Johnson & Johnson

Pt reported that approximately five hours after vaccination, she experienced uncontrollable tremors, fainting, vomiting, chest pain and tightness. Today, extremely fatigued and has some chest tightness. She has a history of chest tightness. Did not seek emergency care last night, but called physician this morning who was not in office and referred to local health dept. Advised that it would be best to consult with local emergency facility and if anything worsens she needs emergency care.

Throughout the night and into the next morning, my heart has been racing and I?ve been having some palpitations. I haven?t had a fever so it?s not related to that.

Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to sleep due to pain and getting up several times at night to vomit.

Syncope after getting vaccine. BP 95/60, P 100, O2sat 96%. Improved after 2 minutes but monitored for 20 minutes.

5 hours after being given the shot, uncontrollable tremors began. Muscles began tensing up, tunnel vision started, extreme dizziness, vomiting, severe weakness in muscles, and fainting. These lasted for about 2 hours before decreasing in severity but continued to be present until about 10:30pm, 13 and a half hours after receiving the shot. Nothing was done to treat the symptoms. As of 12:30pm on 3/10, some minor symptoms are still present, such as muscle weakness and pain, severe migraine, and dizziness.

Dizzy, near syncopal. BP 108/71 (pulse 110), O2 sat 99%. First day of menstrual cycle with painful cramps.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Within 10mins of vaccine, pt seem to have a mild seizure for less than 30sec. Pt had no hx of seizures, on no current medication. Pt recovered, and within 1-2mins she passed out. She was warm. She woke up within 1min, then started to vomit. Called emergency services. She felt better after throwing up. When ambulance arrived, she started to have tingling sensation on her finger tips. States she felt better. EMT advised her to go to the ER. Pt decided to go to ER to get checked up. Let with ambulance.

Fever Couldn't talk Sharp join & chest pains Painful to move eyes Fatigue Bedridden- couldn't move on my own Shortness of breath Lasted 7 hours; took 3 Tylenol @ 500mg each; lots of fluids

Dizziness, Pallor and pre faint feeling, diaphoresis then syncope for 20-30 seconds with inconstancy.

12 hours after receiving the vaccine, I woke up in the middle of the night with severe chills, fever-like symptoms, a headache, and aches all over my body. I also was experiencing a heavy chest and shortness of breath. All but one of the adverse events went away after 24-36 hours - the shortness of breath and shallow breathing have persisted up through today. I am very aware of my breathing and how my chest feels tight, like I'm not getting enough air.

102 degree fever, severe chills, severe muscle / body aches, severe headache exacerbation, severe diarrhea for 36 hours and hypovolemia, severe exacerbation in chronic abdominal pain, severe exacerbation in chronic joint pain, severe fatigue, insomnia, exacerbation in nausea and food intolerance

Started to experience nausea and chills about 8 hours after the shot. A few hours later I had a low grade fever of 100.7 and a headache. My body became very sore and weak and my heart was racing. Woke up around 4am with a headache, fever, and racing heart. My chest feels heavy and I?m very tired and weak. The shot was given to me at a local clinic.

On 3/17/2021 I started feeling I felt like I was going to faint. My heart rate started to go up to 135, I felt dizzy, I had cold sweat & it felt a little hard to breath. This symptoms lasted for about 2 days. I had to see the doctor the same date on the 3/17/2021. He sent me to do lab work.

Immediately after the vaccine was administered, the patient experienced paleness, lightheadedness, dizziness and weakness for about 15-30 minutes. Patient was able to state correct name, date of birth, current president and today's date. Pt denies respiratory distress. BP 102/78. Patient able to drink water and ambulate to private observation area. Pt declined transportation to hospital for further evaluation. Pt reports symptoms resolved. Pt able to return to work. Pt advised to call doctor is symptoms return and to call 911 if difficulty breathing. Pt instructed to continue to hydrate with fluids and to rest.

Patient reports slight chest tightness, cold, clammy upper extremities, jitteriness and slight tightness to the neck. Patient reports that she is anemic and did not eat this morning. Vitals were taken on site by team BP: 127/80 P: 92 and SPO2 ? 100% RA.

Patient was administered vaccine and told to wait the 15 minute monitoring period. After about 4 minutes, I heard her say "I'm not feeling right." I went to where she was sitting and asked "are you ok?" and had her take some slow, deep breaths. I then saw her eyes roll back and she lost consciousness. Thankfully, I was there and grabbed her as she toppled from the chair. I told the staff to call 911 and supported her neck and body in the chair. I could tell she was breathing and she was sweating profusely. I held her and spoke to her, and after about 15 seconds, she began to come out of it. After about a minute she was alert and orientated again. I had her slowly sip a little water. The EMTs arrived in about 5 minutes and the assessed her vitals. She indicated that this was the first time anything like this had happened to her. They advised that since she had fainted, she should go to the hospital for observation, but she declined, stated that she felt fine at that point. Since she was driving, I insisted that she remain another one-half hour before leaving. During that time she drank more water and alternately sat and walked around the pharmacy. She did indicate that she had drank a protein shake that morning, but not eaten. I advised her to in the future, tell her doctor and/or any immunizer about the event. She left, stating that she was feeling fine, and I called her several hours later to make sure that she had indeed gotten home ok. She again said that she felt fine.

Patient is a 26 year old female who presents immediately following administration of a single dose of J&J COVID19 vaccine in the left deltoid. Patient was walking with her mother to their vehicle when she lost consciousness. Per patient?s mother, the patient has a developmental delay and can be a poor historian. Patient states that she has never experienced syncope. She denies allergies to medications and foods. She has never had a vaccine in the past. Patient denies a medical history. Patient states that she takes Concerta and Lexapro on a daily basis. She denies chest pain/tightness, shortness of breath, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Vasovagal syncope with loss of consciousness. Patient not displaying active signs and symptoms of anaphylaxis. Patient was transferred to a cot and very quickly regained consciousness. Patient was A&O x 4 and in NAD. EMS was called to the scene for further evaluation due to limited resources. EMS called to the site for further evaluation due to vasovagal syncope with loss of consciousness. EMS related patient was experiencing orthostatic hypotension. EKD and blood sugar levels were within normal limits. Patient transported to ER.

Pt reported felling cold and heart felt like it was racing. Hx of HTN. Had water and snacks, felt better, left after 30 minutes.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Before vaccination, patient briefed pharmacist regarding very probable likelihood of fainting. Per patient's own account, this event occurs very frequently when recieving vaccines. Pharmacist understood and with conset of patient continued vaccination. Within a minute after administration patient did pass out into catatonic state, followed by epileptic-like convulsions. RPh provided physical support with patient as she was convulsing out of chair and onto floor. Convulsions ended within 2 minute

Patient has a fear of needles. After her injection, she tried to stand up to tell me she does not feel good but fainted before getting to the counter. She hit her head at some point. We gave her some water and called the paramedics. After checking her out she was instructed by the paramedics to go to hospital. She went to the student health center and given information regarding head injury. She later return to collect her Vaccine record card.

Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. Pt received covid vaccine 3/18. Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache on the right side of her head. She was vomiting from 3/28-3/30. On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin. Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. She was started on a heparin drip and brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.

Pt received a vaccine of Johnson and Johnson (Janssen) Covid-19 vaccine. She asked if it was normal that her arm hurt really bad, then she stated she was getting dizzy and light headed. I instructed her to sit on the floor so she would not fall down. She sat on the floor and immediately passed out. She remained unconscious for 60- 90 seconds. We laid her into the prone position. Her arms were twitching. She regained consciousness. 911 was alerted and responded. Pt refused to leave with them. She sat with un an additional 15 minutes before she left for a therapy appointment.

Janssen COVID-19 Vaccine EUA - 102 Fever - Chills - Aches - Headache - Bloody Nose - Pain in legs and back

Within 3 minutes after vaccine patient expressed she was going to "pass out" medics guided her to the floor. Medics and local EMS were present. Patient was unresponsive and apneic w/ ashen color skin, EMS began stimulation efforts. Patient began to arouse and breathe within 3 minutes of efforts. Patient was transported to hospital.

Patient has history of vasovagal reaction to blood draw and vaccines, BP dropped to 90/60 HR80, then 10 minutes later 94/64. Discharged in stable condition

Had the vaccine 11:30am. Beginning around 5pm, I began to feel nauseous and have extreme chills. I took Tylenol and felt better until about 8pm. I then began to feel nauseous again and get extreme chills. I vomited multiple times, and was curled up in a fetal position crying from the nausea, headache, and a feeling of pressure in my chest. I ended up going to bed to sleep it off, waking up in a pool of sweat. I felt better the next day.

I had a reaction within 25 mins of J&J vaccine injection- my heart rate quickly went from 100 to 160 which is very abnormal for me and both of my hands were tingling (as were my feet). I felt a little dizzy and it was getting harder to breathe. It lasted for maybe 5- 10 mins and I had to try and do deep breathing techniques which helped a little. It has been almost 5 hours since my vaccine injection and I feel fine.

Had no side effects whatsoever for many hours. Felt completely fine until about 7:30 pm, while I was making my plate of dinner. Felt lightheaded, dizzy, and hot. I began to black out, so I sat down, which helped for a few moments to subside lightheadedness. I was still feeling hot, so I walked a few feet to my back door and sat down on the steps outside to cool off. Within minutes, my vision blurred completely, I saw stars, and completely blacked out. My mother, who was nearby, heard me fall on the steps. She said my eyes rolled back, my body was completely limp, I was not breathing but rather making gurgling noises from my throat. She propped my head up, which allowed me to breathe properly, and I came to. If my mother had not been nearby, I am convinced I would be dead right now. I saw the light, saw the other side, saw my relatives. I have had a near death experience once before, and this was exactly like that.

Nearly immediate after administration of vaccine- stood up to move to a waiting chair & experienced dizziness to the point of near syncope, heart pounding, nausea, sweating- pharmacy brought juice and watched me. Drank juice but was disoriented enough to spill a bit- sat for about 30 minutes until symptoms cleared up enough to walk around and got a ride home.

Patient walked to her seat in the observation ear and sat down. Within 1 minute she jerked back and fell to her right side hitting her head and face on the glasses display and landing sprawled out on the floor. She had her eyes wide open. She was not aware she fainted and was completely conscious. Her blood pressure was 123/70. 911 was immediately called. The EMTs took her to the ambulance due to low heart rate when they arrived. She ended up leaving on her own accord

TACHYCARDIA; SHORTNESS OF BREATH; ACHINESS; This spontaneous report received from a parent concerned a 26 year old female. 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, 1 total administered on 02-APR-2021 at 10:15 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced achiness. Laboratory data included: Heart rate (NR: not provided) 111 {beats}/min. On 02-APR-2021 20:00, the subject experienced tachycardia. On 02-APR-2021 20:00, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia on 03-APR-2021 20:00, shortness of breath on 03-APR-2021, and achiness on APR-2021. This report was non-serious..; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

same day and the 2 days following Left arm/shoulder/side of neck had major joint pain, headaches, tiredness, sensitivity to light, brain fog, and felt extremely anxious to the point where my heart was racing and i was shakey. As of today (4/12/2021) I am still feeling extremely anxious (as if my anxiety medicine is not working at all) and have headaches and trouble focusing or remembering things, making it very difficult to work. Also having trouble sleeping because of the anxious feeling.

Intense full body aches, starting 10 hours after shot. Fatigue, weakness. Chills. Fever. Heart racing. Body aches and fatigue lasted 24 hours. Chills and fever lasted 12 hours. Redness, swelling, and itchiness at injection site starting 48 hours after shot.

Syncopal event falling off chair striking forehead onto floor. Loss of consciousness about 10-15 seconds. Denies neck pain. Pt reports felt dizzy walking to seat post injection. Complains of headache. Pt declined to have driver pick her up. Left under her own power.

My heart started fluttering even after almost a month after the vaccine but it did start to happen less over time but still happens. After the vaccine for about for days I had intense headaches and body aches throughout my body.

Vomiting, Blurred Vision, Hard time catching my breath, numbness in arms, chest pressure, ear pain, headache, muscle aches, fever, dizziness for about 3 hours starting at 11:00 p.m. Ambulance was called around 2:00 a.m. taken to Hospital Seen by MD tests: Imaging XR CHEST AP PORTABLE MD Apr 12, 2021 The result is abnormalLab CBC WITH PLATELET AND DIFFERENTIAL MD Apr 12, 2021 The result is abnormalLab COMPREHENSIVE METABOLIC PANEL MD Apr 12, 2021 Lab PT-PTT MD Apr 12, 2021 Lab TROPONIN MD Apr 12, 2021 Lab CKMB W/TOTAL CPK MD Apr 12, 2021 Lab P-NATRIURETIC PEPTIDE, MD Apr 12, 2021 The result is abnormalLab MAGNESIUM MD Apr 12, 2021 Lab ESTIMATED GLOMERULAR FILTRATION RA MD Apr 12, 2021 Lab SARS-CoV-2 RNA RT-HDA MD Apr 12, 2021 Lab POCT PERFORM URINE PREGNANCY MD Apr 12, 2021 Pt seen and examined. Workup ordered. IVB, zofran, pepcid, toradol 15mg iv ordered. Reassess. Magnesium 1.4. repletion ordered. covid19 -ve. Upon reevaluation, pt feels better. VSS. Pt is clinically stable for d\c from ER. D\c to home per d\c instructions Strict d\c instructions and parameters when to RTER d\w pt, all of which pt verbalized understanding and agreement.

I had the common symptoms within 24hrs of receiving the vaccine, including headache, body aches, body chills, fever, and tiredness, which lasted approximately 24hrs. I had taken both Adderall and Allegra that day. 4 days after receiving the vaccine, I took Adderall and Allegra and had an adverse reaction (I hadn't taken Adderall the prior 3 days). I experienced palpitations and vertigo/dizziness plus slight nausea. The next day, I took a much lower dose of Adderall and decided to continue taking approximately 1/3rd of my typical dose after an E-visit with my primary care Dr. During the week of 4/5, I was able to increase the dose by a little bit without any adverse reactions. Starting on 4/11, I was able to take 2/3rds of the typical dose without adverse reaction. However, I am still experiencing vertigo/dizziness, which may or may not be sinus-related due to seasonal allergies.

Shot was at 1:50. At 8:00PM I started getting chills and body continues to shiver. Was able to fall asleep and got up to use the restroom around 2:00AM and had dizziness, headache, Nausea and felt faint. Same occurrence happened around 4:00AM as I got up to use the restroom again. By 8:00AM I could slowly get up and move around with out feeling faint or nauseous. Left with fatigue

Within 20mins of injection: Right arm tremors and twitching resembling dystonia, brain fog, nausea, extreme thirst, difficult swallowing, jaw pain, increased heart rate, and fatigue. Drank water and rested. Resolved within 120mins. After 12 hours if injection: nigh sweats, chills, fatigue, headache, and fatigue. Resolved with 600mg ibuprofen. After 48 hours of injection: Muscle tightness and twitching, limping, tachycardia, extreme fatigue and loss of strength. (Resembled POTS flare) Drank water, laid down, and rested. Resolved within 120minutes.

Tight right chest. Severe leg pain. I never have had this type of leg pain before. It?s painful in joint section that I have to walk slow. I am unable to walk up on staircase more than 3 floors. I don?t know what is going on but this never happened before and the fact that I got shot recently made me worried. I am young still, used to walk a lot and also did hiking. I never had troubles with my leg joint until recently.

Sudden onset back pain on 04/09/2021, localized to the center of my spine, so bad i thought i was going to vomit. Tylenol was unhelpful but I had also taken my anxiety medication and 25mg of Benedryl, so the fact that it lasted roughly 4 hours is an estimation because i did eventually fall asleep. Chest pain on 04/10/2021, ongoing but only sometimes excruciatingly painful. Had costochondritis about a year ago, it eventually went away. This pain is the same as that. I was told that people who get costochondritis are likely to get it again, so may be unrelated to the vaccine, but thought i would list it anyways. General unwell feeling lasted until 04/13/2021 Unrelenting nausea lasted until 04/13/2021 Diarrhea started today 04/14/2021

Patient was very anxious at the visit was talking an then eye rolled and she had difficulty talking patient appeared to vagal, patient was placed on cot and monitored by ems staff, patient refused hosptial visit.

Obtained J&J vaccine on 4/4/21 Signs/symptoms started 4/12 and continue today Has intermittent severe headache that ranges in pain from 2-7/10 Current pain is 2/10 Intermittent abdominal pain that radiates to back Pain is mainly in shoulder blades just under her bra line Hurts when she takes a deep breath in Pain rated at 2/10 current but can range as high as 7/10 at times Denies Shortness of breath or difficulty breathing or speaking, states pain only when taking in deep breathing Sometimes the pain will shoot down her back to her hips Intermittent pain across the front of her upper chest States she does not know how to describe it but it is not severe Sore all over Fatigued Afebrile

SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported. On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. 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).

Chills 12 h after receipt of vaccine followed by low grade fever (101 F) and body ache with minor headache. Symptoms subsided by the end of the following day. 1st menstrual period post-vaccination was noticeably heavier with more clots than usual.

Approximately five minutes after receiving the vaccine, the patient began to lose consciousness (fainted) while sitting upright in a chair. The patient lost vision, then hearing, then eventually laid down on the floor until she regained consciousness.

5 Blood clots coming from right nostril, headache, fatigue, stomach pains Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.

4/8-4/9: arm pain, chills, chattering teeth, fever, sweating, dehydration, insomnia 4/9: fatigue, brain fog/confusion 4/8-4/22: random muscle pains mostly in legs, ankles, feet 4/17: insomnia, sweating, neck pain, nausea, dizziness, fainting, muscle pains, dehydration, anxiety/elevated heart rate -> went to ER at 4am on 4/18, tests found no abnormalities 4/17-4/22: neck pain and upper back, fatigue, muscle pains, anxiety/elevated heart rate (intermittent chest pain/sensitivity), insomnia, general discomfort overall and thus depression from not feeling normal for so long

I woke up at 04:00 am with severe migraine; fever and chills. Migraine left 01:00 or 02:00 that afternoon. The fever and chills lasted through the next day - body ache and soreness throughout both of those days. For those two days I did not work. (Ended the 8th when it was time for me to go to bed.) I did have heart palpitations the night of the 9th that I did go get ER -they gave me a dose of Ativan and they sent me home. That took care of the heart palpitation symptoms. I followed up with my provider the following week.

Fainting about 5 minutes after vaccination, we gave patient water, let her rest and put her feet up. She recovered fully after 10 minutes.

Patient presented to ED for 2 syncopal episodes and went into cardiac arrest 5 minutes prior to ED arrival in ambulance. She received ACLS measures and alteplase was mixed and administered for pulmonary embolism concern.

Reaction after Janssen vaccine (1805031), in right arm, at 1:20pm 3-16-2021: - Within 15 minutes: nothing - Within an hour or two after: itchy right hand, pulsing in right side of head behind eye, dizziness - About 8pm, onset like a wall: severe anxiety/impending feeling of doom, shortness of breath slightly, increased heart rate, tiredness, muscle aches, sore skin, feeling of sharp pains in ?blood stream?, chills, nausea - 12pm after sleeping for about half an hour: flushing of face, slight shortness of breath, facial swelling and blotchiness, swollen lips, fast heart rate, feeling of impending doom, nausea, tongue swelling, slight difficulty swallowing, nasal congestion, groggy voice, sinuses full of moving fluid, ear pressure, hot with chills, eye redness, achy body and sore skin, feeling of sharp pains ?in blood stream? - 1am, in addition to previous symptoms (peak of symptoms): Fever 101.4 F, puffy feet that hurt, dizziness - 1:30am, after eating a little: temp 100.8 F, puffiness went down slightly and severe symptoms improved a bit. Still chills - 2:45am woke up drenched in sweat and hot, 100.7 F. Chills mostly gone. Nose very stuffy. Eye pressure/pain. Feel improved. Chest feels exhausted. Still body aches but improved. Ear pressure. - 8am: 99.4 F. Feel better mostly overall. Head feels like a cinder block. Eyes and ears hurt. Body aches mostly gone. Pain at injection site. Chills gone. Sweats gone. Skin still sore. - 1pm: 98.3 F. - Only remaining symptom for next couple days is tenderness at the injection site. -Following a few days: completely recovered. no symptoms, back to 100%

At 3 am the night of the vaccine, I woke up with flu like symptoms, including a headache and shortness of breath. Two days later, I had a severe manic episode that lasted for three days (bipolar was well managed with medication at this point and I had not had a manic episode in months). Along with the manic episode, I developed chest pressure and shortness of breath, along with dizziness and a pounding sensation in my chest. Any physical activity or even a sip of coffee sets my heart off. I am still experiencing these symptoms to this day and caused me to lose my job because I am not able to perform the required tasks. I had a premature atrial contraction prior to the COVID vaccine, but it had cleared up and I had been off of the medication for months with no problems. I have been to the doctor's office (primary care physician-4/15/21 and 4/20/21) twice, the emergency room once (4/26/21), urgent care (4/14/21), and now am seeing a cardiologist for this condition (first visit 4/29/21).

client observed sitting in chair when suddenly she loses consciousness and collapses to floor. Vaccine crew arrives immediately and she is assessed. No skin lesions, redness, swelling noted. Client gains consciousness and when asked about incident, she states: "I have fainted before when receiving a vaccine. EMS arrives and further assesses client taking over patient care.

Immediately agter receiving the shot I broke out into a sweat and began to feel lightheaded. My eyes started to blur like I could pass out. The pharmacist/doctors at CVS gave me some water and told me to elevate ny legs. After 10 minutes they checked my termperature and blood pressure. I stabized somewhat and when home. I was sure it it was my nerves but something did feel right. I had a slight burning in my chest and felt queezy on/off throughout the day. Chills and hot flashes followed. I was anxious and paranoid about the possibility something serious coukd be wrong with me. I felt shooting pains in my lower left abdomen that nught and the next day. The following day I still felt very weak. My arm hurt. My muscles felt like jello and I?m unhappy. I wish I never got the shot and I?m worried about my body?s reaction to it.

Around 4 pm I had flu like symptoms. Headache, back pain, fatigue, chills, sweats. Around 5:30 I started feeling light-headed. I got out of bed and fainted on the floor. Laid there for a few moments. Got water. Laid back into bed and my body completely locked up. It felt like there were pins and needles coursing through my entire body. I couldn?t bend or move my legs. My wrists were bent down and my fingers all locked together. I could not move them at all. I was screaming out in pain. It was the worst pain I?ve ever felt. My roommate called 911. Paramedics arrived and took my temperature and blood pressure. They tried calming me down. eventually I did. And my fingers and legs unlocked but I continued having a severe headache, back pain, muscle aches and nausea. I woke up every hour of the night and threw up several times. It?s been 24 hours after the shot and I am still having headaches fatigue and muscle spasms.

Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Additional Details: Patient receieved vaccine. After about 5-10 minutes the patient stated she was very nauseous. I went to grab a trash can for her and within the 20 seconds or so it took to grab she had what seemed like a single muscle spasm or convulsion then she slid out of her chair onto the floor. She was breathing and coherent right away however she did not remember getting on the floor. Called 911 and EMS came out and took her vitals. She stated she felt fine afterward and did not go with them.

Pt sat down after vaccine. Became dizzy with in 10 minutes. She briefly fainted where she was unresponsive. When she started responding she was very nauseous and vomitted. She stayed sitting and we provided gatorade. She was feeling better 30 minutes later and left the vaccine location

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

My symptoms starting the night I got the vaccine and lasted for 2 weeks after. I had a fever, chills, severe headache, nausea, shortness of breath, muscle aches, fatigue, and pain in my left leg. We ended up going to the emergency room the week after because of fear of blood clots.

Patient fainted in waiting area after receiving immunization. Patient experienced visual disturbances seeing black spots, left sided chest pain, and arm tingling. Checked patient blood pressure, elevated her legs, applied cold ice pack behind her neck. Called 911 and paramedics arrived on time.

Received shot. Saw black dots, pain spread from arm to chest, got up to let the pharmacist know woke up on the floor shaking, head felt like it was bleeding but I didn?t hit me head. Saw black spots and waves of blur in my vision for hours. Meds came decided to observe at home. Did NOT have anxiety. I suffer from anxiety and panic attacks I am well aware of the feelings, coping techniques etc that come with them. Now I have major anxiety that I got a injected with some that may hurt me.

04/14/2021, experienced leg cramps, fatigue, body aches. Visited ER on 04/15/2021 05/10/2021, experienced chest pain, rapid heart beat, exhaustion Visited ER 5/11/2021

BLOOD CLOT; This spontaneous report received from a pharmacist concerned a 26 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: unknown) dose was not reported, 1 total dose, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date (after vaccination), the patient experienced blood clot. The pharmacist thought, that she has been treated, and at the time of this report she was at home, but he was not 100% sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522731-Covid-19 vaccine ad26.cov2.s-blood clot. 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).

At 10pm on 5/18/2021 I started having side effects, 9 hours after vaccination. My face and ears were hot and my body was cold, I felt very fatigued. I took Tylenol before bed and woke up in the middle of the night drenched in sweat. I woke up officially at 8am and felt my face and eyes were swollen, I also had chest tightness. I looked in the mirror and it looks like I was punched in the face. My left eye (the side I was vaccinated) is significantly more swollen than my right side. Since 8am, the swelling and puffiness hasn?t gone down in my face, however, the chest tightness went away. I took Benadryl. It is now almost 4pm on 5/19/2021 and I still have the same amount of swelling and puffiness in my face. It?s extreme enough that I can?t go out in public like this or else someone will think I got beat up. There isn?t any bruising, rather, under each eye there are very prominent dark circles with almost a reddish tint. It seems like this possibly could be an allergic reaction but after reading online it seems like allergic reactions would have happened right after vaccine. I noticed this side effect 19 hours after vaccination when I woke up on 5/19/2021. If it?s not better when I wake up tomorrow on 05/20/2021 I will goto urgent care.

BOTH EYES ARE SWOLLEN/PUFFY/LEFT EYE MORE SWOLLEN; FACE WAS SWOLLEN (SWOLLEN CHEEKS); DARK RED COLOR AROUND EYES; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced both eyes are swollen/puffy/left eye more swollen. On 19-MAY-2021, the subject experienced face was swollen (swollen cheeks). On 19-MAY-2021, the subject experienced dark red color around eyes. On 19-MAY-2021, the subject experienced chest tightness. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chest tightness, and had not recovered from both eyes are swollen/puffy/left eye more swollen, face was swollen (swollen cheeks), and dark red color around eyes. This report was non-serious.

BODY PAIN; HEART PALPITATIONS; VAGINAL BLEEDING; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and was not taking any medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 27A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced heart palpitations. On 15-MAY-2021, the subject experienced vaginal bleeding. On 15-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, body pain, heart palpitations, and vaginal bleeding. This report was non-serious.

FAINTED POST IMMUNIZATION; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 26 year-old white and Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included needle phobia, alcohol use (Social - 1-2 drinks per week; very light drinker) and non-smoker. The product was stored in appropriate temperature conditions (it was stored properly from receipt to administration). The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) administered on 07-MAY-2021 to left arm as prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-MAY-2021, the patient fainted post immunization. On the same day, she was feeling exhausted and had headache. On 08-MAY-2021, she experienced low grade fever and lethargy. Till 10-MAY-2021, she was feeling exhausted and had headaches. On 13-MAY-2021, she identified lack of smell while cleaning house (cleaning products). On the same day, she had positive rapid home test for COVID 19 and she tested negative at health care professional (HCP). On 14-MAY-2021, she was tested positive polymerase chain reaction (PCR) for Covid 19 (headache, exhausted, low grade fever, lack of smell and lethargy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted post immunization on 07-MAY-2021, and was recovering from confirmed covid-19 infection. This report was associated with product quality complaint: 90000179636 This report was serious (Other Medically Important Condition). The narrative states the patient received the vaccine on 07-May-2021 and had a positive Covid-19 test on 14-May-2021 with 7 days elapsed between vaccine and test. There was not sufficient time elapsed for the patient to achieve immunity therefore this report was not considered a lack of effect. The suspected product quality complaint has been confirmed to be voided there was no PQC identified within the reported complaint. Voided based on the PQC evaluation/investigation performed".; Sender's Comments: V0:20210530216-covid-19 vaccine ad26.cov2.s-Fainted post immunisation. 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.

Experienced 2 days of worsening fever, chills, myalgias, mild chest pain, fatigue and malaise. Went to the ER after having a low grade fever, chills, shortness of breath, mild chest pain, and an elevated resting heart rate. Was diagnosed with SIRS as a response to the covid vaccine and hospitalized for observation. Was discharged the next day. Diagnosed with SIRS, possibly due to the COVID vaccine with a secondary diagnosis of asthma.

Patient felt light headed and was dehydrated and need to sit down. Lost color and we elevated her feet.

patient fainted. Patient said she fainted prior that day during blood work and we were warned that she may do so following vaccination. Pharmacist administered vaccine, patient walked to waiting area and sat down. A minute or so later knew she was going to faint and layed on the ground with knees up. Pharmacist sat with patient while she recovered. Patient refused emergency services on several occasions. After 15 minutes patient felt better and left store.

Patient is an employee, after getting her shot, she returned to the sales floor and was talking to a customer (in front of aisle 10&11, pharmacy is in front of aisle 16). patient passed-out and fell backwards from standing position and have hit her head on her fall. Patient regained consciousness, when was helped up but again passed-out. Front end managers brought the patient to the covid waiting area room and was supported on a sitting position. Pharmacist administer ammonia inhalant and patient regained consciousness and was responsive. Patients BP was 108/70mmHg. Patient was transferred on the floor to raise legs, while waiting for 911 response. Patient was transported by fire department to ER for testing.

05/19/2021 Nosebleed and 20 to 30 to stop. Abdominal pain. 05/27/2021 Infection, hospitalized to prevent infection to shunt. 06/01/2021 Pneumonia

Likely pericarditis: I felt a stabbing pain in the area of my heart. It felt like a papercut somewhat left of my ribcage directly on my heart--whenever I touched the area or moved in certain ways, there was the sharp pain. This lasted for about 2.5 weeks and began likely the on April 17 (the date is a bit unclear, but it was within a week of my injection). I was unsure whether this could be a symptom at the time, and I shied away from reporting, but recently saw that this is a rare but known symptom for individuals in my age range.

Leg pain. Started in left leg, moved over into right leg as well. Got xray on left knee- nothing came back. Got ultrasound on leg leg- nothing came back. My legs constantly hurting. Mainly behind my knees, side of my knee, and front of knee . My calves and ankles are also hurting. I feel pain, weaknesses, and throbbing. They are very tired. I visit a sports medicine doctor tomorrow. Also visiting a cardiologist tomorrow. I?ve been having chest pains (which are normal for me prior to vaccine). However, now my heart is feeling like I?m having palpitations. It starts beating faster then normal. I can feel my heart beating now, which I?ve never been able to notice prior. I?m having to catch my breath often, and have to take really deep breaths. This is the first time I?ve ever experienced these heart issues. Visits since vaccine- 2 visits to PCP, 2 visits to urgent care, ultra sound, upcoming sports medicine visit, upcoming cardiologist visit

Patient walked into the pharmacy trying to get vaccinated for Covid. Before anything patient was concerned about her previous Covid positive case (not a severe reaction, was eventually tested negative in April) and also her family history of asthma (Patient herself never had an episode so far). I told the patient it would be okay to get vaccinated, per CDC guideline. As patient filled out the consent form, I checked the screening questionnaire, which she answered "no" to everything except "don't know" to asthma related questions. As everything was set I brought patient into the consultation room, explained what vaccine she is receiving, how long it takes for the vaccine to be fully incorporated into her defense system (2-3 weeks), and what kind of side effects she can expect (muscle pain, elevation in body temperature, redness around injection site). I took extra moments to explain risk vs benefits for blood clotting issue. At this point patient was ready to get vaccinated. I wore gloves, asked patient to roll her sleeves up so I can proceed to wipe the right upper arm area with alcohol and give her an injection. she followed promptly so far to this point. As soon as patient received the vaccination, her body started to slide down the chair. Patient reported to feel dizzy and also reported that she had some "dreams." Fortunately while everything was happening patient's head did not hit anything and patient was in sitting position the whole time of the event. I asked patient if patient was feeling okay three to four times but I did not get any straight answer from the patient. I asked for help, and pharmacy technicians and store manager offered help. Patient wanted us to call her husband and 911, which we proceeded. In the mean time I also reached out to my district manager to report what was going on. Store manager offered a room temperature water to keep her fluid balanced, as she was sweating heavily. Once 911 got to the site, they measured her BP and HR, and it was a bit low. 911 offered a choice to take patient to ER, which PT and her husband first decided to use their own car, and later decided against going to ER. Husband reported that patient is feeling much better, drank a few ounces of fluid and taken a banana.

Body aches and muscle pain of arms and legs - lasted about 36 hours Severe headache - 7 days Fatigue - ongoing, started after vaccine, still persists Chills (no fever) Hypoglycemic episodes - sporadic (did not have prior to vaccine) Syncope - once (cause unknown, happened on 5/17)

patient was afraid of needles to begin with, she warned me that she has passed out before, I gave her the injection, she did with the shot but after 5 mintues , she started feeling dizzinees, and fainting, so I asked to call 911 , she wouldn't let me, I gave her bottle of water , she told me to check bp so I checked bp and it was 80/50, then she said she felt good, few minutes later, i told her your bp is really low so gave her some crackers from the store, she ate, ,but then she felt like throwing up so I called 911, and attended her, emergency came they checked her bp , it was 80/50, they told her they needed to take her to hospital, but she refused, and said she will be ok, she left with her boyfirend, and was ok

Anxiety attack, 30 seconds after shot was administered Frantic crying and behavior Light headed Patient appeared to pass out, but responsive to commands and words, required assistance, was supported, no injuries. Heart rate and pulse was present The following was an experience of 30 minutes

6/28/21 A 26y/o female client 10:25 A client was given the following vaccines; Hepatitis A- Lot #G99R expiration date in the right deltoid; Hepislav B- Lot # 934599 expiration date in the right deltoid: and Johnson & Johnson Janssen COVID vaccine Lot # 202A21 expiration date 08/07/2021 in the left deltoid. 10:30A During routine observation noted client color was pale, skin warm and dry. Client initially states she is ?okay?. After questioning client again this time Client admits she feels ?dizzy?. Client denies any difficulty breathing and B/P 112/70 with a heart rate 76; pulse was strong and regular. 10:35A Client now c/o a ?dry mouth and dry throat?. Client given a minute sip of water was able to swallow without difficulty. Client continue to deny any difficulty breathing or swallowing so couple of minutes later client tried another minute sip of water, but this time had some difficulty swallow. Now client admits she is having ?pain in my throat? and ?chest pains? in the left side. Epi pen -Lot #G201104X expiration date 02/2022 was given in client?s upper left thigh without problems; repeat B/P 118/68 and 911 was summoned by nurse 10:40AM Paramedics arrived ? reported to Paramedics epi pen was given. 10:47AM Client B/P per Paramedics 107/73, heart rate 72; Paramedics report client will be transported to the Hospital ED for evaluation. 3:50PM Noted client was back. Client reports she is feeling ?okay?. Client states she was ?discharged from ED at 13:22? (1:22PM) with the diagnosis of ?allergic reaction?. Client resumed her routine scheduled chores and continue to report she feels ?okay?. RN CCM

1805 vasovagel, pale skin moist, put in reclining position, legs elevated. moist clothes applied to face & neck. pulse 80 strong regular, R 16. 1810 sitting up skin w/d. Patient made full recovery and left the clinic at 1830.

Covid-19 Ad26 Vaccine administered to Left deltoid muscle per standard IM injection protocol. Within a few moments after administration patient stated "Oh. I'm going to faint." Pt. was assisted to supine position and observed to be unresponsive to name calling, appeared pale and slightly diaphoretic with a weak thready pulse. Clinic staff was notified of vasovagal syncope, patient self-revived within 30 seconds. Afterwards cool compress was applied to forehead and pt. provided with water for hydration and was also offered crackers and juice, which she declined. Pulse re-checked approx 2 minutes after pt. revived found to be approx 65bpm and strong, 2+ color returned to pt. face and she stated she felt much better. pt. was observed by clinic staff for full 15 minutes following vaccine administration and vasovagal episode without further issue. Pt. left exam room and clinic under own power in stable condition.

On 3/23, I started feeling odd. My apple watch alerted me that my heart rate had dropped under 40 BPM for 10 minutes. I then made an appointment with my PCP for the following day. They did a EKG and I was diagnosed with Mobitz type 2, but he referred me to a Cardiologist. Cardiologist Dr had me do a stress test and wear a holter monitor for 2 weeks, that confirmed my original diagnosis of Mobitz type 2 block, which ended in me having to get a pacemaker on 6/14.

Racing heart, highest recorded beat was 108, lasted from 7:45 to 8:45 pm Face/throat swelling, I treated with benedryl , lasted from about 8:15 PM to 8:45 PM Vomiting and nausea , I treated with anti-nausea med lasted from 7:15 pm to 9 pm Migraine-like headache , I treated with ibuprofen, started around 9 pm and finally decreased around 4:30 am. I still have a slight headache. Chills - started around 3 pm and lasted until around 6am this morning. Site pain - 10 Am until 3:30 am.

Twitching, convulsing for couple of seconds. Then patient fainted for about a couple of seconds and twitched again for another seconds (less than first onset). Patient was confused and disoriented for a couple of seconds after waking up. We had emergency allergy kit ready/ benadryl injection ready/ and called 911 as soon as she started twitching. Patient was sitting already, so we elevated her legs onto another chair. EMS came and took control of the situation.

patient said she was nervous about getting the shot & needles. I told her to relax and she would be fine. After getting shot she fell over, started sweating & shaking. I called 911. She wanted to lay down. Paramedics took her BP and it was low but she started to feel ok. She refused going to hospital. A friend came and drove her back to work

Approximately 2-5 minutes after administration, she became sweaty, loss of color in her face, nausea and dry heaving, dizziness, tingling and numbness in all extremities, stiffness in lower extremities, difficulty talking and ability to catch her breath.

I developed dysautonomia (elevated heart rate, chest pain, and shortness of breath upon standing. also GI distress) on June 12, 2021. I ended up in the emergency room and being admitted to the hospital twice over the next week and a half. I have been trialing medications, wearing compression socks, and drinking a lot of water and eating a lot of salt. My symptoms have improved a little but my doctors believe I will be managing this for life (or at least a while). Prior to this episode, I got the Janssen vaccine which caused me to have tachycardia for about 12 hours within the first 24 hours. I felt fine for a week but the second week I felt very fatigued and couldn't do much other than sit on the couch for the week.

FEELING NUMBNESS IN THE PALM OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. 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).

Pericarditis - went to the Emergency Room, advised to take NSAIDs for the next two weeks until the chest discomfort went away. It never did, and it's been three months since my vaccine.

PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. 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'm not sure if the Janssen is the same as Johnson and Johnson? But I'm type 1 diabetic and my blood sugars have been at dangerously high levels for 3-4 days now. They still haven't gone down. I've been taking two times as much long acting insulin as I usually take, tripling the amount of fast acting insulin I usually take, and am only eating protein and vegetables (no carbs) to try to keep my sugars in normal range, and even then they are stubbornly sticking around 250 to 400. I want doctors and patients to be aware of this side effect because it was really scary for me and it still hasn't resolved itself.

Post vaccination lightheaded, pale. Placed supine, felt better. No local injection site reaction, hives, SOB, tongue swelling, palpatations. Lungs CTAB. Sat up drank water and ate a banana.

Patient was found unconscious laying back in her chair shortly after receiving her Covid-19 vaccine. Patient was awoken with a light shake on the shoulder, but not to noise. The patient stated they had difficulty hearing, along with nausea and light headedness. The patient denied any other symptoms, including difficulty breathing, abdominal pain, and body soreness. Nothing was administered on the pharmacy's end. The paramedics arrived shortly after and took the patient as she was going in and out of consciousness. Patient was contacted after the incident, in which she said that she was told she had vasovagal syncope. The patient is fine now.

On 3/10/2021 at approximately 2035, a female patient notified vaccine observation staff that she was feeling light headed, queasy and anxious. As staff began to assess the patient she began to pass out loosing consciousness. Staff were able to hold patient before any falls and lower her to the floor. The paramedic on scene began her emergency assessment of the patient. Staff paramedic was able to arouse the patient with a sternal rub. The patient was not fully aware of the event that had occurred. The paramedic place the patient on oxygen via nasal cannula. The patient?s level of consciousness began to improve. The patient stated she has a history of syncopal episode after any immunizations. The patient also relayed that she has a history of anxiety and is complaint with her medication. After secondary assessment of the patient, it was noted that the patient had an extended recovery time from the sycopal episode. She was unable to stand on her own and she still felt nauseous after vomiting. The staff at the clinic notified county EMS at 2055 and care of the patient was transferred.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient became rigid, unresponsive, fixed eyes, dilated pupils, shaking (seizure-like movements), when patient was moved to floor, she became alert and oriented. Dizziness, shakiness, body slower to respond than normal...took some time to get back to normal. EMS called for monitoring and support.

she recieved shot without reaction. she stood up and moved over the waiting area to sit for 15 mintues. after 3 to 4 minutes of talking with her mother (mom left to go get water from front of store). she said out loud "I think I'm going to faint." I rushe out of the pharmacy to help. Her eyes rolled back and she fainted, the she convulsed for 5 top 10 seconds. she woke up 30 seconds later (mom returned by this time). 9-1-1 was called and ambulance came to check vitals and she left on her own accord.

Within 8 hours of receiving the vaccine, I started to feel weak and began to develop a fever. By that night I had a 102f fever. My muscles were very achey, and my heart was racing. I was slightly nauseous but still able to eat a little. By 24 hours after the shot my fever was down to 99f. I started to get diarrhea beginning the second day and has lasted until now the third day after vaccination day.

Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm

The pt doesn't like needles. Gave her the shot no problem. She waited 15 minutes then walked out with her boyfriend. She said she felt faint, then passed out. He caught her then put her in the car. Then she passed out again. He called 911. The ambulance came and brought them back in the store. She got checked out and refused to go to the hospital. She claimed she was fine and left.

Pt had a near syncopal episode after injection. Ringing in ears, pale, shaky, light headed. We lied pt down, BP was 90/60 then increased to 110/70 with rest and a snack.

person reported itching on her arms. Person moved to observation area and was there at the same time as another person with n/v. Person then progressed to n/v as well. While EMS assessed the other person they also assessed her. She was hypertensive. Benadryl was given. She also reported only 4 hours of sleep and not having anything to eat before getting vaccine.

person reported heart racing, SOB, chest tightness. Tachycardia 140-160's. Did remember that she had rxn to unknown medication around age 7. transported by EMS for on site observation

17 minutes after injection my left arm began to feel hot then the rest of my body did too and my throat stared to feel itchy. Dr. started to monitor me to see if symptoms worsened. Then 15 minutes later my chest felt hot and heavy and throat was more itchy. Dr. took vitals then administered epi , monitored throat became even more itchy then Benadryl was given and emergency services was called. Paramedics evaluated and symptoms began to get better, there was no transfer to the ER

I lost vision and became dizzy and lightheaded five minutes after shot. I returned to the clinic and sat down. My blood pressure was under 90/60 once I regained stability.

Increased heart rate, dry throat, anxious, itchy skin. Pt was given 2 tabs Benadryl PO, monitored for an extra 30 minutes and cleared.

