Johnson & Johnson

3/16/21/1am woke with swelling & itchy eyes. lessened but continued 3/16/21 1pm saw orthopedist for injection right knee 3/17/21 1am swelling & itching increased to mouth, ears, tongue . 2 Benadryl 25 mg each taken dozed 15 min couching , voice changed hoarse breathing seemed different, visual disturbances . right very bloodshot red spots seem 2a to ER 200/90. Immediately administered IV Epinepherine, Solumaedral, Pepsid Dozed off feeling better 6am discharged home 156/70 pulse 70 3/24 saw allergist all tests for foods were negative.

Patient was administered vaccine in her left arm per protocol. We did ask that she stay in the post vaccine observation area which she did. Approximately 5 minutes later she did express that she felt her tongue was swelling. She did not have any other symptoms. She was administered 20ml of diphenhydramine 12.5mg/5ml solution. After around 30 minutes her and her husband felt that she was okay to leave and did. Her PCP was notified and we will be following up with her.

"Janssen COVID-19 Vaccine EUA" Dizziness, ringing in ears, nausea (used Sea Bands for nausea, situation was resolved in 12 hours.

Pt stated that approximately two weeks after vaccination she went to her physician office for an issue with her eye. Her eye was severely red. At the physician's office, the physician told the patient that there was a small blood clot in her eye. The patient stated she didn't think anything of it at the time, but now that the CDC came out with the statement about the Janssen vaccination, she decided to report to the pharmacy.

Stiffness /Pain on left side of head from temple down to neck & shoulder. Painful to turn head to left. Sharp pain in temper/ear area down back of head. Painful at times to hold head up. Dull Headache. TREATMENT: 3/18/21 - Primary Care Physician administer Ibuprofen shot to right side of shoulder, Prescribed Muscle Relaxer, referred for X-Ray of Shoulder. 3/30/2021 - Primary Care Physician re-examined - Prescribed Antibiotics for 14 days - referred for CT Scan of Sinus area. 4/6/2021 - Primary Care Physician re-examined referred for CT Scan of Brain/Head. 4/13 - Primary Care Physician re-Examined - prescribed Methylprednis-Olone for 6 days and referral to Neurology. .

Patient received the vaccine on 4-9-2021, on 4-10-21 patient felt "blah," on 4-11-21 patient got up and around and was ok, on 4-13-21 patient was not feeling real great, but was tolerable, on 4-14-21, patient was feeling worse with blurred vision, throwing up, aches, doesn't want to eat, dizziness. Recommended that patient contact their primary care doctor for further treatment. On 4-13-21 pt went to ER and was admitted for one night, on 4-14-21 pt was dismissed from hospital, and is feeling improved.

Pain at left side of head, neck and ear with tender lymph nodes and "throat feels funny", few days later "legs feel funny" with numbness sensation

The day after the vaccine I had a problem with one of my eyes and then the other. It was similar to ocular migraine symptoms. I then started to have stroke like symptoms. I looked at my friends and stated that I did not know their names. I went to a walk-in clinic and then I was hospitalized for three days. My blood pressure was extremely high. All of the tests were negative for stroke and I have worn a Holter monitor. I also had Neurology, Cardiologist consult and many different medications. I have stopped taking all of those medications. I have not had any more symptoms like that since that day and it only lasted less than 15 minutes.

CONFUSION STATE AS CLOSED TO SUFFERING OF DEMENTIA; PAIN IN BOTH EARS; INJECTION SITE PAIN; HIGH FEVER; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 145 pounds, and height was 162 centimeters. The patient's past medical history included covid 19, and concurrent conditions included fibromyalgia, contrast dye allergy, kiwi allergy, raw shellfish anaphylaxis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206AZIA, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced confusion state as closed to suffering of dementia. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced high fever. On 30-APR-2021, the subject experienced pain in both ears. Laboratory data included: Body temperature (NR: not provided) 104 F. On 01-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 104 F, 103 F. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from confusion state as closed to suffering of dementia, injection site pain, high fever, and pain in both ears on 02-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Had noises in my ears like a clock ticking. I have titinus but this was not a ringing noise. A couple of weeks later I woke up with my right eyelid all swollen and bruised and went to the ER where there they did a CT scan to make sure I didn't have a blood clot and I did not. Also my platelets were in the normal range. It took a good week for the swelling and bruising to go down and the bruising even went down my face somewhat. I had an appointment with my eye doctor and he didn't know why it happened, but may have had something to do with my taking low dose aspirin. I did not have any contusion to the eye and it was not hit by anything.

