Johnson & Johnson

Within 7 hours had chills, muscle and body aches, fever, severe headache, abdominal and kidney pain, nausea. Within 27 hours of dose got my menstrual period 2 weeks early with a very heavy flow, despite being on birth control.

At approximately 1058, patient reported feeling lightheaded in vaccination chair. Painted closed eyes and slumped over in vaccination chair. Patient was slumped over for approximately 2 seconds. Nurse supported patient in vaccination chair. Patient opened her eyes immediately. Patient was alert and oriented to person, place, time and situation. Patient reported urinating in chair. Patient reported severe needle phobia, anxiety disorder and history of urination when exposed to needles. Patient given water. Patient able to drink water. Patient offered anti-gravity chair. Two nurses assisted patient into anti-gravity chair. At 1101, nurse assessed patient vital signs: blood pressure 107/84 mmHg, pulse 70 beats/minute, and SpO2 98%. At 1110, patient vital signs reassessed: blood pressure 110/80 mmHg, pulse 80 beats/minute, and SpO2 98%. Patient reported feeling dizzy. Patient given juice. Patient able to juice. At 1120, nurse reassessed patient vital signs: blood pressure 110/82 mmHg, pulse 76 beats/minute, and SpO2 98%. Patient report she felt "better". At 1132, patient reassessed. Patient reported not feeling anxious. Patient able to stand and reported feeling "a little lightheaded". Patient offered to stay for further observation. Patient refused to stay for further observation. Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on v-safe, and to follow up with primary care provider. At 1133, patient left facility with steady gait and unlabored respirations.

Initially patient felt feverish with body aches after receiving the vaccination but this improved after 48 hours. Two weeks after vaccination patient presented to hospital with ascending paresthesias and urinary retention. MRI cervical/thoracic spine with evidence of longitudinally extensive lesion from C6 distally to throughout thoracic cord. Findings overall concerning for transverse myelitis v demyelination.

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

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

Chills and fever were accompanied by sharp joint pains, severe throbbing and pulsating headaches (primarily on the upper right side) and migraines that developing into throbbing and pulsing in the entire body lasting for 10 hours; three fever cycles and the first lasted 10 hours before the fever broke in a sweat; I could not sleep the entirety of the first night and experienced hourly urination and intense dehydration. After first fever cycle I was alert for an hour before second cycle began; after third cycle symptoms changed to nausea and dizziness that prevented me from being mobile without assistance or upright for more than a few minutes, by Saturday evening symptoms went away and I could resume eating, drinking, and walking again

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

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

I had side effects starting one hour after the vaccine - headache and nausea. Muscle pain started 12 hours after and it spread to my other arm - my entire upper body ached. I was nauseous and peeing a lot for 2 days. I did have a few hives, 2 on my arm and 1 on my face and I had not eaten anything high in histamine. The weather that week was stormy and lousy. On Friday-Saturday, I had an intense bought of allergies (plugged dripping nose) and that is very rare for me, regardless of the weather. By Sunday, I had shortness of breath, nausea, and shaking. I tried eating and playing a game to get my mind off it and that didn't help. Usually with my anxiety, I can just tell myself I'll be okay. I told myself I would be okay and if I got a blood clot I would be perfectly fine. It did not work at all. This kind of anxiety was unlike anything I've ever experienced. Nothing I did helped and it felt like everything was going a mile a minute. I decided to take a benadryl, telling myself that this was just the "impending sense of doom" that happens with food allergies. I slept for 12 hours and felt exhausted when I woke up, like I had just been through something tough. I tried to just move past it, but the anxiety got worse and worse. I saw a doctor 06/23/2021 and have started taking Prozac.

