Johnson & Johnson

Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.

Pt is here with c/o diffuse redness and itching rash which started last night; he took the J&J COVID vaccine around noon yesterday from facility; he denies any wheezing, dyspnea or SOB; denies any prior allergic reaction; no h/o anaphylaxis; Pt stated he was not provided with a hotline to call to reports vaccine reactions. Solu-Cortef 100 mg IM x1 given in the office today; will also place him on prednisone taper which he will start tomorrow morning; Zyrtec 10 mg qd also started today; pt is advised to call 911 or go to the nearest ER should he developed wheezing, SOB and difficulty breathing; he agrees with plan and voices understanding. Incident about the vaccine reported to VAERS.

Went most of the day with no symptoms. Performed a High Intensity Workout around 7pm for an hour, and ate shortly after. Took a hot shower and relaxed before bed time around 10pm started to have a headache. By 10:45 when I went to sleep it was an intense headache. Under the covers my body was incredibly hot, without covers I was freezing cold. I woke up around midnight in a sweat and again around 2:30am when I called in sick to work. I then sat in my bathroom for 30 minutes, threw up once, and then feeling much better (Still had an intense headache) I drank some water and fell back asleep in my room. Today is the second day, I have a small headache, have not eaten all day, and slept most of the afternoon. I highly recommend not working out the same day of getting the vaccine, I didn't think to ask about that when I received it. I doubt I would have had this problem if I rested instead.

I woke up with hives over my arms and chest. My left eye was nearly swollen shut and my hands were swollen and in a lot of pain. Whole body is very itchy and sensitive to touch. I took sudafed because it is all I had available at the time.

around 10 pm started with chills and fatigue with a sore injection location. Around 11:30 pm he got light headed and passed out for 4 seconds. After awaking he doesn't remember the last 5 minutes. He laid down to go to sleep and was consistently hot and then cold. He does have a history of night terrors but they have remained dormant for about 2.5 years. Around 12 am he started having one of the worst night terrors I've seen. The following morning, April 2nd 2021, he was feeling incredibly sore and the injection spot was tender. He said "it feels like I got hit by a truck." Seems to be doing okay otherwise now.

Worst chills I?ve ever had during first night. Muscle soreness at injection site. Fever. Fatigue. Slight cough and tight lungs.

Patient sustained a vasovagal syncope event approximately 3 to 4 minutes after their vaccination. Fell to ground sustaining abrasion to right cheek. Advised ER evaluation but patient refused. Observed for 30 minutes w/o sequelae and released at patient insistence. Spoke with patient by phone today and he notes that he feels well and has experienced no new, recurrent, or residual symptoms.

General skin irritation that began to itch and hurt. I then believed that I was having symptoms of Shingles. I went to my GP who then confirmed that it was likely shingles and began treatment with antiviral medication.

I began having general skin irritation on my back and chest all on the upper left of my torso. I developed a rash that began hurting, and believed I was having symptoms of shingles. I made a visit to my GP whom also believed it was a shingles infection and began antiviral treatment.

Only minor chills before bed, 11pm. Muscle aches, felt as tightness in IT bands, made remaining asleep difficult. Got up to use the bathroom around 5am. Upon finishing peeing while standing, I lost consciousness, falling. As a result of the fall, I fractured my cheek bone, cut open my ear, later requiring three stitches, and was concussed, resulting in a loss of memory. I was nonresponsive when my fiance found me immediately following the crash, and was rushed to the hospital via ambulance. Upon arrival to the hospital, my fever was found to be 102 F. As a result of the fall, I have a cheek bone fracture, three stiches in my ear, and a concussion.

As soon as I go the shot I didnt have any severe symptoms, but as I drove (20 min) to reach my home. After reaching my home even after few hours also I didnt have any symptoms. But before I went to sleep (around 12:30 am ), i started to have mild pain near the vaccination sight. Even during my sleep i felt okay, but as soon as I woke up (around 09:00 am) i felt mild symptoms on pain, as I started attending to my regular activties right after 10:00 am, i started to feel severe chills, fever, body pains, lazyness, moderate headache and severe pain at vaccination site. Again I had some food and slept due to severe body pains and even through the sleep also I had severe body pains, fever, nausea and lazyness. As I woke up after my evening nap of 3 hours, i woke up at 6:00 pm and felt chills, body pains., fever and nausea.

Flu like symptoms next day. Hives beginning next day starting on injection arm, and spreading to entire body over the course of the next week. Largest is approximately 6"x3", about 1-2 dozen quarter sized on arms and legs, many more approximately dime sized or smaller covering rest of body.

I took the vaccine around 4pm in 9th of April, it was ok that day , then i slept at 12am and i woke up shaking after 3 hours having sever chills and fever , after that the other day i had really bad fever and muscle pain , the severity was 8/10 , I couldn?t do anything that day .. but the interesting thing that i have CIA and it?s under control by taking loratidine everyday , but since i took the vaccine my rashes flared up , i got lip swelling, rashes all over my body regardless of taking loratidine as usual , and it?s getting worse at night time now since i took the vaccine.

Patient received Janssen( Johnson and Johnson ) Covid vaccine on Friday 4/9/2021. Patient attended work that evening . Mother reports patient complained of feeling dizzy weak fatigued and generally not well when got home that evening at 10pm . Redness pain and swelling noted ot injection site on left arm noted at that time also. Nausea and vomiting began on saturday 4/10/2021. Nausea vomiting dizziness malaise fatigue continued through Tuesday 4/13/2021. Redness and swelling and pain to injections arm. Consulted verbally with family practice physician on Monday 4/12/2021 Benadryl and anti nausea medications used with some improvement . Injection arm visually inspected non-visit . patient missed work and school Saturday 4/10/2021 through Tuesday 4/13/2021 . report received on Thursday 4/15/2021 that patient's nausea vomiting has resolved but continues with dizziness headache and injection site with redness, swelling . Swelling has not increased but has not decreased

The last two nights I have gone to bed with itchy legs on and around my ankles, shins, knees, wrists, and elbows. The itch has been so severe and uncontrollable I wake up in the night and cannot go back to sleep.

BLUE NAILS; CHILLS; FEVER; HEADACHE; SORENESS ON INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 26 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, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blue nails. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced soreness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blue nails on 09-APR-2021, and had not recovered from fever, chills, headache, and soreness on injection site. This report was non-serious.

Pruritic generalized rash 3-4 days after vaccine, not at site of injection, but in clusters of papules/plaques on extremities, trunk and face with sloughing of skin. No systemic symptoms.

Patient got vaccine and sat down for observation. He reports that after 1 minute, he was shakey, sleepy, and very tired. Then he felt like he fell asleep until the person checking him called at him. He had some vision and hearing impairment at the beginning, then after 10 minutes he was better. His arm was hot, he was sweating, his skin was turning white color. His mom came (she was shopping) and said the patient is usually an anxious person, so it was overwhelming to be at department store and getting the shot. After another 10 minutes, he was drinking water, his senses were back, he was fine.

itchy skin on belly. Approximate 10 red dots which are similar to the reaction of Mystique bite. It appears after fever at 37.9C.

I've had a moderate case of SIRVA for the past month. Shoulder pain that is still persisting. I believe this was caused by the nurse administering the vaccine too high on my arm - the shot was very close to my acromion.

Existing facial dermal filler (restylane) became inflamed and sensitive. Swelling lasted throughout the day and had mostly resolved by the same evening with ibuprofen, while still tender to the touch. No medical attention was sought as I determined it was a non-emergency.

Patient received J&J covid vaccine on 4/7/2021. Patient presented to the ED on 5/3 for right arm swelling with redness. Patient was found to have proximal right upper extremity DVT extending to right subclavian vein along with bilateral PE in the ED. The provider noted the patient had no risk factors other than receiving the vaccine, requested a hematology/oncology consult for evaluation hypercoagulable , patient started on bivalirudin while HIT work-up completed plan to transfer to oral anticoagulation upon discharge.

- a 26 yo male, received a Janssen vaccine at approximately 1:30pm on 5/9/21 - Prior to administration, I asked patient if he had any issue with vaccines prior and he stated no. His consent form did not indicate medication allergies or a history or reactions. - Less than 5 minutes after administration, the patients friend, who also received a vaccine, stated that he was having a seizure - I instructed her (pharmacy technician) to call 911. - I observed the patient laying on his side by the wall in the pharmacy waiting area; he was conscious with eyes open. I did not observe him seizing. He did have a red spot on his forehead where his head hit the wall. He was also sweating. His friend stated that he seized for less than 5 seconds. - I gave the patient a frozen water bottle for his head and a room temperature water bottle. - The patient stated he did not want to pay for an ambulance which I relayed to her . - The EMT did arrive anyway and checked on the patient. - The patient and his friend left the store together, without EMT support or transfer. - The EMT team did not communicate with me prior to leaving the store.

BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT ARM; This spontaneous report received from a patient concerned a 26 year old. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Night of I got the regular fever and chills. I then went to sleep and woke up with a throbbing migraine and my legs were so sore I wanted to cut them off. I could barely walk they were so tight. I have now been getting bruising on my legs. I don't know if it is due to the shot though. I shaved my legs and I usually get some bruising after that. My arms have been slightly tense and sore as well. I have reasons outside of the shot to believe that it may not be the vaccine, but I thought I should report it.

Was lightheaded, hot and sweaty, tingly and numb left and right arms. Had him sit down and gave him some cold water. Called 911. They came and evaluated him. Said he was okay to go.

The patient was given the Janssen vaccine around 12pm. After about 15 minutes he left the pharmacy area to find his siblings in the store. He returned and stated that he felt dizzy and fell. He cut his elbow from the fall. He stated that dizziness is all that he experienced. I advise him to sit in the waiting area for about 30 minutes so that we could continue to monitor him.

7/9/21 only - Sharp excruciating neck and back muscle pain requiring pain medication (one dose of Aleve) Onset within 48 hours (beginning 7/10/21): Hives Itching Diarrhea Respiratory/chest pain Difficulty breathing/chest tightness Dizziness/lightheadedness Anxiety attacks High blood pressure As of 7/17/21 I presented to the emergency room 3 times with acute anxiety from difficulty breathing. Per doctors recommendation, began taking maximum dose of over-the-counter Benadryl, symptoms did not subside. On my 3rd trip to the Emergency Room I was prescribed Prednisone (40mg daily) and continue taking 75-100mg Benadryl daily when symptoms worsen to manage the discomfort and sleep.

This is to the best of my ability. I took notes, but they started after my symptoms were bad. This starts at about 12:40pm. It should also be noted that I have been feeling symptoms of either mono or IBD for over a year now (I got diagnosed around the same time and it's difficult to discern what is causing my feelings of general fatigue and headaches, however I haven't experienced muscle fatigue, per se). 0-3 hours: mildly sore arm at injection site only (happened immediately) 3-5 hours: headache, slight nausea, slight muscle fatigue 5+ hours: strong headache, severe muscle fatigue, nausea, chills, fever of 102.6 Started taking notes at the time they occurred, I will note when symptoms went away. 4:38am- 102.0 fever, chills stop (However, I was buried under blankets) 9:00am- 101.6 fever, loss of appetite... muscle fatigue and headache improve but are still present 7:56pm- 100.4 fever, other symptoms remain Next day (in general) Muscle fatigue is virtually gone, fever is gone, headache is present, slight nausea (when eating anything other than small amounts of white rice) and loss of appetite still remain

Pt received the Janssen Covid-19 vaccine. Pt started to feel numbness and tingling in his left hand (vaccinated arm) 15 minutes following the immunization. Pt stated that he felt fine other than his left hand experiencing numbness and tingling, specifically in his fingertips. Pt had no other adverse symptoms. I asked the pt to remain seated for an additional 15 minutes. He stated that he was ok but I convinced him to remain in his seat so we could continue to evaluate him. After a total of 45 minutes of evaluation, pt stated that the feeling of numbness and tingling was gone. Once again, I verified with the pt that he was feeling ok, with no additional adverse feeling or symptoms. Pt stated that he felt fine now and only felt a little soreness at the injection site.

After patient received the vaccine he stated he felt dizzy. pharmacist that administered the dose watched him and asked if he felt like he needed to lay down. said he did not feel like he needed to lay down but then stated he was starting to have a headache and left arm was feeling numb (this was the arm dose administered in). kept monitoring him and after about 20 minutes stated he was beginning to feel itchy. asked him if he was having shortness of breathe to which he responded no. After a few more minutes he was still itchy and gave him 50mg of liquid benadryl. This was at 531pm. He stated his symptoms were about the same and checked his bp 163-99 hr 88. continued to monitor him til about 600pm. By this time patient was able to walk around, no longer lighted headed, and numbness had resided.

Immediately following injection the patient stated he was going to pass out. He lost consciousness for approximately 30 seconds. He was confused and disoriented for a few minutes. Radial pulse was present and regular at 66, O2 sat was 96% on room air, BP was 118/77. Skin was warm and diaphoretic. He was monitored for 30 minutes in Observation area. He refused offer of EMS transport, When he left the clinic he was alert and oriented with no complaints.

FEELING WORSE; FEVER; FATIGUE; PAIN AT INJECTION SITE; SHIVERING; SORE ALL OVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 72 kilograms, and height was 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: Unk) dose was not reported, administered on 31-MAR-2021 at 13:30 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore all over. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced pain at injection site. On 01-APR-2021 07:00, the subject experienced feeling worse. On 01-APR-2021 07:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling worse, and the outcome of fever, shivering, fatigue, pain at injection site and sore all over was not reported. This report was non-serious.

High fever (over 101 degrees F) with Advil starting at 11:30pm on 4/9/21 (less than 12 hours after injection), which subsided by the following morning. Hives and itchiness all around front and back torso, shoulders, and neck starting at 10:45am on Sunday 4/11/21 (47 hours after injection), which began clearing up the following morning after taking Allerclear on 4/11/21 at 11pm. Itchiness has remained, but hives are no longer present.

Around 6 pm the same day I received the J&J shot I started to feel chilly and a little nausea. I went for a walk for about 40 mins started to feel worse. I had body aches throughout my back and chest and in both arms, was freezing. Tried to eat dinner but couldn?t, too much pain and increased nausea. Tried to lay down, but began having a fast heartbeat and fast/some difficulty breathing. The pain in my chest was the worst pain I?ve ever felt. Continued feeling horrible with a fever of 100.7, nausea, headache pains throughout chest back and arms, freezing, and my arms and legs felt like they were becoming numb. Could not stand, very dizzy, tried to sleep through it. I threw up around 11 and did so a couple more times after that. Was finally able to sleep and woke up feeling much better. Arm is still sore at the injection point.

Sore arm around injection site that has spread into the shoulder. Started shortly after receiving vaccine and is still persistent Itchy around injection site, started 1 day after and is still persistent General Fatigue lasted for the day of and the next day. Nausea and sweating started 10 minutes after injection that lasted about 2 minutes.

48 hours after the vaccine was given, both hands developed red welts that lasted about 4 days, then hands have been peeling since. As of a week ago, I noticed that both feet began to peel as well as the continuation of hands peeling.

BODY ACHES; CHILLS; FATIGUE; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 27 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from injection site pain, chills, and body aches, and the outcome of nausea was not reported. This report was non-serious.

NOT FEELING TOO AWARE; DIZZY; TINGLING AT INJECTION SITE; WEAKNESS ALL OVER BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included traumatic brain injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 29-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced not feeling too aware. On 29-MAR-2021, the subject experienced dizzy. On 29-MAR-2021, the subject experienced tingling at injection site. On 29-MAR-2021, the subject experienced weakness all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling at injection site, and weakness all over body on 2021, and had not recovered from not feeling too aware, and dizzy. This report was non-serious.

Patient began experiencing acute hives across their entire body beginning 5 to 6 days after receiving the J&J janssen covid-19 vaccine. Hives will appear on bith arms & hands, both arms & feet, torso, and face. the Patient has been treating with topical over the counter cortizone cream, and taking recommended (2 tablets every 6 hours as needed) doses of over the counter allergy medicine. (Benadryl Allergy, Dipenhydramine HCI 25mg)

ACUTE HIVES FROM HEAD TO TOE OF BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included permanent lung damage, and allergies to insect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced acute hives from head to toe of body. Treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute hives from head to toe of body. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: this patient has had similar events with all vaccines administered in the past. he has even had a similar event at work recently due to a cut on his hand.

Apr 8th: 10:30AM - Vaccination -Mild Fatigue, Body Aches Apr 9th: Vaccine Symptoms -Fatigue, Body Ache, Mild Fever Apr 10th-12th: No Issues Apr 13: Urticaria all over body, started from morning Apr 14-15th: Full Body Urticaria, Acidity, Uncomfortable feeling, Feels like lump in throat Prednisone Medrol Dosepak 5mg/Triamcinolone Acetonide No symptoms during prednisone dosage, itchiness started to appear at 10mg/5mg dosage Apr 20th-23rd: Symptoms Recurred, now including small swelling in fingers and toes Apr 24th-29th: 2nd medrol dosepak prednisone, all symptoms subside. Itchniness appeared in 10mg/5mg dose Apr 30th: Hives Returned, Acidity, Lump in Throat

Hives or Redness on upper center of chest and red flushed looking cheeks. Claims throat may have been slightly scratchy. Administered Diphenhydramine 50mg and observed for an additional 30 minutes. This resolved after the diphenhydramine dose and they were able to leave and return home.

Woke up the morning after my second vaccine dose with small red dots all over my upper back and chest, with a few also on my face.

The evening of the shot, I felt a wave of chills through my body. I felt a sore throat begin. I felt light headed and nausea. By the time I went to bed, my body was extremely sensitive. Entering my bed was painful due to the cold sheets, the cold was contrasted by the occasional heat flash. The night was full of body aches, hot and cold flashes, and loads of sweating. I woke up with a headache and body soreness. That was the worst of it. Spent the remainder of the day resting in bed. Notes: I rarely get sick, maybe like this once every few years. I probably could have drank more water to flush out my system following the shot.

Janssen COVID-19 Vaccine EUA: patient presents to clinic with shoulder pain that started when vaccine administered. Patient reports the immunization hurt a lot more than it usually does when patient receives a vaccine. The following day arm and shoulder continued to hurt. After a few days the muscle became less painful but the pain in the shoulder continued and was deeper as if it was in the shoulder joint itself. Over five weeks later the pain is still sharp within the shoulder with reaching up or across. Patient reports no pain without movement. No numbness, tingling, redness, swelling, bruising, fever, chills, recent injury, or weakness documented. Ibuprofen was not helpful. Patient administered steroid injection during visit and follow-up with physical therapy arranged. Patient reports mild pain relief after injection.