FEELING HEAVY; NECK IS STIFF; SLIGHT DRAINAGE; FEELING WEAK; FEVER OF 100.4; HEADACHE; SPREADING COLD THEN TURNS TO SPREADING HOT OVER WHOLE BODY; SINUS PRESSURE; THROAT IS DRY AND THROBBING; VERY COLD; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and antibody infusion, and concurrent conditions included sulfa allergy, and myosin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced spreading cold then turns to spreading hot over whole body. On 03-JUN-2021, the subject experienced sinus pressure. On 03-JUN-2021, the subject experienced throat is dry and throbbing. On 03-JUN-2021, the subject experienced very cold. On 03-JUN-2021, the subject experienced fever of 100.4. On 03-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4. On 04-JUN-2021, the subject experienced feeling heavy. On 04-JUN-2021, the subject experienced neck is stiff. On 04-JUN-2021, the subject experienced slight drainage. On 04-JUN-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very cold, spreading cold then turns to spreading hot over whole body, sinus pressure, feeling heavy, neck is stiff, slight drainage, headache, and feeling weak, and the outcome of throat is dry and throbbing and fever of 100.4 was not reported. This report was non-serious.

MENTAL DECLINE; COGNITIVE IMPAIRMENT; CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY; EQUINE SYNDROME; CONSIDERABLE WEIGHT LOSS; VISION DISTURBANCES; DIARRHEA ON AND OFF; This spontaneous report received from a consumer concerned a 76 year old female. The patient's weight was 159 pounds, and height was not reported. The patient's concurrent conditions included eggs yolk allergy, shellfish allergy (nausea/vomiting), irritable bowel syndrome, essential hypertension, hypomagnesemia, dysphagia, severe protein calorie malnutrition, muscle weakness, and hypothyroid. The patient was not pregnant at the report time. The patient experienced rash when treated with liothyronine sodium, and sertraline, and paralysis when treated with suxamethonium, and hives when treated with penicillin NOS (not otherwise specified), sulfadiazine, and passed out when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1016022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included alendronate sodium for drug used for unknown indication, amlodipine for drug used for unknown indication, amlodipine besilate for drug used for unknown indication, bupropion for drug used for unknown indication, buspirone for drug used for unknown indication, buspirone hydrochloride for drug used for unknown indication, celecoxib for drug used for unknown indication, citalopram hydrobromide for drug used for unknown indication, dicycloverine for drug used for unknown indication, dicycloverine hydrochloride for drug used for unknown indication, ergocalciferol for drug used for unknown indication, levothyroxine for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, naloxone for drug used for unknown indication, ondansetron for drug used for unknown indication, pantoprazole sodium sesquihydrate for drug used for unknown indication, paracetamol for drug used for unknown indication, prochlorperazine for drug used for unknown indication, propranolol for drug used for unknown indication, bupropion hydrochloride, citalopram, colecalciferol, diphenhydramine, docusate/senna alexandrina, heparin, loperamide hydrochloride, macrogol, magnesium oxide, pantoprazole, prednisone, salbutamol, sodium chloride, loperidine and tramadol. The patient's diarrhea started on 08-MAY-2021 and was on and off for several days. The patient had vision disturbance started around 13-MAY-2021 or 14-MAY-2021. The eyes could not focus, and patient could not use cell phone due to vision disturbance. The patient's other problems started around 14-MAY-2021. The patient had been having nerve issues complications (Equine Syndrome). The patient was able to use upper body fine, but lower body had difficulty to mobilize. The patient was moved into a nursing facility and then had issues after that. The patient was having issues swallowing, tremors in face, problems with hands shaking and her fingers were almost bent in a weird position. On 19-MAY-2021, the patient was sent to emergency room (ER). The patient got infusion treatments of IVIG (intravenous immunoglobulin) and other steroids. The issues progressed to the point that she could not use her hands. The patient was in hospital for 6 days. The patient was progressively getting worse and had challenges of choosing