Symptoms of Patient: Complaint of feeling light headedness and not being able to see. Patient then passed out. 14:55 P-126, SaO2 85 Treatment: Offered patient fluid prior to her passing out. Patient was able to take a few sips of water and was alert and oriented prior to passing out. Patient was lowered to the floor from chair. Patient head was protected as she was lowered to the floor. Patient legs were elevated. Patient Blood pressure checked B/P110/70, P-70, SaO2 99%. Cool gauze was placed on client forehead. Emergency services were called to assist in care of patient. Upon elevation of patients legs patient states, was able to see. Patient alert and oriented x 3. Per patient states, is able to get back in chair. Patient states no longer dizzy. Emergency services arrived. Pulse and oxygen saturation maintaining continuous until they arrived. Patient blood pressure, oxygen saturation pulse rechecked by Emergency services. Patient B/P 110/80, P-67, O2 sat-93%, per emergency services, paramedic services came and assess patient. Per paramedic patient did not need to be placed on monitor. Client was no taken by ambulance. Client signed document with Emergency services patient declined transfer. Per patient feeling better, Patient denies feeling lightheaded and dizzy as if she was going to passout. If repeated and severe side effects reviewed with patient. Patient escorted to car by staff and friend Patient left location at 15:30.

The patient has been known to faint after vaccination and came prepared for the vaccine with a caregiver and a cooling towel. After vaccination, patient was very pale and did pass out/faint. She was sitting on the bench next to her caregiver. Patients episode lasted about 5 minutes. After the patient gained conciousness, I had her sit with her caregiver for another 10 mins or so. After patient was feeling better she was able to leave.

Patient was waiting in car after vaccine and returned to pharmacy at 1:40 (approx. 20 minutes after) stating she was okay now, but she originally felt faint, sweaty, heart racing, and dizzy. Patient didn't receive anything due to event ending before intervention could occur.

Chest pain, disorientation, dizziness, nausea, brain fog, muscle spasms, inflammatory response in prior surgical sites (from 6 months to 2 years old), and fatigue

FIVE MINUTES AFTER RECEIVING VACCINATION, PATIENT FELT DIZZY AND PASSED OUT FOR APPROXIMATELY 30 SECONDS. NO NAUSEA OR VOMITING. PATIENT WAS MONITORED FOR 30 MINUTES AFTER INCIDENT BEFORE SHE LEFT THE PHARMACY.

Vaccine at 12:50 20 minutes after shot: fuzzy, drugged 35 minutes after: face and neck was red and blotchy and itchy. Tongue was itchy. Pain at injection site Drive home was bad. Slurring my words. Eyes were so heavy, hard to keep open. I felt weight on me. Pressure on my chest, heart was tight. Fatigue. Started hysterically crying. Got home, couldn?t walk normally. Sweating. Chills started at 8 Body aches at 9 Woke up with TERRIBLE body aches at 11:40. Skin was so hot, I was shivering cold. My legs hurt so bad. My knees mostly. My ankles. My inner thigh muscles. My lower back couldn?t handle any pressure. It hurt to lay. My left shoulder blade and upper arm hurt bad. Then my head hurt. My hips couldn?t move. My elbow felt weak and painful, like they would break. 12:40 headache got worse. I was shaking. I was nauseous. Chills were awful. Ears were ringing. No appetite for days. Sore joints, muscle pain and fatigue still 4/13

Fever, dizziness, weakness, trouble walking, full body aches, headache, wheezing, difficulty breathing, rapid heartbeat, high fever, cough, shortness of breath, vomiting, heartburn, earaches (pressure in the ear), chills, extreme night sweats

1p (Friday)- Received shot and felt normal rest of afternoon 7p - Started feeling lethargic and dizzy 8:30p - Started getting full body chills and shivers, felt freezing, headache and fever started 10:30p- Body shivers stopped. Fever 102 F 11:30p- Fever 104 F 12:00a- Extremely rapid heart beat, couldn?t slow it down with breathing. Fever still 104 F 1:00a - Fever 103F. No sleep 8:00a (Sat)- Temperature came down to 100F. Bad headache and body aches, worst in hips and legs/knees. By Sunday, temperature back to normal and headache subsided. Still aches in right hip/leg.

Approx 5 mins after vaccination patient reported feeling dizzy, lightheaded and nauseous (dry heaving), pt looked pale and diaphoretic - symptoms lasted approx 5-10 minutes. Left on her own, no EMS needed

Patient became very pale, sweaty and felt like she was going to pass out approximately 5 to 10 minutes after vaccination. After drinking fluids she quickly recovered.

A few minutes after vaccination patient turned pale and eyes started closing. Patient seems to have fainted. Patient was then in and out of consciousness over the next 5 minutes. Patient was given water and was able to drink. 911 was called immediately, and a cop escorted her out of the pharmacy area and to an ambulance outside

Patient was given the Janssen vaccine and fainted just a few seconds after injection. She awoke shortly after after and was given some water and was monitored by pharmacy and store staff until she felt normal, about 30 minutes. Her boyfriend drove her home.

About seven hours post-injection, I started feeling short of breath and chest tightness. I also had extreme nausea, headache, and fatigue. Fatigue continued for about one week. Nausea spells continued for about 2 days.

reports she had dizziness, warm sensation, tongue numbness, decreased appetite, decreased sense of taste, vomiting x1, sore throat, myalgias, and intermittent shortness of breath and chest pain. of note had Covid in December 2020

event time started at 06:30pm of 04/12/2021. patient felt over at home. reported headache, increased heart rate, shortness of breath, chill, pain on head, back, leg, right leg numb. with no bleeding

All administration of vaccine was done properly, however, patient soon developed sudden syncope. Had patient sit in upright chair, legs not crossed, had BP readings done (113/68, HR 67), patient states light headiness and dizzy. Patient had to be in administered chair for 10 minutes before transitioning to another post vaccination chair to be monitor for additional 20 minutes. Patient regained consciousness within a few minutes and was cleared to leave facility after patient was properly monitored in facility.

symptoms: light headed & syncope episode in which patient hit head on pavement Vitals: BP 93/51 RR 16, Pulse 115 O2 67% Intervention/treatment: Oxygen at 6L/minute by non-rebreather , re-assessed vitals, called for EMS transport O2 Sats after oxygen was 100%. Paramedics assessed patient and took a blood glucose which was 118. Patient denied drug and alcohol usage and denied pregnancy NKDA NDMedical Condition other than anxiety and fear of needles. Patient refused medical transport and signed waiver with Paramedics

Believe I may have passed a blood clot through urine or vagina early this morning. It appeared to be quarter sized. Non painful, one time event. Also have intense back pain and leg aching. Still feverish and have mild headache as well.

Fever for first 3 days Body/muscle aches for 3-4 days Fatigue that has not gone away Random headache off and on Occasional dizziness/light headedness, has gotten better over time but still occurs Rapid heartbeat at times

Friday evening I had what I thought was normal reaction: chills, aches, headache, nausea. Saturday it was mostly aches. Sunday was dizziness, aches, nausea and cramping in left leg. Monday was nausea, aches, tingling in hands and feet, headache, brain fog. Tuesday I woke up with major imbalance and needed to use walls to walk without falling over. Dizziness subsided after some time to only rapid movements. I had a warm burning sensation in left leg with tingling hands and feet. Moderate headache. Reports came out of stopping the Janssen vaccine so I contacted my doctor with my symptoms and they ordered blood tests for clots.

Patient received Janssen COVID19 vaccine at 10:15am. Upon receiving vaccine she sat down on chair to wait for 15 minutes post-vaccination. Just minutes after sitting down patient lost consciousness, fell from chair, hit her head on the floor, seize for a short moment, only to momentarily regain consciousness, and faint for a second time. EMS were called and patient was transported to Emergency Department for testing and observation. Patient believes she fainted the first time due to not having eaten much by that point in the day and due to anxiety about receiving the vaccine, and she was told she fainted a second time due to hypotension. She states she has a history of previously fainting during other medical procedures, though no similar previous reactions she can recall after vaccines.

Pt sts that shortly after her vaccine she became lightheaded and dizzy. She had a similar issue when she gave plasma in the past (she passed out completely). She did not tell staff ahead of time that she passes out with vaccines and was sitting in her chair at the time of administration. Pt sts she immediately got lightheaded and dizzy and she passed out before she even knew what happened. Pt did fall out of her chair and hit her head on the floor. She was responsive within 10 seconds per bystanders and was AOX4. She does have a small amount of swelling to an approximate 1" hematoma to the R side of her head just into her hairline. She was treated and released by EMSA. She refused transport to the hospital. She did have pain at the site of the hematoma. PMS was intact X4 and her neuro function was intact per EMSA during exam. Pt left POV.

Patient came into the pharmacy with her mother to receive the JANSSEN COVID-19 vaccine. Per technician that witnessed the event the patient passed out while next to her mother while walking over to the chair to wait 15 minutes after immunization. The mother started yelling and the patient ended up in the chair, did not fall onto the floor. At this time the senior technician called 911. The patient regained consciousness, was breathing but appeared pale in complexion. The patient verbalized that her heart was racing. EMS arrived, patient was put on oxygen and transported to the hospital.

On 03/18/2021 at 03:30AM I had a lot of arm pain from my shoulder to my elbow in my left arm. This lasted until 03/31/2021. On 03/18/2021 I woke up with a headache that would not go away. Next, at about 03:15PM I was not able to walk for about 10 minutes. Then, at about 05:00PM I started menstruating. At 07:00PM I had severe pain in my pelvic area for an hour and a half. At approximately 08:30PM I passed a softball sized blood clot vaginally. I bled heavily through the night. On 03/19/2021 I still had a headache and no energy at all. I continued to bleed heavily all day as well. 03/20/2021 was the exact same as the days prior. 03/21/2021 I was still bleeding heavily throughout the day with no energy. I still had the headache as well. I started feeling dizzy while walking on this day. 03/22/2021 I went to work like normal. I was cold all day. I was still bleeding, headache and dizziness. It was hard to stand for 30 minutes. While climbing the stairs I got very light headed and dizzy. I could not go up the stairs at a normal pace. 03/23/2021 I had the same symptoms all day but I was getting short of breath walking short distances. I still had very little energy and a headache. I also lost all color in my face and hands. I was still cold all day. I noticed some slight swelling in my ankles. 03/24/2021 The symptoms were getting more intense. I was still cold. I finally took some aspirin for the headache because it was very severe. The medication didn't help with it. This routine went on for the next week and the symptoms intensified with each day. Throughout this time I was still passing clots that ranged in size from golf/ping pong ball to baseballs. They were very painful when they passed. The days from 03/25/2021 to 04/01/2021 were all the same as far as how I felt. On 04/02/2021 I woke up with the same symptoms but now I could not stay awake for anything. I slept on and off all day. I only ate one meal a day because I was so tired and I had no appetite. The headache was getting worse as the days went on. The bleeding was still happening. It was not as heavy as the weeks before, but enough to be painful still. I also started having abdominal pain. On 04/03/2021 I was seeing stars when I moved too quickly. My heart rate was elevated with shortness of breath along with the rest of the previous symptoms. My headache however was very intense. 04/04/2021 I still couldn't stay awake on top of all the other symptoms. The dizziness and stars were more frequent. I couldn't move my head without seeing stars. 04/05/2021 I couldn't get warm and I still felt the same way. I called and made a doctor?s appointment for Wednesday the 7th. I had all the same symptoms still and they were getting worse. I had to move in slow motion so I could try to function. 04/06/2021 I woke up drained of all my energy and color. I couldn't shower because of the pain in my body. I couldn't stand because I felt like I was going to fall down. I could barely stand up straight let alone walk very far. I was shaking from being so cold. I had all the same symptoms from the days prior. I was in severe pain. I couldn't sit because of the pain in my abdomen I couldn't stand because of the weakness in my legs. I could barely see anything because of the stars I was seeing. At this point I had no color and I was barely conscious. That is when my family took me to the emergency room.

I began to feel shortness of breath when walking, tightness in my chest, for the same reason any physical effort made me feel like I was short of breath. (The day before I had presented the common symptoms such as fever, chills, arm pain, muscle pain) however this symptom was off the list, at 11:30 in the morning I had to go to an emergency clinic, they checked me with blood test, urine tests, medical exam, electrocardiogram, and chest X-ray. The doctor told me that everything was fine that I could leave. I had to pay a high bill at the hospital. The following 7 days the sensation was disappearing very slowly. However from day 8 it started again, until now on day 13, I still having sensation of shortness of breath when doing physical exercise, it is something that lasts and does not disappear.

6-48h: joint pain, fever, chills, headache, nausea, sore arm and pain around injection site, extreme pain below knees 48h+: original symptoms subsided but developed numbness and weakness left leg and left arm 56 hours: left face partially paralyzed and/or swollen to the point where couldn?t move week. Prickly feeling left skull. Weakness and numbness in leg and arm persisting (decreased feeling on skin on left side of the body) 1 week: saw GP, neurologist, and sought emergent care at hospital for symptoms as doctors feared potential small stroke. MRI, chest X-ray, and blood works all clear. Discharged same day. 1 week+: partial facial paralysis gone, numbness and weakness in left side located to below the knee, but not present in both legs. Pain and uncomfortable feeling in both calves when lying down .

nausea, back pain possible uti foul odor, blood in urine ongoing for 2 weeks, urine urgency, abdominal pain unsure if related to period (Period doesn't typically last two weeks), chills, janssen vaccine small bump on arm where vaccine is, arm is warm to touch with redness around the area, headache comes ago did not have a h/a last week, chest pain

a 27 y.o. female with a history of Covid infection December 26, 2020, positive covid test December 29, 2020. She had approximately 2 weeks of symptoms including generalized body ache and generalized weakness. Fatigue and some headache. Had some persistence of symptoms after that time. Had some benefit from ibuprofen. Was seen at emergency room on January 27, 2021 stating that she felt that all her symptoms of Covid had resolved except for some chest pain which awoke her on January 27. She presented to the emergency room. Had sinus tachycardia at 113 but otherwise unremarkable physical exam, laboratory studies with white blood count elevated 16,004-20, hemoglobin 13.7 g hematocrit 41.8%, MCV 87.1, RDW 12.7%, platelet count 329,000, segs 72.8%, lymphs 20.6%, monocytes 4%, eosinophils 1%, basophil 0.6%. BUN 10.1, creatinine 0.8, AST 24, ALT elevated 56, alkaline phosphatase 68, total protein 7.6, total bilirubin 0.3, albumin 3.6, globulin by subtraction 4.0, troponin less than 0.02, D-dimer quantitative 0.22, urine pregnancy test normal. Chest x-ray normal. Chest pain appears to be musculoskeletal and was reproduced by palpation of her chest wall. No evidence of deep venous thrombosis or pulmonary embolism. D-dimer was normal. Heart rate returned to normal after some intravenous fluids. Patient discharged on Zithromax 500 mg day 1 and then to 50 mg days 2 through 5. Also continued on ibuprofen. Received Johnson and Johnson vaccine April 5, 2021. Over the next week patient started having increasing soreness. Her joints hurt more than usual and her headache was worse. She had a sensation that her legs were "numb and tingly" starting at her buttocks and extending down her leg. Because of reported incidence of cerebral sinus thrombosis or cerebral vein thrombosis patient appropriately presented for screening in the emergency room and was sent for appropriate imaging. April 16, 2021 CT scan of head with and without contrast no acute intracranial hemorrhage, no mass-effect or midline shift. On contrast-enhanced images there appears to be a lobular nonocclusive filling defect in the far lateral right transverse sinus. Lobular occlusive filling defect is also likely present in the mid to central right transverse sinus. Short segment filling defect in the medial left transverse sinus. Remainder of sinuses and internal cerebral veins are patent. Focal lobular filling defect within the confluence of the right and transverse sinus most likely related to arachnoid granulation. No edema hemorrhage of the cerebellum or cerebrum. No other significant findings. April 16, 2021 confirmatory MRI angiogram of head without contrast with no restricted diffusion to suggest acute or subacute infarct. Contrast void in the middle to central right transverse sinus consistent with occlusive thrombus. Nonocclusive thrombus in the far lateral right transverse thrombus. Narrowing of the medial left transverse sinus without complete occlusion. April 16, 2021 2345 hrs. inital hematology consultation. D-dimer and fibrinogen levels have been requested stat and are still pending. If fibrinogen level is low will replace with cryoprecipitate. If D-dimer is elevated barely confirms diagnosis of possible vaccine related thrombosis. The fact the patient is not thrombocytopenic at this time is encouraging, however despite the lack of thrombocytopenia she still has clearly documented symptomatic nonocclusive and occlusive thrombus in her cerebral sinus. From UPtoDate.com Ad26.COV2.S (Janssen COVID-19 vaccine, also referred to as the Johnson & Johnson vaccine) ? On April 13, 2021, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended pausing administration of AD26.COV2.S to further investigate rare cases of cerebral venous sinus thrombosis and thrombocytopenia [33]. As of that date, six cases had been reported, all in females aged 18 to 48 years with onset 6 to 13 days after vaccination; during this period, 6.8 million doses were administered (with 1.5 million doses in females of that age range) [121-123]. Since some vaccine recipients have not been followed for longer than the time frame over which these symptoms develop, the incidence may change with additional follow-up. Initial symptoms included headache, backache, chills, and fatigue, and progressed to focal neurologic deficits. Intracerebral hemorrhage and thromboses at other sites were also seen in some patients. All of the five patients who were tested for the anti-PF4 HIT antibody tested positive. Another case, in a young male who was a vaccine recipient in one of the pre-emergency use authorization efficacy trials, had been previously reported. These cases appear similar to those reported following ChAdOx1 nCoV-19/AZD1222, another adenovirus-vector vaccine. Although rare, the observed number of events exceeded the expected rate among females <50 years old. Given the extreme rarity of these events, the FDA and CDC acknowledge that they recommended the pause out of an abundance of caution and to ensure awareness of these rare events. ?Evaluation and management of possible thrombotic complications ? Recipients should be aware of the possible association and seek immediate care for signs and symptoms suggestive of thrombocytopenia (eg, new petechiae or bruising) or thrombotic complications (including shortness of breath, chest pain, lower extremity edema, persistent severe abdominal pain, unabating severe headache, severe backache, new focal neurologic symptoms, and seizures) [117]. In such cases, some experts suggest evaluation with complete blood count and differential (including the platelet count), quantitative D-dimer, HIT testing, and imaging of any suspected site of thrombosis [113,114,125]. Onset 4 to 20 days after vaccination, platelet count <150,000/microL, elevated D-dimer, and a positive anti-PF4 antibody (HIT antibody) suggest the diagnosis. Treatment with a non-heparin/non-warfarin anticoagulant (eg, argatroban or direct oral anticoagulant) and intravenous immune globulin has been suggested. The CDC recommends not using heparin in individuals with thromboses following receipt of Ad26.COV2.S unless HIT testing is negative [126]. (See "Cerebral venous thrombosis: Etiology, clinical features, and diagnosis" and "Clinical presentation and diagnosis of heparin-induced thrombocytopenia", section on 'Terminology and HIT variants' and "Management of heparin-induced thrombocytopenia", section on 'Role of IVIG'.) As stated above all the 6 cases were "all in females aged 18 to 48 years with onset 6 to 13 days after vaccination" this would certainly fit the timeframe that we are seeing in this case. Recommendations from national guidelines would be to start treatment with dexamethasone immediately while awaiting intravenous gammaglobulin. To pursue intravenous gammaglobulin treatment at 1 g/kg over 1 to 2 days. It is recommended to avoid heparin and instead use direct factor X inhibitor such as Eliquis, which this patient is already been started on. There is unfortunately considerable risk that even though patient's symptoms appear mild at this time, that she may deteriorate in the very near future and I would recommend treating her aggressively at this time with dexamethasone and intravenous gammaglobulin while we are awaiting further testing. Patient clearly has had unusual thrombosis, especially in a 27-year-old. With the fact that she had headache dating back to January, it is impossible to determine the acute versus chronic nature of her venous sinus thrombosis. Covid infection does cause increase in coagulation as well. However, given the small risk of tragic outcome with cerebral vein and sinus thrombosis in the setting of Covid vaccinations, we will proceed aggressively with treatment starting tonight with intravenous gammaglobulin and intravenous dexamethasone. Will require rapid fasting glucoses to evaluate possible hyperglycemia from high-dose dexamethasone. Will consider stopping dexamethasone at 48 hours. Current recommendation for gammaglobulin would be single 1 g/kg or 500 mg/kg over 2 days. No recommendations for treatment beyond this point. Current recommendations for gammaglobulin dosing would recommend using an adjusted dose for patients with greater than 125% of their ideal body weight. This patient at 122 kg on a 5 foot 2 inch frame does qualify for adjusted dose and her orders reflect that. I appreciate the opportunity see this patient this evening and consultation requested by Dr. We will follow patient in hospital. Hopefully she will have gradual improvement and avoid any serious or tragic complications of her cerebral sinus thrombosis. We will have pharmacy report possible adverse reaction to Johnson & Johnson vaccine to the FDA as required by law. April 17, 2021 follow up. No new events. Laboratory studies remained excellent. White blood count is further elevated, however, this may be secondary to high-dose dexamethasone with a white blood count of 16,060. Hemoglobin 14.0 g hematocrit 42.8%, MCV 86.8, RDW 12.9%. Platelet count is actually increased slightly at 374 as of 9:10 AM this morning. Differential shows left shift as expected with dexamethasone. Results from yesterday showed fibrinogen normal at 369 (180?415) pro time normal at 10.4 seconds with INR of 0.97, PTT 26.7. D-dimer 0.23 (0.19?0.50). With platelet count, fibrinogen and D-dimer normal I am inclined to believe that this is not an acute post vaccination HIT-like phenomena. If it were I would still expect to see some degree of thrombocytopenia elevated D-dimer and perhaps low fibrinogen. The other explanations for her cerebral venous sinus thrombosis are either idiopathic spontaneous and merely coincidentally associated at the exact same time as her Covid infection or more likely, cerebral venous sinus thrombosis secondary to hypercoagulable state secondary to her Covid infection from December 2020. Unfortunatly there is no way to accurately date the acuity of the venous thrombosis in her cerebral sinus. HIT Testing is still pending and most likely will not be available for 3-4 more days despite being ordered stat. Have called the laboratory and asked them to check with our outside reference lab what the expected return time is on this test. (LabCorp says "Tuesday April 20, 2021). Patient refused intravenous gammaglobulin infusion which has been ordered last night. Patient has been receiving dexamethasone which was a bridge until intravenous gammaglobulin could be administered. Current guidance from the expert hematology panel (EHP) on Covid vaccine induced thrombosis dated April 7, 2021 from the public health would state that a patient who has a reduced platelet count without thrombosis with a D-dimer normal and normal fibrinogen or thrombosis with a normal platelet count and D-dimer normal and normal fibrinogen are "unlikely cases". They recommend for probable cases who have D-dimers that are elevated to send HIT assay and then give immediate intravenous gammaglobulin while awaiting results. They recommend fibrinogen supplementation, if needed. They recommend a direct acting antithrombin agents such as the Eliquis this patient is receiving. They recommend steroids particularly if there is a delay in getting intravenous gammaglobulin delivered. With the fact that we now have 24 hours in the hospital with no evidence of thrombocytopenia, no evidence of increased fibrinolytic activity or active thrombosis, and no evidence of hypofibrinogenemia, I would argue that her presentation is subacute. In this setting, I do not feel intravenous gammaglobulin would be necessary and does involve a small risk as well as considerable cost. Dexamethasone also involves small risk and negligible cost. I have discontinued both of these medications. My overall impression would be that this was not related to her Johnson & Johnson vaccination which was recent, but rather her more distant Covid infection. It is impossible to definitively answer the question however. The next question is duration of anticoagulation. Risk of recurrent cerebral sinus venous thrombosis is relatively small but the morbidity can be high. Studies have been performed showing medications in the same class as Eliquis have been associated with a decrease in incidence of the recurrence. Most hematologist recommend 3 months of anticoagulation for provoked venous thrombosis including cerebral sinus venous thrombosis. I feel this patient's thrombosis is "provoked", with her association at the same time of her Covid infection (and possibly vaccination). I would recommend Eliquis (apixaban) 5 mg twice daily or Xarelto (rivaroxaban) 20 mg daily with food. I would feel comfortable in discharging patient for outpatient follow up IF Dr and other speciality services agree. Plan 3 months of full dose anticoagulation with direct factor X inhibitor. Circulation 2010 Jun 29;121(25):2740-6 "Long-term evaluation of the risk of recurrence after cerebral sinus-venous thrombosis", Background: The clinical course of cerebral sinus-venous thrombosis (CSVT) is largely unknown because prospective studies with a long follow-up and with the goal to assess thrombosis recurrence rate and predisposing factors for recurrence are lacking. Methods and results: One hundred forty-five patients with a first CSVT were followed up for a median of 6 years after discontinuation of anticoagulant treatment. End points were recurrent CSVT or other clinical manifestations of venous thromboembolism. CSVT recurred in 5 patients (3%) and other manifestations of venous thromboembolism (deep vein thrombosis of the lower limbs or pulmonary embolism) were seen in 10 additional patients (7%), for a recurrence rate of 2.03 per 100 person-years (95% confidence interval, 1.16 to 3.14) for all manifestations of venous thromboembolism and 0.53 per 100 person-years (95% confidence interval, 0.16 to 1.10) for CSVT. Nearly half of the recurrences occurred within the first year after discontinuation of anticoagulant therapy. Risk factors for recurrent venous thrombosis were male sex (adjusted hazard ratio, 9.66; 95% confidence interval, 2.86 to 32.7) and, for thromboses other than CSVT, severe thrombophilia resulting from antithrombin, protein C, protein S deficiency, anti-phospholipid antibodies, or combined abnormalities (adjusted hazard ratio, 4.71; 95% confidence interval, 1.34 to 16.5). Conclusions: The risk of recurrent CSVT is low and is higher in the first year after discontinuation of anticoagulant treatment and among men. Mild thrombophilia abnormalities are not associated with recurrent CSVT, but severe thrombophilia entails an increased risk of deep vein thrombosis of the lower limbs or pulmonary embolism. April 19, 2021 Follow up, no change in condition. Discussed case with Dr, will order Factor V Leiden, prothrombin gene mutation, anti phospholipid and anti cardiolipin antibodies, if she will allow draw. Expect Heparin Induced Thrombosis testing result tomorrow, but with no thrombocytopenia after given heparin, expect will be normal. Will await result. If discharged, would recommend 3 months direct thrombin inhibitor (Eliquis/Xarelto/Pradaxa) at full anticoagulation dose. Then stop, no taper. Overall still feel "provoked" thrombosis due to December Covid, unrelated to J&J Covid vaccine, but can not definitively prove that..

Within one week of the vaccine I felt like I had pressure on my chest and chest pain and I was having a problem breathing. I had a cough and I had shortness of breath. I was really tired. I had that feeling of tiredness for one week. The shortness of breath and tiredness lasted two weeks. I used my inhaler when I needed it and after three weeks it feels better and I no longer have any symptoms.

HEAVY CHEST; ANXIOUS; STRESSED; CHILLS; HEADACHE; MUSCLE PAIN; TIRED; This spontaneous report received from a patient concerned a 27 year old female. 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,and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced stressed. On 13-APR-2021, the subject experienced heavy chest. On 13-APR-2021, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stressed on 13-APR-2021, chills, and muscle pain on 09-APR-2021, and headache on 11-APR-2021, and had not recovered from tired, heavy chest, and anxious. This report was non-serious.

ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia secondary to menstruation. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per and is therefore considered potentially related.

Client received Jansen Covid 19 vaccine and on her way out she was seen passing out on the floor, she was caught and lowered to the ground. Client did not lose consciousness and reports feeling nauseous, she states that she usually passes out when her blood is drawn. Her lying BP was 106/68 p54, sitting BP is 116/81 p 74, standing BP 116/76. She started to vomit and 911 was called. Medic 203 responded and arrived at 12:30, IV line was stablished and client was transported to the hospital.

while walking to the waiting area she was feeling sick and she lay down on the floor before passed out. Never pass out. BP and pulse were stable. Able to sit on a chair and observed for 10 minutes client voices feeling fine and sign the observation release form and went home in accompany of her mother.

Patient presented on 4/17 to urgent care afer significant vaginal bleeding (soaking through a pad every 1 hour to 1.5 hours) and petechia on multiple extremeties. She also had a nose bleed and bleeding in mouth earlier in the day that resolved spontaneously. After obtaining CBC, platelets were <1000. She was on oral contraceptives. She is a non smoker. She received work up for thrombosis, not indication of thrombosis. She did have some muscle aches and fever and fatigue the day after vaccine. Histroy notable for mild diffuse petechiae on all 4 extremeties. As inpatient received solumedrol 125 mg (then switched to prednisone 80 mg daily), IVIG 1 g/kg x 2 doses. she was discharged on 4/19 d/t rising platelets, Vaginal bleeding slowing and Petechia much fainter.

Initial severe headache after vaccine- this resolved in 24-48 hours. Had some LEFT flank pain for a few days. This resolved on its own. Then awoke on 4-17-2021 with LEFT calf pain that was constant and persistent. Called triage on Monday 4-19-2021 for guidance- came to Urgent Care. D dimer done and was positive. Was then sent to ER for imaging with + Doppler U/S LLE DVT- started on Eliquis.

Two events of chest pain and discomfort. One event on April 5th that lasted that full day and another event on April 13th that lasted until about April 21st. I had a CT Scan, EKG, and X-ray and nothing was identified. I began taking aspirin daily beginning on the 14th until the 21st. I am currently not experiencing any chest pain or discomfort.

TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST VACCINE PULLING, ON LEFT AND RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Medium

45 minutes after receiving Janssen vaccine, pt became SOB & complaining of tight chest. BP 120/80 Pulse 110 Pt was transported to Hospital & parents notified.

Patient experienced hives/rash within first half-hour of receiving the vaccine. She took Benadryl and rash subsided. Pt woke up the next day (4/4/21) feeling ill with heart racing, hypertension, and headache. She was scheduled to have an infusion appointment 4/5/21, which was canceled when she was found to have elevated liver enzymes and very high blood pressure. Patient went to ED on 4/6/21 for high blood pressure, lightheadedness, and headache.

APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. 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 suffered a minor nosebleed this morning. I am prone to these but nonetheless fearful as to how big a deal I should make this. Otherwise been okay.

Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.

Received my covid shot Wednesday, March 31st. Experienced a headache afterwards which was tolerable but lasted all day. Had a headache the next day as well, all day. Since receiving the vaccine, I have been experiencing headaches from what appear to be daily, I had experienced headaches before but not this often. It tends to be throbing pain on the right side of my head only.

Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III, and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).

Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.

On March 22 2021, I had leg cramps that felt like Charlie horses, I had a fever of 102 and I missed work. On March 24 I went to my doctor because my legs were still bothering me. That same night I ended up experiencing extreme dizzy spells, I fainted. On March 25 called my doctor I told them my symptoms were getting worse, the office made me a follow up appointment for April 2 for dizzy spells and fatigue. My symptoms continued to get worse, I had a tele visit April 5. Then, I started developing a dry cough. I called again that same day 4/5 for shortness of breath and went in to my doctors office 1:10pm. They did a chest xray. April 6th I had another tele appointment for anxiety Because I started developing anxiety from all my symptoms. April 7th I called again I had blood in my urine and back pain, It was very alarming because my last period was & years ago. April 7th I went to an Urgent Care . April 8th it got really bad. I went emergency room, I felt like I had a lump in my throat and experiencing some chest tightness, my pulse was 101 beats per minute, heart 118, BP was 143/106 I presented with unspecified Right Bundle Branch block and I ended up tachycardia, they did a CT scan of my chest. the doctor gave me Valium & Hydroxyzine. At the hospital I started dry heaving and vomiting. April 9th saw a new doctor still very nauseated and I was experienced nausea and heart palpitations, and rapid heart.

I had the usual side effects, sore arm, fatigue? then 2 days after the vaccine I had a panic attack, then continued to have them along the week. I believe that on the 17th I was taken to the ER with high heart rate, chest pain, tremors? but doctors ran test and believed to be another panic attack, they referred me to a doctor. The past month ive been struggling with extreme anxiety and panic attacks, ive been on escitalopram, weekly therapy. I had no prior history with mental illness.

On 04-02-2021, woke up feeling dizzy and out of it also has loss of consciousness. I went to the movies with my sister and had a seizure some time while at the movies. I went to the hospital and at the hospital I had a second convulsion seizure at the hospital which lasted 10 minutes and something that I had low blood count. They kept me at the hospital for 2-3 days. I also had migraines and taking anti convulsion medication. They performed MRI, EEG's, CT scans and all my exams came back within normal limits. I am not epileptic. I believe I am now stable and taking my medicine as prescribed, I am still out of work and I have not had a seizure since being at the hospital.

4/3/21 - Noticed Skin eruptions on arms and legs 4/11/21 Skin eruptions were getting worse 4/19/21 - began heavy vaginal bleeding 4/20/21 - began feeling dizzy, light headed, hard to breath 4/22/21 - admitted into hospital with Cellulitis, Sepsis, Sever Anemia - discharged 8 days later Red blood count was 5

CHEST PAIN; GENERALISED ACHING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 132 pounds, and height was 177 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse. The patient was not on any medication at the time of event. The patient had no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy. The patient was not breastfeeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included calcium for maintain normal calcium levels. On 10-APR-2021, the subject experienced chest pain. On 10-APR-2021, the subject experienced generalised aching. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, generalised aching, fever, and headache on 12-APR-2021. 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

SYNCOPE; CUT ON LIP FROM THE FALL; FELL; This spontaneous report received from a pharmacist concerned a 27-year-old female. The patient's height, and weight were not reported. The patient's past medical history included syncope (when she had blood draw), and concurrent conditions included fear of syringes. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination into Right Deltoid. No concomitant medications were reported. On 19-MAY-2021 HCP (Health Care Practitioner) reported that the patient experienced syncope after receiving the vaccine. Patient fell face down for about 5 seconds from a sitting position seconds after receiving the shot. HCP called 911. The patient experienced cut on lip from the fall. Emergency medical services mentioned it was syncope and patient did not need to go to the hospital as patient seemed to have fully recovered. HCP reported the patient mentioned this had happened to her before when she had a blood draw. She had a fear of syringes. Emergency medical services advised patient to lie down for blood draws and shots in the future. HCP did not administer any other medications to the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 19-MAY-2021, and the outcome of fell and cut on lip from the fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210540040-COVID-19 VACCINE AD26.COV2.S- Syncpoe. 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

CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache 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.

Patient fainted after sitting down in observation. Disoriented and scared once alert. Complained of nausea and headache. EMS called. Patient alert and agreed to go to hospital. Vitals @ 12:11p: 110/80 BP, 84 Pulse, 98% O2.

Patient presents with tingling to right sided face and right arm, Johnson and Johnson covid vaccine recieved 7/9/2021. no other neuro deficits. equal bilateral hand grips, equal facial symmetry, negative arm drift. Patient is also complaining of chest pain. Patient states that 4 days ago they received a Johnson & Johnson vaccination at clinic, and since then they have been experiencing the symptoms. He states that he called the clinic advice nurse and he was advised to come to the ED for evaluation. He denies any nausea, vomiting, fever, or diarrhea. On exam, patient moves bilateral upper and bilateral lower extremities with 5 out of 5 strength. Her neurologic exam is unremarkable. Laboratory studies are within normal limits, platelets are 323.

Janssen COVID-19 Vaccine EUA: patient in clinic to establish care. COVID-19 infection in January 2020. Reports one week after immunization experienced increased heart rate and shortness of breath while on vacation out of state. Patient went to emergency department (ED) and diagnosed with heart arrhythmia. Patient left hospital before heart echo could be performed. Continues to have some shortness of breath at times but no palpitations.

At 1035 patient complained of feeling light headed and weak immediately following the injection of the vaccine. Lead RN and EMTs made contact with client who stated she felt very weak, dizzy and light headed. Client began to slide out of her chair while fully conscious. EMTs helped client sit up in chair and a first set of vitals were taken while seated at 1035: BP 110/58, HR: 66, RR: 12 skins cool, dry and pale for ethnicity. Client was A&Ox4. Client stated she had the same feeling when having blood drawn. Client was assisted to a wheelchair and to the zero gravity chair without incidence. Client stated she was feeling "incredibly nervous" about getting the shot and explained she was scared to get "myocarditis". Lead RN provided education on the different vaccines and potential side effects and client stated that made her feel better. Client denied any pertinent medical history, denied allergies to any medications/foods/environment. Client stated she had depression and she takes a weekly anti-depressant which she couldn't remember the name of, last dose was Saturday August 17th. Client denied any other medication use. Client stated last oral intake was a pastry just before arrival to the vaccination site. Client was given a bottle of water which she sipped and a granola bar which she ate slowly. At 1040 a second set of vitals taken while seated: BP 100/56, HR: 58, RR 12, skins warm, dry and normal for ethnicity. . Client instructed to rest and relax in the chair for an additional 30 minutes for monitoring. Client stated symptoms of dizziness, weakness and lightheadedness resolved. At 1055 RN took another BP reading: BP 98/60. At 1110 client stood up and walked around the observation area stating she felt much better. At 1125 a third set of vitals taken while seated: BP 98/60, HR: 66, RR 12. At 1128 EMT took another BP reading with the automatic BP reader while client was seated: BP 96/61, HR: 68. Client stated dizziness, weakness and lightheaded feeling had resolved. At 1145 a final set of vitals taken while seated with automatic cuff: BP 101/67, HR: 68 RR 12. Lead RN educated client on ER precautions. Client stated she felt much better and left the observation site on her own accord with a normal gait.

I took the vaccine around 8:15 am at Hospital. They had a special event for Employees. After I was home I felt extremely tired and that improved after i laid down for a bit. However, around 7 PM I became very cold and had a temperature of 100.3 with chills/shakes. It has lasted into the next day with chills being on and off. I experienced muscle cramps as well has some chest discomfort.

Sore at injection site. 5 hours after injection, i had an Increased heart rate, 101 fever, convulsing from the chills, body aches, poor sleep. splitting headache, fatigue, and fever continued to next day. Most symptoms were gone by 48 hours after injection, except soreness around arm. Took ibuprofen to help with symptoms.

patient stated she was fine after vaccine, then after a few minutes she stated she felt dizzy. before pharmacist could get back around counter to patient, she fainted and slid out of her chair. patient was alert moments after landing on the floor. patient was laid out on floor and vitals monitored. once vitals returned to normal and patient felt better, she was given water and a banana. EMT arrived and evaluated patient. patient was taken to hospital per EMT suggestion. time frame: 17:26-17:52

Loss of consciousness, irregular heart palpitations, nausea. Loss of consciousness lasted less than one minute, recovery took about twenty minutes to become stable to leave the facility; lingering ?wooziness? throughout the day. This reaction was more likely due to vasovagal syncope than the vaccine. Patient has a history of vasovagal syncope. Arm soreness, fatigue, and headache presented the following day.

Patient fainted about 2 minutes after receiving vaccine. She experience nausea, dizziness , and a moment of confusion. Patient stated at pharmacy for 1 hour after episode. She was given water and crackers but refused other medical attention. Patient denied shortness of breath: difficulty breathing. Checked patients blood pressure. It was 144/74. Patient left pharmacy after 1 hour. She called when she make it home. She said she was still a little dizzy and nauseous. She had vomited. I asked patient if she was alone or if someone was there with her. She stated her sister is a nurse and was with her. Will follow up with patient on 3/10/21

Patient fainted 5 minutes after immunization. Patient hit head upon falling out of chair. Pt regained consciousness immediately. Ambulance was called due to hitting head. Patient refused treatment by ambulance. Patient felt passing out was due to low blood sugar. She drank 7-up and was helped cleaning up blood and given band aid.

Fatigue, 12+ hours after vaccination Tachycardia, heart rate 130-140 resting,, onset 12+ hours after vaccination Nausea, onset 1 hour after vaccination Headache, onset 1 hour after vaccination

Severe headache, body aches, chills, difficulty breathing, severe muscle aches, heart rate 140, extremely high blood pressure 158/91, dizzy, weakness, fever 103.7, swelling of throat, etc

Within a few minutes after Jannsen vaccination, in the observation area, patient called attention to staff. A few nurses arrived immediately including this RN. She became dizzy, nauseated. Emesis bag but no vomiting occurred. Vital Signs taken with Systolic BP in the 60's, mild bradycardia, significant clamminess. Patient endorses usally HR higher than this. Patient then developed a period of absence x 2, similar to absent seizure. Patient was laid on a stretcher with slow improvement in S-BP to 111 and clamminess. Given the significant hypotension and suspected absence seizures, staff had already call 911. Patient reported only having some popcorn and coffee all day with no meaningful intake of food or fluids once patient became more alert. This RN provided 2 bags of chips with salt and 2-16 oz. bottles of water. This RN encouraged intake. Fire, EMS, and Police arrived. Patient refused transport to hospital. Patient agreed to wait until significant other arrived to drive patient home. Patient stayed for about an hour extra to eat and drink with moderate effect. Patient stood up and felt moderately dizzy but patient was able to ambulate to her significant other's vehicle. The team encourage patient to contact and see PCP regarding the absent seizure and encourage rest with hydration and intake at home. Incident report was filed with facility.

AMI onsite Paramedics were approached by a 28 y/o female stating she was about to ?pass? out as she was kneeling approx. 10 mins after receiving the vaccination which was administered at 16:54. Pt was caught prior to losing consciousness for approx. 30 seconds post vaccination and presenting with sz like activity consisting of decorticate posturing and pupils dilated @6mm. Pt was carried onto available cot via two man carry where pt regained consciousness, coax4 of 4 GCS 15. Pt stated she felt lethargic and was diaphoretic and feeling nauseated, no emesis. Pt was placed left lateral and was placed on oxygen via N/C @2lpm while EMS responded. Pt denies allergies but states being hypersensitive to Augmentin, no meds taken, no prior medical hx but states she?s had similar episodes since the age of 17 being reported as sz like but never diagnosed and denies having a neurologist. Pt also stated that this was the worst episode. While awaiting EMS, pts nausea and diaphoresis had subsided but stated feeling ?heavy?. HEENT-unremarkable, Pupils now equal and reactive, neck-supple ,equal chest rise with clear equal lung sounds ,abd non tender, FROM to extremities x4 with equal weak strength. Upon EMS arrival, report was provided, EOR.

Difficulty in breathing, shortness of breath, shivering, fast heartbeat, coughing, headache, blocked nose.

At about 10:00 p.m. on March 10 patient lost her balance and fell, bumping her head in the process. Residential care staff called emergency services. EMTs detected somewhat elevated heart rate (140+ BPM) and temperature (approximately 102 degrees) and recommended she go to the ER. She was attended to and tests were administered to detect any underlying infections. Tests were all negative. Patient was kept overnight for observation. By Thursday, March 11, her heart rate and temperature were normal and she was discharged just after mid-day. She has had no lingering effects post-hospitalization.