HEADACHE; TIREDNESS; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, tiredness, and injection site pain. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, tiredness and injection site pain was not reported. This report was non-serious.

Diffuse urticarial rash involving right axilla and over bilateral shoulders, developed intense chest pressure and squeezing, heart racing and when those symptoms resolved pt. became very weak. Of note pt. stated was lightheaded for 15 mins after receiving the vaccine

27 year old male with nka no known PMHx vaccinated with Janson vaccine on left deltoid @5:50 while on the waiting area @5:53pm patient was seating on the chair and suddenly fell dizzy patient fell on the floor hitting his face as a result of the impact patient broke his nose, with area of echimosis extending around the right orbit. 2-3 seconds after patient recovered consciousness and revised with no intervention needed... All vitals were stable.... Ambulance was offered for the patient and he refused stating this is regular for him every time he is "stick with a needle". Patient went home asymptomatic apart from tenderness and pain in the area. Next day Follow up calls were intended, but phone was never picked.

Within 24H had rash breakout on back, occasional nausea, fatigue, headache. Most resolved by 48 hours, but then had very swollen lymph nodes and sore joints. By 72 hours only fatigue remained.

6/25/21 Received vaccine. 6/26/21 Started feeling sick, unwell. Patient stated he almost fell over. EMT's at game stated it was because his immune system was working in overdrive trying to create immunity to pneumovax and Covid. On 6/27/21 in am, Patient went to hospital because his shoulder hurt. He was given some medication cocktail by hospital and went home same day. On 6/27/21 in pm the redness in his arm started and got worse and he started sweating really bad. On 6/28/21 He started feeling better, but went to the clinic due to the rash. They gave him cephalexin 500 mg 1tid, but he only took it once or twice a day and didn't finish the course. MD drew a line around rash and told him if rash expands beyond line, to come back in due to possible blood clot. On 6/29/21 patient stated he felt better. 7/9/21 Patient states he has recovered.

A few of days after the shot I had gotten a rash on my back. After about a month and a half went to doctors and was put on prednisone. The medicine had almost gone away and now is back stronger. My back was very sore almost 3 months later with rash worse. Just took my last dosage and the rash is very sore and very red. I also have felt tired and ache.

Muscle aches in armpits began a few hours after receiving the dose. Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time. I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and symptoms were severe enough we considered going to the emergency room. I experienced ringing in my ears and a severe headache. I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep. Fever dropped to around 102 but continued throughout the night. I woke up at 6:30 am and took two more Tylenol. The severe headache continued and I vomited twice. I attempted to take a shower and rinse off, and continue to rest. Fever is reduced to 99 degrees F with help of Tylenol.

Received vaccine at 0900. At 2100, chills, body aches. At 2300, itching left elbow that progressed. Seen at 0600 next day and diagnosed with hives. No anaphylaxis. However, as precaution he was given epi, solumedrol iv, and Benadryl po. Patient discharged to room. He is in setting overseas.

--- 3/20/2021 10:39 AM --- Member received COVID-19 Vaccination, while completing 15min wait post vaccination wait period member lost consciousness, fell to ground on Left side, denies head pain, no edema/brusing noted, not tender to palpation on exam, VS Stable, assisted to exam room and supine position with LE Elevated, Abrasion on L hand, member declined dressing. Completed 20 min wait in exam room, assisted to sitting and standing position with no lightheadedness or dizziness noted, able to ambulate 50 plus feet independently. Member home in Private vehicle.

Headache, diarrhea, tingling in legs, tingling in arm of shot, Arm site where injection was red, warm, raised and got larger since vaccine. Arm pain and redness, warmth, raised continued still. All other symptoms gone

03/30/21 09:35 AM - Vaccine administrated 05:00 PM - Uncontrollable shaking/shivering and dizzy 06:00 PM - Uncontrollable shaking/shivering, very dizzy, fever of 101 07:00 PM - Uncontrollable shaking/shivering, less dizzy but still, fever 102.5 08:00 PM - Shaking stopped, dizziness stopped, chills started, fever 103.5, nausea, very sore muscles in legs and lower back 09:00 PM - Chills, fever 103.9, worse nausea and vomited once, very sore muscles in legs and lower back, headache begins 03/31/21 08:00 AM - Chills gone, fever 101, nausea worse, headache much worse, sore muscles in legs and lower back 10:00 AM - Fever 101, nausea and vomiting, headache very bad, sore muscles in legs and lower back 10:30 AM - Took Imitrex (sumatriptan succinate) for the headache and fell asleep 2:00 PM - Fever gone, nausea and vomiting better, headache better, back and legs muscles feel better, arm soreness starts 04/01/21 - Light headache persists and arm soreness. All other side effects subsided.

Patient had Covid 19 vaccine in his right arm 2 days ago, and today he had a red rash on his upper left arm, which he stated was slightly itchy.

Starting around 8 hours after shot: flu-like symptoms - extreme chills, headache, 100F fever, significant body aches, loss of appetite, mild diarrhea, mild nausea; moderate injection site pain Most symptoms were resolved within 48 hours of shot, with some lingering injection site pain and mild upset stomach

Patient received Janssen Covid-19 vaccination today at approximately 6:20pm. At 6:35, he said he had left arm weakness (arm he received vaccine in), fatigue, was dizzy, and felt "off". Patient did not lose consciousness and refused an ice pack. BP checked at 6:38pm (170/98, pulse 105). Patient stated his blood pressure usually runs high. I offered him an ice pack a second time, but he said there was no need and he felt better. BP checked again 6:52pm (152/101, pulse 99). I recommended that since his blood pressure is usually this high, he should follow up with his primary doctor regarding blood pressure as he may need some medication to assist in lowering it. He said ok. He left the pharmacy area at 7:02pm and said he was fine to leave, he did not want to remain any longer.

Severe chills which result in violent shivering, On-and-off fever, severe joint and muscle pain, headache, hives on left side of face, tenderness at injection site, sleeplessness (though that could also be a result of not being able to sleep due to the symptoms I'm experiencing)

- Fever for approximately 6 hours - Chills, headache, fatigue, nausea, loss of appetite, muscle aches for 24 hours - Soreness at site of injection for 72 hours

LEFT SIDE FACE PAIN; BLISTERS ON THE FACE; FEVER; This spontaneous report received from a consumer concerned a 28-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. 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 03-APR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included benzylpenicillin. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38 C. On 05-APR-2021, the subject experienced left side face pain. On 05-APR-2021, the subject experienced blisters on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and had not recovered from left side face pain, and blisters on the face. This report was non-serious.

Slight rash at injection site noticed later on in the same day as injection. The rash grew and was tender when noticed on Satuday 4/10 more then 48 hours after injection. Arm is still sore as of 4/13.Headache began on Monday 4/13 and is persistent throughout day.

Jansen COVID-19 Vaccine EUA On 04/12/2021 at 11:30pm (5 days after I was originally vaccinated), I started to itch inside of the crooks of both of my arms were starting to itch. After a few minutes of not scratching the crooks of my arms, I had noticed that both crooks of my arms were still red. I then took off my shirt and realized that I had an extensive rash with hives all over my trunk. I also had a sudden onset of nasal congestion and sneezing during this same time period. I took Benadryl and Pepsid on that same night and then saw my primary care doctor the following morning. My primary care doctor diagnosed my rash/hives as a probable result. I was instructed to continue with the Benadryl and Pepsid and watch for any changes.

blood transport vessel in left thigh throbbing for a few hours upon waking in the morning, very sore legs. The rest of the symptoms are considered normal for the covid 19 vaccine and they included fever, headache, fatigue, bodily aches, occasional recurring chills and injection site soreness.

INJECTION SITE REDNESS; This spontaneous report received from a consumer concerned a 28 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-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 redness. This report was non-serious.

Fever, chills, fatigue, muscle aches, headache, a little sore at injection point on arm. No medication taken. Took approximately 36 hours for adverse effects to subside.

Patient experienced vasovagal syncope approximately 5 minutes following vaccination. Patient regained consciousness but was standing at time of incident and has a cut above eye after falling. He was taken by EMS to attend to the cut.

FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit 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.

28 y/o male experienced a syncopal episode approximately 10 min following janssen vaccine left deltoid. He suffered an abrasion to outer left pattela. He struck to left side of his head on the floor. No signs of abrasion or swelling that area. approximately 3 minutes after syncope, he vomited. x3 h= His pupils

Pt reported "pins and needles" in chest and veins, itching, nausea, and feeling hot. Administered 20 mL of 12.5mg diphenhydramine 15-20 minutes post-admin. Pt reported he continued to feel worse, then vomited 5-10 minutes after administration of diphenhydramine. Checked BP after pt vomited, 160/100. He reports that his BP is usually not high. Advised for HR representative to call EMS. Update from HR representative states that pt reported swelling of throat upon arrival to hospital, but appears to be "settling down".

One week after receiving the vaccine I woke up on 5/21 with a mild rash. As the day went on the rash progressed and swelling of lips and uvula occurred around 5pm. I was taken to an urgent care who transferred me to a hospital via rescue. I spent the night at the hospital receiving multiple epi pen injections, and fluids. I was discharged 5/22 with a dose of prednisone. I was fatigued all day. On 5/23 I woke up to swollen eyes and lips and covered in hives again. I went to the ER where I was given steroids and fluids again. The hives went down but did not go away. One 5/24 I took multiple doses of Benadryl and dose of prednisone and in the evening time the hives progressed. Today 5/25 I woke up with swollen lips and checks and hives. I went to my doctors office to be evaluated.

ANKLES SWELLING; ANKLES REDNESS; IN PAIN AND HURTS TO WALK; This spontaneous report received from a consumer concerned a 28 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 expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced in pain and hurts to walk. On 05-JUN-2021, the subject experienced ankles swelling. On 05-JUN-2021, the subject experienced ankles redness. 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 ankles swelling, and ankles redness, and the outcome of in pain and hurts to walk was not reported. This report was non-serious.

Approximately 3 minutes following administration of vaccine, the skin on the patients face, arms, and legs turned red and the patient began to sweat profusely. The patient reported that he was feeling dizzy and had blurred vision. The patient did not report any shortness of breath or swelling of the face, throat, or lips. Physical assessment confirmed patients report of no swelling of the face, throat, or lips. The patient was treated with an ice pack to the back of the neck and was advised to place his head between his legs. The pharmacy student remained with the patient for 30 minutes after the reaction occurred. During the 30 minutes, the patient reported that his dizziness and blurred vision were improving and he was no longer sweating. Physical assessment of the injection site found that there was no redness, swelling, or rash developing. After 30 minutes had elapsed since the reaction, the patient reported that he was no longer dizzy, experiencing blurred vision, or sweating. Assessment of the injection site at this point was the same as above with no redness, swelling, or rash occurring. At this point, the patient was cleared to leave the pharmacy and was advised to go home and rest for the night and not perform any strenuous activity.

Client reports immediately after getting does that his left arm from the injection site down feels "heavy". At 4:04PM Vitals are taken by PHNs pulse 77, blood pressure: 130/80 and oxygen: 97%, . Client reports sensory and motor are intact. No other symptoms reported. At 4:06pm client reports arm is feeling better. At 4:09PM oxygen is 98%, pulse: 72 and blood pressure 122/86 and still feeling heaviness in arm. At 4:14pm, client reports that arm sensation of "heaviness" has resolved. Oxygen: 99%, pulse:76 and blood pressure: 122/82. At 4:19pm vitals oxygen:98%, pulse:77 and blood pressure 110/88 no symptoms at this time. At 4:24pm no symptoms reported and vitals: oxygen:98%, pulse:76 and blood pressure:120/82. At 4:30pm PHN gave ER precautions. oxygen 98%, pulse: 79 and blood pressure: 128/90. Client reports he has no primary care provider and will be returning to his country tonight. No symptoms reported. At 4:33pm last set of vitals: blood pressure:120/86, pulse:79 and oxygen 99%. Client left the facility unassisted at 4:35pm.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel. Pt got up immediately and sat back on the chair. Pt was pale but allert and responsive. After drinking some water and extended observation time, pt was able to walk away. EMT was called but pt refused service.

pt broke out in hives the next day and still today is still having hives. He believes it is due to vaccine

Shivering even when it was really warm Sensitive skin to touch Sweating profusely I went from freezing to overheating out of nowhere Puking Dizziness Pounding headache in back of head for about 10 hours Body aches muscular Felt like my hip bones up my spine and neck were hurting I finally was able to take exedrin and after an hour I was able to relax a little. Enough to fall asleep for a couple hours. 2 hours after I got the shot I started feeling effects. I didn?t sleep until 0400 in the morning because I was in so much pain. Today I have a headache and my body is sore but I feel a lot better. If I didn?t live so far away from my friends or coworkers I would have gone to the hospital. I was too weak and sick to use my phone.

DIARRHEA; FOGGY FEELING; BEING UNABLE TO FOCUS; COLD AND HOT SWEATS; FINGER NUMBNESS WHICH COMES AND GOES; FEELING DEHYDRATED; BODY WEAK/CAN ONLY LAY IN BED; HEADACHE; SORE IN RIGHT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 15-JUN-2021, the subject experienced diarrhea. On 15-JUN-2021, the subject experienced foggy feeling. On 15-JUN-2021, the subject experienced being unable to focus. On 15-JUN-2021, the subject experienced cold and hot sweats. On 15-JUN-2021, the subject experienced finger numbness which comes and goes. On 15-JUN-2021, the subject experienced feeling dehydrated. On 15-JUN-2021, the subject experienced body weak/can only lay in bed. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced sore in right arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weak/can only lay in bed, headache, diarrhea, foggy feeling, cold and hot sweats, sore in right arm at injection site, finger numbness which comes and goes, feeling dehydrated, and being unable to focus. This report was non-serious.

Janssen COVID-19 Vaccine EUA Bruising and soreness around injection site, low-grade fever (~100.25 degrees Fahrenheit), muscle aches mostly along posterior chain from shoulders/neck to legs, sleeplessness, mild headache behind eyes. Symptoms first appeared approximately 12 hours after injection. Patient self-treated with 400 mg of Ibuprofen at approximately 9:00 AM on 7/8/21, roughly 19 hours after injection. Symptoms were minimized.

- Extreme body aches on lower back and thighs/glutes. Could not walk and legs started to cramp for 2 days. - Face and skin began to turn yellowish in hue (Jaundice) -Extreme dizziness and feeling of euphoria where I could not stand -High Fever over 102.5 degrees.

1616- Patient received injection and immediately fell forward from chair and struck plastic chair with right forehead while falling to floor. Staff called for help. 1617- Patient lying on side, not responding to voice or tactile stimulation for 30-60 seconds. Patient spontaneously opened eyes, sat up, and asked 'where...what'. Pulse ox placed on patient HR 50, O2 sat 99% on RA. Code team arrived. BP 86/45 HR 50. Patient pale, diaphoretic. MD advised lowering head between knees. COld pack placed on back of neck. Pt offered juice, patient drinking juice. Patient with small closed laceration above right eyebrow. 1620 HR decreased to 48. This NP advised patient to lay down, feet elevated. Band-aid placed on laceration. MAE, Ice pack placed on forehead. Patient reports mild pain on forehead that increases when pressure placed on forehead. 1622- A&O x4, pale. BP 109/67 HR 58, O2 sat 100%. Patient consented to notifying spouse of his condition. Staff member sent outside to notify spouse. 1627- A&Ox 4, skin pink, BP 114/75, HR 54, 02 sat 98%.. Patient offered more juice. Denies dizziness, reports mild HA. Dsg to forehead clean, dry and intact. Spouse and children at patients side. Patient interacting. Spouse reports patient "didn't eat much and was very nervous". 1632- A&Ox4, skin pink, dry. BP 119/79, HR 55, O2 sat 100%.. Discussed plan with patient to gradually have patient sit up and that we advise following up at urgent care today. Worked with staff to find urgent care. Spouse states she will drive patient. 1634- A&Ox4, skin pink, warm, and dry. Patient sitting up. BP 120/76, HR 61, O2 sat 98%. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. 1640- A&Ox4 skin pink, warm, and dry. Patient sitting up. BP 108/73, HR 65, O2 sat 98%. 1646 HR 62. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. Patient wanting to stand up. Patient assisted to feet, denies dizziness, gait steady. Standing BP 123/70, HR 54, O2 sat 99%. 1650- transported via wc to private vehicle. Patient ambulated and seated in car without c/o. Address for Urgent Care provided to patient's spouse. Patient and spouse state understanding of recommendation for further follow up at urgent care.

Site: Pain at Injection Site-Mild, Additional Details: Pt received vaccine at 4:02 pm, started to feel faint at 405 pm( became pale and diaphoretic per). Called for NP help from in next room. Provided pt with ice packs. BP 100/62. Provided coca cola after patient stated he had not eaten since morning. Patient started to get color in face. BP re-check at 4:22 pm was 110/80. Pt was able to ambulate to waiting room at 4:35 pm. Pt & mom left waiting room feeling better at 5 :05pm

ITCHINESS WITH BURNING SENSATION; WORSE RASH ON ARMS, LEGS, CHEST, NECK, BACK AND ALL OVER BODY; FEVER; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced fever. On 10-JUL-2021, the subject experienced worse rash on arms, legs, chest, neck, back and all over body. Treatment medications included: paracetamol. On 12-JUL-2021, the subject experienced itchiness with burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-JUL-2021, and had not recovered from worse rash on arms, legs, chest, neck, back and all over body, and itchiness with burning sensation. This report was non-serious.

Pretty quickly after the shot (that evening) I felt a tingling/prickling in my finger tips and I swore down in my toes. I developed a few sickness symptoms the next day but definitely felt much better about 48 hours later. What I really want to say now is that I still feel like I notice very minor tingling in my fingers (mainly left arm) but sometimes down in legs or right forearm. Additionally, my upper left arm where the injection was sometimes feels stiff or strange. It isn't pain, but its more like a nuisance.

Patient began to feel cold and clammy, and lose color in his skin. He temporarily lost consciousness for about 2 minutes. I monitored his pulse and respiration and he began to feel better after about 5 minutes. He remained seated for 10 more minutes and left under his own power.

