Johnson & Johnson

seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery.

Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.

On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend. Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling like I needed to burp and that I had GI problems. The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th. I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery.

Dizziness and light headed, with confusion, fatiuge, with head ache. Very severe just after injection. 3 days post vaccine and still feeling dizziness and headache with mild fatigue. Symptoms are similar to a hang over. The symptoms are slightly better than the day of vaccination but still exsist. Symptoms do seem to come and go and are not constant. Little relief is given by tylenol.

12:05 PM - began with severe headache. Did not abate until 2:45 on 3/21/21. Ibuprofen taken to counteract. 3:30 PM mild dizziness. Passed within an hour 4:55 PM Fatigue. Felt extremely tired. Condition persisted and continues to do so as of time of this reporting. 8:15 PM Chills. Passed by 4 AM on 3/21/21

Patient came in to the clinic to receive his dose of the Janssen COVID vaccine. Within the 15 minute post-vaccine period, the patient reported feeling warm, sweaty, having clammy hands, and the feeling of almost "passing out". Patient was taken to a patient room to rest, vitals were taken at 13:16 PM with readings of BP: 91/57, HR 72, SpO2 98%, temp 98.5. Patient denies any past medical history, reports he only takes vitamin supplements, and denies any past history of anxiety. He denied any chest pain or SOB. Patient was provided water and was told to rest for a few minutes. Vitals at 1:42 PM were noted to be: BP 108/71, HR 72, SpO2 99%, and temp of 98.1. He says he feels much better and denies any symptoms at this time. ER precautions were given to the patient Called patient again 4/2/21 at 09:59 AM - pt denies any ER visits, hospitalizations, or any visit to any other healthcare provider since his vaccine. The day after his vaccine, he says he developed a headache with left arm soreness (injection site was left upper arm) which was all improved by Monday, 3/22/2020. He says he took Advil, drank plenty of fluids, and rested for his symptoms of headache and arm soreness. He denies any other symptoms of near syncope after his near syncopal episode at the clinic. He denies any symptoms of fevers, CP, SOB, swelling, drainage, or pain at injection site, abdominal pain, dizziness, lightheadedness, or any other side effects/averse effects of the vaccine. He says he is doing well overall

dizziness and weakness 10 minutes post vaccination. observed patient for 20 more minutes while seated. called 911 for patient but patient refused service. patient was alert the entire time and able to converse coherently. Patient felt fine afterwards to drive home. Followed up with patient on 4/5/21. Patient stated that he's perfectly fine after reaching home with just a slight arm soreness which was resolved the next day.

Pt fell dizzy an faint ~5 min after injection. Offered cold water, glucose tablet, ice pack for symptomatic support. paramedics on scene to evaluate safety of patient before departure

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.

Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number

States he started feeling hot, lowered to the ground. Did hit his head. states this has happened in the past with blood draws. Has allergies to PCN= Hives. Awake and alert x 3 99% O2, RR 18, BP 156/84, HR 88 Feels better while sitting in observation Only medical history hypertension and patient doesn't take any meds

Patient became diaphoretic and light headed. Patient had some apple juice and stated he felt better. VSS HR 56; BP 104/84

Feel headache first days only, but last Sunday I was driving and I need to suddenly stop, because I was so dizzy, lightheaded , after this event this happened again today morning, but not like last Sunday, today was less . I don?t know if this is normal or not .

I waited the advised 15min to assess any allergic reaction. I felt fine aside from a sore arm. I called my wife and drove home. Once on the freeway I felt dizzy. This came on me very fast. I thought I better get off at the next exit.. but instantly blacked out. While unconscious I struck another vehicle going approximatley 65mph, rolled my vehicle on its side, skidded, then rolled back upright. I awoke to my car spun sideways on the freeway, paramedics, and fire dept working the wreck from my window, and no recollection of what happend. It felt instantaneous to me. I ate a breakfast of granola, yoguirt. I hydrated before the shot. I even took extra Vitamin C.

Woke up in middle of night extremely dizzy, lightheaded, weak, and shaking. Went to ER. They gave me an aspirin, drew multiple blood samples, performed two EKGs, and a chest x-ray. They could find nothing wrong with me. After about an hour at the hospital the symptoms begin getting better, and I was discharged approximately four hours later.

Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This lasted for 2 days at the same pain level. On the third day the stiffness, pain, hard to move went down to about 5% of what it was.

Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medication and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:03 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 14:15, the subject experienced dizzy. On 10-APR-2021 14:15, the subject experienced hot flushes facial. On 10-APR-2021 14:15, the subject experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizzy, and the outcome of hot flushes facial was not reported. This report was non-serious.

Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.

LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE; WOOZY/DIZZINESS; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 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 woozy/dizziness. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced feeling warmer than usual. On 13-APR-2021, the subject experienced feeling achy. On 13-APR-2021, the subject experienced feeling sick. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, headache, chills, loss of appetite, weakness, woozy/dizziness, feeling achy, and feeling warmer than usual. This report was non-serious.

RINGING IN THE EAR; DIZZINESS; CONGESTION; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 245 pounds, and height was 183 centimeters. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced ringing in the ear. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear, and dizziness, and the outcome of congestion was not reported. This report was non-serious.

Called Connections on 4/20/21. Pt c/o feeling swollen throat glands, hard to swallow, dry/sore throat, also random dizziness not constant, feeling body aches, tired, runny nose but pt denies sob, difficulty breathing, chest pain. Speech seems comfortable, AO X 3. Pt stated these sx started on 04/13/2021 after he got his Janssen(J&J) covid vaccine on 04/12/2021,he stated sx not getting better its getting more from then. This writer recommended pt to go to ED/call 911 for further evaluation and treatment. Pt took covid test yesterday awaiting for his result. Denies any past medical Hx

Patient reported acute onset of diffuse tingling sensation , light-headed, with cold sweats, blurred vision, and acute complaints of shortness of breath within 9 mins of injection. Shortness of breath was immediate after administration. VS at 11:30 AM T97.4, HR 60, RR 16 BP 88/58 O2 87- rechecked at 95--lungs CTAB Reports a controlled 1600 cal/day diet, OJ and gummy snack given. Patient encouraged to push PO fluids and focused respirations. O2 stabilized at 94-95% on RA VS rechecked at 12:15 PM 96.9 Tympanic, HR 58, RR 16 even and unlabored, BP 98/72 O2 97% Reported feeling better and with appetite, was able to walk around parking lot for several mins to make sure he felt ok to independently leave and opted to depart. A&O x 3. Insight and judgement intact.

Patient lost conscience ten minutes after receiving j&j vaccine. Patient felt dizzy/lightheaded, lost pulse, required CPR and epinephrine. Paramedics were called to the scene, requiring hospitalization.

Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes. Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing. Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move. At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm. I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it. Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine. Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this. I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better. It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.

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

patient became diaphoretic and dizzy, mild nausea hands went tingling and numb. pt was moved to well ventilated area and recovered quickly. regained color and dizziness diminished.

Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.

1. 40 y/o male with no past medical hx c/o lightheadedness and dizziness 8 mins after receiving the Johnson and Johnson vaccine. He reported that he came directly to site after a 12 hrs flight and he last ate earlier this morning. He was assessed and monitored by NP, EMT, and paramedic. BP - 103/68, HR- 62, resp 14, O2 sat 95% on RA, had mild anxiety. He was given H2O and granola bar, allowed to lie down, instructed on relaxation measures. He was kept at site until he reported that he felt better, calm and had no complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs SEs to call 911 and go to the ED and that symptoms may occur up to 3 wks after receiving the vaccine. He verbalized understanding and willingness to comply. He noted that he will be returning to on 6/8/2021. He left site in no acute distress, awake alert and oriented to person place time and situation, calm.

Patient felt nauseous and lightheaded within 2 minutes of vaccination administration. He threw up once and felt better. VSS. Observed him for approximately 30 minutes. Patient reported he felt back to normal. Left in stable condition, without any symptoms. He did report he thinks that he had a reaction because he had not eaten all day. He is not a diabetic.

I experienced after the vaccine, I got super sick for one to two weeks as if I had Covid again, had a terrible headache that has not gone away. Also have horrible vertigo, feel like I am spinning all the time and it has not gone away. I also had SOB and my heart was pounding for one week. My PCP told me that I should wait it out that it was probably my body revolving against the vaccine and I was prescribed a medication for my headache and vertigo. My ear were also checked with an ENT and I have no inner ear problems. I can say that my symptoms came from the J&J vaccine.

Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt started not feeling well. He experienced dizziness, sweating, swelling of the lips and tongue, and shortness of breath. Pt was non-responsive. Rph administered an Epipen and staff called the ambulance. At this time, pt was becoming more responsive in response to the Epipen. EMS came and checked the pt's vitals. Vitals were within normal range. Pt was not sent to the hospital. EMS advised the family to monitor the pt and call EMS if symptoms worsen. Pt is doing okay.

April 17th, felt chest pain and fatigue and shortness of breath. After about two weeks of it, I went to ER on the 26th. I was diagnosed with blood clot on my heart. I spent a week at the hospital Heparin blood thinners and antibiotics - discharged on May 2, 2021. They sent me home with Warfarin regiment. I am still on that. I still have some days where I'm good but some days, I can barely stand and get out of bed due to short of breath, fatigue but not as much chest pain. I think the blood thinners are working. I just have to take it easy and make sure to have some calm days. It could take weeks to months to have the blood clot totally dissolve from the system.

Patient had vasovagal response to receiving the vaccine, became light-headed and briefly lost consciousness. We called Dr. in the attached office and his intern over to make sure Pt. was okay. Gave the pt water and he felt fine after sitting for ~15 minutes

the patient soon after receiving the vaccine started to sweat profusely and felt extremely light headed. we had him sit for a few minutes and drink some water and took his blood glucose to see if it might by hypoglycemia--results were normal (148)-- the patient started to shiver and experience chills but after about 10 minutes the patient started to feel better and in an additional 10 minutes was back to normal. his issues resolved on their own.

Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barely able to turn my neck to the right. A lot of pain and discomfort. Limited mobility of neck.

After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night sweats, headache, dizziness, and chills around 10pm. Along with these side effects I also developed an extreme ringing in my ears. The ringing is so constant that it's difficult to sleep and even think. The ringing has shown no signs of improvement and can best be described as a high pitch sibilant sound.

Pt was vaccinated without issue. Pt advised to sit for 15 mins. After being in observation area for 5 mins, pt stood up and immediately fainted and fell to the floor hitting head on floor. Pt had some bleeding from small laceration on head. 9:50am VS BP 130/80, P 60. Rescue called and was brought to ED for evaluation since he hit his head.

COULD NOT BARELY MOVE OUT OF BED; BARELY WALK; BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 40-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, smoker (vapor about 10 -15 times a day), and non-alcohol user, and the patient had no known allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 25-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate tablet for high blood pressure. On 30-Jun-2021 (5-6 days after receiving the vaccine), the patient started feeling pain in both legs. He had no other symptoms no fever, no aches. He climbs in a machine at his job, but he knew he didn't twist it. On 16-JUL-2021, he visited his physician because the pain lasted for 3 weeks. His physician ordered X-rays and Ultrasound. On 19-JUL-2021, he was notified that he had blood clots in both legs. He stated that it was worse and he could not barely move out of bed and barely walk. Physician prescribed him Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in both legs, and the outcome of could not barely move out of bed and barely walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210743268- Covid-19 vaccine ad26.cov2.s- Blood clots in both legs. 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

Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing.

Patient received single dose vaccine of Janssen / Johnson and Johnson Covid-19 vaccine to R deltoid on 15 MAR 2021 and presented to clinic here on 18 MAR 2021 with excess left shoulder pain (2/10 rest but increased with active range of motion) and slight limitation in range of motion to R shoulder due to pain

Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine. I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.

Severe chills, shaking Fever of 101F Knee partially paralyzed for 3 days in a row (difficulty walking) Severe headache

Patient said he got woozy, light headed, felt like fainting. Gave him some water and observed him for 15 more minutes He called back and said it happened two more times. Today he is feeling fine.

I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a chair, I began to get tunnel vision and felt extremely tired. I broke out in a cold sweat all over my body. I began to lose my vision like I was fainting and I momentarily blacked out or dozed off, then came back awake. I started to get tunnel vision again for a minute, then it faded away. Then I continued sweating for a minute and then it faded away. After a couple minutes I felt fine again. I sat for another several minutes then left at 1:15 feeling ok with just a sore shoulder.

Pt was sitting in chair for recovery. Fell out of chair from sitting to lying position face down on floor. Pt immeditaly sat up on his own. A/Ox3. Sat up in a daze for a few seconds. V/S obtained with b/p 98/56 HR 47 O2 98%. EMS notified. Upon EMS arrival pt was lying back down but a/ox3. Pt refused EMS for further care. Monitored pt for extra 30 min and sent home with wife at side.

Patient received vaccine and was instructed to sit for 15 minutes as required for monitoring. About five minutes in, another patient who received the vaccine together with patient told us the patient had fainted. Patient was slumped over to the side when I came to check on patient. I called the patient a few times and patient started to come to. I asked the patient how he was feeling and if he had any difficulty breathing to assess for anaphylactic shock. Patient was breathing normal, but was sweating and a bit confused. Patient reported feeling dizzy. I explained to patient that he fainted for a few minutes and instructed to sit as I did not feel comfortable having patient lay down in the state he was in. Patient was given water and a fan to help cool him down and legs elevated (patient reported feeling much better with the fan blowing on him). Patient sat at the pharmacy for over 30 minutes before heading to the bathroom. At this point, patient were no longer dizzy and I instructed him to get up slowly and assessed that patient was no longer dizzy before letting him go to the bathroom.

About 10 minutes after shot I asked patient how he was feeling, he said he was hot. I walked out to talk to him and he said he felt dizzy. He turned pale and fell sideways off chair onto floor lowering himself with his knee. He did not bump his head, he was sweating profusely, but did not lose consciousness. I yelled to the tech to call 911. Patient was sitting on floor. He said he did not eat much all day. He was alert and talking. He said he fainted when his wife had their baby. We gave his some orange juice. The paramedics arrived 8 minutes later and checked his vitals. In the meantime we called his wife. Paramedics checked his BP, glucose and questioned patient. Patient refuse to go with paramedics. Wife came and paramedics released him to her.

Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.

I started get chills and sweating around 6pm when I woke up from a nap. I was still tired so I went back to sleep after a hour or two. I woke up again in a few hours with worse chills, minor headache, and minor joint pain. I took over the counter medication, felt a little better and went back to sleep after a few hours. I woke up around 4am to use the bathroom and still had the worse chills, sweats, minor headache and was very dizzy. I decided to lay down on a rug rather than try to make it back to my bed and laid awake for a few hours again I woke up again in a few hours a little better and repeated everything until Sunday night when all my symptoms were very mild. I eat and drank water regularly and took over the counter acetaminophen a few times.

I had chills the first night after the vaccine. In addition to that I have continuous pain in the legs, feeling of dizziness and fatigue even after sound sleep in the night. I am having feeling of nausea and vomiting on a continuous basis which have not gone away even after four days have been complete since vaccination.

Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.

Day 1-3-headache, body pain, cold sweat, so took tylenol. Day 4-6- hard to walk and leg pain, take tylenol. Day 7-13- can walk but my leg and hand pains and shaking and headache feel like electric thru my head, take tylenol. Day 13-present- still have leg pain and headache like electric thru my head and my b ody shake itself when i move or stand little while

Approximately 8 minutes post-vaccination patient started to feel dizzy. Patient then got out of his chair to come tell the pharmacist (myself), during which time I witnessed him starting to sway and attempted to approach the patient. Before I could make it to the patient he passed out and fell to the floor, his bottom hit the floor first followed by his torso. I told the intern to call 911 and stayed with the patient. He never stop breathing and a pulse was always present. He attempted to get up moments after falling and I requested he stay on the ground. After a couple minutes he felt slightly better and I assisted him into a chair. At this point the paramedics arrived and took over patient care while I described

I received the COVID Vaccine at 12:30 PM. My temperature had been increasing all afternoon along with my heart rate. At roughly 8:40 PM, my temperature increased dramatically to approximately 38.9C. This may have happened over a relatively short period of time, since it was 37.9 C at approximately 8:00 PM. My heart rate increased to 150 bpm and I became dizzy. After a minute, my heart rate decreased to roughly 115 bpm. Unsure whether to call EMS or not, I called a friend, who is a Dr. at the local hospital (Dr. is a colleague we do research together.) Dr. was concerned but provided information on what to do and when to call EMS or be driven to the ER. I spent the rest of the evening with a pulse between 105 and 110 and my temperature hovered around 38.9C until at least 12:30 AM. The next day, my heart rate had decreased to roughly 80 bpm and my temperature to approximately 37.8C. I spent most of Tuesday sleeping. Today (Wednesday May 12, 2021) my heart rate is down to roughly 76bpm. My temperature is holding around 37.2C. I have reported this to the CDC through the COVID vaccine reporting app. My resting pulse is usually 62 bpm with a waking pulse of 58-60. My normal temperature is 36.5-36.7C. I have a wellness exam schedule for Monday. Dr. is not my regular GP, but was available at a time when my regular doctor was not available.

Patient was given the vaccine. After sitting in a chair for a few minutes post vaccination, he said he felt dizzy and then fell over and hit the floor face first but had blacked out and did not remember fainting or passing out. He was bleeding because he had hit his face and his lip was split and his tooth was chipped. He also continued to be very dizzy, was extremely pale, and was sweating profusely. The EMT arrived about 20 minutes later and took him to the emergency room.

Patient claims 3 minutes after vaccination, his body felt like "it was on fire", he started sweating and he felt like passing out. He also claims he could not move or speak for 30 minutes. The patient then claims he was completely fine after 1 hour and has no reaction today.

Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head hurts constantly. Tingling still comes and goes. It?s been 5 weeks after vaccination.

COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.

Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side. Elevated heart rate and fatigue. Dizziness and lack of focus. Overall feeling that something is wrong.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

Pt. didn't feel good after the shot. Pt. got out of his chair and fell to the ground. It looked like he passed out. We got medical attention and called 911. We also gave him water to hydrate himself. He was sweating. He needed time to recover while the fire dept came and help out.

I received the vaccine March 15 and just shy of 2 months later; May 10th, 2021 I woke up at 8am with a severe headache. I had a fever as well as the chills. I was nauseous and dizzy all throughout the day. The same symptoms continued on for 1 week. Then they eased up. I didn't think too much about it, but then the headaches have continued. As well as the nausea and dizziness. The symptoms are erratic. They last for 2 days at a time. Then they disappear for a few days. Then the cycle repeats. This has been on going since May 10th.

FEELING FAINT, PALE, SKIN COLD AND CLAMMY, ICE PACK APPLIED TO FOREHEAD STATES FEELING FINE WENT HOME WITH FATHER

The vaccine expires 6 hours after the vial is first punctured. The patient received 1 dose of the vaccine 72 hours after the vial had been punctured. The patient was observed for 15 minutes at the clinic after the vaccine was administered. The patient stated he felt "light headed" 5 minutes after the vaccine was administered. Patient was given water and then became asymptomatic. Patient was then discharged home. No other events have been reported by the patient at this time.

Within minutes of receiving vaccination, pt stated he was hot and thirsty, became unrepsonsive to verbal stimuli. Pt proceeded to have tonic-clonic seizure lasting 25 seconds. Pt lowered to the ground by staff, monitored VS. No incontinence, no biting of tongue. pt regained consciousness, and oriented x3. VSS. pt reported he felt light-headed. When attempted to place in chair, symptoms returned, and pt was placed back in supine position. EMS arrived, and after VS established, EKG indicated sinus rhythm, placed in chair. Pt stated he did not feel good, and similar symptoms began with eyes rolling back and contractures. Pt taken to hospital.

Pain started at elbow and shot down to the wrist and hand. Worsened with time. Could not lift anything, had to wear a sling to avoid movement and pain has not fully gone away until now. It's lessened, but I have to avoid doing many things with my left arm now. Diagnosed with Compression of right radial nerve, left lateral epicondylitis, left ulnar nerve irritation on Friday April 23, 2021.

SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.

have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest

About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.

Patient received Janssen vaccine was told to sit for 15 minutes post observation. He came up shortly after (less than 5 mins post imz) saying he didn't feel well, like he was going to pass out. I immediately came from the pharmacy, my tech sat a chair behind him. I called for optical to call a code white. The patient requested to sit on the ground. At this point, his wife was present. He was sweating. I gave him an ice pack, a water after it was determined he was breathing okay. He was pale, extremely lethargic and sweating. After sitting him on floor I told my tech to call 911. I took his blood pressure, it was 99/73, pulse 75. Very low for him. Hes on blood pressure medicine but been having issues controlling it. He later tells me hes terrified of needles. He also tells his wife he hadn't eaten all day. I stayed with the patient until ems left with him because when standing his heart rate dropped 20 points, after they stuck him again to check his blood sugar. They determined then he should be checked out at the hospital and they took him.

Notified by pharmacy technician that patient had 'passed out' in parking lot. Patient found lying on the ground, pale but awake. Patient had been instructed to wait in the store for 15 minutes after vaccination in case of any adverse reaction but, per police, decided to wait in the car instead. He then began to feel lightheaded and decided to come back into the clinic. He passed out on his way. Civilian notified policeman that patient was passed out and EMS was called. EMS arrived shortly after I went out to parking lot to check on the patient. Patient was alert and oriented for EMS, reported history of HTN. He continued to c/o feeling lightheaded and BP per EMS was 77/48mmHg. Patient taken by ambulance for further evaluation and treatment.

Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.

Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain level to 10. Fever, chills, naseau, dizziness, tiredness.

Woke up 8 hours after receiving vaccine. Violent chills. Light headed. Nauseous. Fever spiked to 103. Headache. Fever broke after 24 hours. All symptoms vanished after 48.

Patient fainted about 2 minutes after vaccination. Was awake and alert within 2 seconds after fait and falling from observation chair.

After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats. This happened both the first and second night. During the day I was taking Tylenol every 6 hours for aches and pain. Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy. The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times). The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack. I mention the last symptom as I have never had an episode like this previously in my life. Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.

KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.

Patient received covid vaccine at 12:56pm on March 31, 2021. At 1:00pm he sat down on the floor. He remained conscious but complained of feeling dizzy. HR was 40. Staff was able to assist pt into a wheelchair and escort him into a private side room. Pt was assisted onto a cot and his legs were elevated. At 1:05 his BP was 130/75 and HR 60's. Patient's skin at 1:06pm appeared pink and WNL. 1:13pm = BP 115/75 and HR 67. 1:23pm = 130/75 HR 68. Patient denied shortness of breath/chest pain throughout the entire episode and did not lose consciousness. At 1:23 patient stated he no longer feels faint, just a bit weak. At 1:24pm patient dangled on cot. 1:27pm = 130/80, HR 70. 1:33pm = left facility in the care of his mother who is driving. He stated he feels a little weak, but not faint or dizzy. He left ambulatory. He refused transport or the need for additional medical care. Follow up call was placed to pt on Friday, 4/2/21. Pt denied any residual effects and stated he is at baseline.

Almost fainted from extreme dizziness. Laying down and having a drink prevented fainting and improved symptoms.

About 10 minutes after receiving the shot, patient felt dizzy. He continued walking and fainted. He was caught by his wife and was let down to the floor. After resting, he regained consciousness. After resting longer, he felt better and was able to leave on his own. After about 2 hours, he said he felt fine and had no lingering effects.

Vasovagal / syncope episode with subsequent fall to the ground, striking head; taken to the Emergency Department, stated prior to syncopal episode felt lightheaded, sweaty, clammy. Patient discharged to home within 3 hours of ED admission.

Vasovagal / syncope with subsequent fall to the ground, striking head; transferred to Emergency Department - stated lightheaded, dizziness, clammy prior to syncope and fall. Patient discharged to home in stable condition from facility within 3 hours.

Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.

As described by the patient: Patient (driver) was feeling anxious, received the shot and almost immediately started to see white spots and was dizzy. The patient asked to be directed out of the vaccine lane (prior to proceeding to the post administration area) to just get some air. The patient got out of the car, felt dizzy and fainted. Patient fell to the ground in a sitting position. Patient was assessed by BLS and refused transport. Patient switched positions and allowed his passenger to drive off scene.

At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I was at the doctors clinic for an appointment and suddenly felt tingling on the left side, temporal area, after some minutes start having rapid heart rate and blood pressure was high, felt lightheaded, weak. The symptoms last for few minutes.

Pt presented w/vertigo night of vaccination on 3/18 and still w/persistent vertigo x 1 month from vaccine.

This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced body aching. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pain at injection site, and had not recovered from dizziness, headache, body aching, chills, and nausea. This report was non-serious.

EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.

THE PATIENT RECEIVED JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE. PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.

Patient vaccinated with J&J vaccine 3 weeks ago with 4.5 weakness and decreased mobility in the arm that he received vaccine in- cannot lift arm above shoulder . No inflammation noted

Patient started filling dizzy about 10 minutes after vaccine. He felt weak and tired and also started sweating profusely. Skin was cold and clammy to the touch. I checked his BP and it was 89/53. I called 911 as precautionary and ems arrived within 5 minutes. Patient had stopped sweating by then and was able to stand and walk with EMS to another area of the store to be evaluated further and monitored.

5/13/21 around 11:30 am Patient received vaccination. Patient directed to post exposure waiting area. Patient after sitting down under a minute started to slouch and fainted. Fell on floor with side of head hitting floor. Patient passed out and then less then 10 seconds later gradually became alert. Patient did not want to lay on floor and was positioned in chair. 911 Call placed and EMS responded approximately 8 to 10 minutes later. Patient declined being sent to hospital. EMS took blood pressure and made sure patient was okay. Patient signed waiver with EMS

started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, was hot and thirsty, I gave him cool wet papertowels, and ice pack a few sips of water and had him sit in imz booth while I talked to him and watched him. He felt better and had his ride pick him.

I, am reporting this VAER on behalf of my brother who is currently incarcerated in a state correctional facility in PA. During a phone call a few days following his vaccine, he told me that his continues to experience shoulder pain and issues with range of motion following administration of the J&J COVID vaccine. When he first informed me, I asked him if the discomfort he was feeling was expected pain and discomfort at the injection site, to which he responded no. He reports that a couple days following administration upon stretching when waking he experienced shooting left upper arm/shoulder pain and reduced ROM the arm in which he received the vaccine. I am reporting this adverse event as he is still having this issue.

I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.

11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.

PATIENT FELT DIZZY, LIGHTHEADED, GOT VERY COLD AND CLAMMY, WAS "OUT OF IT" FOR A FEW MINUTES. TREATED BY LAYING PATIENT DOWN, GIVING COLD WATER, AND MAKING SURE SAFE AND NO AMBULANCE NEEDED. RECOVERED SOON AFTER.

Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feeling dizzy, appeared pale and slightly diaphoretic. Pt had witnessed syncopal episode at approximately 08:50. Pt seated with nurse and site employees at side to assist in ensuring safety. No injury occurred. Syncopal episode duration approximately 30 seconds. Pt became unresponsive, bradycardic and slightly hypotensive. Vitals: 110/55, 50, 13, 98%. EMS activated, PD called, and Capt called to be made aware of situation. Pt given Gatorade 150 ml and endorsed prior syncopal episodes with vaccines and blood draws. 8:53- Pt able to sit upright independently, drink fluids w/ no complication, AAO x4. Pt vital signs stabilized within 5 minutes with no other interventions other than PO fluids. PD arrived onsite 8:56, asked pt if he required medical assistance, pt declined. PD officer given report by lead RN. RA 51 arrived 8:58, report given by lead RN, pt evaluated, performed EKG finding NSR, and fingerstick glucose result of 163. 09:00- pt reports dizziness resolved, and declined transport to hospital by PD and signed AMA. 09:45 pt remained continuously monitored by site RNs, along with PD assessment. Pt exited site ambulatory with no further incidents accompanied by wife.

After about 5 minutes patient became light headed and became prone on the floor. Patient became nauseated and vomited.

A month after I received the vaccine, I started having symptoms of forgetfulness, became foggy, had severe exhaustion, intense headaches, loss of appetite, issues with balance, vivid dreams and apparent hallucinations. My PCP had me see a neurologist and a rheumatologist. I had blood work drawn, tested for COVID and x-rays done. I have a CT scan in the next three weeks. We are going to come up with a plan after my CT scan.

Waited over 20 min without resolution of nausea .Patient with hx of Gerd on PPI . Patient without cardiopulmonary symptoms . Patient encouraged to take PPI and make dietary changes x 24 hrs .Patient reported dizziness during questioning (mild) . Ambulance.

April 24 rush to ER because of urine retention then april 28 he started with facial paralisis wich the doctor said it was bellpalsy but 1 week after all that he lost all the strenght on his legs he was using Foley cateter sin april 24 thrue may 21 and now he could barely move he has limited balance i have to take him out of bed hold him he could not be seat because he feel sever pain on his legs an feets and sever cramps and tingling

5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, didn't leave bed 6/9/21 - Severe side pains and bloating below rib cage 6/16/21 - Woke up to 10/10 pain in my abdominal region, felt like knives were being stuck directly under my rib cage, around this same time, I noticed that both of my inner legs, from roughly my ankles up was going numb to the touch, severe stomach bloating as well 7/6/21 - Everything described for 6/16/21 progressively getting worse to the point where my legs were so sore that I can barely climb up stairs, can't eat much so went to the ER. During the visit they didn't address my leg issues, released me with diuretics to deal with bloating (which have not helped). My stomach is generally bloated anywhere from 50-75% and I have pain in my stomach , legs, and shoulders and seem to be losing muscle and a rapid rate. I'm a healthy eater so all of this is very unusual and extremely concerning. I cannot work as well.

Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresthesia worsened to both sides of my face and has not gone away; have experienced this for 10 weeks now. Also experiencing sporadic parethesia in right forearm down to fingers, and right calf down to toes. I have also experienced intermittent bouts of muscle fatigue/weakness in arms and legs, as well as lightheadedness.

Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21). This then progressed to numbness in lower body (4/12/21), the numbness then became weakness and inability to walk (4/26/21). I was then hospitalized 5/5/21 and had many, many tests. Ultimately I have been diagnosed with neurosarcoidosis and am currently undergoing treatment.

Patient has history of MS well controlled with Cosentix injections. Patient reports approximately one week after taking vaccine he began experiencing pain in his feet and ankles. Reports the pain has ascended to lower back and reports he can no longer lift heavy objects and cannot perform required duties for his occupation. Denies numbness, tingling, burning. Difficulty with walking, especially distances or stairs. Reports pervasive fatigue and sleeping until late in the day but waking up exhausted.

Around 24 hrs after getting vaccine I started to get dizzy when moving around. The dizziness and Nausea has continued for now 9hrs since started.

AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home

Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense headache that dulled after about 24 hours, but has persisted for 4 + days at this point. It is now day 5, and I still feel quite weak and my headache, though getting better, persists. I experienced dizziness on days 1 and 2 that has also dulled, but has not quite fully resolved. Frequent urination on days 1, 2, and 3.

103 degree fever, uncontrollable chills/shaking, headache, nausea, body aches, dizziness, weakness. Fever lasted 36 hours, aches and headache lasted 48. Felt like the worst flu of my life. Sickest I've felt in 10+ years.

Date: 3/23/2021 Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74 O2 100% T 98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. PERLA. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress and left with wife.

Fainted about 7 minutes after receiving the vaccine. Came up to consciousness again after 1-2 minutes, but felt lightheaded and nauseas. Vomited 45 minutes after receiving the vaccine.

Strong increasing fever over a period of several hours beginning around 9 hours after dose. Fatigue, dizziness. Chills.

Dizzy, light-headed, rested for 30 minutes and gave water. Patient state similar symptoms with previous needlesticks

Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.

Patient became dizzy and had a vasovagal response. His heart rate dropped between 40-50 and did not increase how EMS had expected. Patient began to vomit and was transported.

