Johnson & Johnson

Severe headache started within 6 hrs. of injection. Had a slight rise in temperature to 99.9. Very sleepy and tired. Muscle aches in legs and buttocks. Slight nausea. Took extra strength Tylenol. Slept off and on for next 24 hours. Had severe sweats and chills. All symptoms were just like I had had early December, 2020 when I had COVID, as per verified by a COVID nasal test done at local hospital.

LEFT ARM WAS EXTREMELY SORE. BODY ACHES ALL OVER, LOW GRADE FEVER, NO APPETITE, FATIGUE FOR 24 HOURS,

sore throat, dry cough, headache, congestion, runny nose. Patient has hx of pollen allergies. Patient took benadryl and singulair which has helped relieve symptoms. Recommended OTC cough suppressant and if cough worsen contact primary provider.

102.6 fever; chills; bad headache Onset about 8 hours after injection and symptoms lasted about 40 hours. Fever treated by Advil and dropped to 100+ after 24 hours.

Extreme fatigue from 3/11/21 to3/19/21; Severe headache from 3/12/21 to 3/18/21; light-headed sensation 3/12/21 to 3/20/21; fainted 3/17/21; gastrointestinal issues and severe cramping the evening of 3/15/21 to 3/17/21; gastrointestinal issues (constipation followed with diarrhea without cramping).Colo

24 hours after vaccine, scratchy sore throat. later a cough, congestion, headache, feverish but no temperature. sluggishness, fatigue. 3 days later symptoms remain with site of injection painful.

malaise, aches and pains, feels "like a cold" Caller states that she got the first vaccine ons saturday the 13th and within a couple of days starting having runny nose and sniffles, mild headache, shaking to body/hands/arms (shivering) but no fever. Memory loss. hypertension (pre-existing medical condition she takes medication for) and confusion. she has alternated with APAP, ASA, ALKA-SELTZER. she says she always gets sick from the flu vaccine. s/s have been on/off staff adv to f/u w/pcp. adv s/s reported may be ameliorated with OTC analgesics taken as directed on label as well as antihistamines. adv to call back if any questions. someone will follow up to check on her.

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.

FEVER; CHILLS; ACHY; VERY TIRED; MUSCLE PAIN; JOINT PAIN; 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 concurrent conditions included ulcerative colitis, and arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination onleft deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced muscle pain. On an unspecified date, the subject experienced fever, chills, achy, and very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, and muscle pain, and the outcome of fever, chills, achy and very tired was not reported. This report was non-serious.

8 hours later bad chills then fever of 101. It was over within 12 hours Three days later had a strange like feeling of flittering near heart area...has happened 3 times since Blood pressure has increased at least 20 points or more since vaccine Swelling in fingers and toes

FEVER; EXCRUCIATINGLY PAINFUL HEADACHE; INJECTION SITE REDNESS; INJECTION SITE SWELLING; TENDERNESS AT INJECTION SITE; MUSCLE PAIN; BODY ACHE; FEELING HOT AT INJECTION SITE; BLISTERS ON COVID ARM; JOINT PAIN; 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.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 16:30 to right deltoid, for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced feeling hot at injection site. On APR-2021, the subject experienced blisters on covid arm. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced tenderness at injection site. On APR-2021, the subject experienced muscle pain. On 02-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced injection site swelling. Laboratory data included: Body temperature (NR: not provided) 101.5. On 02-APR-2021 11:00, the subject experienced excruciatingly painful headache. On 02-APR-2021 12:30, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) I antibodies found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciatingly painful headache, and fever on 04-APR-2021, was recovering from body ache, had not recovered from injection site redness, feeling hot at injection site, blisters on covid arm, and tenderness at injection site, and the outcome of joint pain, injection site swelling and muscle pain was not reported. This report was non-serious.

JOINT ACHE; TIREDNESS; SORENESS ON THE INJECTION SITE; 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 concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and no known drug allergies. 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, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced tiredness. On 14-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, tiredness, and soreness on the injection site on MAR-2021. This report was non-serious.

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.

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. .

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

WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 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 not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp 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.

The patient is a 76 y.o. female who presents to the Emergency Department with three days of left ankle pain and swelling status post mechanical GLF. Patient reports that she fell onto her left side three days ago. She is not anticoagulated and denies striking her head or any LOC. Since then she has had constant dull left ankle pain which is acutely worsened with ROM and weight bearing. Patient reports a history of fracture to this ankle. Patient notes that she is able to shuffle when wearing her compression stocking, but this elicits pain. She has pain radiating up her LLE, into her buttocks, and up her back "all the way to my neck." Patient has not taken any pain medications symptomatically. Patient reports feeling chills last night.

No reaction at all until 14 days after vaccination. Worked all day came home really exhausted. Went to bed at 6:00 PM. Got up at 8:00 AM feeling exhausted. Came home from afternoon dentist appointment (cleaning) exhausted with aching joints, bones and a slight temperature. Went to bed at 6:00 PM and slept til 8:00 AM. It felt like the same reaction from the flu shots which is why I didn't want to get vaccinated. I started taking 1000 mags at 6 :00PM about every hour 7-9000 mg total and felt fine the next morning instead of in bed for 3 days with the flu shot and no Vit. C. Also, shortly after the shot, I got a tingling at the indent in the back of my neck near the hairline which doesn't quite hurt but I feel the need to press on it. I can't tell when it's going to come or what I've done to make it happen. It's still happening several times a day.

CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from fever. This report was non-serious.

This spontaneous report received from a patient concerned a 76 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 not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.

SLEEP EXCESSIVE; MALAISE; TIREDNESS/FATIGUE; SORENESS IN THE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 76 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 not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 09-MAR-2021, the subject experienced soreness in the arm. On 09-MAR-2021, the subject experienced mild headache. On 10-MAR-2021, the subject experienced sleep excessive. On 10-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep excessive, malaise, and tiredness/fatigue on 11-MAR-2021, soreness in the arm on 23-MAR-2021, and mild headache on 10-MAR-2021. This report was non-serious.

LOSS OF FINE MOTOR CONTROL IN RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included pacemaker for nerve block (4-5 years ago), appendectomy (10 years ago), cataract surgery, and concurrent conditions included alcohol user (occasional, not often), and ex-smoker (used to smoke for 30 years (half pack a day), but quit 10 years ago) and bladder cancer growth (7 years ago). The patient experienced drug allergy with opioids (deathly ill, sick to stomach and passes out). 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: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on right arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced headache. On 21-MAR-2021, the patient lost fine motor control in right arm, and was hospitalized for 2 days. It was reported that, the patient had 2 computerized tomography scans showed no evidence of clot however according to the patient's physician, the patient might have had small clot that dissolved. The patient had no high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of fine motor control in right arm on 21-MAR-2021, and headache on 2021. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 76-year-old female patient who experienced headache and loss fine motor control in right arm, 8 and 12 days after receiving Jansen COVID-19 vaccine respectively. Patient's medical history included pacemaker insertion, ex-smoker, bladder cancer, and drug allergy with opioids. Eight days after vaccination, the patient had headache. Four days later, the patient lost fine motor control in right arm and was hospitalized for one and a half days. Two CT scans showed no evidence of clot. The patient's physician commented that the patient might have had small clot that dissolved. The treatment was not reported, and patient was recovered from the events. Based on the reported information, the causality is considered possible to vaccine for headache and unassessable for the event of loss fine motor control in right arm.

03/28/2021 to 03/30/2021- Admitted Ip via E/R , Dx: Pneumonia, Cardiomegaly, Small pericardial effusion, Esophageal stenosis (s/p dilation), Small hiatal hernia. F/U with PCP for Hopital F/u on 04/01/2021. Visit ER on 04/03/2021- 04/05/21 04/14/21-ReAdmitted IP via E/R. -Dx: Dx: Chest pain, Pericarditis w/ mod-large Pericardial effusion (s/p pericardiocentesis), Hypokalemia, Pleural Effusion (s/p thoracentesis)

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

Chills (no fever) within 24 hours of the Janssen vaccination, lethargic, no appetite. Very dizzy and lightheaded on day 5 and day 6 after the Janssen vaccination with continued lethargy and loss of appetite for approximately 3 weeks. Heavy nosebleed in left side of nostril with large blood clots for 1.5 hours approximately 3 weeks after the Janssen vaccination

the day after the vaccine I got a headache that became a terrible Migraine that lasted for 4 day, subsided and then returned. It was bad and I did call and spoke to the nurse and doctor. I vomited for 4 days. I am a little better but this is day 6 and I am still dizzy and have a slight headache

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.

The same night after the vaccine I had shaking violent chills, my teeth were chattering as well. I also was vomiting a lot , I had lots of chills that I could not get warm this went on all night long. The next day I did experience some bad body aches like the flu. The next day after that I slept all day long and tried to hydrate myself back together. Over the next few weeks I noticed how I was running out of breath so fast. I am now suffering from shortness of breath.

ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

CAR ACCIDENT; WHIPLASH INJURY; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; 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 measles, and chicken pox. On 20-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced headache on the day of vaccination. Treatment medications included: paracetamol. The reporter stated she was involved in car accident after 1-2 month of vaccination. The patient mentioned she received stem cell injections to treat whip lash injury following accident. On an unspecified date the patient reported that she had Covid-19 antibody test drawn by her primary care physician which came negative. On 24-JUN-2021, the patient had another lab test COVID IGG test, and the results came negative on 25-Jun-2021(confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure, car accident and whiplash injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210660662- covid-19 vaccine ad26.cov2.s - Confirmed Immunological failure. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Pt. states after receiving J&J vaccine 03/24/2021, started experiencing on 06/15/2021 tingling, itchiness, head pain, neuropathy. Still continuing.

ASSESSMENT AND PLAN: 1. Palpitations (Primary) Assessment & Plan: Next step would be to take 1/2 dose metoprolol for any Bp <100/70 but pt doesn't want to do that at this time. Will cont asprin prophylaxis and will check tsh given concurrent fatigue. Will call with results. If normal thyroid, will f/u in 6 months or sooner should condition worsen Orders: - TSH, Reflex Free T4; Future - aspirin 81 mg EC tablet; Take 1 tablet by mouth Daily. Dispense: 90 tablet; Refill: 3 2. Essential hypertension Assessment & Plan: Well controlled at present. Limited by palpitations t hat are controlled by metoprolol but when controlled with metoprolol also occasionally cause some low bp and fatigue of unknown etiology. Will cont for now but may need to decrease metoprolol to 1/2 dose for any Bp <100/70 inf uture. Orders: - metoprolol tartrate (LOPRESSOR) 25 mg tablet; Take 1 tablet by mouth 2 times daily. Dispense: 180 tablet; Refill: 3 3. Fatigue after COVID-19 vaccination Comments: suspect much of fatigue is related to covid 19 vaccination. will monitor 4. Gastroesophageal reflux disease without esophagitis - omeprazole (PRILOSEC) 20 mg capsule; Take 1 capsule by mouth Daily 1 tablet before breakfast . Dispense: 90 capsule; Refill: 2 5. Seborrhea Comments: refilled chronic medications Orders: - desonide (DESOWEN) 0.05 % lotion; Apply 1 Application topically Daily as needed (itch) Apply once daily to prevent ear seborrhea. . Dispense: 59 mL; Refill: 3 - triamcinolone (KENALOG) 0.1% lotion; Apply small amount to affected area(s) two to four times daily as needed: avoid face and groin areas. Dispense: 60 mL; Refill: 3

03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain lasting entire day and into evening, difficultly moving

Pt began experiencing aches, dizziness while walking, chills, and headache on 03/11/2021 at bedtime. Pt began experiencing nausea on 03/12/2021 morning. Pt took Tylenol for symptoms, but received mild relief. Pt was advised to continue taking Tylenol as directed, and if the symptoms worsen or do not resolve in 1-2 days to seek medical care. SPI was consulted and Dr. was notified.

Janssen COVID-19 Vaccine EUA: Adverse effects were nausea, vertigo, headache, body aches, chills, cold sweats for 6 days total. Took Bonine for Vertigo and Nauzene for Nausea.

Nurse reported after vaccination patient ?passed out? Patient appeared diaphoretic, pale, lethargic Patient was able to answer questions Patient seen by medical team, The blood pressure and heart rate low , patient provided with IV fluids, patient advised and agreed to go to hospital Patient was transferred to hospital via ambulance

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

HEADACHE; SORENESS AT SITE OF INJECTION; FATIGUE; This spontaneous report received from a patient concerned a 77 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 not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced soreness at site of injection. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, soreness at site of injection and fatigue was not reported. This report was non-serious.

NECK HURTS BY HER SHOULDERS; ARMS BOTHERING; TIREDNESS; HEADACHE; NAUSEA; MUSCLE ACHES; INJECTION SITE PAIN; FEVER; PAIN IN RIGHT ARM; SEVERE NECK SWELLING; 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 coronavirus infection, and concurrent conditions included tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe neck swelling. On APR-2021, the subject experienced pain in right arm. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.6 F, 99.9 F, 101.5 F. On 07-APR-2021, the subject experienced neck hurts by her shoulders. On 07-APR-2021, the subject experienced arms bothering. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and injection site pain on APR-2021, had not recovered from tiredness, nausea, muscle aches, fever, arms bothering, and neck hurts by her shoulders, and the outcome of pain in right arm and severe neck swelling was not reported. This report was non-serious.

UNABLE TO EAT OR DRINK; PAIN IN THE BODY (NECK & RIGHT ARM/SHOULDER); DIZZINESS; SICK; FEELING LOUSY; DIDN'T WANT TO GET OUT OF BED; WANTED TO SLEEP; FEVER; NAUSEA; FELT WEAK; 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 covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 07-APR-2021, the subject experienced unable to eat or drink. On 07-APR-2021, the subject experienced pain in the body (neck & right arm/shoulder). On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced lousy. On 07-APR-2021, the subject experienced didn't want to get out of bed. On 07-APR-2021, the subject experienced wanted to sleep. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced felt weak. On 08-APR-2021 18:50, Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the body (neck & right arm/shoulder), fever, nausea, dizziness, sick, lousy, felt weak, didn't want to get out of bed, unable to eat or drink and wanted to sleep was not reported. 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.

CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; 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 covid-19 positive. 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, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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).

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

PAIN IN ARM; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 77 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 not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. 2021, the subject experienced pain in arm. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and tiredness on 2021. This report was non-serious.

June 4 onset of diarrhea around 1pm. Took OTC Kaeopectate to stop diarrhea. Stools turned to nothing but blood. Fatigue, abdominal pain, nausea. Same symptoms as my daughter (she has filed a report). Saw Dr. at PCP office on Monday, June 7th. Blood tests requested. Stool Sample requested. Awaiting results. Since my daughter and myself both came down with same symptoms within 24 hours of each other we were instructed to complete this form and we have been discussing possibility of food poisoning with our PCPs. Still have nausea, chills, abdominal pain. Bloody stools have stopped for me.

severe headache 2 weeks later, dizzy spells for about a week. Had a CT scan and found out it was a stroke.

This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included hypertension, depression, allergy to cat dander ( sneezing, watering eyes), no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced dryness of mouth (drug allergy) when treated with codeine. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced right and left arm soreness two to three days after the shot. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced redness at injection site. On 10-JUN-2021, the subject experienced bleeding spots under the skin on right arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding spots under the skin on right arm, headache, right and left arm soreness two to three days after the shot and redness at injection site was not reported. This report was non-serious.

:Took vaccine at 1:15pm March 9 then 12 hours later at 1:15 am March she started shivering and threw up once. Felt lousy. Headache No rashes, injection site clear. No fever Took Tylenol 9:30 am for headache

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.

Woke a bit dizzy which lasted all day. Going to bed I coughed and searing pain flashed thru my body. After the initial pains my right hand felt like it'd been crushed by heavy object. It's not as bad this morning but I'm using hemp creme to sooth the soreness.

after receiving vaccine, felt tired, had runny nose on 4/5/21 visited patient around 10am, told us she was going to see the doctor next day 4/6/21 called patient 3x and no one picked up learned that patient suffered from stroke sometime prior night, learned that from sister (approximately 12 hours before patient was discovered in her home) - 911 called and rushed patient to ER patient spent time in ICU, conditioned stabled - continues to stay in hospital, condition continues to be monitored

DIARRHEA; HEADACHE; PAIN AT INJECTION SITE; 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 hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered to the left deltoid, on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, headache, and pain at injection site on 08-APR-2021. This report was non-serious.

with several days of receiving the shot the following symptoms occurred: severe headache backache severe pain in your abdomen or stomach pain in your chest leg pains joint pains shortness of breath

Pt states that she experienced headaches off and on from 03/26/21-04/09/21. Pt states she went to hospital 04/09/21 and was diagnosed with TIA. Pt states that she is now showing signs of improvement with no more headaches (04/21/2021).

NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; 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 asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.

TEMPORAL ARTERITIS; CHILLS; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 78 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 not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced temporal arteritis. On 13-MAR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporal arteritis, swollen lymph nodes, and chills on 2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

Started having muscle pain; I didn't have chills. I was very fatigued - in bed all day. I had a headache and the muscle pains went into my left side and into my left lung and every time I breathed I would get a sharp pain. It went into both of my breasts but worse on left side of breast. This lasted about three or four days. I went to the doctor on Thursday, the 15th. But now everything is cleared up and I feel good. Yesterday, the 22nd I started feeling myself again. Except, I have a tremor that won't go away - I had a slight tremor before the vaccine but now after the tremor it is much worse.

FATIGUE; This spontaneous report received from a patient via a company representative concerned a 78 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. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue. This report was non-serious.