At 9pm (3-13) I began feeling sore and cold with some shivering. Couldn't get warm in bed, continued to shake harder. Slept until 11:15pm and woke up to violent shivering, pounding headache, full body aches, sore skin, achey joints, nausea, swelling tongue and throat. Took 1 dose of nyquil and then tossed and turned all night, very little sleep, symptoms persisted into the next day, but shivering stopped in the night. By morning (3-14) registered a fever of 100.3 which persisted most of the day along with remaining lessening symptoms. By evening I was still very sore, bad headache, and very lethargic/fatigued. Next morning (3-15) low temp of 97.1 degrees, headache, fatigue, lightheaded. Still feel headachy and tired.

Moderate Pain at injection site, severe headache, chills, all over body aches, low grade fever, nausea, vomiting

Monitored for 30 minutes after injection, no symptoms, released back to housing (cell). Approximately one hour later, presented to Health Care Unit with c/o itching, nasal congestion, watery eyes, lightheadedness, nausea, "hard time breathing". Very anxious. Administered 50 mg Benadryl IM without any relief. Patient was sent to local emergency department as precaution. Given epi SQ and additional Benadryl in the emergency department

muscle aches at injection site muscle aches upper back/shoulders About 18 hours after injection 101 degree fever for approximately 4 hours General weakness/lack of energy but not extensive enough to actually hinder basic activities

Injection: local sore left arm Injection + 1 hr : arm sore subsided Injection + 9 hr : body temperature rose to 99.8, light level of chill Injection + 10 hr: temperature rose to 100.4, light level of chill and fatigue over torso Injection + 21 hr: temperature came down to 99.5, light fatigue persisted, light level of right knee joint pain emerged Injection + 24 hr: temperature dropped to 99.1, fatigue and joint pain subsided Injection + 27 hr: temperature dropped to 98.8, no discomfort Blood pressure and pulse normal throughout

I received the Janssen COVID-19 Vaccine EUA at roughly 2:15pm on Sunday 4/11/21. I waited at the vaccination site for 30 minutes and did not have any adverse effects. I went through the rest of my day without any adverse effects. I went to bed at 9:00pm. I woke up at 11:00pm with body aches and chills. I could not stop shivering. I then became very warm. I alternated between freezing/shivering and burning up all night. I felt very sore and my muscles hurt. It was primarily my upper body that hurt, not my lower body. My arms, torso, back, and neck hurt to move. I was very sensitive to everything I touched. It felt uncomfortable to touch the blankets in my bed or the water when I washed my hands. It did not hurt to do that, it just felt sensitive and uncomfortable. Around 5:00am I got a terrible headache. It felt like my head was made out of a lead ball. It hurt to move lift my head. My face hurt and felt like I had pressure. This lasted all day for Monday 4/12/21. After 5:00pm I slowly started to feel better. My body aches went away. I still had a headache, but it was far less severe. It is approximately 7:00am on 4/13/21 as I am filling this out. I still have a minor but persisting headache. My left arm is sore at the injection site. I am feeling much better than I was.

All times in format HH:MM:SS after injection T+00:05:00: Heaviness, weakness in left arm. Gradually cessated over four hours. T+08:00:00: Interrupted sleep; insomnia lasting four hours; visual disturbances (flashing lights, geometric patterns). Ceased within 2 hours. T+18:00:00: Fever of ~1.5 degree F above normal; injection site reaction (soreness); weakness; fatigue; chills; all symptoms ?flu-like?. Slowly resolved over next 18 hours.

Presented with 28 YO male, seated in a chair S/P receiving the Johnson and Johnson COVID-19 vaccine. PT states he was feeling dizzy with shortness of breath. PT was given a bottle of water by RN for hydration. PT skin color starting to change from normal to a pale and PT started to become diaphoretic. Ambulance notified for transport to the closest facility. PT pulse 70 and strong and regular, BP 100/60 and respirations 20 strong and regular. PT denies any medical history or allergies at this time. No other interventions performed with PT due to ambulance arrival and PT care relinquished to EMS with full report, PT care relinquished without incident or injury.

12 hours after receiving JNJ vaccine, experienced fever, chills, headache, sore throat, body aches (these symptoms resolved after 24 hours). 24 hours after, experienced hives on both arms, upper back and hips. Hives eventually were limited to only arms after 3 days. 7 days after experiencing on and off hives, I took an antihistamine until hives disappeared for longer than 24 hours. Hives were not itchy, but large and warm to the touch. No single hive lasted for more than 24 hours. They disappear and reappear randomly on my arms. Specially over veins. It has been over a month since my vaccine and I?m still experiencing these hives that appear and disappear at random. I?ve documented each hive outbreak with photos and currently undergoing blood tests trying to learn more about this issue.

12 hours after vaccine injection, experienced a 103.2 degree fever, sweating (lost 3 lbs in one day) and extreme body aches (unable to sleep due to pain) 24 - 36 hrs after vaccine injection experienced extreme chills & body aches. 96 hrs after vaccine injection, still had a 100.6 degree fever and migraine like headache and developed a rash all over my body that lasted for 48 hours and was only subdued by taking Benedryl.

Headache: 4.5 days - current Nasal Congestion: 4.5 days - current Fatigue: 4 days Sensitive Skin: 2 days Nausea: 8 hours Muscle soreness: 1 day

I had 0 adverse symptoms for the week following my vaccination. On the evening of the 7th day, I developed a rash around my ankles and on my arm around the injection site. That has spread into a full-body rash which is extremely itchy. Antihistamines have helped (Benedryl) but only provide temporary relief. Significant discomfort.

Janssen COVID-19 Vaccine EUA Body rash covering torso and leg appeared morning of 4/12, subsided roughly 12-14 hours later. Also had mild fever first night (4/11) after injection; persisted 4/12 and had completely subsided by morning of 4/13.

I started feeling fatigue and soreness in both of my legs and arms about a 5 after the vaccine. At day 7 I started to feel sharp, cramps, tingly sensation and numbness in different parts of my legs, arms feet and hands. I also had headaches and felt dizzy. Headaches went away by day 15, but the pain, tingly sensation and fatigue in my arms and legs still remain (tomorrow it?s going to be a month since I got my shot). It gets significantly worse when I walk and I feel very fatigued after walking for about 30 minutes. The pin has also appeared less frequently on other parts of my body, like my heart, my neck and around my rib area. Over the last two weeks my legs have also been getting itchy.

Non-traumatic bruising. Petechiae in random areas of body. Denies history of bleeding disorders in self or family. PLT <3.

March 11: fever, headache, pain fatigue, arms turned bright red for about 10 minutes March 12:fever, headache, fatigue, nausea March 13:fever, pain, fatigue March 14:fever, pain, chills, fatigue, nausea, vomiting March 15: fever, chills, headache, tinnitus March 16: fever March 17: March 18: fever March 19: fever March 24: fever March 25: fever Last week or so: chest pains, really high heart rate

Onset of Shingles starting on 6/18, diagnosed by a dermatologist on 6/21. Have never had prior skin rashes or other skin issues other than Vitiligo which I have had since teen years but has not spread since 17-18 years of age. Started as an itch on right chest/armpit area and quickly reddened/blistered. Now taking anti-virals to prevent spread and steroid cream for itching/pain. Has not spread since starting the anti-viral and it is contained to the chest, armpit, and slightly on back.

PAINFUL RED BUMPS ON LEGS AND ARMS STARTED OFF SMALL AND THEN GETTING LARGER AS NICKEL TO QUARTER SIZED; INJECTION SITE REDNESS; FEVER; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included not taking any medications no medical diagnosis, and other pre-existing medical conditions included the patient was not taking any concomitant medications at the time of this report. The patient had no medical diagnosis. 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced injection site itchiness. On 09-JUL-2021, the subject experienced injection site redness. On 09-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 19-JUL-2021, the subject experienced painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itchiness, injection site redness on 16-JUL-2021, and fever on 11-JUL-2021, and had not recovered from painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. This report was non-serious.

Injection Site soreness, chills and fever about 12 hours after receiving Vaccine, slight headache the following morning .

I had a feverish episodes, low grade fever of 100.1 degrees Fahrenheit at the highest with some body aches, headache and mild soreness at the injection site. This took place about 5-10 hours after injection and last for about 24 hours.

Fever to 101F for about 15 hours, site pain for about 24 hours, headache for about 15 hours, shortness of breath ongoing, took 400mg ibuprofen every four hours

After shot, pain/soreness at injection site lasting up to 1 week after shot. Same night around 11:00pm vaccine symptoms include: fever/chills, headache, diarrhea lasting up to 10hrs. Reduced with aspirin. 9-13 days later increase in nightly symptoms including: Headache, stomach pains (upper stomach) Rashes/hive like bumps itching on body spreading to different parts each night ( 3-17-21, rash/swelling on both feet including white bumps that mostly went away with Benadryl (Diphenhydramine) and aspirin), ( 3-18-21, Rash spread to throat and face over night, numbness in upper lip mostly went away with Benadryl (Diphenhydramine) and aspirin), (3-18-21 rash moved to lower back left side, itchiness and sore throat.

Mild Injection site pain, Moderate fatigue, light nausea, and moderate hot and cold flashes; onset about 5 hours after injection. The injection site pain and fatigue will hopefully be cured by getting a good sleep tonight; nausea was offset by Tums. The temperature flashes are still occurring 9 hours after injection and do not seem to be getting worse any more; hands and feet cannot warm up and neck and forehead are hot (no thermostat to look at temperature).

Pt began to feel lightheaded. Stood up to call nurse then lost consciousness, falling to the ground, scraping his face on the concrete. Pt had facial abrasions. Was transported to Urgent Care.

Initial soreness at injection site in right arm, which largely faded within four hours of vaccination; Ongoing as of this writing since 11:30 a.m. on 03/30/2021: mild stomach nausea (started at 11:30 a.m. and still going at 02:00 p.m.; vague chest pain (feels mild and seems like what I would expect from anxiety or drinking too much caffeine--of which I have not consumed), which started at about 01:15 p.m. and still going at 02:00 p.m.; a brief headache that lasted about 20 minutes from 01:00-01:20 p.m.; and a few times I had trouble mentally and visually focusing on my work (I do not mean my vision was blurry, just that I felt somewhat distracted). No treatment sought at this time.

Fever to 103, rigors, chills, diaphoresis, severe muscle aches and cramping throughout body for 36 hours beginning about 8 hours after vaccine administered. L arm pain and cramping at injection location for 6 days following vaccine administration.

Pt reported general weakness and headache at 1120. Vitals were 136/90 bp, 90 hr, and 97% O2 room air. Pt reported no itchiness or hives. Pt stated not eating much in the morning. Pt given water and orange juice . Pt advised to stay for further observation. Vitals reassessed at 1146. BP 142/96, 87 hr, and 97% O2 room air. Patient stated his headache was gone and he felt itchiness in left and right arms. At approx. 1150, patient given diphenhydramine oral solution 50 mg. Patient advised to stay for 30 minutes. Patient declined and stated he wanted to leave. Patient ordered a ride and left facility with steady gait and unlabored breathing at approx. 1200.

Severe body aches, chills, and lethargy for two days following injection. Soreness and bruising at injection site. Non-injected shoulder joint pain with rotational movement since 1 day after vaccine. Has not stopped.

Dizziness, nausea, abdominal pain, pain and swelling at site of injection, full body muscle aches, headaches, fever, chills, and brain fog.

Patient lost consciousness/blacked out and fell out of observation chair. Patient suffered a minor head injury including a laceration. 911 was called. Patient became alert and oriented as well as stopped the bleeding before paramedics arrived. After being assessed by the paramedics, he requested not to go to the hospital and to leave on his own. I requested the patient sit for another 15 minutes before leaving to which he obliged and thanked me before leaving.

Immediately after injection: pain and soreness around injection site. Starting about 3-4 hours later: impaired coordination. The next morning: severe dehydration, disorientation, loss of balance, very low energy, headache, body aches, inability to remain standing or sitting, difficulty walking, fever, feeling hot and cold, sweating and shivering intermittently and sometimes both at the same time, impaired mental focus, worsened pain and soreness around the injection site, nightmares. Slept the majority of the day, rising only to eat and drink lots of water. Symptoms abated throughout the day. By about 7pm, I was able to sit up enough to play some video games. The second morning: most symptoms gone or almost unnoticeable. Hot/cold flashes, impaired coordination and low energy continue, but improving. Attempted to go out for my usual 2-mile jog after work, but only made it about one block walking before becoming both too cold and too tired to continue. The third day, afternoon: completed my usual 2-mile route, at a walk, with frequent stops to rest. No noticeable symptoms from the 4th day after injection, onwards.

I received the vaccine on Wednesday, April 7th. I was told I had an anaphylactic reaction at the time of injection: I started sweating upon receiving the vaccine, my blood pressure dropped, and I almost passed out. I was monitored for 30 mins before being sent home. Other than some fatigue, I was fine the rest of the day. On Thursday, April 8th, I was tired but felt fine otherwise. Friday and Saturday, April 9th and 10th, I felt like I was back to normal and even did some light exercise. On Sunday morning, April 10th, the left side of my body (side of injection) went numb, I had extreme vertigo, shortness of breath, and blotches that appeared in random places. It didn't look like hives, but rather looked like strips of red. I didn't feel like I was having an allergic reaction, but something did not feel right. I consider myself a pretty healthy guy with a healthy lifestyle. I did not feel the need to go to the ER quite yet, but I did have a friend come over to monitor me. My friend did some acupuncture which helped resolve the numbness and dizziness and some of the blotches, and also mentioned concerns regarding blood circulation and potential clotting issues she thought I was having.

On day of: after 8 hours, intense chills of body. Muscle aches from shivering due to chills. Lasted about 4-6 hours, with no residual effects the next day. 7 days after administration: rashes all over body, including both arms, legs, and sides. Rashes were prominent and itchy during the morning, and slowly got better over the day. Daily Claritin was taken in morning.

So my right eye was swollen and had hives under my eyebrow and inside of my nose on both sides and on my mustache above my mouth. I had a headache. My throat was hurting.

Fatigue, slight fever, chills same day and next. Itchy arm starting around 5 days after with on and off pain.

around noon - legs went numb and weak - couldnt walk around 1 - took 2 tylonol and had sharp pains up and down the spine around 2 - face lips jaw were swollen around 4 - rashes on neck and back and welts on arms around 5 - went to emergency room around 6 - doc claims hes allergic to tylonol customer does not believe him and things dont make sense - pain in legs comes and goes

Developed itchy rash all over body 6 days after receiving covid-19 shot. Took Benadryl (25mg) every 4 hours. Rash is starting to diminish on day 3

Bruises on my right leg. Possible blood clot. Right leg has noticeable pain when bending and feels heavier/ different compared to my left leg.

developed shingles around 8/9 days after vaccination. shingles on right lower back. currently still have.

Seizure - I have never had a seizure before and there is no history of epilepsy in my family. I had the Janssen vaccine shot at around 5PM on Thursday and felt mostly fine on Friday. I had typical shot symptoms (tired and soreness near injection sight). On Friday night around 10:00, I was standing talking to one of my friends in the living room when I had a blackout seizure without any warning. The seizure only lasted about 30-45 seconds, and then I became conscious again. It took me about 5-10 minutes to become completely aware and able to stand up. I have never had a seizure before and have not had one since then. Later the following week, I did have a couple of hours where I felt extremely dizzy and lightheaded, but it went away without another seizure. This is also not typical for me.

Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body. Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots

Waves of exhaustion for 5-6 days and discomfort at injection site for 6 days following injection. When the exhaustion would hit, starting the day after injection, I was too weak to go up and down stairs. It seemed significant and was more than normal tiredness, and I ended up needing to take a half day at work four days after vaccination. On the sixth day after vaccination, I was feeling well again and discomfort at the injection site had subsided as well. It was the worst the day after getting vaccinated, which was to be expected. I did not expect it to last so long.

4/27 11pm started to feel cold chills and aches, Sore at injection site 4/28 2am fever started, aches increased, Sore at injection site 4/28 7am fever of 101.9, nausia, stomach aches, cold sweats, body aches, Sore at injection site 4/28 noon 98.9 temp, stomach aches and "queezy" feeling, Sore at injection site 4/48 9pm stomach ache, and queezy, Sore at injection site 4/29 stomach ache continues with queezy feeling. tmep is 98.8, Sore at injection site Question 20 is answered on this area I am currently writing it with the stomach ache and sore at injection site. (is marked no since my fever is gone)

red itchy spots spread all over body forming a rash. Has spread over the course of days once I start3ed seeing the spots. Very itchy!

Moderate Itchiness all over the body. The onset of the itchiness was within 1 hour of the vaccine. The itchiness has persisted every day since then. The itchiness is most itchy in the groin/scrotrum region and inner thighs. Other parts of the scrotum/groin are also itchy every day ever since getting the vaccine. The individual has no STDs and had only normal male itching prior to the vaccine. There is also itching on the arms, lower neck/sides of neck, thighs, and sides of the back, but not as intense itching as the areas described above. I had never experienced generalized itching on my body ever before getting the JNJ vaccine and am positive it is related.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe

Vaccine given on right arm. After 5 minutes the patient reported hive-like spots on left forearm/wrist/knuckles (diffuse and approximately 6-7 red spots). After another 5-10 minutes a few more spots appeared on the left arm as well. No itching or pain or tingling was related. No signs of anaphylaxis noted (no trouble swallowing/breathing, no laryngoedema, no dizziness or weakness, no cough, no tingling or redness on skin other than spots. Patient was lucid and calm. Patient was offered 50 mg diphenhydramine IM as per clinic protocol and refused. Patient was observed for a total of 40 minutes after injection and spots did not spread further, and no new spots formed. Patient was advised to go to the nearest pharmacy and get liquid diphenhydramine and take 50 mg immediately. No follow-up or final outcome available.

Syncope. Pt sustained abrasion to right forehead. BP 140/90 initially, 120/80 when released form recovery area.

I woke up in the middle of night to use the bathroom and I don't remember what I was feeling, but I kept telling my self to just finish peeing and I woke up on the ground, I was pretty out of it, it took a couple minutes to get out of it I had a couple of buries, I felt stages of light headed for a few days it felt like I was giving blood. The next day I felt off, I didn't think I was safe to drive, I did feel better but still off and on Tuesday I felt drained.