Patient received the J and J vaccine June 20. For the next 4-5 days, patient had vomiting, fevers, chills. After that patient developed full body aches, cramps. Patient states that the initial pain was in the level of her spine and radiating down to her legs. She then states that she has and numbness difficulty with walking. She had walking difficulty especially when climbing up steps and initially later needed having help with ambulation. She also has reports that after initial symptoms 7 days after she started having some abdominal discomfort. Most recently she started having some urinary retention issues and was seen evaluated outlying hospital ER on 5th of July. Patient also states that on July 9 she presented a.m. to ER for facial numbness, right side of the mouth . She also has noticed some left-sided finger tingling because of were deficits patient present to ER. Neurology Consultation Note from 7/10/21. Pt is currently admitted to our facility currently. Right facial weakness new Paresthesias weakness Demyelinating process MRI brain with t2 flair hyperintensity differential ADEM vs CIS vs MS vs NMO spectrum disorder Left side ptosis hearing impairment chronic secondary to acoustic neuroma Low suspicion of GBS good distal strength 5/5 ankle bilaterally and knee except for left knee extension 3/5 intact distal reflexes ankle and patellar -Time of onset of symptoms was: Patient has had a progressive course of multiple neurologic complaints from June 20, 2021 when was reported that she received at a intake COVID vaccine -Had symptoms of: Initially had flu like symptoms, followed by bilateral lower extremity weakness, numbness, progressive to have urinary retention, facial weakness on the right side MRI brain Multifocal abnormal white matter T2 hyperintensities, most pronounced involving the subcortical white matter, left greater than right Abnormal signal within the upper cervical spinal cord. Diffusely low marrow signal on T1 imaging suggesting red marrow hyperplasia. Plan: LP ordered for tomorrow AM Follow up CSF results methylprednisolone 1gm x5 days will check blood sugars q.8 hours q4h neuro checks Message Lab for myelin oligodendrocyte glycoprotein (MOG) IgG autoantibody and the aquaporin-4 (AQP4) IgG serum autoantibody Follow up to see if sent.

Patient was about 15 weeks pregnant and this was her first pregnancy. Her anticipated due date was Oct 1st 2021. On April 9th 2021 during a scheduled doctor visit at 3pm both baby and mother were in good health. On the same evening after the appointment she went for vaccination at Pharmacy and received the J&J vaccine. After receiving the vaccine in about 15 mins she felt like urinating and noticed blood in the urine and felt vaginal dilation. Within the next 15 to 20 mins she started experiencing mild labor pains and contractions. In the next 30 mins she started bleeding and was immediately taken to the ER. In the ER it was confirmed that she was having a miscarriage and the fetus was delivered. She also had to undergo emergency surgery to remove any remaining placenta in the uterus.

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

Restlessness and jerking awake when trying to sleep, nerve pain in arms, organ pain particularly kidneys. It lasted about 24 hours from when it started. I?ve had this type of systemic reaction before to sulfa and ondansetron. I don?t know what ingredient in the shot I reacted too.

Nausea (has since subsided, lasted 2 days), stomach upset/cramping, lower abdominal pain, pain near reproductive organs, some urgency with urination

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

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

Numbing in right arm with extreme pain, unable to lift right arm, pain in hips, lowers, knees, and calves, extreme gas, chills, cough, weakness in legs, headache, dizziness, unable to hold urine when standing Treatment: Cold pack, sleep, ibuprofen - healing still ongoing

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

BRONCHITIS; VOMITING; NAUSEA; SORE LEFT ARM; BODY ACHES; POSSIBLE UTI; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hidradenitis suppurativa, penicillin allergy, latex allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the patient experienced body aches, chest pain, intermittent dyspnea, and sore left arm, which resulted in hospitalization. Patient was hospitalized on 13-APR-2021. The patient was discharged on an unspecified date. Patient went to another hospital as patient's symptoms did not subside. On APR-2021, the patient was diagnosed with bronchitis. Patient was not able to provide admission and discharge date. On 25-APR-2021, the patient experienced vomiting and nausea. Patient was additionally in contact with her health care professional regarding a possible urinary tract infection and/or yeast infection. Patient was not having any problem before the vaccine, even though patient can't say the Janssen Covid-19 vaccine caused her issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore left arm on APR-2021, and vomiting, and nausea on 26-APR-2021, had not recovered from intermittent dyspnea, and the outcome of bronchitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210413562- covid-19 vaccine ad26.cov2.s-Bronchitis,bodyaches. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

I am currently lactating and breastfeeding for 11 months. The afternoon that I got the vaccine I got a fever, lethargy and extreme fatigue. I was nauseous and I had diarrhea. My fever was 102. I started to feel better after three days. I also got aa headache that was similar to the Migraines I used to have. I hadn't had a Migraine for 18 months and I had a Migraine daily for five weeks. I went to the care facility eight days after the vaccine because I thought I had a UTI. The UTI was positive and I was told I had some Streptococcus B at the time. I was also experiencing confusion, and tiredness. One month after the vaccine I went back to the care facility because I was have having cramps in my lower abdomen and circulating to my lower back as well as my legs. All tests were negative but I was given multiple antibiotics. After eight weeks I still have lower abdominal cramping, vaginal discharge and headaches. Some of the symptoms were relieved by the antibiotics but they have returned.