Patient fainted 5-10 minutes after the shot. He was seated and fell to the floor. Pharmacist came out immediately to ask him if he had labored breathing. He laid flat on the floor claiming he was dizzy. I called 911 and they took him by ambulance to the hospital

Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands began shaking and eyes were moving erratically. Patient would not respond to verbal commands so called 911. The patient came responsive about 1 minute later and had no recollection of the event. Pharmacist checked bllod pressure and it was low (97/46 ) and upopn recheck in 3 minutes it was high (199/90). Paramedics arrived and patient said he felt fine at that point but he would still go to hospital to get checked out.

PATIENT RECIEVED VACCINE 9:49 AM, MOVED TO POST VACCINATION AREA. BECAME DIZZY AND FAINT, WAS MOVED TO FLOOR FROM CHAIR. PASSED OUT AT 9:50 AM. CAME AROUND 9:55AM WITH NAUSEA THAT DID NOT RESULT IN VOMITTING. PATIENT SAT FOR AN ADDITIONAL 30 MINUTES WITH WIFE UNTIL FELT FINE TO LEAVE POST VACCINATION AREA AROUND 10:30AM. NO INJURY RESULTED. PATIENT ADMITTED AFTER VACCINATION THAT THIS IS A COMMON REACTION TO VACCINATION AND NEEDLES IN GENERAL.

20 mins after shot, I nearly fainted - but subsided within minutes. About 6 hours later, had aches, striking headaches, dizziness throughout the entire evening. subsided by the time we woke up - took tylenol.

4/9/21 Vaccination Center At approximately 1115 while observing people post vaccination I was summoned by companion to assist pt who was ?feeling faint?. On arrival person was conscious and responsive, pale, diaphoretic, with eyes closed, verbalizing he felt like he was going to faint. BP measured at 77/41, HR via O2 Sat device 39-44. Person coached to take deep breaths, able to transfer with assist of one to wheelchair, transported to observation room, self transferred to stretcher and placed in supine position with HOB approximately 20 degrees. BP 91/54, HR 51. Person verbalized immediate relief when positioned on stretcher. Monitored for 20 minutes, BP 133/61, HR 64. Assisted to sitting position on stretcher, tolerated cranberry juice and graham cracker. Self transferred to wheelchair where he was transported to main waiting room, observed for 20 minutes. Person reported return to baseline, ambulated independently out of vaccination center. Person remained conscious throughout.

Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all his vital signs are fine, he called to let us know that he is at home and is feeling well.

PT WAS ADMINISTERED VACCINE AT 11:27 AM AND WAS ASKED TO WAIT OUTSIDE FOR 15 MINUTES. AROUND 11:35 PATIENT STARTED FEELING LIGHT HEADED AND DIZZY. PHARMACY ASSOCIATE ON THE FLOOR ALERTED PHARMACIST. I WALKED OUTSIDE AND HELPED THE PATIENT LAY DOWN ON THE FLOOR , ELEVATED LEGS, ADMINISTERED COLD COMPRESSION. AROUND 11:45 PATIENT STARTED FEELING NORMAL. ASKED THE PATIENT TO STAY UNTIL 12:00 PM. PT WAS FEELING BETTER AND HE LEFT PHARMACY AT 12:05PM

The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm

I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.

COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.

Vasovagal episode. After receiving dose patient complained of feeling lightheaded, nauseous and was visibly sweating. Vitals were taken 10:10 106/60 97% HR: 52. At 1015 vitals were 118/10, 98% and HR 65. Patient was given wet towels around his neck and on his forehead. brought cot to patient and patient placed in trendelenburg position. pt given water and stated he was no longer lightheaded or nauseous but continued to have HA. Pt at that time was being evaluated by both doctors. Patient then walked to monitor area where was continuously checked on until 1100 when his vitals were rechecked (118/80, 68HR). Pt stated he felt better and was released and recommended not to drive. Pt says his brother would drive him home. - RN

ringing in ears, dizzy, scattered headaches, muscle cramps in arms. Classic flu like symptoms 24 hours after injection. 99.9 fever for 10 hours, headache, fatigue. They resolved 24 hours later.

Dizzy, full body sweat, temporary loss of hearing and sight. Symptoms came on 1 minute after injection and lasted for 20 minutes. Lingering ringing and dizziness 24 hours after.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

Case received vaccine at 10:30AM and at approximately 10 minutes into recovery stated he "feels a little dizzy" Case requested a drink of water. Vital signs stable at temp 97.6 Pulse 88 Respirations 16. Pulse ox 99% BP 128/70. He denied any shortness of breath, chest pain, difficulty swallowing itching or scratchy throat. He was advised to be observed for another 15 minutes and stated he was feeling better and returned to work at 11 AM At approximately 11:50 AM patient returned to clinic with boss stating he vomited in the rest room. Patient taken to recover room cot was placed in supine position on cot vital signs continued to be stable with 97.6 88 16 120/70 He complained of funny feeling in his throat. He was give Benadryl Liquid 50mg PO and continued with stable vital signs 97.6 88 20 120/70. He continued to complain of the funny feeling in his throat he was given Epinephrine IM .5ml, He did appear anxious and tearful after speaking with his friend on the cell phone. Vital signs remained stable of 99% SAO2 Pulse 83 Respirations 22 BP 128/70. Throughout entire event he was able to speak in clear sentences with the interpreter assistance. Patient was advised to go to ED for further evaluation and observation. He consented and 911 was called. EMS arrived at approximately 12:30 PM and report was given to EMT on patient event at clinic along with written information on vaccine and vital signs.

Patient was administered 0.5 ml Jannsen COVID-19 vaccine into the left deltoid with no complaints. After completion of vaccine patient continue to sit in waiting area, while sitting in waiting area patient described feeling extremely dizzy and hot. Patient was given water/Benadryl and was able to alleviate issue without any further action necessary.

Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walked away from people around me. Fortunately my wife was there, I called out to her because I was getting dizzy, she came over as I was passing out, I grabbed onto her and we both fell to the floor (I used her to cushion my fall). I passed out on her as she screamed for help. Two male customers assisted me into a chair as I was disoriented, my wife asked me what her name was and I didn't her name as I was pale, trembling, and sweating. The pharmacy tech thought I was going into convulsions and called 911. The paramedics arrived and fortunately I was breathing and slowly coming back. Paramedics remained there and took all my vital signs and stayed with me. Since my vitals were okay and my color came back, I felt much better and was coherent again. This event was at least 30-minutes or more. I declined going to the hospital with ambulance and the paramedics told me to call 911 if it happens again.

patient was given janssen covid- 19 vaccine at 4.30 pm and 10 min later the patient fell forward from his chair on his face as he felt very dizzy and sweating.. Patient regained consciousness right away and was doing fine after a few min.

"Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light headed so I sat on the floor and notified medical personnel. I then passed out for an unknown amount of time but long enough to urinate on myself. Medical staff put me on a bed and started taking vitals. My Blood pressure was low but had a high heart rate. Medical Personnel called the ER to see if I needed to be transfered but it was reccommended to continue observation. After an hour or two I was released to go home. I felt weak for over a week after the vaccination.

TESTED POSITIVE FOR COVID-19; DIZZINESS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced fatigue. On 22-JUL-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive, Influenza A virus infection (NR: not provided) not reported, and Influenza B virus infection (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headache, and fatigue on 15-APR-2021, and had not recovered from tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000186982; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

10 minutes after injection, dizzy spell and vasovagal reaction. Diaphoretic, pulse rate 48, BP 107/71.

Chills, fever 102.7 Fahrenheit, light headed Symptoms started 11-12 hours after receiving vaccine. First measured fever identified at 12 hours mark of 100.9....at 13 hours 101.5 at 14 hours 102.7

03/08/2021 11:31 am Patient C/O feeling light headed and dizzy. Patient also noted pale and clammy and laid himself on the floor. Patient stated that he ate a granola and coffee for breakfast. V/S 97.4 temp. BP 101/60, R 18, Pulse 48. Snacks and water offered, water taken only. Patient then stated that he feels sick and cannot sit up on his own, close monitory in progress. 11:34 am Wife called and notified. 911 rescue called. 11:50 am Rescue arrived and assessed patient declined going to the hospital. 12:00 pm. Patient VS 97.7 temp, BP 110/64, Pulse 56, R 16.. Patient left facility with wife.

25 minutes after the vaccine dizzy, breathing difficulty, fast heartbeat. It lasted less than 10 minutes. 20 minutes later dizzy , breathing difficulty. Lasted less than 10 minutes. Next day only breathing difficulty for 2 periods. Not as bad as yesterday when I received the vaccine.

Rapid onset of nausea and dizzy / lightheaded feeling shortly after standing up from chair within 2 minutes after vaccination. Immediately sat back down to place my head between my knees, and completely blacked out, fallout out of the chair and hitting my head and knee on the floor and nearby fixtures. Regained consciousness on floor about 30 seconds after fainting and immediately felt much better. Pharmacy staff were on hand and promptly called 911, instructed me not to move and took my pulse and monitored me until EMS arrived within 5-10 minutes. Vital signs normal including BP 120/90, 100% o2 levels, normal blood sugar and EKG. EMS assisted in getting me back to seated position and monitored for another 10-15 minutes. Declined transport and had family member drive me home where I rested for a few hours and woke up feeling fine. Very minor bruising / bump on head with no lasting sign of concussion or other trauma. 24+ hours post vaccine no other notable vaccine reactions aside from sore arm / muscles on injection site.

Patient fainted when standing for count. Fell to the floor, lost consciousness, and hit his head against the wall. Reported overnight he experienced chills and lightheadedness

- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21

-fever -body aches -head ache -abdominal pain -extreme dizziness/lightheadedness -dry cough -incresed tinnitus -nervous system disorientation -tiredness -weakness All lasting ~36+ hours.

Janssen Covid 19 EUA the patient felt light headed in Observation after his vaccine. He denied treatment or transport and an AMA was ran through Grossmont ED. Inc# 2021-00021998

Neck numbness - 90 minutes after shot, lasted 30 minutes Dizziness - 120 minutes after shot, lasted 40 minutes Chills - 120 minutes after shot, lasted 10 minutes Body aches - 4 hours after shot, lasted 16 hours Fever - 12 hours after shot, lasted 1 hour Headache - 19 ours after shot, lasted 20 minutes Stuffy head - 20 hours after shot, lasted 1 hour

Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm

I'm feeling totally fine while having a conference call thru TEAMS at my home around 3:30PM on April 12, 2021. Then suddenly I felt a severe headache (as if my head was shot by a gun) at the center of my forehead. This is only the first time I felt that kind of headache. However, it only lasted for about 5-10 secs for that severe pain then after that i just felt dizzy for about 20 mins. Since then, I'm fine now and hoping that I will not feel that same pain again.

Dizziness, Shortness of breath, Irregular Heartbeat Diagnosed with Atrial Fibrillation on 4/13/21 by primary healthcare physician

In sleep, on the night of vaccination, i thought I twisted my left leg ankle. It was not hurting if not moving but hurt when walking on uneven surface or when tried to move the ankle. I used bandage few days. its not completely gone, but much better and hurts when try to push the foot/toe downwards.

Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.

Starting 8 days after injection I will go into a brain fog for several hours mid morning. Difficulty concentrating and motor function seems mildly impaired. Visuon is slightly blurred. Also slight pressure across sinuses.

5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.

The first couple of days had a fever, light-headed, pulsating feeling through my body, and feeling faint at times. Symptoms go away after the third day. Then nearly two weeks later the feeling of being light-headed, pulsation sensation throughout my body, and feeling faint at times came back. It's been a few days of these symptoms returning and it has me concerned.

CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COULD NOT BREATH; SEVERE CRAMPING IN LEFT SHOULDER AND UPPER BODY; DIFFICULTY IN STANDING; SINUS; THOUGHT THAT HE WAS ABOUT TO PASS OUT; BUNCH OF CLOTS IN THE BOTTOM SIDES OF BOTH LUNGS AND ON THE TOP OF ONE OF THE SIDES; BEGINNING STAGES OF PNEUMONIA ON BOTH LOBES OF THE LUNGS (COLLAPSED); CRAMPING IN CHEST; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered to left arm on 06-APR-2021 at 12 noon for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 6-APR-2021 at 12 noon, patient got vaccinated and was fine that day . Next morning on 07-APR-2021, patient woke up with sever cramping in same shoulder which he got the shot in, most pain was in the upper left quarter of his torso to down half way to chest up to the shoulder till the neck . By the end of the day it spread to his whole chest and upper body. Also he had shortness of breath ,could not breath .The cramping and shortness of breath came at same time. He took Advil and went along with his day . He took 3 tablet of Advil 200mg every 4-5 hours all day ( total of 3 dose that day) . By night time the case was progressively worse as the whole chest had a lot of pain . He thought that he had heart attack . He thought that he was about to pass out . He could not stand on his own . So his wife took him to emergency room at mid night at 12:30 am on 08-APR-2021. He stayed there for 5 hours and they did bunch of tests , EKG which rolled out the heart attack .They did Chest X-ray which found things then did D-dimer which its level was very high . They found bunch of clots in the bottom sides of both lungs and on the top of one of the sides. They did ultra sound on the legs which had no evidence of blood clots . They discharged him from the emergency room as they felt that he was ok to be out . After couple of hours after discharge , patient's health care professional wrote for him Eliquis, antibiotic and pain reliver. He was given antibiotic because he had beginning stages of pneumonia on both lobes of the lungs (collapsed) . It was found air sacs in lung with signs of pneumonia in both lobes . He came home and started to monitor his blood oxygen . He stayed in the same position till recovery . He was better each day since last week but still had sinus and cramping in the chest ( very minor but was still there). The lung capacity was very limited to take some steps. Patient stated that he needed a specialist to understand his condition. He had no medical history before that incidence . He was wondering regarding which type of blood thinner was good for this type of blood clots because he read that the regular blood thinners are not good for that type of blood clot which his HCP gave (regular blood thinner). Laboratory data included: Total lung capacity decreased (NR: not provided) lung capacity is very limited. On 08-APR-2021, Laboratory data included: Chest X-ray (NR: not provided) found things, EKG (NR: not provided) rolled out heart attack, Fibrin D dimer (NR: not provided) level was very high, and Ultrasound scan (NR: not provided) no evidence of blood clots. Treatment medications (dates unspecified) included: apixaban, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe cramping in left shoulder and upper body, chest pain (whole chest had lot of pain)/thought that he had heart attack, shortness of breath/could not breath, thought that he was about to pass out, difficulty in standing, bunch of clots in the bottom sides of both lungs and on the top of one of the sides, beginning stages of pneumonia on both lobes of the lungs (collapsed), cramping in chest and sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 44-year-old male patient reported blood clots of both lungs 2 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient denies any medical history/condition prior to vaccination. The symptoms reported were severe cramping of arm that spread to his whole chest and upper body and shortness of breath; the patient thought he had a heart attack, about to pass out and could not stand because of the progression of pain. EKG done at the emergency room ruled out heat attack, D-Dimer was reported to be very high, clots were found in the bottom sides of both lungs and on the top of one of the sides, x-ray showed beginning stages of pneumonia on both lobes of the lungs (collapsed). The patient was prescribed with Eliquis, an unspecified antibiotic and pain reliever. Outcome of the events were not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

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

SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body. On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. 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

Patient was starting to feel sweaty, light headed, and had ringing in his ears. Blood pressure was a little low. After giving him water and staying with him, symptoms dissipated and blood pressure returned to normal

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy

Sweating, Dizziness BP 106/55, HR 78, RR 13 -- > 104/65,62,24 -- > 121/62, 61. Patient stable and released from the vaccination site

Pt became diaphoretic, looked dazed, confused, and about to faint within 10 seconds of vaccination at 1pm. Pt's BP was 110/50, pulse 50. After 10 mins, pt seem to recovered from his symptoms. Later stated that he's had these vasovagal symptoms in the past with other injections. Said he was ok with the previous flu vaccine and didn't think to mention it to vaccinator. Pt stayed until 1:30pm (30 mins after vaccination) and reported he was ok to drive home. Pharmacy f/u in 2 days on 5/12/21 @ 9;15, who stated he is doing well and recovered from all symptoms.

For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, and general malaise. Then, after the first week of having the vaccine, I began to have these symptoms about once a week. Last week, it was on 5/6 when I gradually become colder regardless of layers and my stomach was repelling the idea of food (no vomiting or actual nausea). I went to bed and I was better by morning. Yesterday (5/12), I had the same thing. Chills and the inability to stay warm, loss of appetite, and a sort of sleepy vertigo.

HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.

Patient received his vaccine and sat down in an alternate chair. He stated that he started to feel dizzy and then passed out. The patient regained consciousness fairly quickly. He did fall on the ground out of the chair, but did not hit his head. EMTs were called and he was checked out. He was able to leave saying he felt much better.

Patient was administered Janssen vaccine and instructed to stay seated for 15 minutes as had no prior reactions to drugs or vaccines previously. About 5 minutes after vaccine patient stood up to report to pharmacy counter that he was feeling very dizzy. He was instructed to sit back down. While turning for seat, patient fell and hit mouth on cabinet that resulted in a cut lip. Patient loss consciousness briefly. He was able to respond to verbal commands to roll onto left side. Blood pressure was check and read 94/59 mmHg. Patient remained in this position until feeling well enough to sit up on floor, per ok from paramedics via phone. Patient was perspiring on forehead. Patient took a few sips of water and reported feeling better. Paramedics repeated blood pressure and took patient to hospital. Patient stated he did not remember falling but remembers instruction to roll to side.

Patient was sitting for 15 minute observation and suddenly passed out for about 10 seconds. He was sweaty and pale and mentioned being light headed.

WOKE UP WITH PAIN AND BODY ACHES IN BACK AND LEFT SIDE AND FEELS LIKE THE PAIN IS ENLARGING; FEELING BAD; FELT FEVERISH; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement, and concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient has history of no drug drug abuse or illicit drug usage. the patient was taking blood thinning medications. 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 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced feeling bad. On 04-JUN-2021, the subject experienced felt feverish. On 05-JUN-2021, the subject experienced woke up with pain and body aches in back and left side and feels like the pain is enlarging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt feverish, dizziness, and woke up with pain and body aches in back and left side and feels like the pain is enlarging, and the outcome of feeling bad was not reported. This report was non-serious.

BLURRY VISION; DIZZINESS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced dizziness. On 27-MAY-2021, the subject experienced severe headache. On 04-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, blurry vision, and dizziness. This report was non-serious.

At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats

PT STARTED DEVELOPING " DIFFICULTY IN BREATHING" AND DIZZINESS ABOUT 15 MINUTES AFTER HE RECEIVED THE VACCINE. 8:55 HR 61 RESP 16 BP 115/76 OXYGEN SATS 99% ROOM AIR PATIENT WAS BROUGHT TO MED OBS 1 AT 855, HE WAS GIVEN APPLE JUICE AND WATER. ODI WAS WITH PATIENT SINCE HE WAS foreign SPEAKING ONLY 0900 HR 60 RESP 15 BP 108/74 OXYGEN SATS 99% ROOM AIR 0905 HR 60 RESP 15 BP 118/77 OXYGEN SAT 100% ROOM AIR PT WAS FEELING BETTER AND LEFT BY HIMSELF ESCORTED TO EXIT BY STAFF

Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.

9:48am during his 15 minute wait time, reported having a tingling in tingling in his throat, feeling flushed, and light headed. Declined us calling 911. He reported that he has a lot of allergies to foods and has experienced this reaction after having exposures to poultry products. Patient was brought in the nurses office and vital signs checked and stable. Lung sounds clear on auscultation. Given benadryl 50mg and monitored in office. Once patient reported feeling back to normal he asked to leave and went home. We called patient to verify that he got home and continued to feel fine.

Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatigue

5 mins post administration of J and J vaccine, patient complained of flushing nausea and light headedness. Vital signs obtained 98% room air, post rate of 72, blood pressure 138/72 temp 97.1. Patient provided water and 1 cooling pack and observed for 10 mins. 2nd vital signs were obtained which was 98% room air 72 heart rate 130/70 and 98.1. Patient was observed until symptoms resolved. final vital signs showed 98 room air, 74 heart rate 126/78 BP 98.1 temp. Patient was safely discharge without further incident.

Vaccine at 11:30, at 12:30 he started feeling faint, light headed, heavy legs, little nausea. Monitored blood pressure from 12:40 to 1:50, ranged 142/93 to 163/113. Pt has high blood pressure. Had he sit and recline until he felt better.

Fever of 102 degrees, body aches, chills, nausea, vertigo, fatigue - Rest, fluids, Tylenol - Recovering well 2 to 3 days

Lightheaded, shaky; B/P-135/78, P- 78, pulse ox- 95%; cleared by onsite nursing supervisor Client reports past history of fainting with blood draws

Rash on left foot, both arms and hands. Slight dizziness at times. Slight Fever has been noticed a few times, then went away. Headaches on the first day after, but not on the second day. Treatment was heat pack for head, ice packs for rashes to decrease swelling. Also took ibuprofen

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

At 3am I woke up with: Chills Fever Headache Body aches Throughout the day the symptoms persisted and included: Brain fog Dryness / dehydration Dizziness

Pt experienced dizziness, feeling light-headed, and numbness, and tingling in L arm, face, and BIL LE within 15 minutes of vaccine administration. Pt BP and HR were elevated for approximately 30 minutes after administration as well.

PATIENT REPORTED STARTING TO FEEL FAINT AND BLACKED OUT FOR 30-45 SECONDS WITHIN 1-2 MINUTES AFTER RECEIVING VACCINE. HE EXPERIENCED DIAPHORESIS AND FELT HE WAS GOING TO PASS OUT. DENIED SOB, HIVES, SWELLING, STOMACH PAIN. REPORTED HE HAD NO HEALTH CONDITIONS BUT THAT THIS HAD HAPPENED TO HIM BEFORE BUT THIS WAS WORSE - SAID HE HAD NOT EATEN THAT DAY OR DRANK WATER. RPH GAVE PATIENT WATER AND LEMONADE ABOUT 2 MINUTES OR SO INTO REACTION AND PATIENT SAID HE STARTED TO FEEL BETTER AFTERWARD. 911 WAS CALLED AND PARAMEDICS RESPONDED WITH TAKING BLOOD PRESSURE AND BLOOD SUGAR - BP A LITTLE LOWER THAN AVERAGE BUT UNSURE WHAT PT TYPICALLY RAN AT. BLOOD SUGAR NORMAL AFTER DRINKING LEMONADE. PATIENT TAKEN TO ER FOR FURTHER CARE

chills and restlessness sleeping Sunday / Monday night, Tuesday 9A: quick onset of severe flu like symptoms: dizziness, significant fatigue, loss of any concentration, nausea, lack of appetite. Dimished quickly after 400mg advil taken in afternoon. Mostly gone by 4:30P. Wed 4/7 most symptoms gone.

Patient became light headed and sweating approximately 10 minutes after injection. No fainting or unconsciousness. Gave water and within 5 minutes symptoms subsided. Patient left the pharmacy 30 minutes after injection and was doing well.

Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.

At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomited about 50 cc of yellowish emesis. Vaccinated on the L arm at 0923. Vitals: BP - 128/58, HR ? 62, RR ? 18. Head-to-toe assessment completed. After vomiting, client states he felt so much better. He stated, ?I probably did not eat enough.? He has no PMH, NKA, and did not take any medications today. He has not experienced a reaction with any other vaccine, medication, or food product. Throughout monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition and did not experience dizziness or nauseousness anymore. He was no longer clammy. Client left vaccination clinic at 0948, accompanied by his family, ambulatory, in stable condition.

EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.

Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began watering. It was hard to tell but my throat felt slightly swollen also. I drank some water and a few minutes later things seemed to clear up. Randomly throughout the afternoon I had similar dry/itchy/tingling in my throat but not as strong as the time right after the vaccination. I didn't suspect this was directly related to the virus since I have allergies to grasses, trees, pollen, etc. and take over the counter allergy medicine as needed. At 3:30am today (4/10/21) I woke up having to use the restroom and when standing up out of bed I was extremely dizzy. After laying down in bed the dizziness disappeared. When waking up later in the morning the dizziness/light headed feeling was still present when standing. I also have noticed random strange pinching pain in my legs that only last for 1-2 seconds and sends a quick short pain sensation throughout my body. I have no clue if any of this is related to the vaccination received, but after noticing news articles with issues in a few folks receiving the Janssen vaccine, I decided I would pass this info along just in case.

Became light headed, Fainted, Turned Pale, Sweated. EMTs were called who took BP, Blood Sugar, and ran EKG (I think). and was told all were normal.

I was fine after I got the shot. No pain or anything. The next day I was light headed, had a temperature of 102, and felt total body ache. This feeling was persistent and constant for all of the day after the shot and in the morning two days after the shot. The symptoms then subsided and I was fine for the remainder of the day and have been fine since.

few minutes after patient got vaccine, he fainted, he was pale, dizzy. we laid him down on the floor and after 1-2 minutes he open his eyes and start talking. we observed him for 30 more minutes.

5 minutes after receiving the injection, my husband passed out, starting sweating profusely, and was out cold for a minute. EMS were called and he was seen in ER due to low heart rate and sweating to rule out any heart conditions. He had 2 EKGs - one in the ambulance and one in the ER. He also had to have a CT for falling and bumping his head to rule out that injury. The DX was listed as a vagal response, but we are not so sure we agree given that he is 45 years old, has no priory history or anxiety about shots.

after receiving vaccine, about 12 hours later i had the standard side effect of moderate fever (approx 102), chills, and was very fatigued. The fever was gone the next day, but i took the next day off and stayed in bed. The concerning problem was i developed tingling and numbness throughout most of my body, especially on the side where i had the shot, in my arm, neck mouth and tongue. After about 36 hours after the shot i started to feel about 80% better, but the tingling/numbness continued and i continued to have major fatigue. From day 3-5, i was having some trouble moving around - almost like my legs weren't wanting to respond to my brain. Since these symptoms lasted until about day 5, i got concerned and called the doctor. However, right before talking with the doctor in day 5 i was able to do some yoga and was feeling much better, and it all seemed to resolve. I feel better now.

COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.

NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.

FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.

HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. 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.

Dizziness, nausea and vomiting. Only reporting for what it?s worth to cdc. All manageable but def not psychosomatic byproduct of anxiety.

Chest pain/discomfort, Heart Palpitations/Abnormal Heart rhythm, Shortness of breath, Exhaustion, Lightheadedness and dizziness. Symptoms are ongoing and of intermittent intensity. Aspirin daily for chest pain. See below for diagnostic tests ordered.

Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minutes after the vaccine, he reported feeling very faint and was about to pass out. He wasn't feeling well so 911 was called. He also reported feeling hot and was visibly sweating. He drank some water and sat in front of a small fan until medics arrived. They assessed him and he walked out with them for further evaluation. I called patient at 7:30 to see how he was feeling. There was no answer and his voicemail didn't allow me to leave a message.

Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked if he ever fainted after getting a vaccination or injection and patient reported no. The vaccine was administered to the patient and patient appeared to be fine for the next few minutes after getting vaccinated. Patient was told he could take a seat in the waiting area and wait until his 15-minutes were up and he could go. Patient was seated in the waiting area for about a minute but then got up to walk down one of the isles. When walking down the isle patient fainted and collapsed. This occurred approximately 10 minutes or so after he received the vaccine. Patient was helped to a chair and once seated appeared to shake/convulse (almost like a seizure) for approximately 5-10 seconds before snapping out of it and regaining consciousness. Afterwards he was alert and talking but didn't remember fainting. 911 was called and he was checked out by paramedics. After observing him for 15 minutes or so and determining his heartrate and blood pressure were normal and he appeared to be ok, the paramedics told him they can take him to the hospital to be evaluated further, or he was free to leave on his own without going to the hospital. The patient said he felt fine and declined being taken to the hospital. After another 10-15 minutes the patient left under his own power. Patient mentioned he would possibly be calling his physician and alerting them to the episode.

Patient started to experience dizziness, profuse sweating, pale-ashen colored face, and nausea three minutes after the vaccine was administered. Offered to call EMS, but patient declined and remained conscious. Symptoms subsided after approximately 10 minutes. Patient returned home with his girlfriend.

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

Janssen COVID-19 Vaccine Vaccine Lot Number: 202A21A Pt reported feeling light-headed 1-2mins after shot. unconscious for 15-20 sec. diaphoresis before passing out. 911 called. M410 transported to HEC Pt suffered no trauma or fall. 12 lead ekg performed with sinus brady and 1st degree. no daily meds, nkda. ran 4 miles today; oatmeal/granola, milk protein bar; 13:28 92/43 p 57 ; 105/71 P 42; 112/66 p 49

Bilateral facial paralysis - symptoms started on the right on April 21, 2021. Patient was seen by PCP on April 22, 2021 and started on Valtrex and steroids for the treatment of Bell's Palsy. On April 24, 2021 the left side developed paralysis as well. Patient was seen in the ED. Labs, MRI and CT of the head were performed. Lumbar puncture was attempted but unsuccessful. Patient was discharged home and had lumbar puncture as outpatient on April 29, 2021 as well as additional blood work. Tests showed no malignancy or infectious etiology. He was started on another round of steroids on May 7, 2021. Started physical therapy the following week. Still has minimal facial mobility at the time of this submission.

MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL. MOSTLY AFFECTED RIGHT SIDE.

Severe vertigo with dizziness. I?ve never had these symptoms of vertigo before. Entire room was spinning when I woke up yesterday morning. Almost fell over 2x. This was one week after receiving the vaccine.

Patient was severly dizziness and took it upon himself to lay down on the floor. He was also experiencing nausea, sweating on his head, and fast heartbeat which was conveyed to the EMT. He also requested an ambulance.

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

About 3 minutes after vaccination while seating patient said that he fills that he is going to faint. 911 was called by the stuff. Second later his eyes rolled his and started shaking. In a few minutes he came back and said he fills better. EMS arrived checked his vitals. Hi seemed fine, refused to go to the hospital. Eventually he left after sitting for 30 more min saying he is fine.

On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then nearly had a syncopal episode, had trouble speaking and was leaning to the right. My wife had to hold me up. My brother in law had to carry me to the car as my left leg was not working at all. I was taken by ambulance to the nearest hospital and was worked up for possible CVA (which was ruled out). I was also checked for DVT of lower extremities which was negative. I am still having residual numbness and tingling to my left leg. I am still having symptomatic bradycardia with near syncope.

Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt HR at 49-55, loss consciousness for less than 10 seconds, became diaphoretic. BP at 96/62. Pt felt better after 5 minutes.

On Tuesday, June 8th, I'm driving a car on the highway and a dizzy spell hits me hard with no warning. I got the car pulled off the side of the road but my world was spinning for 2-3 minutes. It scared me enough to go the ER an hour later where I had blood drawn, EKG, CT scan of brain, overnight monitoring, and an echocardiogram. All were normal, but over the course of the next week, I felt the full force of the following symptoms: lightheadedness to the point of almost fainting, brain fog, nausea, neck tightness, headaches, anxiety, and fatigue. I had so many lightheaded moments where I felt I would pass out. My life was affected because I couldn't do anything without feeling like I would pass out. Driving more than a mile is out of the question. Fortunately, I'm a school teacher and all this started on the 2nd day of summer vacation. I certainly would not be able to teach if school were in session. How bad was my brain fog? I have kids who love to play board games like monopoly. I play 5 or more times a week. My brain fog prevented me from playing monopoly with him. It was too complicated for me to roll the dice, count the dice, move my piece the number of spaces, figure out money amounts, etc. . My family was really worried because they noticed how I couldn't think. I felt like a 90 year old man with dementia. As far as my lightheadedness, I never actually fainted, but there were many times I had the "sense of doom" feeling where I was going to die. I visited the ER again a week later and they did another EKG with normal readings again and ordered a holter monitor to be worn for 24 hours, which came back normal. When I finally got into my primary care physician on June 17th, he suspected something terminal, so he orders a brain MRA the very next day. That came back clean, so he orders me to see a neurologist. Once I received news that the brain MRA was normal, my anxiety went away for the most part--I was not going to die! The neurologist prescribed gabapentin 100 mg daily (which is anti-migraine/anti-seizure meds) and a carotid artery ultrasound, which came back clean. (Notice a pattern?) Because of the neck tightness/pain/uncomfortability, I visited a chiropractor thinking neck alignment was off. Chiro realigned me but I didn't feel any better or worse. I have had 2 visits at the chiropractor, specifically for the neck pain and seeking relief. Today, I am 6 weeks from the June 8th out-of-the-blue dizzy spell that changed my life. If I gave a percentage of how good I am today, I would give a 75%. During all this time, I've never had a fever and my blood pressure has been normal every time it's been taken. According to all these tests, I'm the healthiest man in the world--my heart, brain, bloodwork is all great. My episodes are less and less frequent, and I drove today for about 5 miles! Yay! I feel like there's light at the end of the tunnel. In the last week, I've been playing board games much better with less brain fog, but I have my moments with brain fog and lightheadedness. My neurologist and my primary care physician feel like there is no correlation to the vaccine, but the chiropractor I visited has said that he's treated multiple patients like me who are looking for relief from these symptoms in the past 4 months.

Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, difficulty speaking or swallowing, hoarse voice, palpitations, CP, headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms.

Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm headache slightly stronger and discomfort in knees. 4:00pm joint aches specially in the knees, ankles and finger joints. 6:00pm tingling sensation on cheeks and headache persist. Walking uncomfortably because of joint aches.

The 46yo patient came in to get his covid vaccine. His parents reported he has a medical condition/disability that requires him to receive services in their home. After receiving the vaccine the patient reported feeling lightheaded, dizzy, hot, and that his blood pressure felt abnormal. He requested an ambulance and some water. I called 911 and provided him water, but did not administer any epinephrine or any other medications. The paramedics arrived and talked to him for about 15 minutes. He then left on his own accord with his parents and declined further medical attention.

HR 126-67; SPO2-98; BP 154/80; pt. was fine after vaccine then got out of car to use bathroom and as soon as he stood up from the car he lost balance and stated feeling dizzy, light headed and didn't feel right. he Slumped over and was caught by an observer and guided to the ground. Hypoglycemic but not diagnosed. B/S 107. pale, nauseaous. care transferred to the paramedics.

Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal

Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very hot and body below neck felt very chilled. After five minutes these symptoms intensified, feeling hot flushed in face and vision darkened, feeling like a black out may occur. Pharmacist provided water. Symptoms began dissipating after 20 minutes after injection. After 30 minutes, symptoms ended.

Beginning around 10:00pm the day of the vaccination, which occurred at 2:00pm, I began to experience chills and went to bed. I woke up several times during the night and felt feverish. I got up once and felt dizzy and had some body aches. At around 7:00 am the following day I took my temperature and it was 99.4 F. I took acetaminophen at 8:00 am. I went back to bed and was still feverish and sweating. I woke up at 10:15 am and felt much better. My fever was gone and I had no more chills or body aches. After that time no other adverse reactions occurred.

immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.

Pain at injection site, woke up next morning with double vision. With both eyes open, dizziness, loss of depth perception

I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.

He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit. He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck. Coloring came back after about 10-15 minutes and he said he felt better. Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.

Patient received J & J vaccine on Saturday April 3rd. On Sunday he developed a fever of 102 fever and chills. On 4/6 he developed vertigo.

Client was getting ready to leave after 15 minutes observation and he attempted to get up, felt dizzy, fell backwards and fell to ground. He appeared dazed for less than 30 seconds. No difficulty breathing, no shortness of breath. Able to answer questions appropriately, alert, oriented x 3, stated he felt okay. 911 called. B/P 139/82 right arm, HR72, RR18. Pt continued to feel fine, answering questions. appropriately. No history of vaccine reaction. Medication for stomach taken. Per client no heart, or diabetes history. Client stated he last ate breakfast and had a little bit of coffee. He refused medical treatment and his son drove him home.

Immediate dizziness and nauseous. Took 20 minutes to resolve. After 12 hours had extreme fatigue and muscle aches that lasted for 2 days. Could still feel some mild symptoms 4 days after the injection.

Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and started to slide sideways. His body was shaking slightly and his eyes were open but there was no cognitive awareness. This lasted no more than 90 seconds and then patient came to abruptly and reoriented himself on the chair before I had the opportunity to get him to the floor. Patient then stated that he was lightheaded, warm and sweaty. EMT had been called and upon assessment of the patient transported him to the ER.

He received vaccine and stood to go to monitoring area, noted by vaccinator to lower self to ground. Complained of dizziness, nausea and diaphoresis. No LOC. Did not eat prior to coming to clinic. Provided with juice and crackers. VS stable throughout, He declined ambulance or call to 911. observed for 30 minutes in medical triage area and then d/c to home via friend Advised patient to follow up with PCP

DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of medical conditions and no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, dizziness, weakness, and feeling unwell. This report was non-serious.

EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS. Patient became pale, 5 second seizure, dizziness and vomiting. EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers. Patient waited another 30 minutes and stated he felt much better. Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day. He stated he felt better and had no more problems. He did not seek additional medical care.

Severe Nausea, Some Vomit, Stomach Upset, Stomachache, Mild but continuous Dizziness, Severe Fatigue, Muscle Weakness

Date and time adverse event started: 04/11 8-9p.m. (bad headache, flu like symptoms, nausea, chills, lethargy) Adverse events experienced and are they still occurring now: aches and pain subsided , still experiencing dizziness when getting up and working, lightheaded when standing for long periods of time Recommendation: please call your doctor for a check up, I would also recommend you to get tested for COVID just to make sure you don't potentially have it

Dizziness, fatigue, body aches, light headedness, very high blood pressure, mild abdominal pain. Symptoms started day after and worsened. Required an office visit by 1 week after vaccine

Since receiving the vaccine, I have developed tightness in my chest and shortness of breath. At times, it has been severe. Feeling like I might pass out, I went to Immediate Care on 04/12. They didn?t identify a cause. On 04/15, I went to my Doctor, who noted wheezing in my upper lungs. An inhaler and pantoprazole were prescribed. At times, it feels like I am having something similar to an asthma attack. The inhaler has helped. Prior to the vaccine, I didn?t have any history of breathing problems, nor does it run in my family.

HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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).

Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue. The next day, started experiencing BPPV. This last 2 days. This was helped slightly by Hallpike maneuver. Sense of haziness, inability to concentrate/focus, irritable, difficulty sleeping, tired, which are all still here to the time of this reporting.

Immediately after getting the shot I broke out in cold sweats, body went limp, arms and hands were tingling very badly and I lost my hearing to fast ?whooshes? couldn?t really speak or move for at least 15-20 minutes. Then got up and couldn?t stand up felt almost drunk. I had another spell exactly the same about 4 hours later

Immediately after patient was given vaccine, the patient passed out for 1-2 minutes, then vomited, became light-headed, and broke out into sweats. After 2 minutes the patient regained consciousness, however, the other symptoms persisted for about 10 minutes.

pt was hot and lightheaded while sitting then fainted in his chair pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip. Pt unconscious for less than 1 minute. Blood pressure taken about 5 minutes later and was 65/40. 911 was called and paramedics arrive on scene. Care was transferred to them

Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.

Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient state he started to have dizzyness and light headedness for about 3 days starting 5/9 and lasting and getting worse until today. patinet has already tried resting and re hydrating

Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale. When we went to assist him he asked to lay on the floor, before we could help him to this position he fainted, we got him on the floor and on his side, within about twenty seconds he woke up and was very aware of his situation. We applied ice packs under his neck and on his forehead. After about twenty minutes he sat up and started to gain his color back. At this point he told us he had fainted before after a flu shot and and donating blood. Several minutes later he was able to stand up and sit in a chair. Cold packs were continued and he drank a bottle of orange juice. Twenty minutes later he said he was back to normal just felt weak like after a work out. He wanted to use the restroom and was escorted, showed no additional signs or symptoms at this point, and wanted to go home.

B/P 130/ HR 72 R16 O2 Sat 98% Patient states he felt like passing out on the floor: He's diabetic

PATIENT BECAME DIZZY AND FAINTED FOR A FEW MINUTES. WHEN PATIENT WOKE UP HE WAS PALE AND I CHECKED TO MAKE SURE HE WAS BREATHING. HE SAID HE WAS BREATING FINE BUT WAS VERY DIZZY. HE GOT NAUSEAS WITH SENSATION OF VOMITING.

3 minutes after injection patient started to stand up to get pharmacist's attention and pharmacist looked over at patient and noticed patient was clammy and looking like he was going to fall over. Pharmacist told patient to sit back down and immediately grabbed e-kit and headed to patient's side. Patient was clammy (like just got out of shower). At 3:45 PM BP was 128/63 and PR was 44. At 3:50 PM BP was 92/56 and PR 51, at this point RPh decided it was more than a vaso-vagal reaction and administered the epinephrine injection at 3:51 PM - EMS was called. At 3:52 PM BP was 130/76 and PR 59, 3:55 PM 134/86 PR 66, 3:58 PM BP was 148/83 and PR 68 at 3:59 PM EMS arrived and patient declined them taking him to hospital via ambulance due to no insurance. He had pharmacist escort him to his car so he could get his cell phone and back to pharmacy so he could call his son to pick him up and take him to the hospital. Unknown if patient ended up going to hospital.

Within 2 minutes of receiving shot, overwhelming deadening of sound, blackness in eyes, full body sweats, full body discomfort, very close to fainting for first 6-8 minutes. As those symptoms started to diffuse severe muscle cramping started in opposite arm of shot, moved thru body. Within 15 minutes the only symptoms left were the muscle cramps. Those continued for several days. Still lingering today, a week later.

46 y/o male c/o dizziness following Janseen vaccine. Pt was diaphoretic. No PMHx, No allergies, No meds. Vitals: BP=104/65, HR = 78, RR = 22, Sp02 = 97%. BBG = 114. Pt placed on medic stretcher and monitored for 45 minutes. Pt fully recovered and cleared by medical provider to go home with family. Last vitals: BP= 122/75, HR= 65, RR= 20, Sp02 = 98% RA. Cardiac monitor revealed NSR. Pt denied any symptoms when released.

4/28/2021- Patient presented to ED for evaluation after a syncopal episode with fall and head injury, severe headache; loss of consciousness; bradycardia with early repolarization without acute ischemia. 6/3/2021- continued confusion, disorientation; Brain MRI shows early chronic infarct 6/14/2021- Patient presented with continued syncopal episodes, significant confusion ongoing for weeks, diagnosed with large left MCA stroke.

24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle

One or two minutes after administration, patient said we was feeling light-headed, and then that he didn't feel well. He was instructed to focus on his breathing. He did this for a moment (maybe a minute) and then his head fell forward and he slumped forward in the chair. He was held stable in the chair by the pharmacist. After a short time (less than a minute) the patient's upper body (bilateral arm and hand) muscles contracted (maybe a seizure?) and then he relaxed and sat up. He was alert, a little disoriented initially and had no recollection of his reaction other than feeling light-headed and unwell. He then became sweaty and felt a little nauseated. The pharmacy called 911 and the patient left with the medics. At that time he was alert and oriented, but still not feeling well.

Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.

Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat, unable to focus. All began a few weeks after shot and have not gone away.

Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications. He received the J&J vaccine on 04/06/2021. On 04/28/2021 he had a fall from probable syncope. He sustained a laceration to his forehead. He was sent to Hospital for evaluation. He had CTs of head and neck, which were unremarkable. A drug screen was negative. Both before and after his return he was having issues with his speech. He seemed to understand words but when he tried to respond, his speech was garbled . He was observed in the infirmary. There was slight improvement in speech. He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021. This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct. While an outpatient workup was being scheduled, he had another episode of witnessed syncope. This was on 06/14/2021. An MRI at hospital showed a larger infarct than seen on 06/03/2021. He was hospitalized for 3 days. No cause for the CVA was found during this hospitalization. He has continued with speech symptoms and is starting speech therapy in the near future. In summary, this I/M was in a normal state of health with no risk factors for vascular disease. Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021. After multiple tests, no reason was found for the CVA to occur. It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.

I had heightened senses after waking up in the middle of the night. I went to the bathroom thinking I was going to get sick. A short time later I blacked out falling to the ground striking my face.

Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c/o "feeling funny" and felt like he was going to pass out. Client started to have a seizure-like activity, and loss consciousness two times. Ice packs and cooling clothes were applied to clients forehead and neck after client seizure-like activity stopped, feet elevated. Client was diaphoretic, gray, started twitching (which he said is normal when he gets nervous.) BP was low at 86/64. EMT called and client evaluated. Client refused transport to hospital. Client recovered from episode after an hour and left with his wife from the health department able to walk and communicate on his own.

Doctor notes: Progress Notes, MD at 6/28/2021 3:30 PM Chief complaint: Neurologic problem.HPI:6/28/21Consult at request of Dr. 47 y/o man. JJ vaccine 4/6/21. Flew to Syracuse to get vaccine (friend is a pilot). Next AM had fever, flu-like symptoms which lasted 4.5 days. 1-2 days after vaccine developed vertigo. Vertigo occurred while lying down in bed and on getting up from bed. While walking lurched to either side. Couldn't stand on one foot. Turning over in bed with lifting head also caused it. Episodes subsided 1 min after stopped moving. Did not have vertigo while upright. Did not have double vision. No change in chronic tinnitus on L. No change in hearing. No change in speech, swallowing. No confusion. No facial numbness. No limb weakness or numbness. No new HA. Was taking Advil PM for fever, etc. Had covid test and Ab test a few weeks before vaccine. Vertigo lasted 4 - 5 days. On 4/18, after it ended, went on a date, had 2 drinks over course of 7 hours. 2 days later, on 4/20/21 again felt ill with temperature and vertigo, which persisted for another 5 days. Saw his acupuncturist Dr. and vertigo resolved after acupuncture treatment. Continued to have fatigue for several more weeks. Saw Dr. 5/13/21, dx BPPV. Sees functional medicine doctor. Lost 35 lb with diet. Started on B12 Data:3/12/21: covid ab neg5/13/21: covid ab neg PMH/PSH: Strabismus surgery 2002; psoriasis Social History: No substance abuse. Employment - business consultant; musicianFamily History: No neurologic illnessMedications: Vit d 500 daily; b12 1000 daily; topicals Allergies: Dust; shrimp; cocoa PE:General: NAD. MS: Oriented to person, place and time. Recent and remote memory intact. Attention and concentration normal. Normal fund of knowledge. Language - no evidence of aphasia or dysarthria. CN: VA grossly normal. VFF. PERRL. EOMI, no nystagmus. PP intact b/l V1-V3. Face symmetric. Hearing grossly intact. Palate elevates symmetrically. Shoulder shrug 5/5 b/l. Tongue midline.Motor: 5/5 x 4. Tone normal. No tremor or other abnormal movements. No drift. Sensory: PP intact x 4. Coord: FTN normal.DTR: Arms 1; KJs 1; AJs 2. Plantars: flexorGait: Narrow base. Normal heel, toe. Tandem slightly difficult. No Romberg. Impression:Positional vertigo and imbalance in setting of flu-like illness after Johnson and Johnson flu vaccine received 4/6/21. Symptoms currently resolved. MRI Brain/IAC and MRV head ordered to r/o CVA, venous sinus thrombosis. Covid PCR and Ab sent today. I will message with test results. FU PRN I personally spent a total of 60 minutes face-to-face and non-face-to-face time reviewing the patient's chart and documenting in the record. This total time was performed before, during, and after the visit on the same service date. 6/28/2021 3:30 PM1 sst tube, 1 viral swab sent to nyp lab

About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred. Resolved after about 2 minutes after removing glasses and drinking water

Patient felt lightheadedness and dizziness about 10 minutes after receiving COVID 19 vaccine. Patient bradycardic and hypotensive.

After 2 minutes felt wave of flush, heart rate accelerated from 55 to 90, blood pressure rose to 150/100. Experienced light headedness. BP and HR returned to normal after 30 minutes. Light headedness remained for 2 hours. After 20 minutes heart started squeezing feeling and remained for two days. After 2 hours, began feeling sharp pains in heart and palpitations, continued for 5 days. After 12 hours began feeling mild aches and chills and fatigue. Continued for 3 days.

After injection - experienced lightheadedness/dizziness/blurry vision. Patient was hypotensive -and once supine for a few minutes and his blood pressure returned to normal levels.

after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsusual taste in mouth, tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.

PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION. HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT. EPI PEN WAS IMMEDIATELY ADMINISTERED. PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR. PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED. VERY FAINT PULSE. 911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES. PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION. PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING. THEY TRULY FELT IS WAS A VASOVAGUL REACTION. PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.

Did the adverse event start after the first or second vaccination? only one dose (after the shot 5min after his arm completely went numb) when waiting at the site for 15min he experienced nausea and dizziness Recommendation: Please make sure he drinks lots of fluids he could take Pedialyte and if symptoms worsen please contact doctor and go the nearest ER. Mother would like a follow up call tomorrow at 10:00am I told her we would try to call her back at that time if its not busy, if not expect a call later in the afternoon.

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness, right fore arm and lower right leg bottom half felt little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness, little stiff right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)

Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 2021 Hospital course 47M pmh DMII, HTN, HLD, L basal ganglia stroke, pw right-sided weakness, gait imbalance, double vision and slurred speech beginning at 2:00 p.m. 4/22. on admission, double vision resolved; slurred speech, headache and right-sided weakness imbalance gait remain. 4/23am pt developed L pupil dilation and lethargy, MRI brain demonstrating acute stroke, allow permissive htn treat for sbp>220mmhg or DBP >120mmhg, cont asa/statin; US carotid nonacute/benign; TTE pending; ST/PT/OT. Tele benign. 4/24 BPs remain elevated, allow permissive htn to standards <220/120; cont st/pt/ot, a little improved participation today po intake etc. 4/25 cont to improve slowly, will be good candidate. cont allow permissive htn, no events on tele, cont asa/statin for significant stroke, add plavix. 4/26 pt cont improve clinically, BP stabilizing still permissive htn, recommend start home BP meds within 2-3 days once out of acute phase, pt accepted today, TTE benign doppler benign, but doesn't seem like bubble study done, recommend repeat as outpatient to ensure no positive bubble defer to pt's pcp f/u. double vision persists, pt currently w eye patch relief, recommend outpatient ophtho follow up closely after or during time. cont asa/plavix/statin, then transition to asa/statin as rx per guidelines. no afib on tele, consider zio patch on d/c to ensure no afib in young patient w x2 stroke. recommend hypercoag workup outpatient. Acute stroke, L lacunar -asa/plavix/statin -permissive htn -tele -PT/OT/ST -TTE benign, nml ef, no bobble done? -repeat tte outpatient w bubble to ensure no R>L shunt -US carotid nonacute -MRI Brain 4/23 1. Focal patchy restricted diffusion and FLAIR signal hyperintensity in the left medial thalamus/rostral midbrain compatible with acute lacunar type ischemic infarct. 2. No significant intracranial mass effect, midline shift or extra-axial collection. 3. Chronic left basal ganglia infarct approximating the anterior limb of the left internal capsule involving the head of the left caudate nucleus.

on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach ache, nausea, headache, ..the nest day, my legs were so sore that I could barely stand & I had to wait for. while until I could walk. the headache lasted for a few days, the muscle pain is lessening but not gone until today, it makes my legs & feet grow sore & tired very quickly. last Sunday, April 18 2021, started around 5 pm, I started having nausea , then stomach pain so bad & vomitted many times until I was admitted to ER around midnight . the med staff at the ER did X-ray & citi scan, told me there was some bowel obstruction , gave me ivy, painkiller injection & some others then I was transferred to a medical center. they did another citi scan & found everything was ok, I asked what may cause it, they didn't really know beside probably not enough water etc .

NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; LOSS OF COORDINATION; HARD TO WALK; LITTLE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of diabetes except family history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced little fever. On 15-APR-2021, the subject experienced numbness in left arm from shoulder down to finders and in both legs. On 15-APR-2021, the subject experienced swollen right foot 2x bigger. On 15-APR-2021, the subject experienced loss of coordination. On 15-APR-2021, the subject experienced hard to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 03-APR-2021, and had not recovered from numbness in left arm from shoulder down to finders and in both legs, swollen right foot 2x bigger, loss of coordination, and hard to walk. This report was non-serious.

Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.

PT HAS A PANIC ATTACK AND FELT DIZZINESS AFTER THE SHOT. HE WAS SWEATING PROFUSELY BUT COGNITIVE. WE LIED PT DOWN FOR ABOUT 5 MINUTES AND HE WAS FINE.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient fainted 1 min after receiving vaccine, then started seizing in chair was moved to ground with legs up. Was checked to make sure breathing was occuring, after 3 min patient was back to normal. when woke up felt dizzy asked what year and where they were and answered correctly. Ambulancewas called pt denied being taken to hospital. bp low

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt had syncopal episode but recovered quickly

Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.

Patient had a phobia of needle. He was calmed down and made to feel comfortable. Patient got his shot and was fine then after about 2 minutes he started saying " I am passing out" repeatedly then he started rolling his eyes. then he started sliding down the chair but he held his weight up thruoughout.. Pt was encouraged to breathe. 911 was called. After awhile, pt was asked if he wanted to lay on the flow and he said yes. He was carefully lowered to the flow and a pillwas used to support his head. after a few minutes, patient said he was ok howevr he was advised to wait till emergy services arrive. 911 arrived shortly after and took over. No drug were administered.

~01:15PM PATIENT RECEIVED IM VACCINE IN LEFT DELTOID WHILE SEATED. ADMINISTERED BY PHARMACY INTERN, PATIENT REPORTED NO ISSUES. "FEELING FINE, I'M OK" ~01:17PM AFTER RECEIVING VACCINE CARD AND BEING REQUESTED TO WAIT THE 15 MINUTES FOR OBSERVATION, PATIENT STATED THAT HE HAD NEVER FAINTED AFTER A SHOT, ONLY AFTER BLOODRAWS, BUT WAS ADVISED TO REMAIN SEATED JUST IN CASE. IMMEDIATELY AFTER HE STATED HE FELT LIGHT HEADED AND THEN PROCEEDED TO SLUMP IN AN ADJACENT CHAIR. PATIENT WAS UNRESPONSIVE TO INQUIRIES, BUT SNORING WAS AUDIBLE. ~01:17PM PATIENT WAS LOWERED TO THE FLOOR INTO A SUPINE POSITION WHILE NECK WAS SUPPORTED DURING THE MOVEMENT PROCESS, AND EMTS WERE NOTIFIED BY PHARMACY STAFF VIA 911. ~01:18PM PATIENT REGAINED CONSCIOUSNESS AFTER ABOUT ~10-20 SECONDS TOTAL, OPENED HIS EYES, AND WAS SPEAKING TO HIS WIFE AND STAFF. PATIENT WAS ADVISED TO REMAIN IN POSITION UNTIL EMTS ARRIVED TO ASSESS THE PATIENT ~01:21PM EMTS ARRIVED ON SITE TO ASSESS SITUATION, VITALS WERE CONSIDERED NORMAL AND PATIENT REFUSED AMBULANCE TO HOSPITAL. ~01:30 EMTS LEFT SCENE, PATIENT REPORTED FEELING NORMAL AND WOULD BE ASSISTED BY WIFE, LEFT THE SCENE WALKING NORMALLY BELIEVED TO BE A VAGAL RESPONSE FOLLOWING THE IMMUNIZATION

Jansen J & J Vaccine- Intermittent Dizziness & Vertigo. I have been out for work for 1 week which recommended by Dr. I still experience dizziness up until now on and off.

Pt. states after receiving Janssen vaccine 03/16/2021, 2 hours after started experiencing light headedness periodically. Still continuing with more frequent bouts. Vertigo symptoms 2 or 3 times through a week's time. APRN communications noted.

I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating. I slept 13 hours and woke up with a fever . I took IB-profrin and the fever continued for about 3 days. I still have chest pains

severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.

Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache

Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.

Mild reactions including breathing heavy, throat felt swollen while trying to sleep, slight dizziness, some rashes(similar to big mosquito bites). All reactions are mild.

PT HAD COMPLAINTS OF ITCHING OF THE THROAT, DIZZINESS, NAUSEA, AND DIAPHORESIS. PT WAS GIVEN 10MG PO ZYRTEC BUT REFUSED ANY OTHER TREATMENT OFFERED. PT WAS OBSERVED FOR ALMOST AN HOUR WHERE SYMPTOMS RESOLVED. PT WAS RELEASED TO HIS OWN CARE HOME

Patient fainted shortly after administering vaccine. Patient lost consciousness about 2 minutes following the vaccine. Patient regained consciousness and then felt like they were going to faint again. Pt reported some chest tightness and then chills after regaining consciousness.

After 10 minutes of getting Janssen injection patient said they felt like they were going to pass out. Pharmacist had patient lay on their back with feet elevated and had store management apply cold compress to patient wrist and neck. Patient said they felt a little better but had ambulance called to check vitals. Management do not know results of vitals check but patient did leave store on their own accord after vitals were checked by EMT.

Pt stated he was nervous about drs office/vaccines. Shortly after (1 or 2 mins) patient got shot he got warm around the face and said he felt slightly dizzy. So we laid him on his back and elevated his feet. We put cold compress around his neck. This only lasted about 5-10 mins. Called pt couple hours later with no concerns.

CONSTANT NAUSEA AROUND 1 AM; SEVERE HEADACHE; DIZZINESS DESCRIBED AS VERTIGO (WORSENS WHEN HEAD MOVES); FEVER; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral knee replacements, and concurrent conditions included bipolar disorder, non alcohol user, cigarette smoker, migraines, and type 2 diabetes. The patient had no known allergies or drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left arm 03-APR-2021 at around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paliperidone palmitate for bipolar disorder. On 03-APR-2021, around 22:00, the patient experienced severe headache, dizziness described as vertigo (worsened when head moves) and fever around 100 degrees. On 04-APR-2021, around 1:00, the patient experienced constant nausea. Treatment medications (date unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, dizziness described as vertigo (worsens when head moves), constant nausea around 1 am, and fever. 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.

I received the Jansen 1808978 vaccine on 03/25/2021 at pharmacy , on the following day 03/26/2021 at 8:30 pm I became disoriented / dizzy along with severe tinnitus and for the first 30 minutes I lost hearing in my right ear but it?s been over two weeks and the ringing is still going on .

Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!

The fire department came to his house as he is a paraplegic to give him the vaccine, and he can't move, is fatigued, has tightness in his joints, and has stomach issues, and takes Oxybutynin to control his urine and doesn't know what he's supposed to do. Off and on he has had a headache. Doesn't understand why they would give him a shot if it gives people a blood clot and he's a paraplegic. He already has an IVC filter in his veins to prevent him from getting blood clots.

I started sweating profusely within 30 min of the shot. Was light headed and dizzy for approximately 4-5 hrs. Once the sweating stopped I felt severe pain in both knees and ankles. If felt as if you were trying to snap my knees and ankles in half. That lasted 4-5 hrs. After I slept for a few hrs over night I woke up and felt pretty good. Approximately 3-4 hrs after I woke up I felt light headed and nauseated for approximately 3-4 hrs. I felt pretty much back to normal into the third day after the shot. I was slightly light headed and fatigued for approximately 8 days after the shot. After about the 8th day I felt normal again. I said I will never get that shot again. Approximately 25 years ago I had gotten my first flew shot and I was very sick for a week. Never received another flew shot again. Besides the stress and anxiety issues I am a healthy guy. Every 2 years we get full blood work up and my blood levels have always been spot on of where they should be.

EXTREME DIZZINES; BRAIN FOG; VERTIGO; NAUSEA; MUSCLE PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was not reported and height was 175 centimeters. The patient's concurrent conditions included alcohol use 1-2 drinks, and non-smoker, and other pre-existing medical conditions included the patient had no allergies and no history of drug abuse. no prior history of dizziness or vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On 09-MAR-2021, the subject experienced extreme dizzines. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced vertigo. On 09-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme dizzines, nausea, brain fog, and vertigo, and the outcome of muscle pain was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided. did not meet pqc criteria. based on the PQC evaluation/investigation performed. Additional information was received on 11-MAR-2021.The following information was updated and incorporated into case narrative: investigation result added. Additional information was received on 12-MAR-2021.The following information was updated and incorporated into case narrative: reporter telephone number and zip code, event (vertigo, brain fog) and treatment, product (batch number, vaccination time and site), patient history, event description were added.

DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients 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 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism. Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197. On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Since my J&J vaccine, I have limited mobility on my left shoulder, at the injection site, still sore and can not lift my left arm to full extent.

Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at12:12pm pt felt dizzy and faint and was sweating, bp1:12:22pm 117/38 pulse 79, bp2:12:30pm 97/53 pulse 51, bp3: 12:39pm 95/61, bp4: 106/69 pulse 49 at 12:46pm. pt left at 12:50pm advised not to drive had daughter driv ehim home

Patient taken to hospital after feeling very dizzy immediately following shot. Patient was profusely sweating and felt like he couldn't breathe.

About 2 weeks after I received my Covid vaccine I experienced a sharp pain in my chest. I wasn't on going so I didn't worry about it but another week after that I began to feel palpitations and decided to go to the emergency room at Hospital. I was given an EKG and an X -Ray of my chest. They didn't notice any abnormalities so they told me to follow up with my physician. My doctor made an appointment for me to have a stress test. I was on the treadmill for 6 minutes and my blood pressure dropped so low that Dr. called an ambulance to take me to the hospital. I was there from the 27th to the 30th of May taking test. I also had a cardiac cath test which came back inconclusive. Another symptom that now is troubling me is vertigo

Patient received a Janssen shot on 7/1/21 around 9:45 AM. After the shot, he stood in the line for the pharmacy and he said he suddenly feels very light headed and almost fainted after getting a shot. I provided a water and told him to get rested on the chair and check up on him every 5 minutes to make sure he is alright. He said he had allergic (anaphylaxis) reaction in the past and he said he usually does not get vaccinated yearly (flu etc) and the most recent vaccine that he received was the tetanus shot in 4-6 years ago. He said he feels fine (no rash/no more cold sweat) after resting about 20 minutes on the chair and told him to stay around 10 more minutes. Before he left the pharmacy(30 minutes after the shot), I told him if he feels any allergic reaction coming through, go to nearest emergency room/hospital.

Patient received Johnson & Johnson on 6/29 (lot # 205A21A). He presented to the ED on 6/30 with complaint of dizziness. Patient said he felt that the room was spinning every time he sat up or stood up. Patient denied any history of vertigo in the past.

JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone. On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.

A few minutes after receiving the vaccine, the pharmacist was informed that the patient was falling over in our waiting area. The pharmacist got to the patient and caught him before he hit the floor. He lost consciousness for less than a minute and EMS were contacted. The patient was helped into a sitting position, given water and monitored. The patient was alert and by the time the paramedics arrived. He was assessed by them and the patient did not go to the hospital.

SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.

Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation

Dizziness start on Sunday, 3/21/2021 and has been present every day since so far. This is abnormal for me. Prior to that, I have been having some problems breathing after getting the vaccine and have been using my Ventolin more often after the vaccine. Also noticed shortly after getting the vaccine, a feeling of liquid in my right ear. the liquid in the ear did go away a day before the dizziness started. Did not consider the ear or breathing issues as possible side effects as I do have asthma and figured the ear was congestion. Not sure if the dizziness and the feeling of liquid in my right ear are related and/or related to the vaccine.

9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.