DIFFICULTY SWALLOWING; WAKE UP ALMOST EVERY HOUR; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; LETHARGY; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 170 pounds, and height was 175 centimeters. The patient's concurrent conditions included Tourette's syndrome, seasonal allergy, penicillin allergy, non alcoholic, and cigarette smoker, and other pre-existing medical conditions included no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: 01-FEB-2023) dose was not reported, frequency 1 total, administered on right deltoid 07-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for Tourette's syndrome. On 07-APR-2021, the patient experienced soreness on the injection site which lasted for 2 weeks. He also experienced lethargy. Then on the last week of APR-2021, he developed throat pain, cough and high grade fever. His chest was hurt really bad and he felt as if his lungs was on fire. He was also coughing really hard that woke him up every hour. The fever lasted of a day and the rest of symptoms lasted for 3 days. He did not performed COVID test because he just thought the symptoms were just allergic reaction. Then, on the 24-MAY-2021, he started to develop the same symptoms that he had before. It was started as a pain on the throat, he thought it was just an allergy because he had a seasonal allergy. He had a difficulty swallowing which developed into cough. His chest hurt so bad that he felt as if his chest and lungs were on fire. He described his coughing associated with burning sensation that caused him to wake up almost every hour. He also noted that after vaccinated he still followed social distancing and wearing mask protocol. His HCP did not prescribe any medication for COVID-19 infection, but he was taking Tylenol, increased his fluid intake and started using a nasal spray. On 28-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive., Fever (NR: not provided) 102 F and the patient had confirmed covid-19 infection, confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and soreness on the injection site on 21-APR-2021, had not recovered from difficulty swallowing, confirmed covid-19 infection, and wake up almost every hour, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210557859-Covid-19 vaccine ad26.cov2.s - CONFIRMED COVID-19 INFECTION and CONFIRMED CLINICAL VACCINATION FAILURE . 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: SPECIAL SITUATIONS

urticarial rash w/ dermatographia, chest pain, SOB. started about 8 days after shot improving on steroids ECG abnormal w/ neg troponins x2. CTA of chest neg for clot or pneumonia was recently started on Buspar and wellbutrin 4 days prior to getting vaccine

Patient reported in his consent form and verbally that he has a prior history of Vasovagal Syncope, but is manageable and definitely wanted to get his Covid 19 Vaccine at the pharmacy. Patient received his vaccine on his right arm, remained seated in his chair. A few seconds later, he decided to lie down on the floor, removed his mask and started taking deep breaths with his eyes closed. About 3 minutes later, his eyes got dilated, skin started flushing red, started with mild seizure like twitching and patient became unresponsive. So I quick put some ice cold water (from his water bottle) on his face, patted his cheek, put an ice pack on his face and neck and while I was asking his father (who was with him) to call 911, the patient regained consciousness and said he was okay. He continued to put the ice pack on his neck and forehead and in a few minutes the flushing stopped, in about 5 to 8 minutes, patient was able to sit up, lean back against the wall, take a few sips of water and the eat a granola bar. Patient then proceeded to wait in our waiting area for another 15 minutes and then decided to leave , since he was feeling much better.

DISCOMFORT; ACHY HERE AND THERE; FEVER; SWOLLEN ARM AT THE AREA OF VACCINATION; REDNESS AT THE SITE OF THE INJECTION; HEADACHE HERE AND THERE; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and covid-19, and concurrent conditions included immunocompromised, and low immunoglobulin g (igg). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for low igg. On FEB-2021, Laboratory data included COVID-19 virus test positive (NR: not provided) Positive. On 06-JUL-2021, the subject experienced discomfort. On 06-JUL-2021, the subject experienced achy here and there. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced swollen arm at the area of vaccination. On 06-JUL-2021, the subject experienced redness at the site of the injection. On 06-JUL-2021, the subject experienced headache here and there. On 14-JUL-2021, treatment medications included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen arm at the area of vaccination, discomfort, redness at the site of the injection, headache here and there, and achy here and there. This report was non-serious.

3/7/21 - The day of the vaccination, minimal adverse side effects encountered. Minor soreness at the injection site, as well as general tiredness. 3/8/21 - Day after vaccination - mild soreness in arm, shoulder. Tiredness. 3/9/21 - Day - moderate soreness and pain experienced in the injection arm, shoulder, and back. Body aches, chest aches. Occasional waves of discomfort, similar to nausea but without stomach discomfort. Overall tiredness. Occasional mild headaches. No noticeable fever. Total 1000mg paracetamol taken throughout the day. 3/9/21 - Night - unable to sleep soundly due to moderate pain and aches in upper body, lots of discomfort. 1 dose of Nyquil liquid taken to reduce pain and aid sleep. 3/10/21 - Most pain has gone away, just some mild soreness remains. Still some overall tiredness. 3/11/21 - Side effects appear to have subsided by this day.

Fever over 100F about 12 hours after injection, lasting about 12 hours, after subsiding, arms and neck broke out in a hives-like rash (but does not itch). I?ve taken some Excedrine, Ibuprofen, and Benadryl... I occasionally had idiopathic allergic reactions as child, and this seems moderate to me - my breathing is fine, my stomach doesn?t have the rash (my back does a little...) I?m not certain this is cause for concern, but if a handful of other people react similarly, that might be useful information. I don?t feel like I?ve had direct contact with anything that would cause this sort of reaction - & the few environmental allergies I have rarely react this strongly even when I am directly exposed...

Janssen COVID-19 Vacccine EUA was administered on March 19th, and I had head ache and fever that night, and was unable to sleep. By the end of the following day (March 20, 2021) my side effects were essentially gone. I felt normal until Wednesday (March 24, 2021) afternoon where the same symptoms returned but were more pronounced (i.e. worse headache). I am writing this Saturday March 27, 2021 and am still having headaches, sensitive skin, and a mild fever.

Fever, skin pain nausea. Very low blood pressure. The fever last for 6 hours and the episode of blood pressure was in the next morning.

Hives all over body. Saw primary care doctor and was told to take Zyrtec and Pepcid to treat histamine 1 and 2. Symptoms resolved within 36 hours. Recurring small flare ups continue for a week.

Patient fell to the floor 7 minutes after receiving the vaccine. He was monitored and placed on his side then back to facilitate breathing. The patient was unresponsive for 10 seconds and unable to respond to commands. The patient regained consciousness after 10 seconds and was responsive to commands. Initial assessment identified a small abrasion to his left sagittal head with a complaint of a headache. Patient was placed in a sitting position with monitored vitals identified as stable. He denied neck/back pain, numbness or extremity tingling. Vital signs remained stable and patient refused treatment or transport to another facility.

4/8/2021 - light headed, dizzy, vomiting, body aches, fever, headache, vivid dreams (upon waking and throughout day) 4/9/2021 - light headed, vivid dreams 4/10/2021 - light headed and felt like about to pass out (3pm), vivid dreams 4/11/2021 - diarrhea, vivid dreams 4/12/2021 - Skin rash/welts, diarrhea

FLANK PAIN; BACK PAIN; CHILLS; INJECTION SITE SORENESS; FEVER; MUSCLE ACHES AND SORENESS; HEADACHE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 97.4 pounds, and height was 61 inches. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known allergies. the patient did not have any drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flank pain. On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site soreness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches and soreness. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, was recovering from injection site soreness, muscle aches and soreness, back pain, and flank pain, and the outcome of headache was not reported. This report was non-serious.

HIVES RASH; VERTIGO; FLU LIKE SYMPTOMS; FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and non smoker. 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 03-APR-2021 at 11:50 AM for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced flu like symptoms. On 06-APR-2021, the subject experienced vertigo. On 09-APR-2021 23:30, the subject experienced hives rash. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 05-APR-2021, vertigo on 07-APR-2021, and fatigue on 09-APR-2021, and had not recovered from hives rash. This report was non-serious.

Headache and tired for three days after shot. Then 14 days after shot I got a migraine. 15 days after shot I broke out in petechiae. Went to the hospital and had blood platelet count of 1,000. Receiving steroids and IV IG. At risk of fatal internal bleeding.

Rashes and hives on my hands, then feet then legs exactly 1 week after my vaccination. Itching started on the back of my hands and then progressed to the tops of my feet and rose up my legs, I took 2 Benadryl and went to urgent care. The Benadryl started working within a half hour of taking it. The itching started as o laid in bed where the only food or liquid I consumed before getting out of bed was a bottled water. The doctor stated that I may be allergic to the pba?s in the water bottle. I have never been allergic to this before I was given this vaccine. Intense itching and hives have been occurring ever since that day and without taking Claritin or Benadryl daily the itching and hives takes over my whole body. I fear I could go into anaphylaxis if I do not take this medication. I have cut out several different foods and different liquids including bottled water and have fasted yet still am getting a allergic reaction. I saw my family dr and he said it?s likely due to the Johnson and Johnson covid 19 vaccine and I believe that to be true. Other symptoms include facial flushing and upset stomach

DIZZY; CRYSTALS IN THE EAR CREATING IMBALANCE PROBLEMS; NUMB HEAD; RHINORRHEA; NASAL DISCHARGE; INJECTION SITE PAIN; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use, 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 and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced crystals in the ear creating imbalance problems. On APR-2021, the subject experienced numb head. On APR-2021, the subject experienced rhinorrhea. On APR-2021, the subject experienced nasal discharge. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) came out to be clear., and COVID-19 (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever, had not recovered from nausea, dizzy, crystals in the ear creating imbalance problems, and rhinorrhea, and the outcome of numb head and nasal discharge was not reported. This report was non-serious.

Got J&J vaccine at our clinic on 4/9/21. Notes that several hours later he developed HA and hives over his abdomen. Sx got worse overnight, and by the next morning he noticed additional sx of tongue numbness/tingling, so went to the ER. ER diagnosed him with allergic reaction and discharged him with a short course of steroids and Rx for Banophen. He notes that the symptoms returned again on 4/24/21, and again this morning 4/28/21. Went back to ER on 4/24, got more steroids and sx went away. This morning bought OTC Benadryl and sx went away when he took 50-100mg.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting/ responsive-Medium, Additional Details: Pt fainted due to vaccine. Was responsive 1 minute after fainting. Woke up and stayed prone on ground until EMS arrival.

mildly pruritic, multi-focal to coalescing erythemic papules, arising intermittently on arms, chest, back, legs, that started approxmiately 1 week after vaccine. There has not been an anaphylatic reactions have occured, no other enviromental changes have occured, other resident in house (who also received vaccine) has shown no symptoms

Patient received COVID 19 vaccine through work at the company in the location on 05/05/2021. 14:45. Said he didn't feel "right" immediately. Waited the 15 minutes without sxs of allergic reaction and went home. On arrival home felt dizzy and laid down. Had initial ED visit that night and again on morning of 05/09/2021. Full body hives, itching, facial swelling, throat swelling.

At 23:15 (7 hours after the dose) I started to get cold while under my blankets trying to sleep. My teeth began chattering as I started to shiver. I got up out of bed to put on a sweater. With each step I took towards the sweater my body started to fully shiver and contract. After about 4 or 5 steps I could no longer move and I fell over. I started having full body spasms and full contractions. I felt like I pulled every muscle in my body trying to relax and fight the contractions. It felt like I was being tasered for about 10-15 minutes. Once I had the strength to grab my sweater I slipped it on. As my body warmed up these contraction subsided. By 01:00 (9 hours after dose) my body temperature had spiked. I didn't have a thermometer to check my temperature but I wouldn't be surprised if I spiked a fever. I placed a wet cloth on the back of my neck, forehead and chest to cool down. At 06:00 (14 hours after dose) I took a cold shower to further drop my body's temperature. It felt like a full body sun burn where you just radiate heat. I was hot everywhere. At 08:00 (16 hours after dose) I took three (3) 500mg ibuprofen to help fight a nagging headache. I did not have much appetite for food. I regularly eat breakfast in the morning (bowl of cereal). From 09:00 to 12:00 (17-20 hours after dose) I felt groggy. Did not seem or act like myself. Was very tired from the lack of sleep the night prior. Seemed very fatigued. Around 13:00 (21 hours after dose) I took a 45-60 minute nap. Woke up feeling much better. I would say most / if not all symptoms subsided after 22-24 hours.

Twenty-four hours after the vaccine I got fever, chills and body aches. Three days after the vaccine I had irritation in my right eye. The next day my eye was more irritated, and it was uncomfortable. I had a telehealth visit and they gave me antibiotic drops. I was diagnosed by an optometrist on the five days after the vaccine with the Shingles virus. The Shingles are still present on my eye after three weeks and I am taking steroids for that.

Flu like symptoms, fatigue, mild fever, arm soreness, headache. But mostly a large rash all over my torso front and back, arms and legs

Patient stated feeling dizzy and nauseas, patient presented with red hives along right side of the neck, PT also presented as diaphoretic and pale. PTs lung sounds were clear and patients air way remained open. vitals were SPo2: 97% HR: 85 BP: 145/90

ARM SORNESS AND REDNESS AROUND INJECTION AREA, FOLLOWED BY FEVER, CHILLS, HEADACHE, MUSCLE AND JOINT PAIN ABOUT 6 HOURS AFTER RECIEVING VACCINATION. SYMPTOMS LASTED ABOUT 3 DAYS.

I got my Covid vaccine on Wednesday, 5/5/21. That night I experienced the typical side effects (Chills, Aches, Pains, Soreness in the injection site on my right arm). By Thursday afternoon I was feeling significantly better. However, on Friday evening I started to feel a tightness and pressure in my chest and left arm and neck. The chest pain felt like I was having a heart attack but my heart rate was mostly normal. I felt shortness of breath where I couldn't get a good deep breath in and I was also nauseous and had no appetite. At times I felt lightheaded and weak. These symptoms continued over the next couple days. On Monday 5/10/21 I decided to got to the ER to get checkout since I was still having chest pains and tightness. They ran a series of tests and concluded that I was just experiencing typical aches and pains from the vaccine. My symptoms continued for another full week and at times the shortness of breath and chest pains felt really severe. By the following week I was starting to feel a little better on and off. I got my appetite back and and I was able to start exercising again. After about 2 full weeks after receiving the vaccine most of chest pain and pressure + shortness of breath has disappeared and I feel better.

near immediate lump at injection site. minimal bleeding when withdrawing needed. lump measured at injection site 18 mm x 13 mm. no active bleeding, no erythema or bruising. Spoke to patient for 8 minutes during which time no additional signs or symptoms were noted. Discussed next steps. Will call to check on status in 4-5 hours and again in 20-24 hours. Advised to contact our clinic or PCP with any additional questions or concerns. Has appt with PCP 6/3/21 for annual PE. Advised to monitor site periodically.

On Saturday, I woke up to my right arm - at injection site area - was itching. I woke up to numerous nose bleeds. I'm not prone to nose bleeds. Also - consistent since Saturday, Diarrhea; muscles aches; fatigue; vomiting. Problems with keeping liquid and food down now - just started a couple of days ago. Dr called me on Friday -I was doing okay; On Monday - he called again and I wasn't doing well. Have spoken to my doctor each day. And now (since two days ago) it feels like my skin is tearing apart and burning and that the inside of my bones are on fire. At the same time, I couldn't keep food and liquid down anymore. Autonomic immune system is in fight response since Saturday. Haven't been able to get out of bed for last two days. Diarrhea has worsened. - Have been taking Zofran - nausea med for the last two days. To subdue the vomiting. Have a new medication that I am starting today to subdue the diarrhea - can't remember what it's called. Trying to make sure it doesn't go into an autonomic crisis. Only Telemed visits so far - video appts. Have had several fevers doing this time - currently at 100 but went up to 103. I have gone to low grade too and means I have not been doing well at all - on Saturday to Sunday. (Went to high grade - Mon, Tuesday, Wednesday).

TWITCHING AT THE INJECTION SITE; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included the patient had no known allergies. 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, and batch number: 1821281 expiry: 23-JUL-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced twitching at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from twitching at the injection site on 07-JUN-2021. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: fell on forehead after fainting-Mild, Additional Details: pt fainted and fell on his forehead causing his forehead to bleed

Within 2 minutes of the vaccination, the patient became unresponsive and seized, also exhibiting some facial redness and sweating. Within a minute of that reaction, the patient was alert and oriented x4. He noted that he felt dizzy but was not aware of the events that had transpired.

STOMACH PAIN; DIARRHEA; BURNING FEELING IN STOMACH; HEADACHE; FATIGUE; MILD REDDISH BRUISE ON RIGHT HAND; RIGHT CALF A LITTLE SWOLLEN VERY MINUTE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous gastric issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced right calf a little swollen very minute. On 06-JUL-2021, the subject experienced mild reddish bruise on right hand. On 06-JUL-2021, the subject experienced fatigue. On 07-JUL-2021, the subject experienced stomach pain. On 07-JUL-2021, the subject experienced diarrhea. On 07-JUL-2021, the subject experienced burning feeling in stomach. On 07-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild reddish bruise on right hand, and fatigue, and had not recovered from right calf a little swollen very minute, stomach pain, diarrhea, burning feeling in stomach, and headache. This report was non-serious.

It was a fully body rash the developed over the course of 24 hours. The night before I noticed a bit of itching an a bump that seemed like a bug bite. The following morning I had many such bumps in clusters on my neck and arm (and a few more bumps on my legs). At the time I thought I had bed bugs. By about 6 PM, I had more bumps and many of them had spread and turned into welts. There were bumps and rashes on all limbs, my neck and redness on my chest and back, The itchiness was severe. While not extremely painful, it was extremely uncomfortable and seemed like it would be hard to sleep or do anything. Around 9 PM I took Allegra to try and alleviate symptoms. I also used hydrocortison cream and calamine lotion all over my body to reduce symptoms of itching. By around 11 PM, I the rash was spreading into my face in the form of some bumps and redness. I visited the ER after consultation with a nurse over the phone, who said that anaphylactic shock could be a possibility and that it would be best to go in. At the ER, I was treated with 50 mg diphenhydrAMINE , 20 mg famotidine , 10 mg dexAMETHasone. I was given a prescription for dexAMETHasone and instructed to take a refill in 3 days if I still had symptoms. I was discharged a couple hours later. I did not need to refill the dexAMETHasone as the sympoms subsided and was almost unnoticeable by day 3 (and completely gone by day 4).

One minute after vaccination patient began to develop urticaria on his upper anterior chest. Patient complained of dry mouth and throat and "not feeling well". Patient was given 50mg of PO benadryl. Rash on chest resolved but swelling began in face around eyes, and blanchable redness developed on forehead and patient complained of itching scalp and nausea. 24 mg of methylprednisolone and 8mg of Zofran was administered. Patient maintaining a normotensive state throughout events, hr in the 70s and oxygen saturation 96%. at 0910 patient had returned a normal state, no signs of swelling or difficulty breathing. Fire team was called for evaluation and patient was observed for one hour. No return of symptoms.