Chills and body aches - within two or three days after the vaccine and they resolved pretty quickly. I became symptomatic with general UTI symptoms on or about the 4th or 5th of April. I haven't had one of these for about 7 years. I went to Urgent Care on 8th of April - I was put on two meds - antibiotic (Nitrofurantoin) and the other was for something to do with my bladder (Phenazopyridine). My symptoms have cleared up.

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

The night of the vaccine I had muscle aches and I started gagging. The muscle aches were better in a few days. I went to the Emergency room the night of the shot. I was diagnosed with a bladder infection. The urge to gag was constant. I was given some nausea medicine in the ER and it helped a little I became dehydrated after a week. I had no appetite and had the gag reflex problems for three weeks. I was diagnosed with a kidney stone about three weeks after vaccination. My anxiety was also bad during that time. I have been feeling better, less anxious and eating more for the last two weeks.

The same evening I received my vaccine I started experiencing the normal side effects of the vaccine - sore muscles, chills, nausea, headache, fatigue, and my skin hurt to touch on my thighs. I had a fever and muscle aches the following two days, but then felt pretty normal. I had some fatigue still, but was ok. Two weeks to the day after receiving the Johnson and Johnson vaccine I started having hyper-sensitive skin to the point that it was unbearable to have clothing or anything touching me. It started on my right arm just above the elbow. The next day it was on the inside of my arms and elbows. The next day it was my lower back and across my stomach at that same height, then it affected my hands, bottoms of my feet, and ankles. The hyper sensitivity gradually spread on my body, but lingering the longest on the trunk - stomach and back. However, it did affect skin on my entire body. It would prickle or burn sometimes too. When it's on my hands, my hands will ache too. I saw my primary care physician for that after a month of having the persistent symptoms. It's important to know that there was no visible reaction - no rash, redness, etc. To look at my skin, you wouldn't have known there was anything amiss. On April 19 I noticed in addition to the hypersensitivity I also felt like my hands weren't getting proper circulation. I could feel it from my elbows down to my finger tips. My hands felt cold and like a minor burning feeling. On May 3rd my joints started aching (felt it in butt /hips). I started taking ibuprofen and tylenol to try to ease symptoms and ibuprofen seemed to help a little bit with joint pain, but also helped a little with the skin hypersensitivity. It did not eliminate symptoms, but gave a little bit of a relief. From there I had that hypersensitivity down my legs, feet (also ached), chest, back, knees, stomach. In the middle of May I was having joint pain in my hands too. Around May 25th I started feeling a numbness sort of feeling in my knees, fronts of thighs, and feet. Less so in my hands at this point. Started feeling tingling, prickles, and like my feet were cold from in the inside. Felt like they weren't getting enough circulation either. On June 7, I noticed some balance issues. Since then, the balance issues have much worsened, and in addition, I've lost muscle control, experiencing weakness especially in my legs, having a lot of trouble walking, that stiffness is still there - I have trouble even bringing my knees up while standing. Having issues with going to the bathroom- urinating more often than usual, have had fecal incontinence, and feeling like my feet all the way up to halfway up my stomach are partially numb. My PCP referred me to a rheumatologist. I've had bloodwork done and the rheumatologist is now referring me to a neurologist.

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

Approx 8-10 hours after injection - severe muscle cramping all over body, neck pain, headache, frequent urination, chills, excessive sweating, heartburn, nausea (lasting approx 12 hours), followed by approx 8 hours of no symptoms. Muscle cramping and headache then returned for a duration of approximately 6 hours. 48 hours after vaccination, the injection site has become increasingly red, swollen and painful/itchy. Redness has grown substantially in the past 24 hours.

4-5-21 vommiting ,headache 4-6-21 spine pain , headache cont ,vomiting 4-7-21 spine pain , headache cont ,vomiting reaction to morphine and oxy (anaphalactic shock ) x 2 er visits 4-8-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping Er Visit 4-9-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping 4-10-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping ER 4-11-21- 4-14-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping 4-14-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss ,bladder incont. numb and teng in right side face and arm. facale swelling and drooping went to my PCP she sent me staright to hospital due to facial drooping and swelling in Face and convosiont/trimmeres. 4-22-21 spine pain , headache cont ,vomiting (min), seizures/ trimmers ,confussion/memory loss ,bladder i numb and teng in right side face and arm. facale swelling and drooping Fallow up with pcp waiting to see nerology for sezure activity 4-23-21-5-2-21 spine pain , headache cont ,vomiting, seizures/ trimmers ,confussion/memory loss . numb and teng in right side face and arm. facale swelling and drooping

