Johnson & Johnson

Mother of patient describes chills, fatigue, and kidney pain. Is being exclusively managed by PCP who has seen him multiple times. Given Jannsen at mass vaccination clinic by student nurse under preceptor supervision. Error not brought to attention of until 4/2/2021.

Within 8 hours, muscle weakness and joint looseness. By 14 hours, fever 102, severe kidney pain, entire body muscle and joint pain.

18 y/o male received J&J vaccine. Five minutes after being vaccinated, pt complained of nausea. Patient presented with pale skin, diaphoretic, and incontinence of bladder in the observation area. Pt lost consciousness for 15 seconds in the car. After 15 sec, pt regained consciousness and was able to walk and talk. EMT brought the patient into the observation tent to lay on the cot. EMT obtained 4 sets of vitals and completed orthostatic vitals. Last set of vitals are: 10:15am: BP 103/60, Pulse: 74, Respiration 18 and O2 98% on room air. Blood Glucose level was 106. Pt returned back to normal state after 15 minutes in observation. Pt was no longer diaphoretic, pale, or nauseous. Pt is stable, alert, and oriented x4. Pt is walking and talking independently. No EMS services needed. Pt was instructed to follow up with the nearest ER, if symptoms return or worsen. Pt left with his mother, who is the driver.

Patient had a vasovagal response and passed out about a minute after the actual injection of the vaccine. He was unresponsive, was twitching, urinated himself, and when he woke up was slightly confused.

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 Dr, 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, NP tried multiple times to reach out and follow up with pt. Pt did not respond to his PCP.

The patient had a needle phobia and was very anxious prior to the vaccine. Once the patient received the vaccine, he waited in the waiting area for 15 minutes post-vaccine. About 5 minutes after the vaccine, he notified the pharmacy staff that he wasn't feeling well and he was feeling faint. The pharmacy staff provided him with a glass of water and was monitoring him. He said he felt like he fainted and wasn't feeling well. He said he felt warm and sweaty. The pharmacy staff provided him with an ice pack. He then notified the pharmacy staff that he urinated in his chair while waiting post-vaccine. He wanted to be checked out and wanted us to call 911 . The patient began to feel better after about 20 minutes. The EMT arrived and checked the patient. Even though, the patient was feeling better, the EMT recommended the patient be checked further anyways. He was brought to the Triage center and was there for about 1 hour, according to the patient, and was feeling better. He said he felt slightly fatigued that day and the following day, but other than that he was feeling back to normal and no issues. He stated he has severe needle phobia and has experienced these fainting spells and anxiousness in the past. We followed up with the patient and he provided this information to us. He stated he was feeling good and back to normal. He had no further questions or concerns. We told him to follow up with us if questions or concerns came up.

The patient began experiencing nausea and light-headedness around 11:00 P.M. on the 6th of April. Three hours later, he reported lower back pain that steadily increased in severity over the course of several hours. Throughout that same night, severe headaches and impaired kidney capacity (i.e. constant need to urinate about every hour) kept him from sleeping longer than two or three hours. Come morning of the 7th (roughly 8:30 A.M.), he took a single capsule of ibuprofen and performed various lower back stretches in addition to walking around the house. During this time, he experienced a gradual decrease in symptoms and was able to eat a small meal. The patient returned to bed two hours after taking the medication and slept without any further interruptions.

Patient had hx of feeling dizzy/passing out following vaccination as indicated on consent form. Patient began feeling dizzy and sweaty after administration, but during counseling. Patient passed out in chair and urinated. Patient was awoken and given water, then requested to wait while a family member could come to pick him up with a change of clothes. Patient felt well enough to leave with father approximately an hour after fainting.

Within 2 minutes of getting vaccine, patient said he felt 'light, sweaty and like he was going to throw up.' Staff attended to him and he almost immediately slumped over and was unresponsive. While being moved to the floor, he stiffened and arched his back and had urinary incontinence. Seizure like activity lasted less than 30 seconds. EMS was called at 1347 and arrived at ~1355. At 1345, 128/80, HR 63, 02 sat 97%; at 1350 BP 122/80, HR 73, RR 18, 02 sat 98%. Pt was alert by 1350 and remained alert while he was evaluated by EMS. EMS offered pt evaluation at hospital and pt declied. He said he would f/u with Doctor. Roommate was called and provided transportation home for pt. Pt was called 3 hrs later and he said he was doing well.

