Johnson & Johnson

Fever started 10 hours post injection. Fever was 99.1. Also body aches. Next day was fatigued and had small rash at the base of my neck in front.

THURSDAY MARCH 11TH VACCINE SHOT ADMINISTERED. FRIDAY MARCH 12TH DEVELOPED SWOLLEN RIGHT ANKLE AT WORK AROUND 10:30 AM. SWOLLEN ANKLE MADE MOBILITY DIFFICULT. MARCH 18TH ANKLE STILL SWOLLEN ACCOMPANIED FOR THE FIRST TIME WITH PAINFUL RED RASH AND FEVER. AS A RESULT, UNABLE TO PUT ANY WEIGHT ON RIGHT ANKLE FROM MARCH 18TH TO DAY OF WRITING THIS REPORT, MARCH 22. RIGHT ANKLE IS IN EXTREME PAIN. PATIENT HAS NEVER FELT PAIN SO SEVERE IN HIS LIFE. PATIENT CONTINUES TO FELL UNWELL.

Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.

rash. Generalized body rash x 10 days with stiff joints developing 2-3 days ago, after receiving J&J vaccine on 15MAR21; states seen in ED 4-5 days ago and Rx Famotidine and Benadryl with no relief. 60 yo M w/ no known chronic medical conditions, presents w/ 10 days papular, flesh-colored rash to extremities; started 8 days after receiving J&J vaccine. Most prominent on the extensor surfaces of his MCPs, PIPs, elbows, but also extends up both of his arms. 2 days joint stiffness. No facial rash, mucosal involvement, systemic sx, weight changes. No personal or family h/o autoimmune dz. VS w/o acute abn. Well-appearing, NAD. Papular rash as described above. No desquamating rash, mucosal involvement. I spoke to Dr.

RAPID HEARTBEAT; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's pre-existing medical conditions included the patient had no known allergies illness at the time of vaccination: no past history of similar event? no pre-existing acute illness 30 days prior to vaccination? no family history of any disease (relevant to vaccination) or allergy? no. 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 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced rapid heartbeat. On 20-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Heart rate (NR: not provided) 100 beats per min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and rapid heartbeat. This report was non-serious. Additional information received from patient on 31-march-2021 The following information was updated and incorporated into the case: patient weight added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Received shot at 11am. Around 9:30pm that evening started having the chills and a slight headache. Around 1:30am woke up with severe chills and a very bad headache where even my eyes were hurting. Also my arm was hurting from my upper shoulder down to my elbow and was warm. Around 2:00 am I started to throw up and had dry heaves for about 30 minutes. Once that stopped I took 2 Tylenol and fell back to sleep about an hour later. Woke up around 6am with a slight headache, took 2 more Tylenol and by noon time I felt completely fine and not even tired

Local rash (5-10 cm), pain at injection site x 4 days, Fever and chills x 36 hours, muscle aches x 36 hours, nausea, headache

Patient stated he woke up with red welts on his left arm and experienced numbness/swelling on the left side of his face. The patient compared the numbness to the effects of novocaine at the dentist. The patient also experienced fever, chills and sweating. All of the symptoms resolved within a few hours and the patient was feeling better when we spoke later in the afternoon on 4-8-2021.

Rash on right side of back and chest. Back is about five inch diameter cluster and chest is about one and a half inches in diameter. No treatment, rash is still there. First discovered on my chest on the third day after the vaccine. Discovered my back rash on the forth morning.

Gout-like reaction (self-diagnosed) at joint of large toe of right foot. No previous history of gout. Symptoms include significant swelling and joint pain, redness and warmth at affected area. Condition persisted 3 days; condition has begun to subside (at present date, only minor swelling remains).

As I am driving home from the vaccine, I got the shot on my left arm so numbness there seemed normal. I also got numbness in my left jaw and left thigh which seemed strange. I thought later maybe this was a mini stroke. It went on for at least 30 minutes.

In order experienced: 1) muffling effects in ears 2) head ace 3) rash and ich on ears (both, worse on right) 4) sore spot across forehead, center/right 5) rash and ich on throat and neck (right side)

3/31/2021: 6-7 HOURS S/P VACCINATION: HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021: UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021: ABOVE SYMPTOMS CONTINUED . 4/4/2021: STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER . WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021: DEVELOPED A RASH ON BACK.

SWEATING REALLY BAD; WHOLE BODY HURTS; LIGHT HURTING EYES; HIGH ANXIETY; HEART RACING; FEELS LIKE SHIT; PAIN AT THE INJECTION SITE; HEAD WAS HURTING REALLY BAD; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced head was hurting really bad. Treatment medications included: ibuprofen. On 09-APR-2021, the subject experienced sweating really bad. On 09-APR-2021, the subject experienced whole body hurts. On 09-APR-2021, the subject experienced light hurting eyes. On 09-APR-2021, the subject experienced high anxiety. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced feels like crap. On 09-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high anxiety, and heart racing, had not recovered from sweating really bad, whole body hurts, light hurting eyes, feels like crap, and pain at the injection site, and the outcome of head was hurting really bad was not reported. This report was non-serious.

(First of all, I'm not sure the COVID Vaccine caused this) Approximately 2 1/2 weeks after receiving the J&J single dose vaccine (around 22Jan21) I started to experience light itching on my lower back. Within a few days the itching spread to my entire back. By 30Jan21 i saw my primary care physician and a light rash was presenting on my back and chest. I was prescribed some cetirizine for itching. By Saturday 3Apr i had a full blown body rash on my chest, back, down my arms and down to my thighs. My doctor described it as angry red and indicated it appeared to potentially be some type of allergic reaction to a drug. On this date 13Apr, the rash has subsided but some itching continues. We are in the process o

Urticaria -macular papular rash on extremities (arms and legs), sides, back, face, very itchy. The rash started at 5pm on 4/17/2021, one week after receiving the vaccine. Urticaria got progressively worse. was given 50mg of Benadryl PO at 6:45pm. At 7:45pm the urticaria is gradually subsiding but is still present. I also contacted Janssen and spoke with a Pharmacist. I also reported this to Premier to the on call physician which is his PCP group. The on-call physician suggested I also administer Pepcid which I gave him 20mg. did have a sore arm several days after the injection. He is not having chills or an elevated temperature.

DIZZINESS; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has 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: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from soreness at injection site, and dizziness. This report was non-serious.

HEADACHE; PAIN DURING INJECTION ON RIGHT ARM; PAIN DOWN RIGHT ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included triple bypass, back surgeries, and neck surgery.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stomach pain. On 31-MAR-2021, the subject experienced pain during injection on right arm. On 31-MAR-2021, the subject experienced pain down right arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from pain during injection on right arm, stomach pain, and pain down right arm. This report was non-serious.

MACULOPAPULAR RASH PATCH ON FACE, LEGS, ARMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tendency kidney stones, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and drug abuse or illicit drug use at the time of this report. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021 17:00, the subject experienced maculopapular rash patch on face, legs, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from maculopapular rash patch on face, legs, arms. This report was non-serious.

I have severe swelling in both legs from knee to my feet, severe itching and hives, legs have blistered and burst open. I also have a Blood clot in my lower left leg. Have tried 2 kinds of antibiotics, I am on Xarelto 10 mg tab for the blood clot

April 7th cold chills lasted 20 min. April 14th a rash on both forearms and both thighs. Also had swelling of feet and hands with ankle and wrist joint soreness. April 16th started taking 4 Benadryl a day. 3 days later rash gone. Swelling and joint pain also gone.

ITCHING ON PRIVATE PARTS; RASH ON ALL OVER THE PRIVATE PART; ITCHING IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN BOTH HANDS, FEET AND INSIDE THIGH AREA/RASH IN THIS AREA ARE RED ITCHY; HANDS AND FEET ARE BIT SWOLLEN; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hands and feet are bit swollen. On 19-APR-2021, the subject experienced itching on private part. On 19-APR-2021, the subject experienced rash on all over the private part. On 19-APR-2021, the subject experienced itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy. On 20-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on all over the penis, and itching in both hands, feet and inside thigh area/rash in both hands, feet and inside thigh area/rash in this area are red itchy, and the outcome of hands and feet are bit swollen and itching on penis was not reported. This report was non-serious.

The patient developed thrombotic thrombocytopenic purpura (TTP), a week after the Janssen vaccine (Started having symptoms on March 15, 2021- speech difficulty, petechiae, fatigue, and easy bruising). TTP was confirmed by ADAMTS13 level < 5% and the presence of inhibitor on March 19, 2021. In addition, he had schistocytes, thrombocytopenia, and elevated lactate dehydrogenase. He was treated with PLEX, steroids, and Rituximab. He is currently closely monitored at Clinic.

Shortness of breath with a crackle sound which became more pronounced when lying down. I sat upright for about 1.5 hrs and respiration returned to a normal rhythm at which time I was comfortable enough to return to bed. I did not seek medical attention but monitored closely during that time and was prepared to go to the ER if necessary. As I write this I am at 22 hrs post vaccination. Respiration is fine, I have some discomfort at the injection site, a slight headache and some aches and pains which is expected.

INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site soreness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503868.

Moderate headache, joint stiffness, muscle aches and skin sensitivity began 8 hours after injection and lasted 36 hours.

SORE ARM; 103 FEVER; NAUSEA; BRUISING ON RIGHT FOREARM; This spontaneous report received from a patient concerned a 60 year old male. 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: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced bruising on right forearm. On 04-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced 103 fever. On 04-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, 103 fever, and nausea on 04-MAY-2021, and had not recovered from bruising on right forearm. This report was non-serious.

INJECTION SITE BRUISING; INJECTION SITE KNOTTING; INJECTION SITE SORENESS/PAIN; FEVER; COUGH; INJECTION SITE HEAT; INJECTION SITE RASH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.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 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site heat. On APR-2021, the subject experienced injection site rash. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site bruising. On 03-APR-2021, the subject experienced injection site knotting. On 03-APR-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 05-APR-2021, was recovering from injection site bruising, injection site soreness/pain, injection site knotting, and cough, and the outcome of injection site rash and injection site heat was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544451.

Shingles developed on my left lower back and torso approximately three month after receiving the Covid-19 vaccine.

weeping rash in the butt crease. Just reporting it now, but it started in May, I would wake up in the middle of the night with a terrible wet itching sensation in my buttocks. Treated it with athlete's foot Tinactin, other medications. Silver paste. Nothing stops it. Burning sensation when using Tinactin and then would apply other stuff, twice a day after washing area with soap. Nothing changes. Rash on the skin, scaly.

Client received the Janssen COVID vaccine lot #205A21A and expiration date 6/23/21 at approximately 3:01PM. Client arrives to the vaccine observation room and within 10 minutes reports feeling lightheaded and having tunnel vision to EMTs. EMT takes vitals: blood pressure 170/92, heart rate 80 and oxygen sat: 94%. PHNs arrive to assess client. Client is upright in chair alert and oriented x 4. Client denies any shortness of breath. PHNs observe sweating and rashes on left and right arms. Client reports his oxygen is normal for him since he has COPD. Client reports having a history of severe anaphylaxis allergy to penicillin, client reports taking morphine, lexapro, tizanidine, lyrica, and remeron. At 1:15pm client reports feeling "clammy and cold". Clients face is flushed and rash is spreading to neck, upper chest, lower left leg. PHN offers client Benadryl and he accepts. PHN starts calling 911 at 1315. PHN administered 50 mg of IM Benadryl at 1:17pm. At 1:17pm, vitals by EMT: heart rate:88 and oxygen: 94%. Client reports he "feels something in his throat" at 1:18PM. At 1:20pm client reports feeling in his throat is improving. At 1:20pm paramedics arrive and assume care. Client left facility wheeled out on a gurney at 1:27pm. Client will get transported to hospital. PHN alert security that a car left here overnight might belong to client being transported.

BAD REACTION; ALLERGIC GROWTH UNDER SKIN, ON HEAD AND FACE, AND IT IS NOW GOING DOWN TORSO; COLD SWEATS; RESPIRATORY ISSUES; LOSS OF TASTE; LOSS OF SMELL; SLEEPING 20 HOURS PER DAY; RED AND ITCHY GROWTH; NO ENERGY; This spontaneous report received from a patient concerned a 60 year old male. 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced bad reaction. On 29-APR-2021, the subject experienced allergic growth under skin, on head and face, and it is now going down torso. On 29-APR-2021, the subject experienced cold sweats. On 29-APR-2021, the subject experienced respiratory issues. On 29-APR-2021, the subject experienced loss of taste. On 29-APR-2021, the subject experienced loss of smell. On 29-APR-2021, the subject experienced sleeping 20 hours per day. On 29-APR-2021, the subject experienced no energy. On 29-APR-2021, the subject experienced red and itchy growth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction on MAY-2021, and cold sweats, respiratory issues, loss of taste, loss of smell, sleeping 20 hours per day, and no energy on 06-MAY-2021, and had not recovered from allergic growth under skin, on head and face, and it is now going down torso, and red and itchy growth. This report was non-serious.

Started getting symptoms on the right side - both front and back - upper quarter of body and all the way under the ar. Red dots and painful to the touch - with clothes, even when the wind blows. Over time it has gone down. I took the Epsom Salts with the hemp helped a lot. The doctor - said there was nothing he can do. He said the viral medicine can only be taken when the day it starts and not three days later (when I saw him). It's almost gone now.

Numbness in my hands and peripheral neuropathy -- extreme sensitivity to clothing and fabrics, particularly cotton ones. Also: mind fog, but that lasted about three days whereas this lasted two weeks.

Muscle pain in left arm from shoulder to wrist, mostly in tendons or ligaments. Muscle pain went away to be replaced by constant tingling in left arm (like hitting your funny bone, a constant fiery tingle). Constant tingling is now intermittent flair-ups, sometimes so intense that it interrupts my work and causes a safety issue. Injection site still sore to the touch ( a hard touch or press at injection site). Issue still ongoing 12 weeks after vaccination.

Arm rang of motion very painful . feels like bone is broke. Terrible pain when in normal use reaching or yawning . streching. Horrible pain. Like i have been hit with a baseball bat eminating from injection sight outward to shoulder .

Chest, back, and upper arm rash starting two weeks after vaccine injection. Prior to rash, two whelps appeared on lower trunk in symmetrical locations. Full body rash, except for head and feet, appeared gradually. Went to dermatologist in April 2021, prescribed antibiotics, steroids, topical lotion, anti-itch pills, and antihistamine. Went back to dermatologist two weeks after and received more topical cream and higher dose of oral steroids, while continuing antibiotics, anti-itch, and antihistamine. Rash starts to clear, when medicine runs out, rash flairs back up again.

Histimine reaction: re-emergence of poison-ivy type rash on left wrist area (had poison-ivy in this area in 2019) Treating with Benadryl spray / topical, and with Benadryl oral. 48 hours itch and rash still present / no significant change

Onset of a feeling like I was drunk the afternoon of the vaccine. The evening on 3/9 sleeping was difficult and I was very restless. When I awoke the next day (3/10) the only symptom was pain at the injection site. The afternoon of the 10th I began to experience flu like symptoms and was lethargic. No fever but did have chills. Slight headache. Awake the morning of 3/11 and symptoms had subsided.

