Johnson & Johnson

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

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; 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.

Pain, reddness, swelling in right leg, below the knee, when I got up in the morning. Symptoms continued over the weekend. Called Dr. on Monday, April 5, 2021 and got an appointment for the following day. Dr. diagnosed it as phlibitis and sent me for an ultr sound. Prescribed Xarelto 15 mg twice a day for 21 days, then decrease to 20 mg daily.

Patient called in complaining of left calf muscle cramping/ache. Told we would report to VAERS and for her to contact her primary care physician. She stated it started hurting on 4/14/21 upon awakening and it has continued to hurt as of 4/15/21.

Right leg swelling below knee , feels like needles around right ankle, call heart doctor had a scan of both legs found no blood clots have tried using a extra water pill to bring down swelling but it comes back the next day.

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.

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

The 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.

PAIN ALL OVER THE BODY; TINGLING ALL OVER THE BODY; COULDN'T SLEEP; 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 caller states she has no medical problems and takes no medications., and other pre-existing medical conditions included the patient had no medical problems and took no medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced pain all over the body. On 15-APR-2021, the subject experienced tingling all over the body. On 15-APR-2021, the subject experienced couldn't sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over the body, and tingling all over the body, and the outcome of couldn't sleep was not reported. This report was non-serious.

A SLIGHT BRUISE AT INJECTION SITE; SORE ARM; 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced a slight bruise at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a slight bruise at injection site, and the outcome of sore arm was not reported. 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.

Pt received Janssen vaccine on 4/5/21 and did complain of arm soreness on 4/6/21. Arm assessed small bruising noted. Pt working with therapy on 4/8/21- she was complaining of pain, nsg assessed arm and found the RUE was blue in color and hard to touch. NP made aware, ordered warm compresses as needed to arm. MD assessed pt on 4/9/21 for a poss. UTI- IV Rocephin ordered and adm. Pt had an allergic reaction to IV Rocephin, pt sent to ER for eval and treatment. Pt was adm on 4/9/21 and returned to health on 4/15/21. When pt arrived her entire rt arm/hand is black in blue in color. Per patient and daughter- the bruising continued to get worse day by day after she had received the vaccine

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.

5:15pm: Light headedness and soreness along right forearm down to right hand. 5:30pm: BP 184/110. Pt sitting on ground. Alert and talking/laughing/normal breathing. Was told by EMS to not give pt water/food in case of exacerbation. 5:40pm: EMS arrived 6:30pm: Pt discharged, reported BP down to 140/??

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.

Severe low back and both legs nerve and muscle pains every day especially upon standing in morning. Cramping, etc. everyday beginning a week and half post vaccination. Ongoing.

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

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

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.

Patient fainted after the covid shot, she was feeling hot and fell off the chair onto the floor. She hit her left eye and left temple resulting in a bump and a bruise. Patient opened her eyes when I called her name and she was not aware of were she was. Her blood pressure was 95/64 65 bpm laying down and 70/54 114 bpm when sitting. We laid her back down because she was feeling dizzy and the Ambulance arrives 45 mins after called. Because of her bump and her low BP she was taken to the hospital.

At 11PM on 4/8/21, I had sharp, stabbing LEFT UPPER QUADRANT PAIN under the rib cage. For the 1st 15 minutes, they came EVERY 30 SECONDS. For the next 15 minutes, the pain came EVERY 30 SECONDS. For the following 30 minutes, the pain came intermittently for 5 more times until midnight. On 4/9/21, at 1PM my LEFT HAND FELT LIKE IT WAS ON FIRE until 12 noon. Since then, no other problems.

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

Thumb on right hand becomes numb, turns white with apparent loss of blood circulation, and becomes cold. Since April 10, 2021, this has occurred 3 or 4 times without any identifiable cause evident. On April 10, however, the numbness occurred a few hours after a capillary broke and discolored the thumb. Though a capillary break in the fingers is not uncommon, the numbness is a new occurrence. It is not debilitating, though it is disturbing in that it appears my thumb is dying.The numbness dissipates in about an hour. I am not diabetic. In 2002, I did have a mild transient ischemic attack. During the week following the vaccination, cognitive processing was slowed remarkably but has returned to normal.