I received the shot at 1:11 pm. I felt sorta drunk and not safe to drive by 3 pm. Sorta woozy. By 7 I was home and fell asleep and did not wake up until 4 pm the next day. I was sleepy and felt terrible nausea and was sweaty three nights in a row. By the 2nd night I had a headache that was unbelievable. I eventually took Tylenol 48 hrs after the shot and it barely helped the headache. I never ever get sick never have headaches. It was bad. I was also super super irritable and I am generally a happy person. I was so bothered by everyone I was sorta angry at them it was weird. By Sunday night my headache was even worse so bad in my neck on my left side that I had the shot, I could barely move my head. I took Tylenol recommended dose. I finally fell asleep on Sunday night 3 days later midnight sweaty again. Monday morning I woke up and I never felt better. On top of the world amazing. I felt not just good but extra good. Ready to go for it all. It was a very strange experience for over three days. I typically get the flu shot, I stay healthy and never had an experience like this, I don?t get sick luckily. Any I wanted to share this because it was so strange and no one warned me really. . I have felt great since and am thankful I had the shot.

Dizzy and light-headed. Gave water and snack. Symptom duration 30 minutes patient left to go home in stable condition

Patient passed out fell to ground and started with jerking motions. Pateinet was taking by ambulance to the emergency room. Pateints blood pressure and pulse where low when checked by paramedics.

A few minutes after administration of the vaccine, the patient became light headed followed by loss of consciousness for several seconds.

Immediately after receiving his covid vaccine patient started feeling nauseaus/dizzy, and threw up. After throwing up he felt better.

Injection at 9:30 am on 4/8. Dizziness and euphoria beginning at 1:30 pm, 4 hours post-injection. Dizziness became severe at 5:30 pm, 8 hours post-injection with fever, chills, and nausea. Severe headache beginning at 7:30 pm, 10 hours post-injection, becoming severe migraine headache lasting for 24 hrs until ~7:30 pm on 4/9, 34 hours post-injection. Mild headache persisted until 2:00 am on 4/10, 40.5 hours post-injection.

5 minutes after vaccine received, patient reports feeling dizzy and lightheaded. Patient diaphoretic, skin cool and clammy to touch. Patient instructed to drink orange juice. No respiratory issues noted. Patient reports not eating anything today and he woke up at 9 am. Patient reports feeling nervous about vaccination before appointment. Patient observed for 30 minutes. Patient able to answer questions and follow commands appropriately. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to have food/fluid and rest. Patient ambulatory and reports symptoms resolved about 10 minutes after drinking juice. Patient returning to work; manager and supervisor aware of patient's condition and notified to allow patient food/drink/rest as needed. Patient declined transportation to hospital. BP 110/70. HR 74.

Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's going to pass out. He also c/o being dizzy. His skin was cold and clammy. This happened about 5 minutes after the vaccine. We assisted him to a room where he laid down flat and I applied ice pack to his head and chest. Pt felt better after about 30 minutes. Pt stated he had never had this reaction before. Pt was discharged from the clinic with his father, in stable condition.

Fever 102, pain, chest tightness, chest pain, difficulty breathing, unable to move limbs or sit up, general pain in muscles, joints, bones, acute pain in wrist

pt says he is not feeling well. He has become light headed, dizzy, and has severe stomach pain. He has developed some diarhea and has a sour taste in his stomach. He says when he stands up he feels like he may fall and he feels like he has a buzzing in head. He has back pain on this lower right side of his body. He has been taking anti-diarhea medicine medicine and Tylenol. He is not getting any better and will have to contact his PCP.

Patient began having back pain on Friday but by Saturday was having a hard time walking. Having pain at the left elbow, both shoulders, left knee and left foot. Dr. came in to examine patient as well. Think he is having tendinopathy as pain was not in the joint itself. Patient having pin point tenderness. Denies fever.

Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19

Patient states that the day after the vaccine when he would stand or move that his equilibirum was off, causing him to stumble. He described it as if he was "drunk" and stumbling without the alcohol as he does not drink.

Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.

Severe cold/flu symptoms beginning late evening of the shot date, lasting from 11:00PM until 7:00AM the following morning. Body shaking, extreme fatigue, feverish, significant aching in upper half of body including head. Tinnitus. After cold/flu symptoms subsided, heavy fatigue and some tinnitus persisted for 20 days. This was followed by approx. five days of tapering fatigue, after which approx 95% of symptoms had subsided. Unclear 5 weeks later if symptoms are 100% subsided, as diminished activity and exercise over three week period has left an unclear sense of physical norm (I suspect the symptoms are 100% subsided and my energy will return to normal with resumption of exercise habits).

Pt. stated, "I have a history of passing out after shots or blood draws". After receiving the injection, he was asked to remain seated for a few minutes. After 2 minutes he stated that he felt dizzy and warm. He put his head down on the table and continued to feel hot and sweaty. He was given water and the EMS team came in to evaluate him.

The vaccine was administered to the patient. The patient waited in the assigned chair in the waiting area. He was observed to lose conscious and fall out of the chair onto his head. He regained conscious and began conversing with the staff. He remained supine for 10 minutes and then sat up. He reported feeling fine, except for the headache, and was allowed to leave with his spouse.

Never felt "right" after receiving vaccine. Occasional dizziness noted, especially upon standing. Deterioration in health 5/16/21: Was on a bicycle ride in the morning and HR monitor read 180 BPM. Rested briefly, did not feel well, rode home. Continued to not feel well throughout the day. Went to the emergency room at 6:00 PM with irregular HR, fatigue, and chest tightness. Heart rhythm irregular with ventricular ectopy. Admitted to the hospital, cardiac catherization done 5/17 8:00 AM, no evidence of CAD, diagnosed with non-ischemic cardiomyopathy. No risk factors and all probably causes ruled out. Non-smoker, healthy lifestyle, no excessive alcohol use.

The day after I had flu like symptoms. Tuesday morning I was dizzy light headed and went to the doctor, I started stuttering and the doctor sent me to the ER because he was concerned I had a stroke. I developed headaches they believed to be tension headaches. I couldn't finish sentences without stuttering. Nauseous, light headed, and dizziness for some time.

Pt fell from his chair while waiting at the waiting area after the Covid vaccination. Pt said he hadn't eated all day. He did not hit his head and he tried to get up on his own but I supported him to his chair. We called EMS as precaution. They checked his BP, sugar level and EKG. He refused to go with EMS and went home on his own.

initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms. Within 24 hours unable to walk easily. No other symptoms and no physical signs of infection. Urine became dark brown at 24 hours and clinically has myositis with suspected rhabdomyolysis - was admitted for iv fluids and analgesia and is improving clinically but gait still disturbed. No demonstrable weakness and no neuro deficit or symptoms. no other obvious cause for acute myositis so consider ?vaccine related.

May 31 - Hip soreness moved to groin. I am not sure if this is vaccine related. After a few days I went to the doctor - received a naproxin prescription and some stretches. It got worse so I went back to get an MRI and x-rays. I was not able to lift up my right leg while sitting.

Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.

Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in my fingers. Pressure on the chest. High blood pressure.

- Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and tingling in feet and hands, headaches, chest tightness, - prolonged severe daily headaches, blurred vision, high blood pressure

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known 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: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. 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

NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.

1. Severe chills and body aches started about 7 hours post vaccination. Along with severe headache. Severe chills lasted about 6 hours. 2. High temperature of 103 lasted for 5 or 6 hours. Temperature went down to 100-101 for another 10 hours. Tylenol every 4 hours didn?t seem to help. 3. Chills, body ache and headache were so bad that I could barely walk. 4. Fever and headache subsided after about 35 hours.

Severe vertigo, nausea experiences about 5 min after vaccine admin. HR regular, skin diaphoretic, Over course of 15 minutes of observation symptoms subsided, No dysphagia, redness or swelling at site, After observation for additional 15 minutes was able to ambulate and feelings of dizziness subsided. He is not driving and advised to rest for the next 24 hours, and to go immediately to ED or Express Care if any other symptoms develop.

Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.

Dizziness started around the second day after receiving the vaccine. Today is the 4th day after and I am still having bouts of dizziness. It's not enough that I need to sit down, although it is somewhat disorienting.

About 10 minutes after injection, got dizzy/clammy. It took about 5-10 minutes after that with EMTs to wait until my blood pressure normalized, and then I was fine. Walked off site. Slowly throughout the day had an increasingly bad headache, which peaked about 10 hours after the injection. Around that same time, bad fatigue started, and then slight chills. The headache at this point was extremely severe for about 10-12 hours. After that (so 20-22 hours after initial injection) the fatigue and chills subsided, but came back occasionally. The headache was less severe at that point, but in total did not go away until an additional 15 hours had passed. My estimate is that took about 36-40 hours to feel 100% normal again.

Patient began sweating, hyperventilating and "feeling bad like he might pass out" about 5 minutes after vaccine. He lost color in his face about 2 minutes after and asked if he could like down. Paramedics were called and he was taken for care.

At time of vaccination patient felt fine. Morning after: patient stated he had a fever. At presentation to pharmacy(11:00am) , temperature checked any no fever was present. Patient stated he felt tired and couldn't catch his breath. Patient was encouraged to go home and rest as most of the described symptoms were to be expected. He did not. He reported back to pharmacy after 5:00pm and stated at around 2:00pm he felt dizzy and then went unconscious for a brief time (he did not know exact time frame but stated not long. Again temp was checked and was normal. He stated that his breathing was improving, but he was taking rest of day off.

Patient presented to pharmacy feeling anxious, drank energy drink prior to vaccine, and had not slept the night before. He said he had a lot going on at home. After the vaccine he felt dizzy. Patient stayed in pharmacy admin area and then in the waiting area for over 20 minutes to see how he felt. he felt much better after waiting some time. We provided a gatorade to keep him hydrated.

Patient received vaccine, stood up to leave to lobby for observation period, turned back and said he felt light headed, this RN advised that he needed to sit down but before we could find a seat, patient wobbled then fell backwards, striking his head on an upright support.

Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm pain and headache.

Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that evening. ( did not mentione until 4/16.) HE said around 4/11- 4/12 he has cold sweats, dizziness and some coughing started. He said he started to feel better but noticed 4/16 that he was having a little shortness of breath/congestion -- he is taking mucinex to relieve congestion

On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomiting, dizziness, body ache, chills/hotflashes Two days later, mid afternoon: Nausea Five days later, lunchtime for several hours: severe headache Six days later, lunchtime for several hours: severe headache

MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid- 19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.

Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.

About a week after receiving vaccine, both my shoulders and both hips started experiencing pain and weakness that is still ongoing, though improving. Until recently, it was difficult to raise my hands over my head, and it would be difficult to stand up from a sitting position. I have regularly exercised and done resistance training for several years. I'm not sure if this is coincidental nor am I concerned, but a pharmacist encouraged me to report it here.

Patient came to vaccination site for the Janssen Covid-19 vaccine on April 09, 2021. After receiving the vaccine, given by a Medical Assistant, he stated that he was ?not feeling himself and was lightheaded?. Medical Assistant, told him to put his car seat back and that she was going to get the automatic BP cuff to take his BP. Medical assistant also let two RNs, know about the incident and they also observed the patient when he was getting his BP taken by Medical Assistant at 9:10am. The first BP was taken on the left arm and was 199/119 and pulse was 72. The second was taken immediately after on the right arm by a RN and was 191/116 and pulse was 78. At 9:22am, RN called our Pharmacist and explained the symptoms the patient was having. She advised the nurses to call EMS. The RNs then took BP again at 9:23 am on the left arm, this time it was 199/116 and pulse was 72. The RNs explained to the patient they were going to have to call EMS to take him to the hospital due to his hypertension. Patient refused EMS transport and stated he would go to his doctor, but that he wants a manual BP taken. The RNs stated he would need to call someone to pick him up to transport him to his doctor. Patient called wife to pick him up. RN stated at 9:27am that a staff member was going to get the manual BP cuff. At 9:35am second RN checked patient and he stated he ?felt fine?. At 9:45am, second RN checked patient again, and he stated he was ?feeling better?. At 9:55am, second RN checked BP with the manual BP cuff on the left arm and it was 215/118 and pulse 75. At 10:00 am second RN gave patient a bottle of water, because he stated he was thirsty. Second RN asked to check BP again at 10:01am on the left arm, manually and it was 194/115 and pulse was 81. Second RN took manual BP again at 10:06 am and it was 190/110 and pulse was 82. Crackers were also given to patient at this time. At 10:18am wife picked up patient and took him to his MD office at 10:18. On April 10th, 2021, at 10:27am, RN reached out to patient via phone but patient did not pick up or call back.

It was reported that patient had been experiencing difficulty breathing, walking and delusions as per his fiancé . Fiance notified Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and they refused to evaluate patient beyond performing a PCR swab test so, they went back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that patient was COVID-19 positive which was not seen by patient or fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised him the patient was sick, not able to walk, and having difficulty.

starting have shortness of breath/difficulty breathing and back and chest pain. light headed, pain unbearable. Saturday April 23rd Went to er was treated for kidney stones but they could only find one small one, Was sent home with pain medication. Shortness of breath persisted as did bloody cough and pain in chest and all over. Went back to the er on 4/28 as pain was unbearable (chest pain) once given a cat scan and diagnosed with blood clots in my lungs and then an ultra sound and found a blood clot in my leg (just above knee). It is thought that I was mis-diagnosed on the original trip to the er with kidney stones. I have been put on blood thinners and pain medication and will be following up with my doctor.

Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light headed. Patient fainted, with seconds patient was awake and knew where he was. he was clammy and in the face. Gave patient a water, he immediately felt better.

patient was administered dose. he was still sitting and he informed his wife and immunization tech that he was feeling lightheaded. patient started sweating at which time pharmacist was informed. Patient could not stand up and 911 was called. patient was checked by emt and released.

Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission. Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands. Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands. Pt states that he is still having minor headaches.

Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies. Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.

DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED SNACK AND WATER, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.

pt received vaccine and was waiting the 15 minutes i noticed he was slumping in the chair, i caught him prior to hitting the ground. took his bp and was 80/45. raised his legs and he was feeling better, provided a cool compress a few minutes later bp was 128/88. I slowly sat him up and 20 minutes later was fine to leave

1325 Pt lost consciousness and feel to the floor from a sitting position. Per reports, pt hit his head on the floor. EMS team activated. POD Director at pt side along with NP. 1326 911 called and emergency services activated 1327 Pt is not A/O x4 and answering all questions appropriately. 1340 Fire dept arrived. Pt sat up and being transferred to fire care 1341 Patient placed in a sitting position, A/Ox4 and swering all questions appropriately Vitals 1326 HR 50, RR 16, Sat 93% 1328 HR 85, RR 16, Sat 98%, BP 139/83 laying position 1331 Glucose 90 1338 HR 89, RR 16, Sat 99%, 1341 HR 69, RR 16, Sat 98%, BP 140/87 Sitting position 1343 BP 136/83

Nausea; Vomiting; Lightheadedness; Collapsing or losing consciousness. Positive LOC. vomiting x1. EMS was called at 1207 and refused further care. patient waited until a ride came and picked him up.

Chest Heart Burning beginning 5 minutes after injection and continuing for approximately 30 minutes Lightheadedness/dizziness beginning 15 minutes after injection and continuing intermittently for approximately 20 minutes Slight headache at left lower side base of skull. Currently, the dizziness has subsided. Heart burning sensation has alleviated and gone to none and then back to warm but not burning. headache slight still as of 5:15pm

Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.

On June 29, 2021 I got poked by a plant on my left hand, my vaccine was on my left arm, and the reaction was anaphylaxis. I have been poked by this plant before, and I never had a reaction. I had the ambulance and the whole bit come out. I was taken to the hospital and was put on 4 different IVs. I was in the hospital for like 4 or 6 hours. I haven't been hospital again but it happened again 7/06/2021, I had the anaphylaxis again, it was triggered on it's own. No thorns or anything. I took 2 doses of Benadryl. The second dose stopped it. I'm on over on medication, Benadryl, Prednisone, Pepcid, Meclizine (takes care of any dizziness), to keep the anaphylaxis shock from coming back. As soon as I stop taking the medication it probably would come back. I have one more week of medication left.

Patient became extremely dizzy after receiving the vaccine. He passed out and hit the floor. Patient was going to go to the hospital.

migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min). I went to hospital and had CT, ekg, blood work, all were ok. Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure. Surgeon also said to get the procedure but as of now my insurance has not approved payment. I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue. I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay. I have gone from a healthy person who is very active to someone who is always tired and is constantly worried about having another TIA.

CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. 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). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.

5/8/2021 buzz /dizzyness 2:30-7Pm. no fever,no aches. 5/21/2021 woke with body aches and slight fever 99. tylenol . 5/22/2021 slight fever 99 , no body aches . no tylenol 5/23/2021 fever 101, body aches . tylenol 2 tab every 6 hrs 5/24/2021 fever 102.5 no body aches tylenol 2 tab every 6hrs 5/24/2021 PCR test 5/25/2021 fever 101, no body aches , tyelnol 2 tab every 6hrs. started coughingduring day 5/25/2021 received results .negative pcr 5/26/2021 fever 102, coughing went to emergency dept

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt previously had episodes of fainting after getting blood drawn in the past

Janssen Covid-19 Vaccine EUA recieved shot at around 2:15 Pm, around 8:00 pm I started feeling extreme fatigue, dizziness, and sleepiness. About 1 hour later I started getting the cold chills, a headache and shaking. About 1 more hour later I had a fever, achy joints and muscle aches. The symptoms lasted through the night until about 8:30 the next morning when I started sweating. I decided then to take aceteminiphen and Naproxen. This helped me to feel a little better. Side effects were resolved after 24 hours

March 17 at 6pm - Experienced chills and fatigue. March 17, during the evening - experienced pain in left arm, right arm, nausea, chills, hot flashes, restless feeling, unable to get comfortable to get to sleep. Woke up several times during the night. Woke up, took up to 4 Tylenol, still could not sleep. March 18 - Woke up - Fatigued, dry mouth, and in a fog. All I wanted to do was sleep. This is what I ended up doing most of the day. By the end of the day, felt a little better. March 19th - Feeling a little better, but still weak, but still somewhat dizzy. March 20th - Same as the 19th. March 21st - Finally feel 80 - 100% better.

Day 1: injection site soreness Day 2: Extreme fatigue, muscle soreness, aches, fevers, chills, dizziness, nausea Day 3: Extreme fatigue, muscle and joint soreness, aches, fevers, chills, dizziness, nausea Day 4: moderate fatigue, chills, fever spikes, dizziness

Paramedic assessed patient. Pt stated neck tension on the side (R) arm, 3/10 pain, light head, natural low pulse rate. Vitals BP 159/78, HR 51 bpm, respiratory 16. Pt was monitored and stale to leave upon expired observation time frame.

Almost immediately I felt extremely dizzy and lightheaded. Which put me in a state of panic. I did not ask for medical treatment. I will say that the typical side effect from this vaccine is very intense and should be looked at further. I was alarmed to say the least.

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

A few minutes after receiving the vaccine he felt like he was going to pass out. He became pale and diaphoretic, c/o having tunnel vision. He did not loose consciousness.

Starting 96 hours after vaccination: extreme stabbing pain in left deltoid (injection site). Soon, this was accompanied by dull but severe pain in left shoulder and upper left back (top of scapula and around collar bone), extending to base of neck. This pain lasted 2 weeks, and was severe enough to prevent patient from sitting or standing for more than a few minutes at a time, especially during the first week of pain. Painkillers (Acetaminophen or NSAIDs) or muscle relaxants (cyclobenzaprine) did not help alleviate the pain. The pain started on March 17, and finally eased up on April 2 (the vaccination was on March 13). There is still some pain and stiffness in the left arm (currently in the biceps), but it is no longer severe. By the way, in addition to the above symptoms starting at 96 hours, there were the usual expected systemic symptoms immediately after the vaccination (starting at 6 hours and ending at 36 hours): light fever, mild body ache, fatigue and mild local pain at injection site.

Severe Nausea, burning eyes, dizziness, headache, body ache, diarrhea, fatigue. I took my husband to ER on day 5. He was given nausea meds, eye drops and anti- diarrhea meds. I also treated him with an Aleve/Tylenol regimen.

On or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work about 7:00 am due to an extreme headache and muscle weakness. By the afternoon my fever was up to 101. On 4/7 my fever went up to 102.7 and I was shaking uncontrollably, sweating , dizzy, headache, and had heaviness in my chest. I felt as if I were going to have a stroke. The headache was excruciating. I took acetaminophen 500 x 2 and 400 mg of ibuprofen, and Theraflu to try and alleviate the symptoms. On 4/9/21 my fever broke, but the weakness, dizziness and headaches have continued. I currently have ongoing headaches and dizziness. I have not gone to the doctor because I do not have a PCP. I am looking for one now.

Per Dr. : Asked to see patient in medic treatment room 5 minutes after he received Jand J vaccine at vaccine center. Pt. Was in observation, and began to feel lightheaded and dizzy. Pt. Felt like he would pass out. Pt. Notified observer, that got nurse. Pt. Taken by wheelchair back to Medic treatment room. Pt. VSS initially at ^30 Pm, BP 94/70, P 60, R12, O2 sat 100% on RA. No airway swelling, no rash, no wheezing. Lungs CTA B. Pt monitored. Given Sprite, crackers. Felt much better. BP at 6:37 PM was 188/82, HR 66 P Ox 100 % on RA, R12. Lungs remained clear. Pt. Back to baseline. Warning signs and symptoms discussed prior to pt leaving clinic, and pt. Verbalized understanding andd need to call 9111 if these occurred. Pt. Likely had vagal reaction, that full resolved.

dizzy,nausea. Pt received the J&J vaccine on Saturday. Pt had HA and body aches on Sunday. On Monday, pt has severe HA and ringing in his ears and has not gone away. 51 yo M w/ no known chronic medical conditions, J&J vaccine on Friday, presents w/ dizziness (room-spinning) that started this AM and has since resolved. Initially started when he sat up from bed after waking up; a/w moderate nausea (no vomiting). Pt went back to sleep, no sx when he woke up, but sx re-started when he stood up. Since then, dizziness has resolved. Pt has residual nausea, but currently no dizziness. He also reports constant ringing in his ears since this AM, w/ no associated muffled hearing, ear pain, ear discharge. Initially had fevers/

KNEE HURT; BARELY WALK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride. On 13-APR-2021, the subject experienced knee hurt. On 13-APR-2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knee hurt, and barely walk. This report was non-serious.

The day of the shot my lips and tongue were numb until the next morning. The next couple of weeks my tongue would go numb often. I was also feeling tired and unsteady. 12 days after the shot I became very sick for 10 days with severe diarrhea, no energy, stomach pains, weak, shaking, no more motivation. I saw a doctor and was given antibiotics to stop the diarrhea. Now 1 month after I have no diarrhea but still get nausea and shakes . I feel very anxious and will see a therapist and prescribe medication for my anxiety that I have due to the vaccine reaction. I took the vaccine so I can travel abroad much easier but now afraid to travel because of my symptoms. I will get blood tested tomorrow to see if all is ok. This vaccine is very dangerous as it has affected my DNA.

Pain at site of shot. Hot flashes, chills. Before bed got real hot from waste up. Muscle spasms. twitchs at shot site. Light headed, dizzy, shortness of breath. Shot should have been 2nd dose of pfizer. Pharmacist called the next day and told me to remove Janssen sticker from covid shot record card and said to write in pfizer info.

LIGHTHEADEDNESS; CHILLS; FEVER; DULL HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lightheadedness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced dull headache. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness on 08-APR-2021, chills, fever, and dull headache on 09-APR-2021, and fatigue on 10-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210425086.

HEART RATE DROPPED TO 36-37 BEATS/MINUTES; SWEATING PROFUSELY; DIZZINESS/ LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he got the Janssen vaccine on Monday 12-April -2021.Right after vaccination patient started experiencing lightheadedness, sweating profusely, heart rate dropped to 36-37 beats/minutes.he did not see his MD and did not go to ED(emergency department) Patient was feeling much better right now. He was not on any chronic medications. Laboratory data included: Pulse rate (NR: not provided) 36-37 beats/minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 36-37 beats/minutes, sweating profusely, and dizziness/ lightheadedness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210431941-covid-19 vaccine ad26.cov2. s-heart rate dropped. 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.

Onset of severe headache , slurred speech on 4/17/2021. Became aphasic with motor deficits, was not a tpa candidate at hospital due to time of symptom onset. Dx with L MCA ischemic CVA

Developed dizziness and headache immediately post vaccine . Patient without other symptoms . Patient noted to have good oxygenation. Symptoms almost completely resolved after 20 . ER precautions given.

After giving vaccination, while he was waiting in line on pharmacy register, he felt dizzy/lightheaded, chill and was having cold sweats. He sat down on a chair about 30 minutes just to relax. Before the shot, he was pretty nervous about getting vaccinated (needles) and his fiance told me that he hardly gets vaccinated in the past because he is afraid of needles. She was not sure if his reaction is because of his nervousness about the vaccine or if it is an allergic reaction. I told his fiance who was with him the whole time, to take him to the ER if he is having hard time breathing or if his dizziness gets prolonged. I tried calling patient and her fiance on 5/10/21 vaccination day, and 5/12/21 again and left message to follow up but no answer/ call back.

Patient began feeling lightheaded and collapsed out of his chair. The patient did not recall falling from the chair but was conscious when attended to by the pharmacist. He had just started new medications (Lisinopril and Metformin) and had taken them in the morning prior to arriving for his vaccination. The patient did not eat anything in the morning prior to arriving for his vaccination. He was given water, a cold pack, and then orange juice. His symptoms improved and he was able to get up and walk under his own power.

Patient had syncopal fainting and profuse sweating, no difficulty breathing. Ambulance called, assessed patient, transported from pharmacy after about 10 minutes. Patient remained sweating, light headed while still in pharmacy

Pt presents for COVID-19 vaccination at. Janssen vaccine given per protocol. Patient informed to wait in observation area for 15-30 minutes. After 5-6 minutes of observation, pt reported feeling faint and appeared diaphoretic. Per facility staff, pt just admitted into rehab facility and may be going through alcohol withdrawal. Pt then started slumping over the chair and became unresponsive. Facility staff called 911. Upon waiting for paramedics, nurse and staff laid pt down onto the floor. Pt became responsive and started talking again. Respiration and heart rate within normal limits. Monitored pt until paramedics arrived. Pt taken to ER for further evaluation.

Patient received two doses, one in each arm, of the Janssen COVID19 vaccine on 6/3/2021. Patient mistakenly believed he required two doses, one in each arm. Vaccinator administered the extra dose. He asked the patient if he had received the COVID19 shot before, but the patient misunderstood and said that he had not received the shot before that day. Patient reported lightheadedness and nausea approximately 24 hours after the vaccination. Approximately 72 hours after the vaccination, the patient reported no other side effects and said that he was in good condition.

Light headedness, Muddy thinking Ringing ears Difficulty concentrating Sleep disruption Depression Irritability General feeling of being unwell

Running up a hill and became severely short of breath with significant chest pain in center of chest. Had to lie on the ground to rest and catch breath. Several minutes to catch breath and about 10 minutes for chest pain to resolve. One month later had chest pain in center of chest... went to urgent care... EKG and vital signs showed normal. Two months after vaccine, started having forceful heart beat, lightheadedness, fatigue, pins/needles neuropathy in right foot... Lightheadedness and neuropathy was episodic, sometimes for hours, for a week... Fatigue was worse for a week then gradually eased but remains mild to moderate fluctuating... Forceful heart beat has continued but was worse 3 weeks ago and is always worse lying down and improves when sitting up though can be mildly present sitting up... and continues today. Seeing my primary care doctor to assess. Went to clinic 3 times in last month for this... vitals always normal and one additional EKG normal.

Headache, chills, fever, body aches, nausea, and a general malaise were experienced beginning approximately 8 hours after receiving the shot and lasted approximately 36 hours. Approximately 4 days after the shot, i experienced a severe bout of vertigo, which I've never experienced in my life. This included severe dizziness and vomiting for about 12 hours and a headache and light dizziness for an additional 24 hours.

Had the expected fever within 24hrs which okay. But 5 days later out of the blue I felt shaky, disoriented, sweats, fatigued hardly had the energy to stand or even speak, I was fearing I was having some kind of heart attack or stroke. Something in my body was telling me something was very wrong, I have never had a feeling like this before in my life it was pretty scary. I went to a place to be alone and sit since I could hardly stand, I sat for an hour and started to feel some relief. It took almost 4 hours until some sense of normal was back. I came home and went to sleep for the event tired me out immensely. Since that days event and still ongoing I have been having random dizzy spells, I have days with absolutely not enough energy to walk out of bed and have called out of work because of it. I get the feeling I am unplugged and then plugged back in as far as energy goes almost every day. I have worse and better days with that. About 2 to 3 times a week I experience sudden pains and tingling that can go anywhere on my body but seems to focus more on all my extremities and back. Feels like fire/pins/needles and it stays with me for a few hours to an entire day the pain ranges from a 5 to an 8. My legs feel stiff every day now and at times sore yet I have done nothing exertive to cause that. With the stiffness I have trouble getting my shoes and socks on, and getting up from sitting. All these symptoms I didnt have until I took the shot.

Nausea, vomiting, difficulty walking, unable to eat or drink; unable to clear secretions, difficulty breathing

Shot was given at max vaccination site in a shopping mall store. Shot was given in upper rear of shoulder. Continuing shoulder pain that got gradually worse over time. Pain also eventually felt from shoulder down arm. Restricted range of motion. Affects daily activities and ability to sleep. .

SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.

Began feeling dizzy and nauseated. Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning. That went away and have not had any symptoms since

swelled immediately after the shot and was given 2 benadryl before leaving the drive through. Experiened chills, fever and was vomiting all night. Feeling tired and dizzy afterwards and ever since.

S: Patient is a 53 y/o male c/o having dizziness and nausea while he is walking towards his car after 5 minutes of getting vaccine. Reports having high blood pressure. He did take his medication this morning. O: 1st reading vitals BP 150/70 HR 64 Oxygen sat 94 pain 0/10 resp. 18 2nd reading 130/80 Hr 68 oxygen saturation 96 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Cardio: Negative for arm pain, back pain, weakness, palpitations Neuro: Alert x4, negative for limb weakness, neg for slurring, neg Medications: losartan 50 mg daily, carveidlol 12.5 mg bid, famotidine 20 mg every other day, simvasta

Initial symptoms began with pain at the injection site and generalized fatigue. This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation. I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm. There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right. The symptoms persisted over the second day albeit at less severity. Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.

Patient stated feeling dizzy and had syncopal episode witnessed by nurse for 1 minute Patient provided water and seen by medical team The medical team advised patient to be seen in the hospital but patient refused medical transport and signed AMA form Patient agreed to stay in monitoring longer, patients symptoms resolved and was able to ambulate independently with no dizziness

At ~3:10pm, patient received his vaccination for COVID (Janssen brand). Patient was directed to sit in waiting area for 15 minutes for monitoring; during this time, patient started to complain of the following: chest/abdominal pain, "pounding in his head", felt faint, and "scratchy throat" that was not improving. Around 3:35pm, 9-1-1 was called due to worsening chest pain and scratchy throat. EMTs directed me to administer 25mg of diphenhydramine (which as give at 3:46pm) to patient. EMTs arrived shortly thereafter, noting elevated BP (~154/90). Patient left pharmacy area ~4:10pm and was brought to ER via paramedics for further evaluation.

Injection site pain, spreading throughout arm on same day as shot. Next day increased site pain, minor to mederate light headedness with vertigo that lasted severel hours. General fatigue with fever of 99.9 most of day. By 04/09 only experiancing decresed arm pain with minor fatigue.

Patient got dizzy and threw up immediately after receiving vaccine. Very pale. After drinking water and relaxing felt okay, Stayed for 15 minutes and still felt okay

Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still sore and the injection site. soreness site stayed sore for about another 3 to 4 days, but total top arm around site still sore and aching. Arm is hard to lift up at some times and weak to lift anything up sometimes. Arm feels week for about 2 to 3 days and then starts to fill better. Then after a day of the soreness or no weakness in the arm, it starts back hurting again. It now getting worse at night time and sometimes during the day. Some days it hurts so bad that I can't even move it. I don't bother to tell my wife, because it just last for about a 2 to 3 hours. I have been to my doctor yet. But if it keeps bothering me I will make an appointment to see him. It just my arm and hand be very weak to use at sometimes every other day.