5 days after receiving vaccine, hives appeared from shoulders, down to legs. Hands were itchy and warm. These symptoms continued off and on for 5 days. Symptoms mostly appeared in the late evening.

Developed 3 small blood clots in his left lower leg on Saturday, 3/10/2021 - swelling and slight redness along with pain

I'm not 100% sure that this is related to the shot, as it developed 5 days after the shot. That said, i've never had an allergic reaction to anything and have not changed anything in my diet or hygiene habits. Beginning yesterday around 5 pm, both of my arms became splotchy and itchy. As the evening progressed, the rash was all over my body. The "splotchiness" eased after a few hours, but I remained "itchy" throughout the night. This morning it's better, but I'm still slightly "itchy" in my extremities, particularly around my ankles and hands. I have not contacted a Dr, as it appears to be getting significantly better on its own. Just thought I would let you know in case it's something that others are experiencing.

Severe total body Hives, lasting days, requiring multiple medications, treated with medrol, benadryl, pepcid, hydroxyzine

On day 10 after injection painful allergic rash which started oozing 3 days later. Initially on arm, spread to other limbs and back.

ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. 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, UNDERLYING DISEASE

Pain at the injection site, chills, low-grade fever (100.1 was the highest recorded), body aches, extreme fatigue. All symptoms lasted approximately 60-72 hours then felt completely back to normal. Onset of symptoms was 10 hours after receiving the vaccine.

The injection itself was high on my arm and was very painful as it was administered (much more so than a typical vaccination in the arm). The pain has been persistent, and has gotten worse over time. No fever, no inflammation at the injection site other than a red dot that resolved over about one week. On advice of my physician (nurse practitioner) I've been icing the shoulder three times a day and taking ibuprofen 800 mg q 6h - this has not led to any improvement - to the contrary the pain is getting worse and the shoulder is losing substantial mobility. Something seems to have been done wrong - and am wondering if the injection itself was given in the shoulder or tendon rather than intramuscularly.

Dizziness and light headedness beginning approximately four (4) hours after injection. Currently (04/10/2021) experiencing mild light headedness and impaired ability to mentally concentrate and focus. Mild pain with palpation at injection site.

patient reports that the day after his vaccine her broke out in hives covering his entire upper body including torso, back both arms, neck and face. hives last for 24 hours required treatment with OTC benadryl l at home. hives went away after 24 hours and have not returned. patient also reports high fever of unknown because they did not have a thermometer for 24 hours

Pt was immunized at 1:30pm on monday 4/12/21, He presented today 4/15/21 and stated he had woke up Tuesday 4/13/21 with a knot on his left leg that was very painful and had difficulty walking

PT RECEIVED HIS COVID-19 VACCINE AND WAS WAITING IN THE OBSERVATION AREA. AFTER ABOUT 10 MIN MY TECHNICIAN NOTICED HIM SIT ON THE FLOOR FROM HIS CHAIR AND SHE CAME TO GET ME. AS I APPROACED HIM HE LOOKED DAZED AND SUDDENLY BLACKED OUT. IN ABOUT 15-20 SECONDS HE AWOKE AND ABOUT 1 MINUTE LATER HE WAS SPEAKING. ROUGHLY 5 MINUTES LATER, EMS ARRIVED AND CHECKED HIS VITALS, BLOOD SUGAR AND EKG. ALL WERE WITHIN NORMAL LIMITS. WHILE TALKING TO PATIENT AND THE TWO LADIES WITH HIM, WE FOUND OUT HE HAD DRIVEN 3 HOURS FROM HIS HOME TO COME TO OUR PHARMACY FOR THEM TO GET VACCINATED. AND THEY PLANNED TO GET ON THE ROAD AND RETURN. EMS SUGGESTED HE GO TO THE HOSPITAL, BUT AFTER 20 MINUTES HE WAS WALING AND TALKING AND DRINKING WATER. HE AND HIS FRIENDS DECIDED THEY WOULD NOT GO TO THE HOSPITAL. I FOLLOWED UP WITH HIM 2 DAYS LATER ON 4/9 AND HE FELT FINE EXCEPT FOR SORENESS AT THE SITE OF INJECTION. HE ALSO RECALLED A TIME WHEN HE HAD PASSED OUT FROM AN INJECTION WHEN HE WAS A TEENAGER

Approximately 12 days after vaccination, he developed a soft tissue growth at the area of injection. No signs of induration, infection, or inflammation. No signs of clot. Presents as a lipoma, but was not present previously. It does cause him to have some discomfort.

Patient reported radiating pain at injection site over 35 days since vaccination. The pain is not always there but will come and go randomly when using arm.

The patient states that on March 20 he was vaccinated with the Johnson and Johnson COVID-19 vaccine. He states that over the past several days he has developed erythema of the palms and a change of appearance of the palms that ?looks like they aged 3 years.? He states that he has developed new onset pain of the thigh, which has made ambulation difficult. He states that these symptoms were not present prior to obtaining the vaccine.

PAINFUL LUMP/HARD WHEN PRESS IT HURTS; SORE ARM; ALLERGIC REACTION IN SOFT TISSUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included broken wrist in december and a metal plate was inserted, and concurrent conditions included retired, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction in soft tissue. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced painful lump/hard when press it hurts. On 12-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful lump/hard when press it hurts, and sore arm, and the outcome of allergic reaction in soft tissue was not reported. This report was non-serious.

LEG RASH; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A27A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included isosorbide. On 02-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced leg rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and leg rash. This report was non-serious.

Hematoma about 7" long and 3" wide after slightly bumping with piece of lumber. Never had anything like this before.

the next morning and the following two mornings after the shot I had severe headaches. Theu went away without medication fairly quickly the first two days after I got up.. the third day after about an hour I went out and got some advil to get rid of it. About a week after the shot I started getting a rash under my arms and in the ground area. This got worse every dah and spread to .other parts of the body as time went on. Better today (april.23) but still very uncomfortable.

Burning and tingling pain on left side of head and face getting progressively worse. Hurts worse to move facial muscles or touch skin at area. No lesions.

RASH/2 BLISTERS ON CHIN UNDER LIP; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the subject experienced rash/2 blisters on chin under lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/2 blisters on chin under lip. This report was non-serious.

BUZZING IN HIS EARS; RINGING IN HIS EARS; BAD RASH ALL OVER HIS BODY; BOTTOM OF HIS FEET HURT TO WALK ON; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach disorder. The patient was previously treated with esomeprazole magnesium for stomach disorder. 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 buzzing in his ears, ringing in his ears, bad rash all over his body, and bottom of his feet hurt to walk on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the buzzing in his ears, ringing in his ears, bad rash all over his body and bottom of his feet hurt to walk on was not reported. This report was non-serious. This case, from the same reporter is linked to.

Approximately 4 days after the second dose, I developed a raised rash in the shape of the band aid which was placed over the injection spot on my upper right shoulder.

After my vaccine, I experienced redness sensation to my arm. My left arm was swollen and raised bump with a rash. I called my doctor and he thought it was possible cellulitis. He prescribed Prednisone and an antibiotic for seven days. After the seven days my rash was gone but I still had the raised bump. I went to an urgent care facility where they performed an ultrasound of left upper extremity and no blood clot was found. I was told to apply warm compresses to my left arm once a day. To this day I still have an aching sensation to my left arm and is also sore and my left arm is still red but flat in shape.

The afternoon after receiving the vaccine I had a job interview at 1:00PM EST and I wasn't certain I could make it because I felt a little off. I drank a bottle of water that was offered and I started feeling lightheaded and worse. As soon as I stood up, I thought I was going to fall so I sat back down. I waited around for about an hour before leaving. I stood up and felt a little better, but still a little off. I felt okay enough to drive and went to my interview. Once I got to the building, I had no clue how I got there. I completed my interview and remember leaving the building and sat in my car for a long time. I don't remember how I got home. I walked into my apartment and I lay on my bed and didn't wake up until the next morning. In the morning I went to my kitchen and grabbed more water. My ears started hurting, my head starting hurting and I felt off. I called and made an appointment with Dr. and informed her that I did not feel right. She wasn't sure if my feeling was from the vaccine or if it was a sinus infection. She gave me vancomycin 160mg capsule and tobramycin 20mg capsule. I feel that the shot is what messed me up. I felt like someone stuck a pencil in my ears. I felt like I wanted to sleep all the time. I also had chills in 65 degree weather. I had to have the heat on in my house. I'm still feeling a bit of pain around the injection site.

VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.

Patient experienced soreness at injection site and fatigue for about 12 hours after vaccination. on 05/18/2021 began experiencing pain at top of shoulder, radiating to front of shoulder, up neck and down to fingertips.

Skin lesions (blistering sores) and rash on outer skin all over body, particularly arms, chest, back, legs, hands, feet, scalp consistent with and confirmed by testing to be bullous pemphigoid

Woke up one morning with a slight rash on several areas of my body. Neck, side of torso, shoulder, and chest. First believed to be chigger bites or poison ivy/oak because I work and play around both. But it did not look like the chigger bites or poison ivy/oak I had previously experienced. This was a single red spot up to several red spots on areas not usually affected by chiggers or poison ivy/oak. I used OTC creams to treat. Then, I saw a couple of doctors discussing the side effects of the C-19 vaccine. They mentioned Shingles as one side effect. So I researched Shingles and because of the odd red spots and the areas, mianlhy neck and side of torso, I am thinking this was a very slight infection of Shingles.

After a week from shot, developed itchy rash and red pimples on legs. Spread to torso, shoulders and back. Unable to sleep at night. Lasted for over 2 weeks; thank God is finally subsiding. Not a happy person!

my immunologist, stated it caused a "flare" of my arthritis. Pharmacy where I received shot did not tell me to pause my meds before or after shot. Caused extreme pain at site and in my entire L. shoulder area. Pain persists to present day. Doctor gave me prednisone im and p.o. as well as gabapentin and flexaril.

Patient states he has had excessive bruising and inflammation in the leg since getting shot. He has had problems with circulation before but notes that it had not gotten as bad as it has within the last couple of months. Pt traveled out of the country after receiving shot and states that he noticed bruising on his legs and experienced severe inflammation of the legs around 2 weeks after receiving shots (around 3/30/21), noting that at one point they almost "looked purple". Since returning pt states inflammation has not been as severe but bruising continues and he is now noticing it on his arms as well. Patient has gone to see cardiovascular specialist who sent him to get a circulation test (pt not sure name of exam) on 6/24/21. He has an appointment to review results on 7/8/21.

I had severe shortness of breathe, rapid heart rate, bruising on the arm of the vaccinated. I still experience them to this day.

SHINGLES; FEELING TIRED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and neuropathy, 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: 1808980, expiry: JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced shingles. On 14-MAY-2021, the subject experienced feeling tired. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and shingles. This report was non-serious.

Developed an itchy rash on my back and neck within 48 hours of receiving vaccine. Been taking benadryl, using benadryl spray and cortizone cream beginning March 11, 2021. Gives temporary itch relief only.

The patient presented to my pharmacy today, March 30 around 12 noon. A blister, aprrox 3in x 2in x 1in, was located on top of the MCP joints of his right hand.. Pt stated he has been seen by the local emergency facility, his PCP and has been referred out to wound care.

Initially bruising for almost 2 weeks at site of injection. Subsequently, I had unusual bruising at IV site for CT scan with contrast greater than one week, site of blood draw for testing and Power Port IV site for immunotherapy both greater than one week. I have been cancer patient with these treatments regularly for many years and this bruising and length is not normal. Additional information, Heparin is administered to flush port after treatment.

Got heaviness in chest and ring finger turned white and numb around 8:30 a.m. Got heaviness in chest again around 6:00 p.m. and it would not subside so I went to the ER and they gave me 3 nitroglycerin and did several tests to check my heart but could not find anything wrong. I am scheduled for a stress test April 20. The person in the bed next to me had similar symptoms and received he Janssen vaccine the same day I did but about 10 minutes earlier.

I received the Janssen vaccine on March 13. By the next weekend, I had what I thought was a spider bite on the inside of my left thigh. That "bite" got worse--bigger, hot to the touch, and then red. On the weekend of the 27-28 of March, it was red, raised and very painful even when not touched. I called my family doctor on Monday morning, the 29th of March, and I was sent to the Emergency Room, where I was diagnosed with a 7cm thrombosis in my left greater saphenous vein, which is treated the same as a DVT. I was treated first with Lovenox injections, then Eliquis 10 mg 2x daily, now 5 mg 2x daily. The blood clot is still painful to the touch.

diffuse itchy red rash covering legs, and back I took one dose of OTC anti-histamine (diphenhydramine) which reduced the itching for some time, but it has returned. I have now taken cetirizine (one dose) with no effect as yet.

Itching on hands, arms, feet, including welts. Usually take Benadrylr to relieve itching. Symptoms still ongoing at this time.

The injection site is the left arm. Common pain was felt, however, pain sensation traveled down below the left elbow. Persistent muscle cramping is experienced with the calf muscles of both legs. A routine of stretching and daily mile walk before and after vaccination has not eliminated the pain.

Patient started with Left lower leg pain and redness on 4.1.21. Went to Emergency dept on 4.4.21 and diagnosis of Left leg cellulitis and prescribed Doxycycline. Patient came to PCP office on 4.6.21 with worsening left lower leg pain and swelling. Order L lower leg doppler. Diagnosis of L lower leg deep vein thrombosis of tibial vein on 4.7.21 and prescribed Apixaban 5mg 2 BID x 7 days on 4.7.21

Pt here for in office visit converted from virtual. He developed painful rash on Friday late morning 4/9. Bumps on his right side of forehead and pain traveling down front of his right ear and into lower part of his jaw. No tinnitus, hearing issues, pain inside ear. No eye issues such as eye pain, vision issues or blurriness, tingling. He had an eye exam 2 weeks ago. No facial paralysis, tingling or numbness. He has been taking tylenol. No hx of shingles. No hx of vaccine for shingles. Chicken pox as a child. He sees GI for UC. On medication last few years. He last saw his GI last year and is overdue to see him this year. He did get his janssen vaccine 2 weeks ago 3/17.

Inflammation of hands and feet, redness and severe itching. Redness and mosquito bite like bumps on the back of legs, small of back and upper arms that itch.

Fever and chills for the first two days. Then I started having a rash that has not gone away. Have been treating it with cortisone cream and Benadryl pills and cream

BODY ACHE; SEVERE CHILLS; HEADACHE; YELLOW BLOTCH ON INJECTION SITE, DISCOLORATION; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced yellow blotch on injection site, discoloration. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced severe chills. On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, severe chills, and headache, and had not recovered from yellow blotch on injection site, discoloration. This report was non-serious.