4-10 and 4-11-2021 Complained of headache; 4-12-2021 Sister-in-law stopped by around 5pm and noticed facial drooping on left side. My brother took her to a stand alone ER, She was given a CT Scan and nothing was seen on the CT Scan. Asked her to do various actions and was diagnosed with Bell's Palsy. It was recommended for her to go to a hospital ER or follow up with primary doctor for an MRI. 4-13-2021 Early AM lost her balance and fell down. Complained of legs cramping. Lost strength on leftside of body especially hand and legs. Appointment with primary doctor made for next day. 4-14-2021 Had 11 am appointment with primary care doctor who scheduled an MRI for 1:20pm. Sent to hospital ER following a positive result for an ischemic stroke in frontal lobe. Evaluated at hospital ER around 3:15pm. Admitted into hospital ER at 7:33pm.

HEADACHE; This spontaneous report received from a consumer concerned a 78 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested.. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache. This report was non-serious. This case, involving the same patient is linked to 20210520783

At 8:05 am on 05/12/2021 temperature of 102.8 was noted and Tylenol was given. The nurse did not did not document any other symptoms and stated that the patient denied any pain and felt fine. CBC, CMP, Flu swab, chest x-ray and UA with culture were obtained. The resident had a low grade temperature of 99.9 at 2:04 pm on 05/12/2021 and no other symptoms were documented. On 05/13/2021 at 12:15 pm, Nurse noted that resident wasn't 'acting like herself'. Nurse obtained a rectal temperature of 99.6 from resident and the resident had a blood pressure of 159/80, pulse of 66, respiration of 18, and an O2 sat of 95% on room air. Nurse noted that the resident was trying to speak but could not get

BODY ACHES; SHORTNESS OF BREATH; SNEEZING; MUSCLE ACHE; FELT GENERAL TIREDNESS/EXTREME FATIGUE; COLD; 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 right sided breast cancer, and torn meniscus surgery, and concurrent conditions included physical therapy. The patient experienced drug allergy when treated with clarithromycin, and cefuroxime axetil. 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold. On 17-MAY-2021, the subject experienced felt general tiredness/extreme fatigue. On 18-MAY-2021, the subject experienced body aches. On 18-MAY-2021, the subject experienced shortness of breath. On 18-MAY-2021, the subject experienced sneezing. On 18-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on MAY-2018, had not recovered from muscle ache, and body aches, and the outcome of shortness of breath, cold and felt general tiredness/extreme fatigue was not reported. This report was non-serious.

FEELING VERY FATIGUED; 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 fatigue, and other pre-existing medical conditions included the patient was taking 4 prescription medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced feeling very fatigued. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feeling very fatigued. This report was non-serious.

Received vaccination March 29th, 2021, I started getting COVID symptoms headache, fever, body aches, extreme fatigue, Diarrhea, May 9th, 2021. I Called my PCP and they directed to go to the Urgent Care to get checked out. They did a physical Exam, COVID test, and Influenza A-B tests, both came out negative. ER determined that I was diagnosed with "Acute Upper Respiratory Infection - Encounter for Screening COVID-19," nothing too bad. My PCP just wanted to check that I did not have COVID and to check out all the basis. I was in the ER for about an hour and then went home. I self isolated for 2 weeks, symptoms lasted for about a week.

Extreme fatigue April 17-18 (slept all weekend). May 13 vomited dinner. Had chills followed by fever and constant sleeping, which continued until I went to the ER on May 17th. I was given a CT scan, told I had a virus and sent home. On May 21 the chills and fever returned and I was unable to function. I was admitted to the hospital on the night of May 21st and given chest xrays, CT scan, hooked up to heart monitor, etc. and was told I had a liver abscess. I had none of the symptoms of liver problems (i.e., chest or abdomen pain) but went through the drainage process. I am still wearing a drain, which emits very little fluids. I had been unable to eat any solid food since May 14th to May 27th.

SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; 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 type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.

Fever, headache, stomach cramps, rectal bleeding when I tried to go to bathroom. Bleeding lasted 3 days

within a few hours of receiving J&J vaccine, she started having nausea, vomiting and diarrhea. She then started having increased arthralgias with myalgias. She was unable to tolerate foods or liquids for 36 hours. She required IV hydration. 5 large whelps present to back with scattered fine rash to entire body (no itching or irritation). Denied fever, but did complain of chills.

This spontaneous report received from a patient concerned a 78 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included endoscopy, and concurrent conditions included high blood pressure (borderline). The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 at 12:22 on left arm for prophylactic vaccination. . Concomitant medications included lisinopril for borderline hypertension. On 06-JUN-2021, the patient experienced blood from rectum and flatulence at around 04:00 to 05:00, terrible stomach pains, gurgling in stomach and fever at 04:00, sleeps too much, terrible headaches and water pouring off head that could not seen by her eyes. On 11-JUN-2021, the patient experienced weight loss. On an unspecified date, the patient experienced exhausted. The patient was unable to drive. The patient was use the kotex pad. When the patient weighed then the patient had found lost her 5 pound weight. The patient had consistently been the same weight, never moved. The patient was afraid to eat. The patient visited primary care physician office for blood from rectum, flatulence and terrible stomach pains. On 05-MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. Treatment medications (dates unspecified) included: Extra Strength Tylenol (paracetamol) and Gas-X (simeticone). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from rectum, flatulence, terrible stomach pains and gurgling in stomach on 11-JUN-2021, and terrible headaches, and fever on 06-JUN-2021, had not recovered from weight loss, exhausted, and sleeps too much, and the outcome of water pouring off head was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182596. The suspected product quality complaint has been confirmed to be voided because the suspect product did not meet product quality complaint (PQC) criteria based on the product quality complaint (PQC) evaluation/investigation performed; Sender's Comments: V0: 20210627859-COVID-19 VACCINE AD26.COV2.S-Blood from rectum. This event is considered unassessable. The event 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.

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.

Tiredness, pain in right side of the body stopped at knee, dizziness, unbalance, loss of appetite, symptoms continued about a week, pain in back, burning effect, takes Tylenol every 8 hours

1 day after vaccination, patient experienced pain in both arms from shoulder to elbows, headache, and overall felt sick causing patient to lay in bed for several days. Majority of symptoms resolved on 7/21/21. Patient does complain of lingering headache still today (7/22/21). Patient did not take any medications to treat symptoms

About 830 Pm on night of injection I got chills until about 3 am and in the morning i had a headache and was very unsteady but by that afternoon all that went away. On Wednesday morning when I took the bandaid off the injection site was red and itchy which it is today

Mild shivers, then intense dry heaves for about 10 minutes (?) (was in bed sleeping), complete loss of bladder control (never before) when stood up Slept through much of the morning. Was OK after.

79 y.o. female who presents to ED on 3/16/2021 with body aches, headache and nausea/vomiting. Patient's daughter reports patient received the Johnson & Johnson single-dose Covid vaccine 4 days ago (on 03/13/2021 at about 3 PM.) prior to ED visit. The next morning woke up not feeling well. Has had generalized body aches and headache. Has also had nausea and vomiting. Patient is able to tolerate some fluids, but anytime eats anything will vomit. Reports has had some loose stools. Denies blood in the stool or vomit. Reports aching pain to the abdomen, not worse in any particular area. Has pain to the right side of the chest that has been constant for the last 3 days. Chest pain is worse with movement and standing, but not worse with exertion. Denies difficulty breathing, cough, fever, sore throat or congestion.

AFTER GIVING THE SHOT PT REPORTED SEVERE HEADACHE, DIZZINESS AND SHAKY CALLED 911 ,PT REQUESTED TO LIE DOWN ON THE FLOOR , PT WAS BREATHING AND CONSCIOUS ALL THE TIME TILL AMBULANCE WAS HERE AND CHECKED BY THE EMERGENCY STAFF CREW, TOOK HER TO THE HOSPITAL

Patient vaccinated against COVID-19; received COVID-19 Janssen vaccine on 3/10/2021. Patient developed symptoms last week of March. Called Provider with symptoms and then presented to the hospital (admitted on 4/1/2021). Tested for COVID and found to be positive. 4/1/2021. Patient declined, admitted to ICU on 4/3/2021. Patient died on 4/4/2021. Chief Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little over a week) and FEVER (on and off for about a week)Patient was seen due to feeling ill for over week. Patient states that she was trying to fight it on her own but symptoms have been progressing. Patient has felt feverish no known fevers. Has had a persistent now worsening cough. Patient is feeling very tired and weak due to being sick for over week. Patient does live alone. Patient is coughing which is productive with sputum. Patient is eating and drinking well. No N/V/d. No loss of taste or smell. No recent ill exposure.; Has had covid vaccine. Patient did get the Johnson and Johnson vaccine over a month ago. Patient is feeling very fatigue; Having feverish/chills. Patient is taking OTC nightquil which is no longer helping. Patient does see oncologist for her CLL. DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia. Patient's symptoms of cough and shortness of breath have been present for approximately 2 weeks. It was noted that 1 month ago she did receive the Johnson & Johnson vaccine. Upon admission patient was treated with azithromycin, Rocephin to cover for secondary bacterial infection. She was not a candidate for remdesivir due to the length of her symptoms. She was started on Decadron, as well as gentle fluids due to tachycardia for approximately 12 hours. During the night of 4/2-4/3 patient progressively declined requiring more oxygen she was transferred to the intensive care unit. Patient was a do not resuscitate continued decline and after exacerbating all treatment options patient was switched to comfort care earlier this evening. Pronounced dead at 6:45 a.m.

BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 79 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 not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210356833.

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 concurrent conditions included suffers from sciatia nerve pain. 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, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cyanocobalamin/pyridoxine hydrochloride/thiamine hydrochloride for pain, and tramadol for sciatic nerve pain. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced achiness. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on 03-APR-2021, and cough on 05-APR-2021, and was recovering from headache, sore arm, and achiness. This report was non-serious.

Flu-like Illness started Day 2 at waking up. 2 nights of Weird , confusing dreams, chills, Nausea, fatigue - tiredness, some quick headaches, NO fever, lasted through day 5

bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting

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.

SORE ARM; SORE THROAT; 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 concurrent conditions included penicillin allergy, and sulfa allergy. The patient experienced drug allergy when treated with codeine, and streptomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, once a total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and sore throat. This report was non-serious.

BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient felt some pain in ankle, which was slowly moving up to the calf (left leg). The patient was brought to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months. Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The 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).

after getting the vaccine in morning, later that same evening patient felt sluggish, nauseaus, tired. Daughter finally convinced patient to see a doctor. Md prescribed her a cough medication. She still felt bad for another 2-3 weeks, so she finally went to the emergency room where she diagnosed with blood clots in the legs and the lungs. She staying in hospital approx. 4-5 days before being released.

RIGHT ARM WEAKNESS; RIGHT ARM PAIN; MUSCLE ACHES; HOT AND COLD; FLU-LIKE SYMPTOMS; FREEZING; 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 concurrent conditions included high blood pressure, no alcohol consume, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced hot and cold. On 06-MAY-2021, the subject experienced flu-like symptoms. On 06-MAY-2021, the subject experienced freezing. On 06-MAY-2021, the subject experienced muscle aches. On 12-MAY-2021, the subject experienced right arm pain. On 14-MAY-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold, flu-like symptoms, freezing, and muscle aches on 07-MAY-2021, and was recovering from right arm pain, and right arm weakness. This report was non-serious.

Eleven days after getting the shot, my mother in law was experiencing severe back pain and was not able to get comfortable or sleep at night. Before we could take her to see a doctor, she fell while trying to get out of bed at 7am the next morning. She had trouble getting up and exerted a lot of energy trying on her own. She called for my husband and I to help her get up. I grabbed her around the waist and my husband held her walker for her as support. Upon rising (mostly of her own ability) she was so exhausted that we had her sit on her walker and rest a moment. My husband went to check on her twice over the next 15-20 minutes, but when he returned again she was showing classic stroke signs and EMS was called. They arrived quickly and agreed. She was taken immediately to the ER, where they also agreed that it looked like a stroke. She was admitted as they continued to run tests, but she continued to decline more and more each day at the hospital losing motor skills and ability to speak. She was not able to move her right side at all and the left side was fidgety and had uncontrollably flailing that left her bruises on her arm and leg. She was also excessively sleepy. After loads of testings and images, the MRIs finally showed that the brain stem was extremely inflamed and it was an auto-immune response. By this time, she was already a vegetable in the ICU ward under incubation, IVs and a feeding tube. They continued to run more tests and brought in infectious diseases, but they ultimately said her body was fighting an infection that she did not have. They attempted a hemoglobin treatment with an oncologist to shut down her immune system but never consulted with her renal doctor, even through they were very concerned about renal failure. She could not complete the treatment and only received 4 out of the 5 doses they wanted to give her because of her kidney counts. They said that the auto-immune attack was very aggressive and they could not shut it down. In the early morning of 4/28/21, they finally contacted her kidney doctor and she was put on dialysis as a last effort to try to save her, but it was too late and all her organs were failing. She passed at 1:56 pm. Patient was homebound during the pandemic and did not leave the house unless she was visiting her doctor's office. My husband and I have limited contact at our jobs, as we work in small offices, and our children (that also lived with her) were being schooled virtually. There is nothing that I know that could have caused her immune system to go into overdrive, except for the vaccine that was administered less than 2 weeks (which is considered the time frame for vaccine immunity) prior to her symptoms.

DEEP VEIN THROMBOSIS (BLOOD CLOT); FELT UNWELL; SLIGHT HEADACHE; FELT TIRED; 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 concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient had not been tested positive for covid-19 and did not had covid-19. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine. On 02-Apr-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on left arm for prophylactic vaccination. Non-company suspect drugs included: rivaroxaban (form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, from APR-2021, and 15 mg, every 1 day, from 04-MAY-2021, frequency was not reported for deep vein thrombosis. The patient was not taking any concomitant medication while reporting. On 03-Apr-2021, the patient experienced slight headache and felt tired. On the evening of 29-Apr-2021, the patient went to the hospital where the sonogram was performed. Laboratory data included: Sonogram (NR: not provided) Not reported. On Friday, 30-Apr-2021, the patient could hardly walk and had painful leg (pain in back of legs especially calf area and spreading) and on 30-Apr-2021, was admitted to the hospital. The hospital asked her to see family doctor. After discharge, the hospital told that patient had deep vein thrombosis (blood clot). The patient was prescribed Xarelto (rivaroxaban) in hospital and the patient went to family doctor next morning. The family doctor told her to start Xarelto. She was started on Xarelto 15 mg (30mg daily) twice a day from hospital discharge. The family doctor changed the dosage due to age and small size after 5 days to 15 mg daily because patient felt unwell on twice a day dose. The patient had been on Xarelto 15 mg daily since 04-May-2021. The patient would follow up with family doctor on 07-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 06-APR-2021, and was recovering from deep vein thrombosis (blood clot), and felt tired. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556796-COVID-19 VACCINE AD26.COV2.S- Deep vein thrombosis. This event is considered unassessable. The event 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.

headache which started 3 days after and has increased in severity, associated with increase in blood pressure

ABDOMINAL PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 79 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, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced flu-like symptoms. On 28-JUN-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and the outcome of abdominal pain was not reported. This report was non-serious.

HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Patient was given Jansen Covid vaccine Lot# 1805029 Exp: 5/25/2021 to Left Deltoid at 10:40AM, by Rn. Fact sheet was given to pt before and consent was signed. Pt was escorted to lobby for monitoring per protocol. At 10:55AM pt begin to show signs of adverse reaction and was transported back to exam room via wheelchair by staff. Pt was lethargic, flushed, warm and dry and had c/o SOB. Pt was being accessed by Dr., vitals signs taken by staff at 10:56AM BP was 157/69 HR 67 R18 O2 98% glucose reading 84. Pt was offered juice and staff was attempting to arouse pt. Per provider order pt was given IM Benadry 50mg to right deltoid lot# 070110 Exp: 7/31/2022 at 11:03AM by staff. Vital signs rechecked at that time BP 137/68 HR 68 R 18 O2% 98. Pt fully alert and oriented at 11:20am and was speaking to her daughter, daughter was explaining to patient the events that happened. Pt vital signs recheck for 3rd time at 11:22AM BP 11:10AM HR 59 R 16 O2 98%. Pt was transported to car via wheelchair by staff and was witnessed getting into car with no assistance. Pt's daughter was contacted at 2:30PM by staff to check on pt and was told pt is feeling fine

day 1 (Thurs) terrible chills, headache and violent burping and diarrhea (drank plenty of fluids) day 2: (Fri) diarrhea (lots of fluid and took Imodium) nausea every time I ate anything, no matter how small. day 3: (Sat) more violent burps and nausea and vomiting Saturday night (around 8 pm) and diarrhea (began feeling so sick) with no control. Constant diarrhea. Still vomiting day 4 (Sunday) could no longer keep fluid down, ALL DAY horrible vomiting, involuntary vomiting of something that looked like it came from the bowel and not stomach. Horrible smelling. so severe I went to hospital ER at 11pm. And dry heaves Completely dehydrated and diagnosed with severe gastroenteritis. Had IV fluids, zofran,

Difficulty breathing 3/16/21. Taken by ambulance to hospital 3/17/21. Hositalized and treated for double pneumonia.

Client was alert and oriented after the vaccine but stated shortness of breath due to Sinus issues. she asked a question about using a inhaler and was allowed to do so. Client did state that she has had previous reactions to vaccines and was in the 30 minute observation line. She also reported a history of tachycardia. she felt better after using the inhaler and was monitored by EMS and Dr. Blood pressure was 157/76 pulse 80 RR 20 and 97% oxygen saturation. she was advised to seek medical attention post release if needed.

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.