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.

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.

This is a possible breakthrough COVID case. The patient had right-sided weakness for two weeks prior to 4/20/21. She then developed weakness and confusion in the few days leading up to hospitalization on 4/20/21. The patient tested positive for COVID on 4/20/21. The patient was also previously COVID positive on 11/6/2020.

4 days after vaccination patient developed increased prominence and tenderness of varicose veins in both legs with significant hardness of the veins

LEFT ARM SWOLLEN; PAIN AT LEFT ARM/ HURT ON MOVEMENT; 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 stroke, and heart attack, and concurrent conditions included breast cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced left arm swollen. On 23-MAR-2021, the subject experienced pain at left arm/ hurt on movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at left arm/ hurt on movement, and left arm swollen. This report was non-serious.

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

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.

SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's past medical history included anaphylaxis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with formaldehyde solution. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe arm pain. The action taken with covid-19 vaccine was not applicable. The outcome of severe arm pain was not reported. This report was non-serious.

This patient is 77 years old, and had a menstrual cycle that began 5/15/2021 and lasted until 5/18/2021. She has not menstruated in over 30 years. She experienced cramps, low back pain, and irritability.

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

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.

Patient has severe arm pain and still cannot raise her arm above shoulder level without experiencing severe pain.

During the morning hours of 7/14/21 patient became increasingly SOB and eventually went unresponsive, with no pulse or respirations, CPR initiated and EMS transported to Medical center.

Patient arrived at the pharmacy 7-19-21 reporting she began to experience left arm weakness between the shoulder and elbow on 7/3/21 .She was unable to move or use the arm for 3 days, at which time it resolved. She also reports a sharp, bone pain just above the injection site-she experiences the pain only when she touches the area, (began 7/3/21). She continues to experience this pain as of the time of this report. She also reports a feeling of compression/numbness on the on the outside of her lower left leg between the ankle and the knee, this started 7/3/21 it has improved but has not completely resolved. Patient states she has not reported this to her health care provider

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.

3/11/21- pt was feeling fine. She stood up got dizzy and seamed to have a seizure. when she came to she did not know that it had happened. about 5 hours later she stood up again got dizzy and seamed to have had another seizure. her husband called 911. EMTs took her vitals but did not detect anything to be wrong at the time and was advised to see PCP. Next day 3/12/21 she went to her PCP. She had blood work which showed high enzymes for heart failure so was sent to hospital to be admitted. Pt had blood work, chest xray which showed blood clots in both lungs. She was administered blood thinner. MRI of head was clear. Echocardiogram was clear. Pt stayed about 4 days. Enzymes for heart failure was clearing up. Pt was released and had a FU appt w/ PCP on 3/22/21. Pt found out that she also had bilateral deep vein thrombosis in both legs while she was in the hospital. Pt is improving and is almost back to normal.

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

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.

Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021.

I got Bells Palsy within 15 minutes of getting the vaccine. I noticed that my cheek was going numb, and my eye was drooping. I stayed at the facility for 30 minutes. On the way home I couldn?t close my eye. I have had Bell?s Palsy in 2015 and I had mostly recovered with some residual effects to my eye and my mouth was a little droopy. It effects my eyelid, my mouth and the side of my face. Today my cheek was more numb even though my eye seemed to be getting better. The new effects are on the right side of my face in the same area as they were before. It has been eight days since my vaccination.

Patient received Janssen COVID19 vaccine on 3/18/21. The week of 4/12/21, patient noted right calf pain. No swelling or redness noted. Patient was seen in MD office on 4/21/21 and mentioned pain in right calf and that it was improving. MD ordered venous US and D-dimer and both tests were completed and resulted on 4/21/21. D-dimer is positive and venous US is positive for DVT in right gastrocnemius vein. Patient will start on Eliquis 10mg twice a day for 7 days, then Eliquis 5mg twice a day for 6 months. Will have Chest CT to rule out PE on 4/22/21.