BLOOD IN STOOL; TENDER LUMP ABOVE HIS LEFT EYEBROW; FACIAL CONTUSION; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Human immunodeficiency (HIV) infection, seasonal allergy, medical marijuana, alcohol use (glass of wine with dinner), non smoker, and bleeding issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AV1A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 19:30 to right arm for prophylactic vaccination. Concomitant medications included atazanavir sulfate for antiviral, emtricitabine/tenofovir alafenamide fumarate for antiviral, cetirizine hydrochloride for seasonal allergies, amlodipine besilate, and topiramate. He stopped his antivirals medications two days prior to this report and three days after vaccination. On APR-2021, the patient experienced injection site pain. On 10-APR-2021, around noon he noticed a lump above left eyebrow/facial contusion, described as a raised portion the size of a pea, with a red portion an inch by and half. It was tender. It was still present at the time of this report but improved. On 11-APR-2021, after a bowel movement, he noticed fresh blood in the stool around the faeces and afterwards he wiped. On 13-APR-2021, he contacted his healthcare professional (HCP) and they did a coagulation test (NR: not provided) and it was within normal range. He mentioned that the bleeding was a little worse but his HCP was going to retest in a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from tender lump above his left eyebrow, and facial contusion, and had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210431872-Covid-19 vaccine ad26.cov2.s-Blood in stool. 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: MEDICAL HISTORY

He received the vaccine, had very painful going in and tingling going down his left arm and to the elbow which was numb, and the left little finger was numb, and a dizzy spell afterward which was typical for him. He then on the 9th day had extreme intercostal pain in the ribs on the right side and his right shoulder extremely painful, low grade fever, chills, fatigue and inability to draw a full breath. He called the doctor and they were on the way to the clinic they told him to go to the ER based on his symptoms. He went to the ER and they admitted him and did blood work, and then did a chest x-ray, then a chest CT scan and it was positive for pulmonary embolism. He was treated with an anti-inflammatory through the IV and a blood thinner to the stomach. He was hospitalized for 1 full day, and discharged home with Eliquis double dose for 14 days and then a single dose until further notice. He is still having fatigue and aches on the right side of his brain and aches in his feet, but is to see a pulmonologist for his lungs, as it will take up to 6 months for it to resolve. He also has damage to the right side of the heart and lung. Is waiting to get a CT of the brain.

Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves

COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.

Sharp pain to collar bone, neck and shoulder. Sharp pain shoots down arm to fingers. Hand becomes cold and discolored. No treatment to date except ibuprofen which does not help.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling was only located in fingers and hands. Patients Blood Pressure after event was recorded at 106/58. Patient states he naturally runs lower blood pressure and heart rate. Also mentioned that he has a fear of needles.. Patient is now responsive and feeling better.

Started at 430 am on the 13th of April, my stomach started hurting. It does not matter if or what I eat, it still hurts. I got headaches, those have also continued since the 13th. The following week my mouth began to hurt, I started coughing more than normal. First a dry cough, now I'm coughing up phlegm with specks of blood. And I can not stop itching, and I'm getting tired of taking benadryl for it. I contacted my doctor, all I got was these are normal reactions to the vaccine. They last 2 to 4 weeks. I already get migraines, my gut is picky since that shot. I used to eat hot peppers, now if I use pepper on my dinner my stomach is in pain. These side effects should be gone by now. I am one pissed off person.

PT REPORTING BRUISING ON BOTH LOWER ARMS AND KNEES. WAS WORKING ON HIS CAR, AND DID NOT BELIEVE HE HAD BRUISED THESE EXTREMITIES, BUT STARTED SEEING BRUISING ABOUT 48 HOURS AFTER THIS ACTIVITY. FELT HE SHOULD ASK PHARMACIST AT VACCINATION SITE IF THIS MAY BE A CONCERN

ITCHY skin Pins and needles in arms and legs I get feeling like I am being pricked with a pin several times a day in various places on my skin, arms, legs, neck, feet tired and fatigued difficulty breathing snoring

Developed 1st time episode of shingles on April 21st, 2021. Still experiencing very painful post herpetic neuralgia 6 weeks after onset of the shingles. Was given the medication to stop the progression of the episode of shingles on April 25th 2021. Currently taking gabapentin, nortriptyline, percocet and applying prescription lidocaine.

I suffered the worst herpes zoster infection I have ever had. An infection resulted in a scab, below my lower lip, that was about an inch square. It was HUGE. I also know that herpes zoster outbreaks after the vaccine are a sign that the vaccine has weakened my immune system.

High fever 102degrees 48 hours, Headache 72 hours, Injection site pain120 hours, Muscle aches 120 hours. All started 7 hours after vaccine, except injection site pain started from the time of injection 10 am

patient has developed blood clot after getting the J&J shot on 4/6/2021. The patient has had a sore arm since the day he got his vaccine. According to his wife, he started to feel weak on Sunday 5/30/2021. She said his hands were cold that day too, then by Tuesday his fingers turned white, this is when she took him to the hospital and found out about the blood clot. His wife also mentioned that after examination, they found out that he has an extra rib that was pressing on the brachial artery and that might have caused the blood clot. It doesn't seem to be sure that the blood clot was caused by the covid vaccine or not

BRUISING ON BACK OF LEFT KNEE; SEVERE PAIN ON LEFT LEG BEHIND KNEE; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced bruising on back of left knee. On 26-APR-2021, the subject experienced severe pain on left leg behind knee. On 10-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and headache on 20-APR-2021, and had not recovered from severe pain on left leg behind knee, and bruising on back of left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

On 9 April, I suddenly experienced joint and muscular pain, along with inflammation in both shoulders. My right shoulder was in far worse pain, with loss of strength, and range of motion when compared to my left. R Shoulder: 8/10, Left Shoulder 4/10. The pain and inflammation initially set-in at a lesser strength, perhaps 65% compared to the above levels, but increased overnight to the above referenced levels. That pain has lessened over the weeks since, and currently diminishes at a slow pace. Currently the left arm is nearly 100%, with only some inflammation and joint pain left. The right arm is better, but if I do any manual work with it, it becomes inflamed and warm to the touch. Cooling the shoulder works, heat does not. NOTE: in 2015 I fell in an accident and injured my right shoulder. The rotator cuff was torn, and the labrum torn as well, and the pain in the Right Shoulder has echoed that injury (which I had recovered from) greatly. It still feels as if my should was wrenched all over again - and I think that injury may be why the current pain in that shoulder is greater. I have no other explanation for the difference. This isn't easy to figure out - feel free to contact me for more information.

Headache and minor cognitive impairment (10 weeks); eczema on legs (severe; treated with cortisone; lasted 4 weeks)

Injection site swelling and moderate pain within 20 minutes of injection; within 30 minutes the left forearm, left metacarpal region (in particular, tissue surrounding base of left pinky finger) experienced swelling. Left calf (gastrocneuius) experienced mild, yet noticeable, swelling which diminished and was gone within 8 hours. Pronounced fatigue set in within 3 hours after injection and I was in bed the following 2 days. Mild, continuous ringing in the ears began on day 2. By day 4 was back 100% to a normal routine. The only remaining symptoms as of the date of this report are the mild, continuous ringing in the ears and the small, yet noticeable swelling of tissue around the base of the left pinky finger.

PATIENT FELT TO KILL HIMSELF; RETINAL DETACHMENT, LOOSING VISION, BLINDNESS OF LEFT EYE; SORENESS/PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral cataract surgery a few years ago, and concurrent conditions included glaucoma, COPD (Chronic obstructive pulmonary disease), smoker (a little less than a pack a day), and alcohol user (about 1 drink a day). The patient had allergies to some of previous COPD medications (but the patient could not recall which). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A31A, expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced soreness, pain at injection site after vaccination. On 13-APR-2021, 3-4 days after vaccination the patient started losing vision in his left eye. He visited his physician's office- primary care provider (PCP). He was referred to a specialist and was diagnosed with retinal detachment. It was reported that there was a slight vision improvement in his left eye since symptoms started. It was also reported that the patient was going blind from retinal detachment. The patient felt to kill himself (captured as suicidal thoughts), if he did not receive help for his condition. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from retinal detachment, loosing vision, blindness of left eye, and soreness/pain at injection site, and the outcome of patient felt to kill himself was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738594-Covid-19 vaccine ad26.cov2.s- Retinal detachment, Patient felt to kill himself. 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).

rash and welps on neck and chest, pcp prescribed steroids , goes away but comes back when it wears off

GOLF SIZE LIGHT PINK MARKING AT THE INJECTION SITE; QUARTER SIZE BRUISING WITH YELLOW SPOT ON THE LEFT ARM, UNDER RIGHT NIPPLE AND BROWN SPOT ON CHEST AND ON LEFT THIGH; CRAMPING OF THE NECK, FINGERS AND TOES; ARM HURT; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and poison oak allergy, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. patient stated that, he sometimes bruises but it is minor and did not have any medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced flu-like symptoms. On 08-JUL-2021, the subject experienced arm hurt. On 11-JUL-2021, the subject experienced cramping of the neck, fingers and toes. On 22-JUL-2021, the subject experienced quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. On 26-JUL-2021, the subject experienced golf size light pink marking at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and cramping of the neck, fingers and toes on 11-JUL-2021, and arm hurt on 10-JUL-2021, was recovering from golf size light pink marking at the injection site, and had not recovered from quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. This report was non-serious.

mid grade fever, headache, fatigue, mild discomfort at injection site. Fever began approximately 8 hours after injection. Headache persisted for approximately 20 hours after injection. ITC Tylenol alleviated most symptoms

3/9 patient began with rash to left side of face, sore throat, left ear pain and productive cough. Was evaluated @ the facility on 3/10 where the vaccine was administered- Johnson and Johnson. Evaluated @ facility on 3/12/21. Herpes Zoster affecting left side of scalp and face extending to eyelid. Referred to Ophthalmology for evaluation. Zpak discontinued and changed to Amoxil.

Injection site soreness for 6 days. Mental and physical lethargy for 7 days with a mild headache and odd taste in throat for the first couple. Workout reduction of capability of 20% slowly edging back up to 95% on day 6.

Although vaccinated on Friday 12 March (14 days ago and did not experience adverse event), since Friday 26 March I am experiencing persistent, deep, and dull ache in my vaccinated arm (left) around the cite of injection.

Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient complained of a rash and itchiness on 3/17/21 which has not resolved. I counseled the patient on taking benadryl and applying hydrocortisone and to follow up with his pcp if if doesn't improve.

IMPROVEMENT IN HIS BRONCHITIS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced soreness at injection site. On 23-MAR-2021, the subject experienced improvement in his bronchitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 11-MAR-2021, and the outcome of improvement in his bronchitis was not reported. This report was non-serious.

FEELS LIKE SOAR BURNING SENSATION ON LOWER BACK; RASH ON LOWER BACK SPREADING; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 29-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rash on lower back spreading. On 31-MAR-2021, the subject experienced feels like soar burning sensation on lower back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on lower back spreading, and feels like soar burning sensation on lower back. 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.

I experienced after my J&J vaccine, tinnitus worse, R>L. I got skin rashes, eczema on my face and scalp and nose bleeds. I also experienced chills,, fatigue for the first two days. I still continue with skin rashes, eczema on my face and scalp and nose bleeds. I have been seeing my ENT and PCP at this point since I still continue with symptoms.

Beginning March 14 pain in right thigh and right calf. Went to family doctor March 19th said could be dry skin used skin cream no change. Went to hematologist on 26th blood test for blood clots came back normal. On March 29 had ultrasound on right leg for blood clots came back normal. On April 5 went back to famil doctor with pain still in right leg and thigh awaiting blood test results.

INJECTION SITE PAIN; HURTS; 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hurts. On 17-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of hurts was not reported. This report was non-serious.

3/19/2021 - Chills, high fever, body aches, shortness of breath, coughing, and headaches. Symptoms have continued to present date ( 4/13/2021). Taking tylenol, and prescribed medicines. 4/9/2021 - Bright red splochy band around right calf, still having fever, body aches, shortness of breath, coughing, and headaches.

Patient started having lower extremity itchiness about 3 days after vaccine administered. He did not notice any rash on his legs, but itching continued. Then on morning of 4/15 (7 days after vaccine administered), he noticed a rash on upper arms and upper back. Rash is scattered erythematous papules. Somewhat itchy, not painful. Rash has started to spread down arms. No other symptoms noted. Recommended try benadryl, start steroid dose pack if persistent/worsening, try topical steroid

Rash and skin bubbling on sides, arms, and upper legs at 10:10 p.m. on 4/14/21. By 6:30a.m. on 4/15/21, most of the rash had gone away.

Woke up the following morning (1 AM) with fever, chills, and considerable discomfort. This subsided by morning. The following day I began seeing swelling, redness, itching and burning of extremities (mainly the hands, but also feet, ears, face). These symptoms seem to be triggered by the slightest exertions, but have also exhibited without physical activity. These appear to be getting more prevalent each day.

The injection itself was incredibly painful. The nurse giving the injection asked why they were given extra long needles and then asked if I'd like to see it. I said, "Yes." I joked and said it looked like it was more likely for the ass than the arm. She laughed and proceeded to inject me. The injection was the most painful I had ever felt. The next morning, I awoke with pain in my shoulder, neck and back. Though I expected some reaction to the vaccine, I didn't expect the amount of pain and discomfort I experienced. It has continued in large part to the present. I sought medical advice towards the end of the first week. Eventually, I received an MRI which suggested myelitis/discitis. Of course, the MRI was more detailed. I was subsequently hospitalized for four days where I had numerous blood cultures and another MRI (cervical and thoracic w/and without contract). The MRI essentially had the same findings. The doctors are stymied by my history and symptoms. However, given the temporal proximity between the time of the injection and the onset of my pain/symptoms (that has yet to resolve), I think it important to report this matter. I am still is pain and my issues have not resolved.

Over a week after I got the shot I started to notice a discolored area on my elbow. It was itchy and and reddish purple. It was a base ball size area on my left arm on my elbow. I saw the doctor who said it was a vaccine reaction. I was given a steroid shot and some antibiotics. After a week it is much better with only a slight color variation.

SPOTS OF IRRITATING IN ARM; FEELING TIRED FOR ABOUT A WEEK FOLLOWING ADMINISTRATION; PHANTOM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, 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: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced spots of irritating in arm. On 05-APR-2021, the subject experienced feeling tired for about a week following administration. On 05-APR-2021, the subject experienced phantom pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling tired for about a week following administration on 12-APR-2021, and had not recovered from phantom pain at injection site, and spots of irritating in arm. This report was non-serious.

He got the vaccine, and when they administered it on his left shoulder it started bleeding. The younger girl put a band-aide on it, and walked off and called another girl. The other girl took over the band-aide and it was saturated with blood but stopped bleeding, but area was swollen. They then had him wait 30 minutes, and everything was fine, and instructed to put ice on it which he did. The pain seems to have not gone away yet and it's been over 30 minutes. At night he feels it more as he relaxes, it's the same pain as it was when he got the vaccine and he can also feel a little knot if he rubs it. He called employee health and they offered to do an US and gave him our information to call. This pain goes all the way past his elbow on the left side only. Sometimes he can feel it on his back, but it's mainly on the shoulder area.

Exactly two weeks after my one and only J&J vaccination shot my "shot arm" developed deep, dull, and persistent aching lasting for about two weeks. Sometimes I was unable to sleep and over the two weeks took 2 or 3 Advil per night to get to sleep. After about two weeks the pain receded and has gone and stayed away. But no surface indications on skin, no restrictions in range of motion...just persistent, deep, ache. I have subsequently spoken with a friend who also took the J&J shot and reports the SAME symptoms.