Jansen COVID-19 Vaccine EUA Chills - lasting about 2 hrs, fever 99.1, stiff neck, overall blah feeling, loss of appetite. Lasted about 12 hours, sleepy

Patient reports severe headache, nausea and vomiting starting about 6 hours after vaccine. Sometime during the night a fever of 104 which went away with Advil. Nausea/Vomiting/Headache still occurring 14 hours later.

INDIGESTION; FELT LIKE SHE SWALLOWED A ROCK AND IT IS IN HER CHEST; HAS NOT EATEN MUCH TODAY; CHILLS; HEADACHE; TEMPERATURE 101.6; This spontaneous report received from a patient concerned an 80 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.6 F. On 04-APR-2021 01:30, the subject experienced chills. On 04-APR-2021 01:30, the subject experienced headache. On 04-APR-2021 01:30, the subject experienced temperature 101.6. On 06-APR-2021, the subject experienced indigestion. On 06-APR-2021, the subject experienced felt like she swallowed a rock and it is in her chest. On 06-APR-2021, the subject experienced has not eaten much today. Laboratory data included: Blood pressure (NR: not provided) 136/81 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.6, chills, headache, indigestion, has not eaten much today and felt like she swallowed a rock and it is in her chest was not reported. This report was non-serious.

Patient noticed swelling in neck (lymphadenopathy) around 10:30 PM (4-5-21). She said there was no pain or discomfort in left arm, but noticed a "small amount of swelling" at the injection site (left deltoid). She went to bed shortly after. Woke up following morning (4-6-21) at 7:15 AM & had generalized aching at the following body sites: back of head, neck, both legs, & both feet. She compared the aches to a case of "bad flu." Also reports malaise (tiredness, lethargy) and spent the entire day "laying around." On 4-7-21, the aches had resolved but she still felt tired & lethargic. On 4-8-21, all symptoms resolved & patient "felt fine." She did contact her primary care provider, & on 4-8-21 she filled a prescription for celecoxib 100 mg: 1 cap once a day, #30 capsules, which she began later that day.

Patient presented to ED with nonproductive cough, dyspnea, especially on exertion and orthopnea that had been ongoing for 1 week. D. Dimer >20.00

DRY HEAVES; COUGH; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced dry heaves. On 11-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry heaves, and cough. This report was non-serious.

TIRED; NEEDLE TOO SHORT; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced needle too short. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and needle too short was not reported. This report was non-serious. The case was associated with a product quality complaint number. The suspected product quality complaint has been confirmed to be this complaint does not describe a product quality issue. therefore, it will be forwarded to pqv management for review for void approval. based on the PQC evaluation/investigation performed.

ARM FELT HOT; SWEATY ARM; A BUBBLE OF SOME SORT ON RIGHT ARM AT THE VACCINATION SITE; SORE ARM; A BIG RAISED BUMP ON WRIST ON THE UPPER PART OF HAND MAYBE 2 INCHES; This spontaneous report received from a patient concerned an 80 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 not reported, batch number: 2119211A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced arm felt hot. On APR-2021, the subject experienced sweaty arm. On APR-2021, the subject experienced a bubble of some sort on right arm at the vaccination site. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced a big raised bump on wrist on the upper part of hand maybe 2 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, arm felt hot, and sweaty arm, had not recovered from a big raised bump on wrist on the upper part of hand maybe 2 inches, and the outcome of a bubble of some sort on right arm at the vaccination site was not reported. This report was non-serious.

About a week after her vaccine she went to rehab and exercised which she then developed leg pain, she said it only lasted that day and has since gone away. She believes that was from the exercise. A few days later she experienced diarrhea without having any cramping or feeling ill, just out of the blue for about 6 hours and then it went away. She has been tired/ fatigued the entire time.

LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; 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 high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.

RASH ALL OVER FACE ONLY; SLIGHT FEVER; CHILLS; 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 Asian flu, and concurrent conditions included GERD, high blood pressure, arthritis in hands, gout, tuna fish allergy, allergic to tarte/acidic foods., allergic to bread, and no alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:00 for prophylactic vaccination on left deltoid. Concomitant medications included allopurinol for gout, and atenolol for high blood pressure. On 12-MAR-2021 21:00, the subject experienced chills. On 12-MAR-2021 21:00, the subject experienced slight fever. On 13-MAR-2021, the subject experienced rash all over face only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever on 13-MAR-2021, and had not recovered from rash all over face only. This report was non-serious.

DIZZINESS; ALL OVER BODY ACHE; SORE ARM; HEADACHE; 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 concurrent conditions included unspecified health issues, and other pre-existing medical conditions included the patient had no health history that would relate to the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, batch number: 1805022, and 1005022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced all over body ache. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, all over body ache, and headache on 17-MAR-2021, and had not recovered from sore arm. This report was non-serious.

Patient had received the vaccine day prior to coming to ED. Presented to ED with family due to n/v/chills with shaking. She was able to dress self into gown and answer history questions. Then when she laid supine she became cold/clammy with loss of pulse. CPR was started with eventual decision by family to cease.

COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

80y.o. female with past medical history of COPD on 3L O2 at home, Asthma, Arthritis, B12 deficiency, Depression, GERD, Achalasia, HTN and Hypothyroidism presented with a chief complaint of cough and weakness. Patient states that she had the Johnson & Johnson vaccine on March 11th 2021 and believes she got sick from it. Since getting the vaccine, whenever she eats something she begins vomiting for the next 2 days. This has happened to the patient before, as she has a history of esophageal dysmotility/achalasia. Patient began developing a cough and SOB over the last 2 weeks that are getting worse. Patient states that she has no appetite at all and is feeling very weak due to the lack of eating.

FEELING TIRED; MEMORY LAPSES; REAL BAD BODY ACHES; MUSCLE TIGHTNING AS SHE WALKS; SEVERE POST PARTUM SHINGLES PAIN ACTIVATED; This spontaneous pregnancy report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe post partum shingles pain activated. On 26-APR-2021, the subject experienced muscle tightning as she walks. On 28-APR-2021, the subject experienced memory lapses. On 28-APR-2021, the subject experienced real bad body aches. On an unspecified date, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from real bad body aches, had not recovered from muscle tightning as she walks, severe post partum shingles pain activated, and memory lapses, and the outcome of feeling tired was not reported. This report was non-serious.

Persistent and constant headaches since day after receiving Johnson and Johnson vaccine. At first she rated her headache on a pain scale of 3-4. She said it would come and go and wake up with headaches. Sometimes they would get worse.

My arm was in pain. I experienced back pain for two days. I had a fever, chills, neck & shoulder pain, and I felt cold. I took Tylenol and Icy Hot. I already had a prior appointment scheduled to see the doctor so I did not see the doctor for this adverse event. But I told my doctor about my fever and they said the vaccine may have caused it.

HEAD "FEELS LIKE IT IS SWIMMING"; WEAKNESS; FATIGUE; FEELING LIKE PASSED-OUT; ACCELERATION OF BREATHING DURING WALKING OR MOVING; UNSTEADY; 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 concurrent conditions included type ii diabetic, and hiatal hernia, and other pre-existing medical conditions included patient had no known allergies. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included darunavir/cobicistat non-company. On 10-MAY-2021, the subject experienced feeling like passed-out. On 10-MAY-2021, the subject experienced acceleration of breathing during walking or moving. On 10-MAY-2021, the subject experienced unsteady. On 10-MAY-2021, the subject experienced weakness. On 10-MAY-2021, the subject experienced fatigue. On an unspecified date, the subject experienced head "feels like it is swimming". The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness, fatigue, feeling like passed-out, acceleration of breathing during walking or moving, and unsteady, and the outcome of head "feels like it is swimming" was not reported. This report was non-serious.

pt says she felt very strange like she was having some type of reaction and like something was wrong with her. She wants to sleep all the time and stay asleep. She says she has never been so tired and she is scared to even drive. She reported this to her pharmacist. She cant keep her balance and has never been so tired in her entire life, saying she could sleep night and day if she could and has felt bad since the day she took the vax. She also has some brain fog. She had to put her husband in a Rehab because he needs her care and she was not able to take care of him since she was so sick. (she wanted me to take note of these numbers)

Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21

Patient stated that she was very week. Patient stated that she could hardly walk. Patient stated that she felt like she had the flu. She kept her self hydrated. Patient stated she gets tired easily and can not continue her everyday lifestyle.

DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication. On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

CONFUSION; DIFFICULTY CONCENTRATING; WEIGHT LOSS; FEAR FOR DRIVING; FELT EXTREMELY TIRED; SICK TO MY STOMACH; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 80 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: 047A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced felt extremely tired. On 10-APR-2021, the subject experienced sick to my stomach. On an unspecified date, the subject experienced confusion, difficulty concentrating, weight loss, and fear for driving. Laboratory data (dates unspecified) included: Loss of weight (NR: not provided) lost about 30 pounds or more maybe 35 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sick to my stomach on 11-JUN-2021, and weight loss, had not recovered from felt extremely tired, confusion, and difficulty concentrating, and the outcome of fear for driving was not reported. This report was non-serious.