Pt was being obs starting 5:25pm, post J7J vax. After 15 min obs, at 5:40pm, she fell out of her chair and onto floor. Pt's eyes were closed, not responsive, not breathing, and stiff. Immediately 911 initiated, VS initiated, Pt was turned to Right side-lying position. Stimuli initiated (sternal rub, verbal communication). Pt opened eyes after 10 secs and started breathing. at 5:41pm/ Pt was able to answer all questions Alert & Oriented x4. Pt supine, ice packs applied to neck and chest. 5:42pm: 1st VS = BP 110/60, HR 58, RR 18, O2SAT 98%. 5:44pm: Pt vomited into trashcan, yellow emesis. Pt said that last time she ate was 3:30pm. 5:47pm: 2nd set VS = BP 115/60, HR 75, RR 18,, O2SAT 99% 5:50pm: Pt sitting upright position on floor. Pt said she "feels warm" 5:53pm: Fire dept arrived 5:55pm: EMS arrived. 3rd Set VS = BP 118/60, HR 88, RR 18, O2SAT 99%. Pt discloased that she has "fainted once when I was little at a concert". 5:58p: Pt left ambulatory with EMS & her friend.

Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue.

Patient came to the ED with dizziness and tachycardia and was treated with adenosine 6 mg IVP and metoprolol 5 mg IVP x 3 doses and was sent home.

Patient is a 28 y.o. year old G1P0 at 38w6d who presented for fevers, chills and decreased fetal movement. She received her first COVID vaccine 8 hours prior. No cough. She felt well before the shot. No bleeding or leaking fluid. Her COVID test was negative. She was tachycardic to the 140's and the baby was tachycardiac to the 180's starting at presentation. She was treated with oral tylenol and IV fluids. After about 90 minutes of monitoring a prolonged fetal heart rate deceleration was noted to the 60's for 6 minutes. This recovered with repositioning. After another hour a reactive tracing was noted with a normal heartrate for baby. In induction of labor was started.

Patient reported having a brief wave of nausea after waiting 10 minutes in observation. When she got up to leave when her observation period was over, she reported tinging in her lips. 13:18 138/80, pulse 70, resp 20...tingling in lips 13:50 Pulse 72, Resp 12. Feeling better. Drank some water. Lip tingling present but faint. Reports she has to "focus to know it is there". Pulse reg, lungs clear, mentation clear, no stridor, no rash, no lip or tongue swelling. Call placed/Voice message left for follow up on 3/26. No return call received.

4/02/21-body aches dizzyness, nausea 4/03/21-body aches, nausea, dizzyness, fever, chills, chest pain 4/04/21- dizzyness, nausea,worsening chest pain

vaccine was administered around 1115am patient was fine before and during vaccine. known history of fainting. after vaccine was administered patient was seated on chair for post vaccine observation and fainted. so signs or symptoms patient was going to faint. patient was alert and oriented within seconds. no signs or symptoms of any injury or severe reaction.

Approximately 12 hours after receiving the vaccine, I was running a fever of 101.7 F, with associated chills, muscle aches, and a pounding headache. Most notably, I was experiencing tachycardia with a resting heartrate of between 109-127 bpm which was sustained for at least two hours. My normal resting heartrate is between 60-70 bpm.

Patient felt dizzy right after vaccine administration and fainted and collapsed into vaccinating pharmacists arms. Patient immediately regained consciousness but still hot, dizzy, sweaty. 911 called immediately and paramedics arrived to assess vitals in the ambulance, patient walked out of the store to the ambulance with assistance.

Client received Janssen COVID vaccine @ 2:11pm, reported not feeling well @ 2:23pm. Stated, "I can't get enough oxygen". Client placed in zero gravity chair, was noted to be shaky and diaphoretic. Oxygen saturation 100% on room air, pulse 47, BP 122/68. At 2:28pm, client states she's not dizzy anymore, able to drink water, vital signs stable. Client also reports she has fainted before with other vaccines and blood draws. 2:37 pm, client states she feels better. 2:56pm, client able to stand and leave observation area with steady gait and fiancé present.

Pt stated she has severe needle phobia. Syncopal event after shot, BP 160/110, 5 minutes. later, BP 122/74. P70. R22 then R 18 Monitored by EMTs 10:45 am. Feeling better 10:56 am. Home with husband

Chest pain, difficulty breathing within 3 hours of shot Body aches, chills within 6 hours of shot Tylenol and advil

Chest Pain, shortness of breath, fever, chills (9:00pm-3:00am) chills, body aches (April 4th-April 5th)

After receiving the shot, I was required to sit down for 15 minutes. About 5 minutes in, I started to become dizzy, my vision started blacking out, my hearing was muffled, I became clammy, sweaty, and experienced mental disorientation. It became harder for me to breathe, but I never struggled to take a breath. I drank some water and waited for the symptoms to subside. I remained seated and these symptoms went away within 5 minutes. After feeling better for about 5 minutes, I felt cold and was shivering. The woman sitting next to me was completely fine after her shot. I've since felt a slight burning sensation on my skin in areas that I have scratched lightly. I'm also experiencing strange feelings throughout my body- specifically my head, leg, and hand. It feels like I can feel something in each area for a bit and then it subsides after several minutes.

2:00 am woke up with teeth chattering, cold chills, body aches continued to wake up through the night almost hourly in extreme body pain 6:00 am woke up in severe pain, stomach cramping, lower back pain, nauseous, attempted to get myself water and had to sit down in the kitchen in fear of passing out, barely made it back to bedroom before almost passing out again and immediately broke out in a profuse sweat. Body pain and aches continue for rest of day and into the next.

Racing heart, mild fever, body aches - 12-24 hours after shot Nausea - 12-36 hours after shot Hives outbreak - 36 hours after shot

Patient had an episode of vasovagal syncope about 2 minutes after vaccine administration followed by about 10 seconds of seizure.

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

FAINTING REACTION SYNCOPE - PATEINT REPORTS OF PREVIOUS HISTORY OF FAINTING REACTION TO NEEDLE PRICKS IN THE PAST. PATIENT WAS STABLE ABD MONITORED FOR MORE THAN 30 MINUTS

Syncopal episode, flushed, sweating. Denies medical history, allergies or meds. 1630: BP 117/89, Pulse 82, O2 Sat 99% 1645: BP 129/93, Pulse 88, O2 Sat 99%

About 14 hrs after injection, I got really bad chills for a couple of hours, then got very hot and had a 3 timepoints of chest pains (I assume I had a fever at this time but didn?t verify). By 7am when I got out of bed, it felt like a truck hit me. I had a major headache, very fatigue, fever (checked at this point and it was 101), nausea, hotness/chills. By 12pm, I had an 100 degree fever, chills/hotness, and headache. By 6pm, I was only tired. Next day, I was back to normal with a little soreness in my injection arm.

HPI: PT 28 y/o F feeling light headed after J&J vaccination. PT with her mother, became light-headed and dizzy while walking from vaccination site back to vehicle for 15 minute wait. PT became unresponsive with mother and fainted. Parking staff alerted rapid response team, PT regained responsiveness and was given chair to sit on, water to drink. Rapid response team arrived to a responsive, A&Ox4, pale female who was still feeling weak and light-headed. PT was transferred to a cot (in the shade) where she was placed in supine position with legs elevated on a chair. Pt was given water and hard candy to suck on while vitals were taken,, Airway, breathing and circulation were all WNL. PT states she presently has a strep infection (throat area) and has been afebrile, and is to begin oral antibiotics once she picks RX up from pharmacy. PT began feeling significantly better over 10-15 minutes of laying down in the shade. EMS LAFD was called and transfer of care to EMS Station 93 for further work-up was instituted. PT felt much better and was able to stand and ambulate from cot to EMS vehicle without issue. PT chose to go home with her mother instead of being transported by EMS to medical facility. Exam (update as needed): GEN: Alert and oriented x 4, relaxed in appearance. HEAD: WNL EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema, no cyanosis NECK: Supple, without LAD. CV: RRR, no m/r/g

VOMITING; FEVER; ARM SORENESS AT INJECTION SITE; FAST HEART BEAT; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included patient had series of rabies vaccines last year., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fast heart beat. On 05-APR-2021, the subject experienced arm soreness at injection site. On 05-APR-2021 21:00, the subject experienced fever. On 06-APR-2021 02:00, the subject experienced vomiting. On 06-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, arm soreness at injection site, and fast heart beat. This report was non-serious.

C/O tongue and throat swelling, chest pain 15 minutes after injection; tachy, BP 132/84; Hx of anaphylactic reaction to bee stings. Carries own epi. Epi and Benadryl given at 30 minutes after injection. 911 called when pt. reported no change in s/s. Was seen in ER and tx with solumedrol.

Patient recived Janssen COVID 19 vaccine. After receiving the shot, patient went stiff and fainted with rolling of the eyes. Team member was able to help patient to ground. EMS service was called. EMS checked BP and blood glucose which was in normal range and recommended to have caregiver come pick patient up and rest. Patients fiancé came and took home. Team member escorted patient out

Chest Pains 24 hours after vaccine. Lasted two days. No Treatment. Went away on its own. Sharp Stomach Cramps 48 hours after vaccine- 04/09-No Treatment. Ended 04/13. Irregular Menstrual Cycle. Period not due for 3 weeks and started in middle of birth control packet (Lo Loestrin Fe (doesn't usually have a normal flow of blood on birth control)- 04/11 coupled with fatigue and headache. It is 04/13 and am currently still bleeding.

Within 3 minutes of getting the Janssen shot I started feeling really sick, lost my vision and all feeling in my hands. I sweated through all of the clothes and soaked the chair I was sitting in. That night around 7 pm I got a migraine and felt really fatigued I couldn't stay awake and I was really sore. My chest hurt and so did my head. I was nauseated to no end The next day was worse. All day I couldn't stay awake. I felt so sore and sick to my stomach and I coint move too much because I was super dizzy. The next day I was still sick and dizzy By day four I felt fine just dizzy.

After the vaccination was given the patient started to wait her 15 minutes. After 5 minutes of waiting the patient slumped over and passed out onto the floor. Her color was very pale and her eyes were rolling in the back of her head. She regained consciousness but her color was still poor and we called and ambulance because she was still feeling faint. The EMT's immediately took her blood pressure and it was extremely low. She acknowledged that she did not eat or drink anything at all that morning. The EMT's recommended she go to the hospital but she refused. After 30 minutes with emergency personnel she felt better and well enough to leave with her family member who was with her.

SEVERE shaking all over, difficulty breathing, racing heart, headache, dizziness, muscle pain, and muscle weakness. I just tried to wait it out. The shaking (extremely bad, could not control my own muscles at all and I had to lay on my arms so they wouldn't flail out) and racing heart lasted about five hours. The headache and all over muscle pain finally eased up last night. Breathing aches and I am still experiencing muscle weakness.

Extremely high fever, light-headed, fainting, muscle aches, chills, nausea. Symptoms began at about 4 pm. By 8 pm, they were unbearable and fainting began. Fever broke at 11:30 pm after laying under cold towels and taking aspirin at 8 pm. Headache and fatigue lasted until noon Saturday (April 10)

The week prior to delivery (3/22), I started feeling shortness of breath and a headache. I thought it was just normal pregnancy symptoms. That Friday (3/26), I noticed swelling in my ankles. I am a teacher so I asked my school nurse to check my blood pressure; it was high (for me) around 144/88. She said I should call my OB and let them know. I did, and they said to rest for the weekend and they'd see me on Tuesday for my 29 week appointment. We had a weekend trip planned. We took our son there. The next night, I didn't feel right. My belly felt hard to me and I wasn't feeling my daughter move as much, but soon after, I went to sleep. Our two year old son woke us up crying around midnight, and I noticed that I started bleeding when I went to the bathroom. My husband drove me straight to the emergency room. I was diagnosed with sudden and severe preeclampsia. My fibrinogen levels were 100% indicative of a placental abruption. They called the transport team in from hospital so they could transfer my daughter immediately after birth. At 5:57 am on 3/28, my daughter was born via emergency c-section. She is currently fighting everyday at the NICU in the hospital. On Friday, 4/2 I was readmitted for severe preeclampsia to hospital. My blood pressure was 190/115. I had to receive another round of magnesium sulfate. I was released from the hospital on Sunday, 4/4.

Presented to urgent care with chest pressure, abdominal pain, and low back pain beginning last evening

I was fine for the most part after the vaccine. The only thing that hurt was my arm at the injection site. I started feeling nauseous about an hour later. Then at about 9:00 pm, I started to feel really sick. I felt very tired and my whole body hurt. I had a low body temperature, 95 degrees. Chills, fever, shaking, nausea. Very SEVERE symptoms. Felt very disoriented. I thought I was going to pass out and faint. Vision blurry and seen white. Pounding headache. Ears ringing. I could hardly walk that night, I was crawling on the floor. I felt out of breath. My heart was beating very fast. My left side of my chest hurt by my ribs. When I did wake up from sleep, I woke up with blood in my mouth and dried blood on my lips.

The day I received the shot, I started to feel severe fatigue, headache, light-headed, and started running a fever about 6 hours after the shot was administered. The next day (4/6) was worse. Severe fatigue, muscle aches, headache, loss of appetite, fever (101.5 was the highest I notice but seemed to be around 101.1-101.3 all day), and general flu like symptoms. However, I also started experiencing abnormal menstrual bleeding. I am on the Depo shot and have been for some time. Due to this, I do not usually experience any menstrual bleeding so I found this to be a little odd. It was not heavy but it was noticeable and contained quite a few clots. Day 3 (4/7) was about the same except my fever came down and ranged from 99.8-101.1. Abnormal menstrual bleeding continued. New side effect this day included diarrhea. Day 4 (4/8) I started to see improvement. No fever (that I could tell). Remaining side effects included mild headache, fatigue, diarrhea, and abnormal menstrual bleeding. Day 5 (4/9), I had one of the worst nose bleeds I've ever had in my life. I apologize for the graphic description but it lasted about 20 minutes and my bathroom looked like a crime scene after. Blood was pouring out of my left nostril and I threw two large clots that were about the size of slug (or slightly larger than a fun size snickers... I wish I had a better way to describe it). I've had some bad nose bleeds, particularly when I was on Accutane, and this was worse! The rest of the day I felt like I was improving. Energy levels were better. No fever. Menstrual bleeding stopped. Only lingering side effect was mild headache and mild diarrhea. Since then I've continued to feel better and the diarrhea seems like it's improving. Mild headache persists. Only new item is an annoying twitch in my left eye that started on Monday (4/12).

Janssen COVID-19 Vaccine EUA So after the shot I felt tired is but nothing big, then I went to bed around 9 p.m and I started getting chills, and I was freezing cold even under two blankets. I was wearing a fitbit and then noticed my heart Rate went up to the 90s and fluctuated between 90-110 bpm all night into the next morning. I woke up every 2 hours to a new symptom on top of what I was feeling already. It started with chills, then sweating, nausea and a headache. I had a fever of 99.5 at the highest. And then the last time I woke up at 5 my heart hurt so bad, my whole chest muscle hurt with a sharp pain and It hurt to breath. The next day I had a little headache and my body hurt, and I had cramping in my legs for a few days, but I also started my menstrual cycle on the 13th. The leg cramping continued for a few days but only when I sat on my legs for too long.

FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Got J&J vaccine on Friday at 3pm (April 9) and felt Body aches, Muscles hurt, Stomach hurt, Dizzy, Nauseous , Heart rate fast, Clammy Chills, Didnt sleep, Chest tightness, Upset stomach, Fever, Head hurt, Arm hurts and chest tightness feels in-line with where I got the shot, by Sunday (April 11) Flu like symptoms went away, but still have chest tightness uncomfortable and Feels like i have to cough When I take a deep breathe it it feels tight. Have diarrhea everyday since vaccine Still feel weak and dizzy Most of the flu like symptoms have gone away but chest tightness still concerning When I bend over or lay on my right side feels constricted and tight and uncomfortable. Bilirueben associated with liver is elevated and white blood cell count is low. On Wednesday, April 14th I started to get super congestion, runny nose and sneezing and Eyes a little red. Rashes and Hives that were red, blotchy and bumpy started Wednesday April 14 at 6pm and worse at 9pm. Continues to get worse and hurt throughout Wednesday and Thursday night. Developed all over body, legs felt hot. The hives and blotches would disappear and would then reappear at different areas of my body. Called Nurse Triage line and suggested I treat at home with Benadryl since hospitals had 6 hour wait and were full of COVID positive patients. Unable to sleep Wednesday and Thursday due to hives, very comfortable feeling. Diarrhea on Thursday morning , cough and felt shakey. Noticed on Thursday April 15th, some skin on right foot looked like it was pealing. Thursday night noticed some blotching and hives but not as bad as they were the night before. Friday April 16, No redness on legs at 1130am, but Lips feel dried out and Feel a little dehydrated . Bilirueben associated with liver is elevated still and will need to follow up with Doctore in two weeks. However, when laying on right side or bending down feels like something is stuck un chest and need to cough still, with chest tightness. Still had diarrhea until Saturday, April 17th. Chest is still tight and feels like something is stuck. Sunday, April 18th, went for short walk and felt uncomfortable breathing and not normal. This has not resolved still and does not feel breathing is normal.

28 y/o female with h/o obesity (120kg), anxiety and depression, received the J&J vaccine on 3/5/2021 (Lot 1805020). Home meds included only citalopram and an OCP which she had stopped on 3/10. On 3/15 she developed a predominantly R sided headache 9/10 pain, described as the worst of her life that didn't remit with over the counter analgesics and eventually became global in distribution, lasting 4 days. She was seen for this in urgent care on 3/19, given a shot of Toradol and then transferred to the emergency department where CBC showed platelets of 33, WBC 9.1 53% PMNs, 43% lymphs, Hgb 14.1, MCV 87, PT 15.7 INR 1.2. Chemistries were all normal. CT brain was unremarkable.

Started with chest pain, a couple of days after the shot. Fainted on 3/13/21, transported by EMS to emergency room. CT scan was done, Dr. said she has blood clots in her lungs. Was given a prescription for Eliquis 5 mg twice daily.

Janssen COVID-19 Vaccine EUA: Vaccine recipient experienced overheating and syncope. Vaccine recipient was monitored by EMS.

CHEST HEAVINESS; CHILLS; SORE ARM; FEVER OF 103F; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficulty breathing. Treatment medications included: paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fever of 103 F. Laboratory data included: Body temperature (NR: not provided) 103 F. On 11-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and fever of 103f on 08-APR-2021, had not recovered from chest heaviness, and the outcome of difficulty breathing was not reported. This report was non-serious.

I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding. They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.

PATIENT WAS PANICKINK BEFORE GETTING THE VACCINE.WAS VERY NERVOUS AND AFTER GOT THE SHOT HAD LITTLE SEIZURES AND FAINTED FOR FEW SECONDS.REGAINED CONSCIOUSNESS WITHIN FEW SECONDS.WAS TALKING AFTERWARDS.DID NOT WANT TO LIE DOWN SO MADE HER KEEP HER HEAD BETWEEN THE LEGS FOR PROPER BLOOD FLOW.DID COLD COMPRESS FOR SOME TIME.PATIENT STARTED FEELING BETTER AFTERWARDS.PARAMEDICS HAD ARRIVED BY THAT TIME AND TOOK HER VITALS HICH SEEMED GOOD PER PARAMEDICS.PATIENT SIGNDE A WAIVER AND PARAMEDICS LEFT AFTREWARDS. WE GAVE PATIENT GATORADE TO DRINK AND HAVE ONE OF THE PHARMACY ASSOCIATE BE BY PATIENTS SIDE .AFTER STAYING IN THE PHARMACY FOR ABOUT AND HOUR PATIENT LEFT ALONG WITH HeR HUSBAND

Fever over 105, chills, cough, soar throat. aches and pain for 2 days. Led patient to go to the ER on monday 4/12. MD found blood clot at that point. No treatment was given patient was told to follow up with her PCP. Did not go to PCP as yet.

4/5 vaccination. By 1pm, I felt fatigue, HA, light headed, feverish, loss of appetitive. 4/6 same symptoms but worsened; 101.5 fever. flu like symptoms. Abnormal menstrual period 4/7 fever was low. Diarrhea, upset stomach 4/8 low grade fever; 99. HA, fatigue, diarrhea. 4/9 really bad nose bleed with 2 really large clots. Continuing of flu like symptoms. 4/14 HA and flu like symptoms persisted till this date. 4/16 fever and HA stopped. 4/5-4/22 menstrual bleeding continued. *clots in nose bleeds and menstrual bleeding. Tele med on 4/14, 4/15 MRI. *still experiencing some intermittent spotting but not as much.

Patient had vasovagal episode followed by vomiting. Went to hospital s\p vaccination and help there overnight for observation. Released 3/28/2021- in AM

Hours after receiving the vaccine, I became dizzy, and nearly fainted several times. This was resolved once j was able to lay down and elevated my legs. I had no adverse effects in the first 15 minutes after the vaccine, the fainting spells were several hours after I was vaccinated.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient was unresponsive for 30 seconds and recovered quickly - orange juice was given.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt reported feeling faint 2 minutes after vaccination, pt became dizzy, lightheaded, and fainted. pt did not fall or injur themselves, technician observer and pharmacist were in view of the patient during the event. we layed the patient down on the floor and put her feet up and checked her blood pressure (100/70, low per pt hx). pt recovered after 3-4 minutes, but layed on the floor for an additional 15. pt then sat in a chair and fully recovered and sat for 15 minutes. no injuries reported

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness within one minute. Her blood pressure was 107/78 mmHg and heart rate was 62 bpm. She was fully recovered and left the pharmacy after 30 minutes. I follow-up with the patient on 05/08/2021. Patient said she was fine after she left the pharmacy and only had soreness at the right arm.

patient was anxious before getting vaccine. When she got her shot, she was panicking about the pain. .15-20 mins after vaccine administration patient complained of nausea. Patient looked pale and nervous .We had her lie down with her legs elevated and alerted Code White. Patient was responsive and talking .We did some cold compress around her neck and face. Patient started feeling better afterwards ,waited in the pharmacy for about 30 mins post episode.

immediately post-vaccination pt experienced flushing/warm sensation L side of arm/neck/face. Patient sat in chair x15min, given water. Pt states continued flushing with dizziness and inability to focus vision/blurry vision. Had patient continue to sit and observed additional 30 min. Pt reported no change in symptoms, moved pt back to vaccination room to reduce noise/traffic. Checked BP 144/100, pulse 77. Pt given more water and observed. No labored breathing or obvious distress noted. Pt reported tingling of tongue/throat. No signs of swelling of tongue/throat with examination but increased flushing of face/throat/ears. Pt offered benadryl, she disclosed anaphylaxis to benadryl and refused antihistamine. discussed concern of reaction and use of epipen/EMS services. Patient declined, asked for continued observation. observed x 15 min, no change in status. observed additional 15min, offered loratadine (pt states taken safely in past) pt declined. observed 15min, pt states continued tingling in mouth/throat with slight difficulty swallowing, no observed labored breathing, pt able to carry conversation without effort. Recommended epipen and EMS, pt refused. Pharmacist advised against driving and recommended seeking emergent care. Patient refused EMS and left with friend with request from pharmacist to go to ER. F/u with pt 2 hrs later, pt was at ER but no updated status. Phone call F/u with pt next day (5/13, 1pm). pt states given 1 medication (unknown) that reduced symptoms of tingling but HR/BP continued to fluctuate. ER discharged pt home evening of 5/12 and pt has f/u with primary care 5/14/21.

patient felt dizzy and pass out for few seconds , 2 minute after receiving the vaccination . Patient felt hot and then vomited .Patient said she felt better after vomited and drank water . No treatment was given .Patient stayed at pharmacy for 30 minute and deiced to go home.

The patient had a vasovagal reaction to the vaccine within minutes of receiving the vaccine. She was given smelling salts, water, juice, chocolate over a period of 30 minutes and observed while remaining seated. She stayed at the pharmacy for an additional 30 minutes and once she felt better, she left.

R facial edema and pruritus, headache, chest pressure, dizziness, cough. Treated with diphenhydramine 50mg IM in clinic, Benadryl at home.

Pt admitted to the ED with chest pain one day following the vaccination. Pt described this as subtle at first that increased to wake pt up in pain. Sharp pleuritic pain localized in the center of her chest and slightly in the epigastric region. No prior symptoms previously. Pt has been diagnosed with bilateral pleural effusion, acute pericardial effusion and acute pulmonary embolism.

Patient fainted and stated troubled breathing multiple times once regained consciousness. Epi Pen administered and symptoms resolved within 10 minutes. Patient did not need further medical attention.

Brain fog for a week long. Heart palpitations and sever Chest pain a week after vaccination. Seem to be getting better now but not totally gone yet

I had the normal arm soreness. I had rapid heart rate and it continued for about 24 hours. I had a fever of 103 and every part of my body was hurting. I had severe chest pains, severe migraines for abut a month and muscles aches for about 2 months.

Patient received Janssen COVID-19 vaccine. LOT 207A21A. Patient answered "no" to all screening questions. Received vaccine without incident and began waiting period. Roughly 10 minutes after vaccination, patient was found lying on the floor. Appeared pale and was not completely responsive. 911 was called. She tried to answer questions asked but was not able to coherently respond. Breathing was stable throughout. Roughly 5 minutes later she became more alert and was able to sit up. Gave water and sugar tablet. Paramedics arrived and patient was fully alert and responsive. Vitals checked out OK and she was cleared by the paramedics. No epinephrine was administered.

Fatigue, weakness, Acute kidney injury, shock liver, thrombocytopenia, pneumonia, syncope, wide complex tachycardia over last 2 weeks

Review of ED notes show she received IV infusion of normal saline, and IV push of benadryl and compazine after going to the ER for severe headache on 04/17/2021. She first noticed pain when streching the arm shortly after the IV infusion but didn't pay attention to it, then 5 day later she noticed localized swelling and redness. Patient was sent for US doppler which left cephalic vein thrombus detected on duplex US. Was treated with aspirin and had follow up doppler of UE for follow up on LUE cephalic vein thrombosis-negative 5/13/21.

Fever, chills, tingling in the lips, throat swelling, hives, high blood pressure, coughing, asthma attack. The lip tingling was within 30 minutes of my vaccine, and continued for 2 weeks. Throat swelling lasted the first week. Hives lasted 1 week 4 days. Coughing started on day 3 and lasted 3 days. Asthma attack happened one time, during the coughing phase. High blood pressure started the evening of the vaccine and has continued. Doctor has prescribed a low dose of blood pressure medication to help combat it. Fever and chills started on the first day and lasted through the second day.

Patient was experiencing paleness and trouble swallowing saliva shortly after administration of the vaccine. She was fine a couple minutes later.

Pt says " I feel dizzy." Vasovagal syncope . B/ p 62/45. Pt drank half bottle of water and placed in Trendelenburg position. After 2 minutes Blood Pressure 112/ 70 HR 89 left vaccination site accompanied with family member.

PATIENT WAS ASKED TO WAIT AT THE WAITING AREA FOR 15 MINS AFTER RECEIVING THE VACCINE. IN FEW MINUTES SHE SLOWLY WALKED UP TOWARDS MY WORKSTATION AND I QUICKLY RAN OUT AND GRABBED HER BECAUSE I COULD TELL SOMETHING WAS WRONG. A CUSTOMER STANDING BY GRABBED A CHAIR FOR HER AND WE HAD HER SIT DOWN. THEN SHE TOLD ME SHE GOT UP TO GET WATER AND SHE PASSED OUT. I TOLD HER ITS BETTER THAT SHE LAYS DOWN ON THE FLOOR TO PREVENT ANY FURTHER INJURIES AND I HELPED HER TO LAY DOWN. SHE WAS SWEATING AND SHE STATED THAT HAD TROUBLE WITH HER VISION AND HEARING. PARAMEDICS WERE IMMEDIATELY NOTIFIED. MEANWHILE SHE STATED SHE WAS ANXIOUS TO GET THE SHOT AND SHE DIDN'T HAVE BREAKFAST. SO WE GAVE HER WATER, ORANGE JUICE AND CRACKERS. BY THE TIME THE PARAMEDICS ARRIVED SHE STATED HER VISION AND HEARING IS BACK TO NORMAL. PATIENT ALSO WAS FEELING BETTER. PARAMEDICS CHECKED HER BLOOD PRESSURE AND ASKED IF SHE TAKES ANY MEDICATION AND SHE SAID SHE TAKES A ANXIETY MEDICATION AND I AM NOT SURE IF SHE TOOK ANY THAT MORNING. SHE WAS ASKED IF SHE WANTED TO GO THE HOSPITAL AND SHE SAID NO BECAUSE EVERYTHING WAS BACK TO NORMAL. PATIENT WALKED OUT OF THE PHARMACY FEELING BETTER.

On 7/2/2021, 28y.o. female patient presented to the pharmacy with her husband to receive their COVID-19 vaccines. Patient was checked in, screened and requested Janssen vaccine. RPh stepped outside to speak with patient about the potential side effect risks with Janssen due to her age group but told patient ultimate decision of which vaccine to receive was her choice. Patient stated she wanted to stick with Janssen and RPh then proceeded to review the questionnaire with patient that she had filled out online. Patient answered no to all questions including the question about ever having a reaction, fainting or feeling dizzy after a vaccine. She was counseled by the pharmacist of potential side effects and how to treat at home or seek medical attention , v-safe program reporting, vaccine card, waiting 15 mins in pharmacy area to be monitored, etc. Her vaccine was administered at approximately 10:12 by rx tech and a wait time of 10:27 given to pt. Work continued in the pharmacy and the patient and her husband were in the waiting area chairs in front of the pharmacy talking (per him, they were joking about side effects when she started to slump over and he thought she was playing around until she started falling backwards and he tried to catch her by her shirt). At approximately, 10:19, the pharmacist and techs heard a loud noise as patient experienced syncope falling backwards hitting the back of her head on the cement floor and the chair fell out from under her and crashing against the floor. Husband was by her side as RPh ran out to assist asking techs to close the pharmacy down for the medical emergency and to call 911 ASAP, call in around 10:19. Code white was called as well. Assessment following Adv Events protocol: Patient was breathing and awake with dazed/glazed eyes as pharmacist started trying to ask questions to assess her conscious level. After about 30-45 seconds pt came back around and answered name and DOB for pharmacist who was talking back and forth with 911 operator. Patient answered that she felt hot, dizzy and anxious to rph who immediately had cold compresses (cool, wet paper towels) for patient's face and neck. Patient also stated that she had not had anything to eat since 7/1 PM as they had planned to grab breakfast after their vaccines. Store managers arrived as well. Local firefighters from the station just down the street were in the store doing their daily meal shopping and heard the call come across to EMS so they came back to the pharmacy to help. They already had equipment in hand and recorded vitals while RPh was still attending to pt and 911 operator. at 10:24; bp:124/92, pulse 70, O2 sat: 98. Patient stated she felt well enough to try to sit up in the chair again and get off the hard floor and was assisted up by firemen and husband. One of the firemen and RPh assessed the back of the patient's head and no blood or knot was located, patient able to ambulate head and neck and no blood was found on the floor. Patient still able to answer questions, knew where she was, what she had done except in the moment of fainting and knew who her husband was. Patient refused to be transported to the hospital and EMS was cancelled by firemen to 911. Firemen left scene. Rph, rx tech and Assest Protection completed initial questioning for VAERS/SCRT, Incident and EOC contacted while patient and husband still present. Patient asked for some water and was provided her wishes. Rph continued to ask patient questions about how she was feeling as reports were being gathered. Patient stated she thought not eating and her anxiety got to her causing her to faint and still reported no previous issues with receiving vaccines. Also counseled on signs/symptoms of a concussion, soreness to be expected over the next few days and to seek help immediately if any conditions worsened. Patient was given RPh's card and told that she would be followed up with Friday PM at COB and Monday, but if anything changed between then to call RPh at the number on the business card. Upon finishing reporting and standing, patient stated back of right knee was hurting from tangle with chair upon fall; otherwise felt fine just a little tired and laughing. A wheelchair or electric cart was offered to patient upon leaving but she asked to walk out assisted by husband and was released. Reporting: Pt meds tri-sprintec and lexapro 20mg, no allergies, only medical condition is anxiety, no PCP

Patient was given 1 dose of the Jansen Covid Vaccine in the left deltoid by the administering intern. Within 30 seconds the patient became light headed, dizzy and upon standing up, then fainted. Intern notified the pharmacist on duty immediately. The RPh attempted to communicate with the patient of which she was unresponsive. RPh then informed technician to call 911. Patient was red in the face, arms and very hot upon touch. Patients eyes were open but was not lucid of responsive to questions. RPh then administered 1 dose of an Epi-pen. Patient immediately became responsive upon first Epi-Pen administration and was able to sit-up and communicate with pharmacy staff. Patient declined 911 services upon being informed of 911 being called. Patient was able to sit-up and talk stated that she was fine. Patient called her mother to come and get her from the pharmacy after resting for roughly 20min in the immunization room. Pharmacist on duty followed-up with patient about 4 hours later to check-in with how patient was doing. Patient stated she was a little jittery from the epi-pen but otherwise feeling fine. Due to the holiday, RPh told patient she would follow up with the patient and the patients primary care the following day (07/06/21), along with informing patient to also follow up with her Primary Care.

The expected adverse effects of fatigue and head pain began immediately, but that evening chest and left arm pain started. I thought it would end, but the chest pain and palpitations continued daily for the next 2 to 3 months. Afterwards, they would happen on occasion and still do to this date. In the first 2 to 3 months after receiving the vaccine, I would get so winded after walking from the train station or up stairs that I would have to stop. Many times throughout the day I had to stop what I was doing and not only rest but sleep. I was exhausted and felt overwhelming pressure around my heart and increased heart rate daily.

Prior to shot, pt expressed anxiety about getting shots. I used calming conversation during prep to calm her. She received shot in the left deltoid muscle. The patient continued to act anxious and cradled her head in her hands. I asked, "Are you ok?" My colleague offered water. Shortly thereafter, the pt leaned to the side and fell off her chair, unconscious. I was unable to catch her, and she fell and slumped against a partition. I was able to rush over and prevent her from slumping to the concrete floor. A colleague ran back to call 911. Pt had a pulse and was breathing. About 30 seconds later the pt became conscious. She did not want 911 to be called. She simply wanted to rest in the shot booth with her friend. We provided materials to lie down on. Pt walked out with her friend about 20 minutes later.

Abdominal pain began 7/29 and treatment for BV began 7/12. Thyroid panel on 7/9 showed high out of range T3 with TSH and T4 in healthy range. On 7/13 symptoms of heart palpitations, muscle weakness, vision distortion, and elevated blood pressure began suddenly during work. I have history of stroke caused by thyroid storms. Immediately took atenolol, a beta blocker, and called my endocrinologist to prescribe it for the next 30 days. Switched from armour thyroid back to levothyroxine. Atenolol has caused other side effects, heart palpitations are mild and not gone, menstrual cycle is highly irregular. Waiting 6 weeks from the change to levothyroxine for next thyroid panel, continuing atenolol until thyroid levels are in range.

PATIENT UPON RECEIVING VACCINE IMMEDIATELY PASSED OUT IN CHAIR; SHE SLID AND BUMPED HEAD SLIGHTLY AGAINST WALL. PATIENT WAS OUT FOR ABOUT 30 SECONDS. UPON COMING TO, PATIENT WAS FINE. EMTS WERE CALLED TO EVALUATE PATIENT AND PATIENT WAS DEEMED OK AND LEFT WITH HER MOTHER WHO WAS WITH HER AT THE TIME. SHE HAD NO OTHER COMPLAINTS AND MOTHER HAD STATED PRIOR THAT THIS HAD HAPPENED IN PAST WITH OTHER VACCINES. PATIENT IS OTHERWISE OK AT THIS TIME AND WENT HOME WITH HER MOTHER; SHE IS TO CONTACT US AND MD IF ANY OTHER CONCERNS ARISE.

Initial symptoms of chills and heart racing. Initial HR was 119 with slight dizziness. Reassurance, rest, granola bar. Return to normal HR, BP 02 sat normal, normal CV exam

Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was escorted to waiting area and sat in chair. Within 5 mins of sitting down, pt's head fell backwards and hit the wall behind her slightly, slipped out of the chair and fell on floor. Pt got up as soon as she was on the floor. The incident transpired in less than one minute and she regained consciousness. Pt was given water and said she felt \" the blood rushing back\" and felt \"much better\". Had pt stay around for > 30 minutes and was picked up by friend. Per pt, she was not hurt

Patient received the Janssen COVID 19 vaccine at approximately 3:10 pm. After her vaccination, she walked to the observation area and sat down in a chair. Within 5 minutes, she had a vasovagal response, lost consciousness, fell to the floor. Nurses in the observation area assessed her. She was responsive within a few seconds. Patient was transferred to a cot by nurses where she continued to be observed. She stated she remembered "everything going dark." Patient denied any pain, had no obvious injuries. It was unknown if patient hit her head so EMS was called to evaluate her. EMS arrived within 5 minutes of the call and assessed patient. She was medically cleared. Her husband picked her up and stated he would drive her home.

patient given vaccine and during the 15 minutes wait afterward, patient fainted and hit head on floor. Provider on sit attended to patient and advised patient to go to emergency room.

Vasovagal syncope a few minutes after vaccination. Fever of 101.8F 24h after vaccination (3/10/2021). Fever is continuing today (3/11/2021), but is lower at 100.4F. Tingling fingers on hand from vaccination arm (left), swelling from vaccination injection site, headache, and neck pain all developed on 3/10/2021. Headache and neck pain could be due to head trauma from vasovagal syncope. Tingling fingers were not observed on 3/11/2021. *I have had vasovagal syncope in the past, but never with vaccines. It always occurs when I see my own blood.

Felt faint/sweaty 15 minutes after the vaccine was given. Pale and moist appearing. BP 80/40 (pulse 66), O2 sat 99%. Given water and felt better after rest. BP 132/76 (pulse 74).

Per EMS on site client "Passed Out" Syncope for 30 seconds following vaccine. Previous history of syncope with "shots" Anxious with 02 Saturation of 98% pulse 65 Blood pressure 96/66 at 16.55pm. At 17.00 client stated she felt better with Blood pressure up to 101/71 and pulse 85.. Released by Dr after being reclined in her car seat and reporting she felt better. Advised to seek medical attention later if needed. Client verbalized understanding.

Around 8 hours after the shot I started to experience fatigue, body aches, uncontrollable body shakes, blueish lips and sweating (which to me indicated I had a fever). After taking some Advil my lips returned to normal and the body shakes stopped although it was hard to regulate my body temperature. I was sweating but felt cold. The worst of the symptoms seemed to last around 13 hours after they had started (so about 7pm on 3/25 to about 8am on 3/26). It's now been around 30 hours and I'm feeling better but still fatigued and have soreness in my left arm where I received the injection.

8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot and had speeding and heavy heartbeat while body temperature exceeded 100 degree fahrenheit. Dizziness and fever persisted for over 24 hours until taking Tylenol and a night of sleep.

The patient lost consciousness briefly post vaccination. She began to fall from a chair and was caught and was able to respond to prompts. She became nauseated as well. After laying down and had a cold compress at her neck she felt much better.

Nausea and vomiting within minutes of vaccination; lightheadedness and hypotensive (86/66; 93/70). H20, food and rest provided. Recovered within 30 minutes. States history of anxiety related to "needles".

Janssen COVID-19 Vaccine EUA 4/5 - (from time of waking up in the AM) persistent migraine, joint pain, heart palpatations, soreness at injection site, nausea, dizziness, persistent lethargy and lack of appetite 4/6 - persistent headache, joint pain, light-headedness, lack of appetite. Noticed a red welt at injection site (bright red, hot to the touch, swollen) 4/7 - red welt inflamed, still hot, sore, became incredibly itchy, whole arm uncomfortable and hurting. All other symptoms gone 4/8 - Inflammation of welt partially faded but red irritation spread out like it was dispersing. Later became darker red, still itching, began to hurt so much that even light fabric brushing across the skin caused pain. Still very warm to the touch. Doctor diagnosed the welt as Cellulitis and immediately issued an antibiotic.

After 8 hours: headache and fatigue (still experiencing after 24 hours) After 10 hours: Back pain, especially in lower back--unable to get comfortable or sleep (still experiencing after 24 hours) Nausea--couldn't lay on my back because it made me feel like I would throw up. Burping. Elevated heart rate--I felt like my heart was pounding out of my chest. My resting heart rate lying in bed was 90 bpm (I'm a runner and my resting heart rate is usually around 55 bpm). This lasted for 3-4 hours.

About ten hours after receiving the vaccine I started to get a fever, chills, and muscle pain. The fever got worse overnight and I woke up repeatedly with a higher than normal heart rate and a severe migraine that lasted throughout the next day. I took Tylenol (two doses, 12 hours apart) to some relief.

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Shortly after administration of the vaccine (~3 min) pt started shaking, sweating, looking flushed, feeling clammy, dizziness, lightheaded and briefly fainted. Pt was put on the floor and legs were elevated, given water and a snack and started feeling better. 911 was called and an evaluation was done.

Patient was sitting down and started to feel dizzy and her vision was starting to become blurry. She got up to let us know that she was having a reaction and fainted. She was awake immediately after she fell and said that she was experiencing the blurred vision still, extremely sweaty/hot flashes, and ringing in her ears. She drank some water and sat down for a little bit and started to feel better.

Syncopal episode, flushed, sweating. Denies medical history, allergies or meds 1630: BP 117/89, Pulse 82, O2 99% 1645: BP 129/93, Pulse 88

Patient suffered unconsciousness, then a brief seizure 10 minutes following her vaccination. Patient was moved to treatment area where paramedics discovered she was bradycardic, hypotensive, and in a junctional cardiac rhythm. Patient was treated with IV fluids, and monitoring and then transported to Hospital of her choosing.

Burning sensation in arm. Lightheaded. Dizzy. Nausea. Severe headache. Fever. Chills/Sweating. Elevated heart rate / Palpitations.

Body aches and chills (8 hours after) fever, nausea, chills, body aches, dizziness, and chest pain (12 hours after)

Pt complained of burning when vaccine injected. Within 2 minutes pt put her head down; stated she was dizzy and then her eyes rolled back and she started to slump over in her chair and then fainted. Moved pt to the floor. She was unconscious for only 1 minute. Vitals: BP: 110/62, Pulse 48, R: 12, T: 98.1, Pulse ox: 99%, Finger stick for blood sugar: 92. Pt had not eaten for almost 24 hours and has a fear of needles. Within 10 minutes vitals improved: BP: 125/90, P: 67, R: 18, Pulse ox: 99%. Pt is a smoker and had worked all night.

Headache (turned into a migraine), extremely drained of energy, lack of appetite, and felt off all day (4/9/21). The next morning (4/10/21) felt the same as the day before, however, had several episodes where I would get really light headed, dizzy, and nauseous. Went to Home Depot at 2:15pm (4/10) and while there my vision blurred and started to fade, I had ringing in my ears and couldn?t hear out of the right and barely was able to hear out of the left. I got very nauseous and I couldn?t breath. I managed to sit on something and put my head between my legs that helped. Fortunately my step- dad was with me and helped me outside while I could barely see and hear and he stated I was very pale. I was having a hard time talking or being conherent. Once outside the symptoms slowly cleared over about the next 6-7 hours. At 4:45pm my mom decided to take me to the doctor but the walk in had just closed and I went to the ER. They stated I had elevated d-dime and did a chest CT scan to check for blood clots around 7:30pm (I believe not sure exact time) doctor stated they came back clear but when asked if he suspected that the episode and symptoms were due to a dissipated blood clot he would not directly answer it. I overheard him dictating his notes and he started he beloved as such. I have never experienced anything like this before. I still felt drained, headache (migraine), occasionally dizzy, and lack of appetite (4/11/21, 4/12/21) and still currently feel the same drained, migraine, lack of appetite, and occasionally dizzy.

small blood clot when tried to donate blood 2.5 weeks after shot, preventing me from finishing donation

4 days after vaccination pt experienced severe abdominal pain the RLQ and diarrhea. Pt was sent from village to emergency room where i evaluated, exam with significant RLQ tenderness but no rebound or guarding, some LLQ tenderness as well. With exception of mild tachycardia and slight hypertension associated with pain, vitals were normal.