One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.

DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. 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).

RASH; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included rash. The patient was previously treated with diphenhydramine hydrochloride for rash. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine was not applicable. The outcome of rash was not reported. This report was non-serious.

Within 24 hrs, onset of truncal itch, hyperesthesia, dysesthesias, bilat trunk, non-dermatomal pattern. Also significant fatigue and hyperhydrosis. This has persisted to this day. Night sweats and itch are worsening.

Left arm pain and swelling in wrist and fingers. Tendonitis systems in wrist and gout like systems in fingers. Then bursitis systems in left elbow

RIGHT ARM WHICH IS WHERE THE INJECTION WAS RECEIVED IS SORE WHICH STARTED ON 05/20/21 STILL TO THIS DAY 06/07/21. PATIENT HAS FULL RANGE OF MOTION. CAN LIFT ARM A LITTLE MORE THAN HALF WAY TO THE SKY WHEN THE PAIN IS FELT IN THE MUSCLE. AT POINT OF INJECTION THERE IS STILL A SCAB.

My tinnitus is worse on right ear, gotten worse than on my last visit. My tinnitus had not gone away. I I went to see my doctor who ordered MRI of the brain and ears with and without contrast. My MRI was negative, nothing abnormal. Also did a full hearing test, other than normal range of hearing loss. The tinnitus is more variable, louder than it was, get periods of quietness. I have noticed that my tinnitus gets louder during exercise. I can not find rhyme or reason that my tinnitus gets quieter and louder. I have no problem for the CDC to contact my PCP to help with my diagnosis. I also had severe nose bleeds, which have subsided now. My skin rashes are also gone and get treated with topical creams. Before my vaccine, I had oily skin and now I noticed my skin started to get dry, along with tinnitus, and also dry skin on my scalp. When I get dry skin I apply topical lotion.

RED BLOTCHES, ENTIRE BODY; SORE ARM; This spontaneous report received from a consumer concerned a 63 year old male. 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: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red blotches, entire body. On 30-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and red blotches, entire body. This report was non-serious.

The patient developed a maculopapular rash over the entire trunk. Unclear if caused by this vaccine or Shingles vaccine which patient received first in series for on the same day.

SKIN TAG / SPOT ON SITE OF INJECTION APPEARS RAISED AND BLACK; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 260A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced skin tag / spot on site of injection appears raised and black. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of skin tag / spot on site of injection appears raised and black was not reported. This report was non-serious.

On 4/14/21 patient reported a splotchy, itchy rash on the trunk of his body that started about 5-6 hours post vaccination. On 5/3/21 the patient called and said he was still struggling with the same symptoms. On 5/21/21 the patient stopped by the pharmacy and showed the pharmacist the splotches on his torso. The pharmacist suggested he seek medical attention which he did and returned with a prescription for prednisone taper. On 6/15/21 the pharmacist followed up with patient. He said it symptoms were nearly resolved. He will complete another course of prednisone.

Two months and a few days after the initial injection a bruise formed at the injection site. I?ve had very mild pain at that site since the injection. I?m just wondering if that?s normal.

itch and pain at injection site, feeling of numbness around site and into shoulder exacerbated by rubbing/scratching

Fever, chills, hives. Fever and chills gone on 7/5/21. The hives are the reason for going to urgent healthcare on 7/5/21 where they prescribed prednisone and famotidine.

Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient feels tingling in the right arm, wrist, and fingers, and itchiness on right chest

Pt. states that after receiving the J&J vaccine 04/07/2021, started to experience 04/17/2021 painful leg swelling, groin area, and (previous Hernia) irritant. Primary visit recommended leg elevation and compression socks. Still continuing to swell.

FEELS LIKE SOMEONE PUNCHED IN THE ARM AND IT THROBS AT NIGHT; ARM FEEL WEAK AND LIMITS WHAT CAN DO; ARM HURTS ALMOST CONSTANTLY; PAINFUL SHOT/ARM REALLY HURTS IN THE INJECTION SITE AREA/THE SEVERITY OF THE PAIN FLUCTUATES; This spontaneous report received from a patient concerned a 63 year old male. 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates. On an unspecified date, the subject experienced feels like someone punched in the arm and it throbs at night, arm feel weak and limits what can do, and arm hurts almost constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates, arm feel weak and limits what can do, arm hurts almost constantly, and feels like someone punched in the arm and it throbs at night. This report was non-serious.

Patient had autoimmune appearing reaction with rash, iridocyclitis, DVT right femoral vein, thrombocytopenia, lymphadenopathy, aphthous ulcers, pharynigitis rheaumatology consultation, anticoagulation, ophthalmology care, hematology consultation, ENT consultation

Tightening of chest Difficulty breathing Nausea Pain at injection site for over 7 days Fever Tired needing to rest

After receiving the vaccine with in minutes the patients left arm began to swell and bruise. He began to become pale and his eyes rolled back into his head and passed out. He woke up a min later and had SOB. Very pale and almost threw up. Paramedics and Firefighters were called. The eveulated the patients and gave him a liter of sodium choride. His Heart Rate was in the 30's. After several min and a liter of fluid, patient was alert. Once stable he was transported to Hospital.

Patient developed a rash on left hand a few minutes after receiving vaccine. Rash got better before he left but it was still there. I advised him to wait at least another 20 minutes to make sure he doesn't have any other severe reactions. He said he felt okay and left after about a total of 35 mins. I advised him to take benadryl when he got home and to contact his doctor if he felt worse. I left a message with his doctor about the incident. I also advised him to use v-safe to report the symptoms.

Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital.

Woke with bilateral conjunctivitis and scleral erythema. Burning of both eyes. No vision impairment but a lot of tearing. No treatment needed and resolved in 48 hrs.

Patient states he began to feel facial flushing approximately 30 minutes after receiving injection. This was followed by a rash, spreading from torso down. He took 2 Benadryl tablets, fell asleep, and awoke after 2 hours. When he woke the facial flushing and rash was resolved. He also reports that on the morning of the following day, he was drinking coffee and noticed the facial flushing returning, then his arms started breaking out in the rash. He took 1 Benadryl tablet and these symptoms resolved.

very bad sore arm at the injection site. sore throat, diarrhea, fatigue, headache, chill (no fever yet)

Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness, lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed

Just wanted to report a very long time with soreness at the site of the injection. It has now been a week and it is still tender. Maybe this is normal for J&J but it would be nice to have that listed.

Patient received his J&J vaccine for COVID-19 on 03/10/2021. On 3/17, he was at the grocery store when he felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. Pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office on 3/19, where he was given methylprednisolone 80 milligrams IV, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the morning of 3/20/21 to the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.

INSOMNIA; INJECTION SITE REDNESS; FATIGUE; MYALGIA, MUSCLE PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced injection site pain. On 29-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced myalgia, muscle pain. On 07-APR-2021, the subject experienced insomnia. On 07-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, fatigue, myalgia, muscle pain, insomnia, and injection site redness. This report was non-serious.

Pain in lower left bicep in first week, experiencing fatigue/tiredness. After 10 days I experienced severe pain at the site of injection, very small red spot appeared around injection site. Pain was so severe, I took one capsule hydrocodone 5-325 TB at 2 AM. The medication did not cure the pain, and I slept less than two hours. I called my nurse practitioner's office, and they offered an appoint late in the morning. And I couldn't wait that long so I drove to urgent care. Prompt care examined and saw no swelling, ruling out possible blood clot. Prompt care did not have ultra sound. They told me to use ice, heat, and pain medication. Extreme pain continued for about three more days, pain medication did very little to help. Unable to speak directly to the Nurse Practitioner on the phone, due to my disability and alexia, communicating online is very difficult without an assistant present. The pain slowly subsided over the next week.

SORENESS ON INJECTION SITE ARM; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in hip, and smoker. 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 not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced soreness on injection site arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness on injection site arm. This report was non-serious.

Had the single dose Jansen in the left arm in muscle. A couple of weeks later hair top of head fell out. Now balding

BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

ONCOLOGY/HEMATOLOGY SUMMARY: -4/7/2021. Patient received COVID-19 vaccine Johnson & Johnson. A week later he developed an eruption on his trunk which resolved followed by extensive bruising and asymptomatic mucosal bleeding. -5/4/2021. Leukocytes 7.4, hemoglobin 14.9, platelets less than 5K, creatinine 1.02, liver function within normal range. Initiated dexamethasone 40 mg daily x4. -5/7/2021. Platelets improved to 31K, leukocytes 16.6, hemoglobin 14.5, CRP 3.6, ESR 4. Negative serology for HIV, Hep B, C, tick borne disease. Normal ANA. Normal b12, folate levels, low TSH but normal freeT4. -5/10/21. Platelets decreased to <5K. Started prednisone 1mg/kg at 80mg daily with poor response, thus tapered off in 15-20 days. -5/17/21. Bone marrow biopsy. Results pending. -5/18/21-5/20/21. IVIG 1gm/kg x 2. - 5/24/21. Improved platelet count to 133K/uL

BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; SORENESS AT INJECTION SITE; NO SENSE OF SMELL; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced no sense of smell. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 02-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced fatigue. On 02-JUN-2021, the subject experienced soreness at injection site. Laboratory data included: Body temperature (NR: not provided) 99, 100.9. Treatment medications included: naproxen sodium. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, fever, body aches, headache, and chills, and the outcome of fatigue and no sense of smell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604773.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non serious.

I had no symptoms until the next morning when I woke up with very extreme pain in my left arm with the epicenter of the pain on the back of my left hand between the bones leading to the ring finger and the pinky. Whenever my hand was below my heart, the entire hand was dark purple in color. I had read that severe reactions from the shot generally dissipated in a day so I took some Hydrocodone which I had for migraines, kept my hand elevated, and decided to wait it out. The next day the pain was still extreme so I went to urgent care. Urgent care eventually said I needed to go to the emergency room to have an ultra-sound. I did so. After many hours of waiting, they got me into the ultrasound room where they told me they cannot ultrasound the back of the hand because the vessels are too small and don?t show up. So they ran an ultrasound on the shoulder and front of the arm and found nothing. I?m not surprised as that is not where the pain was coming from. I went home and alternately put my left hand in ice water and hot water periodically, which eventually reduced the pain to a tolerable amount. As of today, all the pain is gone except for the region mentioned in the back of the hand. That still hurts, so I'm answering item 20 with a No.

pt. contacted provider on 6/4/21, stating he has pain in his left shoulder. He stated he felt like the vaccination was given to high and he took a picture of where the nurse placed the band-aid. Director verified if band-aid was the actual place of injection the vaccine was given to high and could have caused SIRVA. Pt stated his shoulder was fine after injection and it was over two weeks post injection that he started to feel shoulder pain. On 6/10/21 pt stopped by vaccination clinic and informed staff his pain was worse and was now causing pain down his arm to his wrist. Nurse informed pt to see his physician.

Woke up extremely cold, but skin hot to touch, body very stiff and headache. these continued for several hours. Also was very tired, so took a long nap. Late afternoon, all but headache was totally gone, headache as gone by the next day.

Shingles approximately 5-6 weeks after vaccine. Raised welts on back of neck / shoulder, left side only. Burning / stabbing pain. Lasted about 4 weeks.

APRIL 26, 2021, APPROXIMATE 9:00PM. BOTH ARMS INSIDE THE ELBOW THE FLESH PART I DELEVOP A RASH THAT ITCH, TODAY I GOT SOME CREAM FOR THAT ITCH FROM MY VA CLINIC.

Since May 2021, approx. 5 weeks after vaccination I get rashes on various parts of my body (1st time left face and neck area, 2nd time identical, symmetrical rashes on both left and right upper thigh, 3rd and most recent on the right arm inner bicep area. Rashes usually persist about 10 days then disappear. Red, raised in appearance with very minor itching.

SWEATING; STOMACH ACHE; STING ON THE RIGHT SIDE OF FACE; NAUSEA PREVENTED FROM EATING ANYTHING; NAUSEA; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aches every day due to history of arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced sweating. On 01-JUL-2021, the subject experienced stomach ache. On 01-JUL-2021, the subject experienced sting on the right side of face. On 01-JUL-2021, the subject experienced nausea prevented from eating anything. On 01-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting on the right side of face on 01-JUL-2021, was recovering from sweating, nausea, and stomach ache, and the outcome of nausea prevented from eating anything was not reported. This report was non-serious.

Minor discomfort following Shot at first Following with pain at injection point. I took it more it was cause by person giving shot as it was central to the injection site. Was given by a Pharmacist On May 24th 2021 went for quarterly Dr visit and was put on Jardiance 10mg Tab my weight was 388. I started to get a loss of apatite and abdominal pain. On June 8th it became severe Contacted PCP. PCP ordered a ultra sound ended up going to Went to ER on June 19th. had a cat scan run to look at intestinal and found swelling

I woke up with severe face swelling it continued to my lips and then my tongue . I went to hopital . I was there for around 14 hours until they could monitor swelling and ensure my throat was. not obstructed . I was referred to an allergist that did blood tests and determined i have no allergies. He prescibed an EPI PEN and steroid to use if it occurred again . Symptoms did not go away for about 5 days . Since then I have had 8-10 episodes of severe swelling and welts all over my body.TodayI woke with the left side of my face very swollen and welts on my thigh. I am taking the benadryl and steroid he prescribed. The

patient developed right lower extremity DVT diagnosed ultrasound 7/20/21. He started with acute pain right leg Saturday 7/17 and woke up on Sunday 7/18/21 with swelling right upper thigh and bruising and swelling of right foot. His swelling and pain increased and was seen urgent care where he was referred to emergency room for evaluation DVT.

Systemic: Patient had bruises down both legs at the same location on both legs with no other contributing factors. Blood work at ER visit came back normal-Medium, Additional Details: Patient stated that he called his MD after he started noticing the bruising. MD told him to go to ER. Blood work came back normal. Bruising was in exact same location on both legs. MD believes it to be a side effect of vaccine since there were no other contributing factors for the injury

Headache, muscle aches, pain at injection site, cough & fever of 100.1 F Was fever free by 10am 3/17/21

On Friday, March 12, 2021, at the pharmacy I had an 8:00 am appointment to receive the Johnson & Johnson?s Janssen COVID-19 Vaccine. I received my vaccine in the left arm but the injection seemed to me (and my wife) to be in an odd location, which was very high up on the shoulder near the shoulder joint. Things seemed fine until Saturday evening when I started to feel some tightness in my left trapezius between my scapula and my occipital bone. By Sunday morning that same area was very tight and painful; what we used call a ?crick.? Sunday afternoon I began to feel some sharp pain in my left shoulder joint. I had very little sleep on Sunday night and by Monday morning I had significant pain in what felt like my humerus. I made an appointment with a chiropractor for Monday afternoon and he suggested the vaccine shot might have started an inflammation that led to the tight trapezius, which in turn was causing the cervical spinal nerves to react, thus causing the pain in my arm. At this point I was in a lot of pain and the pain was moving further down toward my elbow. The chiropractor did his usual things and told me to put ice on it and take OCT Ibuprofen and or Naproxen. I was a bit better on Tuesday and decided to attend a three-day pastors? retreat. By Tuesday afternoon the pain had expanded to just below my elbow. I consulted with a doctor friend and he thought it was likely that I was having a reaction to the vaccine and that it would pass. He as concerned to hear of the odd location of my injection. I had another sleepless night and on Wednesday I noticed that the ends of my left thumb and index finder were numb and by that night the numbness had expanded to include most of my index finder. The other arm and shoulder pain continued but varied in intensity. On Wednesday morning I called my wife and asked her to come get me at the retreat and that afternoon I called my doctor's office office and made an appointment for Thursday morning (3-18-21). I'm feeling the cumulative effects of the pain and fatigue. My overall pain level is a little less but still present, as is the numbness in my index finger and thumb. My doctor suggested the nerve inflammation was a reaction tot he vaccine.