I started getting really itchy in my extremities I thought I had mosquito bites from the night before I was outside. I also noticed the tips of my pointer and middle finger on my left hand felt numb. The numbness has gone away but my hands and legs still feel weak, people are saying that I have been walking funny. The itching wouldn?t stop and areas after I scratched 30 minutes or so later had what looked like dried puss. This has been happening for almost 2 weeks and it?s happening all over my extremities. The itchiness is there as soon as I wake up, it goes away and comes back periodically. When I take my pants off it happens to my knees. I have scratched open flesh all over my body little scabs everywhere. I know it?s not poison ivy or anything like that because it comes and goes and I know it?s not hives.

Same day of receiving the vaccination woke up with chills, fever, nauseous, tingling feeling in the index finger. Next day body was in pain, no appetite, dehydration, soreness at injection site.

RIGHT LEG BRUISING ON HAMSTRING; SWOLLEN AREA ABOVE THE ANKLE; TENDER TO TOUCH; RIGHT LEG PAIN IN HAMSTRING; ACHEYNESS/MUSCULAR TYPE ACHEYNESS IN HIS ONE LEG OR ARM; MILD FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 140 pounds, and height was 70 inches. The patient's concurrent conditions included alcohol use, non-smoker, and penicillin (hives) allergy, and other pre-existing medical conditions included the patient had no medical 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen area above the ankle. On JUL-2021, the subject experienced tender to touch. On JUL-2021, the subject experienced right leg pain in hamstring. On JUL-2021, the subject experienced acheyness/muscular type acheyness in his one leg or arm. On JUL-2021, the subject experienced mild fatigue. On 21-JUL-2021, the subject experienced right leg bruising on hamstring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheyness/muscular type acheyness in his one leg or arm, and mild fatigue on JUL-2021, and had not recovered from right leg pain in hamstring, right leg bruising on hamstring, swollen area above the ankle, and tender to touch. This report was non-serious.

Immediately after immunization administered, pt became unresponsive. Remained conscious entire time, but very light headed. Pt was warm, sweating, clammy. After 5min, epinephrine was administered. Pt became more conscious after 5-10min of epinephrine dose. Pt. stayed in immunization area for approximately 70min after event. Wife contacted. Wife arrived 60min later. Pt left under wife care. Pt did not drive home. Pt was given water, and a soft drink after 30min. Contacted pt early evening. Pt reported feeling fine. No further symptoms.

Approximately 5 minutes after receiving the injection, I became dizzy and lightheaded. My eyesight became blurry and my hearing very "tinny". I felt nausea and thought I was going to throw up. I sat down in a chair and was given a granola bar and some water. After about 3 or 4 minutes the majority of these seemed to fade, but I still felt slightly "off". Approximately 9pm that evening I felt very fatigued, so I went to bed. At approximately midnight, I woke up shivering, extremely cold, and sweating. Around 2am I had a fever of 102.3. I took some Tylenol to try to bring my fever down, which seemed to help. Around 9am the next morning my fever was gone, though I still felt extremely fatigued. Later that evening, after several naps, I started to feel a little better. Most of these adverse events were resolved by 28 hours after injection. I had arm soreness at the injection sight that felt like having been punched in the arm for about a week after the injection.

Rash all over the body that causes itching more intensely on the legs, arms, and hands; Inflammation of the lips and loss of sensation in the lips, and inflammation of the hands.

Patient recieved dose at 3:32pm and went to sit out front for the 15 minutes at 3:36pm another patient that was waiting thier 15min came to get us because he noticed he was turning white. I went to check on him and he was yellowish in color and barely able to speak to me. I asked another pharmacist to get me a cold pack and water. By the time we got the cold pack and water, he was not speaking, but eyes were open. I called 911 and the other pharmacist fanned him and placed the cold pack on his head and neck. He started talking within minutes and we waited for ambulance to come just to check him out. He was ablet to verify his name and where he was and EMSA came at 3:50pm. He left to their truck and said he was okay just felt shaky and clammy, but he could hear everyone talking to him.

allergic reaction. Patient reports blurry eyesight, headache, fever, feels like he cant think clearly, patient reports balance has been off, and back pain x 6 hours. Received J&J vaccine at 1800 last night. Denies vomiting and diarrhea.History: pt had J&J COVID-19 vaccine yesterday evening and here with headache, lack of balance (but able to walk), blurry vision with loss of peripheral vision, fever, back pain, some nausea, here for eval. Says he was in his usual state of health before vaccination and no recent sick contact or COVID-19 hotspot visit. No prior co-morbidities and denies recent illness/injury, use of any meds.

Mild/moderate fatigue, muscle aches, brain fog developed 12 hours post-injection, sustained for 4 days post-vaccination and persisting/increasing. Moderate headache for 24-36 hours post-vaccination. All treated with OTC dosages of ibuprofen. Injection site soreness to touch developed 36-48 hours post-injection and sustained at 4 days.

Patient is employee's son. Employee reported that he woke up at 3 a.m. c/o difficulty breathing, face and lips swollen. They gave dose of Benadryl and he seemed comfortable. Visit to Urgent Care in the morning, they administered a steroid shot. By Thursday afternoon, unusual looking rash all over. Visit 4/9/21 to PCP advising good possibility that it is delayed reaction to vaccine, since patient has not had anything different to eat or have contact with.

Systemic: Tasting iron in mouth-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness at injection site

3-4 days after the one dose shot i have been getting random welts of itchy/swelling over my body..most recent is very swollen lips. actively swollen at this moment.. Benadryl does not seem to help. 1 day after shot i had a 102.5 degree fever for 36 hours.

SORENESS AT INJECTION SITE; This spontaneous report received from a parent concerned a 32 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 admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness at injection site. This report was non-serious.

Patient collapsed/experienced syncopy 5 to 7 minutes after receiving the covid vaccine in the pharmacy sitting area , he was walking along the aisle the store and collapsed/fell face down. An ambulance was called and patient was taken to the hospital

I typically faint when getting shots or blood drawn. I did faint about 10 seconds after the initial shot injection. I was conscious throughout but was not able to speak clearly or control my body even though I could hear everything going on around me. After 30 minutes, I was feeling back to normal. The remainder of the day I felt drowsy and a little out of it. At 12:15am I began to get severe chills and shakes. This lasted throughout the night but was the worst from about 12:15-1:00am. I woke up at 4am with a fever and sweating. My entire body was stiff and in pain with aches specifically in my arms and legs. Very sore pain in my left deltoid where the shot was injected and is still slightly sensitive. It felt like my veins were stiff and in pain and it hurt to move. I had what I can describe as flu like symptoms (i.e. my teeth hurt, my body ached, fever, shakes, body stiffness and overall tiredness and weakness). These all lasted until about 6:30am at the worst and were relieved over the next few hours. I started to feel back to normal around 3pm later that day. That was April 11th. Last night, April 12th, I had trouble sleeping because my left arm was in pain from my elbow to fingers. It was a lingering pain that went away by this morning and is mostly gone now (morning April 13th).

(URGENT) MULTIPLE - severe, sharp shooting pain up from left side of neck to upper chest. - Lasted 3 weeks and still will come every now and then. - 2 day neck stiffness (normal) - complete immune system break down: Lost partial taste in tongue, developed oral thrush that was resistant to diflucan and nystatin. - 2 day stint with allergies (Sneezing, stuffy nose, no yellow mucus or fever) - Periodic headaches - swelling of tongue - fatigue lasted weeks. - easily bruising or bleeding under skin after getting minor scratches. Never healed properly (As in disappear) -glossy watery, red eyes with swollen nasolacrimal duct (inside pink corner of eye. Puffy and red.)

I opted for the J&J variant and received it on Monday at 1:00 PM, mere hours before they pulled distribution of it on the national level. I started feeling flu like fatigue, body aches, and a headache 8 hours post injection. I ran a 101+ fever Monday night and got less than 4 hours sleep due to fever and fairly intense muscle aches. On Tuesday morning the headache, fever and muscle aches persisted till the late evening accompanied by general fatigue. By 9:00 on Tuesday night I was feeling significant improvement and slept well Tuesday night with minor night sweats on and off. Wednesday morning I felt 80% back to normal. No fever, minor headache only evident when standing up quickly or sudden head movement, and continued muscles aches body wide specifically in the neck and chest as well as injection site muscle soreness. These symptoms continue to persist into Thursday at the same or perhaps slightly elevated levels. Friday 4/15 symptoms persist with generalized soreness, fatigue, headache, injection site soreness. Not his typical self.

BRUISES ON ARMS AND LEGS; LIGHT HEADED; LITTLE OFF; This spontaneous report received from a patient concerned a 32 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: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced little off. On 10-APR-2021, the subject experienced bruises on arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruises on arms and legs, and the outcome of light headed and little off was not reported. This report was non-serious.

4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl 4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl. 4/9/21 Visit to PCP Doctor, swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches. 4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.

0 mins: Discomfort in arm flowing from injection site to the rest of the body 2-4 mins: Light-headedness 5-10 mins: About 2 minutes after sitting down at the 30-min waiting area, I began to feel more light-headed while checking my phone, though I don't remember it, I fainted and hit my head on the gym floor ~15 mins: I am awake and feel extremely foggy and have low blood-pressure and heart rate ~25 mins: I am told to sit back up in the chair ~26 mins: I start feeling light-headed again and lose consciousness again and am told that I had a seizure for 20 seconds before coming back again

Received vaccine on 4-9, same day experienced chills, fever, light headedness, and soreness around injection site. Symptoms persisted throughout weekend. On 4-17, broke out in hives on arms, neck, and backs of hands.

Chills, light headedness, fever, the same day as received. Then on 4-17-2021 broke out in hives on arms, legs, and neck.

Covid-19 vaccine JJ: 32 y.o. male w/ no PMH presenting 2 weeks after receiving his Johnson & Johnson COVID vaccine after having severe L calf pain found to have thrombocytopenia. From H&P on 4/21, Patient reports that he had both fevers and aches after his vaccine (4/8/2021). Several days later developed low back pain radiating into his left leg which he initially attributed to sciatica. However, several days later, he went for a 6 mile hike, and felt that his left leg was hurting more. He went to PCP, where he received a blood test and was found to have a platelet count in the low 60s. This was initially thought to be a lab error, but he noticed that his left leg was swollen, somewhat red, and appeared that his blood vessels were swollen. This swelling resolves when he is lying down, and is worsened when he is standing. He received an US to r/o DVT, which was negative. However, after his repeat platelet count demonstrated thrombocytopenia, he was sent to the ED. He denies any recent leg trauma, though he has broken his leg before nearly 15 years ago. He denies weakness or issues going to the bathroom. Denies chest pain or shortness of breath. Denies chills, fevers, but did wake up last 2 nights drenched in sweat. He also reports a petechial rash on his legs. As of 4/22, medical team suspects Vaccine-induced thrombocytopenic purpura (VITT). VITT requires 1) thrombocytopenia, 2) documented clot, 3) positive PF4 Ab, and 4) recent AstraZeneca or J&J vaccine. He meets criteria 1, 3, and 4. He has clinical signs of DVT but does not have a documented clot. Patient has L calf tenderness and prominent pooling of blood and vein engorgement of the L leg when he stands up. Possible that he had a DVT or multiple that cleared and now he has post-thrombotic syndrome. This is consistent with the pooling of blood with gravity and relief of symptoms with elevation. As he has had 2 negative US for DVT, unlikely that he has an unresolved DVT. abdominal and head CT are neg for thrombosis.

BODY PAIN; SORE AT INJECTION SITE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient concerned a 32 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced chest pain. Laboratory data included: Blood test (NR: not provided) unknown, ECG (NR: not provided) UNKNOWN, and X-ray (NR: not provided) UNKNOWN. On an unspecified date, the subject experienced body pain, sore at injection site, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, body pain, and sore at injection site, and had not recovered from headache. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

BODY ACHES; HEADACHE; NAUSEA; LOW GRADE FEVER; MUSCLE ACHE; BURNING AT INJECTION SITE; LEFT ARM SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 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 allergies. gatorade since symptoms appeared with minimal improvement.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022, and batch number: 1085022) dose was not reported, administered on 19-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 19-MAR-2021 07:15, the subject experienced burning at injection site. On 19-MAR-2021 07:15, the subject experienced left arm soreness at injection site. On 19-MAR-2021 15:30, the subject experienced body aches. On 19-MAR-2021 15:30, the subject experienced headache. On 19-MAR-2021 15:30, the subject experienced nausea. On 19-MAR-2021 15:30, the subject experienced low grade fever. On 19-MAR-2021 15:30, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site on 19-MAR-2021, and had not recovered from headache, body aches, nausea, low grade fever, left arm soreness at injection site, and muscle ache. This report was non-serious.

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium

12 hours after injection: 100F fever, chills, pain at injection site 18 hours after injection: 103F fever, more severe chills, pain at injection site 24 hours after injection: 101F fever, chills, pain at injection site 36 hours after injection: Normal body temperature, no chills, arm pain lessens but continues 72 hours after injection: Feel completely back to normal.

On 03-04-2021 I started to experience respiratory problems, my nose was clogged up with mucus, had some difficulty breathing and was having like an asthma attack. I do not suffer from asthma prior to this vaccine. I experienced headaches, fatigue, congestion, my ears were plugged and I also developed a rash on my arms and I also noticed a lymph node in my neck that I did not have prior to the vaccine. When I went to see my doctor my symptoms were not as prominent and the lymph node in my neck is decreasing in size.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt fainted-Medium, Systemic: Flushed / Sweating-Medium

Day of vaccination: Pain/soreness at injection site and nearby arm muscles. Took acetaminophen day of vaccination, which helped, and soreness has lessened over time, but still lingers. Morning after vaccination: Muscle aches, chills, feverish. Took acetaminophen every 6 hours and it helped somewhat, particularly in the morning, but was less effective as the day went on. Next day: felt mostly better from feverish symptoms. Pain/tenderness in arm has continued but lessened over time.

Heavy body pain and stiffness, fatigue and malaise for 2 weeks after receiving vaccine. One month later broke out into a shingles rash on left side. Still recovering from shingles outbreak

Inmate reports a red rash to bilateral legs and shortness of breath starting on 5/15/2021. The rash went from ankle to knee. Was not itchy. Rash has improved. Shortness of breath lasted 24 hours and is no longer present.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium

Patient grandmother called pharmacy on Tuesday (05/25/2021) that pt has developed rash on his chest and back after getting the J$J covid 19 vaccine on Friday (05/21/2021). The rash appeared on Sunday, two days after the shot was given. Rash is not itchy or painfull. Pt's grandmother reported AE to v-safe. Patient's grandfather is a pharmacist. Patient was consulted that he needs to call primary doctor ASAP to rule out other causes. Patient was given J&J contact information. Patient stated that he will call MD, also, he did not start any new medication or new detergent or did not change food or lifestyle in the past weeks. Patient's primary provider is DR. was called by pharmacist.

Anaphylaxis including full body urticaria and pruritis, coughing, and bronchial constriction. Immediately took Benadryl and albuterol which helped improve symptoms over about an hour. I had COVID infection about six months ago and recovered without incident from that.

Patient lost consciousness approximately 5 minutes post vaccination with Janssen COVID-19 vaccine. He was sitting in the observation area and fell out of his chair. Patient fell onto his side, and when he regained consciousness he said he didn't feel any pain or headache. Patient recovered consciousness in less than 1 minute and recovered completely in approximately 12 minutes. He laid on the floor for about 7 minutes, and then sat on the floor for another 5 minutes before feeling well enough to stand. Patient had a small patch of skin scraped off his right knee and right elbow, but declined bandaids. Patient did accept a small bottle of water and a bag of pretzels.

Developed hives over trunk, extremities and severe itching within hours of immunization. Also developed abdominal pain, nausea and vomiting which has just today, 5 days later

onset of hives, itching over entire body within 6 hours of receiving vaccine, has not stopped and continues despite topical steroid and antihistamines. Also having abdominal pain and vomiting since hives began.

delayed allergic response of hives that won't fully clear, currently taking different allergy medications and using steroid cream with little relief

The patient had reported itching to his arms and legs, ears were swollen, lumps on his chest. and was getting lightheaded 6 to 7 minutes after he had received the covid-19 vaccine. The patient reported his cousin had an epi-pen, which he used and felt better afterward.

Pt received the vaccination at approximately 4:25pm on 6/21/2021. Pharmacist went over potential side effects before administration. Pharmacist administered the vaccine, filled out his paperwork, and then stood up. Pt stood up. Pharmacist started to ask him to wait in the pharmacy waiting area for 15 minutes so we could make sure that he did not have a reaction. Before the pharmacist could finish, the Patient started to sway. He leaned against the wall, started to bend over, hit his head on the wall, and passed out. The pharmacist called for help from the other staff. Pt's legs were lifted up so that his feet were resting on the chair. He had hit the bridge of his nose against the wall/side of door. His nose was swelling up, turning black and blue, and was starting to bleed. After about 15 seconds, the patient came around. He was able to answer questions coherently. He stated that he did not need an ambulance. Pharmacist retrieved a couple of ice packs for him and put his coat under his head. Patient remained lying down for approximately 30 minutes before he stood up. When he stood up, he did not sway and seemed stable. Pt declined the pharmacy staff to contact someone to drive him home.

I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now, fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time. BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile, weight lifting gets me extremely tired now, now its not as bad, can work out longer. In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now but when I work out I still get tired where I have to stop, sit, or nap.

Pain in injection site and hand, with little difficulty to breathe. that night start feel chili, wake up with fatigue, body ache, headache and fever at 102 degree.

Jansen COVID-19 Vaccine EUA Approximately 12 hours after receiving the vaccine, I began having headache, body aches, and cold chills. 24 hours after receiving injection, most symptoms have gone away, with only a slight headache remaining and soreness at the injection site.

Fever first day and a half. 6 Days after vaccine body has broken out into a rash all over. Woke up on 3/18 and rash was gone. Around 2:30pm on 3/18 , rash came back all over body. Doesn't itch but it does burn.