Woke up Sunday the day after and couldn't walk. Waited to see if it would wear off the next day was admitted into emergency with a minor stroke caused by a blood clot

3/30/21, Tue. Got up and felt dizzy. Went to bed a few times to have a sleep. 3/31/21, Wed. Got up and felt better. Went to work but felt no idea of work related material. 4/1/21, Thu. Got up and felt good, but could not speak too much because of some loss of words. Called for PTO for Thu and Fri. 4/2/21, Fri. Mindset went back but still could not speak too much. 4/2/21, Fri night. After bible study at night, almost all bro & sis said that was symptom of stroke, and suggested us to see emergency doctor. On 11pm, we were at emergency room. 4/3/21, Sat. I was admitted 1-2 am into impatience room. CT diagnosed a big gray area in between speech are and spine. 4/3/21, Sat afternoon. MRI and MRA had been tested. Cardiologist said he could not rule out the last option, which was due to slow heart beat 50-60. But I have slow heart beat since I remembered things from 4-5 year-old. He suggested wearing a heart monitoring device for a 4 weeks after discharged. 4/4/21, Sun noon. Doctor admitted to discharge. They could not find cause, and would like to follow up within 1 to 2 weeks after discharging. 4/13/21, Tue night, I started wiring body monitoring device.

Symptoms started to appear about half an hour to forty-five minutes after the vaccination: 1. The first set of symptoms were that I felt light-headed and I could feel that my neck muscles were a little bit tense when I moved my head to the sides. This first set of symptoms lasted about two to two-and-a-half hours before tapering off. 2. The second symptom which were chills started about three to three-and-a-half hours after vaccinations. The chills lasted about four hours before tapering off. 3. The last symptom was fever that started about nine to ten hours after the vaccination. The fever lasted for about twelve to fourteen hours and tapered off the following morning.

We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the morning and he complained of numbness in his left. We thought it was related to the weather getting warm and we work the night shift, so he rested and increased his water intake. He was able to go to work on Monday night and return home and continued to rest on Tuesday. On Tuesday, there was no numbness, but there was weakness in both his legs. On Wednesday, he felt weakness throughout his body, especially in his legs. On Thursday, he collapsed. He did not lose consciences but his legs gave out under him and he was not able to get up up. He was taken to the hospital. He was diagnosed with a stroke, increased sugars (diabetes he has never had before), acute kidney injury, and uncontrolled increased blood pressure. He was hospitalized and discharged April 19, 2021. He was readmitted 04/24/2021 for another stroke.

Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.

Rash on arm, then bad headaches, real bad headaches, When driving this last Monday. I would pass out at the wheel. At least 4 times I jumped the median. Got lost in a nearby neighborhood. Once I figured out what was going on I went straight home.

Three days after receiving the vaccine, he developed a headache which was intermittent with pain score of 5-8 out of 10. Headache became consistent around 4/11/21. Pain is in the occipital region and occasionally radiates behind the eyes. Also complains of dizziness, nausea, vomiting, and tingling in his hands bilaterally - worse in the mornings and goes away after waking up. He presented to Medical Center on 4/28/21 and transferred to Medical Center for treatment of vaccine induced thrombocytopenia and nonocclusive straight sinus thrombus. He was started on bivalirudin infusion 4/29 @ 0142 via continuous infusion. Still receiving treatment at the time of this report.

After injection patient felt dizzy and fainted. Vasovagal episode. Patient has a history of vasovagal. Patient awaken after ammonia. Vital signs taken by EMS. Patient is hypotensive. Patient was placed on stretcher in trendelenburg . Patient recovered

WAS TOLD THAT IT WAS THE ONE AND DONE AND IT WAS THE JANSSEN VACCINE, BUT LOT # IS MODERNA: He got the vaccine, had no reactions at all for 2 weeks. Then on Friday, 4/23/21 he woke up early with pain in his left arm near the area of the injection and the back of his arm and to his shoulder like he was hit with a bat. It did not move the next day and went to his PCP on Tuesday and referenced Ortho and could not find any doctor and his pain was getting worse. He went to the ER on Wednesday, had a bad experience. Went back on Friday 4/30/21 and nothing was done for his shoulder and needs to see somebody regarding his arm. The arm is painful and painful to move in all directions. They did not do anything for him in the ER, actually made it worse. The ER said that they could not do an MRI as he needed a referral from an orthopedist for that. They wanted to check him for his heart, and they would not listen to him.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: After receiving the Johnson & Johnson vaccine (Lot #204A21A), patient sat down as directed. Several minutes later, patient walked to the pharmacy counter complaining of feeling dizzy immediately before falling. No injuries were sustained. Upon examination, patient was conscious and alert, but dizzy and profusely sweating. Patient recovered within several minutes and stated it was likely anxiety that caused the fall.

Patient got dizzy/and light headed and passed out in the chair. I noticed the patient holding his head and went over and talked to him. He was feeling light-headed and sweaty. We put his feet up in the chair and he briefly passed out for about 10 seconds. He came around quickly and we gave him a drink. He sat for about 10-15 minutes longer and we made sure he was feeling good before he left.

Patient became sleepy, light-headed, and confused within minutes after vaccination. He was nodding off in the observation area. He was difficult to wake up and confused when he did. We called 911 and paramedics came to check him out. They monitored his blood pressure and pulse. His pulse was high (120-130bpm), so they thought it would be best to take him to the hospital so he can be checked out.

Vaccine administered Thursday, 4/1 1:15 p.m. By Sunday I experienced mild headache and upper respiratory scratchiness. By late Monday 4/5 I experienced fatigue, dizziness, upper respiratory scratchiness and increased post-nasal drip, tightness in my chest, muscle soreness and headache. By Tuesday, 4/6 around 10 a.m. in addition to the above symptoms I had a severe headache and lost feeling in my right arm for half an hour, with severe muscle cramps and loss of use in that arm. The muscle issues subsided by early afternoon leaving only fatigue, headache, dizziness and a lingering respiratory tightness and sinus issues. Concerned about vaccine side-effects I was reading about, I made a doctor's appointment for the following week (earliest available), met with a physician's assistant who prescribed an antibiotic (Doxycycline Mono 100 Mg) for the sinus issues but did not address the other issues.

abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays. Xrays were negative. I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis. Back and abdominal pain increase and soreness had spread to the stomach and groin. After the news broke of the cerebral blood clots in 6 women. See attached Continuation Page.

Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsive. His eyes rolled back in his head but stayed open. His jaw became very clinched. He was sweating profusely and not aware of anything goin g on around him. This lasted somewhere between 3-5 minutes.

1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99. I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.

Shortly after the injection my left shoulder (site of injection) remained sore/painful. The pain is a sharp, almost nerve like pain. I have a limited range of motion now and turning my arm, reaching for something can cause the sharp pain to occur. It will go away after about 10 seconds.

I experienced dizziness, headaches, SOB, chest pains, diarrhea, nausea, occurred when I am under physical stress. Walking 10ft or up the stairs triggered my symptoms. Once I stopped moving, my symptoms would dissipate. I called my PCP along with a cardiologist up until today. I was tested for blood clots, had complete blood panel, stress test and nuclear stress test. My symptoms are getting better but still have mildly present. My last meeting with the cardiologist, what he saw after the nuclear stress test, that there was a lack of blood flow where to the lower right heart chamber. He said it probably due to a blood blockage or plague and at this time he is trying to figure it out.

In March I had a pain in my left calf muscle that I could not identify with getting hit or injuring it in any way. I called Urgent care because i read and heard about problem with the J&J vaccine that it was giving people blood clots. Urgent care said there was no need to come in that there was very little reason to believe that it was a blood clot. Then in June I woke up to very severe pain in my left leg from my foot all the way to my thigh. It was hot, swollen and I could barely bend my knee. I went to Urgent Care and they sent me across the street to the Hospital for an ultra sound on my leg. Here are the result from the ultra sound. Real time color Doppler imaging and spectral analysis were performed during ultrasound evaluation of the left lower extremity is performed. There is persistent occlusive deep venous thrombosis within the mid to distal superficial femoral vein extending nonocclusive bleed to involve the popliteal vein and exclusively within the proximal popliteal and peroneal veins of the calf. The doctor put me on 3 week of taking a blood thinner twice a day and then will go down to taking one blood thinner once a day for 6 months. I also saw MD. Here are his notes from my Drs appt. Patient is seen today, 6/14/2021, to discuss management of left leg DVT. Patient presented to urgent care on 5/20/2021. He had noticed soreness in his left leg for a couple of days and then he awoke that day and the leg was swollen. The duplex scan showed that he had occlusive clot involving left superficial femoral vein extending through popliteal vein down to peroneal vein in the left calf. He was started on rivaroxaban 15 mg twice daily. He transitions to 20 mg rivaroxaban daily tomorrow. The leg soreness has eased slightly but the swelling has not improved. He did have a repeat duplex scan on 6/7/2021 which was unchanged. Thrombus persisted but was not worse. He has not had chest pain or breathing issues or dyspnea. He does recall that about 4 weeks earlier he had a muscle spasm sensation in the left calf. He had received a Johnson & Johnson Covid immunization in late February, 2021. He was aware of the public information about venous clotting in women who had received the J&J vaccine and was also aware that it involved cerebral veins. He called his provider and was asked questions about the leg and otherwise the answers were negative. So imaging was not obtained. The muscle spasm sensation did not recur. His family history is negative for clots in his personal history for clots is otherwise negative. He is a maintenance manager. He has not had lengthy travel recently. He also denies any trauma to the legs. He has a history of GERD from which she had developed iron deficiency anemia in June 2020. He had undergone EGD has a result. He also had a colonoscopy when he turned 50 years of age and had polyps removed and then had repeat colonoscopy 6 months later. This evaluation occurred with Dr. of gastroenterology. His colonoscopy was on 12/20/2018. One of the polyps was a hyperplastic polyp. The second was a tubulovillous adenoma with high-grade dysplasia/intramucosal adenocarcinoma, 2 cm size. Polyps were excised. Had repeat endoscopy on 7/10/2019 he had a hyperplastic polyp in his rectum. Also he had a PSA checked in summer 2020. It was 0.5. He is a smoker only of very infrequent cigars, perhaps every 6 to 8 months. PAST MEDICAL HISTORY: GERD Sigmoid colon polyps, resected December 2018 and June 2019 Left leg DVT, May 2021 Sleep apnea Iron deficiency anemia related to gastritis. Diagnosed June 2020, treated with oral iron ADHD History of depression MEDICATIONS: has a current medication list which includes the following prescription(s): amlodipine, escitalopram, esomeprazole, multivit-iron-fa-calcium-mins, prednisone, rivaroxaban, unknown home medication, and tadalafil. ALLERGIES: Patient has no known allergies. PAST SURGICAL HISTORY: Vasectomy 2 colonoscopies, first in December 2018 and second in July 2019 EGD on 2 occasions, first in March 2019 and second in June 2020 FAMILY HISTORY: Father died age 66. He had a pacemaker and was on blood thinners Mother died of a throat cancer. She was a heavy smoker. Died at age 60 1 brother and 1 sister are healthy SOCIAL HISTORY: Smokes cigars, perhaps twice a year. Never smoked cigarettes Alcohol use maybe 4 beers on the weekend Previously married and divorced 3 children, 2 daughters and 1 son ranging in age from 17 through 21 REVIEW OF SYSTEMS: Significant for persistent soreness in his left leg albeit easing over the last 3 days and persistent swelling in his left leg including dorsum of his foot General: Denies weight loss, no issues with energy, denies night sweats HEENT: No mouth or throat soreness, no issues with hearing, no tinnitus, no issues with taste No epistaxis Resp: Denies cough, exertional dyspnea, sputum production. Heart: No palpitations, no exertional chest pain, no lightheadeness or dizziness when standing Gi: No dysphagia. No heartburn, Denies nausea or vomitting. Bowels are regular, no diarrhea or constipation. Denies melena or hematochezia GU Denies hematuria. No dysuria. No incontinuence. Skin: No rash, no petechiae, no dryness. No itching or burning. Musculoskeletal: No bone pains, no joint pains or swelling. No localized weakness Neurologic: Denies headaches, no double vision, no weakness, no change in sensation Psychiatric: Good spirits, sleeping well, no anxiety, normal mood Endocrine: Denies heat or cold intolerance. Heme: No easy bruising PHYSICAL EXAMINATION: BP (!) 142/99 | Pulse 95 | Temp 97.6 °F (36.4 °C) | Resp 18 | Ht 6' 3" (1.905 m) | Wt 295 lb (133.8 kg) | SpO2 96% | BMI 36.87 kg/m² Appears alert, oriented, not in distress. Well developed Psychiatric: Patient is alert oriented ×4, good spirits, interacts appropriately He has swelling in his left leg DATA: CBC: .5/20/2021: WBC 7.49 X10^3/uL; Hemoglobin 14.8 g/dL; Hematocrit (calc.) 43.4 %; Neutrophil (%) 75.4 %; MCV 98.4 fL; Platelet 141 X10^3/uL* CMP: 4/22/2021: Bicarbonate (TCO2) 25 mmol/L; BUN/Creatinine 16; Calcium, total 9.0 mg/dL; AST (SGOT) 41 IU/L*; ALT (SGPT) 38 IU/L; Alkaline Phosphatase 62 IU/L; Bilirubin, Total 0.4 mg/dL; Protein, total 6.9 g/dL; Albumin 4.3 g/dL; Albumin / Globulin 1.7 5/20/2021: Sodium 142 mEq/L; Potassium 4.6 mEq/L; Chloride 103 mEq/L; BUN 13 mg/dL; Creatinine 1.2 mg/dL; Glucose 110 mg/dL*; Calcium, Ionized 1.17 mmol/L ASSESSMENT: 1. Left lower extremity DVT. Etiology unclear. No definite provocation. He did receive a Johnson & Johnson Covid vaccine in late February, 2021. He first noticed a muscle spasm sensation in left calf in mid April, 2021 and then had onset of soreness 2 days before his visit with swelling onset the day of his urgent care visit, 5/20/2021. Currently on rivaroxaban. Transitioning now to the 20 mg daily dose. Family history negative for DVT as is his personal history. PSA was unremarkable and summer 2020. Has had prior colonoscopy in December 2018 and June 2019. Did have finding of sigmoid colon polyps with atypia in 1 and possible noninvasive adenocarcinoma. Repeat scope showed hyperplastic polyp but no additional polyps. Has also had EGDs in March 2019 and June 2020 because of GERD and iron lack anemia. Non-smoker. I discussed with patient that we would usually treat him for 6 months with anticoagulation and then reassess to determine whether it is safe to discontinue therapy. But if he has ongoing swelling and soreness in his leg it would be difficult to stop treatment because we would lose one of our early indicators of recurrence of DVT. I also suggested that we should do a lab panel to assure that he does not have any underlying inherited or acquired abnormality that predispose to this clot, since we do not have any clear-cut causative etiology. (We discussed that the Covid immunization may have been his predisposition, but that existing data suggest that this is a risk factor in females and that most of the episodes were central nervous system venous clots.) PLAN: 1. So we will draw lab panel assessing acquired and inherited predispositions for hypercoagulability. And we will plan to see him back in a couple of months to reassess his status.

Patient was immobile, not able to move when he was found and once transported to hospital they concluded patient had a stroke. He has been hospitalized since 4-25-21.

Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbness in the face (Left) droop 30mins-45mins, 05/18/2021 numbness in the face/difficulty speaking 2-3hrs, 06/12/2021 again numbness in the face05/20/2021 diagnosed with male Breast Cancer. Breast tissue removed. 06/27/2021 severe facial droop, whole numbness left-side of body, Admitted for observation. 06/28/2021 discharged TIA. Currently experiencing numbness.

Customer did not feel right within 7-10 mins after receving the Janssen vaccine. He complained of vision changes, "seeing dots". When he tried to walk, his legs buckled, but customer was slowly assisted to the floor. While on the floor, my technician heard grunting noises coming from him and his left arm was rigid and bent at the elbow. But within 5-10 seconds, he slowly sat up and said that he "doesn't remember being on the fall" and complained of being sweaty and "seeing dots". Paramedics were contacted and took him the hospital. Contacted the customer later in the evening and was informed that he was resting at home after spending half of the day in the hospital. He mentioned that the paramedics treated him with Epipen and bendadryl and then he felt better. He was treated "other things" but don't recall.

2 weeks from the day of the vaccination, 04/16/2021, I had heavy ringing in my ears, started feeling vertigo, nausea, dizziness and lightheadedness and just started persisting on ever since. At least 2 weeks after that, I was trying to wait it out, but it persisted on and I made a tele-doc appointment. The tele-doc prescribed me Prednisone. The tele-doc felt it might go away but set me up with an ENT. A week after that I saw the ENT. The ENT did a hearing test but didn't find anything. I am still having the Nausea and ear ringing, they are the 2 most persisting symptoms. I feel it's pretty detrimental to my quantity of life. I just try to keep going and tolerate the symptoms as much as possible.

Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn't read anything. For the whole weekend I could not read anything. Not blurry vision, just could not read. Also on Thursday, I started to not be able to concentrate. To this day I still have trouble concentrating. I also experience dizziness after my vaccine. For the next two weeks I have had bad bout's of just feeling swimmy and weird. It has made me stay close to bed. I have been unable to do projects, I have had multiple migraines. For treatment, I have taken muscle relaxers and my migraine medicine as needed. I am going to see Dr. on 07/14/2021. I did see a doctor during a health fair on 07/09/2021 who recommended I see my doctor as soon as possible.

face tingling, couldn't move, neck pain same side as the shot, fell over in bathroom and couldn't move, and constipation

Patient c/o mild chest tightness, dizziness and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.

With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to 10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving

Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Painful electric shock type pains from feet up calf muscles. Sensation of no circulation in legs when elevated in recliner. Stumbling/tripping, lack of coordination and balance issues. Lack of mental clarity at times. Heart palpitations or PVC sensations. Difficulty urinating, in that the flow stops and starts as if I'm involuntarily doing Koegle exercises.

DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.

Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note

Adverse impact began within 1 hour of receiving the injection. Headache persisted for 2 to 3 days along with fever. Treated with acetaminophen. Also have experienced chills, fatigue, lightheadedness. Loss of appetite. Symptoms were strongest on day one. It is now day three, and symptoms are diminishing.

Nausea and lightheadedness, increased blood pressure 155/101 and heart rate 113. Pt monitored and BP down to 134/90 feeling better after monitoring.

Patient alert and oriented stated feeling lightheaded soon after arriving to the observation vaccination area. The patient denied chest pain, headache, difficulty breathing or any skin sensitivities such as itching. The patient stated takes a variety of medications including multiple blood pressure medications. BP 82/48 HR 68 RR 18 O2sat 98% and EMS called immediately to assume patient care. As per EMS patient refused medical care at a hospital facility and was discharged.

Lightheaded about 5 minutes after injection. Medical team took HR and BP and was normal Took about 20 minutes and light headedness went away Later that night at around 12:30 am, felt very cold and shivering with severe headache Did not take temperature Had a hard time going back to sleep Got up around 1:00 am to take 800 mg of OTC Advil When walking back up stairs had severe muscle pain in arms and legs Was fine after that Seemed to get better by 2 am No issues next day About 7-10 days later developed severe frontal headaches/sinus pressure No other symptoms Used Neti Pot with saline solution and did nothing Took OTC allergy meds and Advil and did nothing Say my primary care Dr and he prescribed Flonase, Singular and Allegra + continue Neti Pot and Advil as needed Not much improvement on this regime after 3-5 days of use About a week later developed severe pain in bottom right jaw Took OTC Advil and again no improvement Went to Dentist and said not tooth related but probably TMJD Recommend dental appliance to help with grinding About a few days later after this jaw pain developed, developed sharp stabbing pain in bottom of left knee cap. No recollection of any insult that would cause this All three of these pain sites were perfectly fine prior to getting J&J vaccine. No history of pain or injury to these areas prior All of these incidents to me seem to be inflammatory/immune in nature and could be related to J&J vaccine based upon how I reacted to injection. Curious if others are seeing the same thing and if so what should be done or how long should this last?

Patient was scheduled for an appointment for a Johnson &Johnson covid-19 vaccine through a drive thru Thursday April 8, 2021 @12:45pm. We arrived early and he received the vaccine at 12:15pm, waited 30 minutes for reaction and he was feeling fine. Later that same evening, the patient was driving to work on the freeway when he felt a dry throat so he coughed hard, at that cough he felt a massive pain in his head, like his "head was going to explode." He immediately had tunnel vision closing in on him, so he pulled over and later woke up in our parked car with flashing emergency lights on, parked on the shoulder of the freeway. Disoriented and confused why he was there, he looked at his watch and saw he lost 15 minutes when he had passed out. MY HUSBAND COULD HAVE BEEN SERIOUSLY INJURED OR KILLED IF HE HAD NOT PULLED HIMSELF OVER WHEN PASSING OUT. Today we reported this to our doctors office and to you!

Started with Headache at 10pm (Right between eyes) Pain started spreading through entire body. 1020pm Hands itchy and swelling, chest tight 1020pm Took 2 Tylenol and two benadryl 1030pm Itchy hands and tight cheat subsided by 1130pm Headache and severe body aches throughout entire body continued through and did not get better until 04/08/21. Bed ridden for duration. No fever.

Severe vomiting, diarrhea, fever, nausea and severe headache. Significant Trembling and chills followed by high fever, disorientation and dizziness and fatigue. Symptoms started approximately 5-6 hours after shot - began with trembling followed by severe chills and dizziness - followed then another 4 hours later by fever, significant nausea and extreme vomiting and diarrhea - then loss of appetite, fatigue, dizziness. After 24 hours the severe symptoms stopped and there was just another 15 hours of fatigue. 40 hours later everything felt back to normal. Hour 6 to hour 30 after vaccination were horrible.

Woke at 4 am on 4/11/21 freezing, weak nauseous, dizzy and tried to go to bathroom, stumbled back onto bed as I was passing out

Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.

Day 15 after covid vaccine I woke up at 12:30am with extreme vertigo and nausea. It woke me up with violent spinning. I could not focus my eyes at all. I felt very ill. I almost threw up multiple times during the day and could not move my head up or down and to the left without spinning out of control. I saw the ENT later that day and he performed the Epley Maneuver on me. I followed his directions for home care but am currently still experiencing vertigo. The doctor told me it should dissipate within one week. It has not. I have never had vertigo in the past.

My uncle unexpectedly passed away during the early morning hours of April 13. He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well. She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.

HARDLY MOVE; VERY SORE OR PAIN IN THE ARM; CAN NOT SLEEP; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 04-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 can not sleep. On 04-APR-2021, the subject experienced hardly move. On 04-APR-2021, the subject experienced very sore or pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore or pain in the arm, and hardly move, and the outcome of can not sleep was not reported. This report was non-serious.

Patient reports he feels like he cannot get out of bed. The symptoms started the evening of the vaccine and have continued through the reporting date (4/17/2021)

starting 4/8/21 headage, feeling slighly ill starting 4/9/21 pain in right ear tragus during whole day on 4/10/21 in the afternoon: strong vertigo lasting about one minute, no longer pain in ear that day

Bodily aches and pains, Fatigue, Lightheadedness, Fever, Acute and extreme weakness (Rushed to Hospital) Dehydration

Body ache, headache, chills/shakes/lightheadedness, lethargy, increased pain in back and other existing condition area- frozen shoulders, trigger fingers thumb tendon.

Pt did not feel sick the first 15 minutes after receiving the shot, but throwing up and dizzy for two days after. Pt wife reports vomiting day of vaccination (hours post vaccination). Continued to feel nauseas/loss of appetite for ~3 days, then felt better. No other ADR aside from N/V. Patient alert and oriented. All symptoms resolved ~3 days post vaccination, and patient is currently feeling well. Instructed to see PCP if symptoms reappear or worsen

Bradycardia, dizziness, abdominal pain, fatigue, headache. Was not aware of the bradycardia until I went to the emergency room, other symptoms were present Apr 10 - 15. Hospital visit was 13 Apr. treatment was rest, over the counter medications and follow up with doctor.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: BP 117/74 HR 62, second reading 122/111 HR 64, 3rd reading 142/81 HR 63. Patient was loss consciousness within 3 minutes of vaccine. I called the paramedics but he regained consciousness after 1 minute so we cancelled the call. He continued to complain of feeling dizzy so I had him stay for an additional 15 minutes. He has history of fainting with IVs/blood draws.

Patient was feeling dizzy, sweating and pale minutes after receiving vaccination. Patient stated had not eaten since last night. After providing a cold pack and orange juice patient was feeling better. Followed up this afternoon and patient stated was feeling much better, was just having a headache. Advised if symptoms were worsening to seek medical attention

- Occasional fatigue ranging from mild to moderate. - Occasional "drained" feeling like I pulled man G's. - Mild brief dizziness (1-2 times a day), - Constant soreness in hands with mild sensation of having held something that vibrates (e.g., power tool) - Occasional arthritis-like pain in joints (fingers and knees). A few notes: - All of the above sensations have increased noticeably in intensity/frequency since 5/5/21. - I tested negative for Covid-19 on 5/8/21 (PCR). - I have been diagnosed with arthritis in my pinkies. - I am under doctor's care/monitoring for kidney stones which may give rise to some common symptoms such as the fatigue.

According to his wife, patient received the Janssen COVID-19 vaccine at the Center on a Friday afternoon in March; she could not recall the exact date and could not locate his vaccination card. Several hours later, patient began stuttering and was unable to put his thoughts together. Later that evening, he began experiencing muscle aches, nasal congestion, nausea, and was unable to get out of bed. He took some Advil and by the next morning he felt fine and was back to normal. It should be noted that he died suddenly and unexpectedly on 05/05/2021, and an autopsy showed his death was caused by hypertensive heart disease and cardiomyopathy.

Soreness in shoulder/neck/back/arm on the injected side of body (right side). No worse than annoying, but enough to make me avoid any heavy lifting or other physical exertion with that arm (or turning my head too far). The pain started decreasing after about two weeks, and was mostly gone in around a month.

Husband told me he was going to pass out within a few minutes of receiving the shot, I called for the pharmacy tech to come help me before he fell off of the chair. They called for EMS to come and check him out, his bp was 118 over 78. He is home now feeling tired . We can follow up with his doctor if her is not feeling better.

PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.

Adverse Events: Tinnitus, Veritgo, Nausea 36 hours post injection there was a significant increase in volume of bilateral tinnitus which has been constant for 40 years with left side being louder and right side occasionally pulsating. Vertigo and nausea also set in 24x7 for the first week before reducing somewhat. Now 3 weeks post injection my tinnitus has increased from what was a volume of 4 out of 10 for 40 years to a solid 7/10. The vertigo is present although not triggering nausea until I am lying on my back looking up in activities such as lying back to read a book, work under a car, read a phone/Kindle device. The increased tinnitus volume has made falling asleep in a quiet room or focusing on my work where I wear a headset for virtual meetings extremely difficult at times.

I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four days with pain in my left leg. On the 19 I was not able to move my left leg with a lot of pain and a little discomfort on my right leg. Rush to the hospital and right away the found blood clots on my left leg, The ER did not check my right leg and two weeks later they found clots on the bottom part of my right leg. They gave me blood thinner and now Im taking Eliquis twice a day. Symptoms continue, I have the same pain, I dont see any improvent. I did went to work yesterday and I realize that I can do any lifting or be sitting down for at least one hour.

Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.

Patient experienced dyspnea on exertion and lightheadedness shortly after receiving vaccine. He continued with these symptoms until presenting to ER on 6/6/2021 and found to have extensive bilateral pulmonary emboli.

Patient was nervous/agitated prior to shot. Patient told vaccinator that is was all psychosematic and to not to worry. About 3 minutes after injection, patient stated he felt faint. Another staff member noticed he was bobbing his head around. Patient got up from chair and laid on the floor. Staff raised his feet. Once patient was feeling more stable, we moved him to a lift chair in the flat position. Patient stated he gets faint with other vaccines.

patient experienced a vasovagal type reaction within minutes of receiving vaccine. He fainted and bumped his head on the floor. He came to within seconds of fainting and had not realized he had fainted. An ice pack was given to the patient to hold to his left eyebrow bone (where he hit the ground) in order to reduce swelling. He was guided into a chair and observed for about 20 minutes when he wanted to leave the pharmacy. The patient felt well shortly after the fall. I checked in with him 2 hours later and he still felt well.

Massive headache for 8 days. I believe it was encephalitis. Dizziness, fatigue, nausea, terrible neck pain, pain allover skull. Completely out of it. Disoriented, Fever, rash, missed work. Now I have a purple spot on my inside of left leg, found this morning 6/14/21 7:30 am.

minutes after the vaccine patient states he felt light headed. Stated it had been a while since he had eaten. Given water and crackers. Took a sip and ate 2 crackers. Given ice pack for neck. O2Sat 99%, Pulse 70, RR 20, BP 145/104. State he is suppose to take medication for HTN but has not had them for a while. Continued to feel light headed. Placed in recovery position laying down. After laying him down he states his head was hurting. Talkative and alert. BP 160/120, Pulse 62. Respiratory Rate 16, O2sat 94%. At this time he stated he wanted to go to the hospital. EMS called and he was transported to Hospital.

About 4 weeks following vaccination, patient had pain and swelling on the posterior aspect of the L-knee. He could barely flex the knee, and it became discolored initially dark blue and then yellow which extended halfway up the posterior thigh. HE was evaluated by various physicians. Ultimately was diagnosed with hematoma that was aspirated - described as old blood. Cultures were negative. Was feeling better afterwards, but noticed more pain in L-calf. Venous duplex ultrasounds showed no evidence of blood clots. Patient was referred to infectious diseases to evaluate possible ADE secondary to vaccination.

About a month ago I started experiencing (3) distinct symptoms 1- Bladder control issues 2-Numbness/tingling in my left arm which has spread to my hand and is consistently spreading 3-Trouble walking sometimes, my left leg feels out of my control

Patient felt lightheaded, warm 5 minutes after getting the vaccine. It appeared as he was unconscious for few seconds in and out for about 2-3 minute. Upon spouse's request we did call paramedics for help. Patient was doing fine by the time paramedics arrived,. Patient did mention he was very anxious to get vaccines. He did not have any underlying health conditions, His last vaccines was in high school. Patient also mentioned he had no meals the entire day and probably led to lightheaded. Paramedics did not administer any medications.

I became lightheaded/dizzy within the first few minutes. Symptom subsided but came back in a mild way. When I came home and after Seventeen (17) hours, I am still lightheaded, I have body aches and chills. I have no fever.

10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, dizzy, eyes fluttering and 102.0 fever. 645pm - Took 3 Tylenol and BP 144/85 HR 83. Bed rest with Gatorade and water. 1100pm - Took 2 Tylenol. Fever reduced to 99.8. Headache and extremely tired. No energy. Bed rest with fluids. 24 hours after vaccination : Fever almost gone, 11am 2 more Tylenol, extremely tired and weak. Low energy. Ringing in ears. Minor headaches. 48 hours after vaccination; No fever, extremely tired and weak. Low energy. Ringing in ears.

pt presented to ER 0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed and use bathroom and couldn't bear weight or move his right leg. NIH stroke scale score-2, Glasgow coma score =15 183/105, HR 103, RR 18, 02 saturation 95% RA 98.7 oral temp 0/10 pain. clonidine po tablet 0.1mg. EKG=tachycardia 106 normal P waves, normal PRI, normal QRS complex, normal ST and T waves. labs=SARSCoV2 RNA negative, CT head WO=no acute intracranial abnormality by CT criteria. UA=negative, glucose 359

I just thought I should report two changes I have noticed in my body since being vaccinated, the first being about a dozen small pimples on my forehead, which is weird for me, but were evident for several days that week after the vaccine; and I have been very dizzy when I get up in the middle of the night to go to the bathroom, bumping into the wall, which is uncommon for me. I also teach at a community college and I noticed that I get dizzy when I turn to go to the board and sometimes have had to put my hand out to steady myself against the board before writing on it. Not major disruptions, but strange to me. I don't take much in the way of medications, ever. I might take an aspirin once in a while, but I don't take any regular meds or have any other health issues. Just wanted to put this on the record. Thank you.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe

FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15 in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.