Intense Lymphadenopathy, left neck below the ear, hard, warm, fever, headache, swollen, painful. Am onset impaired neck movement but no challenge to swallowing or breathing.

ELBOW PAIN; PAIN IN LEFT ARM FROM SHOULDER TO ELBOW; PAIN IN THE RIGHT ARM; This spontaneous report received from a consumer concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 06-APR-2021 at 10:30 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced elbow pain. On 06-APR-2021, the subject experienced pain in the right arm. On 06-APR-2021 22:00, the subject experienced pain in left arm from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the right arm, and the outcome of elbow pain and pain in left arm from shoulder to elbow was not reported. This report was non-serious.

johnson and jonson vaccine. He received on 4/1 through the state. that night got chills. ha, n/v. the next day just tired. 2 days later got two pink bumps on his R elbow then enlarged. then developed more on other areas on his body. some have been present in one spot for a week. NO sob or rep sx. no pain. He carries an epipen for insect allergy. on 4/9 he developed sensation of throuat closingand administred an epi pen with relief and went to er. At the er he was given iv prednisone, benedryl and pepcid. He was dischared on a medrol dose pack 7 day. taper (3 days left) and refilled epipen. told to take benedryl. no sob. rash is now stable, no new areas x 2 days, larger areas are much improved..

SKIN FLAKING LIKE DANDRUFF; KNEE PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 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 slight headache. On 01-APR-2021, the subject experienced skin flaking. On 01-APR-2021, the subject experienced knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin flaking on 02-APR-2021, and slight headache on MAR-2021, and had not recovered from knee pain. This report was non-serious.

On April 16 patient came home fatigue, pale and legs hurting. The next day complained of right knee pain, Fatigue and looked pale. He woke up in the middle of the night complaining of right calf tightness and pain. On Sunday 18th he started to limp and when we looked at his calf it was double in size, warm to touch, and redness. We then went to the ER and had an ultrasound and CT scan . We were told he has multiple blood clots in the right leg and clots in both lungs. He was then transported to a hospital and given blood thinner shots in stomach. He was released from the hospital 4/20 and given blood thinners and assigned a hematologist. He?ll be on blood thinners 6-12 months, out of work a month and tested regularly to check platelets.

Painful and itchy purpuric rash involving arms, legs, and lower abdomen which started one week after receiving J&J vaccine. A skin biopsy confirmed leukocytoclastic vasculitis. An extensive work-up was performed and was non-revealing for the most part. Rheumatology and Dermatology believed rash was caused by recently administered vaccine. Patient was started on Prednisone 60 mg daily along with Triamcinolone cream and pain medications. His rash and pain gradually improved and he was discharged 6 days later on an oral Prednisone taper.

ARM SORENESS IN THE SAME ARM AS THE INJECTION; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included hypercholesterolemia, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 11-MAR-2021. This report was non-serious.

HUSBAND BEING IN EMERGENCY RIGHT NOW. 8 DAYS AFTER HAVING A COVID 19 SHOT; FLUSHING; WEAK; FEVER; INJECTION SITE PAIN; FEELING SICK; This spontaneous report received from a consumer via a company representative concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included allergic to other antibiotic((can't remember). The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 06-APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced weak. On 07-APR-2021, the subject experienced flushing. On 07-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced husband being in emergency right now. 8 days after having a covid 19 shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, weak, flushing, and fever, and the outcome of injection site pain and husband being in emergency right now. 8 days after having a covid 19 shot 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.

On Saturday April 24, 2021, I began experiencing severe headaches, eyeball pain, light-headiness, weakness and lack of energy, pain at the injection site and flu like symptoms.

HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. 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: UNDERLYING DISEASE

Patient began having fever, chills, rash, and vomiting night of the vaccine (03/31). Patients symptoms have continued for almost 4 weeks (03/31-4/26)and have worsened. Unable to keep down any food other than saltine crackers and some ginger ale. Patient now has a cough, shortness of breath, and lower left abdominal pain. Patient has not been able to follow up with primary care doctor or lung specialist. Encouraged the caretaker to take patient to PCP, urgent care, or ER. Symptoms typically resolve within first week (fever, chills, and fatigue). Symptoms, especially, fever persisting with treatment of Tylenol and Motrin should be assessed ASAP. Waiting to hear back from doctor follow up and if there were any underlying causes for symptoms.

Lightheaded, extreme fatique, red dots on skin and in mouth, bruising, low blood platelets, low hemoglobin

BLEEDING IN EYES; RETINAL TEAR OR DETACHED RETINA; RETINAL TEAR OR DETACHED RETINA; INCREDIBLY PAINFUL INJECTION; REALLY TIRED; This spontaneous report received from a patient concerned a 65 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no eye problem in the past. 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 administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced incredibly painful shot upon administration, immediately the patient was really tired. Three hours after the vaccination, his vision became cloudy and blurry. He then fell asleep. On 05-APR-2021, the patient experienced no peripheral vision. On 06-APR-2021, the patient woke up and had a little improvement in cloudiness but the patient stated that about 20 percent of his vision was still cloudy/blurry. The patient experienced pressure behind eyes, right eye distortion. The patient began to see bright flashes and round floaters. On 06-APR-2021, the patient experienced bleeding in eyes, retinal tear and detached retina that affected the patient's ability to work. On 07-APR-2021, morning, he was then referred to an eye specialist for ongoing eye issues. He went to see physician. He had been back to the eye specialist 2 additional times since then with ongoing eye issues. He had been told he has bleeding in his eyes, a retina tear or detached retina and still no peripheral vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from incredibly painful injection on 05-APR-2021, had not recovered from retinal tear or detached retina and bleeding in eyes and the outcome of really tired was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509138-Covid-19 vaccine ad26.cov2.s-Eye heamorrhage, Retinal tear ,Retinal detachment. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events

The Patient presented with skin peeling from his hands and arms in large patches. It looks very bad (most of his skin is missing from his arms). I advised him to seek emergency medical attention immediately.

THROBBING; ARM SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old male. 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced arm sore at injection site. On 21-MAY-2021, the subject experienced throbbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore at injection site, and the outcome of throbbing was not reported. This report was non-serious.

About a week after the shot, I started getting redness, tenderness, discoloration, and swelling of my right arm. The discoloration began to spread and I went to the doctor on the 21st. The doctor said there was inflammation and because it was warm to the touch, was concerned about blood clots. I was sent for an ultrasound and prescribed an anti-inflammatory medication and advised to take aspirin. Everything cleared up about a week later.

Pain immediately upon injection and continuing for 5 days. Chills and hot flashes beginning 24 hours after injection, continued for several hours. General lethargy for 72 hours.

Pain at injection site followed by Angina, Heart palpitation, Tightness in chest, lowered pulsox, dizziness. Followed by admission to emergency room with diagnosis of ABNORMAL ECG, lowered pulsox, Atelectisis (Chest Xray) Followed by referral to Cardiologist Symptoms are persistent Undergoing further treatments and further tests scheduled as of the date of this report.

Small red dots started appearing on both lower legs ~15 total on 5/28. Three additional dots have shown up on my right arm, and two on my left arm since then. A few more on my legs since then. Now have ~25 in total. Dots are spread out and are not in any patterns or clusters.

It's difficult to say when I first started with this adverse reaction but it was at least 3 months ago. I have experienced uncontrollable itching since then. I have also lost my taste/smell for many foods such as coffee, hamburgers, hot dogs, snacking chips/dip, and normal smell of meat cooking. I experienced a low grade fever (100.6) and chills on the night of March 19 (date I received the vaccine shot) and March 20, 2021. I don't like to go to the Doctors' but I see that I have been seeing the doctors over 11 times since I received the J&J vaccine shot. I am miserable with the itching and it seems that I am very anxious now. The itching occurs mainly at night all over my body--and lately, it has begun to itch on my forehead and face. It is all over my body. I thought I should get this information to you in case someone else is experiencing it. I began my quest to stop this itchy feeling with my primary doctor. She prescribed hydroxyzine 50 mg. I take 1 pill every 6 hours as needed for anxiety. She also ordered buspirone 10 mg 1 pill 2xday but it makes no difference so I will not refill it. I told my doctor that I would go to a dermatologist next for relief. That's how I began going dermatologist. So it has been since around March 30, 2021 that I have been trying to stop the uncontrollable itch. Just not sure if the vaccine caused this problem but I highly suspect that it did.

The morning after I got the vaccine I noticed a rash all over my body in the form of bright red blotches from approximately 1" across. Several are angry looking. Generally not itchy. On legs, torso & arms. Approximately 2 dozen blotches. I am now on day 3 post inoculation and the blotches have not faded. No difficulty breathing. Vaccine was administered by Pharmacist.

A rash broke out on my legs (mostly on my thighs, but a few near my ankles and a few on my butt). It itched for about 36 hours, then stopped itching. Benadryl Extra Strenght Itch Stopping Gel (Diphenhydramine Hydrochloride 2%) relieved the itching. Today (03/16/2021) the spots are smaller but are still visible.

#1 I had reaction to Moderna first (Jan 22) and 3 MDs told me to get J&J as second A few hours following shot developed dry cough, which persisted 4 days. Within 3 hours developed moderate headache which lasted 4 days. After 7 hours became EXTREMELY cold. Had to stay in bed w 7 blankets for 2 days. By 3 days still chilly but relenting. Mild to sometimes moderate nausea developed first day, lessening over 3 days. Fatigue severe starting 8 hours post vaccine, resolving over 4 days. Tiny bit of injection site pain.

Approximately 4-5 days after vaccination, the skin of my face, scalf and around my eyes became itchy. I think there's very minor puffiness of my upper cheeks at either side of my nose. Now, ten days later, the itching persists.

Redness and mild inflammation 3/29-CSPI f/u: Caller states that his arm is still painful and red. He does OT 3 times a week and does arm exercises. ]ADvised: This is a common effect. Put ice packs and exercise your arm (move it around).

Doctor diagnosed that I had an outbreak of shingles over my left eye and forehead following my vaccination of the Janssen Covid-19 vaccine EUA. Doctor is currently treating me for this condition with valacyclovir HCL, prednisone and acyclovir.

TORN ROTATOR CUFF; SHOULDER PAIN (FEEL COMING FROM ARMPIT, SHOULDER SOCKET AND SHOULDER NUMBNESS ON SKIN, PAIN GOING ALL THE WAY THROUGH SHOULDER JOINTS, PAIN RADIATING DOWN IN ARM AND IN WRIST AND HAND); BLED MORE THAN USUAL; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included shoulder injury. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced bled more than usual. On 16-MAR-2021, the subject experienced shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand). On an unspecified date, the subject experienced torn rotator cuff. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand), and the outcome of torn rotator cuff and bled more than usual was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.

ITCHING; BURNING; RASH; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 165 kilograms, and height was not reported. The patient's concurrent conditions included hypertension, thyroid, remission from multiple myeloma, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced burning. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching, and burning. This report was non-serious.

ERYTHEMA ON INJECTION SITE ON RIGHT ARM; SORENESS ON INJECTION SITE ON RIGHT ARM; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10808987, and expiry: UNKNOWN) dose was not reported, administered to the right deltoid, on 30-MAR-2021 15:59 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced erythema on injection site on right arm. On 30-MAR-2021, the subject experienced soreness on injection site on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erythema on injection site on right arm on 31-MAR-2021, and soreness on injection site on right arm on 02-APR-2021. This report was non-serious.

PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at site of injection. This report was non-serious.

ITCHINESS ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; HIVES ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bee sting allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced itchiness on lower extremities, upper extremities and ears. On 22-MAR-2021, the subject experienced hives on lower extremities, upper extremities and ears. Treatment medications (dates unspecified) included: famotidine, diphenhydramine hydrochloride, and cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness on lower extremities, upper extremities and ears, and hives on lower extremities, upper extremities and ears. This report was non-serious.

SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.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 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.

The second week after I got the vaccine I started to have a pressure headache on the side of my head and down my neck. My leg was painful by my knee and it lasted a week. I had the headache and the pain at the back of my neck for one week. The pain medication did not help with the pain. The headache was on both sides but much worse on the right. I had a bump on the back of my neck on the right that was painful. I had a rash on my arm around the site of the injection about an inch around which is still visible after three weeks. The rash was a little itchy.

DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site. His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

ITCHING AT INJECTION SITE; HURTING RIGHT ARM; FATIGUE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced itching at injection site. On 03-MAY-2021, the subject experienced hurting right arm. On 03-MAY-2021, the subject experienced fatigue. On 03-MAY-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hurting right arm, fatigue, itching at injection site and swelling at injection site was not reported. This report was non-serious.

TIRED; ITCHINING ON ARM AND WAISTLINE; RED PATCHES ABOUT THE SIZE OF A GRAPEFRUIT BETWEEN ELBOW AND SHOULDER ON BOTH ARMS AND THREE RED PATCHES ABOUT THE SIZE OF QUARTER; HEADACHE; EXTREME BODY ACHES; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, kidney stone, gall bladder problem, non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no immune disorder, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced itching on arm and waistline. On 11-MAY-2021, the subject experienced red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter. On an unspecified date, the subject experienced extreme body aches, headache, and tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body aches, and headache, had not recovered from red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter, and itching on arm and waistline, and the outcome of tired was not reported. This report was non-serious.

SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.

Swelling of both hands and arms. Hives presenting on both arms and wide spread itching and redness. Referred to physician. Outcome unknown at this time.

Patient complains of easy bruising since receiving his Covid 19 vaccine. Was into the clinic to establish care and reports this. Labs taken and noted platelet count of 25. He states that he has not had any prior issues with this that he is aware of.

Patient experienced dizziness about 40 minutes after dose. Then significant arm swelling at injection site, patient described as "a deltoid on top of his deltoid" started by the same evening. Pain subsequently occurred described as severe that radiated into shoulder and all the way down the patient's arm that also felt like burning. The patient is still experiencing this 15 days later, although admitting it is finally starting to improve. Patient admitted to not being able to do much for the first 1-2 weeks and requiring opioid pain medication relieve the pain enough to sleep at all. Patient contacted primary care as well as drug manufacturer, Janssen.

PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's 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 usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.

extreme pain in location of shot - upper left arm. Substantial loss of mobility in left arm. Cortizon shot, prescription pain pills, physical therapy, but pain and mobility problems continue

Five sites about 3-4 inches in diameter appeared on limbs that were sensitive (mild pain) and warm to the touch for five days following their appearance the day after the vaccine was administered.