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

FLUID IN THE BACK; HEADACHE; NERVE DAMAGE TO THE RIGHT FOOT; BLADDER INCONTINENCE; DIDN'T FEEL TUNING FORK OR COULD NOT SENSE TEMPERATURE OR SAFETY PIN PRICK; WEAKNESS IN BOTH LEGS; NUMBNESS IN RIGHT LEG; POOR VISION; CANNOT WALK; GENERAL WEAKNESS; SHARP PAIN BEHIND RIGHT KNEE; CRAMPS OF THE RIGHT LEG OR TIGHTNESS OF THE RIGHT LEG; EXCRUCIATING PAIN IN BOTH LEGS; PASSED OUT; PAIN IN THE RIGHT LEG; TEMPERATURE OF 104; This spontaneous report received from a patient concerned a 33 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm, on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included baclofen 40mg daily blood type O type. On 09-JUN-2021, the patient experienced pain in right leg that worsen throughout evening and that was leading to excruciating pain. Body temperature was taken and it was 104. After that patient passed out and slept through the night. On 10-JUN-2021 patient went to emergency room for pain and cramping in right leg, the healthcare provider at the emergency room was told to the patient the side effects from the vaccine. On next day patient had episodes of sever pain that persisted the entire day. On 12-JUN-2021 patient went back to emergency room with the complaints of severe pain in the right leg in addition to pain in right foot more specifically the last two toes, she was was urged by the healthcare provider to go to the hospital but the healthcare provider sent the her to home. On 13-JUN-2021 patient was continued to experience pain in the right leg as well as sharp pain behind the right knee which persisted all day, she took pain relievers but consumer does not recall how much was taken due to the length of time these events occurred. Next day 14-JUN-2021 she went back to emergency room and underwent to magnetic resonance imaging (MRI) due to experiencing tightness on the right leg, difficulty walking, general weakness and result was normal. On 15-JUN-2021, the patient experienced pain in the toes, burning sensation and she applied a cold pack and she felt shooting pain. She could not feel the temperature because they were numb. On next day 16-JUN-2021, the patient went to a primary care doctor's appointment and gabapentin was prescribed. The primary care provider also diagnosed consumer with weakness and numbness in right leg, and numbness in right last two toes, and poor vision. Same symptoms was continued to 17-JUN-2021. Next day patient went to neurologist and an assessment was done and she didn't feel the tuning fork and could not sense temperature or the safety pin prick. Poor vision was diagnosed as well as both legs are weak however it was noted that the right leg was weaker. On 29-JUN-2021 , the patient was admitted into the hospital for 11 days and diagnosed with the fluid in the back ,headache, nerve damage to the right foot. She was discharged to a rehabilitation center, which consumer stayed for one day and one night. On an unspecified date, the patient experienced bladder incontinence and cannot walk at this time. Patient was using wheelchair use. Patient had laboratory tests included, blood test and ultrasound the result were unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating pain in both legs, had not recovered from poor vision, headache, nerve damage to the right foot, bladder incontinence, weakness in both legs, pain in the right leg, cannot walk, and numbness in right leg, and the outcome of fluid in the back, general weakness, passed out, temperature of 104, sharp pain behind right knee, didn't feel tuning fork or could not sense temperature or safety pin prick and cramps of the right leg or tightness of the right leg was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210744094-Covid-19 vaccine ad26.cov2.s-Passed out, Nerve damage to the right foot, Fluid in the back.This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210744094-Covid-19 vaccine ad26.cov2.s-Headache. This event(s) is labeled per RSI and is therefore considered potentially related.

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

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

Pt received vaccine on 4/6, on 4/18 started to develop paresthesias in legs, numbness, hyperesthesia, blurry vision and difficulty urinating. She was admitted on 4/23 and MRI of brain/C-spine/T-spine/L-spine showing widespread demyelinating lesions mostly in T-spine. ADEM was primary consideration. LP showed lymphocytic predominance with about 130 WBC, elevated protein and normal glucose. Viral PCR of CSF and nasal swab were negative. Culture negative. She had acute urinary retention requiring foley catheter. She will be discharged today 4/25 with plans to follow outpatient for final MS serologies and neuro/optho follow up for final diagnosis.

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

I developed a large kidney stone. It was the first and only kidney stone I've ever had. I have zero history of having any precious problems or medical treatment for my kidneys. I passed the stone in mid May and had it for approximately one month.