Patient received COVID vaccination and was waiting his 15 minutes in the waiting room, a few minutes after injection, his GF called me over because the patient passed out. As I approach, patient was coming to as he was peeing himself. Patient reported that he felt lightheaded and then did not realize what happened. Gave patient some water and took his blood pressure. His DBP was a little low around 49. Had the patient sit there for another 15 minutes and took blood pressure again and it was 104/60.

After taking the vaccine husband started to feel a bit dizzy then 30 seconds later his whole body when into a shock and no longer control himself and started to shake a little. He had his eyes open but was unconscious for about 1 minute. Then he released his bladder and peed on himself. The pharmacist noticed and came over then he responded and was consious again. Then he began to sweat excessively all over his body. His face turned pale and the pharmacist began taking his blood pressure which dropped very low. He then began to feel nauseated. Then he started to get body chills. We monitored my husband there for another 30min and he slowly was coming back to his normal self. He had a small headache but was fine enough to leave.

URINATION DIFFICULTY; DIFFICULTY HAVING BOWEL MOVEMENTS; NIGHT SWEATS; ACHES AND PAIN IN JOINTS; ACHES AND PAIN IN LEGS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 170 pounds, and height was 60 inches. The patient's concurrent conditions included smokes marijuana, alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced night sweats. On 04-APR-2021, the subject experienced aches and pain in joints. On 04-APR-2021, the subject experienced aches and pain in legs. On 04-APR-2021, the subject experienced severe headache. On 05-APR-2021, the subject experienced urination difficulty. On 05-APR-2021, the subject experienced difficulty having bowel movements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and severe headache on 09-APR-2021, and had not recovered from aches and pain in legs, difficulty having bowel movements, urination difficulty, and aches and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: after receiving the J&J vaccine on 6/5/21 about 1.5 minutes after administration the patient hit his head against the wall and was unconscious. the patient started to mildly seize and lips started turning cyanotic and the patient urinated himself. The whole episode lasting about 45 seconds. When the patient came to he informed me that was epileptic. I kept the patient in the supine position until the paramedics arrived on the scene shortly after.

STOMACH ACHE; LOSS OF APPETITE; DIARRHEA; NAUSEA; NUMBNESS FROM HEAD TO LEGS ON LEFT SIDE; FEVER; PAIN IN KIDNEYS; This spontaneous report received from a patient concerned a 24 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: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in kidneys. On MAR-2021, treatment medications included: paracetamol. On 31-MAR-2021, the subject experienced numbness from head to legs on left side. On 31-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced nausea. Additional treatment medications (dates unspecified) included: calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, loss of appetite, diarrhea, and nausea on APR-2021, numbness from head to legs on left side on 31-MAR-2021, and fever on 03-APR-2021, and the outcome of pain in kidneys was not reported. This report was non-serious.

About 9 hours after getting my vaccine, I started noticing my temperature rising to ~99.0. About 1 hour later (12 AM), it had risen to ~103. I also noticed my heart rate was extremely high (on average 140 bpm, the highest was 225 bpm); this was also accompanied by chest pains which seemed like they were on the right side of my heart; I also had difficulty controlling my bladder and would randomly start to urinate. I had taken two Advil then slept. The next day (~9 am) my fever went down but 3 hours later it had gone back up to ~101, I eventually kept cooling myself (removing shirt, fan on high, etc.) and took one Advil and my temperature started to get normal. For about two days after that, I had pain in my left shoulder - but this was where the injection took place so I wasn't too worried. Currently I am feeling fine, but the initial day getting the vaccine was quite harrowing - I was quite worried I was going to have a heart attack.

while in post vaccination observation, client thrust head back into the wall, while in a seated position. Became unconscious. Left arm tremor- observed. diaphoretic, skin warm to the touch, sweating. When client became alert and oriented, he was fearful of the situation and began to cry. stating he didn't know what happened, he was scared, and he was dizzy and didn't feel well. Patient given emesis bag, given water and Ice pack. He also reports no ability to alert anyone prior he had no physiological indicators of what was about to happen. He urinated himself. He then had the second emesis and EMS alerted and on site to assess patient .

I ended up with a Kidney stone two weeks after taking the vaccine. I had intense pain in my right kidney and it was very painful overnight and the following day the nursing line advised that I go to the Doctor's office (stayed home and went to the Doctor's office for testing the next day). My Doctor advised that I passed the stone and to change my diet so it doesn't happen again).