correct words when talking to daughter. The rehab facility then sent her back to ER, where she was admitted ever since. The patient could not have foods that were not pureed. The diagnosis was chronic inflammatory demyelinating polyneuropathy and cognitive impairment. On 25-MAY-2021, the patient experienced mental decline. The goal was to give IVIG and prednisone infusions monthly, but unsure if it would help her. As on report time, the patient could use hands and swallow better again. The patient's mental/cognitive decline had been very recent and had not resolved. The patient's daughter had been unsuccessful to get hospital to give her a computerized tomogram scan again. Since MAR-2021, the patient had gone from 220 pounds to 159 pounds now (considerable weight loss). On 20-MAY-2021, the patient was 186 pounds. The rehab facility was giving doses of gabapentin 400 mg thrice daily. When patient refused to take it, they refused to help her, so she started taking it again. The patient was no longer on gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision disturbances on 17-MAY-2021, and diarrhea on and off on an unspecified date, was recovering from chronic inflammatory demyelinating polyneuropathy, and equine syndrome, had not recovered from cognitive impairment, and mental decline, and the outcome of considerable weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a consumer concerns a 76-year-old white female who was diagnosed with chronic inflammatory demyelinating polyneuropathy and cognitive impairment; with symptoms of "vision disturbance", "nerve issue complications" with lower body difficult mobility, issues swallowing, tremors in face, problems with hands shaking and her fingers were almost bent in a weird position approximately 8 days after receiving Janssen Covid-19 vaccine. Concurrent illness includes irritable bowel syndrome, essential hypertension, hypomagnesemia, dysphagia, severe protein calorie malnutrition, muscle weakness, and hypothyroidism. The patient complained of diarrhea 2 days after vaccination. On 13th post-vaccination day (PVD), the patient was brought to the emergency room, IVIG and unspecified steroids were given; the patient was subsequently hospitalized for 6 days. On 19th PVD, the patient presented with "mental decline; and >25kg weight loss in 2 months prior to hospitalization was reported. The patient recovered from vision disturbances and diarrhea; recovering chronic inflammatory demyelinating polyneuropathy, and equine syndrome; not recovered from cognitive impairment, and mental decline; the outcome of outcome of considerable weight loss was not reported. No other details reported. Based on the diagnosis of chronic inflammatory demyelinating polyneuropathy, the latency of 8 days from the vaccination does not suggest a plausible explanation. There is an increased risk of cuada equina in the elderly due to vertebral canal stenosis. The advanced age also increases the risk for mental decline and cognitive impairment. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

JanssenCOVID-19Vaccine - Reported i have allergies, some anaphllaxis tosome food and drug., consulted with a Dr. on site before injection. waited 30 and was dismissed. I commented to my son I we drove off that my tongue felt dry. but no swelling. later in the afternoon my tongue continued to concern me. it felt hot and tip was red.(note felt as if I had burnt it with a very hot drink. Day 2 it continued, 8 am I took Tylenal and 11:30am Benafryl. 4:30 pm called Dr. office, Call 911 , 5:00pm taken to ER. Dr. on call Check my throat and tongue.was given 4mg. MethyIprednisolone. sent home. Day 8, still have a slight feeling of dry tongue.

headache, abdominal pain, severely swollen right ankle and severe lower right leg pain, swollen left ankle and left lower leg pain, eyesight also was affected

BITTER TASTE IN MOUTH; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 132 (pound), and height was 5.3 inches. The patient's past medical history included urinary tract infection, and concurrent conditions included irritable bowel syndrome, sinus congestion, non alcohol user, non smoker, and pollen allergy, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021;12:45 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos for drug use for unapproved indication. On 10-MAR-2021, the subject experienced bitter taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bitter taste in mouth. This report was non-serious.