Placed follow up call to patient relative on 4/5/2021 at 1:04pm: reported that the patient is feeling much better today. All his ADE has subsided. Patient rcvd Janssen vaccine on 4/3/2021 at 11:15am in Right IM Deltoid, and at approx. at 7pm that same night patient experienced lightheadedness. The next day on 4/4/2021 patient had a fever, chills, rash on back and swelling on the face and lips. Patient relative reported that she gave the patient Mortin last night (4/4/2021) for his fever as recommended and his fever broke this morning. She also reported that she gave the patient Benadryl as recommended, and this helped cleared up the rash last night (4/4/2021). She reported no contact was made to patient's PCP regarding ADE experienced. Advised if she or the patient have additional information to contact the COVID-19 Information Line back.

Vaccine was given at 11:30AM. Approx. 5 minutes after dose given, patient was lightheaded, broke out into a sweat, pale, cold, and fainted twice in the course of 15 minutes. 911 was called and arrived at 11:45AM.

Pt started to get dizzy, light headed, diaphoretic, clammy upon assessement. Vital signs obtained with b/p 132/68 HR 55 O2 99%. Pt was assissted to floor to prevent falling. Given water with cold compress applied to head. After extra 30 min wait time pt no longer complain of dizziness, light headness or being diaphoretic. A/Ox3. Left w/o any difficulty.

Patient stated feeling little light headed, strange, weakness, feeling warm, sweaty, without visual problems wanted to lay down. Patient awake and alert without anxious. Does not like needles/shots. Felt better after 15 minutes. Patient better after 15 minutes. Patient did not have SOB without swelling without rash. Breathing ok without nausea. 11:45 am- 126/90 HR 59

Pt c/o dizzy, light headed, diaphoretic and clammy. V/S obtained with b/p 132/68 HR 55 O2 99%. Pt was assissted to floor to prevent falling. Given water and cool compress for neck. Pt was held for 30 minutes after time. Pt refused EMS. After time pt was released to go home. A/Ox3.

FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP FROM LYING DOWN/LIGHTHEADEDNESS; HAVE NOT BEEN ABLE TO SLEEP; UNCONTROLLABLE STIFFNESS IN THE LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN THE LEFT SHOULDER JOINT; UNCONTROLLABLE MUSCLE TWITCHING IN THE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included right shoulder surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced uncontrollable muscle twitching in the left arm. On 17-MAR-2021, the subject experienced uncontrollable stiffness in the left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in the left shoulder joint. On 19-MAR-2021, the subject experienced have not been able to sleep. On 29-MAR-2021, the subject experienced dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness. On 29-MAR-2021, the subject experienced room spinning. On 01-APR-2021, the subject experienced fell. 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 uncontrollable pain in the left shoulder joint, uncontrollable stiffness in the left side of neck, uncontrollable pain in left side of neck, have not been able to sleep, dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness, uncontrollable muscle twitching in the left arm, and room spinning, and the outcome of fell was not reported. This report was non-serious.

Polyneuropathy with paresthesia and motor weakness of bilateral upper and lower extremities started about 10-11 days after receiving vaccine. Currently hospitalized, undergoing studies MRI, lumbar puncture for definitive diagnosis.

Patient immediately complained of feeling light headed. Several minutes after receiving the vaccine, they fainted. Resuscitation several minutes after fainting. EMT was called and took blood pressure, temperature and EKG readings. All readings were normal and patient refused transport and hospitalization. Profuse sweating and dizzyness after resuscitation and patient recovered enough to drive himself home 90 minutes later and left the store. After arriving home, patient experienced flu symptoms (nausea, aches, shivering, tiredness) for 24 hours after shot was administered.

3:48 pm Post vaccination reports dizziness and feeling diaphoretic Medical monitoring w/vital assessment: BP 76/60 P55 O2 sat 99%RA; rest w/ po hydration given, symptom resolve; BP 137/98 P71 Reports "feels better"; Released from facility w/wife

Severe Tinnitus flare up and dizziness started approximately 12 hours after vaccine administered. No tinnitus or dizziness in prior two weeks before receipt of the vaccine on April 8th at 2:00 pm. Dizziness resolved after about 72 hours. Tinnitus still present 24 hours a day, every day. Moderately disruptive to sleep and ability to function.

Right Elbow pains within 7 hrs after shot. Next day elbow and right hand swollen and throbbing pain. still swollen and can not bend all the way 3 days later.

c/o of weakness, lightheaded. Placed on stretcher. V/S BP 98/60, HR 60 SAO2 99 color good, skin warm and dry. Patient had fasted for lab work prior to receiving vaccine. Serial v/s done, drank ginger ale and felt better. Discharge BP103/67, HR 72 SAO2 96%

INTENSE HEADACHE. SCALE FROM 1 TO 10: 8 TOTAL INSOMNIA. IMPOSSIBILITY TO FALL ASLEEP ALL NIGHT VERY HIGH BODY TEMPERATURE NAUSEA DIZZINESS I TOOK ACETAMINOPHEN 500mg FROM 10 PM UP TO THIS MOMENT EVERY 6 HOURS SELF-PRESCRIBED REST. NO ACTIVITY OF ANY KIND

Dizzyness, almost fainting, loss of appetite...headaches all day 3-5 after shot....loss off appetite, over 7 days

4 incidents of light headedness, almost dissociative in nature accompanied by ?seeing 3 figures.? This occurred for each incident. Once in the morning, 2 mid day and one at night.

Severe headache, nausea, fatigue, dizziness, felt pressure in head and sinuses, felt like my nose was bleeding but it wasn't but i could feel something draining down.

Janssen COVID-19 Vaccine EUA Within the first minute after injection, I started to feel dizzy and I felt like I was having a hot flash. For a few minutes I continued to get warm and at about the 10 minute point I was taken to the waiting room where I got a drink of water. After drinking the water I felt much better and soon felt normal with the exception of discomfort at the injection site. (My left upper arm just below my shoulder) After six days now, I still feel fine overall however, if I message the injection site, I can still feel a little bit of discomfort.

I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.

Patient experienced dizziness, sweating , palor for about 15minutes immediately following vaccination

After administering the Janssen vaccine the patient began to have dizziness and difficulty breathing. The patient's airway did not completely close up as he was able to respond and talk to me. Called 911 and administered 10mL (25mg) of Diphenhydramine and gave the patient a bottle of water. He was already worked up as he was scared of needles. He continued to breath better but still had difficulty. The EMT arrived in under 5 minutes as they were already on a call close by and was rerouted. EMT administered breathing treatment and took vitals and eventually took the patient to the hospital as a precaution. (Technician administered vaccine)

Patient within 5 minutes after receiving injection was being monitored and began to slump forward in the chair. The patient quickly became completely unconscious and was helped to the floor. The patient was presenting with seizure like symptoms, foaming at the mouth and loss of body functions. Patient remained unconscious for 1 minute or less before regaining consciousness. He was able to speak immediately after. Patient had a rapid heart rate and was sweating. Patients blood pressure was elevated as well. Patients blood sugar was tested and was 146. 911 was called immediately at time of emergency and when they arrived they help that patient sit up. They took the patient to the emergency room since he did not immediately regain all functions and this vitals remained elevated.

STROKE; FELL DOWN; This spontaneous report received from a health care professional (patient's wife) concerned a 54 year old male of Hispanic or Latino other race. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, and high cholesterol. The patient had no known allergies and was non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, administered on 16-MAR-2021 at 16:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination, later on that evening her husband mentioned that he did not feel too good. He took a Tylenol and then went to bed. At around 3:00 that evening his wife woke up to go to the bathroom and noticed her husband was awake. When she asked he responded that he thought he might have suffered a stroke. On unspecified date he experienced fell down and unable to move the right side of his body. On 17-MAR-2021 at around 5:00 that morning, she took him to the emergency room (ER). There the ER department performed a computerized tomography (CAT) scan and confirmed that he indeed had a stroke and decided to transfer him to another hospital. On 22-MAR-2021, he was then discharged. He was hospitalized for 5 days. A few days later on 24 or 25-MAR-2021 she took him to her Doctor Of Medicine (MD.) where they had him do rehab which consisted of daily walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210515350-Covid-19 vaccine ad26.cov2.s- A 54- year- old male of Hispanic or Latino other race presents with Stroke. 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

I got the shot at 1pm and by11pm I had severe shoulder pain with limited movement. 10 am the next day it started to loosen up but still very painful. Went to Dr. and got a anti-inflammatory steroid and pain killers.

Patient reported that he has been experiencing decreased range of motion (limited range past shoulder height), increased pain and soreness with movement, and decreased strength to lift weights that were previously easily lifted. Stated that these symptoms started 2-3 days after he received the vaccine. Stopped by the pharmacy counter 6/12/21 to inquire as to whether this could be related to the vaccine.

To begin, I have always been a healthy, middle-aged male, with no history at all of neurological problems. What follows is a comprehensive summary of all that happened to me shortly (7 days) after getting the Janssen COVID vaccine and the supporting documentation to support the diagnosis of my having developed Guillian-Barre' Syndrome (GBS) as a direct and obvious consequence of the vaccine. THURSDAY, 5/13/21: Received the J&J vaccine at 10:00 AM (LOT NUMBER 205A21A). FRIDAY - THURSDAY, 5/13 - 5/20/21: No obvious reaction to the vaccine, at all. FRIDAY, 5/21/21: During the day, I noticed deep-muscle pain/soreness in both shoulders (deltoid muscles) that increased throughout the day. It felt as if I had been doing heavy-weight presses with the resulting soreness. I attributed it to a delayed reaction from the vaccine (as I'd heard muscle pain, particularly in the shoulders, is a common reaction symptom), as I had no injury or other possible cause and chose to ignore it. It may have even started a day or two before Friday, but wasn't of such consequence as for me to recall it; the only vivid memory I have is the discomfort on Friday, 5/21/21. SATURDAY - SUNDAY, 5/22 - 5/23/21: I had continued shoulder pains, but ignored them because they were not acute and just attributed them to a short-term vaccine reaction. MONDAY, 5/24/21: In the evening, while sitting in the bleachers attending a sporting event, I noticed my buttocks was pretty sore. The bleachers are not normally comfortable, but this was a dull, serious ache across my entire buttocks. I didn't know to what to attribute it (not yet at that time associating it with the shoulder pain), so ignored it. In retrospect, I realized later that the soreness I was feeling at that time was similar to the shoulder pain and was the pain felt from a deep numbness across the buttocks, akin to when a body part (hand, foot, etc) "falls asleep" so deeply that it's numb, but is still very, very sore. Later that night, my upper back began to feel sore, from shoulder to shoulder, down to my mid-back. As the night progressed, this pain increased exponentially to a "Level 10", leaving me unable to sleep but in 15-minute increments, wandering the house to find a spot -- sofa, chair, floor, anywhere -- to give me some comfort to sleep; I slept 2 hours, total, that night. The pain across my back felt equivalent to someone beating me with a baseball bat all over my upper back -- it wasn't an acute, localized pain, but very deep and broad across the area. Normally, Aleve quickly resolves any pain issues I have, but overnight, it did nothing to reduce the pain. TUESDAY, 5/25/21: I began to piggyback Aleve and Extra Strength Tylenol, and that seemed to help abate a little of the most intense pain, but it was still painful and precluded sleep and much of my working. I think it was at this time that I began to notice the pain and numbness going beyond my buttocks, down the backs of my legs, and into my feet, leaving my feet (and toes, in particular) numb and tingling. I also began to notice a problem with balance and gross motor controls (stumbling when walking, nearly falling several times in the shower) -- all symptoms I have never experienced in any capacity. Additionally, I had considerable pain down the backs of my legs, leading me to feel as if my calves and hamstrings had been through a heavy workout the day before and desperately needed stretching -- however, any attempts to do so led to excruciating, stabbing pains in those muscles. I also noticed that the pain in my upper back was becoming more acute and localized in my cervical vertebrae area. Having taken care of a father who has had many back surgeries and suspecting I have my own degenerative cervical disc issues (I've had past neck pains), I began to believe that all the pain and numbness throughout my body might be due to a cervical issue (e.g., bulging disc, stenosis, etc), and so tried to treat the area as such, with hot shower, heating pad, better neck support, etc. I continued to piggyback the two pain meds that day, but the upper back and neck pain and numbness and gross motor issues came back in full that night, again leaving me no relief for sleep -- I could only doze in 15-minute increments and found no position or place to sleep that was comfortable; I was in tremendous pain 10) across my entire back and down my legs. By 2:00 AM, I knew there was going to be no relief, and I couldn't wait until the morning; I drove myself to the nearby ER, again still believing/expecting at the time that this was a spinal issue. In the ER, I was met by a PA who reviewed my situation, determined that cervical imaging was unnecessary, and prescribed Percocet. My blood pressure was recorded at 160/94. I was released after two hours and returned home. Despite the meds, I was still in considerable pain that night and found myself unable to sleep in more than 10- to 15-minute increments. WEDNESDAY, 5/26/21: During the day, the Percocet seemed to abate the pain, somewhat, although it tended to flare up much more at night during the prior 2 nights, anyway. However, I noticed I had an upset stomach by midday, and as the day progressed, the pain in my abdomen grew considerably. By the evening, the pain across my abdomen was unbearable, as bad as it was in my back and legs. Late in the evening, I researched Percocet and saw that abdominal pain and nausea are two prominent side effects. I stopped taking the pain medication immediately, knowing that my back pain would return in full through the night; again, I slept in 15-minute increments in considerable back and abdominal pain for a total of about 3 hours. It was also during the day Wednesday that I noticed considerably worse gross motor skills (e.g., walking, ascending/descending stairs, standing up straight, writing), balance, and increased numbness and tingling in my legs, feet, and hands. At one point, I tried to walk by my daughter in a hallway in the house, and in trying to go around her, I fell against the wall. She thought I was joking; I wasn't. It happened several more times that week. Also, this day or the next, I started noticing additional problems with urinating and defecating. It felt as though I had no control over my abdominal muscles, so could not strain or push when going to the bathroom. When trying to have a bowel movement -- and I knew needed to -- I felt as though I had no control to push; when urinating, I had no muscle support for pushing out the urine. THURSDAY, 5/27/21: Still believing these pain, numbness, and other neurological, problems to be related to cervical vertebrae/disc issues, I had an appointment with a spine orthopedist. He ordered cervical X-Rays and confirmed that I do have disc compression/degeneration, but not excessive and nothing that could explain the pain and numbness persisting all over my back, down to my hands, across my buttocks, and down my legs to my feet. The message: the cervical discs were not the problem. This is when I reconsidered all I had been through, tying back to the initial pain I felt in my shoulders the prior Friday. This is when I realized that my body had been reacting to the vaccine. Never before in my life had I had neurological problem. Never before had I experienced pain, numbness, and tingling across my entire body that way, so until that moment, I hadn't considered the vaccine to be a possible vector for all that was going on with me. The coincidence of these events was FAR too great to be anything but a causal relationship. The likelihood of these symptoms arising on their own is infinitesimal in comparison to a causal effect. The vaccine had triggered a serious and painful neurological response in my body. The orthopedist, knowing I had responded poorly to the Percocet, prescribed oxycodone. I took that pain medicine that day and into the evening, but once again, my stomach and abdomen began to bother me and the abdominal pain returned. Once again, I looked at the side effects of the medicine, and the first two I saw were stomach pain and nausea. I stopped taking the pain medicine immediately. That night, I slept a total of 2.5 hours. FRIDAY, 5/28/21: I was still in considerable pain, and that combined with very little sleep (and none of it good) for 4 days led me to having trouble thinking clearly. My wife insisted I needed to go back to the ER in the morning to see what could be going on. My blood pressure upon being seen was initially approximately 185/140, but what was finally recorded after a second test was 191/112. I waited to be seen for about 2 hours, but I finally met with the ER physician and described my history of problems that week, including my then-belief that this was a vaccine reaction. She ordered full bloodwork, chest X-Ray and CT scans (without contrast) of lumbar and thoracic spine and CT scan with contrast of chest/abdomen. Nothing strikingly abnormal was found in these scans, but doctors (ER physician and neurologist) noted bliteral weakness in lower and upper body. The doctors wanted to order MRIs, but I am unable to have an MRI due to a piece of metal in my left eye. The morphine I was administered helped reduce my pain and my blood pressure upon leaving had abated, somewhat (don't recall my final BP). Both doctors seemed not to believe that these symptoms could be the result of an adverse vaccine reaction, but they were unable to explain a cause. On my inquiry, at my friend's recommendation I ask to verify, the neurologist disagreed that these were symptoms of a presentation of Guillian-Barre' Syndrome (GBS). The ER doctor asked if I was interested in being admitted, but I felt some of my more extreme symptoms (blood pressure and pain -- thanks to the morphine) had abated sufficiently to allow me to leave. After 8 hours in the ER, I left and returned home. My numbness, tingling, some pain, balance, and motor skills issues persisted, but were blunted somewhat (probably from the morphine?). It was either this day or the next, that I was standing outside, and knowing I had problems walking and with balance, I decided to try to run a few steps to see how weak my legs were and bad my motor skills and balance were. Immediately, it was clear that things were worse than I had considered. I had very poor control of my legs -- they flew off to the sides, out of control, as I tried to step; I stumbled a couple times and almost fell; and I couldn't proceed in a straight line, veering off at an angle. I earnestly tried several times, with the same results each time. That night, while the pain was still there, it was tolerable enough that I was able to sleep for a total of about 5 hours. SATURDAY, 5/29/21: Early in the AM, I noticed I was unable to smile. Having a friend who had had Bell's Palsy, I recognized the signs immediately. The left side of my face sagged, I was unable to smile (left side of my mouth sagged), and I was unable to close my left eye. My wife took me to the ER, and we were met by the same ER physician who had seen me the day before. She was shocked about my return so soon after my prior visit. My blood pressure, on being admitted, was 151/102, but as with my other visits, asymptomatic other than the problems described before (pain, numbness, and tingling, in my back, arms, legs, and abdomen; gross motor movement; lack of coordination; and lack of clarity in thinking); no other signs of infection or illness. The Dr ordered a CT scan (without contrast) of my head and other bloodwork. Of note, the CK came back at 712 U/L. The CT scan came back normal. Again, I was administered morphine, which abated my pain and allowed me to relax. After 3 hours, I was released, with prescriptions for Amlodipine for the high blood pressure and Prednisone and Valtrex (Valacyclovir) for the Bell's Palsy. The morphine helped reduce my back and abdominal pain and give me some comfort, such that I could sleep another 5 hours that night, although all other symptoms persisted. SUNDAY - WEDNESDAY, 5/30/21 - 6/2/21: I continued to experience the numbness and tingling in my back (primarily), abdomen, legs/feet, and arms/hands, but my severe pain began to abate, such that I could sleep a bit more easily. I taped my eye shut at night, as my Bell's Palsy eyelid would not close fully, and it teared constantly. WEDNESDAY, 6/2/21: Not having a GP, I finally found an Internist to review my case and symptoms, but primarily to extend my meds (Blood Pressure and antiviral and steroid for the Bell's Palsy), as the ER doctor had only given me a 5-day prescription. The doctor review my situation and continued the meds. Having been prompted regularly by my friend to confirm a GBS diagnosis, I asked this doctor about a possible GBS-vaccine link and after a cursory review, he said he did not think so. THURSDAY, 6/3/21: With the weakness in my left eyelid, my desire to find a resolution to it, and my concerns about its effect on my vision, I had an appointment with my opthamologist, who recommended eye drops until the eye improved and instructed me to stop taping the eye shut. She noted no other problems with my vision. FRIDAY - MONDAY, 6/4/21 - 6/7/21: During this time, the medicines for my Bell's Palsy seemed to take effect, and the paralysis symptoms abated mostly (with some residual weakness in my left eyelid). I continued to experience the other neurological symptoms, however. TUESDAY, 6/8/21: Having been unable to get a timely appointment with a trusted neurologist, a friend with a contact at medical school head of neurology was able to get me an appointment with a neurology faculty member. I met with Dr. that afternoon, and he was the first to really listen to the symptoms I had and understand some of the possible triggers and consequences of them. I started the conversation explaining that I'm a reasonable, rational, and science-based person, an engineer by training and career, and that I firmly believed all the symptoms I was presenting were a direct consequence of my getting the vaccine. Additionally, at my friend's continued urging, I asked if these symptoms could point to a Guillian-Barre' diagnosis. He was at first skeptical of my proposition of the vaccine cause, but was quick to say he was glad I had raised the question of GBS, because he had that diagnosis in mind, as I discussed my symptoms. He believed that the symptoms I had and the way and speed with which they had progressed pointed to a likely GBS diagnosis. He scheduled a follow-on appointment to have an Electromyogram (EMG) and Nerve Conduction Study to assess the extent of the neurological damage and prognosis for resolution, as I am unable to get an MRI and he seemed to feel a lumbar puncture was unnecessary. FRIDAY, 6/11/21: I had my scheduled EMG and Nerve Conduction Study with Dr. The results showed some abnormal neuropathy, but mostly normal in my extremities and indicative of some recovery from symptoms. Although I still had considerable numbness, tingling, and some pain down my legs into my feet and down my arms into my hands, my most prevalent issues at that point were numbness and tingling across my entire upper back and abdomen, but the doctor indicated these tests don't identify issues very well, that they are better designed for testing neurological issues in the extremities. We agreed to reconvene over the phone in several weeks, unless problems worsened. TUESDAY, 6/29/21: During a follow-up appointment with the doctor, I indicated that some of my neurological issues were abating and that my blood pressure had returned to near-normal range. My energy was returning to a degree and my motor skills and balance and control had improved. However, I continued to have significant numbness and tingling across my back and abdomen, and of greater concern, I had increasing tingling and pain going down my left arm to my index finger when I stretched out my arm. This was a new symptom and increased in pain in frequency in the following days and raises the question of what other symptoms might arise. AS OF 7/8/21: CURRENT STATUS: I have continued numbness and tingling in my feet and hands and back and abdomen, although they are reduced from their earlier state. However, I have increased shooting pain in my left index finger when stretching out my left arm. Additionally, I have a mild increase in weakness in my left eyelid, after prior improvement from the Bell's Palsy. My dangerously high blood pressure at the early onset of these symptoms has returned to near-normal levels, although my GP continues to keep on blood pressure medicine (Amlodopine) for now. Finally, a lot of the issues I had thinking clearly and regularly making mental mistakes, all noticeable and commented on by my family, have lessened, although I still find myself making mental mistakes and forgetting information that would have been MUCH less likely prior to this adverse GBS event caused by the J&J vaccine.

TROUBLE GETTING UP; COULD NOT FEEL ANYTHING; BRUISED HIPS ARMS AND BUTTOCKS BRUISES HAD SWOLLEN TO BE SIZE OF A FOOTBALL ON RIGHT BUTTOCKS AND HIP AND FEW SMALLER BRUISES ON RIGHT SHOULDER; DISCOLORATION ON THE BRUISES/BRUISES WERE EXTREMELY DARK; FELT WEAK FROM WAIST DOWN; AS WERE WALKING BUCKLED OVER/ FELTS LEGS BUCKLED COMPLETELY; FELL TO FLOOR BUT DID NOT LOSE CONSCIOUSNESS; BRUISED HIPS ARMS BUTTOCKS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 245 pounds, and height was 76 inches. The patient's concurrent conditions included back issues, and spinal cord stimulator implant, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced as were walking buckled over/ felts legs buckled completely. On 19-JUN-2021, the subject experienced fell to floor but did not lose consciousness. On 19-JUN-2021, the subject experienced bruised hips arms buttocks. On 19-JUN-2021, the subject experienced felt weak from waist down. On an unspecified date, the subject experienced trouble getting up, could not feel anything, bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder, and discoloration on the bruises/bruises were extremely dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from as were walking buckled over/ felts legs buckled completely, fell to floor but did not lose consciousness, and felt weak from waist down on 19-JUN-2021, and bruised hips arms buttocks, and bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder on 04-JUL-2021, was recovering from discoloration on the bruises/bruises were extremely dark, and the outcome of trouble getting up and could not feel anything was not reported. This report was non-serious.

Whole body inflammation water retention adding 1-2 lbs a week. Have gone from 210 lbs. to 222. Muscles aches, fatigue, Got blood and urine tests on June 7th. Trying to find cause for water retention, fatigue and lightheadedness. Doctor stopped losartan and prescribed a daily diuretic. The water retention persists and The body still feel stiff and sore. Especially in the morning.

in mid-June 2021 I started experiencing pain in my feet. They started swelling and feeling tingly... almost like they had fallen asleep. Minor tingling also started occurring in my hands. On certain days the discomfort in my feet was enough to limit my walking. I noticed on certain days my shoes fit tightly and my calfs were very tight with the ankles showing signs of swelling. The symptoms continue through the date of this filing...sometimes better/sometimes worse.

Patient states they received Vaccine on Monday, became confused at work on Tuesday and then presented to ED after multiple seizures overnight Wednesday and then was having trouble ambulating. also complains of left elbow pain

Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.

1. Swollen Lymph nodes on upper chest near shoulder (Left thoracic duct area) and left arm pit large enough to feel by hand, lasting approx 8 hours. 2. Stomach bloating accompanied by stomach discomfort / pain and severe diarrhea for 48+ hours. 3. Intermittent Dizziness and headaches lasting approx 24 hours. 4. left arm and finger joint stiffness, lasting approx 48 hours.

Felt like passing out for 2 minutes. Patient states he was anxious because he don't like taking shot. He states he has history of passing out with shots. VSS: BP 92/61, Heart rate 86 bpm, 02 sat 97%, Blood Sugar 128

Patient in at 1026 reporting dizziness, clammy, pale. Had not eaten yet. 0 CP, 0 palpitations, VS: 101/57, 65, 94%. 0 Meds, 0 PMH. Patient has hx of vagal reactions with shots and blood draws. patient provided snack and water, feeling better after eating and lying down.

The patient received the vaccine at 12:20pm. He was observed per protocol for 15min until 12:35. At 12:35pm he denied feeling any response to the vaccine and ambulated away with a steady gait. At 12:41pm the patient reported back to the nursing area c/o "dizziness" and feeling like he does when he "drinks too much caffeine" and his left arm felt "tingly." Pt was asked to lay down. Vitals were checked at 12:45pm while patient was laying down. BP 180/90, Spo2 96%, HR 69 and regular rhythm per palpation, Temp 97.7, RR 16. Pt was AO x 4. At 12:50pm BP was reassessed 186/100. At 12:55pm pt reported still feeling "dizzy." His face was flushed. His left arm still felt "tingly." He reported feeling "nauseous" and described "heart palpitations." Pt was asked to sit up and given 50mg of Benadryl PO per policy and 911 was called at 12:56pm. Patient laid back down. At 1300 temp 98.5, pulse 63 and RN noted irregular rhythm by palpation, Spo2 97%, RR 16. The ambulance arrived at 1303 and the paramedics resumed care of the patient. The paramedics noted PVCs on their rhythm strip and BP 170/90. At 1311 patient started reporting "epigastric pain" 5/10 pain. At 1313 the paramedics transported the patient to a hospital (unknown which hospital).

Pt wanted to test BP prior to shot. Rph said pt BP was a little high so they waited and took BP again a minute or 2 later. BP had gone down some, so they agreed to proceed. After dose, pt was dizzy, sweaty, unresponsive for a short time. Once he was more responsive, we helped him sit on the floor against the wall as he was quite dizzy. We called 911 and pt refused transport to hospital, but was evaluated.

I gave client his vaccine. I gave one other vaccine and noticed that he was pale and putting his head down. I asked if he felt alright. He said he was dizzy. He was at this point dizzy, pale, sweating, low heart rate in the 30's. We put a cold wet rag on the back of his neck and monitored. We gave him some cold water also. Slowly over the next 5-10 minutes his stats got better, color returned, and was not sweating anymore. He did not feel dizzy anymore. We monitored for an additional 30 minutes. Gave instructions. Sent home with spouse.

After vaccination patient ambulated with steady gait to waiting area to sit recommended 15 min, after sitting in chair in waiting area (1310) reports feeling "hot & dizzy", skin became pale and diaphoretic, eyes rolled back and didn't respond for a few seconds then was able to answer questions, kept complaining of feeling hot & dizzy, and yawning. EMS was called at 1:12 pm and arrived on scene at 1:18 pm. Patient was responsive, sitting BP 58/22, SaO2 96% on room air. Denies shortness of breath or chest pain/discomfort. 1:23 pm BP 98/60, 1:30 pm BP 108/75, 1:26 pm BP= 116/74; alert and oriented x3, speech clear and appropriate, ambulates 50 feet with steady gait/balance. Refused medical care and treatment. Signed refusal form for EMS. Patient's wife, son and parents present with him. Wife reports that he gets worked up about needles especially with blood draws. Patient leaves ambulatory with steady gait in stable condition accompanied by his wife, son and parents. Followed up via phone on 4/8/21 at 12:30 pm, patient reported he is feeling fine with no problems at present time. Reported that approximately 10 min after leaving he had another feeling of being hot for a few seconds then went away after drinking some water then had no other episodes.

Patient reports feeling dizzy, weak, could not stand. Pt was removed from car and placed on stretcher. Pt Vital signs were take and within normal limits. Pt recovered and was sent home via personal vehicle.

Within two and a half hours had diarrhea and vomiting. Body aches started right away me were severe by the night. Fever started the first night and continued through 4 days. Severe fatigue ongoing 5 days out. Trouble concentrating. No focus. Dizziness. Headache. Vomiting returned day 4.

Fatigue for several days, very mild rash, followed by dizziness and disorientation/unsteadiness on day 8

Day 1 / Wed.: Headache, slight dizziness (starting at 4 PM) Day 2 / Thurs: Headache (All day / night) Day 3 / Fri: Light headache (All day / night) Day 4 / Sat: Very bad body aches, muscle soreness, (All day / night) Day 5 / Sun: Extreme diarrhea, light body and muscle soreness (All day / night) Day 6 / Mon: Extreme diarrhea, light body aches / Stomach gurgling (All day / night) Day7 / Tues: Diarrhea stopped at AM. Stomach gurgling / cloudy mind (All day / night) Day 8 / Wed: Stomach still gurgling / cloudy mind. Still happening at time I write this.

Approximately eight hours after receiving the shot, I started getting a headache, body aches, and chills (April 3rd, 8 p.m.). I went to bed and had severe chills and body sweats for the entire night. The primary symptom to report is that my heart raced all night. It felt like it was beating at about 140 to 150 Hz or higher. When I woke up in the morning, it felt like my chest had been pounded on all night. The pain was in my sternum area. The headache and body aches took a little over a day to go away. The chest pain took a couple of days to die down. On April 12th, I walked my dogs in the morning and felt out of breath, which isn't normal for me. In the afternoon, while working at my desk at home, I started getting more and more severe chest pain and then started getting dizzy and felt weak. I drove myself to the local ER and they tested me for a heart attack. All tests came back negative. They suggested going to another facility to get checked for clots or to make an appointment with a cardiologist. The next day, after talking to a doctor friend, he suggested going to the ER facility to get imaged for clots and to get fully checked out. No cardiologist appointments were available till the next week. I went to the ER facility and was there for seven hours getting tested. They came back and said all test results were negative and that my heart looked fine. They did not have any suggestions for what might be causing the pain in my chest.