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

H/A, body ache & feel warm; suggested to take Tylenol or ibuprofen as recommended. Hydrate well and call poison center if any questions or concerns.

I had a low-grade fever, 99.1 degrees the evening of my injection. My normal temperature averages 97.5 degrees. I took two Tylenol and went to bed. The next morning I felt somewhat lethargic but better by the evening.

Not feeling well, no temp, but had pain in back behind lungs thought maybe it was pneumonia but, tested for covid just to make sure. It was positive.

FEELING OF "DID NOT WANT TO BE ALONE"; FEELING KIND OF WEAK; GENERAL TIREDNESS; DIFFICULTY BREATHING; SWEATINESS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, tetracycline allergy, and vancomycin allergy. The patient experienced drug allergy when treated with promethazine, carbamazepine, and topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1802068 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced difficulty breathing. On 24-MAR-2021, the subject experienced sweatiness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 25-MAR-2021, the subject experienced feeling of "did not want to be alone". On 25-MAR-2021, the subject experienced feeling kind of weak. On 25-MAR-2021, the subject experienced general tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, sweatiness, feeling of "did not want to be alone", feeling kind of weak, fever, headache, nausea, and general tiredness on 26-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

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

ACHENESS; TIREDNESS; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced acheness. On 12-MAR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheness, and tiredness on 2021. This report was non-serious.

NAUSEA; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune, prediabetic, cholesterol, tricuspid valve leek, and severe osteoporosis, and other pre-existing medical conditions included patient is allergic to simvastatin and aspirin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. Concomitant medications included pravastatin for cholesterol, and furosemide for tricuspid valve leak. On 15-MAR-2021, the subject experienced flu like symptoms. On an unspecified date, the subject experienced nausea, and headache. Laboratory data (dates unspecified) included: Laboratory test normal (NR: not provided) NEGATIVE (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, and flu like symptoms. This report was non-serious.

DIZZINESS; LOOSE STOOL; WEAKNESS; CHILLS; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced loose stool. On 02-APR-2021, the subject experienced weakness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, loose stool, weakness, chills, and fever on 03-APR-2021. This report was non-serious.

Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke.

WORRIED; CHILLS; HEADACHES; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included colon cancer, and concurrent conditions included codeine allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headaches. On 13-APR-2021, the subject experienced worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headaches on 14-MAR-2021, and the outcome of worried was not reported. This report was non-serious.

PAIN IN NECK; RUNNY NOSE; PAIN IN BOTH ARMS; This spontaneous report received from a patient concerned an 81 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, penicillin allergy, sulfa allergy, arthritis, incontinence, and cataracts, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain in neck. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced pain in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both arms, pain in neck, and runny nose. This report was non-serious.

Family member stated that pt experienced headache the afternoon she received the vaccination then complained to home health nurse that she did not feel well the next day. Patient was admitted on 04/19/2021 with diarrhea and possible pneumonia.

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

Presented to ER with weakness and tired last couple of days. Left side of neck pain and headache, shortness of breath.

At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21. Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion of the left shoulder with sensation of swelling in the arm on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain. She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21 where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy. An MRI was recommended.

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.

My mom had a stroke on 6/17/2021 and was hospitalized. A week or so before the stroke, my mom lost feeling in the fingers of her right hand and didn?t feel well...but she didn?t feel sick, just not her normal self. The stroke spidered out over both sides of her brain. Mom is off balance, her mouth droops on the right and that side of her face is numb. The doctors in hospital could see what happened to my mom but were puzzled why because she?s so healthy with no prior issues which would cause a stroke. We saw mom?s primary care doctor after release from hospital. She was very surprised that mom had a stroke as nothing in blood work, her health or family history would indicate that this would happen. Doctor said it was probably the COVID-19 vaccine.

Pt. states after receiving the 1st dose of J&J 06/24/2021, started experiencing symptoms 07/16/2021 of pain in the left of the head, Primary visit 07/202/2021 and diagnosed with active Shingles on the left side of the head. Treated with Tylenol for pain, recommend of anti-viral drug. Still continuing to develop.

Janssen COVID-19 Vaccine EUA Patient received J&J COVID Vaccine on 3/15/2021 per vaccine card. Patient had an ED Visit on 3/17/2021 for a chief complaint of lightheadedness and was diagnosed with Pneumonia with Chest X-ray showing small bilateral pleural effusions with underlying atelectasis or consolidation. On 4/12/2021, Patient presented to ED as instructed by outside physician for finding of blood clot on CT the morning of 4/12/2021 (Pulmonary emboli at the left upper lobe). The patient had CT scheduled during an office appointment on 4/5/2021. Patient admitted for treatment of pulmonary embolism.

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.

RAISED LESION ON CALF; NON RAISED LESION ON CALF; FATIGUE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and hx of hyperthyroid, and concurrent conditions included seasonal tobacco allergy, does not consume alcohol, and does not smoke. 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 19-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced raised lesion on calf. On 23-MAR-2021, the subject experienced non raised lesion on calf. Treatment medications (dates unspecified) included: bacitracin zinc/polymyxin b sulfate, povidone-iodine, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from raised lesion on calf, non raised lesion on calf, and fatigue. This report was non-serious.

PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 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 not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.

Paraphrase from provider discharge to swing bed note: 83 y/o female brought to ED for fall and left shoulder pain. Baseline dementia, poor historian, early onset Parkinson's Disease. Fully vaccinated for COVID-19, showing no obvious symptoms of COVID. Cough, no dyspnea per review of systems. Problem list includes: Anterior shoulder dislocation, reduction. COVID-19. Essential Hypertension, Acute confusion, baseline dementia, urine + for nitrite and bacteria, started on macrobid. Depression. Unable to enter required fields for Q.#21, Hospitalization. Currently Hospitalized

She got her vaccine, the first day she had a low grade fever. The 2nd day when she went to get a bath that she noticed the rash. The following day she was full blown red and took Benadryl. She had the rash all over her body except for her legs, trunk of her body, back and front. Tiny rash, red to touch, and the arm was hot to touch. No itching, but then the following day after that it was going away, and the following day it was gone.

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

I got the shot on Wednesday and on Friday I was shivering so bad I thought my chest was going to pop out and so nausea. I called my neighbor and took me to the ER . They ran Blood test and urine test and everything was ok. They told me i was a side effect for the vaccine and sent me home. I went to bed and didn't feel good, the next day I still didn't feel good. I got so chilled again and nausea and went back to the ER and say the same Dr. and took my Blood work again and said my blood work was better than the night before. I also had a fever and they told me to take Tylenol and it was just a side effect. I feel so weak and sick at my stomach still.

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.

ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; 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 past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. 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). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

LISTLESSNESS; BODY ACHES AND PAINS; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned an 83 year old female. The patient's weight and height was not reported. The patient's concurrent conditions included abstains from alcohol, non smoker, and low thyroid, The patient experienced drug allergy when treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:00 to Left Deltoid for prophylactic vaccination. Concomitant medications included rosuvastatin calcium for cholesterol, and levothyroxine for hypothyroid. On 08-MAR-2021, the subject experienced listlessness. On 08-MAR-2021, the subject experienced body aches and pains. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, body aches and pains, listlessness, and tiredness. This report was non-serious. Version created to amend previously reported information on 08-MAR-2021. Upon review the following information was amended: Labeling of event (chills) updated to unlabeled from labeled in USPI. Labeling of event (body aches) updated to unlabeled from labeled in USPI and Core. Event ranking has been changed as per labeling corrections. Additional information received from patient on 30-MAR-2021.The following information was updated and incorporated into the case: Reporter tab: primary reporter address added, Patient tab: date of birth, Age at the time of the event, age group, sex, height pregnancy and age at the time of vaccination added. Disease sub tab : abstain from alcohol, non smoker, low thyroid was added. Event tab: listlessness, tiredness, body ache and pains was added along with onset date and outcome as 08-MAR-2021 and recovering/ resolving. event onset date and outcome for events chills, headache, body ache and pains was changed to 08-MAR-2021 and recovering /resolving. Product tab: Concomitant drugs :Levothyroxine for hypothyroid and Crestor for cholesterol and the expiry date for suspect product was added as 25-MAY-2021. Causality was added as possible for the events listlessness, tiredness, body ache and pains. Ranking of events was changed. Seriousness criteria was changed to recovering and resolving.

On Saturday, 4/10/21, approximately 2 hours post vaccination, patient noted a knot on her left lower leg. No pain, redness or swelling noted to left lower leg. Patient took it easy the rest of the day. On Sunday, 4/11/21, patient began to have N/V, diarrhea and fatigue. No fever noted at this time or up to time of this report. As of 4/13/21, at 12:00pm the knot still remains present on left lower leg, along with fatigue and nausea. Patient was instructed to call PCP. Patient has an appointment with PCP on 4/14/21 at 1030am.

fever, pancreatic pain, rapid heart rate and breathing. (pancreatic pain was the main symptom that resulted in the patient going to and staying overnight in the hospital)

FATIGUE; MILKY PRESENSE IN THE VACCINE; This spontaneous report received from a patient and concerned an 83 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject noticed the syringe had milky presence (coded to PT of Product quality issue). Patient also noted that the health care provider did not fill the syringe in front of her and syringe was already prefilled with milky presence. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and had not recovered from milky presense in the vaccine. This report was non-serious. C

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.