Came into ED on 4/14/21 reporting Vague chest pain x 2 days (starting 4/12/21) after receiving J&J vaccine x 3 days ago (4/10/21) at church. No available lot#. Pt monitored and discharged from ED as patient did not appear distress and HR & respiratory normal. Pt advised to monitor and seek medical attention is symptoms worsen.

Patient with complaints of persistent headache and insomnia the night of the vaccination. Patient developed bruising on her leg, shoulder and abdomen the next day. Patient presented to ER on day 4 post vaccination and is admitted at the hospital with ITP.

April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.

Nosebleeds x 3 days following vaccination, which have since resolved. No treatment needed. No other side effects reported.

Had a miscarriage (due date was 12/02/21) Have had high blood pressure which required er visit since getting vaccine

Patient presented to the emergency department with right-sided pleuritic chest pain-she has a pulmonary embolism on CT angiogram. She was started on heparin and admitted to the medical center. She received her Johnson and Johnson vaccine on 03/04/2021.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a vasovagal reaction about 5 minutes post-vaccination. Patient fainted briefly for about 10-15 seconds. Clinic nurse and paramedics came and examined patient. Patient recovered within a few minutes.

Patient said she had a history of fainting with other injections and blood draws. She was sitting in a chair when she began to feel faint. She asked her sister to move her to the floor to lay down. She was out for about 3 minutes and then came to. She sat on the floor for a minute and then transitioned to the chair. We offered cold cloths which she refused. She did accept an orange juice. She was fine after waiting 15 minutes and left the store.

Fainted 10 minutes after receiving shot. Next day, (starting 12 hours after vaccine) severe muscle aches, nausea, fatigue, slight fever, all for approximately 12 hours. Felt slightly fatigued the next day but back to normal after that.

Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient just fainted after recieving covid shot briefly. She stated that she usually faints after receiving shots or needles.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: First BP 108/68 2nd BP 115/78. Patient complained of feeling hot, sweaty, then dizzy. We had her lay on the ground and gave her some water. She recovered within the next 15 minutes.

Initial injection site felt a lot of pressure and at first there were mild symptoms of ringing in the ears and mind fogginess. Within 5 minutes after receiving injection I got up and walked less than 10 feet when I began experiencing extreme dizziness, ringing in the ears, lightheadedness, felt warm, and began to feel chills/tingling throughout my whole body but especially in my head. I ended up passing out and was unable to sit up in a chair without assistance. For about 10 minutes I was profusely sweating all over my entire body, had continued chills/tingling, difficulty breathing and was semi coherent. The nurse at the pharmacy had me sniff ammonia salt and gave me water to help. I waited for 20 more minutes before finally feeling able to get up and walk around the store. Body chills and cold sweats continued for a while but no further symptoms at this time (2hrs after vaccination).

29-year-old female brought to the emergency room by EMS after syncopal episode at sick all this morning. Patient states that she receive the Johnson and Johnson coronavirus vaccine yesterday at approximately 1500. Throughout the evening and overnight she developed the expected side effects of myalgias, mild headache and fatigue. She states because she was not feeling well this morning she was instructed to give us a call. She is sick, she was sitting in a chair and when she was called to code forward she stood up, developed tunneling of her vision with spots in front of her eyes, felt dizzy and then passed out. When she woke up the dizziness had resolved. She states that she feels dizzy intermittently at basel

About 5-10 minutes after the patient received the vaccine, she lost consciousness and fell off her chair. She regained consciousness and I had her lay on the ground on her back. Her blood pressure was 88/69, heart rate was 86 and she was sweating a lot. EMS came and took her blood pressure again and it was 110/80. She went to the hospital for further observation and they did an EKG and said everything was normal, and now she is feeling okay.

Patient had difficulty breathing, fainted, gasping for breath, given epinephrine injection in thigh, started to become conscious and breath more easily, then started vomiting. Called 911 in meantime. Patient taken to hospital.

DIZZINESS, NAUSEA, SWEATING, SLEEPING SENSATION IN A CORNER OF THE TONGUE, BP A LITTLE HIGH AT THE BEGINNING AND THEN LOW. OXYGEN WAS ADMINISTERED AND WAS TAKEN TO THE HOPITAL IN AMBULANCE

PATIENT PASSED OUT WITH EYES OPEN. SHE COULDN'T SEE ANYTHING FOR A FEW SECONDS. SHE CAME TO AND THEN ABOUT A MINUTE LATER, IT HAPPENED AGAIN. SHE WAS COMPLETELY PALE BUT CAME TO WITHIN A COUPLE OF SECONDS AND THEN FELT BETTER. WE DID CALL PARAMEDICS, WHO CHECKED HER HEART RATE AND BLOOD SUGAR. THEY DID NOT TRANSPORT HER.

Patient was very nervous about getting any shots and we discussed ways to help with her anxiety as well as side effects. The patient immediately complained of feeling dizzy within seconds of completing the vaccination. She slumped in her chair and was nonresponsive to me for about 45 seconds. Color was very ashen. We treated patient by leaning her in the triangle position and she continued to talk to me at that point. At 10 minutes patient felt fine and was drinking water. She was observed for about 45 minutes total and felt fine when she left the pharmacy. She kept stating she hates shots and was really worked up about getting the vaccine.

ER- TWO VISITS- 4/10/2021 4/12/2021. I've seen a couple doctors to get follow ups and get stronger allergy medications, I can't recall how many I have seen. I had a rash, difficulty breathing, dizziness, chills, shaking, fast heart rate, throat swelling, extremely fatigue. Still having breathing problems, still getting hives, started allegra and I take it daily, I also have to use my inhaler almost daily, I have never had asthmatic symptoms before this.

minutes after vaccine patient fainted. when i went over to check on her she had a very mild seizure like rxn. then cam to and said "where am I". we administered cold pack to fore head, checked pulse. she came around a bit more and we gave her cold water. then a glucose tablet. color started to come back into her face. gave her peanut butter crackers and a banana. she stayed for about 1 hr. called her sister to come get her.

HIGH BLOOD PRESSURE; DISSOCIATION; FEEL LIKE ROOFIED; CAN'T FOCUS ON CONVERSATION; DIZZINESS; BURNING SENSATION IN BRAIN; CHILLS; FEVER; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced burning sensation in brain. On an unspecified date, the subject experienced high blood pressure, dissociation, feel like roofied, can't focus on conversation, and dizziness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) increased to 190/100. The action taken with covid-19 vaccine was not applicable. The patient recovered from high blood pressure, and body aches, chills, fever, and headache on APR-2021, and the outcome of burning sensation in brain, dizziness, dissociation, feel like roofied and can't focus on conversation was not reported. This report was non-serious.

In ED on 3/11 0246 with the following Chief complaint - I got the johnson and johnson covid vaccine 3/10 at 4pm and now I can't stop throwing up" c/o emesis, fever, body aches. HR 140s. pt is A/O x3. + nasuea, chills fever 101.2. denies throat swelling or SOB. pt presents with swelling at vaccine site and rash to both shoulder blades She does feel lightheaded and dizzy. Denies any recent illnesses. Denies any prior intolerance to vaccines. Fever 101.7F Patient has low-grade fever but nontoxic-appearing. Blood work shows mild leukocytosis with left shift likely reactive otherwise within normal limits. After 3 L of IV fluids she remains persistently tachycardic in the high 130s to 140s. Additional information for Item 18: She states she was feeling fine prior to her vaccine, denies any recent illness, sick contacts, recent travel, CP, SOB, abd pain, dysuria. After eating and drinking patient states she feels a little nauseous and having some indigestion so was given some more Zofran and Maalox. She continues to be presenting tachycardic in the 130s. Given the rest of the reassuring ED work-up I think this is likely autoimmune response to the vaccine however given her current heart rate I cannot discharge her safely. Will admit her to medicine team for observation. SIRS, likely 2/2 vaccine - hold off on antibiotics for now without clear source of infection, procalcitonin negative - tylenol prn for fever Principal Problem: SIRS (systemic inflammatory response syndrome) Active Problems: Tachycardia Asthma 3/12 discharge summary She was given 3L IVF bolus in the ED -- still tachycardic in the 110s, fever has improved. There was concern for adverse reaction to vaccine and she was given prednisone 60 mg x 1 in the ED. Her symptoms have improved and she is able to tolerate PO without vomiting. Of note, she says her entire family had a respiratory viral illness approx 1 year ago which her PCP suspected was COVID 19, but were unable to be tested at the time. Fever has resolved, has been afebrile x24 hours, leukocytosis has resolved tachycardia has improved although still HR in the 110's with ambulation, ordered an echo however patient did not want to stay wanted to follow-up with PCP and have this done there. Vital signs have been stable, patient states back to her baseline and feeling great. Would like to go home.

On 06/28/2021 i received the vaccine. I was sitting in a chair at the pharmacy, unsupervised. Within 5 minutes of receiving the shot I began to feel light-headed, lost consciousness and fell onto the floor and hit my head (according to a witness). I came to and there were staff members/medical personnel present and talking to me. I spoke with them and was immediately brought to the emergency room for further examination. An EKG was administered and a urine sample was taken. Results were normal. I was given acetaminophen and ibuprofen and discharged. Since being vaccinated on 06/28/2021 to today, 07/01/2021 I have experienced the following symptoms: muscle aches/soreness, headache, joint pain, fatigue, nausea, diarrhea

The first night (same day I got the J&J vaccine) I had a fever of 101.5 degrees, tight chest, mild difficulty breathing, strong body aches, strong chills, a splitting headache, and I couldn't sleep that night. By morning the symptoms were gone except a felt very week and still had a mild headache. The headache got bad again by 10:00AM. And grew worse and worse until it was excruciating. I took 800mg of Advil, a muscle relaxant, and 2 hours later a Norco. Nothing reduced the pain. I stayed up and cried all night. I asked a relative to take me to the ER, but they were unwilling. In the early hours of the morning, it started to reduce. The next day I was weak, and I had a mild headache for the next 2 days.

Hand Numbness and tingly. Wednesday Small symptoms kept going on. Blood flow to hands deteriorated. Couldn?t move feet, Feet became dusky. This all happened Thursday after symptoms became worse. Blood pressure elevated 175/100. Usually 110/70. Heart rate 170s generally 65-70. I was at work as a nurse and I about coded. Was taken to er.

Before the shot the patient was very nervous. 5 Minutes later she lost consciousness in her chair but quickly recovered, with dizziness, tunnel vision, sweating, shivering, nausea, weakness. She got better with resting her head down by her knees, had some water, then stood up to go to the bathroom due to nausea, but didn't make it and vomited 2 times. After resting on the floor with pharmacist supervision for about 20 minutes she began to feel better. I called her boyfriend who came to pick her up. She did not want the ambulance.

Patient received vaccination and approximately 5 minutes later fainted. she was helped to a seated position and remained seated for several minutes until able to be helped into a chair. She then stayed seated in the chair under observation for about 20 minutes and returned to a normal general state and was able to be escorted out of the pharmacy to their ride.

Night sweats, headache, fatigue. Fast and elevated heart rate beginning on 3/9/2021 and continuing on 3/10/2021.

Syncope and fell on her hands and knees. No head trauma. No other injuries. BP 110/77, 85, O2 sat 96%. She was observed for 35 minutes. She felt better and went home.

Fever 103.9, Chills, Migraine, Weakness, Hyper-elevated heart rate. Fever resolved to 99.5 F in 4 hours with Acetaminophen during ER visit. Anti-anxiety meds administered to reduce heart rate. 48 hours later, most symptoms where not present. Symptoms lasting 72 post injection hours included weakness.

Patient woke up on 3/12 with headache, body aches, and nauseous. She went to the bathroom thinking she was going to vomit and ending up passing out and then waking up covered in sweat.

I woke up around 5:30 with a high fever. I went to the restroom and on the way back I passed out and was unresponsive for a few seconds (10-20 seconds). I have since being running a fever, breaking out in a sweat, had a severe migraine, and body aches and joint aches. It has been over 24 hours since the vaccine and am still having side affects.

vaccinated 1005 - walked to observation around 1008 vagal response in observation area - slipped to floor - attended by paramedic -small brush burn above eyebrow - no lumps joint head or neck pain - remained conscious throughout incident pulse bradycardic 40 - 50 C/O dizziness pale and sweaty - legs elevated - after 10 minutes symptoms resolved and patient assisted to her feet - symptoms returned - placed on stretcher legs elevated - EMS notifed - transported to ED around 1028 BP on transfer 98/46

Patient collapsed after vaccination, hitting her head. She remained unconscious while vomiting. We administered epi-pen 0.3mg once and contacted 911. Patient was transported to nearest hospital.

6.45pm: started with chills and being very cold including blue lips 8pm until 1am: chills got worse and were uncontrollable. Body was shaking heavily. At some point, body was very hot and I developed headaches and some back/neck aches. Chills continued during that time. I was very thirsty but drinking resulted in nausea. I had one thought over and over again which I couldn't break out of. 1am: Vomitted 1:30am: Admission to ER

Pt had a near syncopal event after the injection. She became pale, light headed BP 102/60. She lied down for 20 min and improved

Patient received vaccine while seated and had no problems. She stood up and walked several feet to the observation seating area and had a seat. A few minutes later she fainted and fell out of the chair onto the floor. We helped her up to a sitting position and gave her a bottle of water and an ice pack. The right side of her forehead appeared red from apparent hit on the floor when she fainted. We had her wait on the floor for about 30 minutes to ensure she remained conscious. Patient reported an ache on her forehead at site of hit. She was also sweating and reported feeling hot. Patient had a partner with her who agreed to escort her to an urgent care clinic in the same building as the pharmacy. Store manager in charge took the patient to the urgent care clinic by wheelchair to be examined.

Janssen COVID-19 Vaccine EUA Patient verbalized fainting after prior vaccines. Patient fainted almost immediately post-vaccination. Assessed and attended at vaccination clinic site. Vital signs within normal limits. Monitored on site for 45 minutes; released with her friend. Vaccine Clinic at a community site.

Heart rate increased hours later, heart rate stayed elevated through the night while I was sleeping. My tracker showed it not going below 90 and was as high as 129. I have never experienced an issue with my heart. My heart rate did decrease back to normal by the afternoon. Also had experience chills fatigue that night and headache the next morning.

Approximately 10 hours after injection I became tachycardic--on average experienced a heart rate of 100-120 bpm (resting hearting rate is 65-70 bpm) which continued for 6 hours. This occurred at the same time as fever (highest 99.4 degrees F) and muscular aches in back and legs. After consulting with doctor, I took a combination of ibuprofen and acetaminophen and half a dose of metoprolol to lower fever and heart rate. Experienced a slight headache and had trouble sleeping due to tachycardia. Tachycardia dissipated 6 hours after onset. All symptoms resolved by 12 PM the next day (approximately 24 hours after injection).

About 12 hours after vaccine - migraine, nausea, chills, high heart rate, sweating , sore arm At around 24 hours - migraine, sore arm but other symptoms gone. At around 36 hours - all symptoms gone besides slightly sore arm around vaccine site.

approximately 30 minutes after receiving vaccine pt had a coughing fit and then continued to have R sided chest pain/tightness causing continued throat clearing/coughing. Hoarse voice as well. We treated as allergic reaction with IV solumedrol 125mg, IV benadryl 25mg, and one 5mg Albuterol neb treatment with good resolution of symptoms.

Arm hurt very badly immediately during and after vaccine in similar sensation to ulnar nerve being struck in arm, bled only a little but caused swelling and then a large bruise developed over the evening of 4/4/2021 and is still dark today (4/7/2021). Concerned my bone was hit with a too long vaccine needle. Had chills/fever evening of 4/4/2021 into morning of 4/6/2021?had to take off work. Have had neurological symptoms ongoing with ?brain fogginess? since 4/5/2021. On 4/6/2021, began to see flashes/spots of light in vision of left eye, which worsened through today. Took off afternoon from work and went to an eye clinic to have eye dilated and looked at, but the spots in vision continue through reporting time (4/7/2021, 5pm CT).

A few minutes after receiving the shot I began to feel nauseous, almost like being car sick while looking at my phone. I also began to feel tightness in my chest. After my 15 minutes were up I asked the administrator of my shot if it was normal that I felt dizzy/chest tightness. They said it was probably fine and just to monitor my symptoms. I went and sat in my car a few min and I began to feel very strange, it seemed very bright out, I felt weak, and my eyes felt very heavy. I wanted to get home so I started driving but on the highway, my heart beat was very fast and I began to feel like I couldn't swallow. At one point felt as though I might be about to choke so I pulled over because I thought I was going to have to dial 911 as my throat was feeling like it was closing up. I tried swallowing a few times with great effort and after a few minutes the sensation started to lessen. My throat hadn't closed up completely, however it did feel like it had swelled up.

severe chills for 1 hour then fever followed by a headache Chills were so bad that I couldn't control my body. I could not stop shaking , I could barely walk, and elevated heart rate

Night of vaccination: Immediate intense pain at injection site - subsided slightly after movement 5:00PM - Chills, tiredness 8:00PM - Low grade fever 99.1 10:00PM - Fever 100.4, extra strength Tylenol taken 11:00PM - fever breaks, immense headache, elevated heart rate 12:00AM - headache begins to subside due to Tylenol, still elevated heartrate 12:30AM - falls asleep Next day: 8:00AM - woke up with slight headache, no fever, slight nausea, arm pain subsided slightly 10:00AM - extra strength Tylenol re-administered 11:00AM - headache breaks for rest of day The rest of the day was waves of tiredness The following day: Tiredness continues, arm pain begins to subside Third day following vaccine: Felt more like myself, occasional sore arm which subsided after the week mark

Patient reported walking to restroom, feeling dizzy and had pre-syncopal episode witnessed by staff and brought to floor Patient stated symptoms improved Patient seen by medical team and ambulance was called and patient sent to hospital

I got slightly picquerism and it was light green. 5 hours after felt mild fatigue. 7 hours after had headache and muscle ache. 12 hours after felt feverish and arm pain in my hands, finger, and shoulder. Still had bad headache. 13 hours later took Tylenol 1000MG. Next day at 4:16PM I still had headache, fever, and muscle ache. Took another Tylenol pill. Then I felt a little better. I had right sided chest pain.

Within ~5 min of vaccine administration, I developed a vasovagal reaction while sitting down. Became sweaty, nauseous, and my blood pressure dropped to 85/57. Took roughly 30 min for pulse and bp to return to normal. Within 8 hours I developed a fever 100.5-101 degrees and body aches.

Seven minutes after receiving the vaccine client began to convulse followed by syncope. EMS was called. Client was caught before she fell. and stabilized shortly after. She states "this is something that happens to her regularly bc she has a fear of needles." Vitals taken are as follows BP 176/123, SPO2 99%, pulse 74.

Extreme nausea, non stop throwing up, was about to pass out. Ended up in the hospital with a 101.5 fever, low blood pressure, elevated heart rate Immediately after getting the vaccine I felt very nauseas and dizzy as well

I sat in waiting area for 5 minutes after shot and felt fine. I got up to use restroom and felt very lightheaded and dizzy. I turned around because I didn?t think I would make it to bathroom and told site worker I felt dizzy. He tried walking me back to car but my sight for super blurry and I passed out. I came back into it pretty quickly after passing out. I was super sweaty after shot.

The patient received the vaccine and after about 5 minutes, she started feeling like she was going to pass out. Her face turned white, and I could tell she was feeling faint. We assisted her to a safe place to lie down. A physician on duty at the clinic attached to the pharmacy examined her. We sat in the room with her for several more minutes. She started feeling better after about 10 minutes and was able to stand with no problem. We had her call her spouse to pick her up.

30 minutes after shot, I was dizzy and headache. Starting at midnight until 9am my heart was racing between 114-124 bpm all night long while laying still in bed. Normal sleeping heart rate is low 60's. Chest pain and racing was obvious. Extreme headache, pain in legs, etc. lasted for 2 days. Fever hit 100.5

Janssen COVID-19 Vaccine EUA Received J&J vaccine at 1:45pm on 4/10/2021. Started feeling slightly lightheaded around 8:00pm. Experienced chills and a fever (elevated to 103.5 degrees), elevated heart rate, headache, and muscle pain from 9:00pm - 4:00am Sunday, 4/11/2021 and could not sleep at all during that time. I took 1 extra-strength tylenol around 2:30am. Finally fell asleep around 4:30am on 4/11/2021 and when I woke up again at 7:30am on 4/11/2021, all side effects were gone. All side effects came on and then went away in about a 12 hour period.

30 year old femail received Janssen vaccine Lot# 1808982 exp: 6/23/21 at approximately 3pm in the left deltoid. Immediately after being vaccinated, pt. requested to remain seated. The nurse noted that the pt. was getting pale so she suggested the pt. take off the surgical mask to get some air. Before pt. had a chance to take off the mask she lost consciousness. Together with another nurse patient was lowered onto the floor. Pt. regained consciousness for 30-45 seconds and then began to have seizure like activity. Her eyes rolled back and her body became stiff and began a jerking motion. 911 was called. This seizure like activity lasted 4-6 seconds at which time pt. regained consciousness and immediately sat up. Pt was pale and diaphoretic. BP 98/64, HR 78, Pulse Ox 99%. Pt vomited multiple times. Ice was applied to the posterior neck and a cold compress to the forehead . EMS arrived and took vitals: BP 78/40. Pt. was aware of person, place and situation. Pt. was taken to Hospital accompanied by her husband. Pt was called by me Friday and she was home. All tests showed no sign of having a seizure.

Patient sitting in waiting area states her legs feel cold and shaky. Patient diaphoretic and pale. Patient layed down on stretcher. VSS, O2 sats 99, BP stable, HR 66.

Patient was nervous about the vaccination. About 5 minutes after vaccination patient got up from waiting area to ask for water and fainted, fell and hit her head. EMS was immediately called, arrived shortly and transported patient.

Weakness / fatigue almost immediately, slept from 6pm to 9pm. Woke up with severe chills / teeth chattering / uncontrollable shivering, my husband said my body was warm but I felt chilled to the bone. Finally got warm enough to fall asleep around 2am. The next day, more chills, headache, fatigue, and general malaise all day. Started feeling better on the third day. Today, tightness in right side of chest--not sure if related, will be calling the doctor.

Patient stated after the vaccine she had a fever and was nauseous but all resolved after 24 hours. She woke up today with chest pain/ tightness and stated it is painful to breathe. She was advised to go to the ER.

102.6 fever by PM of 4/6/2021; chills, elevated heart rate (resting HR at 120-130), oxygen levels at 95-96%; redness, swelling and pain at injection site Fever continued through 4/8/2021 reaching a high of 103.6; chills, elevated heart rate continued but lower to around 110, oxygen levels 96%; redness, swelling and pain at injection site Redness, swelling and pain at injection site still continued through today, 4/13/2021; large border of bruise on upper arm from injection

14 DAYS POST VACCINE EXPERIENCED LEFT CALF PAIN...SHARP PAIN. Applied warm compress and took tylenol. Pain persisted and increased. Visited Urgent Care center on Tuesday, 3/23 and was advised immediate ultrasound needed. Went to Radiology Facility same day and was advised I had a DVT in leg and I needed to go to ER. Went to Hospital ER on 3/23 and was treated in ER with blood thinners (IV) and advised I also had numerous PEs in chest. Released with RX for Eliquis and advised to follow up with PCP and Hemotologist asap. Friday, 3/26 leg was swelling and patient was dizzy with chest and arm sensations. Went back to ER. Double Doppler done. DVT has moved. Assumed another PE has occurred . Continue Eliquos RX. Following up with Hemotologist, Cardiologist and Pulmonologist.

Day of vaccine- Within hours, site soreness, raised red, approx size of a quarter, mildly painful, with a "lump (that is still palpable) under the surface of the skin". Within 5-6 hours following vaccine administration, she reports she developed fever, chills for approx 2 days with fatigue and hot flashes on and off. ** On 4/7/2021, patient states that in the morning she developed pain in her right calf. She saw her PCP.

The adverse symptoms I experienced were abnormally severe/heavy menstrual bleeding and abdominal pain. I was on Day 4 of my menstrual cycle on the day of my injection (April 3, 2021). My menstrual cycle usually starts to go away on Day 4 and concludes by Day 7. But the day after my injection, in addition to experiencing the common side effects of fever, chills, aches, and headaches, I also experienced an uptick in bleeding, which included severe/heavy menstrual bleeding with very frequent and large blood clots. That same day (April 4), I started my new birth control cycle as prescribed. By Day 8 (April 7, 2021), my menstrual bleeding continued to be so severe/heavy that I went to my OB-GYN for testing. The OB-GYN ruled out everything but the vaccine as an environmental factor. It was suggested that I take 600mg of Motrin every 6-hours for 48 hours. My menstrual bleeding continued for several more days until concluding on Day 12 (April 11, 2021) but I am still experiencing abdominal pain.

Shortness of breath, chills, heat flashes, Body aches, headache, sharp leg pain, sharp arm pain, muscle aches, chest pain, joint pain, ear throbbing in left ear, ringing in right ear, fatigue, dizziness.

Shortly after taking the vaccine, I started having some chest tightness, trouble breathing, and was nauseous but thought it was my asthma so I did not report it. It continued to happen and still have more breathing issues than before.

Resting heart rate of 120 for over 12 hours. It began immediately. Laying down heart rate was between 115-120 I got my injection, a few minutes later my heart was fast, but I left anyway. My heart was fast through the day, but manageable. At night I fell asleep, and woke up 1.5 hours later to a heart rate of 123. I got up to use the bathroom and could barely breathe because it jumped to 140 while walking the 10 feet to the bathroom. My heart stayed that fast until the morning

On April 16, 2021 (Day 13 after Vaccine) I was diagnosed with acute deep vein thrombosis (DVT) of my femoral vein in my left leg by Hospital. In other words, I was diagnosed with a blood clot in my upper left leg. Pain in both my legs had started on April 13, 2021 (Day 10 after Vaccine). On April 16, I had a virtual appointment with my doctor, Dr. , who prescribed an ultrasound to rule out DVT. I went to an ultrasound appointment at Radiology at 3:30pm where a blood clot was found in my left leg. I was admitted into the emergency room at Hospital and prescribed medication and follow ups from there. These adverse symptoms developed after I submitted other adverse symptoms to VAERS on April 13, 2021 (Temporary VAERS E-Report Number: 435841).

Around 5:30 pm in the evening following my vaccine I started having chills, headache, nausea, and fever of 101. Chills got worse, whole body was shaking and shivering. Nausea progressed into constant dry heaving. Head was pounding with the worst pain I have ever felt in my life, worse than natural child birth and worse than running marathons. The nausea was so bad and I could feel my fever burning and getting worse. I was about to vomit so got out of bed to go to the toilet to vomit and the whole room started spinning completely out of control. My heart was racing and I could hear it and feel it pounding rapidly through my ears. I couldn?t walk and was so disoriented I crawled to the bathroom to throw up in the toilet. My husband heard me and came and picked me up off the bathroom floor and carried me to our bed. As the night progressed fever got worse, head was in almost unbearable pain, severe body aches over my whole body, heart racing and horrible nausea and dry heaving. I made it through the night. For two days after I had a headache and fever and nausea and body aches and couldn?t get out of bed to care for my children. By the third and fourth day I was able to get out of bed at times and still felt fatigue, nausea, headache and body aches. Anytime I would stand up for 10 days after the vaccine it felt like I was rocking on a boat. I am almost at 2 weeks and still feel fatigue and dizziness at times. On April 15th, 9 days after my vaccination I had symptoms of a blood clot in my leg. I went to the Emergency Room and was diagnosed with a superficial blood clot of the leg as well as swelling in the vein. I am thankful to be alive!

HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

The next day I was very fatigue and had body chills and mild fever. On monday I had chest tightness . I was still able to breathe and noticed that this was not normal. I pressumed my day as usual. On Thursday I went to my local urgent care. They performed an EKG, Blood test to rule out infection and blood clots and a chest x ray. All of my test came back NORMAL. My Dr. stated that it was " CHEST WALL MUSCLE PAIN" The CHEST TIGHTNESS WENT AWAY ON SUNDAY. 1 week later from the day of the injection.

I got sick shortly after the shot with on and off fever chills severe pain in legs and arms.. Severe back pain head ache cough soar throat dehydrated weak tired on the sat following the 8th i coughed up blood. My arm that i got the shot in still has pain and so does my back, i also still have a lingering cough every morning

30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32 ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.

FAINTED; WEAKNESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included lightheadedness from injections. The patient had no history of any reaction to vaccines before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: GL12A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient was fainted after receiving the vaccine and treated with emergency medical services. On the same day, the patient felt dizzy and experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and weakness on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fainted. 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.

at 4/28/21 patient was vaccinated w/ Jessen vaccine and soon became pale and observed to became flaccid and pass out. pt's HR was 50, sat02 99% and BP 70/40. Pt soon observed with BLUE contracting and BLLE adducting followed by urine incontinence. Pt did not fall and was sitting in her chair the entire episode that lasted for approximately 40-60sec. Pt awake and continued to have hypotension, dizziness reported. EMS contacted and pt transferred to local ER for evaluation of suspected syncope and seizure s/p vaccination.

On April 16, 2021 (Day 13 after Vaccine) I was diagnosed with acute deep vein thrombosis (DVT) of my femoral vein in my left leg by Hospital. In other words, I was diagnosed with a blood clot in my upper left leg. Pain in both my legs had started on April 13, 2021 (Day 10 after Vaccine). On April 16, I had a virtual appointment with my doctor who prescribed an ultrasound to rule out DVT. I went to an ultrasound appointment at Radiology at 3:30pm where a blood clot was found in my left leg. I was admitted into the emergency room at Hospital and prescribed medication and follow ups from there...

I was pregnant at the time of vaccination (on March 21, 2021). Estimated due date (spring). There were no complications and it was a very low risk pregnancy. At approximately 37 weeks pregnant, I developed pre-eclampsia with HELLP syndrome. No prior blood pressure issues in my life or during my pregnancy. I was treated for pre-eclampsia by being induced at 37 weeks on spring of 2021. Baby birthed with normal birth weight. Mom and Baby both doing very well now!

In the ED 3/14/21 Patient states yesterday she got the Johnson & Johnson Covid vaccine. She says that today she started having fevers chills generalized body aches generalized malaise and headache. She says she is otherwise healthy denies any sick significant medical history. She endorses some mild shortness of breath associated as well as some nausea and diarrhea but denies vomiting. IV fluid bolus, acetaminophen and ibuprofen

Covid-19 vaccine given to patient @ 4pm on 5/10/21. Patient started to feel hot within the 15 minute observation period. She claimed she felt well and left coming back to the pharmacy immediately explaining "something was not right." She had trouble breathing, hives, facial swelling, throat swelling, itching, flushing, shortness of breath, chest tightness, throat tightness, anxiety and sweating as well as tachycardia. 911 was called. Epi-pen was provided as recommended by 911 dispatch and per pharmacy Immunization protocol. Fire team arrived and gave the patient O2 and monitored stats. Emergency team arrived and took her to the Emergency room,

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium

Two weeks after receiving vaccine, began experiencing chest pains. Doctor diagnosed as costochondritis. Was given an antihistamine to take at night to reduce inflammation. After about a week on the medicine, the symptoms mostly went away, was told 4-6 to fully be down.

Patient friend called out the nurse, upon the nurse arrival patient was already unconscious. Ammonia placed under the nose by the nurse and patient regained consciousness. Paramedic is assessing patient at this time. Patient is now alert and oriented.

Patient has hx of anaphylactic reaction to Amoxicillin ( difficult breathing) arrived at the site with her mother, was informed about the risk of getting vaccinated at non-clinical setting due to her condition. Patient verbalized understanding, agreed to stay 30 minutes in observation area, proceeded with vaccination. After 5 minutes in observation ( 13:35 PM), patient complained of feeling nauseous, dizzy and tingling/ numbness in the upper extremities. Patient vomited x 2, 40 mL of greenish output, noted with pale complex. EMS presented at site was activated. Vital signs initiated, noted with low BP ( 60~/UNK), HR: 70, O2: 99, R:18 in room air. Patient was taken to the ambulance for further assessment by EMT. Patient received an Epinephrine shot to the L thigh by EMT at 13:52 PM. Blood pressure improved to 110/70, HR: 81, R:18, O2: 99%. Patient also received 1 albuterol treatment 6 LPM. Patient was taken to Hospital at 2:04 PM via Bus.

PATIENT RECEIVED JANNSEN COVID VACCINE. TURNED PALE. FAINTED. VOMITED. COUGHED. PATIENT CONDITION RESOLVED AFTER 20 MINUTES. ACTUAL SYNCOPE LASTED MAYBE 1-2 MINUTES

patient fainted within 11min during the 15min observation window. patient woke up within seconds after I approached her to see if it was an allergic reaction. EMS was called immediately.

Started feeling faint and dizzy more often about 2 weeks after the vaccine. After almost fainting at work, the paramedics came to find out it was due to a dangerously high blood pressure of 180/110.

pt became dizzy shortly after administraion (3-5 minutes est.) said she felt like she was going to pass out and then lost consciousness for est. 15-20 seconds. She regained conciousness and answered general questions correctly then felt faint again a few minutes later and passed out for a shorter time 2-3 seconds est. Paramedics called and arrived about 1:20pm checked her blood pressure/ HR 3 times over a course of 10 minutes 88/62,93/62, 108/70 respectively. HR was 60bpm (one reading recorded). EKG -normal ( paramedic ambulance). pt refuse ride to hospital and left facility following paramedic examination- signed waiver a left facility at 1:35pm

Almost immediately after the vaccine at the injection site I got a real bad hot sensation. For about 2 days it was swollen and had localized pain for about 9 days. I was very fatigued. And I developed a severe headache the next day that was so bad I could barely stand it. 4/11 I went to the Primary Care and saw a dr who took bloodwork and prescribed some iron because she said I was anemic. But for about the first 3 days after the vaccine the headache pain intensity level was at a 10, then it lowered on its on to about a level 3 but was still there for about 3 more days and after about day 6 the headache intensity returned to a level 10 and on day 8 I went back to the dr because nothing would relieve the pain and the pain was so intense I couldnt bare it. I had an MRI on 4/21 which came back normal with sinus pressure present and finally about 4/23 the headaches finally subsided. I also notice the next 2 menustral cycles after I had severe cramping and my breast got really tender and sore and I bled longer than usual which is abnormal for me and I also noticed I had developed a cyst in my right breast and had a mammogram performed which did show that I had a large cyst in my breast

I received my vaccine at 11:30 AM and had a 102 degree fever by 6 PM. I began to shake very hard and had significant chest pain in my left side by my heart. The shaking and fever subsided by that Sunday night. However, it is now 6/1/21, and I had to go to the doctor today for my chest pain. While the ECG came back clear, the doctor determined that I have Costochondritis. As this is nothing I ever encountered before, I know that is was caused from the COVID vaccine inflammation response during my fever. This is when it was first noticed. It also causes back pain since it is between the breast bone and rib cage.

Immediate abdominal cramping. Bleeding, bloating, numb legs, ovarian pain, nausea, diarrhea, vomit, dizziness, chills.

patient fainted after getting vaccine paramedics were called and came to check patient but was not taken to hospital. per patient she was fasting

Patient was not feeling well after vaccine was administered. Laid her down and she passed out briefly for 30 to 60 seconds. Patient came to and was alert and oriented, able to answers questions (where she was, her name, day/date etc.) Patients breathing was never abnormal and pulse was present the entire time. Patient was extremely underweight and said she had not eaten or drank much today. Her blood pressure was on the low end but she does not know what it usually is. With patient being so underweight, I was not surprised to see a lower blood pressure reading. Patient sat up and wanted to drink some OJ and eat a snack as she said she felt like she needed to eat. Patient sat for 20 to 30 minutes and said she was feeling better and wanted to go home. She had someone who brought her so she was not going to drive. They were going to go get her something to eat. Her friend came in and then pulled up the car for her so she did not have to walk all the way out in the parking lot.

31 year old with past medical history of peroxisomal vasovagal vértigo was vaccinated on left deltoid area.... With light headedness 1 minute after vaccine... layed on floor for about 8 minutes untill complete improvement and than seated on a chair, 2 minutes after patient felt light headed again and subsequent fainting patients legs were raised and sternum got rubbed and patient woke up 5-19 seconds with mild disorientation that lasted about 3 seconds patient was layed on floor for about 15 minutes sith compete resolution of symptoms. 20 minutes after patient had another episode of lightheadedness and again got layed in the floor for 5 minutes this time with ko major events.

Hot Flashes, chills, increase in non-epileptic Seizures, fever 103.7, body aches, rash around injection site, extreme exhaustion, vomiting, chest pain. Symptoms lasted 3 days with exception of rash, fever and chills which lasted 8days.

Elevated blood pressure and pulse. Sweaty and clammy. Pale. Almost passed out. Hot and cold at the same time. EMS checked patient out and cleared her to go home.

The day after the vaccine I experienced weakness, dizziness and headache that went away without needing any kind of specific treatment and only lasted for a day. Since day three I started experiencing an increase in my arterial tension; the usual values are between 110/70 mmHg to 120/80 mmHg, currently it has been above 130/85 mmHg up to 145/95 mmHg. Along with my increased TA I've been experiencing headache whenever the values go up.

Vaccine given at 9:43 am. Patient passed out and hit the ground at 9:50am, sat her up against the wall on the floor. She complained of being hot and we gave her cold water and an ice pack. She started feeling better around 9:55 am and asked to leave at 10 am.

Irregular menstrual cycle after years of being 100% regular. Extreme cramping, clotting, shorter cycle and heavier bleeding.

Patient was given Janssen covid 19 vaccine. Patient fainted during her 15 minutes post vaccine observation period. Patient regained consciousness and refused emergency medical help. Patient did not get inquired and felt better after after resting in the pharmacy area for over 30 minutes. She was feeling better and left the pharmacy with her father.

Patient had near syncope episode with slow responses. Upon eval pt was bradycardic, hypotensive and lethargic.

Patient stated beforehand she doesn't do so good with needles. Almost immediately after receiving the vaccination, the patient started looking flushed, and woozy. About a minute after receiving the vaccine she fainted while sitting in the chair, her spouse and myself stabilized her to make sure she didn't fall. She was drifting in and out of consciousness for about a minute. When she came out of it she seemed confused as to where she was. She spit up a little bile in our trash can. after a few minutes she stated she was ok so we got her up and to the floor with her feet raised, an ice pack on her neck, some water, and some gummy bears. She rested for about 20 minutes on the floor. She eventually felt good enough to get up so we helped her up and made sure she wasnt feeling dizzy and was feeling ok. She walked to our observation area on her own and waited another 15 minutes and she was doing good so she left the pharmacy.

Pt states she felt dizzy. EMT got behind pt and pt fell into staff. Pt passed out unconscious with eyes wide open, c-spine stabilized. Jaw clenched shut, held her breath, turned blue, sternal rub performed, jaw thrust maneuver performed. Pt in decerebrate posturing, bladder incontinent during episode. Emergency services called. Pt became alert, hyperventilating, began crying. Staff assisted her to cot. States no previous medical history, no allergies, ate two hours prior to vaccination. VSS, pt continuing to hyperventilate and cry. EMS arrived on site and took over. Placed 20g IV in RAC, drew blood, bgl 122.Pt and all belongings taken to Community Hospital by EMS. Pt was AOX4 GCS 15 at time of tx

30 year old female pregnant with EDC 12/12/21. Prenatal lab work detected no chromosomal anomalies. Pt had 3 prior uncomplicated term pregnancies. Pt began bleeding at 12.3 weeks pregnant and went to hospital. Pt passing copious amounts of blood clots. Fetus with heartbeat detected on ultrasound prior to spontaneous vaginal delivery of deceased male fetus.

Mild headache and nausea set in shortly after the injection on Friday, but went away after rest and eating/drinking. My arm was sore for the entire evening. I woke up around 2am Saturday morning and became dizzy. I fell to the floor and passed out for a short period of time. When I woke, I was extremely nauseous to the point of nearly vomiting. I had chills and fever. I could hardly move due to weakness - I needed help getting back into bed. When I woke the next morning, I had 100.3 fever, I had a headache and my entire body was sore. My fever went away late Saturday afternoon, but I still felt mildly nauseous. It is Monday and I still have mild nausea and light-headedness. My arm is only slightly sore.

Patient fainted about 5 minutes after receiving the vaccine. She was in the monitoring area and fell over and hit her head on the ground. I went to her aid and monitored her until the paramedics showed up. She was unconscious for a 10-15 seconds with her eyes open before regaining consciousness. IShe was not having breathing problems or other symptoms of anaphylaxis so i did not administer an epi-pen or benadryl to her. I rolled her on her side in case she became nauseas. Then the paramedics arrived and attended to her.

Left arm went numb about 4 hours after injection and remained numb for 12 hours. Severe muscle aches began 4 hours after injection. Extreme dizziness and nausea. Fever, chills, vomiting started 10 hours post injection. Fainting upon standing. Severe chest pain started 12 hours post injection. All symptoms are continuing except for the numbness in the left arm.

Passed out at home 3 times. Heart racing. Severe leg weakness. Leg gives out after walking for a fe minutes.

Patient felt lightheaded, nauseated, hot and sweaty and appeared pale. She states she has a history of fainting with blood draws and vaccines. VS improved over 25 mins, patient left via own car.

Hour 1 - elevated resting heart rate (110) Hour 4-6 - elevated resting heart rate (110), headache Hour 6-18 - elevated resting heart rate (110), headache, extreme fatigue, chills, body aches, fever (101), cyanosis Hour 18-48 - headache, extreme fatigue, body aches It has been one week and I am still feeling very run down, tired, and body aches.

After being administered the vaccine at 7:12 am, when the nurse stood me up and started to walk me to the holding area, I became dizzy, my legs got weak, and there was a loud ringing in my ears. I nearly collapsed as I reached the seat in the holding area they were taking me to. I placed one 0.5MG tablet of my prescription Alprazolam in my mouth and waited for the nurse to bring water. They took me via wheelchair from the holding area to a secluded spot behind a curtain. There, I laid on a cot, received cold water, and a nurse talked to me while I recovered. It felt like I was having an anxiety attack, which has never happened to me after getting a shot before. Fitbit heart rate data shows my heart rate at 105 BPM at 7:00 am (going through the admission process, walking around the facility), 83 BPM at 7:10 am, 79 BPM at 7:15 am, 74 BPM at 7:20 am. Between 8:15 am and 1:25 pm, my heart rate remained between 63 and 89 BPM. My arm was sore and my skin hurt (an issue that I have when I feel very stressed). Additional symptoms arose around 1:35 pm. I began going through cycles of chills, sweating and overheating. My heart rate ranged from 127 BPM and 93 BPM for the remainder of the night. I took Tylenol at 7:07 PM to help with my fever.