Bilateral upper and lower extremity paralysis, jaw clenching, dystonic contracting of bilateral upper and lower extremities. Urinary retention.

Sunday, April 11 at 5:30pm: Chills, fever (101.4), body aches all over, heart racing Sunday night - peed 4 times that night 1. Monday: Fever (100.5), chills, body aches all over, heart racing, fatigued (did nothing all day but sleep) 2. Monday around 8PM: fever & chills gone, body aches still there all over my body, headache, fatigue 3. Tuesday: Body aches still bad all over and headache 4. Wednesday: Body ache a little better and headache, tingling/nubmness starts in both legs (faintly) 5. Thursday: body ache barely there, soreness in arm at injection site, tingling/numbness in legs (sharp pain) 6. Friday: tingling/numbness in legs - mainly back of my thighs - sometimes also feeling this tingling in my arms and upper back area 7. Saturday: same, tingling/numbness in legs/sometimes in arms/upper back, body still sore to the touch 8. Sunday: same, tingling/numbness in legs - sometimes also in arms and upper back, body still sore to the touch 9. Monday: same, same, tingling/numbness in legs - sometimes also in arms and upper back ? Called DR to speak with nurse about this as didn't feel normal to have this reaction, went into dr for appt on Tuesday, April 20. 10. Tuesday: Saw Dr. at 7:30am about tingling/numbness in legs - sometimes also in arms and upper back. Possible reaction to vaccine or more? Took labs/blood work: Vitamin B-12 (82607), Folic Acid Serum (82746), CBC / Platelets & Aut Diff (85025), TSH (Tyroid Timulating hormone) (84443), Metabolic Panel (80053), Quest blood draw (36415), Sed rate erythrocyte (85651) - ALL came back normal. 11. Wednesday: same, tingling/numbness in legs - sometimes also in arms and upper back, but the tingling this day got a little less intense. Not as painful today. 12. Had follow-up appt on Thursday, April 22 - took more tests. Tingling/numbness in legs but felt like Wednesday as a little less painful - didnt feel it as much in arms/back. Felt more like when your hand falls asleep and blood comes rushing back into it, thats how my legs felt this day, so more soreness than pain. 11. Friday: Symptoms same as the past 1 days, feel like tingling is getting a tad better.

sleepy, not operable, incontinent, nausea, vomiting, tremors in hands, numbness in legs, speech issues

Patient had a reaction immediately after the JJ vaccine. Patient passed out for 10-15seconds, her body stiffened up, she felt hot and then cold and started sweating excessively. Patients eyes closed briefly and then opened. Patient then became conscious and was unware what had happened. Patient is not on any medication and had not eaten all morning. After administering the vaccine a small amount of blood came out. I gave her a cotton ball to apply on the area and to hold. After 20-30 seconds she said she felt faint and hot all of a sudden. Her body then went limp and her eyes began to close. Her body then stiffened up for a few seconds. After shouting her name a few times she regained consciousness and was able to talk. she didn't realize what had happened. Her body was fine again but she had urinated during the episode. Upon speaking to the patient I learnt that she was nervous about the vaccination and she had felt dizzy in the past when giving blood. I observed the patient over the next 45 minutes. Her speech was fine, she was still a little light headed. She was in her seat for 40 minutes, then I asked her to stand and to move a little to see how she was. She was able to walk a bit but then sat down as she still felt light headed. She than sipped on water and continued talking and seemed to get some energy back.

Patient stated she started to feel dizzy and nauseated. I gave her a bottle of soda. As I was about to check her blood pressure, she seemed to lose consciousness. Her eyes rolled back in her head, and she seemed to be out of it for a few seconds. She came back to about 10 seconds later. She was pale, sweating, and had urinated on herself. I gave her a cold rag to wipe her face off. We called 911. Kept reminding the patient to take slow, deep breaths. Ambulance came and checked patient out, but she refused to be transported to hospital. I called to check on the patient later that night. She stated she had taken a nap when she got home, but was overall feeling better

Fever (100.2), lack of balance, body aches (mainly in legs), mild nausea, mild headache, brief period of incontinence, fatigue

Began having severe muscle aches followed by dark colored urine. Went to the emergency room and they determined I had rhabdomyolysis.

Suddenly developed moderate hives/welts on back. Spread to abdomen and chest, then neck and face withing 30 minutes. Was prescribed decreasing dose of prednisone. This was the morning of the 15th. As the day went on my thighs (both, very high up near groin) started aching. Uncomfortable to walk or sit for long periods. Getting worse as today, the 16th, has gone on. My hips are very achy and sore today. Hives have finally subsided.

