Johnson & Johnson

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

SEVERE PAIN at the injection site, beginning two weeks after the injection. It's excruciating, so I've been lying on the couch for 7 days so far, with no end in sight. It kills me to move my arm, so I only get up to use the bathroom. I'm taking 1000 mgs of Tylenol and 200 mgs of Motrin every 8 hours with very little effect (if any). I've called my doctor twice, but they said they can't do anything unless I go in, which is impossible because of the pain. The nurse said they probably couldn't do anything, anyway,

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.

JOINT ACHE; TIREDNESS; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no pertinent medical history and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced tiredness. On 14-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, tiredness, and soreness on the injection site on MAR-2021. This report was non-serious.

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.

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

Noticed bright red disc-type spots on right leg - counted eight Area appeared swollen and was painful to touch Contacted my physician who looked at them Spots faded 2 days later

Patient noticed bruising beginning at injection area several days after receiving vaccine that slowly expanded down the arm, almost to the elbow. Patient came in 2 weeks after receiving vaccine and 3 weeks after receiving vaccine to show pharmacists the bruise; it is now faint and yellow in color and appears to be healing. Due to size of bruise, patient wanted it reported to VAERS. No treatment was done at home.

pain, tenderness and soreness at injection site (left arm) Patient initially applied ice to affected area, but did not want to take any pain relievers. Recommended to see primary provider if symptoms worsen. Patient has an appointment to see provider in June. Placed follow up call on 5/3/2021 at 1000 hours: Pt reports she is still having pain, tenderness and soreness on her left arm at the injection site. Pt advised she have an appt with MD 5/4/2021. Pt only applied ice pack and have not tried any Tylenol or Ibuprofen. *NOTE* Please contact pt mid-morning.

Resident developed Herpes Zoster, red raised, blisters neck and shoulder and hairline areas. Currently being treated VALCYCLOVIR.

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

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

INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 200 pounds, and height was 70 inches. The patient's past medical history included peripheral neuropathy, and myasthenia gravis, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, nitrofurantoin, and benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21AB, expiry: 21-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced injection site pain. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Negative X-Ray. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain. This report was non-serious.

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

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.

Internal pain at the injection site, especially at night when in bed. When using the arm during the daytime, the pain will subside. Treating with, icyhot, hot compresses at night, six Advil/Tylenol through the day, and one gabapentin 100mg before bed. This treatment works if I can get the pills in me before the pain starts and will stay working for about 5 hours, then the pain starts again.

She got the vaccine, no symptoms until about 10 days later on Tuesday 4/6/21 in the early morning she woke up around 3:00 AM and felt like she had been in a bar fight, had painful arm around vaccine site. She could not go back to sleep that night. The next night she went to sleep and everything was fine, no reactions. She slept on both sides of the arm up until the 10th day, and had no problems. The following night again got up to go to the bathroom and felt a pain in the left arm, but still had painful arm during the next day, ache going up through the top part of the arm where injection was, going across her shoulder area and into her back. The pain comes and goes as a dull ache during the day. The pain mainly occurs at night on the shoulder that she got the injection. Last night the same thing happened again and she slept a couple of hours, still having sensations there. When she got up had the big pain again, and filled a hot water bottle which seemed to help. Right now, 4/12/21 she still has an ache in the arm, but during the night it feels like somebody is punching the arm, which has been going on for 5-6 days. Deep breathing also radiates the pain to the shoulder area as well. Did not take anything for the symptoms other than the hot water bottle.

One week later started itching on my face and got hives on one side of face, on arms , a little on chest , hands also itched terrible! My forehead turned bright red. With little red bumps on it!

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.

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

NECK HURTS BY HER SHOULDERS; ARMS BOTHERING; TIREDNESS; HEADACHE; NAUSEA; MUSCLE ACHES; INJECTION SITE PAIN; FEVER; PAIN IN RIGHT ARM; SEVERE NECK SWELLING; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronavirus infection, and concurrent conditions included tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe neck swelling. On APR-2021, the subject experienced pain in right arm. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.6 F, 99.9 F, 101.5 F. On 07-APR-2021, the subject experienced neck hurts by her shoulders. On 07-APR-2021, the subject experienced arms bothering. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and injection site pain on APR-2021, had not recovered from tiredness, nausea, muscle aches, fever, arms bothering, and neck hurts by her shoulders, and the outcome of pain in right arm and severe neck swelling was not reported. This report was non-serious.