I sat down for 15 min and felt fine for the rest of the day. The hives started about 30 mins after I had dinner. It started on my shoulders and back, so I took a Benadryl, which was expired. So, I went to get some more and took a second dose around midnight. I won't up with none, but they were back around noon. That happened for a few days with it happening around lunch and dinner. On Tues, they started spreading more, so I went to the doctor. There was no swelling of the tongue. They lessened over the next couple of days. As of today, I have a small amount of itching, but nothing bad. I've also been taking Claritin since yesterday. I have not seen any the same size as before, but I notice that they seem to be worse at night. I took my BP a few times and it was high at those times, but it went back to normal the next day. I will be seeing an allergist in the near future.

Patient with orolabial swelling on both upper and lower lip with hives present over forearms, thighs B/L, and right upper eyelid. No pharyngeal edema. Normal Breath sounds. Patient administered two rounds of EPI autoinjector along with IV Benadryl and solumedrol. Improvement in Hives and Swelling after medication administration

Temp of 95 at midnight first night. Aches, chills, and fatigue through second night. Incessant itching of scalp and upper facial region, particularly 36+ hours after vaccine.

Approximately 12 hours later i developed a rash under my bottom lip, The following day approximately 24 hours later I developed more rashes on my left cheek, right cheek and under my right eye. Approximately 33 hours after vaccination i developed another rash just to the right of the corner of my mouth. The rash is itchy and is slowly getting worse.

The day after my vaccination my shoulder was sore at the injection site. As the day went on my inner right armpit really became swollen and uncomfortable.

DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious

Muscle soreness at injection site starting immediately after. Within 8 hours: headache, fever, chills, tiredness, and inability to sleep

Injection +8 hours: strong headache, full body sensitivity, body fatigue, flush neck and face, full body chills, full body shivering. +9 hours: hands pale, thumb capillary refill L: no refill, R: 6 seconds. HR98 +10 hours: Temp: 101.4, thumb capillary refill L:2 R:2. Eyes bloodshot, headache over eyes/temples +11 hours: Temp 102.5, HR 109, SpO2 95 +12 hours: full body chills transition to full body slight flush/damp. Headache pulsing behind/above eyes and temples. +18 hours: Temp 100.2, HR 87, SpO2 99, headache continues.

Janssen COVID-19 Vaccine Received vaccine at 1330CST, general soreness around injection site. Around bed time (2200) chills and sore hips, continued soreness in arm. Next morning, woke up at 0700 with significant body ache, fever of 100.2. Significant fatigue. Fever resolved by 1200, took 600mg ibuprofen. Body ache persists throughout the day. I?ve had COVID, side effects of vaccine more drastic than Covid was for me.

Extreme fatigue for over 72 hours. Headache for 24 hours. Muscle pain for 72 hours. Fever of 100.4 for 24 hours. Pain, redness, and swelling at injection site for over 72 hours. Fatigue and injection site pain still not gone.

COVID-19 Vaccine EUA About 12 hours after injection of vaccine I started to get a head ache; and about 16 hours after injection I started to get full body aches (mostly muscle) especially at injection site. Body aches lasted a full 24 hours after they started,

Patient in clinic for sick call. Pt having random bruising and pain in his LE patient does have limp favoring his rt leg. Pt reports having random bruising ever since he received the Johnson and Johnson vaccine. states that he has been having headaches and pain in his feet. Pt reports head aches started about 3 days ago. Pt does report history of family members having clotting issues. Tem 97.8, B/P 105/75, P88, resp 16

As soon as I woke up, I read the Janssen pause news from my bed. I got up to go to the bathroom and upon finishing, I felt my heart rate skyrocket and felt faint. I immediately went back to the bed where I lost consciousness. My wife said my eyes were open and my body was rigid. I came too within a minute of that and was breathing heavy and sweating and very fatigued. My wife had called 911 as I was coming back to consciousness. The EMTs checked my vitals and all was normal. They asked if I wanted to go to the hospital, and I said no. My back was extremely sore all day, and I developed small red spots around my eyes. I went to my doctor later that day and told them about it. They took my blood for tests, which I have not heard back about, and they did not conclude anything, but did set me up with an appointment for an MRI of my head, given my past history.

Fatigue and arm soreness starting approximately 6 hours after vaccination. Fatigue lasted approximately 26 hours. Severe headache, intermittent fever, chills, skin sensitivity to touch along with joint pains and lack of appetite increased in severity peaking at 24-36 hours after injection. Approximately 38 hours after injection, symptoms began to subside. 800mg of ibuprofen followed by 2 excedrine migraine were taken during the period 24-30 hours post injection.

Within maybe 20-30 minutes of vaccination, I noticed a small dull pain in my right calf; I disregarded and walked back to the car. This pain has reduced over the last week, but is still vaguely present. 5-6 hours after vaccination, headache and strong sinus-headache. Laid down to rest. I woke up around 20-30 minutes later with full body tremors and muscle spasms. Muscle spasms particularly violent in my back, feeling similar to if someone was involuntarily using one of those muscle-stimulator elecrode pad systems on me; could feel each individual muscle tensing and releasing at random. Tremors and spasms persisted and then diminished over the next 4-5 hours. 99.7F fever was recorded. Chills, fever, nightsweats, and repeated sleepless rest/waking every 30-40 minutes until the next day. Headache was still strong and present at 4am, took 600mg ibuprofen and continued hydrating. Headache, general soreness, and fever persisted for ~3 days, but manageable with hydration and rest. On day 3 a rash appeared on both my knees/innerthigh just above the knee. Likely not hives, subdermal red speckles that appeared at night; close to 4mm in diameter, skin was warm to the touch and very itchy. Most of the rash was gone by morning, and the itching and warmth was completely gone. I have noticed a very similar rash appear on my front left collar/shoulder area just this morning, but no itch/warmth. Outcomes: Muscle spasms/tremors subsided within a day. Fever/headache subsided within 3 days Knee/Thigh rash gone. More similar rash just appeared on upper left shoulder/collar. Upper calf dull pain still present, but only barely "It feels a bit off" would be the best description.

SWOLLEN LEFT EYE; HEADACHE; INJECTION SITE SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 33 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced tiredness. On 21-APR-2021, the subject experienced swollen left eye. On 21-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and tiredness on APR-2021, and had not recovered from swollen left eye, and headache. This report was non-serious.

4/15/21 woke up with severe pain in left upper thigh. Fatigue and headache began a few hours later. Needed to leave work. Early evening a rash developed in the left thigh and left foot swollen size of balloon and bright red. Went to the ER 10:30PM, admitted from ER on 4/16/21 for possible deep vein thrombosis and cellulitis of left leg. Shortly after admission, unable to obtain venous access, central line inserted for IV fluids and IV vancomycin and Zosyn. Foot swelling increased up to below knee with bright red skin color. No open wound noted on extremity. Ultrasound did not find a thrombosis but enlarged lymph nodes. 6 days later leg still swollen and red, repeat doppler ultrasound negative, but report stated could not compress to complete test due to severe swelling. He was also tachycardic and hypertensive during admission. Infectious disease doctor consulted and confirmed severe cellulitis but it was written in discharge summary the covid vaccine can not be ruled out as a cause of the infection and admission. Lasix was initiated to decrease swelling in lower extremity. He was on SQ heparin 3 times a day during the admission. He was discharged on Doxycycline and Augmentin. After discharge saw primary care physician who palpated large lymph nodes in neck. Mild headache persists. Ultrasound of neck to be completed on 4/27/21. Started on Tizanidine for pain.

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Additional Details: Wife of patient had called the pharmacy hours after patient had recieved his J&J vaccine to inform us of this symptoms a few hours when arrving at home. He experienced fainting, chills, fever, and pain and took a tylenol and symptoms started to subside and has been currently been resting in bed. Wife says they will continue to take tylenol around the clock if needed and will seek medical attention is symptoms worsen.

Breakout of hives on skin any time the skin is excited or brushed against. Rash will usually only last 15-30 minutes and then go away.

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: he was fainted right after the shot. my tech called 911 and i stayed with him. after 1 minute he was responding but still needed medical attention. i waited with him until paramedics come.

Extreme swelling at vaccine site, red spot - after 10 days, still some swelling Nausea, headache, general discomfort (felt like I was hit by a truck) - about 5 days, lessening each day Treatment with acetaminophen

Patient stated he was having hives that come and go that started about 5 days after vaccination. They come on with heat or sweat. he has been taking benadryl to keep them away.

patient was feeling dizzy and head hurt about 5 minutes after administration. He took his bloop pressure which was high 160/98. I kept monitoring the patient and had slight rash on chest which went away and after 5 minutes time . Then started to feel itchy but no rash appeared. after about 20 minutes didn't feel better so gave 25mg benadryl capsule and called 911. EMS took patient to the hospital because patient said tongue felt heavy.

PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 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. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.

Front torso papular rash with itching treated with 2% hydrocortisone cream. Physical symptoms of rash still present but improving . Pt reports itching resolved when hydrocortisone is applied

Patient sat down in a chair to be monitored after his J&J vaccine and he immediately passed out and fell out of the chair. Suffered abrasions to left forehead, under left eye, bridge of nose, and under nose. Regained consciousness quickly. Sat back in the chair and passed out again. Eased him to the floor. He appeared to have some small seizure activity. 911 called. Patient regained consciousness, examined by EMTs. Patient refused to go to the ER. His father came to pick him up . He was up, walking, and said he felt well. He left the vaccine clinic at 2:15pm. I called patient on 7/16/21 to check on him. He said he is fine, and that he has a needle phobia.

Tingling sensation in left arm that radiated from injection site to hand, onset immediately after injection and lasted approximately 2 hours. Additionally, member noted left sided inguinal pain; onset several hours after the injection. Pain described as an constant ache that lasted for 2 - 3 days. Member presented to medical department approximately 3 days after vaccination out of concern symptoms might be related to vaccination. Physical exam normal. Symptoms resolved on own without intervention.

starting on 3/27/2021: right arm slightly sore at injection site. Lethargy/mental fogginess. Joint aches, especially in the low back/hip region. Hypersensitive skin, especially to the thoracic region. Slight pressure in head, not bad like a headache, but still present.

Oral fever, 101.8 +8hrs Muscle and body tightness and soreness +8hrs Chills 5-6hrs Headache +8hrs Home treatment ongoing

Around 8 hours after the vaccine, I started to feel very cold. At around 16 hours I measured a temperature of 100.13 deg. F. Also a slight headache, and soreness near the injection site.

The left ear of the patient became red and swollen. The patient did have on a mask that was tight fitting. The mask was removed on that side and the swelling and redness started to subside. Patient did wait in the pharmacy for 30 minutes before leaving and said he was fine.

Soreness at injection site, body aches, nausea, chills, feeling hot, foggy minded, unable to concentrate or form words, instability while standing/walking, irritability

Sore Arm, Sore Joints (knuckles of hand), Chills, Fever, Aches, Headache, Fatigue, Muscle Weakness. Worst at 12 hours 1st evening - slowly getting better over next 24 hours with rest.

hives, angioedema (other s/s fever/bodyaches/HA) improved in 2 days. Started on 3/27. By the time pt called much improved.

Injections site pain and bruising, diarrhea, severe headache, tires, fatigue, muscle cramping shooting pain, nausea, slight fever.

Janssen dose given at 11:38am. At 11:45am Patient c/o feeling dizzy while sitting in the chair post vaccine (5 Min Jassen). Patient fell backward onto the ground hitting his head and sustaining a posterior head laceration. Vitals taken B/P 101/52 HR 58 RR 16 SPO2 100% RA..... EKG completed and fluids N/S given. Transferred out to ED

Fatigue (36 hours), Chills (8pm 4/8/21 to 12pm 4/9/21), weakness (48 hours), soreness in injection site (all day 4/10/21)

3 minutes after vaccination was given patient stood up and requested juice then fell down and fainted. About 15 seconds later the patient came to. EMS was contacted. Patient had his vitals checked, blood sugar taken. Patient reported to EMS that he was feeling anxious. Patient was asked by EMS questions in relation to time and place. Patient refused to have EMS take him in to the hospital for further tests. Patient was instructed to have a family member come in to take him home and advised him not to drive. Upon a follow up call 30 hours later patient reported he was bruised on his left shoulder, left hip and he had a puncture wound to his Jaw due to his fall. He reported he went to urgent care for follow up. they told him stitches would not be necessary for the puncture wound to his Jaw.

Patient was asked to sit for 15 minutes after. Patient was sitting for about 2 minutes. rph technician, noticed that the patient appeared red, sweating, and about to fall over. Patient went outside and prevented patient from falling over. pharmacy called 911 about the patient, patient was not vomitting, patient was conscious (unconscious maybe about 20 seconds). 911 operator asked for the patient to wait for paramedics to arrive. patient was asked dob and he responded. paramedics took vitals and patient had normal readings. paramedics left afterwards. Then the patient left without any symptoms.

Janssen COVID-19 Vaccine EUA I got swelling and considerable pain at the injection site. The swelling started growing and started giving itching sensation. Right now, I have 2inch by 1 inch size clot with reddish skin and swollen. And I feel numbness or soaring feel in the left arm. I am heading to an in person doctor visit to understand more on this problem.

Sever Allergic reaction. Had hives on face, head, neck, shoulders, back, chest, rib cage, arms and hands. Moved to the mouth and lips. Self administered 25mg of benedryl at 1920. Symptoms worsened. When swelling moved towards mouth at around 2010, patient went to the ED. ED administered 25mg of benadryl and 20mg of pepcid. At 2130 swelling noticeably decreased patient discharged without seeing ED physician. As of 0700 next morning all swelling had dissapated.

large areas of hives on my upper torso and legs beginning at 0800PM on 4/13/2021 and spreading quickly by 0930PM on 04/13/2021. I took benadryl which seemed to help bring down the hives. When I woke up it had moved to my arms and shoulders and my back and legs had cleared up.

Janssen COVID-19 Vaccine EUA 6 days after injection, starting having hive like bumps and redness in my upper torso. They seem to come and go.

Woke up at 2:00AM morning after vaccine with strong fever/chilling Felt very febrile for next two days (48hr) and had very achy body for 3 days after vaccine. Acute soreness at site of vaccination for about a week.

After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm. After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry, offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation. Patient refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation. 45 minutes later the patient was picked up and they went to their physician to be observed. Called patient at 7pm to check in and they stated they "felt better but still off".

About 7 hours after the shot, nausea, fever, chills, fatigue, and headache were all present along with minor injection site soreness. These symptoms lasted through the night and were still present the following evening. The chills were no longer present by midnight and the fever was starting to break. An pain in the foot also started at the same time and continues to exist as of this report.

4/5/21 - Shot 4/6/21 - flu like symptoms 4/6/21 - persistent headaches & pains in body start (pains vary - some shooting some persistent) 4/9/21 - primary care does D-Dimer Test (result 1.46) 4/10/21 - primary send me to ER 4/10/21 - ER does blood work & EKG, all fine. Checks out AMA w/o CT scan. 4/17/21 - Bruise appears between eyes and above nose w/o any trauma event. 4/17/21 - checks back into ER. Blood work fine, CT scan fine. 4/18/21 - headaches and body pain continue to persist (most notable body pain is almost a numbness feeling in legs and arms at joints) 5/11/21 - headaches have subsided partly but numbness body pain persist.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild

Injection site: pain/tenderness General side effects: Nausea, weakness (full body), nearly fainting multiple times, headache, some confusion, dehydration, some difficulty breathing, tired even with rest, low fever

Started with a slight headache, soreness at the injection site and fatigue the day after the vaccination. Then as the night progressed I had chills and then a 101.2 degree fever. Within 48 hours all symptoms had subsided. Took Motrin during the time to reduce fever and headache.

5/11/2021 RASH, RUNNY NOSE, NASAL CONGESTION DIARRHEA 5/12/2021 TEMP 103 F, NO APPETITE, NASAL CONGESTION

Severe pain in jaw and ear on left side, identified 10 hours post injection and continuous Pain at injection site, continuous and not subsided since injection

It has been 25 days since I took the AZ vaccine. Below are the side effects and significant blood test results: Day25: INR 1.29, CRP 4.8 Day 20 INR 1.05 In addition, I have been having an ongoing 37.3 fever since day 15 which goes back to normal 36.5 at night. Moreover i have been having light bruising on the arms and fee without any physical impact. my blood vessels / veins on hands, arms and legs are inflamed and cleary visible. i have been also having a feeling of tiredness and fatigue. Please advise on what I should do. Regards

Severe raised burning itching rash, severe headache, vision blurred, very tired fatigue, joint muscle pain, throat pain, mental fog slowness,severe pain at surgery site, increased tremor, pain in chest, itching keeps waking me up

Severe headache in upper right side of head with light and sound sensitivity followed by a shingles outbreak on right side of face and head.

Fatigue, muscle soreness, body aches, and hives. Hives were only thing treated, went to ER because it was all over entire body. was given steroids and Benadryl. after follow up was given an additional steroid shot.

High fever peaking at 104, lasting roughly 12-18 hours. Motrin and Tylenol to reduce fever. Hives on scalp, hands.

I developed a rash at the shot site that spread down my back and across my neck. My blood sugars have been high since Wednesday. I have been struggling to get them within range since then. I have an antihistamine cream that I?m applying and have had to adjust my insulin to improve my blood sugar levels.

JANSSEN COVID-19 VACCINE EUA 12PM Sore deltoid left side up the neck BY 2PM lightheadedness, dizziness, nausea, headache, fatigue BY 4PM Dry cough and chills, BY 6PM Muscle soreness on the entire left side of body By 10PM 101 fever, aching in every joint of body, trouble breathing By 2AM hot and feverish. All symptoms continued through Sunday, many abating by Monday. However, I am still fatigued, coughing, lightheaded, dizzy, and nauseous since then to even now 3/19/2021. Headache comes and goes and slight difficulties in breathing from the normal. COVID rapid result test came back Negative today from facility.

Just before bed, about a week after getting the vaccine, I started to itch on my feet and arms. I fell asleep and woke up at about 3 AM with incredibly itchy skin from the tops of my feet all the way up to my shoulders. It was so itchy and uncomfortable that it woke me up. I took 2 Benadryl and put some anti-itch lotion on, and was able to fall asleep. I woke up the next morning feeling groggy, but better. The itch has not returned at all in the week since this happened.

Extreme pain in shoulder Injection site is high on deltoid possible in bursa Limited mobility in arm Painful with light touch on entire deltoid Pain worsening each day

Slight pain at injection site at moment of injection, but then no pain after for the remainder of the day. Felt slight body aches at bedtime (11PM). Slept poorly all night due to body pains. Woke to muscle aches and slight join pains, which worsened throughout the day. Low grade temperature appeared at noon the day after the shot, and stayed into the night. Headache began around 5PM and got worse. Tylenol helped at 7PM. Slept from 7:30PM to 7:30AM. Felt back to normal by morning.