SWELLING OF BOTH EYELIDS- UPPER AND CORNER; SWELLING OF LEFT SIDE OF FACE; HEADACHE BEHIND EYES; DIZZINESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included dust allergy, allergy to cats, antibiotic allergy (hives), diverticulitis, alcohol intolerance, and drug intolerance. The patient was previously treated with calcium for hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802025, and batch number: 1802025 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of both eyelids- upper and corner. On 09-MAR-2021, the subject experienced swelling of left side of face. On 09-MAR-2021, the subject experienced headache behind eyes. On 09-MAR-2021, the subject experienced dizziness. Treatment medications included: achillea millefolium/aconitum napellus/arnica montana root/atropa belladonna/baptisia tinctoria/bellis perennis/calendula officinalis/echinacea spp./hamamelis virginiana/hypericum perforatum/matricaria recutita/ruta graveolens/symphytum officinale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-MAR-2021, was recovering from swelling of both eyelids- upper and corner, and headache behind eyes, and had not recovered from swelling of left side of face. This report was non-serious.

BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious

Patient states she had a mouth full of canker sores that started a few days after getting the vaccine.

After receiving the J&J vaccine 6 weeks ago and started getting stomach cramps that lasted a week, after that it subsided but has never stopped, now I can hardly eat anything. I went to the ER two weeks ago but there was no concern because there were no blood clots. Now my bowel is restricted and I've had auto-immune issue about a year and a half ago. Now just cramps and bloating. I also have a tooth that's come loose and I have a strange taste in my mouth since having the vaccine. I saw the doctor and they just called and the doctor stated that I've continue to have problems I should consider having an ultrasound of my stomach. Also, in the past, I went to Hospital.

10 days after receiving the Janssen vaccination I was driving and experienced blurred vision. Pulled over, waited a while then continued driving when vision improved. Arrived home and family member noticed facial drooping on right side as well as slurred speech. Immediately called 911 and was transported to hospital within 30-45 minutes.

Chills throughout Thursday nite 3/4, Fever Friday AM 3/5 102.4F, slept most of day, Fever blisters occurred on top and bottom lips as well as blisters in roof of mouth. Fatigue. Tylenol, topical applications for blisters as well as salt water oral gargle several days.

My mother reported feeling numbness/tingling in her left fingers/hand on the drive home approximately 30 minutes after receiving the vaccine. She wanted to go straight home. When we got home she reported that the numbness had been felt in her head and tongue and it was a very weird feeling. She was numb on her entire left side. It seemed to resolve after a while. She is still very tired and has a low heart rate, but normal blood oxygenation. There is no visible swelling or reaction at the vaccine site. She still has some slight numbness on the left side. She may call the doctor tomorrow if there is still some concern.

Patient at first felt "weird", as described by the patient. About 5 minutes after vaccine, patient complained of a tingling sensation in her nose and around her mouth. After 20 minutes, patient complained of a numb tongue. At this point, EMS was called to assist her and she went to the hospital for further treatment.

Visual field defect and hazy vision. Retinal exam revealed superotemporal branch of retinal artery occlusion in R eye along with posterior vitreous detachment.

Ischemic Stroke requiring hospitalization. Significant reduction in field of vision. Loss of nearly all Left Side peripheral vision

PAINFUL FACIAL SWELLING ON LEFT SIDE OF FACE; DIFFICULT TO OPEN MOUTH; SWELLING IS UNDERNEATH THE EAR LOBE, ON THE NECK AND JAWBONE; This spontaneous report received from a patient concerned a 78-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and phenobarbital and ciprofloxacin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced painful facial swelling on left side of face. On 28-APR-2021, the subject experienced difficult to open mouth. On 28-APR-2021, the subject experienced swelling is underneath the ear lobe, on the neck and jawbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful facial swelling on left side of face, difficult to open mouth, and swelling is underneath the ear lobe, on the neck and jawbone. This report was non-serious.

NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.

Double vision - diagnosed as 6th nerve palsy in right eye. Could take up to 6 months for normal vision if then. Have seen eye doctor and neurologist. Have to wear eye patch.

