Johnson & Johnson

Began as Dizziness on 3/31, then double vision, vertigo. Adm to The Hospital on 4/1. Diagnosed with TIA. Home next day. Now on hear monitor.

FEELING LIKE SINUS INFECTION; HEADACHE; NIGHT SWEATS; PAIN IN LEFT EYE; BURNINIG IN BOTH EYES; PINK EYE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23/JUN/2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced night sweats. On 08-APR-2021, the subject experienced pain in left eye. On 08-APR-2021, the subject experienced burninig in both eyes. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced pink eye. On 09-APR-2021, the subject experienced feeling like sinus infection. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and muscle aches on 09-APR-2021, had not recovered from headache, and feeling like sinus infection, and the outcome of pain in left eye, burninig in both eyes, fever and pink eye was not reported. This report was non-serious.; Sender's Comments: v0- Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.

Three days after vaccination developed symmetric weakness in both legs, myalgia, difficulty walking, dysarthria/dysphagia, along with shortness of breath and right eye drooping. Also recently (4/13/2021) treated with nivolumab/ipilimumab so immune checkpoint inhibitor toxicity is suspected.

I was unable to pin down onset of symptoms. Patient was vaccinated on 04/10/2021 and sometime thereafter developed dizziness and double vision. Patient visited his ophthalmologist on 04/22/2021 and was advised to contact his PCP to schedule and MRI to rule out stroke. Patient is insistent that this needs to be reported despite my explanation that his symptoms are probably not vaccine related. I strongly advised patient to see his healthcare provider for further evaluation or go to the ED of local hospital.

Tinnitus is "louder" than before. Before my vaccination, the tinnitus was only noticeable when it was very quiet, and sometimes not even then. Now it is an almost-constant background noise. So far, it does not interfere with my hearing.

No appetite for days. The smell of food made patient sick. On week two after vaccine, oxygen stayed at 84%, patient couldn?t stand as he had no energy. Patient began to eat after lots of convincing and seemed to be doing at least 20% by week 3, but oxygen was still in mid 80%. On day 20 after vaccine patient had to be rushed to the ER due to sepsis. All vital organs began to fail and on transport patient suffered a mild heart attack. Patient was a healthy 78 year old male that lived alone and drove and had no major health issues before the date of the vaccine.

Per patient upon completing the 15 minute observation period, he experienced ringing in the ears. He said that he had this years (3-4) years ago but hasn't happened since then. He said that the ringing wasn't too loud in the ears but it was there. He left to go shopping and said he'd return if the ringing didn't stop. He came back about 20-30 minutes later and was still having the ringing. It was louder than before but he was still able to hear me talking to him. He said he was okay to go home and would call us if it got worse.

Systemic itching and hives; swelling of lips, inside of the mouth and throat. Seen at ED. Treated with IV fluids and steriods. Released to home after several hours. Physician believes it was from the vaccination and ruled out any other cause(s) for the reaction.

Vaccine was given on 4/1/21. Symptoms started 4/2/21 in the afternoon. Symptoms were described as teeth/gums hurting. At 12:30 am on 4/3/21 his mouth was very swollen and he couldn't talk. Also he had trouble breathing. He went to the ER and was given IV solu-medrol. Patient was sent home 30-40 minutes later with the instructions to take Benadryl PO. In the morning they purchased some benadryl and gave it PO every 4-6 hours all day Saturday, 4/3/21. On Sunday, 4/4/21 at about 5:30 am his gums and lips were swollen again. He made another trip to the ER and was given solu-medrol IV again and PO methylprednisolone for 5 days. At this visit, they also gave lasix IV due to extra fluid around his heart. He was told by the ER provider that he developed congestive heart failure due to the vaccine. Patient followed up with his primary care provider on 4/8/21 and was told that his symptoms of congestive heart failure had resolved. Patient also reported his symptoms of swollen gums and mouth had resolved at this time.

Patient woke up on 4/8/2021 around 0700 with complaints of double vision. The double vision is ongoing. On 4/9/2021 patient still had double vision and then stroke like symptoms at 0700. Patient had slurred speech and right arm weakness. As of 4/14/21 patient still has double vision but weakness and slurred speech has resolved. Patient is a DNR so he did not seek medical care.

CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported. On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and gums started hurting, gum swelling. 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).