Presented to Emergency Dept in full arrest. Patient was working outside when she began having a severe headache and lost responsiveness. CT head in ED revealed large subarachnoid hemorrhage.

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.

Admitted with intractable back pain (known compression fracture). Per ED note, patient found to have cough and labored breathing. New onset A fib

Pt presented to ED w/2 week hx of malaise, myalgias, weight loss associated w/dyspnea and dry cough. Found to be hypoxic, in which she responded well with 2L O2. Labs confirmed COVID-19 positive w/elevated inflammotory markers (lactic acid). Pt had received Janssen vaccine (3/31/21). Was admitted for additional management of her acute hypoxemic respiratory failure w/COVID-19 on 4/23/21. Was treated with dexamethasone, remdesivir and empiric antibiotics which were stopped early. Pt ultimately discharged 3 days later w/follow-up scheduled in 3-5 days.

PER PATIENT, SHE EXPERIENCED HEADACHE AND HIGH BLOOD PRESSURE (182/85) AFTER 2 WEEKS FOR GETTING HER JANSSEN COVID 19 VACCINE. SHE SAW DR. FOR THESE SYMPTOMS. EVENTUALLY HER BLOOD PRESSUE CAME BACK TO BASELINE WITH CHANGE ON HER BLOOD PRESSURE THERAPY REGIMEN. MD WAS NOT SURE IF IT IS RELATED TO VACCINE

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.

I was walking in the airport and I just fell for no reason. I went down slow. I was able to get up on my own, but I have no idea what made me fall. I went to my daughter's house and I was trying to climb the stairs to get to her place, but I couldn't even bring my leg up to step on the first step. I had to physically pull myself up the stairs by my arms. I felt like I lost my strength. I lost control of my bladder. I went to the doctor to have a urinalysis done and there was not an infection. I also lost my balance and would often have chills. Anytime I would start walking it would feel like I was drunk with how I couldn't walk straight. I felt fatigued during this time as well. During time that I would try to speak, I would say something in a sentence that had nothing to do with the topic of conversation. I was thinking I may have had a stroke, but when I went to the doctor and had a CT scan, a brain MRI and blood work done, everything came back normal. All of this lasted three weeks and then just all went away. My doctor diagnosed me with post COVID viral illness, but I never had COVID. She said it's similar to a viral meningitis.

As described to me by her son: 04-01-2021 received vaccine , no issues, waited the 15 min and said she felt fine. Left with no issues. had been to see her MD that morning for routine visit and everything was fine. 04-02-2021: No issues - felt fine. Went shopping and out to eat. Was a bit tired that evening. Son left her home at 6pm and all was good. 04-03-2021: son text her in the morning and no answer. Thought she might be in the shower and text again and no answer. He called her and no answer, so he went over and found her non-responsive laying on her back on her bed with the same clothes she left her with the prior evening. sheriff's office pronounced her dead on 04-03-2021 with what appeared to have been a heart attack.

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.

GENERAL MALAISE; TIREDNESS; This spontaneous report received from a consumer concerned an 84 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 not reported) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced general malaise. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and general malaise was not reported. This report was non-serious.

SHE FELT LIKE GOT HIT BY A TRUCK; FLU LIKE SYMPTOMS; URTICARIA (RASH ALL OVER BODY EXCEPT NECK AND FACE AND SCALP); INJECTION SITE BRUISING; This spontaneous report received from a consumer concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and stress induced rash, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced injection site bruising. On 03-JUN-2021, the subject experienced she felt like got hit by a truck. On 03-JUN-2021, the subject experienced flu like symptoms. On 03-JUN-2021, the subject experienced urticaria (rash all over body except neck and face and scalp). The action taken with covid-19 vaccine was not applicable. The patient was recovering from urticaria (rash all over body except neck and face and scalp), and injection site bruising, and the outcome of flu like symptoms and she felt like got hit by a truck was not reported. This report was non-serious.

The hospital gave my mom the Johnson shot on May 18,21.( I was not informed about it until my my told me on May 20th ) she said she had a headache and stomach, My mom was scheduled for an angiogram that day but they couldn't do it then because the doctor had an emergency. So they schedule it for Saturday but they couldn't do it because my mom had an upset stomach. They then schedule it for the 24th but they couldn't do it because her vitamin k and plasma level's were off. So they gave her vitamin k and plasma in the morning of the 25th and said they could do the angiogram. When she came back to the room her blood pressure was extremely low and she was very bloated. I was told they couldn't do the procedure because she had blood clots in her leg. And the bloating was due to fluids they gave her to flush out the heparin they gave her. Later that evening she passed away

had pink cheeks and tired, a week later woke up with chills and shivering, had heart palpitations, and tightness in upper chest

From 10 p.m. to 1:30 a.m. my heart beat was about 140/ min. then returned to near normal. I could not fall asleep until about 4 a.m. even tho I usually sleep through the entire night. When I finally fell asleep I had weird dreams like when one has a fever; however I had no fever. I experienced chills all night. By noon today (3/21/21) I have no more symptoms and feel back to normal.

Friday 3/19 Confusion, did not know her granddaughter, which grandchild she was kept confusing family names. That was very unusual for her. Saturday 3/20 didn't feel good that day, Sunday 3/21 around 3am got up to go to the restroom got very light headed and fell/fainted hitting her head on the night stand and falling to the floor. When EMS arrived she was in A-fib. That had never happened before. No known heart problems.

Extremely off-balance for a few days (3) after the shot; she could barely walk on her own without falling over. Also had aches and pains everywhere, and especially in both arms, for several days (5) after receiving the shot. Has not felt well since receiving the shot and still feels weaker than normal.

found my mother lying on the floor Monday morning covered in feces...she had been extremely tired after shot. Her Blood sugar was extremely elevated ...and she was dehydrated

A week following my mothers vaccination, she became increasing fatigued. On day 10 following her vaccination she went to bed and had to be helped to her room, this was unusual. She remained in bed for 19-20 hours a day for three days. I called all of her doctors, all of whom she had just been seen by, routine CT scans performed, blood work done, and visit with her neurologist. Her oncologist suggested we seek a hospice evaluation, even though her CT scans showed that her cancer had only slight growth, nothing to be concerned about. Her primary care office ordered the hospice evaluation and it was performed on Thursday, 3/18. They said ?she may just be having a bad week following her vaccination? and ?lets revisit this the following week?. her condition continued to deteriorate significantly over the next few days, so much that she began sleeping 21?23 hours a day. On the following Tuesday, 3/23, she was admitted into the hospice system. Now, four weeks later, we are in the final weeks of her life. She refuses food and water now, and her nurse says that it won?t be much longer. She went from a relatively healthily, senior woman, with underlying health issues, none of which presented her imminent demise, to dying at home within weeks of receiving her J&J vaccine. I have no idea if he demise is in anyway related to her vaccine, but thought it was important to report her symptoms.

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.

April 9- mild headache and 2 dizzy spells 2 to 3 minutes each April 21- severe dizzy spell, 10 minutes long April 21- Dr. examination followed by blood work and brain CAT scan. All tests came back normal. April 23- severe migraine, feeling very sick, no appetite April 24- present- lite headed dizziness, unsteadiness

Lethargic 4 days; headache, weak legs (knees buckled), odd pains various locations, tingling in hands and wrists, dizzyness, weakness, sore throat two weeks,

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.

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.

FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. This event is considered unassessable. The event 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.

Family reports general malaise post treatment, followed by fever and chills 4/3/2021, and cardiac arrest 4/4/2021.

Pt reports fever; BLE edema; H/A - on & off with dizziness; Abdominal cramping; looses stools w/ offensive odor; fatigue started on 4/6/21

SEVERE PAIN IN LUMBAR REGION OF SPINE; HEADACHE-3 DAYS; SEVERE SCIATIC NERVE PAIN IN LOWER LEFT LEG AND CONTINUING GOING DOWN THE KNEE WITH A LOT OF PAIN; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included herniated disk, non smoker, non-alcohol user, diabetic type 2, high blood pressure (HBP), arthritis spine, penicillin allergy, bee sting allergy, ragweed allergy, juniper allergy, strawberry allergy, grape allergy, asthma, and chronic pain, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was not ill at time of vaccination, had no previous history of similar events and had not experienced any adverse events after previous vaccinations. The patient did not have acute illness 30 days prior to vaccination and hospitalization in last 30 days. Patient had no family history of any disease or allergy related to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 11:15 upper left arm for prophylactic vaccination. Concomitant medications included nebivolol hydrochloride for high blood pressure, hydrocodone for pain, and metformin non-company for type 2 diabetes. On 09-MAR-2021, the subject experienced severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain. On 09-MAR-2021, the subject experienced headache-3 days. On 09-MAR-2021 21:00, the subject experienced severe pain in lumbar region of spine. On 10-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sciatic nerve pain in lower left leg and continuing going down the knee with a lot of pain, and severe pain in lumbar region of spine on 23-MAR-2021, and headache-3 days on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210322279.