This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included ductal carcinoma, and ductal carcinoma surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history of drug abuse or illicit drug usage. The patient was previously treated with lisdexamfetamine mesilate, and vitamins nos. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Product properly stored from receipt to administration. Concomitant medications included letrozole. On 08-JUN-2021, the subject experienced dry irritated cough. On 08-JUN-2021, the subject experienced sneezy. On 08-JUN-2021, the subject experienced irritated throat. On 08-JUN-2021, the subject experienced dry, raspy and voice changed. On 08-JUN-2021, the subject experienced breathing changed. On 08-JUN-2021, the subject experienced chest irritated and irritation to lungs. On 08-JUN-2021, the subject experienced smell of chemical. On 08-JUN-2021, the subject experienced slight headache.The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry irritated cough, sneezy, slight headache, irritated throat, dry, raspy and voice changed, breathing changed, chest irritated and irritation to lungs, and smell of chemical. This report was non-serious.

BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

2 days after vaccination, patient started having vertigo, nausea and headaches. That day she tried to notify her doctor unsuccessfully. 2 days after that patient's headache became extreme and she lost her vision in one eye. Family doctor prescribed migraine medication and referred her to her eye doctor for the next day. The eye doctor told her he believes she had a stroke after a full exam. Stroke confirmed with MRI per family doctor. The stroke was in the occipital area. Referred to neurologist at present time. Vision loss persists. Patient is starting physical therapy and following up with neurologist, eye doctor and cardiologist.

Woke up with lost of vision in left eye for 4 to 5 hours on April 6th, 2021 in the morning. Patient went to her ophthalmologist that afternoon. The sight came back but very blurry. Retina specialist seen her on 4/13/2021 and diagnosed mini stroke (TIA) of her left eye. He urgently Guide her to go to ER on 4/13/2021.

SWELLING TO EYES; RED ITCHY BLISTER LIKE RASH; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included muscle ache, and concurrent conditions included high blood pressure, high cholesterol, thyroid disease, horseradish allergy, and cataract. The patient experienced drug allergy when treated with rosuvastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, ezetimibe, levothyroxine sodium, lisinopril, and rosuvastatin calcium. On MAR-2021, the subject experienced swelling to eyes. On MAR-2021, the subject experienced red itchy blister like rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling to eyes on 2021, and was recovering from red itchy blister like rash. This report was non-serious.

TRANSIENT ISCHAEMIC ATTACK; BLINDNESS UNILATERAL; VISION BLURRED; COMPUTERISED TOMOGRAM HEAD; ECHOCARDIOGRAM; MAGNETIC RESONANCE IMAGING HEAD; ULTRASOUND DOPPLER; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1231357) concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure, and atrial fibrillation, and concurrent conditions included diabetes, and other pre-existing medical conditions included patient has no allergy or illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, magnesium, and mecobalamin. On 06-APR-2021, the patient woke up with lost of vision in left eye for 4 to 5 hours. Patient went to her ophthalmologist; the sight came back but very blurry. Retina specialist had seen patient on 13-APR-2021 and diagnosed transient ischaemic attack of left eye. The patient was guided to go to ER on 13-APR-2021. On 06-APR-2021, the patient experienced blindness unilateral, vision blurred. The patient was admitted in the hospital on 13-APR-2021 and was hospitalized for 3 days. Laboratory data included: Computerized tomogram head (NR: not provided) UNKNOWN, Echocardiogram (NR: not provided) UNKNOWN, Magnetic resonance imaging head (NR: not provided) UNKNOWN, and Ultrasound Doppler (NR: not provided) UNKNOWN. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210500771 - Covid-19 vaccine ad26.cov2.s- blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient had been working all day in her flower gardens. At 4:30 p.m. she felt like she had double vision and difficulty talking. She does not remember much of what happened after that, but her husband said she had sudden onset of right arm weakness, leg weakness and drooping of the right side of her face. Denies having numbness. He immediately called 911 and EMS took her the Hospital. She had a CT scan of the head that was negative. When she arrived at the emergency room her symptoms had resolved, but she had recurrent episode of her symptoms in the emergency room with an NIH score of 5 scoring a point for level of consciousness, best language, and dysarthria and 2 points for facial droop. She was given tPA and her symptoms resolved. A CT angio of her head and neck did not show any large thrombus. She was transferred for ongoing care and neurology evaluation. Neuro deficits resolved. Patient was discharged the second day after the event on Aspirin, Plavix and Lipitor. Hospitalist (Dr) asked me to file VAERS report given recent Janssen vaccine administration.