RASH ON FACE, CHEST, FOREHEAD, FOREARMS, HANDS IN BETWEEN FINGERS; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash on face, chest, forehead, forearms, hands in between fingers. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on face, chest, forehead, forearms, hands in between fingers. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedure.

Patient states 3 weeks after getting vaccine she got muscle weakness and got shingles for 4 weeks. She asked her md and he stated it was probably from the vaccine.

Administered on 4/9 Jenssen. On 4/14 patient daughter complained mother had a red itchy rash on bicept and on legs and ankles (red, bumpy, and itchy). Patient instructed to take benedryl and to contact primary care doctor. Pharmacy and Patient contacted doctor. RX medrol dosepak prescribed to picked up. Patient's rash resolved. Family thinking this was related to the vaccine since patient had not tried any other meds nor was outside. Doctor did not think was related to Vaccine per patient's daughter. Filing Voluntary VAERS to report rash 5 days later.

Pt developed a rash about a week after the vaccine was administered. The rash begins as a small red dot similar to a bug bite and over time becomes a large inflamed rash. The rash has so far only appeared in the patients legs and the patient complains of intense itching. The patient went to urgent care a few days later and was prescribed triamcinolone 0.1 % cream. A few days after that the patient went to see her primary physician and was prescribed Bactrim DS and Ketconazole 2% cream. She visited the pharmacy were she got the vaccine 4/30/21 to inquire if the rash could be related to the vaccine and ask for recommendation for the itching.

woke the next day with what appeared to be hives on lips and chin, spread to neck under chin and left arm. very uncomfortable and itchy.. taking benedryl for itch and calamine lotion to relieve itching.

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 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

About March 30th I had very large bruise on my left foot. Don't remember bumping it but it is possible I forgot. April1, 2021 I had another large hard red bruise on my left front forearm. Felt like a hematoma underneath bruise Don't remember ever having such large bruises even when I did bruise. The one on my left foot on top front of foot was very large black and blue about 4 inches wide. The one on arm was red about 2 inches circle.

DIARRHEA; HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered to the left deltoid, on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, headache, and pain at injection site on 08-APR-2021. This report was non-serious.