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

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.

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.

Patient was discharged from the hospital after massive PE. She went to the hospital at 2am last Saturday. Patient described unbelievable pain from shoulder neck and arms. She could hardly walk to her car. Went to ER. There they ran tests and found many blood clots in lungs. Blood clots had stopped the blood in that area. They were not definitive but said it sounded like that. Got a breathing apparatus after because it's been hard to breathe and she has been shaky. Her shot was administered 04/12 during chemo. Hospital April 24. She was discharged and given a blood thinner and pain medication - Oxycodone & Eliquis.

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.

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

INFLAMMATION OF THE BALL OF RIGHT FOOT; BRUISING OF THE RIGHT FOOT AND TOE; TINGLING IN THE BALL OF FOOT; SWOLLEN BALL OF FOOT; THE BALL OF FOOT WAS DISCOLORED/ DISCOLORATION (DEEP RED AND PURPLE) HAD SPREAD TO THE WHOLE BOTTOM OF FOOT AND BIG TOE; 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 fractured vertebra, and concurrent conditions included no alcohol use, non-smoker, mast cell activation syndrome, seasonal allergies, and drug allergy, and other pre-existing medical conditions included the patient had seasonal and atypical (gastric and dermatologic) sensitivities to medications. 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced inflammation of the ball of right foot. On 25-MAY-2021, the subject experienced bruising of the right foot and toe. On 25-MAY-2021, the subject experienced tingling in the ball of foot. On 25-MAY-2021, the subject experienced swollen ball of foot. On 25-MAY-2021, the subject experienced the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation of the ball of right foot, had not recovered from bruising of the right foot and toe, and the outcome of tingling in the ball of foot, swollen ball of foot and the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe was not reported. This report was non-serious.

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.

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

(07/20/2021) sharp pain in right heel, usually walks 5 miles/day without pain. Experienced sharp pain (10), during walking. After icing the foot, got it down to a 5 on the pain scale.

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.

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.

recurrent acute embolic stroke noted on MRI brain. Received vaccine on 4/10. Seen in ER 4/11 with confusion. CT head negative and discharged home. Admitted 4/13 with worsening L weakness and fall at night. Acute stroke noted on MRI imaging.

Patient was in store and top of chest started hurting and down left arm. Patient states that they called 911 and ambulance took her to the hospital. She was tested and found to have mild heart attack with blood clot in vein of her heart. Had procedure to remove clot was put on blood thinner and is now wearing a heart monitor for the next 30 days. Is on Brelinta for the next 30 days as well. Patient went back to ER on Tuesday night (4/13/21) due to SOB spent 12 hours at ER before being transferred back to hospital. She spent another day and half before discharge diagnosed with fluid buildup.

No side effects after I first got it, it was 2-3 day later I started having rash between shoulders and across hips, hives and itching under the skin, it's been a few weeks now and I've had pain in my breast and some shortness of breath.

Arm pain and weakness radiating to the muscle of shoulder and shoulder blade that has lasted since receiving the vaccine.

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).

Patient became asphasic and was unable to keep her eyes open approximately 5 minutes after injection. Placed on stretcher, vital signs stable. Epi pen injected into her left thigh. Started to complain of chest pressure approximately 25 minutes after epi, ambulance called. Triaged by EMS and taken to ER

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

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.

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

Vaccine given at 545 PM, pt left the clinic and came back at 623 with complaints of shortness of breath and facial numbness. Vitals were 150/80 97% on RA HR 80 and RR 18. At 630 PM vitals were 115/65 HR 92 100% on RA and RR 18. Pt reported all symptoms had resolved by that time and left the clinic.

4 to 5 inch bruise to injection site, soreness to left arm starting from shoulder Patient has applied cold compress with no relief. Recommended applying heating pad to left shoulder and to takeTylenol as directed. If symptoms worsen advised to see primary provider.