I developed a splotchy red rash that spread quickly around my body. It was mildly itchy and worsened in the evening. After waking up it largely went away but came back again in different places the following night.

Major symptoms, roughly 20 hours after vaccination, 10-15 minutes after waking, while walking and standing: - Extreme pain in right hip joint. Pain is sharp, stabbing, burning. Pain radiates down leg, and right foot numb and tingly - Overheating - Lightheadedness, blurred vision, confusion - Fainting or loss of consciousness, falling to ground Timeline of events: 2021-04-08 13:00 Injected with Johnson & Johnson 13:00 - 13:15 Very slight nausea 13:15 - 22:00 Very slight nausea and fatigue 22:30 Lymph nodes in neck feel swollen, ears feel slightly clogged (typical early cold symptoms) 23:30 Insomnia and chills 2021-04-09 00:00 - 07:30 Insomnia, poor sleep, and cycles of chills and overheating while trying to sleep or sleeping. Stronger nausea than before 07:30 Wake up, knees feel slightly weak when walking 07:35 - 07:40 While walking inside a market. Right hip joint begins to hurt with sharp, stabbing, hot pain. The pain radiates down right thigh. Right foot begins to feel numb and tingle. This pain increased over 5 minutes, to excruciating levels, with right leg feeling numb, and sharp stabbing tingles in right foot. Difficult to walk normally 07:40 - 07:45 Pain becomes overbearing, and market counter used for support. Begin to feel light headed. Begin to feel hot, and begin to overheat within ~2 minutes. Walk outside market (outside temperature 32 - 40F) to cool down. Lean on car hood for support, and become increasingly lightheaded. Vision becomes blurry. Stumble and fall onto face. Regain consciousness after unknown time, groggy and with blurred vision, lightheaded feeling. Attempt to stand and fall again onto face. Regain consciousness after unknown time. No longer feeling extremely hot. After roughly 1 minute, regain clear vision and lucidity. Pain in hip and leg completely subsided 07:45 - 09:00 Driven to hospital. Treated by hospital staff for laceration in forehead requiring 7 sutures. EKG reports normal. Concussion check negative. 09:00 - 00:00 Occasional nausea, fatigue, weakness (same as weak cold) 2021-04-10 11:00 While walking and standing in line. Right hip joint begins to hurt, with pain radiating down right thigh. Right foot begins to feel numb and tingle. Begin to feel warm. Hip Pain remains at manageable level, and walking normally is easy. Hip pain is roughly 1/3 of pain of 2021-04-09. 2021-04-11 07:30 - 11:00 Occasional slight pain in right hip and left hip joints. Hip pain is sharp and burning, and roughly 1/10 of pain from 2021-04-09.

These symptoms lasted 6hrs Cold chills, fever, nausea, headache, body aches, soreness at injection site. These symptoms lasted 12hrs Headache, soreness at injection site

Patient developed hives over 90% of his body 4 days after receiving the vaccine. The doctor who treated him thinks it was an allergic reaction to the vaccine. He is currently being treated with steroids and reports being about 50% better at this time. He still has doses to take.

Second day after vaccine shot I experienced extreme fatigue and pain. Third day I broke out in hives all over. Today I?m still in hives and have a pink eye.

MARCH 9: BODY ACHES AND HEADACHE, SLEEPLESSNESS. CONTINUED OFF AND ON OVER FOLLOWING DAYS. MARCH 18: BLOOD PRESSURE AND PULSE WERE TOO HIGH TO DONATE PLASMA MARCH 21: DIDN'T FEEL NORMAL, GASTROINTESTINAL ISSUES, FATIGUE, SLEEPLESSNESS, ABDOMINAL PAIN, RAPID WEIGHT LOSS, LOSS OF APPETITE MARCH 26: URINE STARTED DARKENING TO ORANGE COLOR DESPITE STAYING HYDRATED, FEVER, MALAISE. APRIL 1: WENT TO DONATE PLASMA AT BIOTEST PLASMA CENTER AND NOTICED BLOOD PLASMA WAS AN ODD COLOR. APRIL 4: EMERGENCY ROOM PRESENTED WITH ABDOMINAL PAIN, JAUNDICE, WHITE/LIGHT COLORED STOOL. BLOODWORK, ULTRASOUNDS, CT'S WERE DONE AND SHOWED INFLAMMATION IN LIVER/GALLBLADDER/GI TRACT. HIGH BILIRUBIN. APRIL 5: COLONOSCOPY PERFORMED. DIAGNOSIS: ULCERATIVE COLITIS. ERCP PERFORMED WITH LIVER BIOPSIES. DIAGNOSIS: COMMON BILE DUCT BLOCKAGE WITH CHOLECYSTITIS AND HEPATITIS. STENT WAS PLACED. POSSIBLE PRIMARY SCLEROSING CHOLANGITIS- DEPENDING ON BIOPSY RESULTS. APRIL 6: CHOLECYSTECTOMY, MORE LIVER BIOPSIES TAKEN. APRIL 7: LIVER BIOPSY RESULTS/DIAGNOSES: OVERLAP SYNDROME OF AUTOIMMUNE HEPATITIS & PRIMARY SCLEROSING CHOLANGITIS. PLACED ON PREDNISONE. AWAITING APPROVAL FOR REMICADE INFUSIONS WITH POSSIBLE NEED FOR LIVER TRANSPLANT IN THE FUTURE AS PSC PROGRESSES. AS OF APRIL 18: JAUNDICE STILL PRESENT, BILIRUBIN NOT DECREASING. BEING REFERRED TO MEDICAL CENTER FOR FURTHER OBSERVATION AND TREATMENT.

I have developed a rash and have itched severely. Visited an urgent care and was told it was poison ivy or something similar. Was given a steroid shot, oral steroid, and a steroid cream but the rash and itching remain.

TWO LUMPS ON LEFT SIDE OF NECK; ITCHINESS; PAIN; FATIGUE; FELT FEVER; CHILLS; MILD MUSCLE ACHES; This spontaneous report received from a patient concerned a 35 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: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced mild muscle aches. On 10-APR-2021, the subject experienced felt fever. Treatment medications included: paracetamol. On 11-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced two lumps on left side of neck. On 13-APR-2021, the subject experienced itchiness. On 13-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, mild muscle aches, and felt fever on 11-APR-2021, and fatigue on 13-APR-2021, had not recovered from two lumps on left side of neck, and the outcome of pain and itchiness was not reported. This report was non-serious.

SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

one hour after shot, patient developed rash on right arm. Injection site was left arm. At 8 p.m. the patient developed a fever on 103F and severe body aches.

HIVES; This spontaneous report received from a patient concerned a 35 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.

8 hours after injection felt tired 10-12 hours after injection I had extreme chills that caused me to tremble, fingers and toes felt very cold, elevated resting heart rate as high as 115 bpm, body aches all over which got worse throughout the night. 12 hours after injection I went to bed. Chills and body aches continued. I didn?t feel like I could get warm. Slept on and off throughout the night. Woke up 16 hours after injection and chills were gone and had night sweats. Still really achy all over. Woke up 20 hours after injection and still had body aches and felt groggy. Body aches turned into joint aches and still continue 48 hours after injection. Minor injection site pain started approximately 36 hours after injection.

After take it , there are some herpes coming out around the right eye. I visit at urgent care and the MD provide the prescription. Sulfamethoxazole, acyclovir & trifluridine ophthalmic solution 1% eye drop. Also, the skin is itchy with small red bumps. So far the symptoms of itchy skin is stronger than before.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted just after admisntration, he passed out for less than 10 second , all of the first aid requirments done, vitals were normal called 911 and they arrived at the location in 5 mintutes , patient monitored for about 30 minutes after and walked out the store himself

DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.

Patient presents with raised bumps arms, trunk, and thighs x 1600. First noticed on L shoulder and has spread since. J&J vaccine today at 0830. Patient denies pain, trouble breathing, fever, or CP. Patient took 1000mg tylenol at 1145.

Patient developed rash spots on belly and legs in the evening. The rash spots are almost gone by the next day in the morning

covid reaction- SOB, rashes. HPI:35-year-old male with chief complaint of cough and shortness of breath. Symptoms have been present since the beginning of May. He reports this started after receiving his coronavirus vaccine. he reports he gets short of breath with walking short distances as well as he is unable to lay flat as he wakes up coughing and having difficulty breathing. He denies any heart history.

Patient has had a rash show up on both arms. The rash is primarily on the inside of the arm. It has been red, very itchy, and painful. The rash has improved as of today 6/8/21 but is still present.

INJECTION SITE PAIN; This spontaneous report received from a pharmacist concerned a 35 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: Unknown) dose was not reported, administered on 16-APR-2021 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 injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.

Clint returned approximately 30 minutes after administration complaining of increased redness and burning on injection site and hands and feet. A cold compress was applied to area and the client was asked to stay for continued observation. VS- p - 118, B/P - 135/88, SpO2 99% Client c/o increased itching of palms. Assessed as having generalized anaphylaxis. Client refused IM or PO Benadryl. Epi pen was administers and EMS activated. Client was transported to local ER via EMS. Client discloses he has "never had any vaccines in his life."

03/23/2021 awoke with felt pulled shoulder, heat, pain on the backside of a pull shoulder like a knot and had shoulder issue of pulled shoulder to severe pain still had function of arm but still had use of arm. Had difficult time sleeping and had pain presented at the injection site and the top of the arm. It took a day for the pain to change from the shoulder to the injection site to the top of the arm. 9/10 for pain for three weeks starting not able to use the left arm and inflammation of the was restricting the nerve and pain. Lack of sleep for three weeks do no sleep and shoulder, neck, torso, and ribs, not able to sit down. Not able to user the left arm with daily test that required the use of the left arm. Week three doctor for appt. early April No imaging, observation and range of motion, flexibility and strength evaluation then they prescribed the Gabapentin because of lack of sleeping . Went to a Dr. a week later for the doctor did the same test and pain evaluation was wanting to do imaging. Same the timeframe of the J &J being pulled from market and they did not want to image just increased the dosage Gabapentin. Symptoms that he had did not show side effects of blood clotting.

Soreness at injection site for 3 hours. Pain in upper arm/shoulder joint started a few hours after injection, and is diminishing into Day 2. Pain in various joints is very noticeable by 9:00am the day after injection. Left hip joint pain up to a 6/10 on pain scale. Also pain in right hip, knees, and right shoulder, not to exceed a 4 or 5 on pain scale. Also at 9:00am on Day 2, headache is quite noticeable and persisting through Day 2. I rarely get headaches normally.

I have pain internally at the injection site that isn't subsiding and it has been over two months. The pain affects my range of motion and ability to perform tasks as simple as reaching for my seatbelt, washing my body, and doing a push-up.

Shoulder around injection site still has pain. Usually the pain is behind the or at the side of the injection site. The pain comes and goes and it is noticeable. I still have full range and use of my shoulder. However, after four months of having the shot, it is strange how the pain/soreness is still there. My doctor said either to have physical therapy or to try to self therapy which I choose to do.

after vaccination patient had classic anaphylactix reaction, fainting, dizziness, hypotention 90/60,sweating , feelinf hot, wide spread redness

Patient fell from chair to floor hitting head and sustaining small laceration above left eye. He also experienced mild seizure activity that lasted approx 10 seconds. Patient quickly regained consciousness and was assisted to triage area. BP 140/86, HR 82, O2 sat 97%RA. EMT came and assessed client and cleared him to leave. Client ambulated out of facility without difficulty

High fever (99-103F) for about 12 -16 hrs, numbness in arm for 1.5 days, injection site soreness lasting 4-5 days Rested and hydrated for 2 days Returned to work after 2 days

Felt fine immediately after the vaccination. Later in the evening around 11pm, my body felt achy. I had very little energy, and felt cold despite a warm temperature in my house. I woke up the next morning feeling an entire body ache and minor pain at the injection site.

Fully body itching and hives, started taking Benedryl every 4-6 hours and it seems to keep it under control. Still taking Benedryl every ~6-8 hours, but less often at this point. I've never experienced anything like this before in my life, and the only thing "different" that I can point to is the vaccine.

Aching and soreness all over body particularly at injection site. Mild headache. Fatigue and lethargy. Difficulty moving around.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt fainted after a couple minutes after vaccine administration. We were able to assist him down to the floor. Pt regained conciousness within a minute. Shortly after, we noticed a rash. Gave pt 50mg benadryl. Paramedics called. They checked pt's blood pressure and pulse. All were normal.

Six days after vaccine administered, full body rash developed in patches across both thighs, abdomen and both arms. Non-serious, albeit itchy.

Large generalized case of urticaria on right side of back. Very hot to touch. Complained of stinging, burning. Patch bright red in color, raised in texture. Still present four days after it popped up. It popped up three days after after vaccination. It is now peeling like a severe burn. Patient did c/o a severe headache the day after the vaccination for about 24 hours.

Day 1 (vaccination date 10Apr2021) - did not notice any symptoms other than soreness on left arm which was the injection site. Day 2 post vaccination (11Apr2021) - headache like symptoms where there was heavy pressure on the back of the skull (Occipital knob/bone and around the parietal bone), felt clammy and hot/sweaty, shortness of breath, and very fatigued and nauseous. Temperature seemed to fluctuate throughout the day around 100 degrees almost like a low grade fever. Day 3 two days post vaccine (12Apr2021) - headache like symptoms seem to have settled but still felt clammy / sweaty / hot. Day 4 (13Apr2021) Injection site in left arm is still swollen and sore. Shortness of breath still present.

On the evening of 4/8/2021 at around 8 pm I began experiencing an upset stomach (felt like I might throw up) and then shaking in my stomach started and I got a lot of chills and a headache. Then I spiked a very high fever and sweat like crazy. I was shaking like crazy and had to call a doctor on call twice. I had full body pain and was very sleepy. The fever and chills lasted a bit over 2 days but unfortunately the pain in my body had not gone away. Currently (4/14/2021) I have pain in all my joints and my neck and back and I noticed a rash around my right knee. I have felt very tired. I have felt some mild shortness of breath, which may be seasonal allergies (discussed with a nurse earlier, my oxygen levels are 98 percent today, so I am breathing fine, but there is a sensation of shortness of breath) . I have consulted my primary care office about the above and they are speaking to the doctor. I am trying to limit my exposure to any hospital setting until the 14 days (2 weeks) is up from the vaccine. Hopefully these symptoms will go away soon and hopefully none are related to a blood clot issue. We'll see if my doctor or you guys may recommend a future platelet test?

Patient felt faint, stood up for assistance and lost consciousness and fell to the floor. It was warm at the site and wait time approximately 1 hour. Patient admitted that he was dehydrated. Has a history of fainting.

Johnson & Johnson Vaccine on Saturday, April 10, 2021 - 1 p.m. 11 p.m.: Sharp pain inside of L thigh Sweats, Chills, escalating fever All night, fever increasing to 103 High blood pressure 160/130 Sweats Lymph nodes very swollen No sleep overnight Sunday, April 11, 2021 Aches and pains both legs Fever continued through Sunday 100F Migraine started at daybreak, lasted all day (Lots of Tylenol and Advil, alternating) Arm with shot started to hurt Few hours of sleep was interrupted again by inside thigh sharp pain in L leg Monday, April 12, 2021 Running fever 100 Blood pressure high Arm started to show rash in the evening Woken up with sharp pain in L leg. Caused limp all day Monday. Fever broke Monday evening. Tues., April 13, 2021 Sharp pain in L leg Leg felt hot Called physician, no return call Called pharmasist, told me to go to ER due to J&J Blood clot potential issue and my symptoms Went to the ER, long wait to get an ultrasound on L leg to make sure blood flow normal Released Didn't sleep well. Continued to have leg pain took advil to get rest Wednesday - Thursday, April 14-15, 2021 Felt sore on leg, went about my day normally Was in Bed at 11 p.m. Friday, April 16, 2021 Was woken by sharp pain under L armpit 1 a.m. and left arm hurt/sore Took Tylenol and Heartburn meds had trouble falling back asleep Fell asleep 4 a.m. Woke up 8:30 a.m. with sharp pain under armpit still Blood pressure 145/112, ten minutes later 145/108 Called my physician again and they told me to drop everything and goto a different ER to get an angiogram done - The first ER did almost nothing that needed to be done according to the physician.

SORE TENDER PAINFUL TESTICLES; HEADACHE; SORENESS IN ARM AT INJECTION SITE; This spontaneous report received from a consumer concerned a 36 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced soreness in arm at injection site. On 13-APR-2021, the subject experienced sore tender painful testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and soreness in arm at injection site on APR-2021, and had not recovered from sore tender painful testicles. This report was non-serious.

BODY ACHES; CHILLS; RASH; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 36 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: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced body aches, chills, rash, hives, headache, nausea. Treatment medications (dates unspecified) included: epinephrine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and nausea on 02-APR-2021, and had not recovered from hives, headache, and rash. This report was non-serious.

Janssen COVID-19 vaccine EUA: Hives with associated itching and burning, hypertension Treated with IM Solu-Medrol and Benadryl, sent home on Prednisone taper

Swelling of fingers and feet the next day after receiving the vaccine. It has been over 2 weeks and I still have swelling of my fingertips, hands, and feet. I also have excessive dryness on both hands and feet. My fingers feel like they are secreateing sticky moisture. Fingers feel sticky like they have glue on them.

SWEAT; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa medications allergy, tramadol allergy, alcohol user, and cigarette smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23/JUN/2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced sweat. On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced injection site pain. On 14-MAY-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea, and tired on 14-MAY-2021, was recovering from fever, and sweat, and had not recovered from headache, and injection site pain. This report was non-serious.

SHARP HOT PAIN THROUGHOUT BODY; DIFFICULTY CONCENTRATING; INJECTION SITE PAIN/BURNING; FATIGUE; SHARP PAIN IN FOREHEAD; This spontaneous report received from a patient concerned a 36 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced sharp hot pain throughout body. On 26-MAY-2021, the subject experienced difficulty concentrating. On 26-MAY-2021, the subject experienced injection site pain/burning. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced sharp pain in forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain/burning on 26-MAY-2021, and had not recovered from sharp hot pain throughout body, difficulty concentrating, fatigue, and sharp pain in forehead. This report was non-serious.