Hour 2: numbness in right jaw, numbness in right leg, and abdominal cramping Hour 5: continued numbness in right leg, groin pain Hour 8: chills, shakes lasting 45 minutes), followed by fever for several hours, highest recorded temp of 103.8, took ibuprofen to reduce fever, numbness on right side continued Day 2: numbness on right side, low grade fever, patient stayed in bed and continued taking fever reducers Day 3: numbness on right side, now including arm and back, and abdomen pain brought patient to primary care doctor; strength, pinprick, and vibration tests came back normal. Patient was instructed to return home. That evening patient began experiencing numbness on left side in her ankles, and left calf. Numbness is described as electric pulsation, tingling, and dull feeling. Patient can walk, lift limbs, and control muscles. Patient then experienced breathing difficulties, tightness in chest, sharp pains in chest. Abdomen pain intensified. Mouth numbness and difficulty swallowing. Dizziness grew stronger when patient sat or stood. Day 4: breathing issues and chest pains resolved. Numbness throughout body continued and is described as moving in intensity from one area to another. Often intense in the legs, ?feeling like weights?. Day 5: patient goes to ER seeking answers. ER preforms routine lab work and collects a urine sample to test hydration and electrolytes. Patient shows some signs of dehydration. IV is given. Referred to neurologist.

Around 9-10pm the day of our vaccinations, both my husband and I experienced extreme reactions to the j&j vaccine. We had fever, chills, elevated heart rates, nausea, vomiting, splitting headaches, all for approximately 6 hours.

Fever, fully body aches, headache, sinus pressure and pain, blackout vision, dizziness, weakness, fatigue, cough to inability to breathe, shortness of breathe, chest pressure and pain, mild left side facial swelling and numbness. Scared to contact emergency services due to cost. Took otc ibuprofen and suffered through night and next day. Slept on and off many hours over weekend. Some improvement but most symptoms still linger.

Client had injection site pain at first Client complained for post vaccination syndrome on Monday client complained of chest tightness and pain Clients BP was elevated at the time. Client is now hospitalized

I felt the vaccination spreading through my body as I got really heavy and lost consciousness. I woke up to my husband holding my head and yelling my name. I had been seizing and had bitten my tongue. I was very white and nauseous and cold and shaky. They gave me water and a cold pack. The seizure probably only lasted for 5 seconds but it's hard to say. I felt very fatigued afterwards. I stayed for 10 more min and drank water and then they sent me on my way.

Pt fainted after 10 minutes of administration. But by the time I walked out in the waiting area, pt came back and sat up again.

Patient reported feeling dizzy, anxious, fatigued and chest tightness Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form Patient stated symptoms improved and will be driven home by mother

Patient stated she had a history of fainting with blood draws. Patient stated she did eat before vaccination. Nurse on hand as well as another person to assist if needed. Patient was administered vaccination by medic within 3 min started feeling nauseated and sweating she lost consiouness. Medic and public health nurse able to lie on floor patient safe and did not hit her head. Ambulance staff paremedic on site. B/p taken 90/58, O2 98% 66 Pulse. Cool cloth to head and ice packs to neck. Within a minute Patient regained cauntiousness. Juice given. Patient was able to eat a cookie. Stated she was feeling better. Assisted tranfer to wheelchair to monitoring station for additional 30 min. Patient declined to be taken to local hospital via medics. B/p reassed at 0112 10/98 100% o2 68 pulse. Patient able to talk and drink water without any problems. Patient was present with husband. Patient monitored a aditional 30 min. before leaving. Patient gait steady and no slurring of speech. Patient was advised if any problems arise to seek 911. Patient stated she would not be driving home her Husband would.

dizziness right after receiving vaccine. 12 hours later severe headache, fever, chills, body aches, slightly elevated heart rate, vomiting.

Patient was given the Janssen Covid 19 vaccine on 4/7/21 around 11:55am in her left deltoid. She was accompanied by her husband at the clinic. After the immunization she was seated in the waiting area to be observed for 30 minutes after her vaccine. Approx. 5 mins after the vaccine was given, the patient passed out in the chair and I (the pharmacist) was alerted. The patient came back to when I arrived at her seat and was able to talk and asked for water. Her husband stayed by her side while I went to obtain water and I heard her husband say she passed out again and then regained consciousness. He layed her on the floor while I called 911. An ambulance came and took the patient to the hospital.

Patient states feeling light headed. BP taken at 11:57 am 139/100 given bottle of water monitored. 12:02 136/103, 12:12 am BP 140/104 advised patient relax and stop talking on the phone. 12:18 pm 136/103 am given bottle of Gatorade: stated slight dizziness, 12:28 pm BP 135/96, HR 72, 12:40 pm 130/99, HR 72, 12:54 pm 118/95, 1:30 pm BP 126/97. Patient states feeling a little tired dizziness has lessened. No other symptoms voiced or noted. Color is good. Patient ambulated to car with out any S/S of distress. Advised to call 911 if SOB, light headed, dizziness, chest palpitations or BP goes exceeds 100 diastolic., RN

Immediate arm pain and muscle cramping around left side of body specifically the diaphragm. Twelve hours past vaccination: Chills, Extreme Body Aches, Muscle Pain, Chest Pain, Shortness of Breath, Headache, Dizziness, Nausea, Extreme Fatigue, Burning Hot but no registered fever.

Patient stated that she passes out from all vaccines or pain like bee stings. 30 seconds after vaccinating patient she passed out. She passed out 5 times over the next 10 minutes. We gave her some chocolate candy and a water, then she started feeling better after that.

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

HEART RATE INCREASED; BODY FEELS HOT; CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a parent concerned a 31 year old female. 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 12:40 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced heart rate increased. On 05-APR-2021, the subject experienced body feels hot. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced muscle ache. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, heart rate increased, headache, body feels hot, and muscle ache. This report was non-serious.

Dizziness / stomach pain during first hour. Woke up in the middle of the night with general malaise. By noon on Saturday (injection on Friday at 5:15pm), steadily rising fever. Peaked at 102.2 around 2pm. Continued in the 101 range until the following morning (Sunday). Additional persistent symptoms: Severe headache. Light sensitivity. Muscle pain. Joint swelling. Kidney pain. Chest heaviness.

Headache, muscle aches, fever, fast heartbeat, dizzines and weakness in the first day. the following days I have felt like when asthma starts, and I get tired quickly

Patient fainted and lost consciousness for about 30 seconds after receiving vaccine. When patient regained consciousness , she was alert and coherent. She was able to hold a conversation until the emergency personnel arrived. They took vitals and she was released to go home without further treatment.

Friday 4/9 Shortness of breath Hard to breathe Sore arm Saturday 4/10 Bad headache Sound wheezy MONDAY 4/12 Shortness of breath Left shoulder/chest pain

i have been experiencing chest pain, chills and 101-102fever since april 6. my arm joint are warm to touch. crqamping on my stomach. still experiencing it today April 13th

All regular side effects on day 1 + day 2. (Fever, chills, bone and muscle aches, headache). Shortness of breath started the next day on Sunday , extreme, far beyond normal asthma or any asthma attack. Went to urgent care on Tuesday- they said it was likely a side effect of j &J and tested me for COVID, kidney disease other things, all came back negtative. Apparently I wasn?t the first person they had seen with shortness of breath. Blood in cough and spit on Wednesday after 2.5 days of shortness of breath. Dizziness (extreme) throughout and chest pain, sternum hurt, chest tightness. Went to Er. They ran a lot of tests and they too said they had seen others with shortness of breath from j and j. They ruled out many things like pneumonia, a birth control blood clot, any lung diseases with X-rays and blood tests. I was given torkeril to ease the chest pain and tightness which it did. Blood stopped coming up in tissues. Doctor said likely inflammatory reaction to the vaccine in lungs, (I have a piece of paper proving that) and cartilage and sternum., which hurt extremely when he touched it. Blood was likely from burst capillaries from overcompensation from trying to breathe. Recommended I return if more blood came up, which it hasn?t. Shortness of breath has not subsided. I can?t even hold a phone app without being winded. So email back, don?t call.

Redness/swelling at injection sight. Soreness at injection sight. Dizzy, migraine, nauseous, fainting spell, and body aches.

Within 20 minutes my arms were tingly, but that was short lived. Later in the evening I got a nose bleed that coagulated right away. First in my right nostril, and a couple hours later when laying Down for bed, in my left nostril.

4/6/2021 Around 5 pm I began experiencing fatigue, which lasted for one week. 4/6/2021 Around 7 pm, I had a temperature of 100, which quickly escalated to 103 by 8:30 pm. I took two Tylenol around 7:30 pm, however my temperature remained at 103. Around 11 pm, I took two ibuprofen. Finally, around 3 am, my fever broke. My temperature returned to normal by 8 am on 4/7/2021. 4/6/2021 I experienced a racing heartbeat from 7:00 pm until midday on 4/7/2021. 4/6/2021 I experienced a headache beginning at 8:00 pm. I still have a mild headache as I write this, on 4/14/2021.

CHest pain radiating to Back and Jaw , nausea , lightheadedness , Admitted for 2 days to hospital for testing Diagnosed with Pericarditis-

Pt presented w/ chest pain, pulmonary embolism confirmed via CTA Chest on 4/15/2021 1 week after J&J vaccination (4/7). Also tested positive covid on 4/15. Being treated with heparin infusion

Per NP note, "This is a 31 y.o. female presenting to the emergency department with a chief complaint of intermittent headaches onset five days ago s/p Johnson and Johnson vaccination. The patient's headaches are localized to the right front side of her head and are described as severe and "throbbing". She notes that these headaches are nothing like she has experienced before. Associated symptoms include dizziness. The patient was instructed to come here by her nursing school, who is concerned she may be at risk of CVA due to the recent vaccination. The patient got a notification from CVS warning about risks of the vaccine which prompted her concern as well. The patient denies any facial changes, fever, sore throat, cough, nausea, vomiting, diarrhea, urinary complaints, abdominal pain, shortness of breath, or chest pain. The patient has no other symptom complaints at this time."

ABOUT 5 MINUTES AFTER THE INJECTION THE PATIENT BECAME DIZZY AND LIGHTHEADED , ALMOST FAINTED. SHE WAS HELPED TO A IMMUNICATION AREA WHERE SHE STATED THAT HER HEARING AND VISION WERE FADING. AFTER 5-10 MINUTES SHE STARTED TO FEEL BETTER , AND THEN THE SYMPTOMS RETURNED AGAIN FOR ANOTHER 15 MINUTES. THE PATIENT'S TEMP, BLOOD PRESSURE, AND PULSE WERE CHECKED FLUIDS WERE GIVEN AFTER ANOTHER 15-20 MINUTES THE BEGAN TO FEEL BETTER AND CALLED HER HUSBAND TO PICK HER UP

PE. Pt was placed on therapeutic Lovenox and supplement oxygen which was weaned off and pt discharged home.

Approximately 10 minutes after injection, I passed out. Witness said that I was unconscious for approximately 1 minute. My body shook, and it appeared that I had a seizure. Immediately upon waking I started vomiting and having uncontrollable bowel movements for about an hour. I felt confused for about 30 minutes and was unable to speak for a few moments upon waking. When I arrived at the hospital I was still vomiting and having uncontrollable bowel movements. I was given fluids and zofran and sent home without further testing.

The next morning I went to urgent care because I was experiencing really bad chest pains and body aches where an EKG and chest X-Ray were perform and I was released and advised if the symtoms got any worse to come back or got to the ER. For the next week the chest pain persist and got worse. I experienced severe chest pains, struggled with breathing at night, was extremely tired and felt worn out. I had sharp pains throughtout my body so I went to the ER where a EKG and D-Dimer test was perfomed and was advised it was elevated and I left. I went to the ER later that day who checked the D-Dimer who advised it was normal and was I was released from there as well after monitoring. The next day I began having sharp pains in my stomach and diarreah which prompted me to now go to hospital where a CT scan, X-Ray and EKG was perfomed there also which all results came back normal and advised I reach out to a Cardiovascular Specialist for the Chest pains and I have an appointment scheduled for 4/21/21 for further followup on that

NOSE BLEED; BODY ACHES; CHILLS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. 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: 1808982, 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 body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and severe headache on 09-APR-2021, and had not recovered from nose bleed. This report was non-serious.

Presented to ED 4/18 with severe L sided chest pain since 4/17. Arm weakness and numbness 4/18 that lasted a few hours but resolved. No vision changes. O2 sat was 100% on room air. Diagnosed with PE. No recent mobilization. Does not smoke or use illicit drugs. Was admitted to the hospital telemetry unit 4/18-4/20. Discharged on apixaban. I do not have any information on the vaccine Lot number received.

D-dimer is mildly elevated - 0.64 lower Abdomen pain - moderate, lightheadedness since 7th day of vaccine (04/16)

Saturday 4/10: 3:00 pm- first sign of headache -anxious and fatigued, series of falling asleep and waking up confused 10:41pm: First sign of chills and running ?hot and cold? Sleep was disturbed with intense vivid dreams and waking to sweat and running hot and freezing cold Sunday 4/11: 2:15 pm: Headache, sweating, diarrhea 6:51 pm: experienced confusion, brain fog, muscle tightness all over body Monday 4/12: 8:15 am: Woke up to muscle soreness, brain fog, and stuffy nose with green mucus. Left arm from at injection sight still sore. 8:53 am: Experienced disorientation and concern about safety driving to work 10:53 am: Dizziness and overall feeling of being unwell. Series of running hot and ?clammy? Expressed that everything seemed like a dream-like state. Experienced forgetfulness, confusion and uncertainty. 11:59 am: Ran hot and cold going from sweating to shivering cold. 12:02 pm: Questioned ?what?s real and what?s imagined?, hard to grasp reality. Fatigued, confused and trouble at work concentrating. 12:35- 1pm: Shivering cold, difficulty regulating body temp 2:30 pm: Starting feeling a little better, body temp started to go back to somewhat normal Tuesday 4/13 1:13 am: woke up sweating drenched and anxious, confused and achy. Experienced unusual amount of milky discharge not usually present in between menses. Throughout the day experienced less confusion as before, but still sore and not well overall in general Wednesday 4/14 4:15 am: woke up with major feet cramps, toes curling in without release for over an hour. Intense pain that had not been experienced before with the length of the duration of the cramp in both feet. 7:15 am: Feet cramped on and off, noticed left eye swollen (previously has happened before but not sure reason why). Took a Claritin and drank water to help with the cramping. Experienced immense anxiety about driving vehicle to work due to the muscle spasms now mostly on the left foot. 8:07 pm: Left foot was still cramping up sporadically throughout the day with lingering pain when muscle was relaxed Sleep throughout the night was accompanied by vivid intense dreams and waking up with more cramping in feet, more the left foot now Thursday 4/15 7am: Cramps in feet were still present, decided to check in to an urgent care to check it out 9:30 am: MD Now Urgent care visit- ran urine analysis and blood tests. 10:30 am: Discharged from Urgent care with following diagnosis: Acute cystitis without hematuria, abnormal urinalysis adverse effect of vaccine, initial encounter cyanosis of skin, shortness of breath and protein found in urinalysis. Instructed to immediately get CT angiogram to rule out blood clot. 12: pm Admitted to Mount Sinai Emergency Room-blood work, XRay and IV given. details below Discharged with the following diagnosis: Foot cramps - Primary Local reaction to COVID-19 vaccine Friday 4/16 Subtle and lingering muscle spasm on left food. Experienced chills and consistent headache throughout the day Saturday 4/17 10 pm: Began to run a fever however did not check the temperature. Radiated heat and friend took care of me throughout the night as I sweated with confusion Sunday 4/19 Complete fatigue and tiredness, cramping in the foot seemed to have subsided. Still was running hot throughout the day. Monday 4/20 Took off work due to exhaustion and muscle ache and what seemed to be a fever Thursday 4/23 Followed up with General Practitioner Dr. Franco and was advised to report my experience with the Johnson and Johnson vaccine. Feeling better as of Friday 4/24 with slight fatigue but body temperature seems to be ok. No signs of the lingering cramping in the left foot but still slightly achy all over the body.

WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

Client received Jansen Covid Vaccine on the Left arm and immediately started to feel "weak and lightheaded" client looked pale and sweaty. Position client laying on a cot and elevated her legs. Her BP was 113/75, client is responding appropriately to questions and indicates that is starting to feel better. 5 to 10 minutes later, client indicates that she her Left arm is "numb and tingling" as we are asking her to describe her symptoms she is starting to slurred her words and she said that she can not feel her left side. 911 has been called and on-site paramedics are evaluating the client. Engine on site and transported client to the hospital.

RAPID HEART BEAT; VERTIGO (CAN'T WALK AROUND); TINGLING IN RIGHT SIDE OF HEAD; NUMBNESS IN RIGHT SIDE OF HEAD/NUMBNESS TO THE RIGHT BODY; SEVERE MIGRAINE; BRAIN FOGGINESS/COULD NOT THINK CLEARLY/COULD NOT SPEAK CLEARLY; FLU LIKE SYMPTOMS/CHILLS/FEVER/NAUSEA; LOSS OF APPETITE; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced flu like symptoms/chills/fever/nausea. On 13-APR-2021, the subject experienced brain fogginess/could not think clearly/could not speak clearly. On 14-APR-2021, the subject experienced vertigo (can't walk around). On 14-APR-2021, the subject experienced tingling in right side of head. On 14-APR-2021, the subject experienced numbness in right side of head/numbness to the right body. On 14-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced rapid heart beat. Laboratory data (dates unspecified) included: Heartbeats increased (NR: not provided) 70 bpm, and MRI brain (NR: not provided) Normal. Treatment medications (dates unspecified) included: vitamins nos, and metoclopramide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine, and the outcome of flu like symptoms/chills/fever/nausea, vertigo (can't walk around), brain fogginess/could not think clearly/could not speak clearly, rapid heart beat, numbness in right side of head/numbness to the right body, loss of appetite and tingling in right side of head was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

THROMBOSIS; Dizziness; Pass Out; Weakness in the all side of the body; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included sea food allergy, and other pre-existing medical conditions included the patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 11:25 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included metformin for drug used for unknown indication. On an unspecified date, the subject experienced thrombosis, dizziness, pass out, and weakness in the all side of the body, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: X-ray (NR: not provided) heart, head and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombosis, dizziness, pass out, and weakness in the all side of the body. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This is a report of a patient, who was noted to have thrombosis on unspecified time after receiving the covid-19 vaccine ad26.cov.2. Patient's height and weight were not reported. Patient medical history was not reported. Concomitant medications included metformin for unknown indication. Patient is allergic to seafoods. On an unspecified date, the subject experienced dizziness and passed out. She also had weakness on the left side of the body. Patient was noted to have thrombosis. Patient was hospitalized, where laboratory and diagnostic tests were done. Results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.

Started experiencing chest pain on March 26th in the evening. I went to my primary care physician that Friday and she performed an EKG that came back normal. She told me if the pain persisted to go to the ER to where they could further evaluate me. A week later I went to the emergency room. They performed a CT scan and EKG and ran blood work everything came back normal. They did state that I had a pulmonary nodule that was benign and to get it rechecked in one year. For aftercare I was Referred to a cardiologist. Upcoming appointment is May 14th 2021.

Began on 3/26/21 with numbness in face. Woke up on 3/27 with numbness in feet. Spread to my feet and up legs and arms through next couple days. Fatigue increased dramatically, though it was present prior. Dizziness, sharp pains in left ear in skull, nerve issues. The following is a log from when the symptoms became most intense, so significant I have not been able to drive myself and been working from home due to balance issues, no feeling in feet, and neurological symptoms. After different a week and a half,, i sought medical care and began logging daily as follows: Fri 4/9: fatigue was high, neuropathy present. Balance was off. Stabbing sharp pains into the left ear but behind the ear in head. Dizzy spells with static feeling rush in forehead lasting a few seconds and passing. Gate while walking feels awkward and difficult. Think walking after sprinting on a treadmill plus's stiffness Sat 4/10: couldn't eat. General malaise. Fatigue. Neuropathy and balance issues present. Gate slightly improved. Noted increase in joint pain and popping in wrists elbows hips and knees. Needed white noise to cover ear ringing to sleep. Sun 4/11: feeling a bit better. Able to eat. Gastric issues after eating. Slightly more energy but neuropathy and balance was frustrating like superglue on my fingers and areas of my feet with no feeling at all surrounded by pins and needles. Aching in wrists and pain shooting down through to heel of my foot. Ear ringing more noticeable. Two instances of ice pick ear pain. Monday 4/12: neuropathy present, balance improved. No digestive issues. Feeling more stable while walking. Still numb in hands and feet and part of my face but less pronounced. Ear ringing unbearably loud and constant. Tuesday 4/13: slightly less energy but neuropathy still seems improved and not losing balance as much. Ears obnoxious, joints popping and cracking constantly. Pain in wrists and hands. One instance of ice pick ear pain Wednesday: same as Tuesday, but no ear pains. Had to take a nap in the middle of the day due to worn out feeling. Laying in bed felt something in my back snap, then a stabbing pain into my lower right side of my back. Aching like the skin was hurting for hours. Thursday: other symptoms same as Tuesday. Ears ringing crazy loud, stiff in the hips more noticeably. Neuropathy present with dizzy waves/vertigo. Low back skin pain right side continue. Also right hip. Gate while walking is starting to feel like it did before after a few days of improvement. Friday: back still hurting. Neuropathy increased. More numbness than previous few days. Very stiff throughout lower back hips and legs. Low back pain. Gate while walking feels awkward and robotic. Ears ringing. Joints throughout cracking/popping. This is not historically common for me. While washing dishes got shooting pain down my left wrist back of hand almost shooting down the veins to in between my pointer finger and thumb. Painful to touch. Immediate strong increase in the pins and needles in my hand concentrated in finger tips but now radiating up forearm too. .numbness in feet and part of my face. Whole body aching. When trying to sleep kept getting head rush static attributed to Benadryl to sleep and staying up too late. Saturday: very tired. Back hurting in morning. Felt better after getting up. Kept feeling head rush like static in forehead continuing on and off throughout the day into the night with dizziness almost like I might pass out. Nausea and low appetite Fatigue higher than normal. Neuropathy still present. Ears ringing insanely loud and constant. Aching and stiffness in hands wrists and legs and feet in heel/sole. Chest pain in sternum. Had a few months ago almost daily for awhile. Went away til now. Sunday- neuropathy the same. Ears ringing the same. Stiffness throughout. Dizzy spells and static in forehead. Nausea and low appetite. Fatigue. Ice pick ear pain starting in evening a few times throughout the night. Monday. Neuropathy the same. Ears ringing the same. Slightly less pain and popping in joints. Fatigue high. No appetite. Ice pick ear pain starting in morning happening several times. PREDNISONE STARTED WEDNESDAY Wed April 21: feeling about the same. Ringing in ears, neuropathy same, fatigue high. Appetite improved. Ice pick ear pain a couple times. Neuropathy seemed to improve towards the end of the day, when it usually is worsening. Felt nauseas and sick to stomach before bed with digestive issues. Dizzy spells all evening with static feeling. Ears ringing constant. Thursday: neuropathy improved, still present and noticeable but I was able to walk normally and had more feeling than previous. Joints still cracking and popping. Not as nauseas or sick feeling throughout the day. No ear pain. Dizziness occasional, less than day before. Ears ringing constant. Friday: neuropathy still improved but present and noticeable, able to walk more normally than previous. Joins still the same. Not as nauseas or sick feeling. Chest pains in sternum and stabbing ice pick ear pains on and off all day. Very painful in the ear. Light headed/easily motionsick, but better than Wednesday worse than thursday. Ears ringing constant. Saturday: Neuropathy still improved, joints are stiff but not in pain. Light headed easily, ears ringing constant. This is the worst day for the ice pick ear pain yet. Repetitive ?attacks? concentrated in the morning enough to make me have to drop and hold my head. It was very painful and higher frequency than ever seen previously. Sunday: Feeling sore in my hip joints. Ears ringing constantly. Ice pick ear pain only happened twice. Neuropathy slightly more than day previous but okay and balance still improved. Chest pains in sternum present. Episodes of blurred vision/double vision towards the end of the day.

On the 28th of April, 18 days from the shot, I went for a walk and came home around 6:30 p.m. to the outside of my right calf bright red and hot. I went to the ER where an ultrasound was performed and they found a DVT blood clot. I am now on an anticoagulant, Xarelto and have an appointment with my doctor on the 5th to schedule more imaging and blood work.

Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: pt gets nervous during shots

Arm slightly sore at injection site. Right arm, right shoulder, upper back, neck, left shoulder, left arm all extremely stiff sore and weak. Fatigue. Slight headache. Chest feels weak when breathing but not sure if it's due to upper body muscle weakness.

Pt received vaccine and roughly 5 mins post vaccination pt became delirious and then fainted. Pt was put supine on ground to prevent falling. 911 was dialed. Pt came to roughly 30 seconds after fainting. Paramedics came and treated the pt 10 mins after episode.

The patient received the Janssen Johnson & Johnson vaccine from a certified immunizing technician. She was asked to wait 15 minutes after receiving the vaccine before leaving the pharmacy and remained seated in the post vaccination waiting area chair. She began feeling dizzy and lightheaded. She was caught by her family members and the pharmacist on duty before she fell. She briefly had a mild seizure and lost consciousness for a minute. When she regained consciousness she stated that she felt nauseous and was seeing double. 911 was called. EMTs arrived and checked her alertness and how she was feeling. The EMTs then took her off in a stretcher to the hospital out of an abundance of caution due to brief loss of consciousness.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient experienced lightheadedness, then passed out for about 20 seconds at around noon on 05/09/2021. Patient has recovered. Paramedics were called. Patient refused to go with paramedics.

Pt Came to outdoor clinic and received Janssen Vaccine in a her left arm seated in a chair. Five minutes later patient felt dizzy and passed out. Patient was lowered to the floor and woke back up immediately. Pt remained in a lying position and was slowly helped up into a sitting position. Pt stated she felt dizzy once again and passed out. Pt again immediately came to and stated she was embarased. Pt remained alert and oriented inside the trailer in lying position. Vital signs stable @5:45pm , BP 100/60, P66 ,T96.7, P66. EMS called to the scene . Vitals taken again at 6:00pm BP 110/70, P55, POx 99. Pt refused to be transported to the hospital and said she feels fine . Pt left with her boyfriend at 6:15 pm

Within 15 mins I was sweating and nausea, shaking, I passed out for less than 30 secs. I was shaking.

On Wednesday May 12th around 615 pm I started having symptoms of a stroke. I was scrambling my words, couldn?t talk right and my left side of my face wouldn?t move when I spoke or smiled. When I smiled my whole smile shifted to the right. I had my girlfriend call 911 because I knew I was having a stroke. The symptoms lasted about 6 or 7 minutes. By the time the emt got there I was talking fine and my face was back to normal. I went to hospital where a cat scan was done on Wednesday night and came back fine. The doctors decided to admit me because they wanted me to get an MRI in the morning, which I did and came back that I had a minor stroke. The doctors think the stroke had something to with me being on an estrogen birth control as well as some family history but my primary care doctor recommend me report this because I did get the Jansen vaccine and it could have triggered what happened. I was discharged on Friday 5/14/2021 and I know have to take aspirin every day for the rest of my life, plavix for 21 days, and Lipitor until my doctor thinks I can come off.

April 12 - stomach pains, came and went April 15 - stomach cramps, dizzy, like was going to faint, heart palpitations, felt really hot, disoriented/brain fog, had to sit April 16 - went to urgent care, checked blood levels, normal Went to doctor on Tuesday, tests normal Pain went away Thursday

superficial venous thrombophlebitis in the right leg pain, tingling right leg then neck discomfort/left sided chest pain treatment -NSAIDS, elevation, compression stockings, movement

passed out, later had chest pains, high blood pressure, high heart rate and was checked for a PE via catscan. Still experience racing heart periodically almost 2 months later.

Systemic: Patient fainted 2 times due to feeling dizzy and on one occasion for 5-8 seconds was shaking like a mini seizure. EMS came and cleared her, she refused the trip to hospital-Medium, Systemic: Seizure-Mild, Additional Details: As described above

On May 4th, I fainted shortly after waking up. Light headed and unable to sit upright, stand, or walk. Had a fever. Called out of work. Headaches, chills, nausea, pain at injection sight, bedridden for most of the day. Around 3/4 in the afternoon I called the doctor's office (phone kept ringing) so I called the nurse through the insurance company. Nurse advised me to stay home for now but to seek medical care if symptoms persisted for more than 3 days. Symptoms continued but were less severe on Wednesday May 5th causing me to miss another day of school. On Friday May 7th at about 12:50 AM I awoke to severe abdominal pain-the kind the pharmacist had warned me of when getting my vaccine. I could not stand or move. I never take aspirin and yelled for a family member to give me Tylenol. I called the nurse from my insurance company and she asked me a series of questions and advised me to seek immediate medical attention. My family called 911 and an ambulance was sent to the house. They checked my vitals and suggested a family member take me to the ER. My family took me to the Emergency Center. I was wheeled into the ER. ER did test but put "Abdominal Pain, Unknown Cause, (Female) on my paperwork. I missed another day of work due to my ER visit. Symptoms lessened but persisted for several days.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Looked over at chair patient was passed out, thought she was having a seizure. Had techinician call 911. It took a minute for patient to come to. She felt hot, and kept feeling like she was going to pass out. Ambulance/Fire came and she signed off, they stated that she just passed out, that it is common. Patient left feeling ok and on her own.

The day after I experienced extreme muscle and joint pain that lasted about a week. And it started to get better but the following Saturday I got a very terrible headache. And over the course of that week I started bruising very easily and all the veins all over my body were very prominent. The headache wouldn't go away and I started to have chest pain by that monday. And at that point all the muscle and joint pain came back and it was very very painful. At that point I called my primary care provider and they scheduled me with someone else in the clinic because i was having the chest pain. And they did a test for covid and urged me to go to the emergency room, which i did. After that I went to the emergency room and sat for 5 hours, they did bloodwork to check clotting factor, basic blood panel and also a CT of my head. According to them, everything was normal and they sent me home with a terrible headache. My biggest complaint was the bruising all over my body but no one ever looked at that.

Suffered a stroke on May 9, 2021. Rushed to the ER and administered TPA, then surgery was performed to get out the rest of the clot. Symptoms: Fainting, Right side paralysis, slurred speech

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Additional Details: PATIENT FELT DIZZY AND LIGHTHEADED ABOUT 5 MINS AFTER ADMINISTRATION OF THE VACCINE. THEN PATIENT FELT SLIGHTLY BETTER ONLY FOR A FEW MOMENTS THEN NOTIFIED THAT SHE WASN'T FEELING GOOD AT ALL. I TRIED TO HAVE PATIENT ELEVATE HER LEGS UP ON A CHAIR BUT WHEN SHE STOOD UP, SHE IMMEDIATELY DROPPED, ALMOST LOOSING CONSCIOUSNESS BUT I WAS THERE TO CATCH HER AND GENTLY LAY HER ON THE GROUND. THE PARAMEDICS WERE IMMEDIATELY NOTIFIED. PRIOR TO THEIR ARRIVAL, SHE WAS CONSCIOUS AND FEELING BETTER.

Right after my vaccination my period was 15 days late. It?s usually on the date by one day less or more but never 15. Period is very heavy with tons of blood clots some have been as big as a strawberry ( I?ve never had blood clots in my period ever ) cycle is completely off days are all messed up I?m ovulating the day my period stops.

Patient received the J&J vaccine in her L arm at 1:11 pm. Patient was sitting in the observation area and started to complain of feeling warm and dizzy, began at 1:19 pm. Vital signs taken at 1:22 pm, BP 108/66, HR 50, T 97.0, RR 16, O2 99% RA. Patient stated she felt sweaty, cool/clammy and dizzy. She appeared pale and diaphoretic. Patient ambulated indeendently into the seccluded first aid room. Patient lied down onto the cot. Vital signs taken again at 1:28 pm, BP 102/58, HR 54, RR 15, O2 98% RA. Patient said her baseline BP was "normal" but couldn't remember the numbers. Legs elevated, patient stated she was starting to feel better. Denied dizziness or nausea. At 1:38 HR was 43, 911 called at that time.

31 year old female with no know medical condition vaccinated on left arm, deltoid area started complaining of light headedness and decreased blurry vision, patient was lay down on the floor and while in the process faints, pateint legs were raised and patient recouperated conciousness 5 seconds after, patient recovered completely and was discharge home

5 MINUTES AFTER VACCINE GIVEN PT WENT UNCONSIOUS AND HAD WHAT APPEARED TO BE CONVULSIONS FOR ABOUT 4-5 SECONS. PT REGAINED CONSIOUSNESS. EMS WAS CALLED PT WAS STABLE. PT DECLINED EMS TRANSPORT TO ER. PT LEFT CLINIC

- April 3- April 5: fevers over 100 - April 5 - April 11: migraine 24/7 - April 5- April 30: extreme exhaustion, difficulty waking in the morning, completely black out in bed, difficult to breathe when waking up - April 12 - today July 4th: leg tightness/pain and exhaustion easily. Unable to keep up with regular activities without feeling exhausted. Shortness of breath/labored breathing, overall body weakness, unable to talk/walk/breath when it happens. I lie down for hours with an ice pack on my chest. Doctors have ran blood tests, checked for blood clots and everything came back normal. - April 3 - today July 4th: Period has been irregular, ovulation days are unpredictable. Prior to vaccine, I had regular periods and regular ovulation dates.

Patient received COVID -19 vaccine Johnson & Johnson on 7/1/21. On 7/2/21 from an outside facility, patient presented to urgent care with chest pain/tightness, SOB, lightheadedness and fatigue with headache. She was referred to the Hospital ED department for further evaluation. Per ED visit, patient reassessed and feeling better. She felt comfortable discharged home. File this incident for record keeping.

Bilateral Pulmonary embolism based on CT chest, symptoms started after 5-6 days of J&J COVID vaccine. Possible pancreatitis

NUMBING AND TINGLING SENSATION IN ARMS, HANDS AND FEET; MUSCLE SPASMS IN ARMS AND LEGS; TWITCHES; CHEST DISCOMFORT WHICH COMES AND GOES WITH HER CYCLE; ANXIETY WHICH INCREASES WITH HER CYCLE AND IS RELIEVED AFTER HER CYCLE; INCREASED PMS SYMPTOMS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline hypertensive, and pms symptoms, and other pre-existing medical conditions included patient had no known drug allergies. patient was not taking any current medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, chest discomfort which comes and goes with her cycle, anxiety which increases with her cycle and is relieved after her cycle, and increased pms symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort which comes and goes with her cycle on 08-JUL-2021, and the outcome of numbing and tingling sensation in arms, hands and feet, muscle spasms in arms and legs, twitches, anxiety which increases with her cycle and is relieved after her cycle and increased pms symptoms was not reported. This report was non-serious.

INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.

After receiving the vaccine at 9:30pm, I was awoken at approximately 4:30am that night/the next morning with an extremely high heart rate. After about thirty minutes, I was able to calm down and my pulse/heart rate dropped down to a level that still seemed elevated, but no longer caused a great deal of concern. This event was followed by nausea for the remainder of the day.

'AT APPROX 1007AM, PT C/O LIGHTHEADEDNESS AND DIZZINESS. PT WAS COLD, CLAMMY, PALE AND DIAPHORETIC. NURSE TOOK HER VITALS: B/P100/70, P 38 02 92% RA. PT STATES SHE DOES HAVE A 'PHOBIA OFNEEDLESAND WAS VERY NERVOUS ABOUT COMING TODAY' PT WAS BROUGHT INTO THE NURSERY ROOM WITH ASSISTANCE TO A COUCH. PT WAS INSTRUCTEDTO LAY FLAT. A MAKE SHIFT PILLOW WAS PLACED UNDERHER FEET TO ELEVATE HER LEGS. PT WAS ALERT AND ORIENTED X3. PT DENIES SHORTNESS OF BREATH, CHEST PAIN,OR HEADACHE. SITE OF INJECTIONWAS ASSESSED AS PT C/O A SORE ARM. ARM WAS W/O BRUISING OR SWELLING. PT WAS GIVEN WATER TO DRINK AND STATED SHE WAS 'STARTING TO FEEL BETTER'. PT CONTINUED TO LAY FLAT FOR APPROX 40 MINUTES. PT VITALS WERE RETAKEN: 110/78 P68 PO2 98%RA. PT MOTEHR WAS CONTACTED BY A HOSPITAL VOLUNTEER TO INFORM HER OF WHAT OCCURED. PT STATED SHE FELT WELL ENOUGH TO LEAVE. PT INSTRUCTED IF CONDITION RETURNS ORSHE EXPERIENCES ANY SHORTNESS OF BREATH ORDIFFICULTYBREATHING TO CALL 911. pT WASABLE TO SIT UP WITHOUT DIFFICULTY OR ANY COMPLAINT OF DIZZINESS. PT AMBULATED TO HER VEHICLE WITH 2 PERSON FOR SAFETY. PT WAS DRIVENHOME BY A FRIEND/VOLUNTEER AT THE VACCINE CENTER. 1222: VOLUNTEER CALLED TO CHECK ON PATIENT STATUS, NO ADDITIONAL ISSUES REPORTED - 3/8/21 @ 1253

VIS given and discussed, no concerns voiced; Pt instructed to stay in clinic area for 30 minutes after receiving vaccine due to history of anaphylaxis to latex. Patient had epi pen in her purse. Patient experienced diaphoresis and light headedness approximately 15 minutes after receiving vaccine. Was able to walk over to exam table and layed down supine position. Patient appeared pale and diaphoretic. Patient agreed to use her own epi pen from her purse. NP gave her 1 mg epinephrine with her own epi pen from her purse in her right thigh. Blood pressure checked immediately after giving epinephrine, which was 118/78. Heart rate 104; oxygen saturation 94%. Ambulance called and arrived approximately 30 minutes after patient receiving vaccine. Patient denied wanting benadryl to be given and stated she felt a lot better, but felt dizzy if she tried to sit up. Stated that she feels that way when she uses her epi pen. Ambulance arrived within 10 minutes of giving epinephrine. IV started and taken to the hospital.

The patient presents with a complaint of palpitation while in observation area. Began feeling nauseated with lightheadedness and seen black spots no emesis. No chest pain. No respiratory distress. EMS on site. Patient agreeable to transfer to ED. Family on site. Supination PO fluids given and tolerated relaxation and deep breathing encourage throughout.

Felt fantastic until 7 hours after the shot at 5pm on 3/13/21. Then body aches began followed by fever (100.7 taken by ear) and then headache. Headache and body aches became intense by 6:20pm on the day I received the vaccine. I took Tylenol Extra strength which helped the body aches and lowered the fever a bit but did little for the headache. Chills started around 10pm accompanied by vomiting and severe diarrhea at 1am. Blood pressure spiked at 142/101 shortly after third vomiting episode. Called family to take me to ER but didn?t end up going because I was able to get vomiting and blood pressure under control by 3am. Figured doctors would just hook me up to an IV of fluids and send me on my way anyway, not something I can afford. No more fever or chills since 4am on 3/14/21. Headache and diarrhea and slight nausea still persisting 29 hours after the shot. Treating symptoms with Tylenol, water, pedialyte, chicken broth, and toast diet. Unable to care for my children, worst I?ve felt in years. Regularly get the flu shot with no side effects.

On the night of Monday 15, I started to have a fever over 102.2 degrees. Took Ibuprofen for the fever. At 3:00 AM of the same day started to feel weak. On that moment I lost consciousness and passed out. In my opinion, I experimented a down on sugar, which had never happened before. My husband was able to catch me and sat me on the floor. A minute after I recovered and my husband gave me fruit (Melon) to raise my blood sugar. On that moment I had lots of nauseas and diarrhea. I was feeling weak and dizzy all night and the next day. Today Wednesday March the 17 I have been feeling much better.

Patient woke up in the middle of the night with swelling in the face, tachycardia 125-130 bpm, BP 142/90, achy joints, sore throat, labored breathing, chills, nausea, fever 102.7

At about 2:35pm, 15 minutes post vaccination, patient was seated and leaned forward. She did not lose consciousness, but appeared pale. She stated she felt weak and dizzy. A cot and privacy was provided for patient. Patient states she did not eat or drink that morning so 8 ounces of juice was provided along with a cereal bar. Oxygen saturation remained WNL at this time and throughout the episode. At 2:40pm BP was 145/82. 2:44pm = 142/86. 2:46 = 148/84. 2:47pm = sat up on edge of cot. 2:55pm = 142/94. 2:57 = standing. Patient walked around at 3:00pm. HR remained WNL throughout the entire episode. Patient refused hospital/ambulance transfer. 3:05 = patient states she feels well enough to drive home. Patient refused help with transportation. 5:00pm on March 19 (same day), writer called patient for follow up. Patient states she feels better but still some feelings of dizziness and weakness. Patient was advised to reach out to her PCP for his or her awareness and/or recommendations. Patient was also advised if symptoms progress to call PCP office for triage or head to ER if necessary. Follow up call was placed on 3/23/21 at 10:30am. Patient states she felt weak and dizzy throughout the weekend and Monday, but states today she is at baseline.

Severe body aches, weird taste in mouth, chest tightness, difficulty breathing, fever, chills, the next day I think I hallucinated during the fever and extreme body aches. Most symptoms lasted 24 hours but the rest of them continued.

Patient went home asymptomatic 15 minutes after receiving the vaccine. She returned to the vaccination center 30 minutes later with complaints of repeated loose to watery bowel movements. Upon arrival she appeared pale and complained of dizziness and of being nauseated. No vomiting occurred but she was retching and burping loudly. After arriving to the center she had one more episode of diarrhea. She was afebrile, pale, had a strong regular pulse, a regular heart rhythm, clear bilateral breath sounds and complained of feeling dizzy. No abdominal pain.

1:42pm - took shot on upper right arm, felt needle and medicine go in, arm hurts and sore 4pm - arm hurts and sore, body starting to feel achy, start of headache 4:26pm - muscle that was injection feels vibratey, center of chest a little heavy and sore 6pm - arm hurting a little more, completely sore, a little itchy near top of right shoulder 6:46pm - bit more itchy all over, headachey, feeling hot 8pm - bad headache, warm to touch but having chills, soreness and aching, arm sore/hurts really badly, inside of nose hurts 10:23pm - woozy, pain and sore all over, burning up/fever, chills/shaking, heart fast, extremely dry mouth 11pm - thinny racing heart that was hurting, every time i tried to calm down then my heart got fast again, every muscle hurts down to feet to my neck 6:15am - still hot but not too hot, headache moderate, woke up covered on sweat possibly fever and tasting vomit a little, right arm sore, walking around weak but not feeling like im gonna fall over, ear pain on left ear, inside of nose hurts 12:42pm - no longer super hot, walking fine, right arm hurts bad and itches a little, moderate headache, body aches and esp in abdomen, vaginal itching

ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health. The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. 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.

At approx 23:31 03 Apr 2021 I experienced uncontrollable shaking and muscle rigidity. This lasted approximately 1 hour where upon I began to experience chills and extreme coldness. Approximately 1 hour later at approximately 01:30 I began to experience a spike in temperature around 101/102 degrees. I began experiencing shortness of breath, cough and congestion with rapid onset of nausea . Around 02:30 I had rapid onset increased heart rate, sweating, and severe headache. This lasted until approximately 07:30 on 04 Apr 2021. Upon waking I continue to experience low grade temperature around 100.4, moderate headache, joint and muscle pain, moderate fatigue and nausea. I took 2 Tylenol arthritis beginning at 08:00 on 03 Apr 2021 and repeated every 8 hours to current time of 17:00 on 04 Apr 2021. I have also taken meloxicam QD in addition to my rescue inhaler Xopenex and Zofran ODT for nausea.