Patient at clinic to receive Johnson & Johnson vaccine. Patient started complaining of being lightheaded. BP was 112/65, pulse 82, Temp 98.5, O2 sat 99. Patient began having tremors and weakness when standing. Physician evaluated patient. Patient became short of breath when talking. Physician ordered 50 mg Benadryl IM and advised staff to call ER. Patient taken to hospital emergency. A message was left for family to inform them. Member was discharged home same day.

SORENESS IN ARM; INJECTION SITE REDNESS; 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 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced soreness in arm. On 24-MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site redness on 26-MAR-2021, and had not recovered from soreness in arm. This report was non-serious.

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.

DVT Left lower extremity, pain developed about 10 days after vaccine, diagnosed 4/19/21 on Ultrasound, no prior history

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.

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.

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.

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.

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.

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.

Checked BP, was 199/99, was going to call Dr. in AM, but starting having tingling in left cheek. Went to ER, as my Mom died of stroke, where my BP registered 216/126. After CT scan, MRI, leg dopplers, echocardiogram, and bubble test, all which were uneventful. I was kept for observation until Tuesday afternoon. I was put on Plavix and Lipitor and released. I don't know if this was just a coincidence, but figured I should report it just in case. At the time of my vaccination, i had NO pain at the injection site, but a week later and since have had a slight pain at the site.

Right hip pain causing difficulty walking which is new onset immediately following vaccination. Woke with symptoms next morning. Started with generalized weakness midnight after the vaccine.

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.

LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 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 (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.

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.

WOKE UP FROM SLEEP DUE TO PAIN; RIGHT ARM PAIN; RIGHT SHOULDER PAIN; This spontaneous report received from a consumer 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced woke up from sleep due to pain. On 05-JUN-2021, the subject experienced right arm pain. On 05-JUN-2021, the subject experienced right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, right shoulder pain, and woke up from sleep due to pain. This report was non-serious.

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

severe cramps, lst in the calve of my right leg every night for a week, then 2 days later severe cramps in the bottom of my feet for a week, then 2 days later cramps in my big toes for a week, this last week had severe cramps in my abdoman area and back that lasted for 3 days. went to chiropracter for adjustment thinking it was my back (did not help) Called and made an appointment to see a Dr. for Monday June21, 2021 to check out severe abdominal pain and back pain.

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

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.

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.

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.

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.

CLIENT HURT HER ANKLE COMING OUT OF HER BED ON 4/10/21 AND DEVELOPED A BIG BRUISE, SWELLING, AND COOL TO TOUCH THAT DIDN'T HEAL AND REQUIRED A UREGENT CARE VISIT ON 4/21/21. SYMPTOMS HAVE STAYED THE SAME , NOT PROGRESSIVELY GETTING WORSE. CLIENT WENT TO SEE HER PRIMARY AND HE SAID IT WAS 'ANGRY' AND NEEDED A VISIT TO URGENT CARE FOR AN ULTRASOUND TO RULE OUT A BLOOD CLOT.

a couple of weeks after taking the vaccine her right arm was so sore it was almost paralyzed. It was bruised then turned red and painful. The pain is like a burning sensation. It was sore from elbow to shoulder blade. She has been applying hot packs and seems to help. She says her symptoms are getting better.

Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)

Pt w/significant cardiac hx p/w from LTC facility w/increasing confusion, decreased appetite, weakness over 4-5 days. No reported hx of cough, SOB, N/V, fever, or URI symptoms. CXR findings were clear. Ther was concern for dehydration due to worsening renal function. Pt tested positive for COVID-19 (4/24) despite Janssen vaccine (4/7) and pt stating they had COVID in December 2020. Pt admitted for additional management of COVID-19 infection w/acute metabolic encephalopathy, acute on chronic CHF, & AKI. Treated w/dexamethasone & remdesivir. Ultimately discharged 5 days later (4/28).

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

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.