After the Covid-19 Vaccine on Mar 26, 2021 I had an adverse reaction to something that may or may not be related. On Friday, Apr 2, at 2:00pm I felt a weird case of Vertigo that lasted approximately 3 mins. The next day, Sat. Apr 3, at around 9:30pm I had a longer very severe case of the vertigo. I went to bed shortly afterwards. On Sunday,Easter morning April 4, at 6:30am I woke up with a very severe case of vertigo (Meniere's Disease). It lasted about 3 hours of sever heaving and extreme dizziness. I could not cope and had to just lay there not knowing what was wrong/going on. It finally went away after about 3 hours. The next morning, Mon. Apr 5, I called my Dr to make an appointment and went in 2 days later. There were no other cases of it and he could not figure what caused it and I either could I. So far so good that I have not had another reaction and feel fine today after nearly 3 weeks. :-)

Cerebellum Stroke 4/11/2021. Presented in the Emergency Room of both hospitals with dizziness, nausea, unable to walk. Treated 4/12-4/14 and then again 4/15-4/19.

ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. 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

Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vaccination. pt complained of left leg swelling.

DIFFICULTY IN BENDING RIGHT KNEES; SEVERE RIGHT KNEE PAIN AND JOINT PAIN; HEART PALPITATIONS; DIZZINESS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 5.9 inches. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced flu like symptoms. On 24-APR-2021, the subject experienced difficulty in bending right knees. On 24-APR-2021, the subject experienced severe right knee pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations on 07-APR-2021, and dizziness, and flu like symptoms on 24-APR-2021, and had not recovered from difficulty in bending right knees, and severe right knee pain and joint pain. This report was non-serious.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after administration pt began to sweat and fainted. Pt regained conciousness after 3 seconds and then remained under observation of the rph until pt was confident they would be able to make it home on their own. #4 benadryl was given to take home but instructed to take if symptoms came back.

Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Approximately 10-12mins after the J&J shot was administered, the patient got our attention to let us know he wasn't feeling well and might faint. I quickly tended to him as he slowly passed out. I craddled his head to make sure he did not hit it on the countertop. Pateint was seated. After approximately 30 second the patient started to come to. We gave him some water, took his bp, had him wait 30mins and took his bp again before he left with his wife.

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

First day after very tired that night started throwing up for three nights with extreme vertigo and exhaustion, stop throwing up after three days , got medicine for the vertigo four days after shot took it for three days slowly the vertigo went away but just reappeared today

LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old male. 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: 1816022, and batch number: 1816022 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 light headed. On MAY-2021, the subject experienced fatigue. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, light headed and weak was not reported. This report was non-serious.

Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all, since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021

After 5 minutes from giving the vaccine. Patient started to say he was getting dizzy. He lost coloration at first, but could speak just fine. Then a few seconds later he appeared to lost consciousness, his head fell back, and he started to have jerking movements. He was making noises that almost sounded like a snore to me right at first, but it was more than likely him gagging on saliva. 911 was called, and his symptoms continued for roughly 30-60 seconds. EMS took him to hospital where they diagnosed it as vasovagal syncope and just gave him some fluids.

Starting approximately one week after vaccination I started to experience onset of loud tinnitus primarily in my left ear. I have experienced mild tinnitus for 8 years but this was much more severe. The night of 04/19/2021 I noticed the onset of dizziness which progressed to strong vertigo the morning of the 20th. It was so severe I was unable to work and stayed in bed for the better part of two days. It was accompanied by the increased tinnitus. I scheduled an appt with my primary care physician for 04/23 and by Thursday 04/22 the vertigo had decreased to a general dizziness with tinnitus in my left ear. Dr prescribed Meclizine 25mg to me which has not appreciably addressed the symptom which as of 05/21 continues to be a constant mild dizziness with pronounced tinnitus in my left ear. I am planning to see an ENT that specializes in AIED (auto immune inner ear disorder) which I suspect was triggered my my immune system response to the vaccine. I should note that 8 years earlier I had a milder but similar case of vertigo w tinnitus which was never diagnosed despite extensive testing (vestibular migraine as a diagnosis by exclusion). It gradually subsided over 2 years with only mild tinnitus remaining as a symptom.

pt started having pain in his left foot. He now has to limp since he has trouble putting any weight on it. He has some pain in the calf and chin also. He states he has never had any pain or problems with this foot in the past. Pt will make an appt to see a doctor regarding his foot.

I woke up and had a fever of 103. also had chills felt like I had covid. I couldn't walk on my right leg , my calve in my right leg was super red. I called my Doctor and he told me to take Tylenol. I felt better about 2 days later but my right calve was sore for a week.

Day one was headache as expected and right arm pain. Day two I had bad headache (9) joint pain in my shoulder and hips, loud ringing ears. shortness of breathe, left lung pain. This repeated for three days so I tested by BP and found it to be 160/130. Past day 3 I started with adrenaline spikes where heart would race up and I felt like hulk and blood pressure spikes out of the random. 5/24/21, I saw my family doctor and since my BP was so random high and then low she did not want to give me meds since it could drops too low at time. For my difficulty breathing and lung pain she gave me an prescription inhaler. As of today I still have the ringing left ear, shoulder joint pain like a pin stuck in it and unable to raise over my head without using my left arm to support, high BP on average 140/132. 167/151, 126/89, 122/91,110/87, 126/84 are some examples. These at the lowest is 10+ point higher than my normal range of 120s over 70s. Headache continues but may be due to the higher than normal BP.

My arm got sorer and stiffer. Followed by I could barely lift it and can hardly steer my car. Hard to put on and take off t-shirts. Hard to lift with my arm and it is weaker now.

Vaccine administered in right deltoid. Patient felt dizzy and fainted in the observation area within a few minute of receiving the vaccine. Patient was pale, nauseated, and felt light headed especially when standing or walking. Blood pressure was 101/51. Patient was taken to urgent care, kept under observation for three hours, and was released when he felt well enough to drive home.

SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.

USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)

Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.

trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness

Could not walk for two days had to sleep in bathroom of home, had to crawl into shower to go to bathroom. Start on Thursday morning and last till Saturday morning. Then I was able to stand but slowly able to move

June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs. Dizziness and fatigue.

PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and 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: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left leg. 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).

two weeks after shot I starting having pain in my right shoulder. thought I over worked it, but week by week it continue to get worse. To the point that it wakes me up 4-5 times a night. While on vacation it hit a tipping point in pain and my pinky finger and ring finger started going numb on my hand. I started to research and thought it might be a nerve issue... from top of shoulder blade to my fingers I get pain. Pain to the point I have a hard time moving my arm in certain directions. two day prior to returning from vacation I called the doctor to have it checked out. On July 12th I saw my doctor (knowing nothing about J&J) and he thought I just needed a steroid shot for inflammation and was given the shot. watching news I heard about these nerve issue with J&J, men over 50 and everything they were saying fit me perfect. The next day I followed up with my doctor (Put a call into him) and a nurse called me back and informed me it probably had nothing to do with the J&J shot. I called the location that gave me the shot and they recommend that I complete this from. Today, 7/17/21 I am still in pain with numbness in my fingers.

Patient felt lightheaded, afraid he was going to pass out. Offered to have him elevate his feet or lie down. Gave a bottle of water to drink. Kept him under observation for an hour. Symptoms subsided and he left.

Extreme fatigue--slept for over 24 hours after receiving vaccine Shortness of breath Dizziness Irritable diarrhea the first day Had to leave work the next day as dizzy and unsteady and diarrhea

Apprx. 6 hrs after the shots (both my girlfriend and I experience almost identical symptoms) Severe chills, Fever, severe headache, severe muscle pain throughout the body, chest pains, diarrhea, nausea, vertigo, increase heart rate! Two days later and I am still experiencing vertigo, diarrhea, nausea!

Chest Pain Chest Tightness Lightheadedness Headache Pressure in Head Cough Swelling in Ankles Leg Weakness Tiredness starting from day after shot until today.

pt states later in the day after taking the vax he developed a bad headache and dizziness. Next day pt is still having some headache and dizziness. Pt will call his PCP if his symptoms don't improve.

Fever, chills, dizzy, nausea, fast heart beat, headache, very tired , and weakness. Taking Tylenol. It?s been 4 days and still ongoing.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient passed out for a short time.....told me he normally has a vagal response to shots and not to be surptrised of he passes out.....patient fully recovered prior to leaving....he was monitored closely

Pt presents following syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to right deltoid. Pt?s wife states that he was sitting in the car when he started to complain of dizziness, lightheadedness, and nausea followed by +LOC x1 minute. He had no head injury or other trauma. On immediate evaluation he is conscious and endorses nausea and lightheadedness. He denies medical problems, medications, or any Hx of allergies. He states that he has syncopized multiple times in the past after getting vaccines and giving blood. He also states that he was nervous to get the vaccine today. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, or CP. Following repeat vital signs that showed improved sitting BP of 113/70, Pt refused medical transport and signed out AMA with EMS. Pt was driven home by his wife.

Patient stated feeling dizzy, diaphoretic, blurry vision Patient vomited and had syncopal episode EMS called and evaluated patient Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be going home with son

Pt. walked to the front of the Pharmacy from the post vaccination waiting area (4 feet) asking for help because he was dizzy. He was sweating and having shortness of breath. Pt. was taken to the seat where he fainted. Pt. was laid on the floor with his legs up in a step. He gained consciousness in less than 1 min. Pt was pale. Pt. was given an alcohol swab to smell. 911 was called. First responders took his blood pressure again and blood sugar. Uncle's pt. was called and came to the Pharmacy to pick him up to avoid pt. having to drive his car back home.

I got the shot at 10 am, then at about 7 pm I got chills and achy. I layed down and had a hard time getting up. When I got up at 10:30 to check and see if I had a fever, I measured it at 103.5 F. I took 2 tylenol at 10:30 and at 130 am my fever was 102.5. I just thought this was a larger reaction than what is typical, so I thought I would report it. Additionally, this mass vaccination site had a number of adverse reactions (within 15 minutes of injection), so I thought I should report this to someone. Disappointingly it is near impossible to talk to anyone on the phone these days to get or give information. I called the VAERS phone number, but was on hold for 15 minutes and gave up.

Pt became dizzy and called for help. Upon arrival ambulance was called and pt was ALOC w/bilateral weakness slowly progressing and sweating profusely. Pt was A&O x 3 to self and location. Then patient seemed to have lost consciousness completely for about a minute. Pt was still breathing normally, and was tachycardic. Left sided drooling was present. By the time the ambulance arrived patient regained consciousness and strength. Pt stated this happened before when he had a root canal fixed. Stated he seems to have anxiety induced seizures. Pt VS were taken by EMTs and where stable, Pt refused to go to the hospital. He called his wife to pick him up and pt was monitored until she arrived.

+ lightheaded and nausea, and then syncope followed by hypotension consistent with vasovagal response.

PATIENT BECAME DIZZY, SWEATING PERFUSELY, CONFUSED WITH A BP OF 154/144 AND A PULSE OF 48. LIED PATIENT ON THE GROUND AND RAISE HIS FEET ABOVE HIS HEAD. PLACED A COLD COMPRESS ON HIS FORHEAD AND GAVE HIM SOME WATER, CALLED 911. AFTER 5 MINS THE PARAMETICS WERE ON SCENE AND HIS VITALS BECAME NORMAL AND HE WAS TRANSPORTED TO THE HOSPITAL FOR OBSERVATION.

Client brought to observation area after J & J vaccination to left deltoid. C/O dizziness, nausea, sweating. Initial O2 sat of 87% (note extremities cool to the touch. Placed on 10 LPM NC at 100% At 1028 am 98/69 blood pressure 100% O2 sat on 10 LPM 1031 am 98/69 Client then on RA and continued at 100% Client c/o mild dizziness. Later ambulated to bathroom without aide He works at the college and will rest in his work room. He reported very mild dizziness, MAEW, NAD, Speaking in full sentences. 1103 am VS of 113/72 64 22 Client directed to call 911 for difficulty breath and f/u with a health care provider as needed. Note client stated he does not have health coverage presently Client DCd home at 1105

dizzy,nauseaus,headache. sick on sunday the 4th called 911 on Tuesday night the 6th for transport to hospital. couldn't walk. had a stoke.

Patient received his J&J vaccine on 3/19/21 at at outside location. Patient was admitted to the hospital for acute urinary retention on 4/7/21 and had a catheter placed via cystoscopy. He was discharged on 4/8/21. On 4/14/21 he presented to the ED with chest pressure/palpitations/dizziness. He stated that he has had chest pressure for 1 week prior to the this. CT revealed a saddle pulmonary embolism. he was admitted to the hospital for further work-up and treatment.

At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, slurred speech. Called plant nurse. She said my face was drooping, I couldn't smile or stand. She called Ambulance. Ambulance arrived and decided symptoms of stroke and called for helicopter to take me to medical center. When I arrived they did CT and I was later told it showed possible areas of no oxygen to brain. They gave me TPA drug and almost immediately I could see improvement - my headache cleared. Throughout the next couple hours I regained movement on right side and all functionality returned except weakness in right arm. I stayed in ICU for 24 hours as required after receiving TPA and while additional tests were ran then was discharged on Friday, April 16, 2021

slight headache within hours, disappearing within 36 hours. arm soreness beginning next morning, continuing for 5 days, escalating for the first 2 1/2, then decreasing in similar intensity. Yesterday, however, I started to have a bad headache at 4 a.m., then felt generally more ill to a level of almost incapacity by evening - bad headache, general weakness, dizziness, some muscle pain, bad nausea. Used Aleve and Ibuprofen and by 11pm started to feel normal again. By the next morning, I felt fine - tired like I just got over something, but fine. Not sure it was injection related, but wanted to share.

1 week after receiving the vaccine, what I believe to be a gout flare started in my right foot. The joint of my big toe became very swollen and red, painful to the touch and the rest of the front part of my foot also became swollen. It was difficult to walk or even put pressure on it for 5 days and I treated it with ice, elevation and 600 mg ibuprofen 3X/day. Symptoms are starting to resolve , but the joint is still swollen and red, though the pain is subsiding. I am able to walk with a normal gait, though there is still stiffness and some pain.

PRODUCT LOT WAS VERY SLOPPY AND HARD TO READ (PRODUCT LABEL ISSUE); DIZZY AND FELT LIKE FAINTING; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included feeling faint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: OU1A71A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:03, the subject experienced dizzy and felt like fainting. On an unspecified date, the subject experienced product lot was very sloppy and hard to read (product label issue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and felt like fainting on 08-APR-2021, and the outcome of product lot was very sloppy and hard to read (product label issue) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

Freezing ,hot ,cold, sweets disy ,lack of appetite constipation no energy inside feel like burning and boiling ,weak general stomach ache bad ,heart palpitations , tingling legs and feet , dehydrated

LOSS OF BALANCE, POSSIBLE VERTIGO; POSSIBLE PREMATURE VENTRICULAR CONTRACTIONS, FLUTTERING IN CHEST; This spontaneous report received from a consumer (company representative) concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced possible premature ventricular contractions, fluttering in chest. On MAR-2021, the subject experienced loss of balance, possible vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible premature ventricular contractions, fluttering in chest and loss of balance, possible vertigo 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.

BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . 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).

After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.

Fevers started on Wednesday evening, April 14th. Over the next three to four days, the fevers and chills continuously got worse. Patient experienced fatigue, congestion, headaches, sore throat, body aches, neck pain. Conducted a televisit on Sunday, April 18th, and then went into the doctor on Monday, April 19th. The day of the doctor appointment, the patient could not get out of bed and could not stand for longer than 15 minutes at a time before extreme fatigue set in. Blood tests were taken at the doctor, a Z-pack was prescribed. The evening of the 19th, the doctor called after hour to send patient to emergency room to be admitted to hospital. Patient went immediately to Medical Center at which point, the patient was admitted for the next 19 days. The patient was released from the hospital on Saturday, May 8th. While in the hospital, the patient saw almost every "category" of doctor possible. Patient experienced fevers every night for 15 days straight, and after release from the hospital and "fever free for 4-5 days, experienced fevers again for the next week. Doctors were unable for the first two and a half weeks of hospitalization to draw a conclusion about what was the cause of the sepsis (systemic). Patient received daily blood tests, MRIs, CAT scans, spinal tap, bone marrow biopsy, echocardiogram, etc. Patient spent the first two and a half weeks on an antibiotic, antifungal, and antiviral. The "final" diagnosis, which is still not confirmed, as histoplasmosis, which per the doctor would not have placed the patient in the hospital. Determined the fevers were officially "fevers of unknown origin" with a diagnosis of MIS-A and a vaccine contributing factor. Medication put patient in kidney failure and did not address the fevers (patient had fevers of 103+ for 25+ days in a row). On May 27th, doctors are conducing new fungal tests and patient is discontinuing antifungal medication because of severe liver damage. Patient was not and is not in a situation where histoplasmosis is a logical conclusion based on the patient's daily activities.

BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted 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

DIZZINESS WHEN STANDS UP; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizziness when stands up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness when stands up was not reported. This report was non-serious.

Pt received JJ vaccination, sat in the observation area for 15 minutes, when his 15 minute observation time lapsed the patient got up to leave and I noted pt walking towards the exit with a staggered gait. I immediately asked the patient if he was ok and got him seated. Pt noted to be diaphoretic with no signs of distress. Pt was breathing and speaking in clear complete sentences and denied chest pain, shortness of breath and swelling to the mouth/ throat. Pt stated he started to experience tunnel vision when he got up and felt dizzy. Its vitals were taken and noted to be stable. I offered to call EMS which patient declined. Pt drank water and ate chips while being observed and vitals were repeated approximately 10 mins later at which time patients vitals were stable and diaphoresis resolved. While patient was being monitored I noted he seemed to be experiencing nasal congestion and left eye watering. Pts lungs remained clear to auscultation bilaterally. I offered to call EMS again and pt agreed. I called EMS who arrived approximately 4 mins later. Pt was evaluated by EMS and taken to local hospital with a stable disposition.

About 5 minutes after vaccination, patient complained of dizziness/spinning. It continued for several minutes when he became syncopal and briefly unresponsive. Heart rate 40. Glucose 103. BP 108/60. Respiratory rate 20 and sonorous. Placed on monitor which showed sinus bradycardia. 20 minutes after vaccination, patient recovering and able to talk but diaphoretic and weak. Taken to ER by paramedics.

Have developed constant plugged up ears, with non stop tinnitis and vertigo episodes since 6/7/2021 and symptoms are constant and ongoing

FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.

Patient stated that after vaccine he could not breathe, throat was swollen and he gets dizzy every day.

Diarrhea and soft/loose stools EVERY DAY since to this day! Leg swelling...mostly in right leg & foot. Trouble walking. Some unusual & day long blurred vision.

7.8.21: Patient reported weakness, lightheadedness, fever, possible numbness/tingling (also s/p heart cath) 7.9.21: Presented to ED - fever, headache, myalgia, neck stiffness, weakness in lower legs, difficulty walking, numbness - left AMA 7.9.21: Presented to ED - with generalized weakness - He was discharged on 7/7. He had noted BLE weakness during his admission and noted worsening of his weakness following his discharge. He returned to the ER on 7/8 but left AMA. He presented to ER on 7/9 with right arm and BLE weakness and MRI showed numerous small acute ischemic foci bilaterally. CTA was negative for significant stenosis or occlusion. He was evaluated by Neurology and felt that there was a high likelihood of cardioembolism as the etiology of his strokes vs cocaine. They recommended cardiac monitoring for evidence of afib as well as DAPT x 21 days followed by ASA monotherapy. He was noted to have an elevated troponin on admission and was placed on a Heparin drip. Cardiology did not feel that repeat cardiac cath was warranted. An Echo with bubble study was performed and showed EF 45-50%, diffuse hypokinesia, mild DD and no evidence of shunting. He has been accepted at hospital with plan for transfer there today. Assessment / Plan Multifocal stroke - suspect shower embolism vs r/t cocaine use - Echo - no evidence of shunt - per Neuro - DAPT x 21 days followed by ASA monotherapy - 30-day cardiac monitor at discharge Elevated troponin Recent IWMI CAD Ischemic CM - EF 45-50%, diffuse hypokinesia Cocaine use with possible vasospasm - s/p Heparin drip - no indication for repeat cardiac cath per Cardiology - ASA, Plavix, Metoprolol, Lisinopril, Lipitor - Norvasc - counseled on cocaine cessation

PERSISTENT NUMBNESS IN LEFT LEG, BOTH ARMS AND RIGHT LEG HALFWAY FROM SIDE OF LEG TO HALFWAY AROUND THE CALF, BETWEEN ANKLE, KNEE AND HIP; LIGHTHEADEDNESS; SORE ARM; MUSCLE ACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient takes no prescription or over the counter medications and has no medical conditions and describes self as healthy. the patient had no known allergies and was not a drug abuse or illicit drug user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. On APR-2021, the subject experienced lightheadedness. Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) within range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness, and sore arm, and muscle aches on 12-MAR-2021, and had not recovered from persistent numbness in left leg, both arms and right leg halfway from side of leg to halfway around the calf, between ankle, knee and hip. This report was non-serious.

PER PATIENT REPORT: 2 WEEKS AFTER VACCINE PATIENT HAD LOSS OF FUNCTION IN ARMS AND EXTREME FATIGUE. THE PAIN CONTINUED TO INREASE IN HIS JOINTS UNTIL AT 4 WEEKS IT WAS INPACTING HIS SHOULDERS, HIPS AND WRISTS. AT ALMOST 8 WEEKS POST DOSE, HE WAS JUST RELEASED FROM THE HOSPITAL. HE WAS ADMITTED DUE TO INABLILITY TO WALK. HE HAS LOST 27 POUNDS IN 5 WEEKS. HIS CURRENT THERAPY OF PREDNISONE HAS HELPED HIM REGAIN USE OF HIS LEGS BUT HIS ARMS ARE STILL WEAK

On 6/24/2021 I woke up with gastral issues, which subsided late in the evening of 6/25/2021. On 6/26 went back to my normal routine and worked out in the gym and 6/27 played basketball for 2 plus hours. I was fatigued on 6/28 and 6/29. On 6/30 still fatigued went to the gym and did a light cardio workout and developed a heat rash on buttock and upper thighs. I took a Benadryl which cured the heat rash. on 7/1 in the evening I developed a dry cough that was pretty intense. At this time I noticed my eye sight was blurry at a distance. 7/2 the cough went away, Looking back I now notice I had balance issues on 7/2. On 7/3 eyesight was worse and I was seeing double. I went and had an eye exam and the Dr. thought I may have a retinal issue in my left eye and suggested I go to the hospital which I did.

Client tripped and fell while leaving the site of the POD. He hit his chin, head and wrist on the ground. He did not lose consciousness and had no bleeding. His vital signs were as follows: BP=118/72, Pulse=74bpm. On examination, client was conscious and alert X 3, and was talking coherently. He refused to go to the emergency room and stated that he did not want the EMT to be called. He was observed for 30 minutes and decided he felt well enough to leave. He was asked to call ?911? if he developed any symptoms including a headache or dizziness and he voiced understanding.

Headache beginning at night (Wednesday). Headache increasing in strength throughout the night until it became very very painful throughout the following morning until mid afternoon (Thursday).. Dizziness and nausea beginning late morning day after shot (Thursday) for about 3 or 4 hours, making it difficult to stand up. By 3:30 or 4:00 most severe symptoms seemed to lesson, or disappear. Over the following 4 days have had slight headache and general fatigue.

About 8 hours after injection, minor chills started. One hour later, chills became severe. About 13 hours after injection, I felt like I had a full blown case of the flu...fever, chills, sweats, light heaviness, body aches and general nausea. Sleep was irregular. Next day, symptoms subsided, but still had body aches and fatigue, and I called in sick for work.

Patient received Jassen vaccine @ 1:49pm, while in the recovery area, @ 2:00pm c/o feeling lightheaded, no other symptoms. VSS taken promptly by recovery RN: 112/80, 97,18, Sats 97.1 on RA, neuro status wnl, skin wnl, general assessment stable, client stated did not eat lunch prior to vaccine, nothing to eat or drink since early am. Provided w/oral hydration, monitored, Vitals rechecked 2:06 pm: 112/81, 86,18 Sats 96.1 on RA, monitored for additional 15 minutes, symptoms resolved, denied any further c/o anykind, dc from recovery area @ 2:20 PM stable.

Fever, sore throat, muscle pain, headache, and sometimes dizziness. Treatment: Tylenol every 4 hours, Emergen-C, Benadryl

First 4 hours post injection no serious side effects, slight headache was settling in. At approx. 8PM (7 hours after shot) I had fairly a severe reaction of horror for the next 16 hours - all night long. Heart racing/energy beyond, deep chills and severe whole body shaking to the point of my back going out (dont' have a bad back), fever, migraine headache so bad (i dont get headaches) and body aches from a horror movie. I'm a jock, run daily, healthy, no smoke, drink or drugs. This lasted all night long well into the morning. At 3Am i considered going to the ER, but didnt. By 2pm the following day most of it went away. Two days later (today) i am dizzy, heart feels fast or racing, naseuous earlier , and exhausted. I can deal with it now, but it's very uncomfortable. Frankly, I regret getting the vaccine, wish i had not. I had covid last March, it was no big deal beyond what a flu would have done...with some shortness of breath on and off for a few months. The reaction to the vaccine is viccious compared to covid itself (for me, just my experience). Hope this all stops and goes away. Thank you for your work!

Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator.

brief hint of dizziness about 4 hours after shot. 12 hours later (this writing) : dizziness, nausea, headache, body aches, fatigue ? all mild, but don?t feel like doing anything today.

Janssen COVID-19 Vaccine EUA Passed out while seated, 3-4 minutes after receiving vaccine. Fast onset of extreme nausea followed by blackout. Duration of blackout unknown. Woke up on floor not knowing how I got there. Sat up, nausea and lightheadedness returned, then dissipated with no further blackout. Felt rush of blood from head to toe and felt okay after that. Pharmacy staff took blood pressure, readings were close to normal (slightly elevated). Paramedics were called by pharmacy, and their BP readings were also close to normal. After all that, aside from some fatigue, no other appreciable side effects over the next 48 hours. No nausea, flu-like symptoms or fever, and very little soreness at injection site.

After 4th day of receiving J&J Covid Vaccine to present, I have dull headache, fogged brain, equilibrium seems off, slight loss of balance, increased heart rate of 170-190 BMP, my normal rate is 70 BPM, I took 25Mg of Metoprolol which brought my rate down to 70 BPM. I have increased wheezing and feeling shortness of breath, whereby having to using my albuterol inhaler quite often and I also took 20MG of Prednisone after which my breathing has improved.

the day after the shot, started feeling unwell (approx 24 hours post shot). Slurring words, stumbling around and general unwell feeling with a fluttery feeling in chest. No previous heart issues of any kind. After it continued for an hour or so, I took him to the ER and it was discovered that he was in AFIB. 2 rounds of meds and tests, but stayed in that rhythm. They ended up doing a cardio version and it went back into normal sinus rhythm. Follow up with dr, placed on Eliquis, EKG, stress test and sleep study have found no other contributing factors atthis point.

Got J&J COVID vaccine on 4/10/21, at noon, in right arm. About 24 hours later suddenly felt dizzy which lasted a minute, but since then has felt dizzy and right leg has felt tight and swollen.

LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR ABNORMAL 319; URINATION PROBLEM; MALE GLAND (REALLY BIG) WAS SWOLLEN/ RED; FEELING OF PASSING; LIGHT HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 57 years old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes (did not take any medication). Patient was assaulted before getting the Covid-19 vaccine and was cut in the neck and needed blood transfusion last OCT-2020. Patient got several vaccinations. Last vaccination he received was in 1980. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, 1 day after vaccination, patient experienced light headache, feeling of passing and weakness. On 11-APR-2021, after 2-3 days of vaccination, patient was suffering from urination problem which included swollen male gland/ redness (peeling of the skin /flesh is visible /getting worse) and pain during urination. He had pain upon pulling back his foreskin (he was not circumcised and never had such problems). On unspecified day, he had trouble in vision. He visited two doctors regarding the problem who stated that patient had left eye trauma (cataract). On unspecified date. he also had rashes all over the body (specifically arms) referred as eczema. On an unspecified date, he had shoulder pain/soreness/wound on both shoulders right as well left. Skin of the left shoulder was peeled and flesh was visible. He stated that peeling of the skin was moving towards the back of his shoulder and was getting worse. He had tattoos on his left and right shoulder/arm. As per patient, he was given a lot of shots in his right during his profession. Patient has abnormal blood sugar level. On 23-APR-2021, Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 319. Treatment medications (dates unspecified) included: bismuth subsalicylate and took 7 up to alleviate symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye trauma/ cataract, urination problem, rash all over body arm/eczema, weakness, feeling of passing, light headache, and male gland (really big) was swollen/ red, and the outcome of shoulder pain/sorenes/wound and blood sugar abnormal 319 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210448488 - COVID-19 VACCINE AD26.COV2.S - left eye trauma / cataract . 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). 20210448488-COVID-19 VACCINE AD26.COV2.S-BLOOD SUGAR ABNORMAL 319 .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

Two blood clots in right leg below the knee, calf pain, swelling of lower leg and foot, painful to walk

patient was fine until a week later when started getting dizzy and throwing up. taken to ER, but didn't tell them had been vaccinated. Couldn't find anything wrong and was sent home after a few days. Went to ER again and this time wife told them he had been vaccinated week before symptoms started. Did brain MRI and found a blood clot. Pt currently in rehab.

The night after the COVID vaccine had fever 101.4, feeling cold, until the follow day. Went to the Emergency Department the following night because I noticed that I was drooling, feeling very dizzy and weak.

Mild to moderate arm pain for first 2 weeks. Progressed to severe arm and shoulder discomfort with decreased mobility during 3rd week.

THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence. On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.

Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a gait issue. Developed Bell?s palsy. Weakness and at times severe pain in shoulders and arms. Tingling sensations in hands. Decreased feeling in legs and feet. These weaknesses are bilateral. Started with general feeling ?off? approx April 1, progressed to severe back pain April 13, visit to ER April 16 diagnosed with pneumonia sent home with antibiotics. Back to ER April 21 with severe back pain and beginning to have difficulty walking and weakness. Sent home with naproxen and muscle relaxers. Back to ER on April 24 fearing a stroke due to face droop. Admitted. Several tests run to R/O stroke,myasthenia gravis, lymes disease. Diagnosed with Bell?s palsy. Sent home on April 28. Still extremely weak. Using a walker. Still in pain. Sent back to ER per physician for another brain MRI on may 4. Not done due to argument between ER staff and physician who sent him in.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: 3 minutes post vaccination patient was pale, experiencing diaphoresis, felt funny. Immediately he drank apple juice and right after still felt like he was going to faint. As he was sitting upright in chair talking his eyes rolled back in his head and he became unresponsive. I had him lie down and propped up his feet. Called 911 and took his blood pressure. He regained consciousness but was still not coherent. He attempted to sit in chair again and immediately felt like he was going to pass out

VACCINE WAS ADMINISTERED PRIOR TO PATIENT LOSING CONSCIOUSNESS. PATIENT REGAINED CONSCIOUSNESS AND REPORTED DIZZINESS AND BRUISING ON HEAD. 911 WAS CALLED, AND EMS ATTENDED TOPATIENT.

DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. 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 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.

Extreme dizziness/ vertigo. Room spinning. Started this morning. Had muscle soreness yesterday. Recurring pain down right leg. I need to call Dr.

First few days severe headaches and neck aches. These were gone after a week. Intense pain in legs and knees. VERY difficult to walk and stand from getting up in the morning until mid day. Painful most of the days and evening. I wake up multiple times at night with pain. I wake up about 5 or 7 times/ night. Very difficult to walk up and down stairs.

Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started feeling numb. I went into my kitchen and all of a sudden I started feeling dizzy. I lost all strength in my legs and in my left arm. I really couldn't move my arms or my legs and I felt really light headed. I had to have my 5 year old boys get me some water to drink. My son noticed that my heart was beating really strong and really fast. I saw water boiling over in the pot on the stove and I couldn't even get out of a chair to turn it off. I couldn't stand up. I finally managed to go back by my bed from the chair and slowly moved around. I tried holding my phone and it dropped out of my hands a couple of times because I couldn't hold it. A couple hours later, I felt a little better, but I had to fight to get around. We fell asleep and when I woke up, I still felt bad. I took my children to school and told them that I was going to the hospital to get checked out. At the hospital they performed multiple tests and they back showing I had stroke. I was treated for suffering from a stroke.