ON AND OFF TINNITUS; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included gall bladder surgery, and cataract extraction, and concurrent conditions included hypertension, general osteoarthritis, high cholesterol, osteopenia, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced on and off tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off tinnitus. This report was non-serious.

2 pm (1 hr after vaccination...felt strange feeling in the brain ... my son did, too on his shot.) 8 pm Shook so much and teeth chattered; didn't want my teeth to chip. Jumped in a hot shower for 15 minutes and that went away. I thought maybe my blood pressure had dropped too low; had same reaction when first put on too much blood pressure lowering medication. Or sometimes allergy makes the blood pressure drop. For 24 hours after that I was on the couch or in bed lying down; brain hurt(BAD headache), stiff neck, a big effort to lift my head off the pillow so I didn't unless I had to go to the bathroom. I laid back down asap due to slight nausea. No appetite. Whites of eyes were uniformly pink, eyes glassy. 3/23 Sore spot to the touch on left temple just above the eyebrow.

POOR VISION; DOUBLE VISION; BLURRED VISION; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataract surgery on left eye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 12-MAR-2021, the subject experienced poor vision. On 12-MAR-2021, the subject experienced double vision. On 12-MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor vision, double vision, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Approx 4:00pm ,Pt in for J&J vaccine, within minutes of receiving injection, pt?s husband said ?we need help? This writer saw pt begin to slide down in chair and eyes flutter, pt lost consciousness for approx 10 seconds, never completely came out of chair. Paramedics also responded with this writer to assist pt. Pt was assisted onto gurney and first set of v/s was taken, pt has become alert and aware of name/place/date/time. Negative history for meds or medical issues but states she did once pass out before from an injection and believes the thought of this particular vaccine made her nervous and she held her breath while getting vaccinated. 4:05pm bp=128/75, Pulse ox = 95%, R=16. Pt denies HA/dizziness/blurred vision/weakness/nausea. Remains alert . Water and Gatorade given to pt. 4:10pm P=78, pulse ox =95%, pt remains calm/alert/responsive/stable 4:15pm, assisted pt to sitting position, pt denies any adverse s/s. 4:20pm: BP= 134/78, P=78, Pulse ox =96%, R= 16. Assisted pt from sitting on gurney to sitting back onto chair that she started in, states she feels fine. 4:35 pm: pt is able to stand w/o assist, remains alert/aware, states she feels fine and is ready to go get her drink. Pt ambulated on her own to her car, accompanied by her husband and this writer. Pt left clinic in stable condition. Home care instructions given and advised on when she would need to seek further medical assistance. Pt and husband verbalize understanding of info given

While waiting the 15 minutes after shot was given, noticed a tingling sensation that traveled from my left arm, across my left shoulder to the back of my neck. It subsided about 15 minutes later. April 22 - Started mild symptoms of stiff and sore neck; ache in lymph nodes below left ear; pimple at the hairline at the nape of my neck. Discomfort moved to different areas near my left ear. May 5 - Discomfort moved up above my left ear- all other symptoms remained. Became a full blown headache above my ear to my temple. Headache was a sharp, stabbing painwhich moved around on left side. At one point, I timed it at every 16 seconds. May 7- Went to emergency room. Had a full workup. All tests

Pt noted neck stiffness, and tingling around neck/throat area. Pt requested 30 minute observation. When time was up she reported the symptoms. Pulse ox checked by MA, 98%, verbalizing coherently. Given Benadryl 25mg po and discharged to neighbor for transportation home. Pt given ER precautions and she verbalized understanding.

Pt states nausea, aches, general malaise, dry mouth since the day after her shot and continuing as of today 04/09/21

TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.

Numbness and swollenness of my lips. the top lip was worse. About a week later this started to extend down to the cheeks in my face. It was even difficult to drink

on 3/22/2021 pt developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was administered 65 mg IVPB alteplase 3/22 1245 with last known well 3/22 1000. Received Covid vaccine 3/18/21. Pt was usual state of health prior to stroke with no illnesses. initial NIH score was 18. post tpa NIH of 12 am of 3/23.

