g, palpable strong radial pulse PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Skin pale, cool, and clammy. No rashes. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Patient unconscious upon arrival. CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vasovagal syncope. EMS called immediately to respond to the site for further evaluation. Patient placed into a reclined position. Patient not displaying active signs or symptoms of anaphylaxis. Upon regaining consciousness, patient was alert and oriented x4. Once the patient demonstrated ability to control airway, he was given candy and water. EMS arrived and an EKG and BGL were performed, both of which were normal. Vital signs were stable. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention. Medications administered: None Disposition: FD EMS called to the scene for further evaluation. Patient elected to go home after evaluation by EMS.

patient stated he felt light headed about 5 minutes after the inection, then collapsed gently to the floor and rested there. after a few minutes he asked to sit up. with 2 peoples help he sat up. after a few more minutes he was helped to a wheel chair where he passed out for approximately 5 seconds. He had some water after that and was feeling better. He went home with a family member.

Patient had presyncopal episode after vaccination, patient stated he felt dizzy, eyes blacked out Patient seen by medical team and vitals were stable Patient has history of syncopal episodes Patient stated symptoms improved and refused medical transport and signed AMA form Friend will be driving patient home

I passed out in my vehicle right after the vaccine was administered. A nurse found me unconscious at the vehicle and called 911

After giving the vaccine, I was talking with the patient and he said he felt dizzy. He passed out and while he was out/when he was regaining consciousness, he started having seizure like movement. EMS was called and were here within 5 minutes. The paramedics took his vitals which were all WNL. Approximately 15 minutes later, the patient had a repeat episode. The paramedics and I suggested that the patient go to the emergency room via ambulance. He declined and left with his wife. They both reported that he would seek care at the emergency room.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Medium

The patient became clammy, sweaty and pale. Patient almost passed out. Basic symptoms of syncopy. Patient laid to floor with knees up and hands behind head. The patient came to rather quickly. The EMS squad was called and they took over with blood pressure and portable EKG machine. The patient had a gatorade and rested for about an hour and his wife drove him home. I called him 2 days later to check in on his status and he said he got a good nights sleep and felt much better with just a sore arm.

sweaty, pale, dizzy. PB 117/75, PO2 97%, HR 86. After laying down, drinking water, felt better (so symptoms)

Major symptoms, roughly 20 hours after vaccination, 10-15 minutes after waking, while walking and standing: - Extreme pain in right hip joint. Pain is sharp, stabbing, burning. Pain radiates down leg, and right foot numb and tingly - Overheating - Lightheadedness, blurred vision, confusion - Fainting or loss of consciousness, falling to ground Timeline of events: 2021-04-08 13:00 Injected with Johnson & Johnson 13:00 - 13:15 Very slight nausea 13:15 - 22:00 Very slight nausea and fatigue 22:30 Lymph nodes in neck feel swollen, ears feel slightly clogged (typical early cold symptoms) 23:30 Insomnia and chills 2021-04-09 00:00 - 07:30 Insomnia, poor sleep, and cycles of chills and overheating while trying to sleep or sleeping. Stronger nausea than before 07:30 Wake up, knees feel slightly weak when walking 07:35 - 07:40 While walking inside a market. Right hip joint begins to hurt with sharp, stabbing, hot pain. The pain radiates down right thigh. Right foot begins to feel numb and tingle. This pain increased over 5 minutes, to excruciating levels, with right leg feeling numb, and sharp stabbing tingles in right foot. Difficult to walk normally 07:40 - 07:45 Pain becomes overbearing, and market counter used for support. Begin to feel light headed. Begin to feel hot, and begin to overheat within ~2 minutes. Walk outside market (outside temperature 32 - 40F) to cool down. Lean on car hood for support, and become increasingly lightheaded. Vision becomes blurry. Stumble and fall onto face. Regain consciousness after unknown time, groggy and with blurred vision, lightheaded feeling. Attempt to stand and fall again onto face. Regain consciousness after unknown time. No longer feeling extremely hot. After roughly 1 minute, regain clear vision and lucidity. Pain in hip and leg completely subsided 07:45 - 09:00 Driven to hospital. Treated by hospital staff for laceration in forehead requiring 7 sutures. EKG reports normal. Concussion check negative. 09:00 - 00:00 Occasional nausea, fatigue, weakness (same as weak cold) 2021-04-10 11:00 While walking and standing in line. Right hip joint begins to hurt, with pain radiating down right thigh. Right foot begins to feel numb and tingle. Begin to feel warm. Hip Pain remains at manageable level, and walking normally is easy. Hip pain is roughly 1/3 of pain of 2021-04-09. 2021-04-11 07:30 - 11:00 Occasional slight pain in right hip and left hip joints. Hip pain is sharp and burning, and roughly 1/10 of pain from 2021-04-09.