Pain well after injection of shoulder/arm injection was given in. From shoulder to elbow, rarely to wrist. Not joint pain but feels like muscles/nerve Can not lay on that side, limited comfortable positions. limited motion during the day because of varying amounts of pain.

sudden flushing of upper body starting around 4PM 3/6/21 - about 50 hrs post-dose - took Benadryl 50mg seemed to diminish some 30-40 minutes later - itch gone, still minor redness on upper chest, shoulders and face

Started itching on various parts of body on Monday or Tuesday. Every day got worse. Noticed rash on arms and feet on Tuesday. By Friday the 2nd, red rash all over body. Went to clinic and doctor prescribed Prednisone. Also taking Benadryl and using Hydrocortisone cream. Today better as long as I continue taking Benadryl.

A MINOR ITCHINESS; RASH ON BOTH ARMS FROM ELBOW DOWN; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, overweight, alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine. 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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced a minor itchiness. On 06-APR-2021, the subject experienced rash on both arms from elbow down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms from elbow down, and a minor itchiness. This report was non-serious.

ITCHING; RASH ALL OVER BODY; CHILLS; HIVE; FATIGUE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced itching. On 02-APR-2021, the subject experienced rash all over body. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced hive. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, hive, rash all over body, fatigue, and chills. This report was non-serious.

On 4/12/2021 Patient states that he had itching On 4/13/2021 and 4/14/2021, symptoms escalated On 4/14/2021 Patient states he had a rash on arms, neck, and entire body. He went to Dr. for evaluation. Was given a steroid shot at office, and Medrol Dosepak to continue at home.

LIGHTHEADED; FELT STRANGE; BRAIN FOG; SORE ARM/ARM FEELS PUNCHED; FELT UNWELL; TIREDNESS; LOCAL REACTION / REDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid19 infection, and concurrent conditions included high blood pressure, and white coat syndrome. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported the company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On NOV-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) Elevated. On 10-APR-2021, the subject experienced lightheaded. On 10-APR-2021, the subject felt strange. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced sore arm/arm feels punched. On 10-APR-2021, the subject felt unwell. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced local reaction / redness. Laboratory data included: Blood pressure (NR: not provided) Low grade 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, felt strange, brain fog, and felt unwell on 10-APR-2021, and was recovering from tiredness, sore arm/arm feels punched, and local reaction / redness. This report was non-serious.

ITCHING; PAINFUL; HIVES; RASH; MUSCLE ACHING; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, 3 heart stents, and blood thinners, and concurrent conditions included allergy to x-ray contrast, occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and never had chicken pox or shingles. 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 05-APR-2021 at 16:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle aching. On 07-APR-2021, the subject experienced itching. On 07-APR-2021, the subject experienced painful. On 07-APR-2021, the subject experienced hives. On 07-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, painful, hives, and rash, and the outcome of muscle aching was not reported. This report was non-serious.

rash on right thigh - approximately 20 cm long and 2 cm wide. it had mild itching that was treated successfully with benadryl lotion. it disappeared after 3 weeks.

Mild fever, chills, fatigue and brain fogginess I first 36 hours. At 48 hours developed temporary hives, swelling, ichiness in right abdominal area and genitals. This took two additional days to resolve with no subsequent recurrence.

FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 100 F, 101.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of injection site pain was not reported. This report was non-serious.

FULL BODY RASH WHICH WAS DESCRIBED AS ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no preexisting condition. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced full body rash which was described as allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body rash which was described as allergic reaction on 16-MAR-2021. This report was non-serious.

patient stated he received the Johnson and Johnson shot on 5/5/2021, on 5/6/2021 patient stated he is experiencing pain at injection site along with muscle aches and tired

Received shot at 10:00am on 5/5/2021. On 5/6/2021 Patient began to feel ill with fever, chills and body aches. Spent most of that day in bed. On 5/7/2021 presents to Clinic, fevers, chills and body aches had improved but noticed "rash" - right lower extremity was red, hot to touch, swollen, pain with "tightness" and "burning" sensation at site. Denies itching. Right Lower Extremity well demarcated area of erythema, hot to touch and remarkably TTP, particularly at anterior surface of leg. Erythema extends on anterior surface of leg from ankle up to 8cm inferior to the knee cap ;the erythema on the posterior surface of the leg extends from ankle up to about half way up the calf. Erythema is confluent. Anteromedial surface of the skin has diffuse petechiae. Negative Homan's sign and no calf tenderness, 2+ pitting edema from ankle to midway up the shin.

Intermittent chills lasted 10 days. Intermittent low grade headache lasted 8 days, Severe skin rash / spots ongoing, but slowly going away. Joint pain, Very low energy ongoing.

Severe Immune Response. Fever, Rash, Itching, High Heart rate, Weakness, Shortness of breath. Treated at Emergency room May 09, 2021 Follow up office visit with Dr May 10, 2021 May 12, 2021 May 17, 2021 and June 03, 2021

Severe pain at injection area , it is not constant but generally every day since 06/05 2021 especially at night. Also there is a lump on my shoulder.

I have had a severe skin breakout on my right thigh bumps that appeared after a week and are still there. In addition severe pain in my lower back on the left side which was there before the shot. Also, I have been languish and tired since the shot.

Fever of 100° began @ 10 pm 3/23/21and ended @ 8am on 3/24/21. Minor achy shoulders, back and injection site. Due to MS, fever raises inflammation in quadriceps making walking very difficult. Treated with Tylenol, cool compress and rest. General feeling of fatigue 3/24/2021. All symptoms completely resolved 3/25/2021

PATIENT SAID GOT A RASH ON TRUNK ABOUT 24 HOURS AFTER VACCINE. STARTED TO HURT A DAY LATER, SO DECIDED TO GO TO URGENT CARE. PHYSICIAN AT URGENT CARE DIAGNOSISED HIM WITH SHINGLES AND TREATED HIM WITH ANTIVIRAL. PATIENT THOUGHT IT ODD SO CLOSE TO THE VACCINE, SO HE REPORTED IT WITH ME.

Severe chills starting 11 hours after administration. Severe fatigue entire day after administration, milder fatigue for 2 days thereafter. Swelling of injected deltoid muscle noted 3 days after injection, swelling reduced over following 4 days. Bruising 3 to 4 inches in diameter noted 3 inches below injection site (at approximate location of deltoid insertion) developing 5 days after injection and still noticeable 2 weeks after injection. Bruising still noticeable at time this report submitted

Severe rash (bright red welts) spreading around shoulder area (top of arm to neck) Left side, where vaccine was administered.

Pt reports skin discoloration/patches started on lower left arm, denies itching, pain, or blistering. Patches are red, similar to "burst capillaries", per pt. Reports discoloration noted on 4/7/21. Reports discoloration has developed onto right arm yesterday. Reports appointment with pcp scheduled for 4/19/21. Started Benedryl 25mg last night with little change noted in patches. Denies other complaints.

PAIN AT THE INJECTION SITE FOR 2 DAYS; This spontaneous report received from a consumer concerned a 68 year old male. The patient's height, and weight were not reported. The patient's 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced pain at the injection site for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the injection site for 2 days on 13-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210350479.

Flat red rash with bumps started on back day after vaccine. About one week later shoulder and neck pain. A few days after that chills and fatigue and increased neck pain requiring emergency room visit. Had fever, elevated BP and decreased oxygen level with extreme neck pain. Treated and released with medication. Negative CT of head and neck. Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath. Throat was not examined in ER night before. Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom. He is recovering now.

LOWER INTESTINAL DISCOMFORT; FOGGY THINKING; FORGETTING THINGS; DIARRHEA; HOT EAR; COULD NOT SLEEP; NAUSEA; HEADACHES; INJECTION SITE PAIN; INCORRECT PRODUCT ADMINISTERED; ARM PAIN; FELT LIKE POSTICTAL PHASE OF EPILEPSY; DISORIENTATION; DAZE/FEELING WONKY; ITCHING; OVER-SENSITIVE SKIN; FACE FEELING "SUNBURNED"; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included polycythemia year diagnosed, and concurrent conditions included frontal lob partial focal epilepsy, recovering alcoholic, nicotine free, vegetarian, anaphylactic shock to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no any 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: 042A21A, and UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included oxcarbazepine for frontal lob partial focal epilepsy. On 06-APR-2021, the subject experienced felt like postictal phase of epilepsy. On 06-APR-2021, the subject experienced disorientation. On 06-APR-2021, the subject experienced daze/feeling wonky. On 06-APR-2021, the subject experienced itching. On 06-APR-2021, the subject experienced over-sensitive skin. On 06-APR-2021, the subject experienced face feeling "sunburned". On 06-APR-2021, the subject experienced incorrect product administered. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hot ear. On 13-APR-2021, the subject experienced could not sleep. On 16-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced foggy thinking. On 18-APR-2021, the subject experienced forgetting things. On 19-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 111/70 mmHg, and Body temperature (NR: not provided) 96.7 F. On 20-APR-2021, the subject experienced lower intestinal discomfort. Treatment medications (dates unspecified) included: ibuprofen, cortisone, hydrocortisone, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 19-APR-2021, arm pain on 06-APR-2021, and headaches on APR-2021, was recovering from face feeling sunburned", had not recovered from nausea, and the outcome of injection site pain, disorientation, daze/feeling wonky, felt like postictal phase of epilepsy, over-sensitive skin, diarrhea, foggy thinking, forgetting things, hot ear, lower intestinal discomfort, could not sleep and incorrect product administered was not reported. This report was non-serious.; Sender's Comments: MAC comment: V0; Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Extreme pain to arm Swollen at vaccine spot Pain radiates to neck and shoulder blade Cannot lay on arm Began 22 days after vaccine

BLOOD IN THE URINE; SHINGLES; RASH LOOKING LIKE SHINGLES; FATIGUE/FEELING TIRED; BAD HEADACHE; LOSS OF APPETITE; FOOD DOES NOT TASTE QUITE WELL; NUMB AREA; ITCHING; FELT LIKE ELECTRIC CURRENT GOING THROUGH; PAIN 24/7; BUMP AND IT SPREAD TO SHOULDER AND IT SEEMED TO AFFECT THE NERVE; DISCHARGE FROM RASH; This spontaneous report received from a patient concerned a 68 year old white, not Hispanic or Latino male. Initial information was processed along with the additional information received on 10-MAY-2021. The patient's height, and weight were not reported. The patient's past medical history included ruptured pancreas for which he had a major surgery, eczema, femoral by pass of the right leg to increase blood flow, and blood in urine (which had occurred due to unspecified medical conditions and was cured), and concurrent conditions included prostate cancer, home bound (got vaccinated at home), and the patient was on foley catheter. The other pre-existing medical conditions included the patient had no known allergies, no history of mumps or chickenpox when he was a child and had not been in contact with anyone having chickenpox. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination. Concomitant medications included triamcinolone for eczema. On an unspecified date in 2020, 6 months ago at the time of reporting, laboratory data included: Blood cholesterol (NR: not provided) unknown, and Lipids (NR: not provided) unknown. On 06-APR-2021, after vaccination the patient experienced bad headache for a couple of days, fatigue/feeling tired, loss of appetite that was still lingering. Per patient the food wasn't tasting quite well. on an unspecified date the patient experienced rash like shingles. On 27-APR-2021, the nurse said that the patient experienced a kind of rash that looked like shingles on left shoulder and left neck and had dark colored urine which indicated blood in urine (patient was on foley catheter). On an unspecified date in 2021, the patient experienced a small bump ( injection site lump) at the site of shot on the left arm which spread to the shoulder and it seemed to affect the nerve, the area was generally numb, itching and electric current going through (electric shock sensation), the pain was 24/7 and discharge from rash. The bumps ruptured easily and the patient was advised not to spread the discharge from rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headache on 08-APR-2021, was recovering from fatigue/feeling tired, had not recovered from rash looking like shingles on left shoulder and left neck, loss of appetite, blood in the urine, and pain 24/7, and the outcome of numb area, food does not taste quite well, injection site bump spreading to shoulder and affecting the nerve, itching, discharge from rash and felt like electric current going through was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516869-COVID-19 VACCINE AD26.COV2.S-Blood in the urine . 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

had redness and tightening of the legs, went to ER, found very small blood clot in right calf. Gave rx blood thinner eloquis along with current plavix and asa

WEAKNESS; MUSCLE ACHES; SWELLING; ITCHING; RASH ON EXTREMITIES AND BACK ON THE LEFT SIDE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's concurrent conditions included diabetes mellitus 2, alcohol user, non smoker, gout, stomach ulcers, cholesterol, and blood pressure, and other pre-existing medical conditions included patient does not have known allergies. patient does not have drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prevention of covid-19. Concomitant medications included lisinopril for blood pressure, atorvastatin for cholesterol, glimepiride for diabetes mellitus 2, metformin for diabetes mellitus 2, metformin hydrochloride/sitagliptin phosphate monohydrate for diabetes mellitus 2, febuxostat for gout, and pantoprazole for stomach ulcers. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash on extremities and back on the left side. On 29-APR-2021, the subject experienced swelling. On 06-MAY-2021, the subject experienced weakness. On 06-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Non-reactive for Lyme, and Skin biopsy (NR: not provided) Insect related. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on 09-JUN-2021, was recovering from weakness, and muscle aches, had not recovered from rash on extremities and back on the left side, and the outcome of itching was not reported. This report was non-serious.

BILATERAL FOOT SWELLING; BILATERAL FOOT REDNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient have no health conditions/medications. 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: 1805022, expiry: 09-JUL-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced bilateral foot swelling, and bilateral foot redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral foot swelling, and bilateral foot redness. This report was non-serious.

Patient report tingling in both legs, dehydrated, chills, dark spots all over body w/ burning sensation, and shaking

Patient was exposed to a family member who was COVID-19 positive and tested positive on 7/16. Symptoms start on 7/16 with cough, fever, chills and SOB. Primary care doctor recommended he go to ED and receive casirivimab/imdevimab. Patient received the infusion on 7/21 morning. Then came back to the hospital in the evening due to worsening SOB and was admitted for hypoxia requiring oxygen. Patient was started on remdesivir (7/22) and steroids and lovenox (7/21). No longer febrile starting 7/23. Asymptomatic rash noted on patient's chest on 7/25 and no longer requiring oxygen.

pain in the deltoid area of injection arm that "felt like needles" soon after getting vaccine; pt thought the pain would go away after some time, and although the pain has gotten better, he still feels discomfort in the arm. Pt is just reporting to pharmacy today because he was expecting the pain to resolve with time.

PRURITUS THROUGHOUT THE BODY ALTERNATES IN DIFFERENT AREAS OF THE BODY/ ITCHINESS (BACK OF LEFT ANKLE, BACK OF BOTH ARMS, SIDE OF LEFT LEG ON CALF AREA AND WAIST AREA,LEFT HAND),ITCHY AREAS WITH RED MINOR BUMPS SIZE OF A QUARTER TO HALF-A DOLLAR LIKE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 262 pounds, and height was 69 inches. The patient's past medical history included rheumatic fever in childhood, and concurrent conditions included alcohol user, and non smoker, 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 expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area, left hand), itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area,left hand),itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. This report was non-serious.