The patient presented with chest pain around 5 pm on 4/4/21. Patient reported "pain came out of nowhere." Patient reported pain was non-exertional and non-positional. He described it as "a constant burning sensation" located in the center of his chest with radiation upwards toward his jaw and shoulders, bilaterally. He was transferred to COVID unit, became hypotensive, hypoxic was seen by house MD. Lung exam crackles bilaterally. IV fluids stopped, patient was given 40 mg Lasix, Morphine 2 mg and started on a small dose nitroglycerine drip. POX 70s, low 80s so Bipap ordered. Patient developed v tach and arrested, resuscitated, defibrillated, received multiple meds, intubated by anesthesia, transferred in ICU on Levophed and Epinephrine. Arrested in ICU. Lines were placed by ICU team, arrested again in ICU. Was maxed out on 4 pressors, despite CPR, pulse could not be obtained, patient was pronounced dead 4/6/21 at 3:31am. 1. Triple vessel CAD 2. Moderately severe LV dysfunction with and EF 30% 3 The recent NSTEMI is secondary to the occlusion of the SVG-OM1. There is a large thrombus in the SVG which makes PCI of this vessel unlikely to be successful. 4 The native OM1 is chronically occluded. It may be possible to attempt to open this with CTO techniques, however, at this time continued medical treatment. 5. Perclose

4/15/2021 approximately 1030 am client found to be AMS, non-responsive, aphasic, aphagic, left-sided facial droop, teeth clenched, left eye closes, right eye with deviated gaze. 911 called, client to hospital ER, work up/evaluation, admission for stroke related to blood clots found left frontal and right temporal lobes, per spouse. Client discharged 4 days later to home s/p CVA, bed-bound, remains aphasic, aphagic, non-communicative, no response to verbal stimuli. PLEASE NOTE: hospital admission. Unable to complete section 21. Admit for 4 days.

CHANGES IN VISION; HEADACHE; This spontaneous report received from a patient concerned an 80 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced changes in vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of changes in vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521409.

1 WEEK AFTER VACCINATION- EXPERIENCED HEAD ACHES , SORE THROAT AND EAR ACHES. AROUND 2 WEEKS- PATIENT. FELT DIZZY AND PASSED OUT. STILL HAS SOME BRUISING IN THE ARM NEAR BICEPS.

Patient would like it on record, patient had the Johnson and Johnson Covid Vaccine on Saturday 4/10, right after taking the vaccine, patient felt a sensation rush to the top of her head and throat, she got dizzy in the top of her head and had a loud noise in her left ear, patient states all symptoms subsided Sunday morning

Pt developed L eye vision changes on 3/17/2021 but did not seek medication attention until 3/22 when he saw ophthalmology and was advised to go immediately to ER. After a temporal artery biopsy to r/o temporal arteritis and head/brain imaging studies, he was diagnosed with non-arteritic anterior ischemic optic neuropathy. He was treated and discharged home with close follow up. On 4/5/2021, he developed hematuria and was again hospitalized and found to have an obstructing L ureteral stone. Pt was hospitalized 3 days for first issue, 7 days for second issue.

The day after the injection, my lips and tongue became swollen. Saliva dwindled to near-nothing but occasionally dribbles from the left mouth corner . Could not whistle. Could not speak a clear 'esss'. Speech impeded. Mouth and lips 'puffy'. My ability to taste became severely limited. Today, 11 days later these symptoms are reduced to perhaps 30% of the worst values on about the second day after the injection.

Summary: dose exacerbated two of my allergic symptoms. Approx 33 hrs after receiving dose, noticed my eyes were "stinging", (symptom I have, spring and fall for a day or two each, controlled by Patanol 1 drop ea eye BID. (Did not use the med at this time), although I followed my usual routine of un educated "tears" in the eyes at bedtime and 2x in morning. Awaking next morning found eye surrounds (lids, ...) were quite puffy, perhaps 1/4 "swollen shut", eyes still stinging though still not terribly so. Also noted morning breath measurements (Peak flow, FEV1, on a hand-held device) were 5-10% lower than normal. No "sore arm" or other musculature symptoms. At ~ 50 hours post-vaccine, am "better", will now go use some Patanol.

Apr 10, 2021 ? Jan and I both received Covid-19 Immunization at The Event Center using Janssen (J&J) 042A21A Apr 11, 2021 ? Awoke with slurred speech. Left side of face a little droopy. Vision partly blocked by what I thought was droopy eyebrow. April 12, 2021 ? Made appt to see Dr. After initial checkout and some discussion she sent me directly to ER. Arrived and was checked in and admitted; IV installed, CT Scan, chest ray, MRI and many other tests were administered. One was X_RAY recording me as I drank barium water. I was diagnosed as having had a Stroke by Drs as well as resident Physician. My dosage of (Imdur) Atorvastatin was increased to 80 MG per day. Other meds remain the same. @ Dr: 226.4#, 95% ox, 56hr, 120/72 bp hospital has complete records.

URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, 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 administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. 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).

hypedrthyroid,treated with methimezole for1 month waiting for time to check resilts on july 24 had monoclonal amtibody infusion 2 days after getting covid-19

The days after the shot the patient was sleeping 12-14 hours a day which was not normal. On 04/15 pt started to feel dizzy and signs of blurry vision began. They went their general physician ruled out stroke & clot, then recommended they see an eye dr since the vision was the worst symptom. By 04/21/2021 the pt lost 100% of their eye sight. They eye dr after doing a scan discovered the pt had temporal arteritis. They believe the vaccine could had caused the body to lose the fight against the temporal arteritis and pt eyesight was lost.