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

Since receiving immunization over 2 weeks ago, the patient has been experiencing on and off soreness and swelling in arm. Patient has been directed to contact doctor for treatment.

SORENESS IN ARM; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight was 100 pounds, and height was 162 centimeters. The patient's concurrent conditions included osteoporosis, hypothyroid, pollen allergy, alcoholic, and cigarette smoker, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. patient had healthy appetite. 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 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.

Left Side Weakness with slurred speech. Started Sunday. Send to hospital. Still in hospital as of this writing (4-12-2021 @ 15:00) Charge nurse admittedly does not know if this is just a coincidence or cause by vaccine

Immediately after receiving vaccination I saw a red mark with tiny raised red dots on it approx. 5 inches down from the injection site. I told the nurse and she had doctor look at it and he said not to worry about it. However, as the day went on my entire left arm turned red. I went to my primary care doctor the next day and he told me to ice it and put lotion on it. The redness is going away 3 days later however I can still feel the dots under the skin . They are not painful.

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.

SHORTNESS OF BREATH; SHARP PAIN IN LEFT ABDOMEN; SHARP PAIN IN UPPER THIGH; HARDNESS AT INJECTION SITE; TENDER ARM; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, fibromyalgia, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced hardness at injection site. On 29-MAR-2021, the subject experienced tender arm. On APR-2021, the subject experienced sharp pain in left abdomen. On APR-2021, the subject experienced sharp pain in upper thigh. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in left abdomen, and sharp pain in upper thigh on 15-APR-2021, and had not recovered from tender arm, hardness at injection site, and shortness of breath. 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.

Janssen COVID-19 Vaccine EUA HPI The patient presents urgently with a friend after right lower extremity venous dopplers revealed an acute DVT. The patient apparently presented to podiatry, for foot pain and the doppler was ordered. When the result was positive yesterday, office reportedly told radiology to call my office after I had already left the office. The patient reports the pain in her RLE is improved. The patient denies any trauma to the leg or recent prolonged immobilization including car/plane trip. Of note she does say she received the J&J covid vaccine a month ago. Discussed risks of DVT and treatment options. Discussed association with breast cancer and Arimidex as well as covid vaccines. Will try to treat with Eliquis 10mg bid for a week then 5mg bid. Will discuss with oncology whether she may stop Arimidex. If she can, will likely treat with Eliquis for 3 months; otherwise will treat with Eliquis until she completes her course of Arimidex. Will report possible adverse event to VAERS. 5/7/21 ADDENDUM Discussed case with oncology, who corrected me that Arimidex does not increase risk of VTE. Will continue Arimidex with long term anticoagulation. Patient will be notified.

stroke-like symptoms; left side extreme weakness; gran mal seizure with loss of cognitive function; gran mal seizure with cognitive awareness; loss of depth perception and dizziness. Treatment: increase in lamotrogine from 200mg/150mg to 200mg/200mg

Resident received J & J vaccine on 4/10/2021, on 4/13/21 noted to have mild pain and edmea to left lower extremity. 4/14/21 MD ordered doppler which showed DVT to left popliteal and left posterior tibial veins, orders for anti-coagulant given. 4/15/21 resident stating mild pain, no other adverse effects noted.

Daughter reports following day case became "body heavy" Reports since then has had paralysis in arms and legs and puritis all over.

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

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.

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.

I received Botox on 2/19/21 In the right arm for post stroke treatment of muscle spasticity. Then I received the COVID-19 shot in the right arm on 3/12/21. Coincidentally within the following week, I developed extreme weakness in the right leg. It is severe enough that I'm still having trouble walking at all even with help. So I'm wondering if there was an interaction between the vaccine and the Botox that caused this. I've had adverse interactions between medications before.

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.

SORENESS OF BOTH ARM; This spontaneous report received from a consumer concerned an 83-year-old female. The patient's weight was 180 pounds, and height was 148 centimeters. The patient's concurrent conditions included high-blood pressure- 142/69, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. There was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21L, and batch number: 206A21L expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced soreness of both arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 142/69 mmHg. 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 soreness of both arm. This report was non-serious.

