Johnson & Johnson

Nausea, vomiting, headache, body aches, fever and chills. Treated with ES Tylenol 500mg -2 tabs. Ondansetron ODT 5mg tables. 1 liter NS intravenously. Urine specific gravity 1.030 at admission to clinic. Observation 4 hours. Fever resolved, headache and body aches resolved, nausea resolved. Repeat urine SG at discharge 1.005. Ambulatory out of clinic.

Frequent urination Insomnia ( unrelated to frequent urination) Feelings of severe dehydration Muscle ache Headache

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

BLOOD IN URINE; FEELING BAD; BODY ACHES; CHILLS; EXHAUSTED; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iga nephropathy, non-smoker, and non alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced blood in urine. On 11-APR-2021, the subject experienced feeling bad. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood in urine on 13-APR-2021, and chills, was recovering from feeling bad, and had not recovered from body aches, and exhausted. This report was non-serious.

I have had Pain and soreness throughout the entire left side of my body.. and very sore left side kidney area pain. the pain runs from the side up through my arm and into my neck

After approximately 12 hours of receiving the vaccine shot my entire body ached. Every muscle in my body was tight, making it difficult to move. I also experienced a strong headache behind the eyes, and difficulty urinating.

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

Sore arm, headache x 2 days. Severe myalgias and Rhabdomyolysis developed after 5-6 days. Briefly, 30 yo gentleman h/o bipolar disorder, opioid use disrder (on methadone), nicotine use disorder (vaping), recent Janssen COVID vaccination (about 1 week ago) who was admitted with a few hours of myalgias and dark urine, notable recent moderate exercise and over-ingestion of gabapentin. For Rhabdomyolysis: 4/16/2021: CPK peak 95,694; AST peak 779, ALT peak 282, Cr 1.0, Plt 279 Treated with aggressive IV hydration with improvement.

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

BATHROOM FREQUENCY/WENT TO BATHROOM ABOUT FOUR TIMES; URINE WAS LIKE A LIGHT PINK COLOR; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 03-MAY-2021, the subject experienced bathroom frequency/went to bathroom about four times. On 03-MAY-2021, the subject experienced urine was like a light pink color. The action taken with covid-19 vaccine was not applicable; and action taken with adalimumab was not reported. The outcome of the bathroom frequency/went to bathroom about four times and urine was like a light pink color was not reported. This report was non-serious.

Patient had seizures for an unknown time and urinated in his seat. Pharmacy is next to an urgent care so the doctor from urgent care checked him in to make sure vitals were stable. Unknown outcome.

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

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

FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported. On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

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

I was diagnosed with Transverse Spinal Myelitis at ER in town on April 27th. I had been suffering from sever back and neck pain for over a week. I reported to the ER due to the inability to void my bladder. I had full back, neck, and Brain MRI?s after being admitted to the hospital and neurologist Dr. made the diagnosis of Transverse Spinal Myelitis. I spent 3 days in the hospital and received 5 IV steroid treatments to treat my condition.

SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.

4/8 got vaccine. Then on 4/20 patient developed myalgias in back, legs, and jaw and headaches, tingling in hands, normal strength. Then on 4/25 developed Bells palsy treated with prednisone and valcyclovir for possible meningitis (no LP). Full body pain particularly in LE persisted even though Bells palsy resolved. He then developed confusion and intrusive thoughts, as well as urinary retention. He was direct admitted to our hospital. Neuro exam was notable for diffuse myalgias and 1+ patellar reflexes bilaterally. Patient was treated with gabapentin for neuropathic pain control, urinary hesitancy improved, no strength deficits. Lumbar MRI showed cauda equina enhancement consistent with ascending infectious or inflammatory process like GBM.

Possible kidney infection or inflammation in the kidneys. Blood in urine and raised creatine levels in blood. Fever, light headed, near faint incident.

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

Muscle Aches, EXTREME kidney pain (I'm going to drink cranberry juice after work, Hopefully that will help)