After receiving the COVID-19 vaccine the patient was waiting in the store after the shot and was walking around. He had gotten dizzy while walking in an aisle, and lost his balance and fell.

Both feet swollen, right toe hurts, heels hurt. First few days was hard to walk. It is better now but still a little swollen and heels and right toe hurt

diaphoretic, hypotensive, dizziness skin: pale. Diphenhydramine 12.5mg oral 1x given. time Course 10:46 of initial injection to 10:10 am

Got injection on Tuesday June 2. On June 6 in the evening I started to feel dizzy, faint, foggy feeling in my head. Almost like a stroke type symptoms. I was unable to ambulate. I got real tired and just felt like going to sleep. I laid down around 5 pm and got up at 5 am. I do not sleep more than 4 or 5 hours nightly. I went to ER due to not feeling any better. I was admitted to the hospital immediately.

My joints started to hurt and I became less flexible/mobile to the extend that I started walking with my cane and experienced difficulty getting up from a seated position. My Doctor did a a steroid injection in my back but it did not work. I took a couple of pain killers and some muscles relaxers when I could not bare the pain which also did not work (even tried using my conversion table and that did not work and then the pain went away on its own). My doctor passively agreed with me that my pain could have been caused by the vaccine since I suffer from chronic pain and it may have been an autoimmune surge in my system.

Patient stated he felt as if he was going to faint and that this feeling happens often when he receives shots or sees needles. EMS was called and EMS took vitals. BP: 113/62. HR: 60. Patient stated he felt better after several minutes and EMS sent patient home.

Initially inability to move the left arm to put it into the jacket. Then bouts of labile hypertension, inability to find his word and then slurred speech and global problems moving his limbs and fine motor issues

24 hours after getting the vaccine I started feeling sleepy and groggy. 48 hours after the vaccine I felt very groggy and off balance, like I was half asleep or had been drugged with a sedative. I also had low energy and exerting myself (with long walks, etc) made me feel wiped out and exhausted . After one week I started to feel better, but still felt slightly groggy and off balance, like I was drugged with a mild sedative. Now on July 1 -- one full month since getting the vaccine -- I still feel slightly groggy and off balance, no matter how much sleep or rest I get. I also still have lower than normal energy and muscle soreness. The grogginess and off balance is most noticeable when walking or moving my head quickly.

Numbness in fingers, toes, and left side of face. Some nausea in stomach and intestines Dizziness and unbalance Malaise with any kind of physical exertion Stiffness/pain in the lower back of head

"When I woke up, I felt sick to my stomach, experiencing nausea, sharp pain in my back towards my right shoulder. I felt dizzy, and feeling in my head, detached fatigued, feeling like I kind of had a head cold, but didn't. Dull ache in my head on the (R) side. Strange transient pains in my body. My heart felt like it was racing, and I felt like someone had punched me in my lower stomach".

- FELT DIZZY & NAUSEA ABOUT TEN MINUTES AFTER RECEIVING VACCINE - DECLINED EMS EVALUATION - HAD FRIEND DRIVE HIM HOME, AGREES TO GO TO DOCTOR / ER If CONTINUES TO fEEL UNWElL TOMORROW OR WORSE SYMPTOMS

Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak, face turned white. I was close to passing out but didn't. I requested attention after about 10 minutes. While being treated by medics they mentioned color had returned to my face. I felt better enough so I refused to go to hospital and was driven home. Later that morning, 03/08/2021 about 10 AM, I developed a fever and body aches with sharp pains thru out my body and joints. First temperature check was 100.5. My fever, pains/weakness increased thru out that day and overnight with chills. Highest temp check was 102.8 that evening prior to bedtime. I don't know if it could have been higher at some point overnight. It felt like I had a moderate to bad case of the FLU. The next morning, 03/09/2021 the fever broke down to about 101. By 03/11/2021, aside from a little residual weakness I felt more like myself. However, as of the writing of this report my temp seems to fluctuate between normal and 99.8. Will report this to my Doctor on next visit. Worth noting that I haven't had any Flu like symptoms to that degree in many years.

About 10 minutes after shot patient vomited and felt dizzy Dizziness lasted about half hour Gave patient chips and donut and water Patient admits to eating a very small bowl of cereal and taking metformin previous night at 7pm Also admits to not taking high blood pressure the e medication this day Patient blood glucose was 202 right before eating chips Patient felt much better after about 40 minutes late Was sent home in a car service and confirmed her got home Also we stated if situation worsens to seek medical attention ASAP hr representative called his emergency contact and informed this person of incident and told to monitor patient

Shortly after leaving the facility, after waiting the required 15 minutes post vaccine, I was driving back home on the freeway when I suddenly felt light-headed and as though all the energy had left my body (as though I was about to pass out). Then, without warning, I passed out, while driving on the freeway. Fortunately, I did not hit anyone, or was hit by anyone, and must have bounced off guardrails after crossing traffic twice and going off the freeway into the middle of an off ramp, where I finally came to. I did not suffer any injuries in the accident.

Vaccine was administered on 4/6/21. On 4/7/21, I felt extreme dizziness and vertigo until I got to sleep; it is less severe to date, but still present.

Patient woke up on 4/3/2021 at 7:30am with the symptoms of Light Headedness, Dizziness, and not feeling like himself. He got up and continued with his normal daily routine until around 10:30 when his vision started to double and he was off balance on his feet. He was taken by ambulance to a Hospital at 11:15am upon arrival his vision trippled and his eye right started to veer outward. He was taken in for a CT scan immidiatly and then was transfered to another campus to have a MRI scan done. He was then admited to the hospital for evaluation where he stayed overnight and was released the next afternoon (4/4/21)

patient became dizzy almost immediately upon standing after imz . asked wife for something to drink before she received her covid imz. he started fanning himself. i asked technician to come stand with him and observe while i attended to his wife's imz. i checked his bp because i wasn't sure if he was just anxious (both he and his wife reported that he always got nervous with shots even though he had received numerous imz. his blood pressure was 88/58mmhg with hr of 48. i got a mat to have him lie on the floor to elevate his feet but he declined. he sat another 10 minutes and said he felt better and said he was ok to leave with his wife without further assistance.

4-2 headache, fever, fatigue, chills, light-headed, body ache 4-3-21 Headache fever(101 deg), fatigue, dizzy, nauseous 4-4-21 severe dizzy. headache, fatigue nauseous 4-5-21 Monday dizzy, miss work,nausious, headache 4=6=21 Tuesday headache, dizzy lightheaded, tested for Covid 19/negative 4-7-21 return to work but experience headache, nausea, lightheaded 4-8-21 dizziness and headache 4-9-21 some dizziness and headache 4-10-21 light-headed, headache, little dizzines 4-11-21 light-headed 4-12-21, headache 4-12 headach, lightheaded 4-12-21 lightheaded and headache at times 4-13-21 sharp pain in head/ headach

4/4/2021 - feeling off, somewhat run down /// 4/5/2021 - feeling more run down /// 4/6/2021 - exhibiting sore throat and swollen glands throughout the day then at 5:45 was eating cocktail shrimp when I lost function and control of my right arm as well as a slight problem with my gait. As soon as the event took place my sore throat and swollen glands stopped immediately. My wife took me to the hospital where I was entered into stroke protocol. I was subjected to a series of tests including: EKG, ECHO, Platelet Cnt, Lipid Panel w direst LDL reflex, Hemoglobin, MRI Brain w/o contrast, CTA Stroke Alert (head/neck), CT Stroke Alert Brain, ECG, Basic Metabolic Panel, CBC, Protime - INR, APTT, Troponin I, Covid19, Influenz Influenza A/B, RSV PCR, and POCT GLUCOSE. I was kept for observation and determined I had suffered a small stroke. Released from the hospital 4/7/2021.

Started have headaches and feeling dizzy. On Sunday 04/18/2021 systoms became reaaly pronounced. Even felt as if my breading was erratic.

This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502D, 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 didn't feel good. On 25-MAR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced pinched nerve. On 13-APR-2021, the subject experienced felt like hot fluid was running down the inside of his right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, pinched nerve, felt like hot fluid was running down the inside of his right arm, and didn't feel good on APR-2021, and tired on 28-MAR-2021. This report was non-serious.

After my J&J vaccine, I experienced left hip and joint pain. I could not lift my left leg up. The next morning after my J&J vaccine, my left leg started hurting more and I could not ambulate. My left hip was hurting so bad I could not sleep at night. I went to the doctor 03-17-2021 to get monitored and he said it could be arthritis. I was prescribed by Dr. cyclobenzaprine 10mg and naproxen 500mg. I feel that my pain is inside the joint, hip pain region and to this day, I still have sleeping problems due to my pain in my left leg and left hip pain since the J&J vaccine. I will have a follow up with Dr. in the coming weeks.

3/26 office appointment: New onset right and left sided chest pain with associated shortness of breath, fatigue and intermittent lightheadedness. Labs drawn. CT scan showed Scattered small occlusive and nonocclusive emboli within small distal pulmonary artery branches bilaterally. Started on apixaban. Has appointment with Hematology on 4/29

PASSED OUT; LIGHT HEADED; VERY SLEEPY; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient was very sleepy and experienced arm pain. On 08-APR-2021, the patient passed out in shower and felt light headed, he awoke in shower with no known duration and with no injuries The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, and the outcome of light headed, arm pain and very sleepy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210420738-covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.

BLOOD CLOT IN UPPER THIGH; NO PULSE FROM KNEE DOWN ON RIGHT LEG; RINGING AND BUZZING IN EARS; PURPLE TOE; COULD NOT MOVE; FEELING CRAPPY; TIRED; NAUSEOUS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Barrett's esophagus, and controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular batch number: 1805031, and expiry: unknown) dose was not reported, 1 total administered in left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included Nexium (esomeprazole sodium) for Barrett's esophagus, and lisinopril for high blood pressure. On 25-MAR-2021, the day after the vaccination, patient felt crappy and could not move, had tiredness and nauseous. After 10 to 12 days of vaccination on an unspecified date in APR-2021, the patient had ringing and buzzing in ears, pain in the bottom of feet on walking, and purple discoloration to front of the right toe. The patient had visited health care professional (HCP). The patient had undergone some tests and HCP identified no pulse from the knee down on his right leg and a blood clot in upper thigh. The patient had experienced pins and needles and buzzing on his leg. He has also has a ringing and a buzzing in his ears and the bottom of his feet hurt when he walked on them. The patient was scheduled for an appointment with cardiovascular surgeon on 28-APR-2021, prior to the visit the patient has to tested negative for COVID. The patient went to take test on 23-APR-2021 and results not yet received. Laboratory data included: Peripheral pulse absent (NR: not provided) no pulse from the knee down on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling crappy, tired, nauseous, no pulse from knee down on right leg, blood clot in upper thigh, ringing and buzzing in ears and could not move was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.This spontaneous report received from a patient concerned a 58 year old male.; Sender's Comments: V0: This 58-year-old male patient was found to have blood clot in upper thigh with no pulse from the knee down 10 to 12 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions include Barret's esophagus and "controlled" high blood pressure; concomitant medications includes Nexium and lisinopril. The symptoms reported were ringing and buzzing in ears, pain in the bottom of feet on walking, pins and needles and buzzing on his leg, and purple discoloration to front of the right toe that prompted consult with HCP, who advised the patient that there was no pulse from the knee down on his right leg and a blood clot in upper thigh. Prior COVID test was negative. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after injection dizziness. 48 hours after injection neck and head pain on left side, arm soreness, and swollen lymph node on left side of throat. Minor pain in mouth and throat with fatigue and dizziness. Neck and head pain decreasing on day 3 with all other effects resolving but injection site is still fairly sore. Overall, I would say this was probably a normal response associated with my immune system reacting to the injection. I had the virus the first week of December 2020. I would classify my infection as moderate. I was sick with fever, chills and severe body aches and it lasted for 10-14 days.

Sudden onset arrhythmia while walking at normal pace indoors. Past experience with occasional SVT (more than 5 years ago since last) seemed consistent. Past successful mitigations did not stop episode which lasted approximately 3 1/2 hours. Some minor dizziness and slightly out of breath under non-stationary conditions (consistent also with prior events).

Pain in left upper arm about 10 days after injection, shooting down arm to hand, reduced mobility of the arm, didn't improve for 3 weeks thus saw my own doctor. She referred to orthopaedic doctor. Saw him on 5/12/2021, he diagnosed adhesive capsulitis in left shoulder possibly caused or exacerbated by the swelling due to the vaccination in that same area. Revisit in 3 weeks after dr. visit. Taking ibuprofen to reduce inflammation.

Stomach pain very constant for about a week Nonstop liver pain all day and night Dizzy and could not keep balance

May 10 started to experience numbness and tingling in both hands and feet. May 20 got in to see a neurologist symptoms worsened became difficult to walk. May 20 admitted into hospital.

Received shot at 1:10pm and was asked to wait 15 minutes before leaving. At 1:20pm I became very lightheaded and anxious. I stood up to look for a drinking fountain then woke up on the floor surrounded by people. Blood pressure was 80/40. Spent next two hours in ER on an IV. I was released once BP came back up. After getting home, I developed chest pain on the left side which I still have after three days so far.

FELT LIGHT HEADED; DISORIENTED; SWELLING OF STOMACH; SWELLING OF ARMPITS; SWELLING OF HANDS; ANXIETY; FEELS LIKE VERTIGO; This spontaneous report received from a patient concerned a 58-year-old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (took 6-7 months to clear), and concurrent conditions included smoking, fatty liver, high triglycerides, dieting, and seasonal allergies. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to left arm on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergies. On 09-MAY-2021, 30 minutes after vaccination the patient felt light-headed and disoriented and he drove to the hospital where he consulted in emergency room and did blood work, and did X-ray of heart and lungs. They put him on IV (intravenous). Patient was admitted for 4 hours and discharged. On 09-MAY-2021, the patient also experienced swelling in both hand, stomach and in his armpits. Since after discharge patient felt disorientated sometimes. The patient felt nervous and also felt like vertigo. Patient was completely disoriented and felt dizzy when he was walking (prior day of reporting). He still had swelling on hands and recovered from swelling on stomach and armpits. Patient felt anxious sometimes and could not walk and he mentioned it could be partly due to unemployment and overwhelming medical bills. The patient mentioned that he had covid-19 in OCT-2020 which was pretty bad that made him decided to take vaccine. He was worried how long these symptoms will persist at a time and unemployment added to his anxiety. He also mentioned about seeing doctors to rule out other rational other than the vaccine. Patient had lab test during his emergency room visit. Laboratory data included: Blood test (NR: not provided) as Not reported, and X-ray of heart and lungs (NR: not provided) as Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of stomach, and swelling of armpits in MAY-2021, and had not recovered from felt light headed, disoriented, feels like vertigo, anxiety, and swelling of hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Felt Light-headed, Disoriented. 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 V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Swelling of stomach, swelling of armpits, swelling of hands. 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).

BILATERAL SWOLLEN LEGS FROM HIP TO FEET; SWOLLEN TESTICLES; DIFFICULTY AMBULATING UPSTAIRS; DIFFICULTY PUTTING ON SHOES; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and aortic aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included furosemide for heart surgery. On 04-MAY-2021, the subject experienced bilateral swollen legs from hip to feet. On 04-MAY-2021, the subject experienced swollen testicles. On 04-MAY-2021, the subject experienced difficulty ambulating upstairs. On 04-MAY-2021, the subject experienced difficulty putting on shoes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs from hip to feet, swollen testicles, difficulty ambulating upstairs, and difficulty putting on shoes. This report was non-serious.

Overall flu like symptoms and extreme weakness now lasting 12 days. Insomnia for 8 days. Extreme pain from hips up back to neck, and ribs front and back still continue. Periodic cold sweat mainly in the mornings and sense of unsteadiness in my head.

Injection site slightly stiff post injection. 06/12/2021 02:00pm. experiencing extreme vertigo symptoms. One hour later reclined for a 2 hour nap. Awoke feeling a small bit better. Upon arising experienced chills, body aches, fatigue and extreme "over the toilet nausea". BP slightly elevated

COVID-19 PNEUMONIA; DEPENDENCE ON VENTILATOR; NOT ABLE TO WALK; COULD NOT WORK; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol user (not often), and non-smoker, and he had no chronic medical history. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 10-APR-2021 (Saturday), he was feeling bad and 11-APR-2021 (Sunday) and 8 days later went to the hospital. He did a polymerase chain reaction (PCR) covid-19 test at the hospital on 16-April-2021 and result was positive. He went back home but on 28-APR-2021, because his oxygen levels dropped and had trouble breathing. He was ventilated for 18 days. He was hospitalized for Covid-19 pneumonia (pneumonia, feeling bad and lost 45 pounds) for 36 days. He was discharged from hospital on 03-JUN-2021. On an unspecified date, he was not able to walk. He had home therapy and nursing therapy to be able to walk again and he lost 45 pounds. Since unspecified date, he could not work for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 pneumonia on 03-JUN-2021, and dependence on ventilator, and could not work, and had not recovered from not able to walk. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182426. The suspected product quality complaint has been confirmed to be not voided. The patient received the vaccine on 09-APR-2021 and had a positive Covid-19 test on 16-APR-2021 with 7 days elapsed between vaccination and test. There was not sufficient time elapsed for the patient to achieve immunity; therefore this report was not considered a lack of effect for Janssen COVID-19 vaccine.; Sender's Comments: V0: 20210622074-covid-19 vaccine ad26.cov2. s-Covid 19 Pneumonia, Dependence on Ventilator. 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).

An old injured right ankle I dislocated when I was 20years old swelled up and I was unable to walk on for three days. It still is very sore.

I am finding my ability to stand, walk, or hold my arms above my head for any period of more than a few minutes difficult. Yesterday I was unable to hold myself upright sufficiently to sit in a kayak (never got to find out for how long could I try to paddle). Mentally I am constantly having short-term memory challenges, for example just recalling the word fatigue to describe my situation I have had to write on a note paper as I repeatedly forget the term until I read it. Bringing groceries from our vehicle into the house I am finding near impossible (what used to take 1-2 minutes has taken me over 15 in the past 3 weeks on multiple occasions). I find myself falling asleep repeatedly during work, even though I am sleeping well at night. Some days are better than others, with a strong correlation to temperature.

Awoke with the the room spinning, dizziness, headache, brain fog, vertigo, fatigue. I have had these symptoms for over 2 months now. Have reported it to my doctor and 2 neurologists. On going. Taking Tylenol, Naproxin, Aspirin, Motrin for relief. Also take Dramamine to help with dizziness.

21 hours after injection, lethargy and tired. Approximately 40 hours after injection, loss of motor function on left side, specifically, could not lift left leg to climb stairs, combined with soreness in left hip and shoulder. Hip pain is mild to severe, and deep, mostly around the top of the femur. Approximately 8 hours later had sharp, shooting pains deep in the left leg/. Felt like it was in the femur, paint started at the top of the leg and shot down to the knee. Pain duration approximately 1 second, with multiple, sporadic occurrences over the next several days. Approximately 3.5 days after injection, numbness in left hand - small (pinky) finger and radiating along side of hand to wrist. Loss of motor function on left side resolved after approximately 8 hours, pain in hip, pain in shoulder and shooting pain in leg and hand numbness continue. Shooting pain is intermittent, shoulder pain is intermittent, hip pain and numbness in hand are constant.

I got up and was light headed and dizzy the day after. I went to the Urgent Care and they said they couldn't find anything wrong, and gave me medication to help with the dizziness. Dizziness lasted one day and just some fatigue.

PATIENT GIVEN VACCINE AFTER ALL PROCEDURAL ITEMS WERE COMPLETED ANDWAS LEFT SEATED IN A CHAIR ASSIGNED FOR COVID 19 MONITORING . PATIENT STARTED SNORING/GURGLING AND I LOOKED OVER TO SEE IF PATIENT WAS CATUALLY SNORING . PATIENT WIFE CALLED HIM BY NAME HE DID NOT ASWER RIGHT AWAY, I RAN TO TO ATTEND TO HIM AND I NOTICE HE WAS PALE , SWEATLY AND CLAMY ALSO WARM TO TOUCH. I CALLED HIS NAME HE ASWERED I THEN TOOK HIS PULSE WHICH WAS NORMAL AND GAVE HIM SOME WATER TO SIP AND ALSO GAVE PATIENT A CANDY WITH MENTHOL THEN HE STARTED GAINING BACK COLOR . HE FELT WEAK BUT STARTED FELLING BETTER. HE SEEM TO HAVE DIZZY ,LIGHTED HEAD SPELLS RIGHT AFTER VACCINE WAS ADMINISTERED. I MONITORED PATIENT FOR 45 MINS HE WAS ABLE TO GET UP AND WALK AND SAID HE FELT BETTER. ITS SEEM LIKE IT WAS MORE OF A FAINTING SPELL BUT BECAUSE HE WAS SEATED AND BEING MONITORED HIS RECOVERY WAS GOOD. PATIENT GOT UUP AND WALK AROUND AFTER RECOVERY AND I TOKK HIS NUMBER SO THAT I CAN FOLLOWUP AFTER CLOSING

lightheaded, nausea; B/P- 160-97, P-58, pulse ox- 96%. Client reports history of diabetes, took med this morning but had not eaten lunch. Client also past history of fainting with blood draws and injections

Headache, Myalgia, Arthralgia, NauseaVomiting, LIGHTHEADED, FATIGUE Narrative: Other Relevant History:

Couple minutes after receiving the vaccine patient was: diaphoretic heart rate mid 30's did drop to high 20's, weak, diazzy. Blood pressure 149/80. Incident lasted approximately 15-20 minutes and symptoms resolved. Action took was monitor patient.

Felt tired, put down head, next I remember waking up in chair and feeling things were not right, took deep breath and got up and told pharmacist and sat right back down, felt light headed, started sweating a lot. drenched clothes in sweat, Had water sat for 30 minutes got better enough to go home. Asked store to not call 911,

Patient reports feeling spacy, difficulty focusing, light headed. Has been happening since he woke up at 3:25 am the day after getting the vaccine. There seems to be a lot of confusion for the patient. No fever present any day after getting the vaccine. Patient reports that he feels "High as a kite."

Woke up the next morning with Dizziness never experienced before. Has persisted. I went to a doctor on 4/7 and he said I have Vertogo. I have never had vertigo in 59 years until I got this shot.

Chills, Aches, Fever, light headed, headaches, Eyes being very tired and sore ( I could feel this behind my eyes in the sockets).

Client reported prior to vaccination, that it is common for him to become faint and possibly "pass out" when receiving injections, having blood draws completed, and IVs started. Verified that client was feeling well and had eaten breakfast and was hydrated prior to injection. Client sitting in chair and tolerated injection well. About 5 minutes after injection given, client reported that he was feeling faint. Client was clammy and pale, and lost consciousness for about 30 seconds. Wife present and held his head and stood next to him in the chair. Client did not fall, and stayed seated in the chair. He slowly regained consciousness, and when able to sit and speak, client was offered water, which he accepted. VS collected - BP sitting in RUE - 108/78, P - 64, R - 16, O2 sats - 96%. Client started to regain color, and report that he was feeling better. Granola bar offered and client ate. Wife reported that this is a common event for client, when having blood drawn, IVs started, or injections given. Client states that he has "passed out many times before." Client stayed seated in chair, with RN and wife in room with him. By 0945, client states that he was feeling "back to normal." No s/s of allergic reaction. Wife to drive home and stay with husband for the rest of the day. Discussed s/s of allergic reaction, and other s/s that require immediate medical attention. Wife and client verbalized understanding.

3min 16s after injection: dizziness, weak and extremely tired, nauseous; flush face and headache (forehead) drank power ade (10oz), moved to cool/cold area; remained inactive; after several minutes (3-6min) symptoms improved, then repeated (symptoms returned but less severe, then mitigated) two more times over next 18 min stayed at dr. office for another 20 minutes with no more adverse reactions (mild headache and slight tiredness; no other symptoms)

Individual called LHD to report adverse reactions to vaccine including, SOB, dizziness, weakness, vomitting, headache and chills lasting 8 - 10 hours.

Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A "scan" showed blood clots in brain and heart. This individual passed away on 4/4/21.

SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 194 (unit unspecified), and height was 71 inches. The patient's concurrent conditions included gout, alcohol use, non-smoker, cipro allergy, high cholesterol, and high blood pressure, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 in left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, febuxostat for drug used for unknown indication, losartan for drug used for unknown indication, pravastatin for drug used for unknown indication, probiotics nos for drug used for unknown indication, selenium for drug used for unknown indication, vitamin d nos for drug used for unknown indication, and calcium. On 08-MAR-2021, the subject experienced swollen lips. On 08-MAR-2021, the subject experienced swollen throat. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced flushed face. On 08-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, swollen throat, dizziness, and flushed face on 08-MAR-2021, and flu-like symptoms on 10-MAR-2021. This report was non-serious.

The night after the shot, I started feeling some pain in my right leg from about the hip down the thigh. It got progressively worse and I was actually having difficulty standing. It peaked around Monday, but as of today (Friday 4/16/2021) it is definitely still there. However, it is diminishing in pain. I think it will go away with time so I haven't seen a doctor yet. I don't experience leg pain so this was a surprise. I thought maybe I perhaps slept in a wrong position but I would assume it would go away. I don't see any discoloration in the area.

I received the shot at 1:10pm on Friday, April 09, 2021 in my left arm. I woke up at 03:30am the next morning with a temperature of 101*, I was sweating profusely. I would then get the chills. My body ached all over. I had a bad head ache. I had nausea most of the day. At 5:00pm my lower right jaw swelled up and was hard as a rock then subsided and became like jelly. That lasted a couple of hours. By 10:00pm I felt much better.

On 4/14/2021 patient woke up with stomach cramps and diarrhea. states he could not walk, and had no energy from dehydration. patient states he had SOB. Patient has emergency alert system, so he pressed the button and an ambulance took him to the ER.

BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no 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 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Systemic: Fainting / Unresponsive-Mild, Additional Details: PATIENT WAS WAITING IN THE OBSERVATION AREA WHERE HE FELL DOWN AND LOST CONSCIOUS FOR FEW SECONDS.911 WAS CALLED. HE WAS COHERENT, NO OTHER SYMPTOMS, VITALS WERE FINE, HE WAS NOT HOSPITALIZED. HE GOT A SCRATCH ON HIS LEFT EAR.

(Hips) both left and right. Adverse pain making walking, standing and laying in bed extremely uncomfortable. Ibuprofen for action of course, 3ea 250 mill in AM again at PM. Before ibuprofen pain level 6 out of 10. After ibuprofen 4. NOTE: problems persistent to date...

DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021. This report was non-serious.

I woke up the next day with a fever , the fever went and then I had trouble breathing with congestion I went to urgent and went on antibiotic the congestion cleared up then I had extreme tiredness for 3 days I am still having trouble with my left arm and cannot reach it above my head the energy level has returned to normal around Thursday and Friday of last week but the rotation of the left arm is still difficult

No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.

Client was seen by his doctor on April 13th related to severe headaches . He stated that he had headaches prevaccine and was given Tropromax for it which he only took for 2 days as it caused him dizziness. He had CT scan of Head and MRIs on April 13 and 14th and then again on April 27th. The scan on April 27th showd a blood clot with 80% blockage in carotid artery and was dxd with a blood clot via CT scan. . He was told to get to Hospital where he was admitted to ICU for 4 days Client was also dxd with Factor5 Leiden at that time. Per client he ha a stroke and is recovering. Per client still unable to work r/t poor balance and dizziness

Chills, vomiting, dizziness/vertigo, loss of motor function of right arm and leg, arm and leg were weak, uncoordinated, unbalanced. Could not write. The symptoms starting on May 4 and have been ongoing. Course of steroids have helped but still continue to have symptoms.

THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient became unresponsive with gasping but remained with normal pulse, pt came to within a minute

PASSED OUT; LIGHT HEADED; DEHYDRATED; FELT WEAK; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure, controlled high cholesterol, stroke like symptoms in MAR-20219, however he was not diagnosed as having stroke because all tests were negative but he still had the symptoms, and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021 after vaccination, the patient felt weak but it was not significant. On 05-JUN-2021, the patient felt weak while doing daily activities. The patient had not felt anything and had breakfast. He got in the sun and got dehydrated as not had water for three hours during the day. Later, he got water. The patient had taken one drink of alcohol, sat down and got light headed then passed out for less than a minute. It was reported that, upon contacting emergency services advised patient to visit emergency room to check him as a precaution but the patient denied. It was reported that, the patient's heart, blood pressure, and blood glucose were normal. The patient was fine at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 05-JUN-2021, and light headed, dehydrated, and felt weak on JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210613161-covid-19 vaccine ad26.cov2.s-passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Pt claimed that after 6 days after vaccination, his left arm is still sore when moved. He also claimed that he is limited mobility of his left arm due to the vaccine with out feeling some level of pain.

Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.

patient experienced lower back pain, nausea, dizziness, tightness in chest, asthma symptoms patient went to see the primary doctor and was evaluated

Pt came in for the Jansen COVID shot around 11:00, after receiving it he went to the waiting area and a few minutes later seemed to momentarily pass out in his chair, his wife called us over and Pt described feeling warm and dizzy. He drank some water and ate a candy bar over the next few minutes. Pt continued to feel dizzy and was sweating. After a few minutes Pt appeared to continue having extreme syncope and we called 911. Paramedics arrived a few minutes later.

Skin flushing on neck, chest and back. Heart pounding, lightheadedness, 60 pt spike in systolic BP lasting over 1 hour. Tingling sensation on upper body including both arms.

I did not feel well for several days following the injection. I was tired and had a headache. However as the days went bye I stopped exercising and did not feel like working or even leaving the house. On the night of May 24 I began to have the worst headache of my life, my heart was beating irregular. By the morning of the 25th I got up and passed out. I was sweating, heart pounding, nauseous, chest pain, shortness of breath, pain in my shoulder blades.

1151? Patient stating "I am not feeling well". Patient dry heaved, no emesis. Patient diaphoretic and reporting nausea and dizziness. Legs elevated and code team called to immunization room. 1153? BP 113/77, HR?77, RR?18, 98% on RA. Dr. here to assess patient, code team at patients side. Patient sitting and refusing to lay down, Patient denies chest pain or shortness of breath. Offered juice, small sips. Offered crackers, patient refused. Dr. assessing patient, reports RRR, clear breath sounds 1200? Patient wanting to go home. Discussed with patient that symptoms need to resolve before being cleared to go. O2 sat 98%, HR 72 1205? Attempted stand. Patient reports 'spots'. Patient returned to sitting position. Discussed rationale for laying down. Patient refused. Feet elevated. 1210? Attempted stand, dizziness reported. Patient returned to sit. O2 sat 98% HR 71 1220? Advised patient to call for a ride and that patient should not drive self. Patient continues to reports dizziness with standing. Denies CP or SOB. 1235? Transportation ride called for patient for transportation home. Patient unable to find ride. O2 sat 98% HR 70 1240? Patient stating "I swear I feel 100x better". Discussed with patient MD recommendation that he not drive due to persistent dizziness. 1250? O2 sat 96% 81 HR Patient stating he wants to 'just leave'. Asked patient to sit down so we could notify MD of patients desire to leave. Patient stating he is better and does not want to wait. 1257? Dr assessing patient. Patient standing and ambulating without complaint. Patient stating he is "walking out the door", refuses transportation. Patient denies dizziness, HA, chest pain, or unsteadiness on feet. Patient advised by staff we did not recommend that he drive and should wait for transportation or other driver. Patient offered crackers and juice, declines. Patient ambulated out door and to private vehicle while being observed by staff. Patient drove car out of paring lot.