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.

Pain in right arm at the injection site, beginning 16 days approx. after the shot and continues to this date (3/31/21).

SHOULDER SWELLING; SHOULDER PAIN; SHOT WAS EXTREMELY PAINFUL; FLUSHED FEELING; DIFFICULTY LIFTING THE ARM; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 100 pounds, and height was 157.48 centimeters. The patient's concurrent conditions included arthritis in left shoulder and mammals allergy. The patient had no illness at the time of vaccination. The patient had no past history of similar event. the patient had no adverse event after any previous vaccination(s). The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization or acute illness in last 30 days, with cause. The patient had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for left deltoid prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced flushed feeling. On MAR-2021, the patientexperienced difficulty lifting the arm. On 15-MAR-2021, the patient experienced shot was extremely painful. On 19-MAR-2021, the patient experienced shoulder swelling. On 19-MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder swelling, and the outcome of flushed feeling, difficulty lifting the arm and shot was extremely painful 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.

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.

PERSISTS SORENESS IN THE LEFT SIDE ARM (NOT THE INJECTION SITE); This spontaneous report received from a patient 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, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced persists soreness in the left side arm (not the injection site). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persists soreness in the left side arm (not the injection site). This report was non-serious.

Swelling or lump at injection site, upon examination and ultrasound, a necrotic lymph node was found an axillary area of same arm

Severe reflux within two days of vaccine; Severe abdominal pain and probable gastric bleed within 6 days of vaccine; Daily heart palpitations within two weeks of vaccine; Two acute strokes within a month of vaccine and a third stroke event after the first two acute strokes causing paralysis on right side and noticeable cognitive dysfunction.

Left arm started aching, and it continued down my left side and down into both legs. Tylenol and cold packs helped a little for about two months before clearing.

CAT SCAN HEAD - SOMETHING IN HEAD; FEELING LIKE A BLOOD CLOT ON INNER UPPER THIGH OF RIGHT LEG; DIFFICULTY BREATHING; CALCIFICATION OF LUNGS; NUMBNESS IN BOTH FEET AND TOES; DIZZINESS; OFF BALANCE; RIGHT LEG TINGLING/FEELS LIKE WATER RUSHING; FELT LIKE BUGS RUNNING IN HEAD; ELECTRICAL SHOCK LIKE BUGS IN HAIR; SQUEEZING IN FACE; WHOLE BLOOD WAS DROPPING OUT OF BODY; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 230 pounds, and height was 66 inches. The patient's past medical history included stroke, and concurrent conditions included atrial fibrillation, allergy to medications, non-smoker, and non-alcohol user. The patient was not pregnant at the time of reporting and the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride for atrial fibrillation, and warfarin sodium for stroke. On 01-MAR-2021, the patient's laboratory data included Doppler scan and results were normal. On 04-APR-2021, the patient got dizzy right after the vaccination and off balance which exasperated everything. On the same day, the patient experienced tingling in right leg, felt like water rushing, both feet toes were numb, on right side felt like a blood clot on inner right thigh, difficulty breathing, calcification of lungs, felt like bugs running in her head, electrical shock, like bugs in her hair and squeezing in her face. The patient felt like her whole blood was dropping out of her body. The patient described everything comes and goes and one day it was there and another day it was not, then it came back. It was reported that, the patient visited her physician for the tenderness in her leg for possible blood clot issue and she did not know the results. On 29-JUN-2021, the patient's laboratory data included computerised tomogram (CAT scan) of brain and lungs which was abnormal, showed calcification on the lungs and that something was in her head. The patient had visited an ear, nose, throat (ENT) physician, internist, pulmonary physician, and cardiologist and it was made aware that all the side effects were from the vaccination. The patient had scheduled upcoming appointment with gastroenterologist physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 04-APR-2021, had not recovered from right leg tingling/feels like water rushing, numbness in both feet and toes, feeling like a blood clot on inner upper thigh of right leg, difficulty breathing, calcification of lungs, felt like bugs running in head, squeezing in face, electrical shock like bugs in hair, and whole blood was dropping out of body, and the outcome of off balance and CAT scan head - something in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728298-covid-19 vaccine ad26.cov2.s -this case concerns a 84 year old female-feeling like a blood clot on inner upper thigh of right leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, "Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted "excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling." Suspected insult stemming from J&J COVID vaccination reaction.

Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021. Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive .

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.

Presented with right hand/arm pain, numbness, and weakness since morning after receiving injection on ipsilateral side. Workup and imaging confirmed acute arterial thrombosis of the right upper extremity requiring surgery and thrombectomy.

PROVIDER HIT THE BONE/BONE HURTS; SORE ARM NEAR SHOULDER; PROVIDER HIT THE MUSCLE; INJECTION SITE PAIN STILL HURTS SINCE 4 WEEKS; This spontaneous report received from a patient concerned an 85 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: 18050221 or 1805022) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced provider hit the bone/bone hurts. On 19-MAR-2021, the subject experienced sore arm near shoulder. On 19-MAR-2021, the subject experienced provider hit the muscle. On 19-MAR-2021, the subject experienced injection site pain still hurts since 4 weeks. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm near shoulder, injection site pain still hurts since 4 weeks, and provider hit the bone/bone hurts, and the outcome of provider hit the muscle was not reported. This report was non-serious.

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

Pt has long hx of allergic (mild - moderate, rash and flushing) with different food preservatives and medication. Was cleared by doctor to get J&J but told to wait 30 minutes before discharge. Several minutes after getting vaccine, pt reported facial flushing and lightheadedness. Pt instructed to sit in reclined position in exam room and given bottled water (which she did not drink due to allergies to preservatives). Physical Exam. BP 167/95, T 96.6, RR 22, O2 95%. Lungs CTAB. Airway clear and non-edematous. After 30 minutes, pt felt well enough to go home on own. Pt given clear ER or PCP clinic return precautions.

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.

Extreme pain occurred in left thigh on 4/25/2021, went to ER. Was diagnosed with spontaneous bleed in gluteus muscle. Sent home from hospital 4/28/2021. Pain reoccurred 5/5/2021 and was again admitted to the hospital. Doctors unable to determine exact site of bleed. Stopped blood thinners to allow bleeding to stop and leg to heal. Inserted IVC filter on 5/9/2021. Had to go to to a rehab facility from 5/11 to 5/19. Saw doctor on 6/21 who ordered an MRI to be sure of no blood clots. Found out on 6/23 that there were blood clots in the lungs and was sent to the ER. Admitted to the hospital again. Had to stay until they could take out the IVC filter which was done on 6/28/2021 and she went home on 6/29/2021.

I RECEIVED THE JENSEN VACCINE ON JUNE 21ST. HAD NO REACTION FOR TWO DAYS. WHEN I WOKE UP ON THE THIRD DAY MY LOW BACK, BOTH HIPS, BOTH THIGHS, KNEES AND FEET HURT SO BAD I COULDN'T STAND ON THEM. I SPENT 3 DAYS IN BED AND SLOWLY BEGAN TO MOVE ABOUT. TODAY JULY 24TH I AM STILL HURTING WITH THE SAME PROBLEMS I DESCRIBED. MY DR. IS SEMI RETIRED AND LEFT NO ONE IN CHARGE OF HIS PATIENTS. HE HAS NOT BEEN INFORMED OF MY PAIN.

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.