Patient received J and J vaccine . 2 weeks later had vision loss in both eyes. No light perception in the right and counting fingers in the left. Diagnosis is central retinal artery occlusion in both eyes. Work up for other causes are negative

Nausea, vomiting, body aches, episodic low-grade fevers, frequent chills, mild dyspnea on exertion, and sensation of being slightly short of breath, pain in legs, intermittent blurry vision, feeling jumpy.

June 10th achy pain across top of head June 22 ears and head clogged and pressure in Eustachion tubes ears and sinus loud roar in ears , hearing muffled, tinnititus saw primary care giver, told to take Flonaisse and Zyrtec no relief, saw Nurse prescribed Amoxicillin No relief

3/13/21 ER HPI: 83 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. The patient comes in because her blood pressure at home has been very high. It is actually not reading on her cuff. She has a very dull headache on the left side of her head, but states it is very mild. No chest pain. She might be a little bit short of breath, but not much more than normal. She denies any current neck pain. She states a few hours ago she had a little bit of pain in the left side of her neck that was just brief and then way. On my initial evaluation her systolic blood pressure was around 240. The patient does have a history of anxiety. She states she has had typical anxiety, but nothing new. 3/15 office followup note: Subjective: Patient is 83 y.o. year old female that is here for ER follow up. 2 ER visits over the weekend. BP was elevated into the systolic 200s. Has ringing in ears when BP was elevated On Saturday: Left side of throat dry Left side of face "doesn't feel right", hard for patient to describe When she woke up on Saturday, couldn't see out of left eye, this has improved Says her voice doesn't sound the same, "gravely" She did not tell the ER doctor on Saturday about the neurologic symptoms. In her 1st ER visit she had a chest x-ray which showed no acute disease. Cardiac enzymes were negative. ER doctor increased her losartan dose and gave her p.r.n. clonidine. In the early morning hours on Sunday, she returned to the ER. Blood pressure was elevated again at 208/85. Patient was given sublingual nitro and a Norvasc 5 mg tablet. After the sublingual nitro, blood pressure was 144/84. ER doctor discharge patient with follow-up today.

Patient after taking a nap and applying ice to swollen cheek. Also c/o red swollen tongue and swelling of Rt cheek last night at 2 am. The tongue is no longer swollen but it is still red and her cheek swelling has decreased. She also has a hoarse voice. No Benadryl in the house. Patient urged to go to ED immediately to be evaluated.

Patient received her Janssen COVID 19 vaccine at approximately 12:22pm and then was instructed to wait 15 minutes to be observed for adverse reactions. At the end of of her 15 minute observation approximately 12:37 she reported she was experiencing pounding in her ear.

SWEATY; LOSS OF TASTE; WEAK; FEELING OF RASH UNDER SKIN; TIRED; INCREASED TEMPERATURE 98.1F; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, on left arm, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced loss of taste. On 14-MAR-2021, the subject experienced weak. On 14-MAR-2021, the subject experienced feeling of rash under skin. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced increased temperature 98.1f. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle aches, and nausea on 14-MAR-2021, and had not recovered from sweaty, tired, weak, increased temperature 98.1f, feeling of rash under skin, and loss of taste. This report was non-serious.

Immediately got headache and that headache has been present for weeks (waxes and wanes in pain and intensity). Also dizziness which has gotten worse. Two days ago, she felt so dizzy and faint, she fell onto her husband in the kitchen, bruising herself. She saw her MD for a checkup last week and did not mention the symptoms to him.

UTI 3/16/2021-3/20/2021. UTI 4/28/2021. Sensitivity to light 3/24/2021 - current. Blurry Vision 3/20/2021 - 3/24/2021. Partial blindness 4/04/2021 - current. Headaches 3/24/2021 - current. Doctor ruled not a stroke. Stroke of the eye due to blood clot or plaque build up is the highest suspected cause. No previous incidents of this nature had occured.

Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.

Patient received Moderna COVID vaccine at a health dept clinic in February and experienced blurred vision and 3 weeks of fever afterward. CDC consulted and the recommendation was to use Janssen COVID vaccine as second dose with monitoring for 30 minutes. Allergist agreed. After Janssen vaccine, patient was fine for first 28 minutes, then experienced blurred vision, light-headedness. At 10:10 patient became palor and lost consciousness. EpiPen given and patient immediately responded. EMS called and 50 mg IM diphenhydramine given. No SOB, wheezing, or CP. Positive for palpitations

BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes. On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.

Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems. This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.

Feeling quite ill. Did not sleep night before trip to hospital. Terrible taste in mouth. Taken to hospital emergency room morning of April 18, 2021. Admitted to hospital by ER physician. Reason: blood c lots in both lungs.

BLOOD CLOTS IN BOTH LUNGS. SHORTNESS OF BREATH. UPPER BACK PAIN. WEAKNESS. SWEATING AND COLD. NO COLOR IN FACE -- GREY. LOSS OF EYE SIGHT -- STARTED WITH BLURRED VISION.

WARM ARM; EYES WERE BOTHERING; LEFT ARM PAIN THAT WENT UP TO SHOULDER TO BACK AND DOWN TO HAND; HEADACHE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A214 expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced warm arm. On JUN-2021, the subject experienced eyes were bothering. On JUN-2021, the subject experienced left arm pain that went up to shoulder to back and down to hand. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, left arm pain that went up to shoulder to back and down to hand, warm arm and eyes were bothering was not reported. This report was non-serious.

Covid-19 Vaccine was administered on 07/19/2021 at 1:45 PM after (15) minute observation patient c/o mild throat discomfort. Notified provider. Per provider observed patient for additional (15) minutes. Obtained vitals : (LA)130/80 mmhg Pulse: 62 Oxygen: 98% . Per provider okay to release patient home. Notified patient if symptoms worsen, please go to nearest emergency room and/or follow up with PCP. Patient verbalized understanding and agreed.

Patient reported right side of face red, hot and swollen beginning evening of 03/11/21. Ear aching. Pain and aching all over the body. Fatigue, nausea, dizziness and loss of appetite.

DRY MOUTH; This spontaneous report received from a patient concerned an 86 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dry mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dry mouth was not reported. This report was non-serious.

HEARING LOSS; CHILLS; VISION LOSS TO BOTH EYES; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polyethylene glycol (peg) allergy, and propylene glycol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 11-MAR-2021, patient experienced vision loss that lasted for an hour. Subject attributed it to the PEG and propylene glycol allergy. Later on the same day, she experienced chills that lasted until 14-MAR-2021. The subject also began having some hearing loss and further probing reveals she was referring to her ears feeling "stopped up" and it "sounded like she was in a deep well". She had not sought medical care at this time. Subject was encouraged to seek medical treatment for issues that won't resolve, would seem serious, or, would be bothersome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision loss to both eyes on 11-MAR-2021, and chills on 14-MAR-2021, and the outcome of hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210328836-Covid-19 vaccine ad26.cov2.s-Vision loss to both eyes, Hearing loss. This events is considered unassessable. The events 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 events.

Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Severe, Additional Details: shot 4:23pm, pt complained of seeing stars, being nausous, weak, was going in and out of concsiousness for 30 -45 seconds. Had patient elevate legs a while seated and took bp at 4:30pm was115/36 pulse 52. pt tried to vomit but nothing came up.Took 2nd bp at 4:44pm 137/91 pulse 75. Moved patient inside pharmacy had her lay down flat with legs elevated for 8 minutes. complained of tingliness in both arms up to elbows. 3rd bp at 4:50pm was 127/80 pulse 65, 4th bp 125/82 pulse 77, left at 5pm

Arm blistered; headache; body felt "heavy." Went to the emergency room. Checked-out. Didn't find anything. Told to take Tylenol every 8 hours. Took Tylenol for 2 days. Took the vaccine before vaccine was taken off the market. After vaccine was taken off the market, I was very scared. Still having aches, pains and eye problems.

7/15/2021: Patient presented to the ER due to persistence of COVID symptoms after testing positive on 7/11/2021 with no oxygen requirement & discharged home. Patient developed nausea, was unable to keep anything down, had bitter taste associated with loss of smell. 7/18/2021: Patient medically cleared for discharge, saturating well on room air and tolerating diet with no episodes of nausea or vomiting. 7.26.21: as of today, discharge cleared, awaiting placement. Note: Patient received J&J COVID-19 vaccine in May 2021.