ITCHING ALL OVER BODY; RASH; SORE ARM; FAST HEART BEAT OF 140 BPM; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vicodin drug allergy, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 23-MAR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced fast heart beat of 140 bpm. On 23-MAR-2021, the subject experienced rash. On 23-MAR-2021, the subject experienced sore arm. Laboratory data included: Heart rate (NR: not provided) 140 pm. On 23-MAR-2021 16:15, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from itching all over body, rash, and fast heart beat of 140 bpm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

patient passed out and fell down on the floor . Patient was alert and oriented, no swelling of lips or tingling on tongue . We had called 911 they came and checked her vitals.

PATIENT RECEIVED VACCINE- SAT FOR AWHILE THEN WALKED AROUND WITH HER HUSBAND IN THE STORE; PATIENT PASSED OUT; 911 WAS CALLED; PT REGAINED CONSCIOUSNESS WITHIN 1 MINUTE; WATER AND GLUCOSE TABLETS GIVEN. BLOOD PRESSURE AND PULSE OX CHECKED. NO PROBLEMS BREATING. PARAMEDICS FURTHER CHECKED PATIENT AND RELEASED WITHOUT ANY FURTHER TREATMENT. PATIENT REPORTS SEVERE MEDICAL PHOBIAS AND HISTORY OF SIMILAR REACTIONS

Approximately 5 minutes after her Janssen COVID19 vaccine the patient started coughing and felt her throat tightening. I had her sit down and told her I was giving her an Epinephrine 0.3mg shot. The shot was given in her left thigh and within a minute her throat cleared. I gave her a bottle of water. She said her heart was racing but it eventually slowed down. I asked her if she wanted me to call 911, she felt it was not necessary. Patient sat in our waiting room & checked in on her every few minutes, her symptoms improved. Patient was here over 45 minutes. She wanted to go & felt fine. I told her to call us or go to the emergency room if any problems arise.

Syncopal, did not fall, disoriented, at shot table, got shot then passed out. 0riginal BP 63/34, P 49 BP 96/53, P 65, nausea

Patient received vaccine and then fainted while still sitting in chair. Vaccinator caught patient and put her head between her legs. EMS was called, and patient work up before they arrived from next room.

Patient reported feeling dizziness and loss of hearing in the left ear. First blood pressure taken was low at 73/36. Retaken 3 minutes later and was within normal range at 121/83. Symptoms resolved 10 minutes later.

about 12 hours after receiving vaccine, I experienced EXTREME cold. My body could not get warm. I shook violently all over my body. I took tylenol. Then, I experienced extreme heat and could not get cold. I felt like I had a fever and took some tylenol. I did not take my temperature. I started experiencing chest tightness. It feels funny in my chest like I cannot breathe fully. Everything has gone away except for the chest tightness.

Pt received the vaccine where patient started to have Chest Pain, sob, and dizziness. Ems was called to pt's bedside. Pts symptoms continue and patient wished to be seen in ER. EMS took patient as requested.

There was no reaction on 04-01-2021 when the shot was administered. At 1:00am on 04-02-2021, I awoke to fever, sweating, racing heart rate, headache, and severe body ache. The racing heart, fever, and sweating lasted until 6:00am. The headache and body aches lasted until 04-05-2021. On 04-03-2021, I also experienced an allergic reaction around 8:00pm. My face, neck, and throat were red and itchy and my upper lip began to swell. I took three doses of Benadryl and the allergy symptoms went away.

Patient stated before vaccination she has a history of becoming faint with blood draws in past. Nursing there when medic vaccinated. Patient stated two min after she started to become faint. Patient lost consciousness Two assist to floor. Patient did not hit or injure any body parts. Patient breathing unlabored even. B/p 100/60 R 16 o2 98%. After 1 min patient arouse. Ice to back. Patient assisted to sitting position. Patient able to drink juice and cookie. Monitored 30 min. Declined EMS assist to hospital. After 30 min patient states she is feeling better and not dizzy. No slurring of speech able to swallow and gait steady.

Uncomplicated first and only pregnancy - 30w1d at time of vaccination - due date 6/9/21 - at routine prenatal appointment on next day, blood pressure was elevated: 140/96, 140/98, 146/82, 145/90. Concern for pre-eclampsia, hospital monitoring required.

10 hours after receiving vaccine, my muscles and joints started hurting, heart was racing, pounding headache, chills, I felt super hot but never ran a fever. Sweating profusely, I developed a cough. About 14 hours after receiving the vaccine, I felt like my heart rhythm was off, I could feel it skipping beats, then start beating really fast.

within 5 minutes of immunization: syncope, nausea later that day: feeling winded, lessened syncope and nausea overnight: fever 103 F, chills, body aches, headache continuing through today: occasional, mild lightheadedness, nausea and feeling winded

INJECTION GIVEN AT 1:47PM AND CLIENT REPORTED FEELING LIGHT HEADED AT 1:52. CLIENT ASKED TO SIT BACK IN CHAIR AND BREATH NORMALLY. REMOVED SWEATER AND REQUESTED WATER. OBSERVED IN CHAIR AND FAINTED IN CHAIR AROUND 1:55 P.M. FOR 1 OR 2 MINUTES. IN PROCESS OF CALLING 911, CLIENT REGAINED CONCIOUSNESS, AND CLIENT SAID FEELING OK, SO 911 CALL WAS CANCELLED. AT 1:57, SPO2 92, PULSE WAS 62. BP WAS TAKEN AT 1:58 AND 115/71.

Patient arrived at pharmacy to receive her vaccine. Patient seemed nervous. Pharmacist asked if she has any questions and whether she's eaten or drank anything today. Patient states that she's had a little something. Pharmacist engaged patient in conversation during vaccination. Patient was able to raise her arm and walk to waiting area after vaccination to wait her required 15 minutes waiting time. After around 5 minutes, pharmacist went to check on patients at the waiting area, and patient got up and mentioned that she's not feeling too well. In the next second, she had fainted on the floor. Associates in the store called 911 while pharmacist and pharmacy tech stayed beside the patient to monitor breathing and heart rate. Pulse was faint but breathing was steady. Patient was completely unconscious for a good 3-5 minutes, but she started opening her eyes when EMS arrived. After EMS took over, patient was able to sit up with assistance, talk, and respond. Patient was taken out of the store on a stretcher. EMS recorded that patient's BP was 132/82.

I received the shot at 11:25AM. At around 7:30PM, I felt the symptoms of the common cold: head ache, weakness, body aches, chills. By night time around 10PM, I had fever of 100F. The next day, Saturday, April 10th, I got my period in the morning. I had migraine and felt weak all day. Felt fine by 6PM. On Sunday, April 11th, I woke up feeling good but then around 12PM I got a heavy nosebleed.

FEVER, CHEST PAIN THAT HAS NOW LASTED 8 DAYS, SOB THAT HAS NOW LASTED 8 DAYS, CHEST TIGHTNESS THAT HAS NOW LASTED 8 DAYS. HEADACHE

Approximately 3 min after receiving the shot, I began to feel light headed. Light headedness increased over the next few minutes and I began to feel faint. My activity device indicated my heart rate took a sharp drop. At this point, I thought it best to lie down. I spent the next 5-7 minutes on the floor until I was able to sit up without feeling faint. I waited an additional 15 minutes before leaving. I felt somewhat shaky, but felt better by the minute.

Shortly after receiving the COVID19 (Janssen) vaccine the patient reported being faint. While seated with her partner the patient briefly lost consciousness. She regained consciousness quickly and was provided with water, a snack, and a cool/damp towel. The patient was instructed to elevate her legs and maintain a clear airway. Patient remained seated. Patient affect normalized within 10 minutes and the patient reported feeling much better shortly thereafter. Patient and her partner remained waiting at the pharmacy for a total of 30 minutes to ensure that she was alright. Patient reported that she has experienced fainting episodes in high stress situations in the past (eg at concerts, events, etc) and maintained that she will be ok.

After a few minutes receiving Janssen Vaccine at 12:45pm . Patient had syncope, patient fainted for about 10 seconds sitting on chair, regain conscious after. Decline additional treatment or call for emergency. Patient refused to stay for 30 minutes because of her anxiety. contacted patient at 1:55pm. Patient was back to home resting without any addition symptoms. Patient was instructed again to contact MD or emergency if any symptoms worsen ie skin rash , SOB, swelling or severe dizziness.

I received the vaccine on Saturday morning at 11am. Within ~12 hours of the shot (Saturday night), experienced intense chills and fever (reached 104). Fever was managed through the night and the following day with Tylenol, but varied between 99 and 102 the following day. I had muscle aches and fatigue on Monday and Tuesday. Mild Chest tightness began Tuesday.

Started to feel very cold and muscles started to tense and shake around 10:00pm. As I was laying down trying to sleep my heart rate increase to approximate 151bmp for approximately 9 mins and remained above 110bmp all night. When I woke up the next morning around 7:25am my heart rate was still approximately 110 bmp and I had a severe headache and nausea. After taking an extra strength Tylenol and eating a piece of bread I went back to sleep for 90ish mins and woke up feeling a little better. At that point my heart rate had dropped below 100 bmp.

Received vaccine at 3pm on 4/8 and adverse event happened the morning of 4/9. Leg cramps/pains, dizziness, shortness of breath, weakness, and fatigue. I passed out in the morning at a doctors appointment and took a couple minutes to get back consciousness. All color was drained from my face for hours and had to receive 2 bags of fluid. Still getting dizzy/light headed 5 days out from the vaccine.

Patient had a mild vagal reaction immediately following the injection of the vaccine and was observed for 15 minutes following and eventually cleared to leave the vaccination site

8 hours after vaccination I had a fever, vomiting, body aches, chills, I fainted, and had extreme leg pains. The symptoms went away after 24 hours. I took acetaminophen when the symptoms started and for the next 48 hours after.

7:00 pm Friday started getting left arm: numbness on whole left side of body, left side of face swelling and droopy. Felt a sharp pain in left arm near basilic vein and started swelling like a ball. Felt shortness of breath and dizzy with blurry vision. Almost passed out when stood up. Was rushed to the ER. Had Sharp pains shooting through left leg.

32-year-old otherwise healthy woman presents to the emergency department with increasing fatigue and palpitations with tachycardia. She received her Covid vaccine on March 8, had 3 days of subsequent myalgias with fevers, T-max 101.9 seemed to improve but she began having urticaria symptoms and was seen in this emergency department yesterday, 4/12 progressive recurrent urticaria symptoms unresponsive to antihistamines they were ultimately treated and improved with epinephrine. Today (4/13/21) the patient had fatigue and progressive weakness with palpitations with exertion walking up the stairs. She presented with tachycardia, her heart rate of 130, BP 140/79, she is afebrile with 100% pulse ox on room air. She has no evidence of exudative pharyngitis or oropharyngeal allergic reaction. No signs of meningitis. She has no evidence of pneumonia. No abdominal tenderness. She does have some nausea. She denies any urinary frequency urgency. No abnormal vaginal discharge. No other rashes. COVID test negative. Patient admitted for observation

Janssen COVID-19 Vaccine EUA Patient received Janssen vaccine 4/9/2021. Patient presented to ED 4/14/2021. Patient is a very pleasant 32-year-old female, with past medical history significant for taking bromocriptine for prolactin issues as well as metformin for type 2 diabetes, presents to the emergency department for evaluation of continued headache over the last 1 week. Patient also reports chills, sweats, body aches ever since receiving the Johnson and Johnson coronavirus vaccination 1 week ago. The headache started after receiving the vaccination and has been continuing ever since. It does not fluctuate in intensity. It is caused her blurred vision and difficulty focusing. No tinnitus or hearing loss. No slurred speech, vomiting, numbness or weakness or tingling to the extremities or any facial droop. No history of strokes or aneurysms. She is not on blood thinning medication at all. No upper nor lower extremity swelling or redness. No abdominal pain, nausea, vomiting or diarrhea. She reports the continued subtle shortness of breath and body aches since the vaccination as well. No rapid heart rate, long flights, long car rides, surgeries nor oral contraceptive use. Patient started on heparin drip. Neurologist recommended transferring patient to higher level of care. emergency department physician is willing to accept the patient at their facility. Patient transferred to the facility.

Patient received J&J Janssen vaccine 4/8. She reported nausea, abd pain, fevers, and fatigue since received vaccine. On 4/13/2021 presented with worst headache of life, trouble speaking, and abnormal gait. Exam showed L sided motor weakness and impaired sensation. Initial CT normal, received tPA for presumed stroke. Platelet count normal. Currently admitted to critical care unit at Hospital.

bruising, shortness of breath fever severe headaches joint paint , bloody noses, left leg pain, body aches

The first 24 hours were very difficult for me. I have never been so sick in my life. I got the typical muscle aches, chills, etc. In fact I got every side effect listed plus more. I want to discuss the other side effects. On day 3 I started to develop extreme chest pain and pressure. It is a dull pain as if someone if sitting on my chest that will not go away. I also started to experience sudden bouts of dizziness and vertigo. It will not go away. Today is Day 7 and I spent the night in the emergency room because my chest pains got so strong. However, all the work up came back okay. I also have this strange feeling of electrical shocks running thru my head, those last about .5 seconds and go away, but it is a very weird feeling I have never experienced. I also have a strange desire to constantly burp, when I do my chest pain feels better. If I don't burp my ears start to feel full and sometimes they ring. Its Day 7 and I still feel SO miserable. Why id no one speaking about these chest pains? I know 5 people who have experienced the same.

RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rapid heartbeat. On MAR-2021, the subject experienced feeling anxious. On MAR-2021, the subject experienced loss of sleep. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced skin felt hot. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced achyness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, feeling anxious, loss of sleep, nausea, skin felt hot, cold, and achyness on MAR-2021. This report was non-serious.

The patient presents to Urgent Care today with complaint of fever and dry cough x7 days. She had the J&J covid vaccine on 4/9 and began not feeling well on Saturday. She developed a fever and chills and tachycardic. She said every day since then her fever has been going up and down. She started to vomit on Sunday, last time she vomited was Monday night. She was having diarrhea as well. She denies rhinorrhea or congestion. She denies throat pain. She went to the ED on Tuesday and she was given fluids. She said she felt a lot better on Tuesday when she left the ED. She said now she feels bloated. She does have an appetite but because she feels full she isn't eating a lot but states she drinks 1 gallon of water a day, her water bottle is with her. She is having some sob. She denies chest pain. She has bilateral lower back pain when she is sleeping. She took anti nausea meds which did help. She has been taking ibuprofen.

Severe headache, nausea, diarrhea, tachycardia, shortness of breath, fluid in lower lobes of lungs, elevated O BNP, high temperature >103. Blood pressure increased

Pt states she had weakness that began about 30 minutes after vaccination. This included muscle spasms and muscle pain "all over." She states she had flu-like symptoms for ~1.5 days after vaccination and then felt ok until approximately 3/22/2021, when muscle weakness began and has not stopped. She presented to another hospital on 3/29/2021 to the emergency room and "had a full work-up including EKG, x-rays, and lab work" and was told she had a viral illness. She was given a prescription for azithromycin and ibuprofen, as she was complaining of sore throat. She presented to the emergency room on 3/30/2021 with c/o generalized weakness, back pain, myalgias and chest pain. She also c/o fever and chills. Temp in the ER was 98.5F. Physical exam revealed "diffusely tender abdomen, no rigidity or guarding" and "diffusely tender back all throughout." 3/31/2021-saw family physician w/ c/o cough and myalgias, negative for back pain and chest pain/palpitations. Sore throat and cough were improved. Was diagnosed with an apparent viral illness and supportive care. She was advised this could be a viral illness and discharged to home in stable condition. 4/11/2021-Pt reports she went to urgent care b/c felt she had a bad ear infection and eyes were hurting (mostly right); was diagnosed with sinus infection and that ears looked ok. Was told to stop azithromycin and begin amoxicillin and ibuprofen. 4/16/2021-presented to emergency room. "Patient with 3 weeks of progressive symptoms of headache, blurry vision, nausea, weakness, and poor control of her bowel and bladder. Symptoms are constant with gradual progression with a duration of 3 weeks. Timing is constant. Severity is now severe. Quality is sharp, tight headache." Vision changes got worse when she was on the flight there. "No exacerbating or alleviating factors. Not associated with fevers. Does have some nausea and muscle aches. Diffuse tremors and difficulty walking without assistance. PE revealed mild psychomotor retardation, tremulous and diffuse weakness, and Romberg present. Mild right sided papilledema. 4/17/2021- further HPI recorded-The patient is presenting for evaluation of headaches, paresthesias, numbness. The patient is a fairly good historian and tells me that symptoms began after she received the Johnson & Johnson COVID-19 vaccine. Patiet began to feel fatigued, malaise, numbness and weakness over the legs. Patient had some mild blurriness of vision in the right eye. Symptoms have been persistent and patient began to have some difficulty with walking and feeling off balance. Patient describes the headaches as primarily right-sided. According to nursing staff, the patient has also had some incontinence of urine today. Patient has had some numbness over proximal legs and "private areas". 4/19/2021 ? Assessment as per Infectious Diseases physician; Pt with continued intermittent headaches. Has continued difficulty bearing full weight due to unsteadiness. No loss of sensation at arms/legs. Has action tremor, wide gait, hyperreflexia of arms/legs bilaterally. ADEM Hyperreflexia CSF pleocytosis Fatigue Headache, new onset Patient has nonspecific findings of CSF pleocytosis as well as clinical findings concerning for ADEM. No infectious cause for this problem; temporally associated with receipt of Janssen COVID vaccine. 4/19 Assessment as per Neurologist; Question of transverse myelitis/ADEM: Perhaps induced by the Covid vaccine On steroids MRI scan of the thoracic spine shows demyelination but no contrast enhancement Continue to work with therapy services No signs of CNS infection and antibiotics discontinued. The patient continues on methylprednisolone 500 mg iv q 12 hr at this time (4/19/2021).

Tonight I started to develop pain in my mid-back, where my kidneys are located but only on the left side. I also have headaches that wont stop with electrical zaps in my head. I also have weird digestion noises located near my liver region. I have developed a rash on all of my neck. I also woke up with the left side of my fact frozen, it took a while for it to start working again. Might be Bells Palsy. Non-stop chest pain which has gone from terrible to manageable over the last 10 days.

BODY ACHES; LOSS OF APPETITE; DYSPEPSIA; UPPER CHEST DISCOMFORT; SORE THROAT; CHILLS; NAUSEA; SHAKING; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, personality disorder, alcohol dependence, opioid dependence, seizure, and adjustment disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced dyspepsia. On 13-APR-2021, the subject experienced upper chest discomfort. On 13-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, loss of appetite, dyspepsia, nausea, chills, shaking, upper chest discomfort, and sore throat. This report was non-serious. This case, from the same reporter.

After getting the Johnson & Johnson shot at 3:15PM on Saturday (I did pass out at the vaccine clinic approx 2 minutes after receiving the vaccine and had to be escorted to a room to lay down) I developed chills, fever, and aches that night, but that's not what I'm reporting. Sunday night, I developed painful red spots on my right inner labia. Monday morning, they had multiplied and darkened. I went in and saw my gynecologist, at 2:00PM. By that time they had worsened again. She could not immediately identify it, but swabbed it to test for herpes. She also prescribed an anti-viral, a rotating dose of OTC 600 ibuprofen and 500mg tylenol, and that I should pick up Orajel for topical numbing. By Wednesday, the herpes test came back negative (as I expected, having never had herpes), and the spots had grown in size and turned into black and grey ulcers that were shedding with necrosis and were extremely painful. In addition, I was experiencing near exhaustion. Dr. diagnosed them as Lipshütz ulcers. A severe immune response to the vaccine. In addition to the antiviral, she prescribed a steroid to help quiet the immune response and a few days worth of Hydrocodone to help with the very acute pain. As of writing this on 4/20/2021, I am still not fully recovered, although Dr. believes it will be cleared up completely in the next couple of days.

Headache Abdominal pain Irregular menstrual cycle: usually I never have one (IUD), and I had a period the day after the vaccination and it was heavy. Chest pain

4 days of right upper extremity pain and swelling with diagnosis of right upper extremity axillary vein DVT that was treated with DOAC apixaban.

Dizziness/vertigo. Feels like I?m falling for a split second or the earth shifted to the side. Also strange heart palpitations every so often, one or two hard beats then normal. Saw cardiologist in 2020 and there were no abnormalities. I did not have the covid virus.

On day 15 after receiving the vaccine, I still have heart palpations. Heart palpitations started the day I received the vaccine and it hasn?t gone away.

APPEARED PALE; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and fibromyalgia, and other pre-existing medical conditions included no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: 26/MAY/2021) dose was not reported, administered on 19-MAR-2021 14:20 for prophylactic vaccination. Concomitant medications included celecoxib, cyclobenzaprine hydrochloride, lithium, and losartan. On 19-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Remained WNL. On 19-MAR-2021 14:35, the subject experienced appeared pale. On 19-MAR-2021 14:35, the subject experienced dizziness. On 19-MAR-2021 14:35, the subject experienced weakness. On 19-MAR-2021 14:40, Laboratory data included: Blood pressure (NR: not provided) 148/82 mmHg. On 19-MAR-2021 14:44, Laboratory data included: Blood pressure (NR: not provided) 142/86 mmHg. On 19-MAR-2021 14:46, Laboratory data included: Blood pressure (NR: not provided) 148/84 mmHg. On 19-MAR-2021 14:55, Laboratory data included: Blood pressure (NR: not provided) 142/94 mmHg. On 19-MAR-2021 15:00, Laboratory data included: Heart rate (NR: not provided) Remained WNL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from appeared pale on MAR-2021, and dizziness, and weakness on 23-MAR-2021. This report was non-serious.

SYNCOPE EPISODE; NECK PAIN; LOSS OF APPETITE; BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, hepatitis C, HIV, opioid dependence, polysubstance abuse, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021 about one hour after the vaccination, the patient experienced neck pain, loss of appetite, body ache, dizziness, vomiting, chills, headache, and nausea. On 13-APR-2021, the patient experienced syncope episode and other symptoms got worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from syncope episode, chills, neck pain, loss of appetite, headache, nausea, vomiting, body ache, and dizziness. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked.; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-syncope. 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, UNDERLYING DISEASE

I have APS and am on warfarin maintained at a therapeutic level of 2.5-3.5. I received the Johnson & Johnson Vaccine on April 7,2021. On April 9,2021, I noticed swelling and tightness in my left leg, on April 13,2021 I noticed severe swelling in my right leg too. I met with my primary care physician who sent me for imaging which confirmed clotting. I was referred to the Emergency Room since my INR was 3.7 but I was still clotting. I was sent home with out treatment from Medical Center because I was therapeutic on my warfarin. On Friday April 14, I went to the ER after speaking with a hematologist at the facility. I was admitted and was put on fondaparinux.

As soon as I got the shot it felt like something was flowing through my body limb by limb. My chest starts to feel tight and my upper back my arms were tingling. My right calf and right lower abdomen began having a sharp pain. About 25 minutes later I began sweating and felt like my chest was going to rupture. My heart was racing. Broke out in hives. After about 8 hours I was bedridden Ill. I was puking, fevering, headache and could not move my body I was in so much pain. I was afraid to go to sleep cause I thought I was going to die.

On and off headaches since vaccine. 4/28 right calf pain/ cramping, 4/29 11am quick onset severe pressure headache followed by left side face, arm, and leg numbness/tingling/weakness. Within 1 or 2 minutes heart felt like it was racing combined with body shaking/shivering. Ambulance to the hospital by 11:45am, and she was treated with tPA Alteplese after a CATscan came back negative. Symptoms improved over a few hours. I am writing this 23 hours after the ambulance transport and patient continues to have outside and inside mouth numbness and throat numbness all on left side. Blood work hass been normal except low potassium, leg ultrasounds negative. MRI results pending. Patient is still hospitalized as of 10am on 4/30.

Within about a minute of receiving the vaccine, Patient stated she was feeling lightheaded. She started to lose consciousness/faint. I kept asking her if she was with me, and she would slowly and softly respond yes. Ice packs were placed on her neck and wrists and feet elevated. Patient stated that she was sweating. Within 5 minutes patient was approaching normal. Patient was kept and additional 15 minutes in the pharmacy and observed. Water was given to her at this time. Patient stated they felt fine by the time she left.

Overly tired, shortness of breath, chest pain, leg pain After 3wks of symptoms patient(self) went to hospital and it has been discovered patient has ( self) has a blood clot in Right lung. Patient (self) has no record or history of blood clots. Was treated with heparin while in hospital. Has since been discharged and sent home with a prescription for anticoagulant.

Patient returned to pharmacy 30 to 40 minutes following injection after sitting in the pharmacy area for 15 to 20 minutes and reported a little tightness at the top of the rib cage bottom of the neck. She did not report any shortness of breath/dizziness/light headedness, patient color was good, injection site was not inflamed and pulse was normal. Patient sat for 20 additional minutes and reported that tightness may have been elevating. I requested her two friends to take her to the nearest emergency room at Hospital for monitoring.

Patient is a 32-year-old female new patient 5 months post partum & currently breastfeeding, with seasonal and perennial allergic rhinitis and history of childhood asthma, referred by the emergency department to discuss anaphylaxis like reaction to the Johnson Johnson COVID-19 vaccination on 4/28/21. She received her vaccine around 2:00 p.m. She began developing itchiness in her palms/soles of feet and scalp that quickly developed into a a welt like rash about 3-1/2 hours after receiving the vaccine while on a walk with her husband; this was shortly followed by facial swelling over her right eye. They made it home and she got in a cold shower to cool down, became dizzy, started seeing spots and had difficulty breathing. Her husband called EMS and she was hypotensive when they arrived. She was given 2 doses of epinephrine (0.2 mg each per ED note) and a dose of Benadryl which helped. Shortly after the 2nd dose, she began having difficulty swallowing, maintaining the ability to breathe through her nose. She was given a 3rd dose of epinephrine and transferred to the ED; during transport an IV was started with an epinephrine drip. She was seen at Emergency Department; she was given IV fluids, solu medrol, tryptase level and had a normal EKG. She was discharged with an epi pen prescription. Tryptase is still pending at the time of her visit. She started a new prenatal vitamin at 11 am 4/28/21. Otherwise, she reports no new foods, medications or topical products. She did eat before going on a walk, pepper jack cheese, wheat thins, and black bean hummus. She is pretty sure she was not stung by a bee prior to onset of symptoms yesterday. Interestingly she reports recent urticarial episodes that occurred in February of 2021. These occurred when she was visiting her in-laws and occurred in the middle of the night, 2 nights in a row during the middle of her visit. She has never had hives previously. She reports no family history of hives or anaphylaxis. She reports no use of new topical products or medications.

Pt was given the vaccine. Within less than 5 minutes, she said she was feeling light-headed and proceeded to pass out. She fell to the floor, and I went out to assist her. She was able to keep her head from hitting the floor, and I supported her head as she regained consciousness. She tried to sit up but lost consciousness again and appeared to convulse (arms and legs drawn up). She regained consciousness again, and was completely lucid. We called 911 and EMT arrived and continued their usual procedures including checking blood pressure, heart rate, and blood glucose. Her BP was 130/80 laying, and 80/60 sitting. Her pulse was 50. Her blood sugar was 56 before consuming glucose and 71 after. She was given water as well. She declined a ride to the hospital but did have a friend give her a ride home.

Within 17-20 minutes of receiving the vaccine, I felt a burning, hot sensation in my throat. I let paramedics know and sat for about 10-15 more minutes. My mouth and throat became extremely dry and I had a tingly feeling in my feet. I also experienced high anxiety. An ambulance came and proceeded to bring me to the nearest hospital. In the ambulance, I began coughing, which caused tightness in my lungs and moments of needing to cough. My vitals were normal in the ambulance and I was given IV fluids. I arrived at the hospital around 4:30 pm. When checked by triage about 2 hours later, the nurse reported my vitals were normal, and that I shouldn't need epinephrine or lab work. She reported that "hopefully a triage doctor would be able to see me soon." I continued to cough into the evening, and began wheezing from coughing. I waited in the ER waiting room until just before 10pm. Triage could not give a time estimate of when I could be seen. I needed an inhaler or nebulizer treatment long before. I left the hospital after the nurse removed the IV port. At this time, the nurse reported my "rash on my chest was gone," although she did not mention a rash earlier in the evening and I did not notice it (had a jacket on). I did not need to sign or receive discharge paperwork because I was never seen by a doctor. I took Benadryl and gave myself a nebulizer treatment once I got home and all adverse reactions were gone the next morning. I experienced flu-like symptoms the next day.

Patient was sitting and state she felt she was going to passout. Patient became very pale in the face, took blood pressure and it was 80/55.

Approximately 12 hours after injection, I began to experience heart palpitations, heart racing and shortness of breath. This went on for several hours before finally falling asleep. The day following the injection, more and more symptoms began to arise such as muscle soreness, cold/hot sweats, low-grade fever (99.5%), chest pain/pressure, sweating, dizziness/disorientation and a headache. Monday night I experienced the low-grade fever however after going to bed, woke up around 5AM barely unable to stand, very disoriented and upon taking my temperature, I took note that I had a fever of 100.9%. Today, Tuesday May 11th, I am experiencing chest pain/pressure, low-grade fever, headache and am lethargic.

Lost use of my right arm so I went to the hospital they checked for a clot I teated slightly positive with the blood test then the did an ultrasound and couldn?t find one. The only explication for my Paralysis is a mini stroke.a Also besides the numbness and loss of use I have hyperreflexia.

About 2 minutes after receiving the vaccine, while parked, I started getting very light headed, felt dizzy, and my heart starting beating extremely fast, and then slowed down and started beating very very hard, and felt like it was going to pound out of my chest. I then had a warm sensation in my throat and started feeling like it was getting harder to breathe. I rolled down my Window, and looked for someone to wave over for assistance, but there were cars in the way, so I closed my eyes and focused on breathing deep and slowly to see if that would make it any better. After about 5 minutes my heart rate went back to normal, I felt I could breathe normally, and wasn't so light headed anymore. I should have reported this to someone when they told me I could leave, but I wasn't sure if it was an actual allergic reaction. Or if it was just a stress reaction. I felt like I should at least report it here, because I was completely fine before the injection, during the injection, and right after, until about 2 minutes after being parked.

NOSEBLEED THIS AM FROM 0700 - 0715H. ONE EPISODE; HEADACHE - FRONT OF HEAD CONSTANT TODAY; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and on birth control, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not had no known drug allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced headache - front of head constant today. On an unspecified date, the subject experienced nosebleed this am from 0700 - 0715h. one episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache - front of head constant today, and the outcome of nosebleed this am from 0700 - 0715h. one episode was not reported. This report was non-serious.

I experienced chest pains, felt like hard time breathing, little cough that felt like an asthma attach but not quite. I've had PE blood clots I went to urgent care on 04-23-2021, where they did CT scans of the chest and upper abdomen and lab work and my exams were negative. I can say today that I have recovered from my symptoms.

The morning after my vaccine I woke up feeling very ill, I had a fever of 101 and I was extremely fatigued, dizzy, joint pain and headaches. I stayed home from work. Over the next few days my fever subsided but my headaches, body aches, nausea and dizziness continued. My headaches worsened and on 4/15 my Dr ordered a brain MRI as well as blood work to be sure of no clotting. The MRI came back normal but I later went to the ER due to worsening severe headache and rapid heart rate. I was later discharged and the Dr told me he believes I am having a more severe pro-longed reaction to the vaccine and that he thought my symptoms would subsided around two weeks post vaccine. I am still currently having sharp headaches and joint pain, I have needed to miss work multiple times due to all of this and not feeling well enough to work or do my normal activities.

15 minutes after the vaccination I passed out and a week later I lost feeling in my leg and had to go to the ER and now I'm currently wheel chair bound with no diagnosis but all the doctors can say is it from the COVID 19 vaccine.

Patient transferred from outlying hospital for higher level of care. Patient had previously presented to ED with complaint of localized pain in the right calf for 4-5 days. Patient also noticed swelling in R calf. CT chest showed acute pulmonary embolism within distal right pulmonary artery extending into the segmental arteries to both right upper and right lower lobes. Patient was treated with heparin drip. Echo showed EF 68% and hypokinetic free right ventricular wall and apex. Echo also showed reduced right ventricular function. Patient underwent bilateral lower extremity duplex ultrasound which showed acute right femoral, popliteal, posterior tibial and peroneal vein thrombosis. Patient was transitioned and discharged to home. Patient received J&J COVID-19 vaccine in March 2021. Patient denies cigarette smoking/vaping, illicit drug use, ETOH use. Denies recent travels or long distance travels. Denies use of oral contraceptives.

After we left the vaccine site, I felt like my heart was racing and it continued for the rest of that night. I tried relaxing and laying down but the feeling wouldn?t go away. The next morning I woke up with a terrible headache and feeling nauseous. I had diarrhea, and I felt exhausted. I was on the couch most of the day. Later that day, I took my temperature and realized I had a fever. I took some Tylenol and felt fine when I woke up the following morning. I was approximately 3 months pregnant at the time and f vaccination. My due date is September 17.

Severe menstrual cramping. I have never experienced physical pain like this in my life. My first cycle after the Jansen vaccine, I had an acute cramp attack that lasted about 15 minutes. This was in April. I almost asked my partner to take me to the hospital. During the second cycle I had since being vaccinated, on the first day I started menstruating, I nearly fainted and was seeing stars while trying to get home. I had taken two Advil and this was not enough to help at all. I took two more shortly afterwards. The blinding pain lasted for 20-30 minutes. I can?t express the severity of this pain. It was unprecedented and terrifying. The rest of my menstrual cycle is different as well. The first day was extremely heavy aside from being alarmingly painful, and then from the second day on, it was very light. I also believe that I may have developed seasonal allergies post-vaccine as I have never had them in my life. I am currently struggling with this common discomfort.

Brain felt like it was on fire after day 2 stayed that way for a month and I had two severe noise bleeds never have one in my life until the shot I also was very fatigue for over a month. I was given bultaphane and prednisone to take for a month by tidelands Dr . I did wait almost a week prior to going to doctor but symptoms got worse I went to doctor.

Patient received vaccine and did not got and sit down, was watching her husband get his and about 5 minutes after giving the shot, she fainted and fell backwards, was alert in about 10 seconds after hitting the ground, ems was called, vitals monitored until they arrived, no anaphylaxis

CHEST PAIN; BLURRED VISION; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 81.64 kilograms, and height was 160.02 centimeters. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced blurred vision. On 24-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.0. The action taken with covid-19 vaccine was not applicable. The outcome of the chest pain, blurred vision and fever 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.

swelling in face swellling in arm swelling in legs swelling in gums, lips, tongue swelling in nose swelling in throat intense pressure behind eyes and in gums (feels like my teeth are shifting from the intense pressure) intense fatigue and purple around eyes relentless palpitations that last 24+ hours entire body swelling 24/7 visible swelling in my lips and tongue for over a month my entire body has become hypersensitive and allergic to things that were previously safe for me like shampoo, conditioner, deodorant, makeup, and toothpaste new things keep happening, but this is where i?m at right now

General: Beginning at 8 hours post vaccination, patient experienced headache and chills. Several times during the night patient woke up to a pounding/racing heart as well as experiencing some confusion/confusing dreams. The following morning, noted experiencing a severe headache (at which time OTC medications were taken to relieve pain) as well as a low-grade fever of 99F (normal body temp of 97.9F). Slight headache continued for a week post vaccination. Menstrual: Patient experienced a cycle that was 46 days long for the cycle following the date the vaccine was given. Previous four cycles ranged in length from 28 to 34 days. Onset of period was approximately two weeks late.

Patient presented with syncope immediately following that administration of Janssen vaccine. Vaccination nurses helped patient to the floor where consciousness was restored without aid. Patient appeared pale and diaphoretic. BP 95/60 HR 56. EMS was called at 18:03 when symptoms did not resolve. Patient was helped back into chair. EMS arrive at 18:10 - BP 100/60, HR 66, SpO2 98%, blood glucose 107, 12 lead EKG SR 66 18:16 BP 110/86 HR 67 Patient reported last food/drink was 6 hours prior to vaccine Patient reported history of anxiety and syncope with vaccinations Patient refused transport to hospital

Had her Johnson and Johnson covid vaccine on 4/8/21 LMP 4/14/21 Pt began spotting 5/9/21 which was day 25 of her cycle Day 2-5 very heavy bleeding Day 5 passed clot 11 days of bleeding Pregnancy test positive on 5/19/21 and 5/20/21 Presented to ED w/ intermittent RLQ abdominal pain and vaginal bleeding and spotting since 5/9 with positive hCG, 52 on 5/20 and 209 on 5/27 with OB ultrasound on May 28 that showed no IUP and small hyperechoic nodule adjacent to the right ovary that could represent an ectopic pregnancy and patient opted to avoid methotrexate treatment at the time. Returned to the ED on 5/30 with ongoing symptoms of RLQ cramping but no vaginal bleeding. OB ultrasound shows right adnexal structure measuring 2.6 cm, larger than structure 2 days ago. Pt diagnosed w/ Right ectopic pregnancy - successfully treated with methotrexate

2 weeks after the shot I had a scary night where I had severe chest pain. I sat up for a few hours hoping I wasn't having a heart attack and taking water and tums. I have never had chest pain before or since. I was very concerned and wondered if it was the vaccine. I didn't have anything unusual to eat or drink. I was happy when it finally resolved that same night. I also experienced Bell's Palsy 2 months after the vaccine. (~June 1st) I have never experienced Bell's Palsy. I am not sure if either of these events were related to the vaccine, but I have no intention of getting a yearly covid or flu vaccine now that I have Bell's Palsy. It is terrible, and I'm not taking ANY chance of getting this again even if that means I get the flu and covid yearly. I placed my trust in science, and not I am not sure I made the right choice. Although I hope my facial movement and ability to use my lips and face come back, I realize that some never recover.

Pt. suffered a vasovagal response within about 2 minutes after recieving vaccine. Pt reported feeling faint and her skin color turned pale. BP Was 70/41, was layed supine in the observation area. 2nd Blood pressure was obtained once Pt. was laying down 110/70, After about 2 minutes of waiting she sat up in observation and another BP Reading was obtained 120/80 and she was placed back into a seated position, Pt reported feeling better, however we did observe her for a full 30 minutes to ensure no other reaction was noted. Final Blood pressure at discharge of care was 121/85 Pt. reported feeling good, Pt was given ER Instructions if anything got worse.

I experienced two months after my J&J vaccine- soreness to my left arm with pain that lasted two weeks. I also experienced SVT, supraventricular tachycardia, my heart rate went up to 103 bpm and my heart rate could not go down. I went to ER where they helped my heart rate go down and I am still being monitored for SVT.

Right after the dosis, around 4 hours after, I started to feel nauseous and dizzy. I returned home, took a shower, and soon started coughing and a very high fever, followed by chills. I had between 38 and 38.7 C of fever until 9 AM the other day. I felt pain all over my body in a very different way, not like the flu. On Saturday, the day after the vaccine, I had low blood pressure and a complete loss of appetite. On Sunday, I had no symptoms.

I had upper respiratory infection few days after the vaccination date that lasted for 2 weeks. The infection was moderate in severity that I had to take a week off from work but I did not go to hospital. Then after 3-4 wks post vaccination (the third week of June) I started abdominal pain and diarrhea that was severe enough to cause me dehydration and hypotension. Till now (July 4-2021) I still have bouts of diarrhea and postprandial pain. I lost 6 pounds in the past 3 wks because I am avoiding food. I did go to hospital and I am being managed symptomatically at home.

After the vaccine, my chest started hurting. Doctor mentioned that I had heart arrithmyia. Ever since I had the vaccine I've had chest pains and shortness of breath. Like, if I try to carry something up the stair in my home, I get really winded.

Patient became lightheaded, pale, and dizzy several minutes after vaccine. She vomited into a trash can and had fainted into her chair during the minutes following the husband alerting the pharmacy team she was having a reaction (we were there to witness and aid the patient.) After vomiting and having water, the patient recovered quickly. We monitored her one on one in the vaccine room for about 10 to 15 additional minutes and also took her blood pressure and temperature (both normal.) Patient remarked that she felt completely fine thereafter.

Said she passed out twice in succession to each other. In about a 5 minute period of each other. Now, if feeling normal after 24 hour mark is past

Within seconds of receiving vaccine RN asked client if she was feeling fine as she appeared pale. Client stated "I feel lightheaded". RN signaled lead PHN assistance. RN set up anti-gravity chair and client was able to transfer self without assistance. Client reported medical history of acute psychosis and schizophrenia, no current medication and allergies to Cipro. PHN took first set of vitals at 1402: blood pressure 104/70, pulse 65, oxygen sat 99%. PHN observed client start coughing to clear throat and asked client to elaborate new onset. Per client no shortness of breath, denied throat closing, but felt "heaviness over throat, like when you eat popcorn". PHN did not note any swelling or redness on face or neck area, no tongue swelling and client able to speak in full sentences. Client declined blurry vision, headache, or chest pain. PHN offered client Benadryl and client declined due to not having a ride and taking public transportation, per client would wait a few more minutes for symptoms to improve. At 1405 client reported throat feeling not improving and wanted Benadryl, per client "does not like shots and wants oral". At 1406 PHN gave client Benadryl 50mg PO. Vitals at 1407: blood pressure 100/60, pulse 50, oxygen sat 99%. Per client dizziness same and "throat itch improved". Per client swallowing saliva just fine. Per client had no breakfast this morning, RN brought client juice and client begin to take small sips. At 1410 PHN took pulse manually, 53. Per client is aware pulse and blood pressure run low, and has not followed up with primary provider, but has been seen at ER when she felt chest pain 2 weeks ago. PHN advised client to make appointment with provider. Vitals at 1413: blood pressure 97/73, pulse 54, oxygen sat 99%. Per client dizziness and throat discomfort resolved and stated "I feel tired". PHN Ivonne gave client ER precautions and advised client to follow up with provider. At 1415 PHN reminded client of possible side effect of drowsiness with Benadryl, client verbalized understanding and stated "I live close, bus stop is right in front of my house." Vitals at 1419: blood pressure 110/69, manual pulse 48, oxygen sat 99%. Per client "feeling fine". Denied lightheadedness, headache, blurry vision, shortness of breath or chest pain. Per client wanted to leave. Client left facility with steady gait against medical advice at 1424.

I had been off my period for 2 days when I got the vaccine and started my period again 3 days later (day 5 of my cycle). The period lasted for 13 full days and was the heaviest period I?ve ever had with thick clotting and blood. After that period I went 2 full months with no period. This has NEVER happened to me before.

Hospitalized with weight loss, thirsty, blurry vision, leg cramps, cuts on arm with skin infection and generally feeling bad. Diagnosis: Type 1 Diabetes

Had generalized tonic-clonic convulsions. CT scan of the head revealed a subarachnoid hemorrhage in the L cerebral hemisphere.

TACHYCARDIA IN 220'S, SHORTNESS OF BREATH, HIVES,DIFFICULTY BREATHING, AIR WAY CLOSURE: occuring approximately 45 minutes after injection. EMS was called and Benadryl was and EPI on hand. Primary care order Epi on hand prior to vaccine appt and Benadryl to be taken.