MARCH 9: BODY ACHES AND HEADACHE, SLEEPLESSNESS. CONTINUED OFF AND ON OVER FOLLOWING DAYS. MARCH 18: BLOOD PRESSURE AND PULSE WERE TOO HIGH TO DONATE PLASMA MARCH 21: DIDN'T FEEL NORMAL, GASTROINTESTINAL ISSUES, FATIGUE, SLEEPLESSNESS, ABDOMINAL PAIN, RAPID WEIGHT LOSS, LOSS OF APPETITE MARCH 26: URINE STARTED DARKENING TO ORANGE COLOR DESPITE STAYING HYDRATED, FEVER, MALAISE. APRIL 1: WENT TO DONATE PLASMA AT BIOTEST PLASMA CENTER AND NOTICED BLOOD PLASMA WAS AN ODD COLOR. APRIL 4: EMERGENCY ROOM PRESENTED WITH ABDOMINAL PAIN, JAUNDICE, WHITE/LIGHT COLORED STOOL. BLOODWORK, ULTRASOUNDS, CT'S WERE DONE AND SHOWED INFLAMMATION IN LIVER/GALLBLADDER/GI TRACT. HIGH BILIRUBIN. APRIL 5: COLONOSCOPY PERFORMED. DIAGNOSIS: ULCERATIVE COLITIS. ERCP PERFORMED WITH LIVER BIOPSIES. DIAGNOSIS: COMMON BILE DUCT BLOCKAGE WITH CHOLECYSTITIS AND HEPATITIS. STENT WAS PLACED. POSSIBLE PRIMARY SCLEROSING CHOLANGITIS- DEPENDING ON BIOPSY RESULTS. APRIL 6: CHOLECYSTECTOMY, MORE LIVER BIOPSIES TAKEN. APRIL 7: LIVER BIOPSY RESULTS/DIAGNOSES: OVERLAP SYNDROME OF AUTOIMMUNE HEPATITIS & PRIMARY SCLEROSING CHOLANGITIS. PLACED ON PREDNISONE. AWAITING APPROVAL FOR REMICADE INFUSIONS WITH POSSIBLE NEED FOR LIVER TRANSPLANT IN THE FUTURE AS PSC PROGRESSES. AS OF APRIL 18: JAUNDICE STILL PRESENT, BILIRUBIN NOT DECREASING. BEING REFERRED TO MEDICAL CENTER FOR FURTHER OBSERVATION AND TREATMENT.

High fever (103.1F), difficulty urinating and sever chills within 12 hours of vaccination. Maintaining 100F fever 24hrs post vaccination

2021-03-20 07:30 PM - chills, 11:00 PM - vomited, 11:30 PM- seen in the Emergency Department 2021-03-21 11:30 AM - fatigue, somnolescence, nausea 2021-03-22 08:00 AM - nausea, 11:30 AM - altered mental status, vision loss, headache, balance problems, numb left arm and hand, hypoxia (SpO2 < 50%), 01:00 PM - seen in the Emergency Department, 03:00 PM Creatinine > 6.8, eGFR < 10

Fever, muscle aches, fatigue, headache, burning while urinating. After 2 weeks of a fever which would have 100 degrees and peak at 102 I went to the doctor on 3/29 and was diagnosed with a kidney infection. I was prescribed cipro 2x day for 10 days.

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

36 Y male patient from another country with a past medical history significant for mild HTN (on 2.5 mg amlodipine) who was in his usual state of health until approximately 4/17/21 when he developed acute onset left volar forearm tingling sensation. He had received the Johnson & Johnson vaccine on 4/2/21 in his left arm and states that he did not experience any noticeable reactions after vaccination. He also recalls having had sustained a minor superficial scrape on his left volar forearm by a trash can lid when he had taken out garbage, which occurred very shortly before the onset of this tingling sensation. The tingling sensation then progressively worsened and became more diffuse across most of his body. He then developed fevers up to 102 at home, chills, neck pain, headache, and pain in all extremities (primarily arms but also in his legs). He initially went to the Health Care ED on 4/28/21. He was afebrile at the time and his vital signs at that time were unremarkable with the exception of elevated diastolic blood pressures (90-104 mm Hg). WBC 10.1 with normal differential, electrolytes and liver enzymes within normal limits. Influenza, RSV, and SARS-CoV-2 PCR were negative. Urinalysis showed few bacteria but no WBCs. Chest x-ray was clear. Blood cultures were drawn and patient was then discharged. Patient returned to the ED on 4/29/21 and reported fever to 102-103 d F, chills, nausea, weakness, body aches, and bilateral foot paraesthesias. He was afebrile (98.8) and his vital signs were within normal limits. His WBC was slightly elevated to 12.2 with a normal differential. His ESR was 11, CRP 1.5, CMP within normal limits. He was noted to have urinary retention and a foley was placed and he was given tamsulosin. Patient then returned to the ED again the following day, on 4/30/21, with worsening generalized pain and weakness and difficulty walking. ED course: temperature 101, heart rate 100s-110s, BP 140s-160s/70s-90s, RR low 20s, SaO2 high 90s. Labs remarkable for WBC 13.1 with 82.4% N, ESR 7, CRP 5.9, lactic acid 2.6, RF 10, urinalysis unremarkable, HIV antigen/antibody negative. Several imaging studies were performed. MRI T spine showed "Extensive cord signal abnormality in the cervical and thoracic cord as detailed above, with associated expansion of the cord (most pronounced in the cervical cord). Differential includes acute transverse myelitis, demyelination, infection (HIV, syphilis, other viruses)/parainfectious phenomenon, subacute combined degeneration, and inflammatory etiologies. An underlying mass or masses are not excluded but less likely given extensive multifocal patchy involvement. Recommend postcontrast imaging at this time for further workup. Consider brain MR as well to assess for systemic white matter disease." A lumbar puncture was attempted in the ED but was unable to be performed. Patient was given empiric IV ceftriaxone 1 g q24h and admitted to the hospitalist service. He was evaluated by neurology and was started on Solumedrol 1000 mg for acute transverse myelitis. 5/1/21 MRI brain showed "Multifocal patchy white matter signal changes, predominantly in the subcortical white matter, also present in the bilateral thalami and bilateral middle cerebellar peduncle, and redemonstration of extensive cervical cord signal abnormality and expansion. No associated restricted diffusion or enhancement. Broad differential, but given pattern of involvement findings are most concerning for ADEM (acute disseminated encephalomyelitis), other considerations include other demyelinating processes, toxic-metabolic pathology, or potentially atypical viral infection." Patient was given methylprednisolone for ADEM with transverse myelitis and clinically improved. He was hospitalized from 4/30/21 until being discharged to home in a wheelchair on 5/6/21.