BAD CHEST PAINS, PAIN IN CENTER OF CHEST; FEELING OF HEART NOT BEATING RIGHT; BLOOD PRESSURE OF 212; CELLULITIS IN HER WRIST; This spontaneous report received from a patient concerned a 78 year old female patient. The patient's height was 166 inches and weight was 138 pounds. The patient's concurrent conditions included white coat hypertension, asthma, severe allergy to codeine, abstain from alcohol, and non-smoker. The patient was not pregnant. The patient received vaccination with covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 09:00 in left arm as prophylactic vaccination. Concomitant medications included estradiol. The patient reported that about 15-20 minutes post-vaccination on 02-APR-2021 as she was waiting in waiting area of vaccination clinic, she started to get bad chest pain which was in the center of her chest. She experienced heavy pressure in her chest. No arm pain or sensation was reported other than her chest. The patient further explained that she could feel that her heart 'wasn't beating right' and reported as 'heart feeling wonky'. The patient felt the top of her heart beating faster than the bottom. The vaccination paramedic took her blood pressure which was 212 (patient did not have any other information on her blood pressure). The paramedics called ambulance and after a 15 minute drive patient arrived at emergency room at 9.30. The patient had an echocardiogram or 'an ultrasound' of her heart and was told that it was not functioning properly that her ventricle was functioning at 40% of normal. The patient was put on nitroglycerin and heparin drip. Blood test was also done which showed troponin levels at 113 or 116, 'somewhere in there'. The patient was told that 'some type of cardiac event had occurred'. The patient's tests were reviewed same night and patient spent the night in emergency room because there were no beds. On 03-APR-2021, the patient was transferred to a hospital where she was put on nitroglycerin and heparin drip. The patient was moved again to another hospital on night of 04-APR-2021. The patient had angiogram and CT of vein and arteries. No clot was found by that time. The patient was discharged on 06-APR-2021. The patient saw a cardiologist on 15-APR-2021 who told patient that 'he thought she had some kind of clot that dissolved in the hospital'. Since patient has been home, she experienced pain and discomfort in arm and wrist with cellulitis in her wrist. The patient was taking cephalexin 500 mg three times a day for 10 days. The patient said it was due to angiogram she had because the angiogram team had hard time with her angiogram and had to go in twice. The patient had been taking percocet 5 mg tablet as needed for pain. The patient attempted to report these events online and left a message for someone to call her back but email did not work as she was unable to send. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad chest pains, pain in center of chest, feeling of heart not beating right and blood pressure of 212, and cellulitis in her wrist was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 78-year-old white (non-Hispanic/Latino) female patient was hospitalized for chest pain, palpitations, and blood pressure of 212 within the hour of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent illness included white coat hypertension, asthma, severe allergy to codeine; denies smoking and have abstained from alcohol. The patient complained of "bad chest pain" described as heavy pressure on the chest and that she could feel her "heart was not beating right/heart feeling wonky/top of her heart beating faster than the bottom". Blood pressure was 212 when it was checked, the patient was transported to the emergency room where echocardiogram showed that her ventricle was functioning at 40% of normal; Troponin was 113 (or 116). The patient was started on nitroglycerin and heparin drip. CT Angiogram of veins and arteries done 2 days after the vaccination showed no clot; by the attending cardiologist thought that some kind of clot might have been dissolved. Due to difficulty of doing the angiogram, the patient had cellulitis in her wrist with pain and discomfort in arm and wrist; the patient was taking cephalexin and percocet for the cellulitis and pain. No other details reported. The short latency and the advanced age confounded the event. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

UNABLE TO RISE UP ARM; KNOB LEFT ARM; LEFT SHOULDER PAIN; 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 vitiligo, and pruritus, and concurrent conditions included diabetes mellitus, hypertension, severed leg cramps, osteoarthritis, venous reflux, sulfonamide allergy, iodine allergy, shellfish / lobster allergy, shrimp/ lemon/ pepper allergy, no alcoholic 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, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced unable to rise up arm. On 27-APR-2021, the subject experienced knob left arm. On 27-APR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left shoulder pain on 28-APR-2021, and had not recovered from knob left arm, and unable to rise up arm. This report was non-serious.

1) Pain/soreness at injection site - Ongoing 2) Fever Blisters around mouth and lips - Ongoing 3) Large pustule under nose - now healed

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.

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

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

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

Pruritic rash over lower back. Red, dry, slightly raised 18 x 12 cm Micro-papular rash over upper abdomen, diffuse and subtle. The itching over lower back was intense for 3 nights but now seems to be subsiding on its own. No prescription medications were required. Patient was advised to use emollients and topical steroid or Benadryl prn if itching returned. Monitor clinically.

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

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.

DVT to left arm, pt came to appt reporting left arm redness and swelling. Sent to hospital for venous doppler ultrasound that confirmed DVT to site. Pt started on blood thinners at this time.

POSSIBLE UNEXPECTED BENEFIT (RELIEF FROM CHRONIC PAIN OF 20 YEARS); ITCHING; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included multiple abdominal surgeries, and concurrent conditions included breast cancer, chronic pain, chemotherapy, abdominal aneurysm, allergy to egg whites, and penicillin allergy and macrodantin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced itching. On an unspecified date, the subject experienced possible unexpected benefit (relief from chronic pain of 20 years). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 02-APR-2021, and the outcome of possible unexpected benefit (relief from chronic pain of 20 years) was not reported. 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.

First week of April, patient noted itching on top of both feet with pink discoloration. Then moved up to the outside of both knees where pink circle developed and itching. Then moved up to both arms all over, tops of hands, elbows. Finally moved up to her scalp. Still reports experiencing itching on both elbows.

CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INJECTION SITE FULLNESS; This spontaneous report received from a patient concerned a 79 year old female Initial information was processed with the additional information received on 28-JUN-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to antibiotics, allergic to food, non-alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prevention of COVID-19. No concomitant medications were reported. On 02-APR-2021, the patient experienced injection site fullness with administration. The patient had titers drawn to assess for immunity. The physician ordered the wrong lab test at first. In JUN-2021 (2 and a half weeks ago from report time), the patient had a quantitative study drawn and results of lab were stated as 25 (units not provided) and it should be over 250 (units not provided). The patient had a confirmed immunological vaccine failure. The test was ordered by primary care doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site fullness on 02-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184220.; Sender's Comments: V0: 20210661118-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure . This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS

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

Caller is an 80 YOF that received the Janssen Vaccine. Just today she noted that the site was bruised. she is a retired RN and had them do the Z track method to admin medication. she does not report pain to site but does say the bruise is noticeable. She has also noted some memory lapses where she forgets something she just read and this is not typical for her. adv to continue to monitor site. may apply warm compresses to site. if pain, take OTC analgesics. adv tof/u w/PCP if s/s persist/worsen.

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.

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.

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

She was Janssen COVID19 vaccine on 3/8/21. She came in on 4/14/21 reporting that starting around 4/6/21 the injection arm started hurting. The pain was not localized to injection site and varied from the shoulder to the wrist and was on and off. Could sometimes keep her up at night. She was advised per guidelines to contact her PCP.

Day #1 post vaccination patient had red, itchy arm from shoulder to wrist on right side. Resolved on day #2 after vaccination.

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.

RASH ALL OVER FACE ONLY; SLIGHT FEVER; CHILLS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included Asian flu, and concurrent conditions included GERD, high blood pressure, arthritis in hands, gout, tuna fish allergy, allergic to tarte/acidic foods., allergic to bread, and no alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:00 for prophylactic vaccination on left deltoid. Concomitant medications included allopurinol for gout, and atenolol for high blood pressure. On 12-MAR-2021 21:00, the subject experienced chills. On 12-MAR-2021 21:00, the subject experienced slight fever. On 13-MAR-2021, the subject experienced rash all over face only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and slight fever on 13-MAR-2021, and had not recovered from rash all over face only. This report was non-serious.

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.

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

4/2/2021 - pain in right arm starting at injection site. Over next 18 hours pain ran along arm to shoulder to upper back. Pain starts as sharp, then burning. Patient had difficulty sleeping. Started on ibuprofen (1000mg) at 8am on 4/3/2021 and heating pad. Pain dulled a bit. Additional info: on 3/27/2021 Patient woke up with a droopy eyelid that was diagnosed as Horner?s Syndrome on 3/31/2021 . Sent to ER at Hospital for MRI/MRA/CT, scans showed nothing conclusive - no evidence of stroke, aneurysm, clot, cancer, or anything pressing on optical nerve. Have followup with Dr at Hospital Neurology. Blood work ordered to check for evidence of other conditions that could deteriorate the myelin sheath.

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.

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

HARD SPOT AT INJECTION SITE; HOT AROUND INJECTION AREA; REDNESS AROUND INJECTION SITE; ARM PAIN AROUND INJECTION SITE; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hard spot at injection site, hot around injection area, redness around injection site, and arm pain around injection site. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from hard spot at injection site, redness around injection site, hot around injection area, and arm pain around injection site. This report was non-serious.

SORENESS IN SHOULDER AND NECK FORM ELBOW; BUMP UNDER NEATH INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, stent placement, heart attack, breakout in hives, and itching, and concurrent conditions included type 2 diabetes, hypertension, anxiety, penicillin allergy, iodine contrast dye, sulfur allergy, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included insulin for type 2 diabetes. On 26-MAY-2021, the subject experienced pain at injection site. On 27-MAY-2021, the subject experienced bump under neath injection site. On an unspecified date, the subject experienced soreness in shoulder and neck form elbow. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8 to 9 out of 10, 5 out of 10. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, bump under neath injection site, and soreness in shoulder and neck form elbow. This report was non-serious.

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

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.

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.

UPPER LEFT ARM PAIN/SORE/ACHES; CAN NOT SLEEP; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced can not sleep. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced upper left arm pain/sore/aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upper left arm pain/sore/aches, and the outcome of can not sleep was not reported. This report was non-serious.