Chest pain, shortness of breath, fever, chills, headache, body aches, canker sores, and exhaustion within 12 hours of short. Within 24 hours, spotting, continued fever, body aches, sore throat and sinus congestion. Exhaustion, chills, canker sores and sinus pain have continued. Bruising and sore arm

Vasovagal response. After receiving the Janssen COVID 19 vaccine, Patient reported she sat down in her chair. She began to feel dizzy, her palms became sweaty, and diaphoretic. She began to lie herself down on the gym floor but lost consciousness before completely lying down on the floor. LOC for for several seconds after which she began to respond to observation nurse. Fall was unwitnessed so EMS was called to evaluate the patient. She was medically cleared by EMS.

Patient was administered the vaccine, during her 15 min observation she stated "my lips feel tingly". Patient appeared pale, her feet were elevated, she reported that she had not eaten since the previous evening. She was able to drink 11.5 oz of orange juice, blood pressure was 175/122, apical pulse was 68, blood glucose was 76. Butterfly IV was started by assistant clinical manager who administered diphenhydramine 25 mg. Clinical director was notified and orders received to continue to monitor the patient until systolic blood pressure had declined to 140-150 then she would be discharged if asymptomatic. The patient rested and was monitored, blood pressure declined to 145/82 and she notified her primary care physician to follow up the same day. She was summarily discharged and was seen by her physician later in the afternoon.

Patient fainted following vaccination and hit her head. Pharmacist provided first aid and verified patient was ok. Patient refused medical transport, pharmacist sat with her until another person came and picked the patient up.

Yesterday I got the Johnson and Johnson vaccine. I was the last appointment, so they observed me for 5 minutes, and I left. After riding in the car for a few minutes, I noticed that I was having a hard time breathing and my throat felt like it was starting to swell. By that time, the clinic was closed, so I went to the emergency room just in case and sat in my car since they didn't allow people to sit in the waiting room because if covid. It started becoming increasingly difficult to breathe, and I was feeling more and more swelling of my throat and tongue. I was having a lot of dizziness, nausea, facial flushing, palpitations, and some mild confusion. I then started getting numbness in the bottom half of my face. Over time, the numbness spread, mostly staying on the left side of my body (face, scalp, lower arms and legs, left side on tongue and inside of mouth). I also started getting a prickling burning pain sensation for brief periods of time where I had numbness. I had decided that if my breathing worsened at all, I would go to the er even though I can't afford it. After about an hour and a half, my breathing started to feel less constricted and like there was less resistance. The swelling in my throat was mostly in the upper throat where I had difficulty swallowing but not as much difficulty breathing. The numbness continued to get worse and was sometimes disappearing and reappearing in the same spot. At 9:30 pm we went to go get some benadryl. I continued feeling less and less swelling and having an easier time breathing. At that point, I went home. Once I was home, my breathing continued to improve and the numbness started to dissipate. In the middle of the night, I started itching and getting widespread hives and getting a sharp burning pricking pain that would last a few seconds in different areas. The numbness also started coming back mostly in my face. I continued to have difficulty swallowing. I am feeling much better today. I still feel some slight swelling in my throat when I swallow, but my breathing is fine. I'm still itchy and occasionally breaking out in hives. Im having mild lower facial numbness. I'm also starting to get the normal side effects of fever, headache, arm soreness, and body aches. I'm taking benadryl every 4 hours.

About a minute after I had the injection, my arm started hurting and it felt like hot water was coursing through my veins. I got an immediate headache that progressed into light headedness, my vision got blurry and I saw colors and then I started to lose my hearing, it felt like there was cotton in my ears. The nurses said I went pale and they called it a panic attack, but it was unlike any panic attack I have ever had in my life. I?ve had my TDAP updated a few years ago and got a flu shot and did not feel anything like this. I was rolled out of the room on a wheel chair because I was too dizzy to walk and then threw up several times into a bag and peed myself. It took about 20 minutes before I felt normal again. The following day my arm felt numb and incredibly sore, I couldn?t raise it that far up without excruciating pain. I felt weak, fatigued and dizzy and was unable to use the bathroom. I had fever sweats and chills on and off. I was not able to sleep well, but I think that?s because of the pain in my arm.

Fever of 100 to 101 (by 09:00 PM) that Sunday evening. Fever gone by 2 pm Monday. Body aches remained. By Tuesday evening, 8 pm, I noticed extreme Breast tenderness and I called my doctorand talked to the nurse - lactation nurses - on the 17th.That persisted for more than 48 hours. (I am breastfeeding.) When I bent over, I had chest pain with that. Told to monitor it and if I got a fever to call back to call the doctor. Didn't get fever and my tenderness in my breasts went away and so did the body aches.

I exp headache, fever, body aches, chills, sweating and racing heart rate(tachycardia). I went to ER for heart rate shot up to 155 beats per min while sitting in a chair was prescribed Migraine and Benadryl. I do exp heart rate regulation which is usually under control unless I'm hot.

Patient started experiencing rapid heart rate around 4AM on 3/26/2021, she had reported to the pharmacist she also has had some dizziness and has stayed in bed. She did have some of the other usual side effects of the vaccine - chills, mild headache, tired. The rapid heart rate has not subsided or worsened. She doesn't have a primary care doctor. The pharmacist recommended she call 911, which is recommended, just in case it is an allergic reaction and it can be treated quickly.

Starting the around 10 pm the evening of my vaccine, March 6, I had chills. When I woke up in the morning I had a headache, muscle aches, slight difficulty breathing with chest heaviness, and fatigue. At 2 am on March 8 I awoke with dizziness and room spinning, sweating, weakness and lightheadedness, and nausea. Later that morning most of the symptoms subsided except for slight lightheadedness. By March 9 all side effects had resolved.

At about hour 10 post shot, I began feeling foggy. 11 hours- chills while also feeling hot Elevated resting heart rate (100bpm) Fatigue Headache

Chills (from 10:00pm-12:00am), fever of 104.6F (from 10:00pm-7:00am next morning), rapid heart rate (10:00pm-7:00am next morning).

Patient reported burning sensation on injection into left deltoid and localized painful reaction. Within approximately 10 minutes following injection, patient reported dizziness, weakness, and nausea. Patient tried to stand and reported that she experienced syncope, fell, and struck her head. Patient called out pharmacist's name. Pharmacist arrived to find patient lying on the floor. Patient had visible mark and bump on her forehead. Pharmacist elevated patient's feet. Patient elevated herself under her own power to a seated position. Patient was given water and blood pressure was taken. Blood pressure was 128/86 with a heart rate of 76. Patient requested pharmacist not contact 911. All events occurred within 15 minutes following vaccination. Patient reported she would visit urgent care following departure from pharmacy but unknown if patient will follow-up. Patient left under her own power and was driven home by husband.

Approximately 5 days after vaccination I started experiencing VERY strong heart palpitations, so much so I am able to see my chest move while they're happening and have captured it on my cell phone. The only other time I have experienced heart palpitations was while pregnant, I am not currently pregnant. So far, the palpitations have continued with less severity approximately two weeks from onset. I have contacted my doctor and he has advised if they do not resolve by the end of this week/this weekend, I should contact him and we will look into an EKG and/or holter monitor. Often while having the palpitations I am completely at rest. They have occurred randomly throughout the day and evening. They have not woken me during the night if they have happened while I sleep. I wear a smart watch daily and my heart rate appears to be normal. My heart does not race during the palpitations. There is no pain or discomfort felt while it happens. I have been able to work out every couple of days without feeling like something is wrong.

Symptom/time of onset/duration/treatment/outcome Fatigue/April 1st,1:00pm/11 hours/rest/recovery Fever (up to 104.2 F)/April 1st, 2:00pm/ongoing/single ibuprofen dose at 8pm April 1st to lower temp/current temp 99-100 Chills/April 1st, 2:00pm/3 hours/rest/recovery Body aches/April 1st, 3:00pm/ongoing/none/ongoing NUMBNESS IN LEFT HAND: Started at about 3:00 pm with the onset of fever and chills and continued on and off for the rest of April 1st. Affected the left side of the left hand including the leftmost 2-3 fingers. Called doctor, ADVISED urgent care but I waited it out; no treatment for this symptom. Has not returned April 2nd.

15 wks pregnant due date 9-21-21, symptoms included fever, nausea, vomiting, rapid heartbeat, insomnia, muscle aches, sore arm, very tired.

1 minute after vaccine was administered I felt faint and fainted. Blood pressure remained low for 45+ minutes after.

around 5 minutes after vaccination patient fainted in our waiting area. The patient wife and myself we held the patient and laid him down on the floor and elevated his feet. patient woke up a couple minutes later. we called 911 by the time 911 showed up patient got better and left with her wife.

Shortly after receiving the vaccine, patient complained of coughing, shortness of breath, neck pain. HR=119 and unable to auscultate blood pressure. C/o warmth and feeling of throat swelling, burning in throat after coughing. Patient was placed on floor initially supine and then onto right side. Bluish discoloration around eyes and lips, and encouraged patient to use her inhaler. Ox reading 98% after a few minutes. EMTs present and took blood sugar, 87 and given dextrose orally followed by water. Patient stated that she had a donut and waffle for breakfast. Encouraged to eat lunch with some protein. Relayed that she had an ablation and tubes tied last week. Received allergy shot recently but not new formulatin. She also mentioned that she received a steroid injection for her migraines.

Chills - 6 hours Fever - 8 hours High heart rate (sleeping average 83, wake average 103 when normal is in 60s) - 20 hours Headache - 4 hours

Immediately following vaccination patient passed out in the chair. Woke up approximately 10-15 seconds later, skin very pale white, clammy. Patient stated she "did not feel right". When asked to describe her symptoms, the patient said she felt "tingly and dizzy". Pharmacist gave patient water bottle and a breakfast bar. Patient ate most of the breakfast bar and then said she felt like she was "going to throw up". Patient then vomited 3 times in the trash can. Immediately after vomiting, patient's color skin color returned to normal and she stated she "felt much better". BP checked and within normal range. Patient stayed at the pharmacy for 45 min for observation and drank a second water bottle. Refused medical care and refused to have someone pick her up from the pharmacy. Pharmacist followed up with patient via a phone call at 6:20pm. Patient said she was feeling much better and had no other adverse reactions.

Approximately 13 minutes after the vaccine was administered patient reported feeling faint. She was sweaty, shaky, hyperventilating, tingling in her fingers and reported a rapid heart rate. Patient was able to speak in full sentences and answer questions. The pharmacy team immediately called 911. The pharmacist assessed the patients symptoms and determined the patient was not experiencing anaphylaxis as she was not experiencing swelling or throat closure. No emergency medications were administered. The patient layed down on her back and elevated her feet. The EMT arrived within 5 minutes and assessed the patient. Patient was taken to the emergency department.

Tachycardic and anaphylactic shock. Heart beat over 140 out of the blue while laying on couch, throat felt like something was lodged in it, Voice became very raspy, felt out of breath.

After vaccination, nurse observed seizure activity while patient sitting in chair. Tonic-clonic motion in arms. Seizure activity lasted approximately 3-4 minutes. Skin pale, cool and clammy. Blood pressure 94/72, pulse 68. Respirations 16. O2 sat 97%. EMS called and patient was transported for evaluation. Follow up phone call to patient 4/7 at approx. 5 pm. Patient resting. Stated she had negative CT at the hospital and has neurology appointment tomorrow, 4/8. Follow up phone call will be placed 4/8 after neuro appointment.

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

About 12 hours after shot (2:30 am), I woke up with a fever (100.5-101.0), chills and shaking, a racing heart, and pain in my neck and left shoulder (though I got the shot in my right arm). These symptoms continued throughout the night. The next day I had a low-grade fever that responded to Tylenol, and generally felt fatigued and achy. The next night I had some chills and shaking (though not as bad). The following day I had a headache and fatigue but no fever.

Itching skin, chest tightness, 0 SOB, 0 dizziness, 0 nausea, IM Benadryl (25 mg) given, symptoms - pt felt better. BP was 110/62. 73 HR. Pt felt better - husband will drive home.

Janssen COVID-19 Vaccine EUA About five minutes after receiving the shot I suddenly got tunnel vision, started sweating and felt like I was passing out. I laid down and vitals showed that my blood pressure went down to the 50s. I recovered after around 20 minutes of monitoring and rest

Patient had a moderately severe syncope reaction. Patient had trouble communicating, reported loss of vision and hearing, light headedness, dizziness, semi consciousness. Patient was seated when the episode began. By the time staff were notified, patient was barely conscious, and could not be safely told to put their head between their legs for fear of falling. Patient came out of the episode within 10 minutes before emergency services could arrive.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium

Approximately 5 hours after I received the vaccine, I started to feel extremely fatigued and experienced some muscle aches. I took an Aleve and laid down for an hour long nap. At approximately 7:00pm, I woke up with more extreme muscle pain. By 8:00pm, my muscles were so tight and painful that it hurt to move, lay still, or go to the bathroom. It felt as though all of the muscles in the back of my body (from my back to my butt and legs) were spasming, Over the next few hours, my temperature rose to 102.7 and my heart rate spiked to 140-150 bpm. I also experienced chills and a headache. We sought the advice of a 24-hour nurse, who let us know these symptoms were likely normal side effects. I went to bed around 12:00am, and my temperature had dropped to 99.9 around 3:00am when I woke up to check it. My heart rate eventually dropped below 100 bpm around 8:00am. I woke up around 10:00am on Saturday feeling much better than the day before. My temperature was around 99.1 when I woke up, and my symptoms included mild muscle aches, a moderate headache, and moderate fatigue. I continued to feel better throughout the day, with the headache gradually subsiding and a minor sore throat toward the end of the day. On Sunday, I felt back to normal, other than experiencing some mild-moderate fatigue.

After about an hour after shot, light headed. 12 hours later, dizziness, rapid heartbeat and pain or ache in isolated spot in upper left thigh. Discovered 2 days later, a red spotty area on upper left thigh where the ache was.

Approx 6 mins after vaccination pt fainted. She recovered on her own within a minute and was very diaphoretic and pale, but was alert and oriented x 3. Pt then stated she was feeling very nauseous and proceeded to vomit. 911 was called and B/P 87/58, HR 91 and O2 99. EMS arrived B/P was fluctuating and pt was brought to ED for evaluation

days 1-3 the expected fever (101), headache, dizziness, extremely sore arm and body aches, tiredness, difficulty falling asleep Day 4 swelling in left armpit about half a golf ball size with pain and soreness into left upper chest, called family drs office they said it?s a listed possible effect of the vaccine Day 7 vomiting, diarrhea, stomach pain, dizziness, flu-like symptoms. Urgent care visit - test for covid came back negative, given medication help keep fluids down. Severe symptoms lasted for 3 days. Diarrhea persisted for 8 days. Followed up with family dr. Continuing to feel unwell - tired, occasional dizzy/lightheaded spells, lesser stomach pains, soreness under left arm into chest area, difficulty sleeping, tightness and darkening of veins in arms especially forearms

Itchiness and slight hives for a few hours at injection site Onset of the following symptoms about 12 hours after injection: Tachycardia (HR up t0 148bpm at rest) Heart palpitations Severe headache Fever (100-101) Chills Soreness in arm for one week Treated with tylenol Felt okay after 36 hours

"Janssen COVID-19 Vaccine EUA" This writer was having a session with a client and her mother at the playground on 4/8/2021 and writer felt weak towards the end of session. Per mother's report, writer's eyes rolled back into her head and writer was about to fall backwards off the picnic table, but the mother caught writer. This writer was unconscious and then came back alert, but could not see for two minutes. This writer experieced severe abdominal pain and needed to use the restroom right after and had a bowel movement. dehydration (J & J vaccine night before at7pm) headache, difficulty breathing and blurred vision and a fever of 99.4 the next day. This writer was taken to immediate care and an EKG and Urine test was done. This writer was diagnosed with Syncopal Episode and dehydration.

Started with chills pretty shortly after the vaccine was injected. After about 6 hours I could tell I was not feeling great. My husband said I looked very pale and out of it all of the sudden. I became extremely tired and disoriented. I don?t remember driving myself home that evening after picking up my kids from dance. By the time I was home it was now around 8 pm. I was so cold my entire body was trembling. I kept taking steaming hot showers but I couldn?t feel it, I was still freezing and shaking. I was very weak and started having extremely horrible body aches and pains. Specifically my legs were hurting the worst, I remember my hip joints felt like they?d buckle underneath me. I got a headache that was unbearable. It felt worse than a migraine. It hurt to move my head or use my eyes at all. I went to bed and was under several blankets and a heating pad while also running a space heater right next to me. I still could not get warm at all. I hallucinated that I could see each ache and pain on my body and watched them move through me. By 4 am I was now hysterical and crying. I was in so much unbearable pain and so scared. I had to call off of work for this day. I was so out of it I called my daughter off of school but also called for my mom to come get her and take her to school. I kept my youngest home with me. My head was still the absolute worst headache I have ever felt in my life. I couldn?t open my eyes and it hurt to move at all. I had to call a friend to come pick up my youngest daughter because I was unable to take care of her, I could barely stay awake and alert. I tried another hot shower and everything still felt cold. I was now nauseous from the head pain. Around noon on this day I finally had the strength to drink some water and was able to take Tylenol. I laid on the couch for hours still shivering and in unbearable pain. I was still very scared that I was having such a bad reaction that I would die. I called my husband to come home from work and be with me because I was scared. I took more Tylenol a couple hours after the first dose. Around 6 pm I started to feel better. I was able to eat again that evening. I had a headache though for about 3 weeks after that gradually weaned away.

Tachycardia. I had the expected side effects of headache, chills, body aches, fatigue and fever (102.6 F) but began to experience symptoms of pounding/racing heart that worsened through the evening. By 10:00 pm my heart rate was bouncing around between 130 bpm and 155 bpm, and I was beginning to have pain in my lower legs/ankles. Was told by a on call nurse for my clinic to go to the ER. I was in the ER for about 5 hours, roomed the whole time as they worked to get my heart rate down and checked to make sure I didn't have a blood clot. They performed an EKG and CT Scan of my chest, both were fine. I was eventually allowed to leave after 4 am on 4/10/21 after my heart rate got into the high 90's with only small spikes into the 110's with slight movement and once my fever had broken.

5 hours after shot, I felt a slight ache in my knee. Within the hour, my whole body was engulfed in aches, chills, pain and uncontrollable shaking. Then my head starting hurting and I felt extremely hot. My legs and chest were pink and hot to the touch. Very high fever, head pain , nausea and heart palpitations. I took Tylenol which helped with the fever. The next day I had some minor aches and dizziness. Later the same day, I had sharp aches/pains down my back and an upset stomach. That night I had a fever again but not as high. Today, two days later, I feel back to normal with the occasional ache or cramp.

3/22/2021 5pm- Received shot ~10pm- adverse events started.As I was falling asleep, it started with restless legs. Quickly, I was shaking so violently I couldn't control my body. I made it to the shower to try and relax my muscles. My heart was uncontrollable and I had difficulty breathing. 4/4/2021- 4/5/2021 Woke up at night shaking similar to the first time, but not as terribly Low-key nausea and shortness of breath, fatigue, dizziness and weakness have been constant.

The day after receiving the vaccine, I experienced common side effects of fever, chills, body aches, and nausea, which lasted for 24 hours, and then I felt better. Then, 3 days after receiving the vaccine, I suddenly began to have extreme stomach pain, so bad that I could barely walk or stand up straight. My chest felt tight and I had shortness of breath. I thought about going to the ER, but called my GI specialist instead as I thought it could be related to the Xifaxan I was taking, but the office was already closed. The GI office called the following Monday and said the Xifaxan should not cause extreme stomach pain and to go to the ER if it persists, but by this time I was feeling much better. The severe pain lasted two days in total.

Lower extremity swelling, leg pain, burning in the ankle, chest pain, shortness of breath, shoulder blade pain

Migraines Light Headed/Dizzy Swollen Gland on right neck Swelling on right side of face Rash on neck and chest Pain on Right side of face Throbbing pain in Ear on right side

PATIENT RECEIVED JANSSEN VACCINE ON 4/9/21. 10 HOURS POST-DOSE PATIENT REPORTS FLU LIKE SYMPTOMS AND 4 EPISODES OF SYNCOPE. SHE THEN REPORTS PAIN IN LEGS AND ABDOMEN. ULTRASOUND OF LEGS WERE NEGATIVE FOR BLOOD CLOTS. TODAY 4/14/21 SHORTNESS OF BREATH HAS NOT IMPROVED AND PAIN IN LEGS IN ABDOMEN HAS NOT IMPROVED. PATIENT IS GOING TO ER FOR EVALUATION.

Got my vaccine on Saturday 04/10, today 04/14 I start feeling pain in both of my arms this morning, is a weird feeling like I feel my veins, I had a hearth pain, as soon as I wake up I felt a headache, I had it all day, on the left side of my head and after on the back area, it stoped around 6 pm, in the day I had diarrea, fatigue, pain in my joints, shortness of breath, pain in my arms and in my legs, itchy skin .

Pt received Johnson & Johnson COVID vaccine last week 4/05/2021. The following day she started with chest pain/pressure, palpitations and left neck pain. These pains come and go. Left arm with episodes of feeling hot and numb. Vaccine was given in R arm. Reports left arm hot and numb, feels weak. 3-4 episodes daily. Duration of several minutes. Starts randomly. Improves spontaneously. Denies weakness, color change. Affecting entire L arm but mostly bicep region. Neck pain has since improved. Continues with episodes of L arm numbness, and chest pressure and palpitations

Due to history of vaccine reaction of hives to flu vaccine, took 25 mg benadryl 1.5 hours prior to receiving covid vaccine. approximately 1 hours after vaccination, experienced sharp, constant retrosternal chest pain that is was non-radiating. on 4/11 experienced fever, and developed hives to right arm that injection was given as well as nausea without vomiting or diarrhea. Fever continued x 4 days with maximum temperature of 102.9 on 4/12. Chest pain continues as of 4/15. On 4/14 at approximately 2am was awoken with worsening chest pain and at that time also noticed development of a metallic taste in mouth, and since that time have been unable to taste anything but metal regardless of what is eaten or drank. Still with chest pain and metallic taste, hives resolved 4/12 evening and fever resolved on 4/14 late evening.

Intense headache with no relief from ibuprofen and Tylenol (still have it) Acid reflux. No relief from over the counter medication (still have it) Dizziness (still occurring) Heart palpitations Cold chills Night sweats ( continue to today) When any part of my skin is touched anywhere in my body it feels like pins and needles Fever on the first day over 103 ( subsided within 24 hours)

PATIENT SEEN IN THE EMERGENCY ROOM WITH SHORTNESS OF BREATHE, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, HEADACHE, RECTAL BLEEDING AND VOMITTING BLOOD. SYMPTOMS STILL UNRESOLVED.

SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).

I was 9 months pregnant at the time of the vaccination. My due date was April 3, 2021. The actual date of delivery was March 20, 2021 by C-section. I gave birth to a son weighing 8 lbs 6 oz. I had no complications during this pregnancy. I left the hospital on March 22nd. On March 25, I was experiencing shortness of breath and a low pulse (35 bpm; my usual pulse is in the 50s-60s). My OBGYN told me to go to the emergency room, where they did a CT scan. The CT scan showed a small pulmonary embolism. I was in the hospital until March 27th, where I was treated with Heparin and then was released with Lovenox injections. I am currently on the Lovenox. After seeing the pulmonologist for a follow-up appointment, he advised me that I would be able to stop the injections after 3 months.

The patient received the Janssen COVID-19 vaccine on 4/9/21 as documented in MIIC. This reporter has no other records of the day of administration. Patient's last menstrual period was 07/22/2020 and Estimated Date of Delivery was Apr 28, 2021. On 4/11/21 at 0218, two days after administration of the COVID-19 vaccine, the patient was admitted to the University of Hospital Birthplace for spontaneous rupture of membranes x 7 hours contractions since 4/10/21 2330. Per discharge summary note 4/13/21 in EHR: ?The patient is a 33 year old now G4P2022 who presented to the Midwife service with rupture of membranes and subsequent onset of spontaneous labor. She was noted to have mild range blood pressure and transaminase levels double the upper limit of normal, meeting criteria for preeclampsia with severe features. This was noted just prior to complete cervical dilation and her delivery was completed by the service. She was subsequently transferred to the OB MD service for further management. Her postpartum course was uncomplicated. She was continued on magnesium for 24h postpartum. She was started on nifedipine XL 30mg for blood pressure management and her BPs were wnl. Her ALT downtrended from 137 to 109. Her AST downtrended from 139 to 70. Creatinine returned to baseline. On PPD#2, she was meeting all of her postpartum goals and deemed stable for discharge. She was voiding without difficulty, tolerating a regular diet without nausea and vomiting, her pain was well controlled on oral pain medicines and her lochia was appropriate. Her hemoglobin prior to delivery was 13.5 and after delivery was 11.2. Her Rh status was positive, and Rhogam was not indicated.? Per Labor and Delivery note 4/13/21: ?Labor Course: arrived in active labor w SROM. Elevated BPs, abn PreE labs, new dx of PreE w severe features late in active labor, MD consult, plan to start Mag So4 after birth as patient was starting 2nd stage of labor as diag become clear. She progressed to complete and pushed, after which she had a spontaneous vaginal delivery. No nuchal cord was noted. Apgars of 8 and 9 The cord was double clamped after 60 seconds and cut. IV pitocin was started. The placenta was then delivered using gentle traction and suprapubic pressure. The uterus was noted to be firm after fundal massage. The perineum was assessed for lacerations and none were noted. The placenta appeared intact with a 3V umbilical cord. See details in below: Pain meds: epidural IUP at 37 weeks gestation delivered on April 11, 2021. SVD delivery of a viable Male infant. Weight : 6 pounds 4 ounces Apgars of 8 at 1 minute and 9 at 5 minutes. Labor was spontaneous. Medications administered in labor: Pain Rx Epidural; Antibiotics No; Perineum: Intact Placenta-mechanism: spontaneous, intact, with a 3 vessel cord. IV oxytocin was given. QBLs was 243. Complications of pregnancy, labor and delivery: PreE w severe features Anticipated d/c date: 2 days?

Patient presented to the ER on 4/20/21 with headache. On Saturday (4/17/2021), the patient had "the worst headache I have ever had" along with severe inner left ear pain. Patient took an ibuprofen which helped with the pain for about an hour then the pain came back. Pain got worse 2 hours later when she drove home from work. She called the RN line and was told to take ibuprofen and follow up in the AM. The next day 4/18/2021, patient went to urgent care and received Toradol and was told it was a migraine. Today 4/20/21, patient still had pain and noted feeling left sided facial numbness and blurry vision that correlated with when she got the headache. Patient went to an urgent care today and CT scan revealed a blood clot. She was then sent to the ED for evaluation. In the ED, she has no headache and facial numbness and has minimal left ear pain. Her headache is localized to the left side of her head. Patient denies fever, chills, and COVID symptoms. Patient was started on argatroban drip per hematology recommendation.

PRESSURE ON CHEST; COULD NOT GET OUT OF BED; TIREDNESS; This spontaneous report received from a patient concerned a 33 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, non smoker, and allergic to aspirin, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced could not get out of bed. On 13-APR-2021, the subject experienced tiredness. On 14-APR-2021, the subject experienced pressure on chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and the outcome of pressure on chest and could not get out of bed was not reported. This report was non-serious. This parent/child case is linked to 20210436123.

PERIOD CRAMPS; ABDOMINAL CRAMPS; ACCELERATED HEART RATE; RASH AT INJECTION SITE; HEADACHE; TIRED; ITCHY ON ARMS; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight was 140 pounds, and height was 61 inches. The patient's concurrent conditions included allergic to polyethylene glycol, allergic to red dye, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced itchy on arms. On APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced period cramps. On 10-APR-2021, the subject experienced abdominal cramps. On 10-APR-2021, the subject experienced accelerated heart rate. On 10-APR-2021, the subject experienced rash at injection site. On 10-APR-2021, the subject experienced headache. Laboratory data included: Heart rate high (NR: not provided) accelerated, and Pain scale (NR: not provided) 8 (unit not reported), 6 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, abdominal cramps, accelerated heart rate, rash at injection site, itchy on arms, and period cramps, and the outcome of tired was not reported. This report was non-serious.

BLACKED OUT; VERTIGO AGGRAVATED; BROKEN NOSE; FALL; BUSTED LIPS; COULD NOT EAT ANYTHING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vertigo, non-alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known drug allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total, administered on right arm on 03-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included meclozine hydrochloride for vertigo. On 03-APR-2021, 15 minutes after vaccination the patient felt dizzy. On the same evening, the patient experienced fever, vomiting, sweating, dizziness and chills. On 04-APR-2021, the patient could not eat anything and experienced black out and fell from which the patient experienced busted lips and broken nose. The patient was taken to the emergency room and was hospitalized on 04-APR-2021. During hospitalization the patient had blood test and chest X-ray which was normal and COVID-19 virus test was negative. At the hospital the patient was diagnosed with aggravated vertigo due to vaccination but according to the patient it was not her vertigo since she did not get her usual vertigo symptoms before blacking out (dizziness, room spinning, or feeling like about to fall). The duration of hospitalization was 1 day. On 07-APR-2021, the patient went back to the hospital to follow-up and the patient's physician ran tests for blood work and computed tomography (CT) scan of her head with no abnormal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blacked out, vertigo aggravated, broken nose, fall, busted lips, could not eat anything, chills and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210423964-covid-19 vaccine ad26.cov2.s -Vertigo aggravated. 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 VO:20210423964-covid-19 vaccine ad26.cov2.s-broken nose, black 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).

by 4:45 pm I felt off. By 6:30 pm I felt like I couldn't move very well. It affected all the bones I have ever broken or sprained before. Had cold chills, my temperature was 95.1. I felt like my blood pressure was high. I had a bad headache and took advil. April 11th I still felt off and had a headache. Around 4:30 pm I had rectal bleeding. Wednesday April 14th I had very bad leg pain in my right leg. Friday April 16th I went to urgent care for Leg pain and slight chest pain. They sent me to the ER. I had a chest Xray and ekg done and both came back normal. I was able to have a vascular ultrasound Monday April 19th in right leg and it showed no blood clots. I still have leg pain April 22nd.

Pt had a brain bleed on April 14th at approximately 2:00 in the afternoon and was emergency airlifted to Medical Facility. She stayed at hospital until April 21st. Pt is currently unable to read and recall information such as words, and her own birthday.

THROAT SENSATION LIKE TICKLE; COUGH; SHORTNESS OF BREATH; LIGHT PRESSURE ON CHEST; FELT LIKE HAVING AN ALLERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and endometriosis, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced watery eyes when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A 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 injection site pain. On 10-APR-2021, the subject experienced throat sensation like tickle. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced light pressure on chest. On 10-APR-2021, the subject experienced felt like having an allergy. On 12-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Laparoscopy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like having an allergy, throat sensation like tickle, and injection site pain, and had not recovered from cough, shortness of breath, and light pressure on chest. This report was non-serious.

Patient got the J&J Covid vaccine on 4/2/2021, presented to the ER on 4/20/2021 with complaint of left chest and shoulder pain. This has been progressively getting worse over the past 3 days. She denies any overt shortness of breath or cough and her vital signs are stable.

Severe headache that lasted 12 days. Tachycardia that lasted 8 days. Resting heart rate would jump from 70 to 115 while sitting and would feel pounding heart and that I couldn?t catch my breath.

Client complained of pain and swelling in right calf area 2 -3 days before going to ER , at ER. Doppler study confirmed popliteal DVT

Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB

24 hour normal vaccine reaction (fever over 101, chills, fatigue, etc). Extreme sensitivity to caffeine (no sensitivity experienced before) Shortness of breath and dizziness, feeling of constriction in chest, worst in first week after vaccine also accelerated by caffeine intake. Symptoms lessened after stopping intake of caffeine, but are still present when exercising or stressed in third week. Seem to be lessening over time.

Patient received Johnson & Johnson COVID -19 vaccine on 4/12/21. On 4/16/21, patient presented with elevated blood pressure and some tingling in her arm. Patient reported fever and body aches for about 2 days after received the vaccine. Per ED visit, provider documented this was a reaction related to COVID vaccine. File this incident for record keeping.

I was very ill on Friday night after receiving the vaccination. Flu-like symptoms, high fever, shortness of breath, pain in my abdomen, horrible headache, nausea, dizziness, loss of consciousness and leg pain (both legs). The flu-like symptoms passed on Saturday, but by Tuesday, April 13 I was continuing to have a terrible headache, abdominal pain and leg pain. I saw my primary doctor on the 13th and was sent over to the hospital for an ultrasound of my leg. No clots were found and I was told to continue trying to recover at home unless it got worse. I was seen at the emergency room on April 14th for abdominal pain, leg pain, dizziness and headache. The nurse told me I was probably hysterical over the vaccination being pulled, and I told him this was not the case. They performed CT (without contrast) on my abdomen and head, then released me with instructions to return if I was worse. By the 16th I was unable to walk as my left side was completely numb. I went back to the ER. I had a CT of my abdomen and head with and without contrast. I had a lumbar puncture and several labs. I was given IV antibiotics for some infection they found in my urine. I was given fluids and pain meds, and my BP was shooting up to 145/94 (which is very high for me), when standing. My vision was blurry and I was unable to remember much of the last week. I was admitted from the 16th through the 20th and had an MRV, 2 MRIs, more lab work and medicine for my headache. I was released on the 20th and the headache was unbearable and I was still numb on my left side, going back to my doctor on the 22nd. He suggested the ER, and the ER admitted me back to the stroke unit. I was released on the 22nd with a diagnosis of a hemiplegic migraine that could cause stroke-like symptoms (ZERO history of headaches previously). I was sent home with a walker and home health services. PT visited on April 30th and ordered two visits per week for the next month. I am unable to walk without a walker. I cannot shower or use the stairs without assistance. My memory is still foggy. I am unable to concentrate for long. I often stutter and can't remember basic words. I have also stopped and forgotten where I am at a given moment. I am on Depakote nightly for the headaches, and they have lessened slightly, but when they flare up it is debilitating and I often vomit. I have instructions to follow up with my primary tomorrow morning and see what the next steps are.

Patient ended up light headed and fainted in the pharmacy waiting area. she recovered within seconds and didn't need us to call 911. She stated that she had just gone on a bike ride and hadn't eaten anything all day before she received her vaccination, which is what she thought was the cause of her fainting.. She waited in the area for at least 20 minutes before she said she felt ok to leave. She was eating a protein bar while waiting, to help with the low blood sugar.

TREMBLING; BOTTOM OF FEET PAINFUL; BAD/SEVERE HEADACHE; EXTREME FATIGUE; SWELLING AROUND MOUTH; SWOLLEN HANDS AND FEET; ITCHY ON THE TOP FEET WITH RED BLOTCHY RASHES; NUMBNESS AND TINGLING SENSATION AT LEFT SIDE OF EXTREMITIES AND BODY; SWOLLEN THROAT; SEVERE SHARP STOMACH PAIN; TINGLING AROUND MOUTH; SEVERE SHARP CHEST PAIN (STERNUM AREA); SORE THROAT; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 130 pounds, and height was 169 centimeters. The patient's past medical history included surgical removal of left ovary and fallopian tube, and cyst in ovary, and concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 7/10. On 10-APR-2021, the subject experienced severe sharp chest pain (sternum area). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced difficulty in breathing. On 10-APR-2021, the subject experienced tingling around mouth. On 10-APR-2021, the subject experienced swollen throat. On 10-APR-2021, the subject experienced severe sharp stomach pain. On 11-APR-2021, the subject experienced swelling around mouth. On 11-APR-2021, the subject experienced swollen hands and feet. On 11-APR-2021, the subject experienced itchy on the top feet with red blotchy rashes. On 11-APR-2021, the subject experienced numbness and tingling sensation at left side of extremities and body. On 11-APR-2021, the subject experienced bottom of feet painful. On 11-APR-2021, the subject experienced bad/severe headache. On 11-APR-2021, the subject experienced extreme fatigue. Treatment medications included: bismuth subsalicylate, diphenhydramine hydrochloride, famotidine, and ibuprofen. On 12-APR-2021, the subject experienced trembling. Laboratory data included: Fibrin D dimer high (NR: not provided) elevated, and Platelet count (NR: not provided) Normal. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 14-APR-2021, Laboratory data included: CAT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sharp chest pain (sternum area), sore throat, swelling around mouth, tingling around mouth, itchy on the top feet with red blotchy rashes, and severe sharp stomach pain on 13-APR-2021, difficulty in breathing, swollen hands and feet, numbness and tingling sensation at left side of extremities and body, swollen throat, bottom of feet painful, bad/severe headache, and extreme fatigue on 20-APR-2021, and trembling on 16-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Patient experienced sudden dizziness and nausea within 5 minutes of receiving Janssen COVID-19 immunization. Gave her water, crackers and cold/wet rags for her forehead as she felt hot. Took her temperature, returned normal. Gave her a trash can to keep near. Kept an eye on the patient and realized she was getting red in the face and more dizzy than she had been. Went out and stood next to patient, with her mom on her other side. Began to experience light sensitivity, feeling like the room was spinning. Patient almost fell out of the chair while sitting still. Mom used a personal pulse oximeter on patient, all results normal. Asked the patient about other symptoms, such as chest/abdominal/leg pain, headache, shortness of breath. Patient reported a headache, dizziness, nausea and leg numbness roughly 30 minutes following the vaccine. I recommended going to the ER, mom believed it would pass with time, but insisted she never responds this way to immunizations. Patient began to experience stabbing chest and abdominal pain around 45 minutes. Patient's mom was still hesitant to take her to the ER immediately on her own and asked us to call her PCP. He wanted the patient to go to the ER. Patient believed she would fall if she stood, offered to get a motorized cart, wheelchair or call an ambulance to transport her. Both patient and mom requested the ambulance. Asked a technician to check patient medications and allergies for EMTs, retook the patient's temperature which was normal again. Stayed with patient until EMTs arrived, reported all symptoms patient was experiencing.

patient received Janssen covid 19 vaccine. she informed me before she received it that she gets dizzy with needles and has fainted in the past with drawing blood. I gave the vaccine and pt said she was okay. a couple minutes later she said she was feeling very warm and asked for something to fan herself with. I asked another pharmacist is get her a cold compress. When she came back with it and went to give it to the patient she fainted and slumped in her chair; she did not fall out of the chair. she was unconscious for less than 30 seconds and lost bladder control. I continued to rub her wrists and neck with the cold paper towel and she regained consciousness and said she was okay. we observed her for at least 20 minutes more and then she left. she said she did not require any further medical attention.

I am a diabetic patient and I take insulin (short acting and long acting) and metformin (1000 mg) daily to control my blood glucose. I am noticing from past few weeks (~3 weeks) my glucose reading are abnormally high (~350- ~390) even after taking my regular insulin after lunch or dinner. I haven't changed anything in my diet and I am doing my regular exercise. The only thing that has changed is the vaccination.

BODY ACHES; HARD TO BREATHE; DIZZINESS; HIGH HEADACHE; LOW HEART RATE; MIGRAINE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced migraine. On MAY-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) Low. On 07-MAY-2021, the subject experienced body aches. On 07-MAY-2021, the subject experienced hard to breathe. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced high headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from migraine, and the outcome of high headache, body aches, hard to breathe, low heart rate and dizziness was not reported. This report was non-serious.

Chills and body aches (12-24 hours post-vaccination) Numbness/tingling in left leg, numbness/tingling in right hand (weeks 2 & 3 post-vaccination) Fatigue, headache, loss of concentration (weeks 5 & 6 post-vaccination) Ruptured vein in left leg (week 6 post-vaccination) Headache and delerium (week 7 post-vaccination)

Patient received the covid vaccine 5/14/2021 around 220pm and was waiting post vaccination for observation. About 2-3minutes after receiving the vaccine the patient lost consciousness and fell out of the chair on to the floor. The patient stated she lost consciousness and was very anxious.

I received my Janssen vaccine on 3/31/21. On 4/29/21, I had a virtual appointment with a naturopath about a completely separate health issue (mold illness), and she asked me to check my blood pressure. I checked my blood pressure using my father in law's at home cuff, and it was 149/99. I continued to check over several days and had persistently elevated readings, ranging from 122-165/93-107. My last known normal BP reading was in February of 2021 and was 110/70, which is my typical BP. I had not checked my BP at any time between February and April because I had no reason to believe it would be elevated. On 5/2/21, I had a reading of 165/107, which prompted me to go to the ER. At the ER in triage, my BP was 188/144. EKG was normal and troponin I was normal. I was monitored for a few hours with BP around 155/100, and after a dose of Nadolol, my BP came down to 122/79. I also had chest pain/tightness during this experience, which may have been due to anxiety. My BP has continued to be persistently elevated (now coupled with anxiety about what is going on, which doesn't seem to be helping the numbers!), and I had to return to the ER on 5/5/21 after getting an at home reading of 180/122 (this was about 1 hour after taking a dose of Nifedipine). At the ER triage, my BP had come down to 140/109, so they sent me home. My BP has now remained elevated at around 135-140/95-100, while taking 30mg Nifedipine ER daily.

Patient stated that she was having problems breathing, sweating and felt tingling all over. She said she felt she had a tight chest. An emergency response was called and the patient blood pressure, pulse and O2 was checked and was normal. She was given an ice pack to the back of the neck and stopped sweating. Upon questioning, she had not eaten anything all day and had only drank some pepsi and milk the day. Within 20 minutes she feeling much better and said she was feeling normal again. She was checked by a provider to make sure everything was ok.

patient passed out shortly(3-5 minutes) after receiving her vaccine. Patient got dizzy, fuzzy then blacked out for about 30 seconds then came to. After a few minutes patient was feeling better and left about 20-30 minutes after incident.

Severe headache, nausea, dizziness, light headedness, increased blood pressure, pain at injection site, neck pain, abdominal cramps, muscle aches

change in mental status agitation anxiety high heart rate high blood pressure diagnosed with PRES cause of adverse reaction of anti rejection prograf that she was on for 9 months, could covid vaccine have triggered this serious medical condition

When vaccine was administered, 4/6/21 - I passed out. Within 24 hours - i was vomiting and had severe nausea. I had extremely bad headaches that went away for 2 days then started up again extremely bad the Monday (4/12/21) after my vaccine. Visited my primary care doctor on Wednesday (4/14) as they wouldnt go away. advised to take motrin. On friday (4/17) they still had not gone away and went to Urgent care due to fear since the vaccine had been pulled for preventative measures. they did blood work and advised to take some decongestants as the weather had been strange (Snow and 80degrees in the same week) that helped.

About 5 minutes after receiving the vaccine, the patient walked up to the pharmacy counter from the waiting area and said she is about to faint. I was able to catch her before she fell to the floor. She was laid down on her back and her legs were lifted (911 called). Her BP was 92/63 and PR was 65. She was conscious and alert this entire time. When checked again in 5 minutes, BP was 112/75. When fire rescue arrived, she was alert. She reported not hitting her head. Waited another 20 minutes, then left.

Patient sat in front of pharmacy for 15 minute monitoring period. A few minutes after receiving the vaccine the patient informed the pharmacist that she was feeling dizzy and asked for water. The pharmacist went to get water. Upon returning the patient was awake and alert and told the pharmacist that she thinks she passed out. Called 911, firefighters and paramedics responded and evaluated patient who was feeling much better by now.

Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient fainted but woke up very quick. Vomitted once the started feeling better. No signs and symptoms of allergic reaction. We called 911 and was checked on site. The 911 personales reported no issue but patient caregiver asked that patient to be checked at the ER.