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

While sitting down during the post-vaccination period, patient asked his wife for water about 10 minutes after receiving vaccine. Pharmacy staff provided water and pharmacist went over to check on the patient. Patient expressed feeling "hot" and wanted an ice-pack, which was given. Patient expressed feeling "faint," after which he briefly lost consciousness. Pharmacist immediately started checking for pulse and obtained Emergency Kit. Patient regained consciousness quickly without need of CPR or administration of Emergency Kit medications. At some point patient also released his bladder, most likely during the syncope episode. Patient expressing feeling "nauseous" and asked for something to throw up in. Pharmacist quickly got a trash can and gave to patient, shortly after which patient started vomiting. Pharmacist was attending to patient and asked patient if he wanted 911 to be called, to which he replied "No" and that he just needed some time to sit. Patient also stated he did not eat much that day. Pharmacist offered Pedialyte, to which patient agreed, in order to replenish fluids/electrolytes lost due to vomiting. Patient also asked for some crackers since he did not eat much earlier. After taking sips of Pedialyte and taking bites of crackers, patient could not hold anything down and continued to vomit. At that time patient's wife asked pharmacy staff to proceed with calling 911. 911 was called and paramedics took patient's vitals upon arrival at the scene. Vitals were all stated to be normal. Patient agreed to be taken by ambulance to the hospital. A couple hours later patient's wife informed pharmacy staff that patient was doing much better and was expected to be released from hospital soon. Before receiving vaccination, patient did share that in the past he had "felt faint" when giving blood but it was not made clear that patient had felt faint or fainted during vaccinations prior. After the incident patient's wife confirmed that patient had fainted in the past both after giving blood and after receiving vaccinations. Pharmacist called patient at 9:12 AM the following day (4/3/21) to see how patient was doing but was only able to leave a voicemail message.

Left-sided face numbness and tingling in tongue approx. 12 hours after receiving the shot Extreme fatigue, back pain/kidney pain, joint pain, extreme pain in both feet, vertigo, ringing in ears, stiff neck, back pain, heaviness in legs, difficulty sleeping, brain-zaps (forget my thoughts)

-Active symptoms : Right lumbar kidney area intermittent pain has been happening since vaccinated. -Inactive symptoms: Flu like symptoms for 2 weeks only. Fatigue for 3 weeks

day followimg shot: i awoke to extreme pain in all muscles and joints, profuse sweating, blurred vision, headache just behind my eyes muscle/joint pain lasted approx 24 hours; ibuprofen offered some relief. sweating lasted 3 days and resulted in dehydration to the point where my kidneys ached; i drank as much water as i could but my urine remained dark headaches/blurry vision lasted 2 days 5 days after the shot, the soles of my feet began to feel itchy, and the itchiness has been ongoing even up to now (7 days after shot) 7 days after shot, itchiness has also begun affecting the palms of my hands

New onset headache, eye pain, paresthesias, and urinary retention 2 weeks after getting covid-19 vaccination on 5/14/21