RAISED LESION ON CALF; NON RAISED LESION ON CALF; FATIGUE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and hx of hyperthyroid, and concurrent conditions included seasonal tobacco allergy, does not consume alcohol, and does not smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced raised lesion on calf. On 23-MAR-2021, the subject experienced non raised lesion on calf. Treatment medications (dates unspecified) included: bacitracin zinc/polymyxin b sulfate, povidone-iodine, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from raised lesion on calf, non raised lesion on calf, and fatigue. This report was non-serious.

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

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

Large circular, red ring, white inner circle, mark in middle, very itchy, new ones every day. Located on torso, none on arms/legs/face

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.

Red spots varying in size on left and right side of face, and left and right arm. Similar in color. Legs swollen and red from the knees down,

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

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

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.

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.

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

LITTLE PINK COLOR OF THE CHEEK; 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 past medical history included childhood asthma, and concurrent conditions included high blood pressure, mold allergy, dust allergy, and allergy to trees. The patient experienced severe allergic reaction when treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) NEGATIVE. On 22-MAY-2021, the subject experienced little pink color of the cheek. The action taken with covid-19 vaccine was not applicable. The patient recovered from little pink color of the cheek on 22-MAY-2021. This report was non-serious.

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

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

04/0821 resident receive J&J Covid vaccine at the facility in the left deltoid and on 4/13/21 swelling was noted to her left upper and lower extremities. Physician was notified and orders were obtained to perform a Doppler of the affected extremities and to commence Eliquis 5mg po bid . 1st dose of Eliquis was administered on 4/13/2021 @ 1900-2300.

LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.

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.

Patient called - received J&J Covid Vaccine 3/12/21 - has had sharp burning pain in her right arm ever since. Has seen primary care physician several times for it. He advised her to report to us. She can barely use her arm.

PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.

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

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

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

BLACK AND BLUE ARM IN VACCINE INJECTION SITE; 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 strawberry allergy/peach allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0424214, 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 black and blue arm in vaccine injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue arm in vaccine injection site on APR-2021. This report was non-serious.

BAD RASH ALL OVER HER BODY; 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, and batch number were not reported) 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 30-APR-2021, the subject experienced bad rash all over her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad rash all over her body. This report was non-serious.

RED RASH ALL OVER BODY EXCEPT FACE; 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 high cholesterol, sulfa allergy, and lobster allergy. 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, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced red rash all over body except face. Treatment medications included: menthol/zinc oxide, and triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body except face. This report was non-serious.

SORENESS ON THE ARM FROM THE ELBOW UP; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was not reported and height was 65 inches. The patient's past medical history included colonoscopy, rheumatic fever, and whooping cough, and concurrent conditions included penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfur, and tetanus vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 22202A, and expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced soreness on the arm from the elbow up. Treatment medications (dates unspecified) included: magnesium sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness on the arm from the elbow up. This report was non-serious.

HEADACHE; ARM HURTING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 31-MAR-2021, vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and arm hurting. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and arm hurting on 01-APR-2021. This report was non-serious. Version (1) created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Age group, age at the time of vaccination was updated.

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.

pt had her J & J vaccine at medical center- on april 8th ... on the 20th , she developed arm pain, in the same arm, lower than where the shot went in. she also said it "burned" when she got the shot. she has had extreme pain, hasn't slept in 6 nights. went to ER on 21st, and did telemedicine with NP on 24th. xray was negative.

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

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

PT has a diffuse maculopapular rash over much of her body consistent with urticaria. She was on no new medications and had no new topical exposures or new medications.

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.

ITCHY ON THE ARM WHERE GOT SHOT; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received Covid-19 Vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-Mar-2021, the patient experienced itchy on the arm where she got shot. The action taken with Covid-19 Vaccine AD26.COV2.S was not applicable. The patient recovered from itchy on the arm where got shot on 08-Mar-2021. This report was non-serious.

RASH; This spontaneous report received from a patient concerned an 88 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 25-MAR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 27-MAR-2021. This report was non-serious.

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.