86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8. Patient's last known well was at 10 AM on 4/8. GCS on arrival 15. NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria). In the EMS blood glucose was 122, no meds were given. Patient is not on any anticoagulation. Patient's blood pressure was elevated at 233/78. Patient denying any headaches, nausea, vomiting. Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit. Neurology contacted in the ED for stroke code. Patient outside of TPA window. CT head was negative. CT head negative for acute intracranial infarction. Chest x-ray negative for any acute cardiopulmonary findings. Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off. CBC showed mild leukocytosis (14.8) likely reactive. CMP unremarkable. PT/INR was also obtained. After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke. After discussion with family and the physicians the patient refused admission. Upon reexamination no further worsening of her initial symptoms, blood pressure controlled. Patient was discharged in a stable condition. She was discharged AMA. Patient was thoroughly explained the risks and benefits of leaving AMA. Patient said she understood and was advised to come back if the symptoms worsen. Patient was discharged with aspirin, Plavix and atorvastatin. Recommended to follow-up with the PCP tomorrow soon as possible. Also advised to return to the ED if any of the symptoms return.

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.

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.

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.

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

Patient was admitted to the hospital 12 days (3/24/21) after vaccine dose administration (3/12/21) sent in for refractory abdominal pain, nausea and vomiting. On admission, a CT Abdomen/Pelvis with contrast was largely unremarkable including reported demonstration of patent portal vein. During the course of the hospitalization the patient developed a portal vein thrombosis visualized on 3/26 by ultrasound. She also received Heparin SQ from 3/27/21 through 4/2/21 but not sent home on anticoagulation. Her course was also complicated by a seizure and Bacteroides bacteremia. MR Brain did not demonstrate thrombosis

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

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

ARM SORENESS; This spontaneous report received from a consumer concerned an 87 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.

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

CONSTANT DIZZINESS; WEAKNESS TO THE POINT OF CONCERN; 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 past medical history included cardiac arrest, and concurrent conditions included chronic obstructive pulmonary disease, diabetes, high blood pressure, and henoch-schonlein purpura. 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: Unknown) dose was not reported, administered on 04-MAY-2021 19:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weak. This report was non-serious.

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.

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 reports stabbing pain in Right hand, including thumb and second finger. Patient reports stabbing pain in Left hand including thumb, 1st and second finger. Onset occurred in the middle of the 2nd night post vaccination. Numbness and poor coordination of hands followed. States she has seen a chiropractor and talked to heart doctor but no one has diagnosed specific issue.

Fasting Blood sugar increased from 100 to 150 and stayed elevated for 2 weeks. Felt weak and lost balance.

89 yo female received J&J COVID-19 vaccination on 3/20/2021. On 3/24, pt determined to have cardioembolic stroke. CTA showed acute R M1/ICA occlusion. She went for thrombectomy where TICI2b revascularization was achieved. Patient was taking apixaban 2.5mg BID prior to admission. History of cancer and DVT, on chronic anticoagulation. LKW 3/22 (2 days after vaccine) with intermittent spells of expressive aphasia an L sided shaking. CTH neg. BL duplex with no DVT.

On 3/24/21, pain in right leg. On 3/30/21, pulse dropped to 37 and she passed out and was unable to recover, so called 911

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.

BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.

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

Resident had been experiencing cognitive decline over approximately the last month. Resident was treated for UTI on 4/29/21, labs were obtained on 5/3/21 and were unremarkable. Resident had seizure like episode at approximately 0830, resident was DNR Comfort Measures and resident's family did not want resident sent to hospital. Resident expired at 0920 on 5/21/21.

Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.

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.

Janssen COVID-19 Vaccine EUA Patient was found on the ground in home and admitted for observation on 6/24/21, reported frequent fals. Patient was provided J&J COVID Vaccine on 6/25/2021. On 6/26/2021 at 8:14 pm patient was noted to have left sided facial droop. Pt alert, confused. Can lift arms and legs for full 10 seconds. No weakness noted. Pt unable to tell when touching her left arm with her eyes closed x 3 attempts. Denies tingling/numbness in this arm. Not present in face/left cheek or left leg. 14 MRI brain showed small right MCA infarction on the background of considerable chronic microvascular changes. MRA head and neck showed diffuse intracranial and atherosclerosis without significant. stenoses or occlusion.

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.