Swelling in the eye on the bottom, and a little on the face, itchy, red, and is claiming to have tachycardia These symptoms are likely not due to COVID vaccine. Check with cardiologist for tachycardia and make sure eye drops have not expired or have not been contaminated. If symptoms worsen seek medical help.

PLEASANT MILD DROWSINESS; TINY PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 69 year old white,non Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced pleasant mild drowsiness and tiny pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pleasant mild drowsiness, and tiny pain at site of injection. This report was non-serious.

ITCHY RASH OR ITCHING ON ARM AND THIGHS; RED BLOTCHY HIVES ON THIGHS, BUTTOCKS AND ARMS; SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 185 pounds, and height was 69 inches. The patient's concurrent conditions included copd, emphysema, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and no history of hives/rash ad did not have drug abuse history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin, levothyroxine sodium, metoprolol, and paroxetine hydrochloride. On 05-MAR-2021, the subject experienced mild headache. On 06-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash or itching on arm and thighs. On 13-MAR-2021, the subject experienced red blotchy hives on thighs, buttocks and arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy rash or itching on arm and thighs, red blotchy hives on thighs, buttocks and arms, and mild headache on MAR-2021, and sore arm on 07-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20210330252.

Strong headache lasting about 2 weeks, nausea, red raised sores up to half inch diameter clearing some after 12 days on face and scalp

ARM PAIN AND SORENESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's 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: Unknown) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On FEB-2021, Laboratory data included: Antibody test (NR: not provided) No Igm or Igg detected. On 06-MAR-2021, the subject experienced arm pain and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain and soreness. This report was non-serious.

COLD SORE ON THE LIP; FEVER WHICH WAS DESCRIBED AS FLU LIKE SYMPTOMS; MUSCLE ACHE; FEELING TIRED; ITCHING; RASH THAT APPEARED ON MIDCHEST AREA BETWEEN THE STOMACH AND THE PECTORALS; RED BLOTCHES; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's 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: 1805022, and batch number: 1805022 expiry: 05-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced rash that appeared on midchest area between the stomach and the pectorals. On MAR-2021, the subject experienced red blotches. On 05-MAR-2021, the subject experienced fever which was described as flu like symptoms. On 05-MAR-2021, the subject experienced muscle ache. On 05-MAR-2021, the subject experienced feeling tired. On 10-MAR-2021, the subject experienced cold sore on the lip. On 17-MAR-2021, Laboratory data included: Biopsy (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: fexofenadine, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sore on the lip on 16-MAR-2021, and fever which was described as flu like symptoms, muscle ache, and feeling tired on 08-MAR-2021, and was recovering from rash that appeared on mid chest area between the stomach and the pectorals, red blotches, and itching. This report was non-serious.

initially had mild headache and diarrhea but this resolved after a few days. Then around 4/25, developed atraumatic bruising and swelling and pain to the left biceps region (opposite side from vaccine). denied current headache/visual symptoms/abdominal pain or other bleeding/bruising.

Slight bruising , swelling, and pain on back of hand of vaccinated arm upon waking up. Patient also reports generalized aches and pains that he did not have prior to vaccination.

After my J&J vaccine I has soreness to my right arm at the injection site. On 04-08-2021 woke up with a head cold, loss of sense of smell. I On 04-09-2021, I went to clinic where I got tested for Covid-19 and my results were positive at 11:20pm.

Hives 3/15/21: patient reported rash to arms day after injection; seen by APRN-CNP for rash to lower extremities with open areas and oozing. Referral to Dermatology. 3/18/2021: Seen by ( Dermatology) for 4 large spots on legs. Rash was present for approximately a month but became bigger since J&J shot with addition of hives; rash present on arms 4/1/2021: punch biopsy of hives' instructed to use Sarna lotion for itching, start; Diprolene twice daily for 2 weeks on, 2 weeks off, and 2 weeks on.; rash now present on arms and new sores forming on lower legs. Report showed hypersensitivity reaction. 4/9/21: patient hives worsening. Provider contacted patient PCP,. . Kenalog-40 injection given. Hydroxyzine HCl also prescribed to be taken TID as needed for itching. 5/10/21: PC with provider . Hives had returned. Still using Zyrtec, ointments and Sarna cream; recommended increase of Zyrtec to BID; Referral to allergist pending

ITCHING ON ARM; SOME REACTION; RASH ON ARM; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 14-MAY-2021 was received on 14-MAY-2021 and concerned a 69 year old male. The patient's weight was 106.59 kilograms, and height was 185 centimeters. The patient's pre-existing medical conditions included the patient did not had any medical history. 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 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced itching on arm. On MAY-2021, the subject experienced some reaction. On MAY-2021, the subject experienced rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arm, rash on arm, and some reaction. This report was non-serious.

Injection Site soreness, by bedtime, slight fever, chills (all night), overall aches (like the Flu), terrible headache upon waking. No appetite, symptoms continued for 3 days. Back to somewhat normal on day #4.

I'm not sure if this is from my vaccine. I started getting hives well over 2 months from receiving it. I went to my ER twice with severe hives the second time was given Hydroxyzine 50MG that cleared my hives up with in 2 hours. This was Sunday 5/23 night at about 3 am I stayed hive clear till Thru 5/27 at about 5 PM. Now the Hydroxyzine is no longer working.

CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MILD PAIN IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) 1 total dose was not reported, administered on 01-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The patient did 2 antibodies tests and they were negative. On 28-MAY-2021 his result came out negative. The second test was done on 04-JUN-2021 and test came out negative(confirmed immunological vaccine failure). He took the vaccine, he did not have any side effects. He only had mild pain in the site of injection went away the same day after 4 hours. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. On 04-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild pain in site of injection on 01-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210616495-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

fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash.

PASSED OUT ABOUT 15 MINUTES; DOES NOT REMEMBER ANY OF IT; RASH ALL OVER HIS BODY; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once in total administered on 18-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. In MAR-2021, the patient broke out in a rash all over his body and passed out and was out for about 15 minutes or more. The patient's neighbor helped to get into bed. The patient does not remember any of it and don't know if it was vaccine or whatever was wrong with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over his body, does not remember any of it and passed out about 15 minutes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210347765 and 20210347766. Version created to amend previously reported information on 21-MAR-2021. Upon review, following information was amended: The case upgraded to serious and new event passed out about 15 minutes added in case.; Sender's Comments: V1: Version created to upgrade case to serious with event (passed out about 15 minutes added). 20210342307-Covid-19 vaccine ad26.cov2.s-passed out for about 15 minutes or more. 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).

Muscle pain at site of injection making it difficult to sleep. No known injury to the affected area and has been ongoing for about 3 weeks.

HIVES ON EAR AND HEAD; FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart problems, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hives on ear and head. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on ear and head on 28-MAR-2021, and fever on 27-MAR-2021. This report was non-serious.

RASH ON RIGHT LEG; This spontaneous report received from a consumer concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced rash on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on right leg was not reported. This report was non-serious.

Patient reported a rash that started on 4/12/2021. Rash is pinpoint, flat, red dots. Rash started on inner thighs and has now spread to navel and chest area. Rash is burning and itching. Patient has reported that he was mowing the lawn on 4/12 and thinks he saw poison ivy. Patient has not tried any treatment for his rash.

diffuse itchy body rash on arms, legs, back, stomach. Large areas of erythema, macular spots, raised blisters filled with clear fluid Seen 3/21-at Urgent Care-treated with abx for cellulitis of right calf; Seen 3/23 by PCP and started on steroids with referral to dermatology. Seen 3/24 by dermatology added topical steroid cream. Seen 4/13 by dermatology for flare up after steroids weaned; steroids restarted. Seen 4/20 rash not responding to steroid dose increased and dapsone added

Right lower leg sudden onset severe swelling, pain, redness. Went to urgent care doctor who then performed assessment, blood work and ultrasound. Placed on Xarelto 15mg twice daily for 21 days.

arm sore for 1 week. still some residual pain. might be coincidence but i have broken out in rash, itch, burning sensation ( fells like sunburn) 4 times since shot. episodes last about an hour.

om 5/8/21 at 9:00 PM, felt light headed, stepped outside for air, returned to closest chair, calling to significant other, I feel dizzy. Sat in chair, staring blankly, not responding to calling, or physical touch. breathing shallow, facial and lip color pale, pasty white gray. weak pulse. 911 called, and responded 8-9 minutes later. By the time they arrived, patient had aroused and aware of his surroundings,. Although color was slow on returning to normal. EMS arrived, BP 120/80. Patient refused to go to ER . On 5/10/21 at 2:00am, patient woke up and had a nosebleed lasting 2 hours, pouring from nose. 911 called and transported to medical center for cauterization, nasal packing and observation. 5/11/21 developed a reddened rash on right hand, lasted 5 days. Nasal packing removed on 5/13/21. No further complaints at this time.

Patient developed a rash and bumps on his arms and reported a burning sensation in his feet. He saw his primary care doctor, and they referred him to dermatology. He will be following up with them in June or July.

Patient experienced severe diarrhea, sore arm, achey joints, fatigue, depression, chest and lung pressure, injection site pain, leg pain. 2 to 3 weeks after the vaccine, patient experienced tinnitus and head pressure Patient noticed a blood pressure increase

I developed red rashes on my chest and stomach and a blotchy face. The stomach rashes we?re in some places very itchy. I still have a itchy spot on my stomach. On the morning of March 29, 2021 I could not get warm. I covered myself with blankets and in the evening after not eating anything I went to bed. The next day I was still cold. I didn?t feel better until the next day. I am still blotchy.

REDNESS OF LEGS FROM KNEES DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included past history of cancer (15 years) that has recurred, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:30 for prophylactic vaccination on Left arm. Concomitant medications included enzalutamide for cancer, gabapentin for cancer, rosuvastatin for cancer, ipratropium for drug used for unknown indication, leuprorelin acetate for drug used for unknown indication, loratadine for drug used for unknown indication, megestrol acetate for drug used for unknown indication, meloxicam, and metoprolol. On 24-MAR-2021, the subject experienced redness of legs from knees down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of legs from knees down. This report was non-serious.

FELT A LITTLE WEIRD; LITTLE TROUBLE FALLING ASLEEP; FELT SLIGHT WEAK; SORE AT THE SIGHT OF THE NEEDLE STICK; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced felt a little weird. On 15-MAR-2021, the subject experienced little trouble falling asleep. On 15-MAR-2021, the subject experienced felt slight weak. On 15-MAR-2021, the subject experienced sore at the sight of the needle stick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little weird, little trouble falling asleep, felt slight weak, and sore at the sight of the needle stick on 16-MAR-2021. This report was non-serious.

Janssen COVID-19 Vaccine EUA Itching on left shoulder of back Dizziness when first getting up from sleeping or reclining

got up out of his chair to leave from his 15 minute wait and fell face down on the floor. He did not put his hands out and received a cut on his left cheek below eye from glasses. He was assisted onto his feet and back onto his chair. Vital signs were BP-117/64, Pulse 85, RR 18, O2 sat 98% (WNL). Water provided to patient. Had him take several deep breaths. Band Aid applied to cut on cheek. Patient did not complain of any symptoms. Denies dizziness. Refused to seek further medical attention or go to ER. He was then assisted back to his car by staff after the incident.

BACK PAIN IN KIDNEY AREA, BRUISING THAT LOOKS LIKE LIVER SPOTS. REPORTS THAT THIS BEGAN RIGHT AFTER VACCINE.

SWELLING FOREARM; RED AND BLUE ARM; SWELLING ELBOW; ITCHY ARM; INFLAMMATION IN ARM; BRUISED ARM; ARM SWELLING UP AROUND RIGHT SHOULDER WHERE GOT THE SHOT; This spontaneous report received from a consumer concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-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 swelling forearm. On APR-2021, the subject experienced red and blue arm. On APR-2021, the subject experienced swelling elbow. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflammation in arm. On APR-2021, the subject experienced bruised arm. On APR-2021, the subject experienced arm swelling up around right shoulder where got the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling forearm, red and blue arm, swelling elbow, itchy arm, inflammation in arm, bruised arm and arm swelling up around right shoulder where got the shot was not reported. This report was non-serious.

Starting on 04/13/2021 noticed very easy bruising seems to be improving. Starting 04/16/2021 backache right side near kidney area, still on-going. Starting 04/18/2021 sore on tongue and right inside of mouth.

ITCHING; REDNESS OF SCRATCHES; WELT ON ARM; SWELLING; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A 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 itching. On APR-2021, the subject experienced redness of scratches. On APR-2021, the subject experienced welt on arm. On APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, redness of scratches, and welt on arm, and the outcome of swelling was not reported. This report was non-serious.

CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 08-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 20-MAR-2021 05:00, the subject experienced chills. On 20-MAR-2021 05:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from chills, fever, and nausea. This report was non-serious.

10 days after receiving the Janssen vaccine, patient experienced extreme / debilitating fatigue, muscle soreness, stiff joints that lasted 72 hours. At the same time as the fatigue onset, a severe rash with inflamed welts and blood-filled blisters covering torso and abdomen - front and back also appeared. The rash was severe for 3 days and slowly subsided; scars still visible today - red dots.

PSORIASIS GETTING WORSE, LEGS, ARMS, BACK, NECK, HEAD HAS PSORIATIC PIMPLES AND PSORIATIC BREAKOUT; SKIN SLOWLY STARTED BREAKING OUT; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 180 pounds, and height was 70 inches. The patient's past medical history included psoriasis, and concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had not taken any medication for many years. patient did not have no known allergies and did not have history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout. On APR-2021, the subject experienced skin slowly started breaking out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis getting worse, legs, arms, back, neck, head has psoriatic pimples and psoriatic breakout, and the outcome of skin slowly started breaking out was not reported. This report was non-serious.

One day after vaccination, I developed severe body chills with shivering that lasted about 24 hours. And, my face was flushed and hot. In summary, my body had chills while my face was hot. These side effects ended after one day. However, about a month later, May 9, 2021 the above side effects occured again. Also lasting about one day.

BUBBLES ON BOTH LEGS; LEGS WERE SWOLLEN; BUBBLES POPPED UP AND LEAKED YELLOW LIQUID; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, allergy to lyrica, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use and had no fever, no cough, no asthma, no sob. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced bubbles popped up and leaked yellow liquid. On 13-APR-2021, the subject experienced bubbles on both legs. On 13-APR-2021, the subject experienced legs were swollen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bubbles on both legs, and legs were swollen, and the outcome of bubbles popped up and leaked yellow liquid was not reported. This report was non-serious.

STARTED TO FEEL LIKE SOMEONE IS STANDING ON MY STOMACH IN THE MORNING/HE THOUGHT HE WAS CONSTIPATED/ PAIN THEN STARTED TO MOVE FROM THE LEFT SIDE THEN IN HIS BACK; BLACK AND BLUE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included liver transplant, and concurrent conditions included diabetes, and spider bite. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced black and blue at the injection site. On 06-JUL-2021, the subject experienced started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue at the injection site on JUL-2021, and had not recovered from started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. This report was non-serious.