Fainting/ seizure after injection could only see white for 3 hours and extreme chronic chest/ heart pain within 2 hours of having the shot

Presented with stroke-like symptoms less than 2 months after injection. 2 days in hospital, plus return to Emergency Room 2 days after release. Confirmed with neurology on 6/8 that it was indeed a stroke with no pre-existing conditions. Previous blood work (prior to covid short) came back normal.

Fever and muscle aches for 24 hours; This month, on May 27th, I Had chest pain. Dr had me go to ER - and they did tests - the chest pain went away after about two days.

1. Chest pain 2. Elevated troponin 3. Myocarditis Went to hospital first than transported to another facility, then transported to another facility.

EMT Bustamante noted the client was splashing water on her face and hugging her caretaker in the observation area. EMT Bustamante approached the client and asked how she was feeling. The client reported anxiety to EMT Bustamante at 1:34PM. EMT Bustamante escorted the client and her caretaker outside the building and she was seated on a bench. Vitals obtained at 1:34 PM were as follows: BP 130/90, HR 110, and O2 99%. 2 RN's responded at 1:40PM. The client at that time stated she was having "anxiety." 2 RN's left the scene. At 1:49 PM the client stated she "couldn't breathe." RN responded and provided an emesis bag to the client. The client started using the emesis bag to breathe into. RN counted with the client to slow her breathing down. At 1:50PM the client stated she was "starting to feel better." RN played a 3 minute meditation for the client. At 1:53 PM the client was provided an ice pack on the back of her neck. Vitals obtained at 1:55PM were as follows BP138/82, HR 115, and O2 99%. The client noted frustration about her anxiety and increased heart rate. The client also noted "weakness" in her right arm. At 2:03PM the client received emotional support from her caretaker via a hug. At 2:10 the client stated she was "feeling better and almost ready to leave." The client took 2 puffs of her Albuterol inhaler around 2:12. The client stated she uses the inhaler PRN for a history of asthma. The client also reports a history of anxiety which is not controlled with medication. At 2:14PM vitals obtained were as follows: BP 128/84, HR 127, and O2 99%. The client subsequently stood up and stood underneath a tree in the shade. The client received another emotional support hug, was provided a new ice pack, and continued to splash water on her face. RN offered to call EMS services, and the client declined. RN educated the client and her caretaker of s/s of anaphylaxis, when to seek EMS, and to follow up with PCP regarding anxiety symptoms, and V-safe. The client voiced understanding of this. RN escorted the client out of the vaccination site. The client ambulated unassisted with a steady gait. RN visualized the client entering the vehicle to be driven home by her caretaker at 2:27 PM.

About a week or two after receiving the vaccine, my period started getting heavier than usual. The next period was even heavier. My most recent period started on June 19th and got extremely heavy (1 pad per hour, heavy clotting) in the past two of three weeks. I had my Mirena IUD removed on June 27th, because I thought it was affecting my period. My period slowed for the 3 days it was out, then started heavy again after starting the mini pill. I was bleeding so heavy that I was dehydrated and hospitalized on July 9th. I was drinking a lot of water that day, but eventually threw up and felt like I was going to pass out. I had tingly and cold fingers and toes. After stopping the mini pill that night, my period has slowed but not stopped.

Had all side effects within 24 hours of vaccine- went to bed with a headache and chills, had body aches and slight nausea the next day. Then it all went away aside from some lingering arm pain. A few days after the shot I had tingling and numbness in all 4 limbs. I also had random sharp pains in my right leg. I woke up Friday morning and my right arm felt like ice cold water was dripping down (but wasn?t). My husband took my blood pressure and it was really high and my chest felt tight. Given that the vaccine was just paused for blood clots we went to the ER. They ran labs and said I didn?t have any clots. Here is the timeline of what happened after: Saturday & Sunday & Monday: Felt normal again Tuesday: Felt short of breath Tingles started to come back Wednesday: Leg and arm numbness Thursday thru the next few days were the worst: Thursday: Random sharp pains, back, thigh, ab Right calf felt a bit swollen and more sensitive Tingling on back of head Tingling in leg and arm High anxiety pain in chest No appetite High blood pressure Friday: Muscle twitching in thigh, sides and random places Random tightness/sharp pain in thigh Blood pressure and heart rate went back to normal High anxiety pain in chest before bed Didn?t sleep well keep panicking awake (not normal) No appetite Saturday: Right calf slightly swollen after walking around Still had muscle twitches and it?s always in the same spot in my thigh Did a teledoc appt which was totally unhelpful High anxiety pain in chest- felt like I was going to pass out at one point and we took my blood pressure in that moment and it was high ?happened after dinner No appetite Note: anxiety is not something I?ve ever had Sunday: Swelling in leg returned Sharp pains randomly A little heavy to breath at times Tension in my head ? felt cold After I ate dinner chest heaviness returned Sensory overload- watching tv couldn?t do. Sound of humidifier plus tv gave me major anxiety. Turned humidifier off and it instantly got better No appetite Next few days Leg feels numb tingly in morning Slightly tingling in my right hand Light headache Some random twitches and sharp pains in thigh still The next month all seemed fine. It wasn?t until I got a small cold that the tingling flared up again. Right leg continues to be a problem-tingling and numbness comes and goes daily. I?ve also had a few episodes of chest tightness out of the blue. Last night I woke up to find my right arm also tingly and numb.

Patient lost consciousness for approximately 30 seconds immediately after receiving the vaccination. Her eyes and head rolled back, and there was a small amount of foam coming from the mouth. The patient did not enter anaphylaxis or stop breathing at any point. A pharmacy technician called 911 while the pharmacist moved the patient to the ground to lay down and monitor for further reaction. The patient was provided with food and water. EMS arrived on the scene approximately 10 minutes later. They took the patient's pulse and blood pressure, which was slightly low (100/58 - I believe). The paramedics determined that the patient experienced syncope and there was no need for further evaluation at the facility. The patient remained in the pharmacy for about an hour until she felt strong enough to go home.

Immediately after vaccine was given patient felt numbness in arm extending from where shot was given to hand. She said her arm was completely numb but had tingling in hand and fingers. Also complained of tightness in chest, shortness of breath. Patient was able to move hand and fingers. Said tightness in chest was like she felt when her back was out of place. Patient reported no swelling in throat. Observed & followed up with patient for 1 hour. Her tightness in chest improved but was still experiencing numbness in arm and tingling in hand & fingers. She was following up with a medical facility.

FLUID IN THE BACK; HEADACHE; NERVE DAMAGE TO THE RIGHT FOOT; BLADDER INCONTINENCE; DIDN'T FEEL TUNING FORK OR COULD NOT SENSE TEMPERATURE OR SAFETY PIN PRICK; WEAKNESS IN BOTH LEGS; NUMBNESS IN RIGHT LEG; POOR VISION; CANNOT WALK; GENERAL WEAKNESS; SHARP PAIN BEHIND RIGHT KNEE; CRAMPS OF THE RIGHT LEG OR TIGHTNESS OF THE RIGHT LEG; EXCRUCIATING PAIN IN BOTH LEGS; PASSED OUT; PAIN IN THE RIGHT LEG; TEMPERATURE OF 104; This spontaneous report received from a patient concerned a 33 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm, on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included baclofen 40mg daily blood type O type. On 09-JUN-2021, the patient experienced pain in right leg that worsen throughout evening and that was leading to excruciating pain. Body temperature was taken and it was 104. After that patient passed out and slept through the night. On 10-JUN-2021 patient went to emergency room for pain and cramping in right leg, the healthcare provider at the emergency room was told to the patient the side effects from the vaccine. On next day patient had episodes of sever pain that persisted the entire day. On 12-JUN-2021 patient went back to emergency room with the complaints of severe pain in the right leg in addition to pain in right foot more specifically the last two toes, she was was urged by the healthcare provider to go to the hospital but the healthcare provider sent the her to home. On 13-JUN-2021 patient was continued to experience pain in the right leg as well as sharp pain behind the right knee which persisted all day, she took pain relievers but consumer does not recall how much was taken due to the length of time these events occurred. Next day 14-JUN-2021 she went back to emergency room and underwent to magnetic resonance imaging (MRI) due to experiencing tightness on the right leg, difficulty walking, general weakness and result was normal. On 15-JUN-2021, the patient experienced pain in the toes, burning sensation and she applied a cold pack and she felt shooting pain. She could not feel the temperature because they were numb. On next day 16-JUN-2021, the patient went to a primary care doctor's appointment and gabapentin was prescribed. The primary care provider also diagnosed consumer with weakness and numbness in right leg, and numbness in right last two toes, and poor vision. Same symptoms was continued to 17-JUN-2021. Next day patient went to neurologist and an assessment was done and she didn't feel the tuning fork and could not sense temperature or the safety pin prick. Poor vision was diagnosed as well as both legs are weak however it was noted that the right leg was weaker. On 29-JUN-2021 , the patient was admitted into the hospital for 11 days and diagnosed with the fluid in the back ,headache, nerve damage to the right foot. She was discharged to a rehabilitation center, which consumer stayed for one day and one night. On an unspecified date, the patient experienced bladder incontinence and cannot walk at this time. Patient was using wheelchair use. Patient had laboratory tests included, blood test and ultrasound the result were unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating pain in both legs, had not recovered from poor vision, headache, nerve damage to the right foot, bladder incontinence, weakness in both legs, pain in the right leg, cannot walk, and numbness in right leg, and the outcome of fluid in the back, general weakness, passed out, temperature of 104, sharp pain behind right knee, didn't feel tuning fork or could not sense temperature or safety pin prick and cramps of the right leg or tightness of the right leg was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210744094-Covid-19 vaccine ad26.cov2.s-Passed out, Nerve damage to the right foot, Fluid in the back.This event(s) is considered unassessable. The event(s) has an 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). 20210744094-Covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.

AFTER THE VACCINE PATIENT REQUESTED TO STAY SEATED, SHE WAS DIZZY AND PASSED OUT AND FEL FOR A BRIEF MOMENT.

Mouth and throat tingling and slight swelling, dizziness, rapid heart beat, shaking, difficulty breathing.

Immediate post vaccine: injection site soreness (mild), still present at time of event reporting (42hrs post vaccine) Approx 6hrs post vaccine: uncontrollable, full-body muscle tremors and chills. Came in waves lasting 15-45 seconds each, with rest periods of 30 seconds-2min. Overall, this event lasted approximately 1 hour. 9hrs post vaccine: patient was awoken around 3am with an increased resting heart rate of 100 bpm. Patient's normal resting heart rate is approx 76. Increased heart rate persisted until 18hrs post vaccine, at which point heart rate began to gradually return to normal. Normal resting heart rate returned about 26hrs post vaccine 9hrs post vaccine: acute joint discomfort, primarily in hips. Resolved around 17hrs post vaccine after patient took ibuprofen Unknown start time: Fever of 101.4. Patient took temperature 16hrs post vaccine and took ibuprofen at this time. Body temp went down gradually, returning to normal approx 20hrs post vaccine 16hrs post vaccine: general fatigue. Unknown if reason is solely vaccine or combination of vaccine and lack of sleep due to adverse events. Continued until patient slept from 28-40hrs post vaccine.

Subject woke up to use the bathroom and passed out while on the toilet. She called my name immediately prior to the event. She fell prostrate on the floor resulting in facial bruising/cuts. Subject regained conciousness one minute later. She was able to work the next day and had chills for the next 2 days.

Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 1:19PM: Pt expressed anxiety, received vaccination, c/o of panic attack and sad down by the chair. 3 secs later, looked flaccid, unresponsive, discolorized, jerked breafly, bladder incontinent, loud sound, no difficulty breathing, no allergic reaction. RPH open airway, layed on side, head raised and called 911. Pt immediated had a deep breath and became responsive, alert/oriented x3. Ambulance, SaO2 97%.Pt later didn't see the need to urgent care, husband insisted, transported out by ambulance.

Shortly after receiving the Janssen vaccine, Patient began feeling "a rush going down her body, dizziness, and felt the medicine in her arm." She became pale and diaphoretic. She rested 30 minutes, attempted to stand to transfer to a wheelchair, felt dizzy again. She laid down again for approximately 10 minutes and slowly sat up and stated she was "feeling better. Patient's father picked her up and drove her home.

Chills then a few hours later faster heart rate and feeling very hot. Due 6/17. No pregnancy complications.

Client got very quiet and lost eye focus immediately after vaccination. She reported feeling dizzy around 2 minutes after vaccination. After reclining client, they lost consciousness about 9 minutes after vaccination for 3 minutes. EMS was activated, upon regaining consciousness, clients mental status was still altered per staff report. Client was then transported via EMS to local ER.

34-year-old woman with no significant past medical history presents with syncope event after receiving a COVID-19 vaccination prior to arrival. Patient describes lightheadedness and eventually falling forward. She did sustain facial abrasions to her forehead, bridge of the nose, and right zygomatic arch region. Complains of mild headache with without any nausea.

pt. presents with a headache. HX: DM Type 1; BG: 282; onsite medic present. pt. declined EMS/ER. pt. decided to have spouse come pick her up to take her home. pt. left her vehicle at the vaccination site. BP: 131/78, HR: 86: RR:18

Janssen COVID-19 Vaccine EUA Sunday night 3/7/2021 to 3/9/2021: Fever, weakness, dizziness, swelling left upper arm (where I got my shot) 3/9/2021: difficulty breathing, fast heartbeat

Patient complained of light headedness and heart racing on and on 15 minutes after vaccination shot as if she had consumed a lot of red bull energy drinks.

Patient felt nauseous, light headed, and heart racing. Patient stated that her heart racing was not abnormal for her. Patient laid down on ground, drank some water, used a cold compress, and felt better. Patient left to hospital at the end however.

Janssen Covid-19 vaccine EUA Extreme aches, chills, sustained fever of 101, fatigue, nausea, headache, weakness and dizziness. Heart palpitations/racing heart. Vaccine site soreness. Onset was 8 hours after receiving vaccine and has continued for 24 hours.

Out of nowhere got a headache felt extremely hot and dizzy. Then lost consciousness and fell to the ground. Was white as a ghost. Once I came to my hand and arms were numb and tingling. I was sweating but cold. Ambulance was called and they took my vitals and blood sugar. Everything was normal. After about 10 mins I was able to stand and felt better after getting all of my color back. I have felt fine the rest of the day besides some fatigue and body aches.

Muscle pain-mild from hour 8 to hour 15 Nausea- all morning- mild Chills- from hour 8 to hour 20 Fever- up to 100.8 until alleve taken at hour 19 Extreme fatigue- noticed from hour 8 through hour 24 Headache- from hour 3 until hour 24; decreased with alleve but not completely gone Palor- until hour 24

Heaviness in chest within 30 mins of shot Headache starting two hours after shot Within 24 hours: fever, aches, weakness, tired, along with headache . Treatment: rest and Tylenol.

Date: 3/22/2021 Problem: Notes: Time: 12:40P Upon arrival to nurses station. Patient noted pale, clammy & sweaty. BP 60/33 HR 48, RR18. Call placed to EMS Patient awake, alert &oriented x 3. Vaccinator stated that patient loss consciousness approx. 1-2 minutes after receiving vaccine. Patient states that she had a granola/ breakfast bar for breakfast & had not eaten lunch. Patient feet elevated to elevate patient BP. EMS Arrival pending. Will continue to monitor. Time: 12:50p EMS Arrived. Patient assessed by HFD. Patient declined to go to hospital. Snacks & water provided to patient. Patient rested an additional 15 minutes. Will continue to monitor. Time: 1320 Patient went home with fiancé in stable condition.

Patient mom reports patients eyes rolled back into head and she slumped in her seat for 20 seconds during her first 15 minutes of observation. Mom brought patient to me for assessment. When patient presented to me, patient was alert and vitals were normal. I asked patient to remain seated for 15 more minutes of observation. Mom did say patient exhibited this behavior once before at the eye doctor. I informed mom to please check with patients doctor for follow up. Patient exhibited some mental disability and thats is why the mother is involved. I dont believe patient is capable of taking care of herself.

3/18 vaccination About 16 hours later, I started to experience chills, low grade fever, body aches, light cough. Sat., I woke up with fever, body aches. Took Tylenol to relieve symptoms. Sunday I had a fever that spiked to 101.7 with elevated HR. Chills, cough was worse, congestion in chest. I went to the ER. EKG was normal. Elevated WBC. F/up PCM; repeated blood panel. WBC still elevated. Continued with intermittent cough, congestion and low grade fever. Treatment to include steroids and doxycycline. To repeat WBC in 4 weeks with PCM.

Systemic: Abdominal Pain-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: Patient states her vision went \"dark\" and felt \"like she was going pass out\". However, she was still responsive by nodding her head or providing one-syllable answers. She was hypotensive, lightheaded and dizzy, broke out in cold sweat, nauseous, felt tingling sensations in her extremities, and had slight abdominal pain. She began to feel better after laying her down and propping her feet up while waiting for paramedics to arrive.

Immediate reaction - extremes dizziness and profusely sweating, nauseous and felt I was going to pass out. This happened about 5 minutes after I received the shot.

34yr old female with shellfish allergy (reaction: anaphylaxis), exercise induced asthma, previous issues with injections/blood draws (reaction: dizziness) and other comorbidities presented for COVID-19 J&J vaccine on 4/7/21. CMA administered the JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1318. Within 2 minutes of administration, patient became lightheaded and shortly after passed out. Patient had one convulsion (arching back, tense limbs) lasting 5-6 seconds. Once relaxed, patient was arousable. Patient denied hives, shortness of breath, throat swelling, or chest pain. At 1325, BP 48/31, MAP 76, HR 79. Patient assisted to Trendelenburg position and remained lying for 20m. Patient developed chills and tremors during this time stating she was cold. At unknown time later, patient endorsed feeling better and was lifted to sitting position and allowed to sit for another 10minutes. At 1346, final BP 105/58, HR 73. Patient endorsed feeling back at baseline. Provider released patient and patient discharged. Of note, provider notes patient with vasovagal syncope and convulsions after receiving J&J COVID vaccine. Patient has history of vasovagal reactions.

Patient felt dizzy while smoking, weakness chills and ended up passing out, once awake oxygen was 85 ended up resuming to normal after just a few minutes

PATIENT FAINTED ABOUT 1 MINUTE AFTER RECEIVING THE VACCINE. SITTING IN CHAIR, SLUMPED FORWARD AND HIT FACE ON THE FLOOR. PATIENT REGAINED CONSCIOUSNESS SHORTLY THEREAFTER AND WAS MONITORED FOR 45 MINUTES BEFORE LEAVING WITH HER BOYFRIEND WHO SAID SHE WAS OK. I CONTACTED PATIENT LATER IN THE DAY, AND SAID SHE IS OK BUY MAY HAVE TO BE CHECKED FOR A BROKEN NOSE

Vaccine administration at 1522, at 1533 patient states not feeling well. Took to Emergency Department. Flushing, hives, shortness of breath, throat swelling, tachycardia, dizziness.

Around 5.5 hours after I got the shot my blood sugar bottomed out. I had a hot flash, started sweating and my vision went blurry. I couldn?t walk 3 feet without having to sit with my head between my knees. I passed out in a 5 foot walk but luckily i sat down on my couch as it was happening. I?m not diabetic, haven?t ever been hypoglycemic. Ibuprofen and food after about 2 or 3 hours is a must.

client is a 34 year old female with history of asthma and allergy to ibuprofen. she started exhibiting apprehension, shortness of breath and difficulty breathing at 10: 40 am; Initial vital signs assessment revealed a blood pressure of 160/102; O2 sat 100%; pulse 82; RR: 20; temp 97.7 F; lung sounds were normal; orbital cavity was in tact without signs circumoral of edema; pt began to have trouble speaking during assessment; pt used her albuterol inhaler and epinephrine IM was given in the left thigh at 10:42 am; Blood pressure at 10: 52 am was 128/92; pulse 84; Pt stated that she felt better immediately after epi was given; EMS was activated at 10: 40 am and arrived at 10:55 am; pt was escorted by ambulance to a local hospital in stable condition.

After the shot was administered the store had me wait in case there was a reaction. While I was sitting down, waiting for about 15 minutes I felt dizzy and fainted. My head hit the floor. The store called the paramedics. I woke up sweating and the paramedics arrived. The paramedics took my bloodpressure and reported it at 84 over 50. They waited while I felt ready to stand up. After a 3 to 4 minutes I felt I could stand up and they took me outside. Once outside they took my blood pressure again and it was at 110/80. I opted to go home instead of the hospital and I feel tired.

I received the vaccination 4/2/21 at 11am and at about 6pm the same day - I felt a sudden flush and felt like I was going to faint in the middle of Grocery store. Got very clammy and sweaty and weak - immediately left the store and started projectile vomiting outside the store and all night the first night. Had extremely joint/bone pain throughout my entire body for 4 days straight in bed, very weak, chills and night sweats, day 2 I had a little energy and drove about an hour and immediately started vomiting again for day 2-day 5. Day 5 I woke up with swollen eye lids and hands and thought it was an allergic reaction to something in my house so took benedryl, but didn?t help. The swelling went down on day 6. I?ve had no energy and very foggy brain and been very down. My chest has felt like an anxiety attack 24/7 all week. I am on day 10 since the vaccination and my chest pain has increased. I still have foggy brain and been very out of it and weak still. I vomited day 1-day 5. Really bad pain in my hips and arm where I received the shot.

Tingling and minor numbness in left arm going up to my left side of my chest also some random shooting pains throughout my arm and chest

5 Hours after Administration of shot - Severe uncontrollable Chills, Extreme Muscle Aches, Fever, Rapid heartrate (in excess of 130-150 for over 2 hours). The following Day - Extreme Fatigue

Patient had fever peaking at 104.5, full body sweats (when no fever was present), exhaustion, light headed/dizziness, micro-blackouts, joint pain, muscle pain, migraines, lacked focus/concentration, and was easily winded while doing every day tasks. Symptoms lasted for 5 days.

Upon receiving vaccine pt immediately stated she felt lightheaded, then stated it was becoming worse and passed out in chair in vaccine booth. Assistance called pt lowered to floor and then assisted to w/c when fully awake a few moments later. Pt stated she immediately felt better. Pt escorted to back recovery area and vitals taken by staff and monitored. VS were as follows HR 88, Resp 20 and BP 92/70. No injuries or abnormailities noted

8 hours post vaccination Friday 4/9/21 : chills, headache, muscle aches, very tired Saturday 4/10/21:not hungry, headache, nausea, chills, fever, rash on chest, hands feel like they are on fire, body feels heavy and weak, very tired Sunday 4/11/21: dizzy, nausea, not hungry, achey, tired, heart racing Monday 4/12/21: dizzy, tired, not hungry, body feels heavy, heart racing if too much movement Tuesday 4/13/21:DIZZY, tired, heavy feeling body (like moving through mud), heart races if I move too much

Pt received vaccination. Pt reports that she started feeling more fatigued and short of breath the week following injection. However, on 09Apr2021 pt had increased SOB and chest pain while shower, went into the doctor. After scan discovered Massive PE. Pt decompensated quickly and required intubation. Upon transfer to medical center, there were complications with ET tube and pt coded and required resuscitation for 6 minutes. Pt recovered and was transferred. Pt had Chest Xray, doppler of Blilateral lower extremities. Confirming PE and also left Popliteal DVT. Pt was on heparin drip which was switched to lovenox for proper anticoagulation. Pt was extubated on the 11th, is recovering. .

Over 2 days of chills and fevers. Over 4 days of feeling lethargic. Headaches for 2-3 days after. Reported chest pain in daily check in. It was not an option so I wrote it in. 2 weeks after the shot I still have mild pain when breathing in and feel like I am winded more easily to the point that even before the vaccine was in the news I made an appointment with my doctor. He did EKG and D Dimer tests. Both came back normal but I still don?t feel myself.

Reported to facility with chest pain, AMS, shortness of breath, elevated Ddimer. Suspected PE, given antithrombolytics, transferred to higher level of care

Patient came in apprehensive and anxious about recieving shot, fearful of needles. After administration of the vaccine she appeared relieved afterwards and recieved a card with a note to wait for 15 minutes for any reactions. Her mother escorted her to her car, 10 minutes later, her mother came in saying "she's having a seizure!" We had a certified nurse that was administering the shots that went out to check on her and we had a technician call 911. Patient appeared disoriented in the car and clammy to touch. We checked her blood pressure, and the nurse reported it was a little low. After paramedics arrived was being treated as a vaso-vagal response and she was transported to the nearby hospital.

Approximately 5 hours after the vaccine I developed a very bad headache followed by chills, sweats, congestion, chest pain, body pain, muscle pain, fatigue and fever. The muscle pain and weakness was so bad I would loose balance when walking. I then started to menstruate clots, not my normal cycle timing, which lasted about 2 days. The clots subsided but I am still bleeding today. I was in bed for 4 days with severe immune response symptoms. After those symptoms subsided the fatigue was so extreme it was hard to function.

VACCINATED MARCH 31ST, headache appeared on Saturday April 3rd, associated to minor nose bleeds and blood tinged sputum.

I woke up the day after my vaccine and felt very dizzy and fainted. (I had other symptoms that I would've expected after the covid shot as well... mild fever, chills, etc.)

Blood clots (i started heavy menstrual cramps a day after the shot and I saw exceeding amount of blood clots which has never happened this excessively before) Fever, chills, headchae, nausea (all very severe level)

Unusual Heavy menstrual bleeding with clots starting hours after receiving shot. Headache and fatigue day after shot. Menstrual heavy bleeding continued for 6 days outside of normal cycle. Day 7 having moderate leg pains and stomach pains and occasional headaches.

DVST: R internal jugular, transverse/sigmoid sinus thrombus with associated intraparenchymal hemorrhage in R temporal lobe. Presented transfer from outside hospital after presented with 2 weeks headaches, blurry vision and 2-3 days neck stiffness and nausea with 1 episode of vomiting.

I was given the vaccine at 11:10am and by 5:30pm I was beginning to feel tired and unwell. At 6:45 I had a fever, body aches, pain in my arm, headache, and chest pain. These symptoms continued for three days and my fever reached 102.7. After three days the fever and body aches subsided but the fatigue and chest pain continued. The chest pain has continued with increased heart rate during small bursts of activity. I called the clinic that administered my shot on April 9th and was told chest pain was normal up to 10 days and if it continued to be a problem to go to the ER. After 11 days of chest pain I went to the ER on April 13th and they did an EKG, CT with contrast, and blood work. They concluded I was fine. I was told it could be esophagitis so to take 2 15mg Prevacid a day which I have done with no relief. I was also informed it could be muscle related so I have iced, taken anti-inflammatory medication, and have not exerted myself. It is now April 19th and I am still experiencing chest pain and racing heart rate with minimal exertion.

Janssen COVID-19 Vaccine EUA: patient presents to the emergency deaprtment (ED) reporting headache (10 out of 10 pain, difficult to keep eyes open) with neck pain, blurred vision, nausea, and photophobia for two weeks prior to arrival. Patient is four month post partum and breastfeeding. Patient diagnosed with cerebral venous sinus thrombosis and intraparenchymal hemorrhage. Admitted and underwent venous sinus thrombectomy. Currently still hospitalized.

4/10/21 Patient presented to Urgent Care with Arm Pain (left arm painful and tingly since COVID shot 4/8; now pain is different and there is a lump on her forearm she can feel). 4/13/21 Contacted the office to schedule an appointment regarding worsening symptoms. Scheduled appointment. 4/14/21 cont. Seen in office by PA for: 1. Left arm pain - tender nodule L forearm, will get US due to recent birth, Johnson and Johnson vaccine, FH of DVT, to r/o DVT causing the lump, await results. Symptomatic care in the interim, may use warm compresses. - USV VENOUS UPPER EXTREMITY DUPLEX LEFT; Future 2. Paresthesia of left arm - site of reported injection and superficial induration 1.5cm from acromion process, suspect SIRVA due to sit of administration of vaccine, recommend symptomatic care with warm compresses, gentle massage if benefit noted, pt is breastfeeding so recommend local care at this time, consider PT, pt declines at this time as she will be on vacation next week. Discussed possible cortisone injection but deferred due to recent COVID vaccine 6 days ago, pt agrees as there is some recommendation to avoid steroids in close proximity to vaccinations to avoid blunting the immune response 3. Family history of DVT - see #1 4/15/21 After speaking with the DVT clinic Dr contacted the patient and recommended she take an 81mg low dose daily aspirin, until symptoms resolve, around one month. And repeating venus duplex in 7-10 days. Determined she would go prior to her leaving for her trip as she planned to be out-of-town during that time frame. (Per provider result notes.) 4/16/21 Patient was seen in emergency department for: Patient presents for evaluation of multiple concerns. Following the Johnson & Johnson COVID-19 vaccine she was recently diagnosed with superficial thrombophlebitis in the left forearm by ultrasound, has been taking aspirin and symptoms have not worsened. Left upper extremity exam is quite reassuring today, I see no clinical evidence for DVT and she is neurovascular intact. I did not feel that repeat ultrasound was necessary at this time, but she does have this scheduled next week so I advised her to keep that appointment. She has a very slight headache which has been present since the day she received the vaccine, currently 2/10 without vision or other neurologic concerns. No abdominal pain. I have low clinical suspicion for CVST or PVT at this time. Advised return if she develops worsening headache or new neurologic symptoms. Patient complained of new onset left lower lateral breast pain and lump starting today. She is currently breastfeeding and notes decreased milk production today. She does have a tender fullness on exam but no redness or visible swelling, she is nontoxic and well-appearing without fever. She has history of mastitis in the past, but she states her PCP recommended she be evaluated for possible blood clot in the breast. Advised the patient that I have very little concern for that at this time, if anything it would be superficial and not amenable to anticoagulation but I did not feel that imaging was necessary at this time. I will cover her with antibiotics for lactational mastitis, she has cephalosporin allergy but states she had formal testing for penicillin allergy and tolerated this well so I prescribed Augmentin. She will use a warm compress and continue nursing, I did recommend she start on the right side to initiate let down on the left. 4/20/21 patient was seen in the office for: Patient presents for follow up of recent ED visit. She was seen here last week for left arm pain/nodule/paresthesa following her Johnson & Johnson vaccine. She also reported a slight headache that was present since day of vaccine. An US was performed and showed a left cephalic vein thrombus of LUE. She was advised to start ASA 81mg daily for the next month and get repeat US in 7-10 days. She then called in with left breast pain/swelling and was directed to the ED for evaluation of possible blood clot. She does have hx of mastitis several weeks ago. The ED did not pursue additional imagining of breast, they told her it was likely lactational mastitis and they did prescribe augmentin and warm compresses for this. Today, patient presents states he feels "a lot better". Regarding the left breast lump, redness, swelling she states this has completely resolved. She did not start the augmentin as she was worried about this potentially causing thrush for her daughter; she explains she had mastitis 7-8 weeks ago and was on antibiotics and then her and her daughter continually passed thrush back/forth to eachother 3x so she was hoping to avoid this. She did treat with frequent feeding/pupming, and warm compresses and symptoms resolved. She was told to see us for elevated blood pressure in the ER, per review of EMR and her DC papers, her blood pressure in the ED was 130/75. Today her blood pressure is 122/78. Regarding her left arm symptoms, she states the numbness/tingling has nearly resolved; she will occasionally get a very mild tingling in her 4th/5th fingers that resolves after a few seconds. She denies pain or swelling of the arm. She no longer can palpate the clot and thinks that it is gone. She no longer feels swelling or tenderness in her left axilla. She stopped the ASA and started motrin/warm compresses as was advised by the ED. Her mild headache continues since the vaccine but is somewhat improved. She denies worsening or severe headache; denies vision changes, dizziness, lightheadedness, speech difficulty, etc. Phone encounter also from 4/20/21: Phone call placed to DVT clinic to get their guidance as Dr had talked with them last week. Reached RN, who reviewed with Dr. After review of patient's history/chart/growth of superficial clot, Dr recommended that patient not travel as planned and continue on 81mg ASA daily. They would like us to place a referral so they can see her later this week or early next week. They also want us to place order for repeat US either this coming Friday or Monday and they will coordinate to get this done at their office/same time as appointment. I did place phone call to patient to discuss and give their advice. They had just left this morning for another state by car. I reviewed Dr advice to not travel and she will discuss with her husband if they are going to run around or not. She was agreeable to continuing on the 81mg ASA Daily and repeat US/visit with DVT clinic in 5-7 days as recommended.

about 5 days after receiving the vaccines patient experienced fever, tachycardia, rash, body aches, joint aches, muscle aches, headaches , weakness and fatigue. Patient was seen by a provider on 03/22/2021 where a rapid flu and covid tst were ordered to rule out any other illness. At this time due to the muscle aches and weakness provider did order a left LE venous doppler which was negative. All symptoms subsided approximately 3 weeks post vaccine

I had a fast heart rate (approx 120 beats per minute while resting). I called my consulting nurse who advised me to go into Urgent Care. I went to Urgent Care. They gave me an EKG, which showed my increased heart rate, but nothing abnormal. I was given Tylenol to see if that decreased my heart rate, but it didn't. I was told to drink lots of water to see if dehydration might be why my heart rate was increased. The Urgent Care doctor consulted with an OB Doctor and concluded that my increased heart rate was due to my body's response to the vaccine in connection with the pregnancy. At the time of the adverse event, I was 23 weeks pregnant. My estimated date of delivery is July 13, 2021. This current pregnancy is my 3rd. My second pregnancy ended in a miscarriage. During my first pregnancy, I developed Gestational Diabetes and Preeclampsia. I needed insulin to manage the Gestational Diabetes and I was induced at 37 weeks pregnant because of the Preeclampsia. My daughter had to be in the NICU after birth for 5 days due to low oxygen, low blood sugar, low muscle tone, dusky color, and no cry.

1) Bilateral acute appearing pulmonary embolism right greater than left, clot burden moderately large. 2) . Probable portal vein thrombosis with partial superior mesenteric vein thrombosis. 3) Changes of mild diffuse colitis are suspect. Potential etiologies for colitis includes infectious processes, inflammatory processes, as well as ischemic etiologies. 4) Splenomegaly. 5) Thrombocytopenia. Platelets of 39000

patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin). Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".

During my menstrual cycle I usually have no symptoms other than tender breasts. So these symptoms were very unusual. Leg pains, pain and pressure in pelvis, clitoral pain, pain around vaginal opening, stinging like acid during urination that sent a shock through my entire body, uncontrollable bladder, nausea, large blood clots, lower stomach pain, flank pain, hot/cold chills, if I touch my belly button the pain radiated to my vagina, ovaries hurt, cervix pain, dryness, unable to get comfortable, crawling out of my skin, and constant urge to urinate, depression. I landed myself in the ER where they told me to take Tylenol and Motrin and sent me on my way. These medications were not able to control the amount of pain I was in. I have now reached out to a couple specialists.

Patient began having symptoms of chest tightness and throat tightness 4 hours after receiving her first dose of the Janssen vaccination. Patient went to the ER were she presented with fever, chills, lip tingling, finger tingling and feeling like her tongue was swelling 10 hours after getting the vaccine. Patient received antipyretics and Benadryl and began to feel better. On re-exam patient was still hot to the touch and tachycardic. Patient was diagnosed with a vigorous immune response to the vaccination.

Three days the vaccine I got very short of breath with confusion, dizziness and light headed and disoriented. I felt like there was pressure in my chest and I had some brain fog. I felt like I had water in my lungs. My right arm bicep was contracting and twitching. I had Vertigo which made it very hard to sit down without feeling off balance. I was unable to drive. I tried to hope it would pass but I went to the ER on 4/14/2021. The dizziness was getting worse after five days and the pressure on my chest was unbearable. I was advised to drink some water and take Tylenol. My blood pressure was lower than normal. I finally felt better on 4/21/2021. I could finally get out of bed and not feel like I was going to fall down. I could not drive for about two and a half weeks. I still feel a little out of breath and my brain is a little foggy but it has gotten a little better.

Immediately after, the usual - nausea, arm pain, faintness. The next day - chills/fever, fatigue, nausea. Persisting for nearly 3 weeks to present - enlarged spleen presenting with spleen pain (something I haven't experienced since December with covid and in earlier 2020 with mono), fatigue, back pain, indigestion, nausea, right arm soreness at site of injection, joint pain

HEADACHE; BLURRY VISION; NECK STIFFNESS; NAUSEA; VOMITING; CEREBRAL VENOUS SINUS THROMBOSIS; DURAL VENOUS SINUS THROMBOSIS; RIGHT INTERNAL JUGULAR VEIN THROMBOSIS; INTRAPARENCHYMAL HEMORRHAGE; LOW PLATELET COUNT; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID: 1224712) and concerned a 34-year-old white female. The patient's weight and height were not reported. The patient medical history included being 4 months post-partum. The patient had no drug, food or other product allergies, and had no chronic or long-standing conditions. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration and batch number not reported), dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. From an unspecified date, the patient had 2 weeks of headaches and blurry vision, 2 to 3 days of neck stiffness and nausea with 1 episode of vomiting and had been transferred to the current hospital from another. On 04-APR-2021 (12 days post-vaccination), the patient was diagnosed with dural venous sinus thrombosis (DVST), transverse/sigmoid (cerebral venous) sinus thrombus (CVST) with associated intraparenchymal hemorrhage in the right temporal lobe as well as thrombosis of the right internal jugular vein (thrombus). Magnetic resonance imaging (MRI) impressions showed there was a re-demonstrated of intraparenchymal hematoma in the right posterior temporal lobe measuring approximately 6.2 x 3.6 cm in maximal axial dimensions. There was surrounding edema and associated mass effect with effacement of the right temporal horn and right-to-left midline shift measuring 5 mm. There was medialization of the right uncus without transtentorial herniation. The basal cisterns were otherwise patent. There was dural thickening and hyperenhancement overlying the hemorrhage. There was prominent cortical veins along the right frontal temporoparietal convexity consistent with venous congestion. There was also a small are of vasogenic edema in the right anterior temporal lobe separate from the hematoma. There was a right mastoid effusion, but normal orbitals and the calvarium and skull base were unremarkable. Magnetic resonance venography (MRV) results revealed non-opacification of the torcula, right transverse sinus, right sigmoid sinus and upper internal jugular vein compatible with occlusive thrombosis. A small amount of thrombus also extended into the left transverse sinus. The superior sagittal sinus, remainder of the left transverse sinus, left sigmoid sinus, left upper internal jugular vein, straight sinus, vein of Galen and bilateral internal cerebral veins demonstrated normal contrast opacification. The patient's platelet count was 126 upon admission (normal range [NR] not provided), with other workup laboratory test results reported as pending. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the right internal jugular thrombus, intraparenchymal hemorrhage, DVST, CVST, headache, blurry vision, neck stiffness, nausea and vomiting was reported as unknown. This report was serious (caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0: This case concerns a 34-year-old white female who experienced cerebral venous sinus thrombosis (CVST), dural venous sinus thrombosis, right internal jugular vein thrombosis, and cerebral hemorrhage 12 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient was noted to be 4 months post-partum. She presented for medical assistance with a 2-week history of headaches, blurry vision, and neck stiffness for 2 to 3 days as well as nausea with 1 episode of vomiting. Magnetic resonance imaging showed a large hematoma in the right posterior temporal lobe with surrounding edema and associated mass effect resulting in effacement of the right temporal horn and right-to-left midline shift measuring 5 mm and occlusive thrombus within the torcula, right transverse sinus, right sigmoid sinus, and upper internal jugular vein. A small amount of thrombus extended into the medial aspect of the left transverse sinus. The platelet count on admission was 126,000. Although the post-partum status of the patient may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration) and considering the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.

Began with gassy feeling on 4/14 that progressed to stomach pain on 4/15, then heartburn evening of 4/15 through the day on 4/16. Heartburn faded (did try taking Tums, with little effect), changed back to mainly stomach pain. Stomach pain daily 4/19 - 4/29, mainly occurring (1) before & after breakfast, (2) late afternoon, (3) evening. Began taking Prilosec (omeprazole) on 4/30; stomach pain similar to previously described 4/30 - 5/1. Symptoms became more intense, heartburn and heart pain on 5/2, stomach pain 5/3, heartburn and heart pain 5/4. Stopped Prilosec 5/5, symptoms receded to mild heartburn and stomach pain 5/5 - 5/6. Currently deciding next steps for treatment. Stomach pain can be soreness, occasional twinges, all located just below left ribcage. Heartburn upper left, feels warm but also sore (kind of like someone punched me there).

Patient admitted to acute care hospital approximately 7 weeks after receiving Janssen vaccine with thrombocytopenia. Platelet count 4000 at PCP and patient advised to present to the ED. On admission 5/5/21, repeat platelet count 8000. Emergent CT completed which ruled out cerebral venous sinus thrombosis. PT, INR, fibrinogen and d-dimer were normal. Hematology felt that it was most consistent with immune thrombocytopenia and unknown if any relation to her COVID vaccination.

Patient fainted. Given water and lemonade and requested patient to remain in place for 30 minutes. Episode passed, patient reported feeling fine.

Patient was given vaccine at about 2:30 pm and then about 2:32 pm the patient became unresponsive in the chair. Patient was covered in sweat and had low blood pressure (101/65) upon regaining consciousness. Gave the patient an ice pack to cool her down and she began to regain color in her face and her blood pressure returned to 130/82 before she left. Patient did state that this is not the first time she has passed out around a needle.

5-14-21 1735: had arm pain from injection, light headedness slightly dizzy 5-14-21 0200 woke up with headache took ibuprofen 800mg 5-14-21 0630 am woke up feeling fatigued and like my body weighed 500 pounds I'm 510 and weigh 160 pounds but started to feel better after moving around so I decided to work out from about 930 til 1030 am 5-15-21 approx 1120 in the am was showering after working out : Lip tingling and numbness followed by lip swelling, slight facial swelling and feeling of throat swelling like need to cough to get something out of throat , heart racing but was a little anxious (no new foods or products and have never been allergic to anything before) took a benadryl 25 mg tablet approx 1135 but felt like throat feeling swollen getting worse so I went to ER. Approx 5 pm 5-15-21 slight fever, muscle aches headache began to worsen lingered through until currently filing report benadryl 25 mh taken 8pm per MD orders to take around the clock for couple of days

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was unresponsive for 10 seconds then after she became responsive should couldn't remember today's date or where she was for about 30 seconds. Then she was ok. Talkative and could answer all of my questions perfectly. She was very sweaty and thirsty. Patient drank 2 bottles of water and was monitored for 30minutes before she was allowed to leave the store.

Experienced seizure event on 5/11/2021 ER reports non- verbal upon admission, altered mental status, urine screen positive marijuana & benzodiazepines. Tested positive for Covid-19 5/11/2021 Hospitalized 5/11/2021- 5/18/2021. D/C diagnosis: Acute metabolic encephalopathy Active issues: hypolalemia, Seizure (HCC) , Covide infection, AKI (Acute kidney injury), elevated troponin, elevated LFTs. Hospital Attending Hospitalist MD Consults: Doctor of teleneurology

I experienced headaches, aches and pain whole body, feels pulsation to my hands, like carpal tunnel syndrome, My whole body feels icky, I had shortness of breath, my doctor thinks I have inflammation and I am now on prednisone medication. Pain in my back and all over and difficulty sleeping. These aches and pain come and go and move to different parts of my bodies and also resting heart rate that comes and goes. To this day I continue to have aches and pain on my body and also still on steroid prednisone medication.