COUGH; CHEST HEAVINESS; VACCINE HURT GOING IN; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy shots, and concurrent conditions included bronchitis in oak and cedar season, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for allergy. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced chest heaviness. On 08-APR-2021, the subject experienced vaccine hurt going in. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, had not recovered from chest heaviness, and the outcome of vaccine hurt going in was not reported. This report was non-serious.

FLU LIKE SYMPTOMS; INSOMNIA; PAINS IN LEGS; HEADACHE; This spontaneous report received from a consumer 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 not reported, batch number: Unknown) 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 an unspecified date, the subject experienced flu like symptoms, insomnia, pains in legs, and headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) not reported, and Doppler scan (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, headache, pains in legs and insomnia was not reported. This report was non-serious.

DIARRHEA; STOMACH PAIN; BACK PAIN; COUGH; SHORTNESS OF BREATH; RUNNY NOSE; CHILLS; FEELING TIRED/ FATIGUE; FEVER; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcers, blood count are always high, allergies to pain medication, and cigarette smoker, and other pre-existing medical conditions included 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 and batch number: 206A21A expiry: 23-JUN-2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced back pain. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling tired/ fatigue. On 15-APR-2021, the subject experienced diarrhea. On 15-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 15-APR-2021, was recovering from feeling tired/ fatigue, diarrhea, stomach pain, back pain, cough, shortness of breath, and runny nose, and the outcome of fever was not reported. This report was non-serious.

FEVER; NIGHTMARE; DIZZINESS; DROWSINESS; NIGHT SWEATS; FATIGUE; 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 not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced nightmare. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced drowsiness. On 06-MAR-2021, the subject experienced night sweats. On 06-MAR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmare, dizziness, drowsiness, and night sweats on 20-MAR-2021, and fever on APR-2021, and was recovering from fatigue. This report was non-serious.

SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. This event is considered unassessable. The event 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.

86 yo Female, in wheelchair, accompanied by granddaughters,had Janssen Covid19 Vax in Larm 10:28am.10:30 adverse reaction of feeling tired,weak/nauseous. Not diaphoretic. 10:32 V/S HR73,BP120/65,RR26/02%97%. Shallow breathing. 1034 EMS called as Attendee still symptomatic. 10:39am V/S HR77,BP130,RR16,02%99%.Attendee stated she felt better. 10:48am EMS arrive took V/S HR68,BP153/83,RR16,02%97%.Monitored Attendee.EMs offered to take Attendee to ER. Attendee refused. EMS left 10:57am. Attendee sat, rested. Had snacks and drinks offered by grandaughters.11:09am V/S HR66,BP150/70,RR19,02%99.Attendee and grandchildren educated on home discharge/adverse reason instructions.Discharge to home at 11:15am with granddaughters.

Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care.

Pt states she got her COVID vaccine on Wednesday 3/17 and has been having nausea, vomiting, hoarseness, and fever since.

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.

HEADACHE; ARM HURTING; 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 pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 31-MAR-2021, vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and arm hurting. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and arm hurting on 01-APR-2021. This report was non-serious. Version (1) created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Age group, age at the time of vaccination was updated.

new onset headache (3d post vaccination) no history of similar headaches. increased word finding difficulty (nondense aphasia), decreased alertness/malaise, chest pain

SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; 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 atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. 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: 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.

Patient experienced shingles approximately 3 weeks after getting the shot, followed by congestion in the throat, followed by itching on the back that is still occurring.

FATIGUE; RESTLESSNESS; TINGLING IN HANDS AND FINGERS; ITCHY RASH ON BOTH ARMS; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and concurrent conditions included hypertension, and other pre-existing medical conditions included statins allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180898, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced restlessness. On 09-APR-2021, the subject experienced tingling in hands and fingers. On 09-APR-2021, the subject experienced itchy rash on both arms. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restlessness, tingling in hands and fingers, and itchy rash on both arms on 10-APR-2021, and had not recovered from fatigue. This report was non-serious.

On 2/27/21, pt had new onset chest congestion, exhaustion and shortness of breath, but no fevers (measured at home) nor orthopnea. Visited primary doctor who urged her to visit ED. On ED visit on 3/4/21, she was found to be in afib RVR (heart rate to 170s) that was refractory initially to dilt push, dilt oral, dilt gtt. On 3/7/21, stroke alert was called because of new right arm dis-coordination, and on 3/8/21, MR brain showed an acute right cerebellar artery infarct (which did not leave deficits). Prior to the vaccine, pt had absolutely no symptoms of heart failure or cardiac diagnoses. She was hospitalized from 3/4/21-3/13/21, 3/18/21-3/23/21 for afib RVR, congestive heart failure, and acute kidney injury which required dilt and diuretics. However, she was later hospitalized on 4/8/21-4/11/21 again for afib RVR, congestive heart failure and acute kidney injury. Finally after continued outpatient amiodarone, she returned to normal sinus rhythm. Patient has shared that she has never experienced such drastic health changes in her life and these frequent hospitalizations occurred after her Janssen shot.

Patient received J&J covid injection 4/1/21. From 4/1-4/7 patient felt very fatigued/lethargic. 4/10-4/13 patient was having intense stomach pains and an intense headache, she felt off and states it was like nothing she's felt before. She thought she was going to have a stroke. Pt took her B/P on 4/11 it was 182/104, pt took an Aspirin and a half. An hour later it came down to 133/90. Pt states she wasn't thinking straight, she went to sleep. 5 lb recent weight loss d/t loss of appetite from not feeling well, 4/9 172 lbs, 4/13 167 lbs

Pt had Her Johnson and Johnson COVID shot on April 1. three days after this have coughing, and this was followed by a steady decline in her mental status and functioning. She was walking , talking , feeding self prior to time she go the shot. She could shortly not do any of these.

SORE THROAT; LEFT SIDE OF NECK PAIN; PAINFUL SWALLOWING; LOT OF PHLEGM; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, gout in left foot, split nails issue, seasonal allergies, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included biotin for split nails issue. On 18-MAR-2021, the subject experienced sore throat. On 18-MAR-2021, the subject experienced left side of neck pain. On 18-MAR-2021, the subject experienced painful swallowing. On 18-MAR-2021, the subject experienced lot of phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, left side of neck pain, painful swallowing, and lot of phlegm. This report was non-serious.

4/12 3pm patient went to get up from recliner, body was very stiff and had severe muscle spasms and cramps from back, stomach, pelvis, thighs and legs down to feet. Legs swollen (enlarged veins) patient said. Patient slumped over and went down to floor. crawled to bathroom and applied Hemp Vana every few hours until some relief. 4/13 moring took 2 tylenol -muscles from hips down burning, stinging and sore. Called doctors. 4/14 patient continued applying Hemp Vana but then switch to Arnicare pain relief. Patient mentioned diarrhea and nausea with headache(she did not mention before) seemed little better(on and off) 4/16 up at 8am diarrhea and throwing up -muscles very sore -spent day exhausted and resting 4/17 patient used warm wet towels and arnicare. 4/18 diarrhea and nausea stopped 4/19 muscles beginning to relax. leg and thigh swelling going down 4/20 Saw dermatologist for other issue. He lower back and thighs and recommended patient to see ultrasound vascular surgeon for pelvic ingestion syndrome and recommended doctor.

Patient presented to the ED 5/18/21 with voice slurring, headache, leg swelling. Patient with symptoms starting on Friday 5/14/21. Patient with profound weakness of her lower extremities, unable to ambulate around the house which is new. Patient also reporting she feels "different/wrong." While here in the Emergency department, patient fell onto her rear while at ultrasound, did not hit her head. Unable to stand on her own after. Patient was found to have an acute left lower extremity DVT on 5/17/21: Acute deep venous thrombosis throughout the left lower extremity with most proximal extension of thrombus into the common femoral vein noting that the external iliac vein could not be visualized

As per Daughter of PT, PT is in the hospital. Daughter of PT states that that on 04-07-2021 after receiving the J&J vaccine her mother developed severe right leg pain and is hard for her to mover leg, her right leg gets stiff and has difficulty to ambulate. Daughter of PT also states that her mother?s memory started to be off since receiving the J&J vaccine and that her doctors at the hospital placed her on Parkinson?s medication because the doctors think she displays symptoms of Parkinson?s disease. Daughter is at the hospital due to a fall injury and should be coming home soon. Due to the fall injury she has had lab work, x-rays, CT scan and lab work. Daughter of PT since the J&J vaccine she has had more frequent headaches on a daily basis than before.

VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.