Patient received COVID vaccine approximately one week prior to admission. Patient developed acute rhabdomyolysis requiring hospitalization. She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours. She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain. Upon arrival to the emergency room she was unable to lift her legs to get out of the car. In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0. She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500. She continued to worsen, developing increased swelling around the mouth and neck. She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.

On 3/7/2021 my body was aching and very sore. Later on 3/8/2021 headache, 3/9/2021 vomiting and diarrhea, 3/10/2021 I had aching muscles, 3/11/2021 I broke out in hives. 3/12/2021 I had anxiety very bad, arms gained a rash and hot. Went to the emergency room and was dehydrated was prescribed steroids' and benadryl. Loss hair and loss 10 pounds in two weeks. It also affected period, it started heavy and stopped. On 3/22/2021 I felt dizzy. On 5/21/2021 have muscle twitches and aches.

Arm pain immediately lasted for about a week. Very bad brain fog very hard to connect thoughts and speak the first couple days. Over a week later and I still have that but slowly getting better. Constipated since I?ve gotten the vaccine, can?t go without laxatives and even then it?s just a little. My body odor has been very bad since I got the shot,. Shooting pains in organs throughout lasting a few seconds at each time off and on during the day, has subsided since day 1. Light Kidney pain since the vaccine that hasn?t gone away.

On 03/10/2021 bad headache, fever, leg arm went numb . Headache lasted for three days, other symptoms went away after 24 hours. I had several A-VIB events in the 24 hours, and went into kidney failure, and was hospital for three days. The Thyroid, Cholesterol and kidney failure.

Trulicity was given but had been doubled as of 5/25/21 and started taking it as of 6/8/2021. This slowed digestion to a near stop. Kidney pain, lack of appetite, constipation, blood in urine. Doctor stopped higher dose and treatment reduced as of 6/19/2021. Dehydration was found at checkup and two bags of saline solution was administered.

Slight chills started to set in 8 hours after the injection. After an hour long bath, the chills were extreme. I shivered and sweated for 12 hours overnight with a severe headache. I tossed most of the night and had to get up to pee 3 times throughout the night - which is extremely uncommon. By 24 hours after the injection, I still had a strong headache and was mostly able to regulate my body temp. By 36 hours after, I felt tired but no longer had a headache or chills. My injection site is red, raised and very tender.

Pt seen in emergency room on 4/4 for abdominal pain and vomiting that began the evening of receiving her covid vaccine. Pt found to be in fulminant liver failure and ultimately transferred to a tertiary level care center at hospital.

Violent chills, fever, muscle stiffness, muscle pain, sharp nerve pains, mild shortness of breath, stomach upset, frequent urination, fatigue, brain fog

pt says she had some uncomfortableness in her private area the morning she woke up to get her vax. She urinated before getting the vax. About 30 minutes after taking the vax she has to urinate again and she had pain while urinating and blood clots in her urine. She contacted her PCP and was told to the emergency room. On 5/5/21 she went to ER. They took vitals and gave her a urine test. Pt was diagnosed w/ UTI. They told her that the vax had flared up this condition. They gave her Nitrofurantoin mono-mcr 100mg and Phenazopyridine 200mg. She has other flu like symptoms including cold sweats, shivers, and body aches and pain, body is hot to the touch but no fever.

KIDNEY PAIN; LOWER BACK PAIN; PAIN IN LEFT SIDE; DIZZY; VOMITING BILE; NAUSEA; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removed, and concurrent conditions included anxiety, and post-traumatic stress disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced dizzy. On 22-MAR-2021, the subject experienced vomiting bile. On 22-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced kidney pain. On 26-MAR-2021, the subject experienced lower back pain. On 26-MAR-2021, the subject experienced pain in left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting bile, had not recovered from nausea, kidney pain, lower back pain, and pain in left side, and the outcome of dizzy was not reported. This report was non-serious.

I experienced after my J&J vaccine at about 8pm, felt very fatigued with pain at the injection site, felt like drunk feeling which lasted one week. The main thing is that I slept a lot and was unable to work which lasted 9 days. The thing that I went to urgent care for pelvic pain, body aches and pain, developed an UTI and my symptoms cleared at home with medications. At the urgent care lab work and urine culture was performed. When I went to the urgent care they said I also had tachycardia. My symptoms have resolved.