Patient came in today on 7/14/21 and stated that he has been experiencing symptoms after the vaccination. He had a rash and severe itchiness that has since gone away. He states that he has been having leg cramps and has been experiencing muscle weakness. The muscle weakness has been getting progressively worse. He is also experiencing nerve tingling, all of which he did not attribute to the vaccine until recent news about Guillen Barren Syndrome associated with the Johnson and Johnson Covid 19 vaccine.

LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Patient presents to ED with left hand swelling, fever, and left arm pain on 3/10/21 after receiving his COVID 19 vaccine at Clinic on 3/4/21. I'm unable to determine the route of administration from the immunization documentation. Patient reports that the swelling significantly increased over the past day with increased swelling in his left hand and pain from his left clavicle to his left hand. Patient is febrile upon presentation with a documented temperature of 38.7 and sinus tachycardia. EKG is otherwise unremarkable. Patient has been diagnosed with left arm cellulitis and is being admitted to our hospital. He has been started on vancomycin 800 mg and Zosyn 3.375 g IV.

Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Additional Details: Patient's heart rate is typically in the 80's. After vaccination, night of and morning after, patient's heart rate went up to 113.

Pt developed edema and pain to LLE from knee down to ankle on 4/9/21. Describes skin tightness and redness.. No fever, but with chills. Given crutches to avoid weightbearing on left leg. Pt is being worked up for potential blood clot, US Left venous duplex. Pending results for exams, Sent to emergency room on 4/13/21 by reporting nurse.

Patient recived Janssen COVID vaccine at alternate site, came to ED with complaints of pain and rash starting in same arm and spreading. Diagnosed with Shingles

BLOOD PRESSURE INCREASED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included death of wife, and concurrent conditions included high blood pressure, stress, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced blood pressure increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 05-APR-2021, and had not recovered from blood pressure increased. This report was non-serious.

INJECTION SITE PAIN; ARM PAIN; This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 arm pain. On 11-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and arm pain. This report was non-serious.

Patient describes having arm pain for 16 days after administration. sometimes the pain extends into his neck and down his arm to his wrist.

SEVERELY DRY SKIN; ACHY BACK; ITCHINESS IN LEGS/ARMS/BUTTOCK/BACK/BELLY/UNDER ARM; This spontaneous report received from a patient concerned a 72 year old male. 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: Unknown, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced severely dry skin. On 22-MAY-2021, the subject experienced achy back. On 22-MAY-2021, the subject experienced itchiness in legs/arms/buttock/back/belly/under arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severely dry skin, achy back, and itchiness in legs/arms/buttock/back/belly/under arm. This report was non-serious.

Patient presented to the ED on 6/7/21 with abdominal pain that had started earlier that day. CT abdomen, CXR, and urinalysis were done and all came back negative. Patient denied any respiratory symptoms. On physical exam, he was found to have severe swelling, erythema, and ecchymosis on his left leg extending into the upper thigh and knee. A lower extremity doppler was done and found extensive occlusive thrombosis within the left lower extremity beginning in the external iliac vein and extending into the common femoral, femoral, profunda, popliteal and visualized deep calf veins. No evidence of PE or DVT in the RLE was found. Vascular Surgery was consulted, who did not recommend any procedures, but patient was started on a heparin drip. Hematology later saw the patient and changed the heparin drip to rivaroxaban on 6/9/21. Infectious Diseases was also consulted for possible sepsis.

SMALL AMOUNT OF PAIN AT THE INJECTION SITE THAT LASTED A FEW SECONDS/ARM PAIN; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 174 pounds, and height was 71 inches. The patient's concurrent conditions included diabetic, copd (chronic obstructive pulmonary disease), smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage.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 02-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included dulaglutide for diabetic, and metformin for diabetic. On 02-JUL-2021, the subject experienced small amount of pain at the injection site that lasted a few seconds/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small amount of pain at the injection site that lasted a few seconds/arm pain on 02-JUL-2021. This report was non-serious.

Headache and pain behind Rt. eye, developing into a low grade reaver and vomiting. By Tuesday the 11 I developed a rash on my face with pain shooting behind my eye to the back of the head. Tuesday at Emergency room eye was swollen closed, rt. side of face was broke out in scabs and sharp pains through the eye and scalp.

ARM PAIN AT INJECTION SITE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included diverticulitis, and rectal bleeding, and concurrent conditions included arthropathic psoriasis. 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. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ustekinumab for arthropathic psoriasis, pneumococcal vaccine conj 13v (crm197) for prophylactic vaccination, amoxicillin, azithromycin, fenofibrate, fluticasone, folic acid, lisinopril, loratadine, metoprolol, omeprazole, rosuvastatin calcium, sulfamethoxazole/trimethoprim, and tamsulosin. On an unspecified date, the subject experienced flu like symptoms, and arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and the outcome of arm pain at injection site was not reported. This report was non-serious.

MINIMAL DISCOMFORT AT THE INJECTION LOCATION; TIREDNESS; HEADACHE; SORE TO THE TOUCH ONLY; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient has blood type of a (RH negative).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on right arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced minimal discomfort at the injection location. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced sore to the touch only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minimal discomfort at the injection location, tiredness, headache, and sore to the touch only. This report was non-serious.

VACCINE TASTE (STRONG BITTER ODOR); INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced vaccine taste (strong bitter odor). On 08-MAY-2021, the subject experienced injection site reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine taste (strong bitter odor) on 12-MAY-2021, and injection site reaction. This report was non-serious.

On 4/11 i got vaccinted vaccine Johnson & Johnson on Left Arm, on 4/19 I feel my left leg muscle pain from my left sholder to my feetand feel very tied weak body sometime my leg cramp and spasm, until May 18 went to see doctor, did ultra sound and xray on my left leg to to check for blood clut, everything negative, only at my knee have mild osteoarthrosis on 5/26 my left foot swalow and on June 9my right foot start pain cannot step on the floor, then start take 5 advil next day morning right foot pain it no more until now i still have a my muscle pain have to take Advil for pain killer

This spontaneous report received from a physician concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock (black widow bite), and concurrent conditions included allergy to scallops, and allergy to insect bite. The patient had no allergies to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 18-MAY-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient felt some redness, irritation, warmth and soreness at injection site for about an hour afterwards and also experienced a brief fever from 18:00 on the day of vaccination which disappeared by the next morning. The patient also had some intestinal flu symptoms, muscle cramps and triple urinary output for about 72 hours post vaccination and he mentioned that the muscle cramps started around injection site and moved gradually down until it reached his lower extremities. Patient also experienced narcolepsy and said that the episodes would last either 90 minutes or 3 hours and would happen periodically for about 60 hours post vaccination and patient also said narcolepsy episodes would show up without any warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from narcolepsy, muscle cramps started around injection site and moved gradually down to lower extremities, intestinal flu symptoms, and triple urinary output on 21-MAY-2021, injection site irritation, injection site warmth, injection site soreness, and injection site redness on 18-MAY-2021, and fever on 19-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708286-covid-19 vaccine ad26.cov2.s-narcolepsy. 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).

Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence.

Patient developed rash on 3/8/21 two days following covid 19 vaccination. Red, patches, pruritic encompassing chest, back, legs, arms, and abdomen (sparing face, palms, and soles). Dermatology stated on prednisone 20mg daily to help. Due to progression, patient presented to medical center on 3/19/21. Rash appeared to have some pustules and desquamation. Also, had some swelling and pain to the areas. Dermatology biopsies on 3/20/21 which showed findings consistent with drug eruption. Rash began to improve on 3/23/21 and patient was discharged home with continued Triamcinolone cream for presumed acute generalized exanthematous pustulosis.

Approx 10 minutes after injection, pt reported his lower checks were starting to itch and he felt a little swelling in his check bones. Pt also stated he wasn't having any trouble breaking, skin tone look normal, pt was able to communicate with no problems. He stated the symptoms he was experiencing were something he was used to. It happens to him when he eats chicken and certain kinds of foods (especially seafood/shellfish). I offered him benadryl and an ice pack while he was here. He refused the ice pack, but did agree to low dose of benadryl. He took one Allergy Relief 25mg softgel and then continued to set for a little over 30 minutes total before he said he was fine and left with his wife. I contacted him around 11:50am, he was doing fine and enjoying a good lunch.

On March 8, 2021 I went to pharmacy and got the J&J covid vaccine. There were no apparent adverse effects. On March 30, I work up with a rash on my right leg. After about 2 days the rash appeared on both legs. As of April 9, 2021 the rash has not cleared completely! I have photos which I will try to attach to this report.

pruritic rash starting in the left shoulder region and spreading more diffusely over time to side and right side of back. He was seen in ED and 03/07/21, given IV Solu-Medrol and prescriptions for Medrol taper plus Pepcid. Reportedly he is seen his primary care provider several times in the interim but presented back to the ED on 3/29/21 for a pruritic rash. He was admitted for 48 hours during which time he underwent nondiagnostic skin biopsy, and was discharged home on steroids and the proton pump inhibitor. Within 48 hours of discharge she was readmitted with a mild lactic acidosis and persistent rash.

blurred vision, hallucinations, rash around his eyes, HA, running nose, off balance patient refused going to emergency room, is waiting to consult with provider

Patient noticed blotches on both legs approximately 6 to 7 days after vaccine was administered. On 03/30/2021, patient fell to ground, unable to get up. Patient was taken by ambulance to Hospital emergency room. Scans revealed patient had multiple blood clots and was operated on. Later in the stay, patient developed widespread hematomas in groin, stomach, rear, and both legs. Patient was released from hospital on 4/8/2021.

Headache, muscle aches, diarrhea the following day and one week later. Soreness and discoloration at injection site the following day to date.

I am submitting this report because of symptom onset relative to vaccination date, and because I have not experienced this cluster of symptoms before. My wife and I received the same lot number of the J&J vaccine on Saturday, March 13. We both had slight fatigue that evening and into the following day and she has had no further symptoms. On Tuesday, March 16, I had a mild ache around injection site with no further symptoms until Saturday, March 27 when I experienced a brief episode of lightheadedness. (CONTINUED BELOW)

Red itchy skin that started on arms. It advanced to raised bumps on arms and torso and upper thighs. It began on 3/19/2021 and he still has residual redness and itchiness, although it has receded a bit, as of 4/15/2021

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Patient called pharmacy to say he had developed a Rash and Hives the evening of his vaccine (vaccinated in the morning). Patient treating at home with hydrocortisone 1% and oral benadryl.

Pt developed petechiae on BLEs the same day he was given the vaccine (5/4/2021) and the petechiae started to improve 3-4 days later. No other adverse symptoms reported.

WEAKNESS; TIREDNESS; PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 01-JUL-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced pain at site of injection. On 20-MAY-2021, the subject experienced weakness. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at site of injection on MAY-2021, had not recovered from weakness, and the outcome of tiredness was not reported. This report was non-serious.

Shingles all over body. Patient reports having shingles on penis and buttocks. Also reports MD stated having shingles on his bowels/intestine.

74 y.o. male presented to the ER with complaints of right elbow pain and swelling. The nursing home did call the office yesterday requesting for x-ray of the right elbow. Bed x-ray did show an impression of: Unremarkable limited view left elbow without evidence definite fracture or dislocation this was read by the radiologist. Patient did have CT scan right elbow today showed an impression of: Diffuse soft tissue edema prominence subcutaneous soft tissue gas along the dorsum forearm proximally, in no acute pathology or CT evidence of acute osteomyelitis, no vascular pathology. It is noted that patient has swelling, redness pain, and erythema to the right elbow. Upon examination the patient does grimace pain movement of the right level. Patient does have a large pocket of fluid noted to the right medial epicondyle region and to the medial right upper forearm. Skin is hot to touch, but patient's pulses were noted at 2+ 2+, and CMS is less than 3 sec. Patient did also have lab work a white blood count noted of 5 point, hemoglobin is 10.4, hematocrit was 31, platelet count is 201. BMP showed a nonfasting glucose of 107, sodium was 135, calcium 8 1, and his GFR is 84. Patient's sed rate is elevated at 45. Patient's lactic acid noted at 0 4. Patient did also have blood culture in the emergency room and that result is pending. Patient's procalcitonin level is noted at less than 0.00. The patient was started on vancomycin 1 g IV piggyback every 12 hr. Patient was admitted to medical inpatient as it deemed that he will need longer than a 2 midnight stay for monitoring and IV piggyback antibiotics.

YELLOW SKIN AT INJECTION SITE; OOZING AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old male. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On an unspecified date, the subject experienced yellow skin at injection site, and oozing at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the yellow skin at injection site and oozing at the site of injection was not reported. This report was non-serious.

Felt stickers or stinging sensations on the back and I went to the doctor at 6/11/201. It went from the sternum all around the left side of my waist under my arm. Red blisters like chicken pox. Painful. Diagnosed as Shingles - gave me a 10 day regiment of Valtrex and that ended two days ago. All of the blisters have popped and are scabbing over and still have the pain and the itching. It's healing up. It will go on with pain and itching for awhile the doctor said.

STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.

"Janssen COVID-19 Vaccine EUA" 4 days after the vaccine was administered, my shoulder (muscle) began hurting slightly at the spot I received the vaccine. This is now the 6th day after I received the injection and each day the discomfort is increasing. Is this increases of discomfort normal 6 days after the vaccine was first received?

Rash on chest, back, neck, and scalp that itches - using body lotion After showering on March 15,2021 my face was bright red. That went on 5 day after every shower. I am using Benadryl (Antistamine ) it help some what.

pt presented to pharmacy 3/23/21 with a half dollar sized hard mass. Pt complained about itching at the site the day after vaccination, site still was red to pink 15 days after injection, injection site was extremely sore but has improved and pt has more arm mobility...pt refused to go to dr, ..pt was concerned that everyone else he knows has improved and his arm is still sore

It started with a familiar reaction and that was I had tingling and pain in my feet it started with both feet and it was significant, like when the feet goes to sleep and it is coming back and you feel the pins and needles feeling, and it was exactly what I get with CIDP. It moved from both feet up to both hands and I was not really afraid because that is what happens with CIDP when your auto immune system is stimulated. I get numbness on my feet and in my hands. I thought that the vaccine stimulated my immune system. The CIDP has been in remission and maybe the shot has stimulated my nervous system. The other day I noticed that when taking the hot plate from the microwave it was hot but I did not feel it at all. I thought the food has not heated up, when my wife touched the plate she said it was very hot and I did not feel the plate hot at all. I also felt pain in my left foot to a point that I am not ambulatory. The pain is so extreme in my left foot if I try to stand up. I have been in my bed for the last 2 days. I am not sure if it is the CIDP or GOUT that is attacking my foot but it has been triggered by the vaccine. I also have severe pain in my left leg. I called my cardiologist and I have a phone consultation with him today to check for clot formation. The pain has subsided a bit today, but yesterday the pain in my leg was very intense. I also had pain at the injection site and felt a little feverish since yesterday around 3PM and it went to 101F and this morning I am fine again. I did not take anything for it and this morning I woke up and I felt well (in regards to the fever). I did not have fever before then.

Rash and itching on both arms, both legs, both feet, stomach area. Worse on right arm. Dermatologist prescribed topical steroid oint, sarna anti-itch cream, and aquinil to wash in shower instead of soap. Rash has improved everywhere but on feet. Itch has improved everywhere but not completely gone