Pt received vaccine in LUE. Pt c/o pain in LUE, shortly after stopped responding and eyes rolled back in head, became diaphoretic and warm w/ seizure-like activity noted w/ hands contracted and UE/LE rigid and not immediately responsive. Pt was laid down on back and responsive shortly after. VS obtained and stable. Pt had no recollection of event. Continued to monitor and obtained stable orthostatic VS prior to allowing pt to leave. 1149 - lying down - BP 160/82, HR 59, O2 99% RA 1152 - lying down - BP 118/76, HR 75, RR 13, O2 99% RA 1159 - sitting - BP 121/80, HR 66, O2 100% RA Orthostatic VS Lying @ 1210 - BP 118/75, HR 63, O2 100% RA Sitting @ 1212 - BP 129/84, HR 55, O2 100% RA Standing 1215 - BP 120/84, HR 66, O2 98% RA

Attendee received Johnson & Johnson vaccine at 14:20 in the left arm. Lot# 205A21A. Attendee was directed to observation area. At 14:35 voiced complaints chest tightness and anxiety. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. Attendee refuse to go to the cot. 14:47 – Reported being anxious and that he is going on a flight out of the country later today. Did not want 911 to be called. HR: 77 BP: 125/70 RR: 19 O2Sat%: 99 14:55 - Attendee decided that he was leaving. He did let them get another set of vital signs, before he left.

Patient reports when received injection it "didn't feel right". States 2 days later developed numbness/shooting pain in upper lateral aspect of arm down to elbow. States occurs around 3 times a day and lasts anywhere from 10 minute to 1 hour in duration. Worse when raising his arm/using computer.

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.

Moderate pain at injection site beginning +6 hours from vaccine. Moderate swelling at injection site for 48 hours from vaccine. Fatigue beginning at +6 hours from vaccine requiring additional sleep and continuing for at least 72 hours. Fatigue results in some periods of moderate weakness and general malaise requiring lying down. Stomach cramps and discomfort.

Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect.

1515-Vaccine administered-Employee was monitored for 15 min and returned to work. 1600- Employee developed hives, reported to occupational health and benadryl administered. APRN present in Occupational Health. Patient stated he felt that his throat was swelling. Epi-Pen was administered while an ambulance was called, employee was transported to ER.

Patient was standing with hands on knees and stated that he was "going down". Paramedic was standing nearby. Patient's eyes rolled back into his head and paramedic helped to guide patient to the floor. Pt tried to crawl while on his hands and knees prior to rubbing his face into the carpet as he continued to crawl. Paramedic rolled patient over onto his back and patient rested there for about 10 minutes. Pt got up with standby assistance and sat in chair. After 5 minutes pt passed out again and was turned over on his back on the floor. Pt vital signs were taken and were stable. Ice pack placed on patient head. Pt had visible bruises to the face (nose, eye and forehead). Pt has a history of passing out with vaccines and stated that he had not taken his blood pressure medicine today. Pt placed in wheelchair and taken by EMS to the hospital.

Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.

Janssen COVID-19 Vaccine EUA I received my dose at 3pm on March 12, and experienced no adverse events until about 5 or 6 hours later. Between 8pm and 9pm, I felt a bit tired, though wasn?t sure it was vaccine-related at first. However, I shortly afterwards started feeling much more tired, and experienced chills and shivering. I went to sleep. My wife later said I felt very warm, though we did not measure my temperature. During the night, at one point, I got up to go to the bathroom, and became very dizzy and nearly fell over, though I was able to catch myself and did not experience any fall or injury. I went back to bed. At some other point during the night, I started sweating. My wife later said I felt cold at that point. For most of the following day, Saturday, March 13, I no longer felt dizzy nor overly hot or cold, but had a migraine and mild nausea. I did not vomit, but I also ate very little during the day. I did eat a little in the morning, and had some water throughout the day. For the most part, I laid in bed, drifting in and out of sleep. At about 7pm on March 13, I took two Tylenol to try to fight the headache. By 8pm I felt almost completely better. I ate more bits of food, and have felt fine since then. Sunday, I woke up and felt back to normal. I ate normally as well.

At 6 pm, 7 days post vaccination, the patient developed a red urticaria rash starting on the back. This was extremely itchy, spread to the front torso, the upper legs , and the abdomen. The arms and face were not affected. This lasted almost 24 hours . Benadryl and hydrocortisone cream 1% were utilized. The patient also experienced some loss of appetite the first three days post vaccine. The dates for this were March 18-19. By the 24 hour mark, the rash was clearing.

Seven days after vaccine was administered Patient started having symptoms of difficulty breathing, rapid heart rate, and breaking out in a rash all over his torso and upper arms. His lips also got quite swollen. The rash eventually spread down both his legs. He was taken to the emergency room at Hospital, as he was visiting there at the time. He was given benadryl, and prednisone once his Covid test came back negative. Blood work, chest x-ray, CT scan of both stomach and chest, EKG and blood work all came back normal. His resting heart rate was 120 and above, and he required two liters of oxygen to stay in the mid 90's saturation level. He spent five days in the hospital before the rash was mostly faded on his torso and his lip swelling had come down. He was discharged on 3/24/21 with the advice to see his primary care physician, and to be monitored carefully for oxygen saturation and heart rate. The family could not think of anything he had eaten or come in contact with that would have caused any reaction. At this time we think it was a reaction to his Janssen vaccine based on all the tests at the hospital coming back normal.

Patient went to School 4/1/21 to receive J&J vaccine. Patient came to see Dr. on 4/7/21 claiming his symptoms started on 4/2/21. His symptoms included erythema multiforme on lips and in oral cavity.

hives, slight shortness of breath, feeling tired, no energy, sleepy starting from approximately 45 minutes after vaccine administration. pt instructed to take loratadine 20mg (2 10mg tabs), went to sleep for approximately 3 hours and woke up feeling fine

Chills from 2100-2400 5APR Elevated resting heart rate (160bpm) 2300-0700 6APR Joint pain in every joint 2300 5APR-1700 7APR Swelling and pain at injection site 5APR-9APR

Scattered skin rashes and itchy patches: Back of right thigh, inside of right elbow, upper face, back of left shoulder

Progressively worse flu-like symptoms beginning approximately 6 hours after injection (~915pm): elevated temperature, psychosis, shivering/shakes, skin-pain, breaking to a sweat by around 5:30am. Treated with 1000mg acetaminophen at 11pm, 600mg ibuprofen at 3am, 1000mg acetaminophen at 5:30am, and 1000mg acetaminophen at noon the next day (20 hrs after injection). Intensity of symptoms gradually subsiding and no plans for additional medication if current trajectory continues.

CHILLS; HEADACHE; INJECTION SITE PAIN ON HIS ARM; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced injection site pain on his arm. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 06-APR-2021 19:00:00, the subject experienced chills. On 06-APR-2021 19:00:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from headache, and injection site pain on his arm, and the outcome of chills and sore arm was not reported. This report was non-serious.

Immediately after, tingling in lips. Day after, HS exacerbation. Large sores on inside of thighs that created a burning sensation and weeping wounds. Have been present for 3 days

Started as headache. Headache increased and sinus pain and tingling skin sensations in upper left face area after 24-36 hours. Symptoms steadily increased until 4/13, visited ED on a doctor friends advice. Small lesions had s started to appear at hairline Was diagnosed with shingles, prescribed 7 days acyclovir. Now 1 day into acyclovir treatment, progressing as expected, shingles symptoms increasing. Follow up PCP appointment planned for 4/15.

The evening after the shot, I felt common side effects like headache, lack of energy, weakness, fever, chills, body aches, and inflammation. But my skin was also very sensitive to the touch. Upon 100% recovery from the common side effects on Monday, April 19, my skin sensitivity went away but was replaced with intense itchiness that has continued and gotten more intense since then to this day (Wed.). I am developing a few small welts on hands and feet. So far, my symptoms are very mild and not alarming, but are noticeable and bothersome. I do hope they will go away soon. I thought you should know about the skin issue since I have not seen it reported anywhere this far after the shot.

In addition to common side effects including fatigue and headache, my arms became covered in rashes, particularly my elbows. The rashes persisted for about 10 days and are starting to vanish.

The night of the 9th, I had injection site pain. That lasted for three days, at least. Significant pain but it didn't stop me from work. It wasn't consistent pain - I was having trouble getting my arm up. Thursday, - 18th - I suddenly felt tired and feverish. I did a PCR test on the evening of the 18th. Then there was fever between 98.9 - 100.4. I had cough and sore throat and I had runny nose. The fever kind of subsided after I took Tylenol on the 18th and then again 19th and 20th, as well. My COVID result was negative. I made an emergency report on the 19th with my doctor. I had a virtual appt with her. She was under the opinion that it was a bacterial infection or allergic reaction. When I took - Levocedrizine - my runny nose symptoms got a little better. On 19th, she prescribed me Erythromycin - I took the full course. of that and my fever left the Sunday after I started that. I finished the full course of it by Tuesday. I still had a cough but I did not have any other symptoms after the course of medication (five days- I took two the first day and then one of the next four days after that) was finished. Note: I use CPAP at night. My cough took some time to subside - it probably subsided by the 26th.

Hives all over my body hands,leg and tummy. Itchy and 5he effect lost for 10 to 15 mins then go away I have taken video and pics.

Left arm became very sore at spot of vaccine 19 days after shot. It feels like I was punched in the arm. There was little to no soreness after shot or anytime until 19 days after.

I experienced heart racing and my throat swelled up. Pain at the injection site. I also experienced chills, weakness sensation to my body no fever and body aches. To this day I still have the pain at the injection site, left arm and no chills. At times I feel my joint feel stiff and I am able to move a bit better.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: About 5 minutes after the shot, the patient lost conciousness, fell face forward on the ground. Face appeared grey, was unresponsive, but was making grunting sounds. His body appeared to be shaking lightly, possible seizure, was not responsive. Oral benadryl was not possible at this point. Turned patient on back/side in order to adminster the epipen. Patient quickly became alert and responded. No injection site reaction. Paramedics arrived shortly to check vitals and transfer him

fever, body aches, fatigue, cold sweats, migraine, runny nose, sore throat, soreness around injection site, muscle aches around injection site.

SUSPECTED SINUS INFECTION; TIGHTNESS OF NECK; BODY SPASMS; UNABLE TO SLEEP; SEVERE PRESSURE HEADACHE; DIFFICULTY CONCENTRATING; LIGHT HEADEDNESS; PAIN AROUND LEFT EYE; TIGHTNESS OF FACE; NUMBNESS OF FACE AND NECK; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness of face and neck. On 12-APR-2021, the subject experienced severe pressure headache. On 12-APR-2021, the subject experienced difficulty concentrating. On 12-APR-2021, the subject experienced light headedness. On 12-APR-2021, the subject experienced pain around left eye. On 12-APR-2021, the subject experienced tightness of face. On 30-APR-2021, the subject experienced body spasms. On 30-APR-2021, the subject experienced unable to sleep. On 30-APR-2021, the subject experienced tightness of neck. On 04-MAY-2021, Laboratory data included: CT scan (NR: not provided) CLEAR. On an unspecified date, the subject experienced suspected sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate, naproxen, azithromycin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pressure headache, difficulty concentrating, light headedness, body spasms, unable to sleep, numbness of face and neck, tightness of neck, pain around left eye, and tightness of face, and the outcome of suspected sinus infection was not reported. This report was non-serious.

Pharmacist gave a Johnson + Johnson shot to the patient. After the shot the patient got up and sat down in a "Post-Vaccination waiting area" chair. A few minute later the patient got up and walked towards the pharmacy asking for water, as he was walking to the pharmacist the patient fainted, fell to the ground and bumped his head on the counter. Patient woke up a several second later confused and laid on the floor. Code white and 911 was called. Another pharmacist grabbed an ice pack and a bottle of water for the patient. Patient said he went to the dentist office recently and received a shot in the mouth and something similar happened as well. The patient did not disclose this information to the immunizing pharmacist. Patient told us to cancel the 911 call and asked to leave, the pharmacist recommended he stay a while longer so we can monitor him. Patient said he had no history of diabetes or seizures. Patient forehead was slightly red.

Patient in chair sitting position at time of vaccination, minutes later fell out of chair face forward and on carpet floor lying on left side breathing hard. Patient had rug burns on face. Patient lost consciousness for about 1 to 1 and a half minute patient snapped back immediately and slowly came back to being oriented. EMS arrived to check over patient, patient was nauseated and vomited. Patient complained of neck discomfort, EMS pressed on patients neck and EMS felt it was muscle related. Patient refused additional service from EMS. EMS advised patient to seek additional services from hospital if symptoms worsen.

red bump from injection itchy at injection almost passed out at the gym this morning was dizzy and need to sit for a moment on the floor

Patient adverse events and reactions the following: Breakout in rashes, hives and wheals all of his body. He had to be injected with two epipens and other meds to avoid anaphylaxis shock. Patient has an abnormal heart rate and gets monitored weekly on the effects of the shot. Breakout in rashes, hives, wheals, and have fast/pounding heartbeat daily.

HOT & COLD FEELING; HEAVY PAIN IN LEFT CALF WHEN TOUCHED IT; FEELING LIKE GETTING SICK/LAYING IN BED MOST OF THE TIME; PAIN IN ARM AT INJECTION SITE; SLIGHTLY STUFFED UP NOSE; CALF LITTLE HOT TO TOUCH; This spontaneous report received from a patient concerned a 37 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced calf little hot to touch. On 25-MAY-2021, the subject experienced slightly stuffed up nose. On 25-MAY-2021, the subject experienced hot & cold feeling. On 25-MAY-2021, the subject experienced heavy pain in left calf when touched it. On 25-MAY-2021, the subject experienced feeling like getting sick/laying in bed most of the time. On 25-MAY-2021, the subject experienced pain in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm at injection site, had not recovered from heavy pain in left calf when touched it, feeling like getting sick/laying in bed most of the time, slightly stuffed up nose, and hot & cold feeling, and the outcome of calf little hot to touch was not reported. This report was non-serious.

Shingles outbreak on left side of face/ head beginning ~ 5 weeks after Janssen Covid vaccine (fever, inflammation, blisters, rash, swelling, nerve pain, headache, occular complications)

Hives outbreak approximately a week following injection, suddenly appeared on feet and hands, thought it resembled ringworm initially. Quickly spread and appeared nearly symmetrically as itchy raised red patches, moving on both arms (shoulder/bicep) and legs (inner thigh). Individual areas quickly resolved as it spread further down the limb until reaching the hand/foot and disappearing leaving no trace. Experienced three (3) flareups starting in similar areas of the hand/foot, arms/legs, with each recurrence pushing further up the limb/body until stopping around the abdomen/back/neck. Largely ceased after about 48 hours, but still observing occasionally on sides of feet/ankles days later.

37-year-old foreign-speaking patient walked into the vaccination site accompanied by wife at about 11:45am. They requested the Janssen Covid-19 vaccines for the both of them. Patient signed all necessary consent forms and pre-vaccination checklist requirements, and entered the vaccination section at around 11:50am. The Janssen vaccine was administered at 11:57am. At 12pm patient started to experience light-headedness, dizziness, and change of LOC. At 12:01pm charge nurse called 911. Patient?s wife and observation nurse asked patient how he was feeling but patient was unresponsive and disoriented for about 30-60 seconds. Soon after patient was able to speak and started complaining of being nauseous and observation nurse handed patient a garbage bag to throw up. Charge nurse hooked up patient with pulse oximetry at 12:02pm with a reading of 98. Nurse assessed if patient is experiencing any symptoms of hives or redness, shortness of breath or any difficulty breathing or swallowing, and patient denied any symptoms. Administering RN hooked up patient with the blood pressure machine and BP reading was 167/156 with a pulse of 56. At 12:03pm BP reading was 139/75 with a pulse of 62 and pulse ox reading of 95. At 12:06pm BP reading was 153/115 with a pulse of 67 and pulse ox of 95. Patient also stated that his left arm started to get numb and tingly feeling. At 12:07pm first responder 911 came and took over. Patient was hooked up to EKG and found some arrhythmia and was advised to go to the hospital to further evaluate. Patient agreed and was taken to the nearest hospital at about 12:20pm. Action taken: Charge nurse called 911 for help and hooked up patient with pulse oximetry and assessed patient for any sign and symptoms of any allergic reactions to Janssen Covid-19 vaccine. Administering RN and observation nurse continuously monitored patient?s B/P, Pulse, Pulse oximetry, and LOC until first responder paramedics came.

Patient fainted momentarily and fell to the floor from seat. Patient was breathing and groaning before being flipped face-up. Patient was sat upright on the floor and was alert and awake within one minute. Mild impact to right forehead on fall with slight bruising. Suspected vasovagal syncope. ED called, but patient declined ambulance transport to hospital for further help/examination/treatment. Patient stayed at pharmacy for extended amount of time for observation and in order to calm nerves. Patient called friend/family for transport from pharmacy.

It has been 4 months since I got the j and j shot and I still have pain at injection site, that radiates outward on my upper arm and shoots down to my elbow. It is always there, however certain motions and positions irritate it more.

PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient concerned a 37 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.

I've had skin rashes on hands and fingers (similar to a form of contact dermatitis in appearance) since April 11th. I've had what appears to be angular cheilitis since June. I've had irritation, itchiness, and skin peeling around both eyes since June.

FLU-LIKE SYMPTOMS/FEVER/BODY ACHE/CHILLS BUMPS/SLIGHT COUGH; SUPER DROWSY; EYES HOT/ON FIRE; COLD SWEATS; HOT SWEATS; THIRSTY; DRY THROAT; NO APPETITE LAST NIGHT AND THIS MORNING; BLOOD PRESSURE NOT HIGH; COULDN'T GET MUCH SLEEP LAST NIGHT; DRY MOUTH; HIVES; UNABLE TO SMOKE AS IT MAKES HIM NAUSEOUS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced flu-like symptoms/fever/body ache/chills bumps/slight cough. On 20-JUL-2021, the subject experienced super drowsy. On 20-JUL-2021, the subject experienced eyes hot/on fire. On 20-JUL-2021, the subject experienced cold sweats. On 20-JUL-2021, the subject experienced hot sweats. On 20-JUL-2021, the subject experienced thirsty. On 20-JUL-2021, the subject experienced dry throat. On 20-JUL-2021, the subject experienced no appetite last night and this morning. On 20-JUL-2021, the subject experienced blood pressure not high. On 20-JUL-2021, the subject experienced couldn't get much sleep last night. On 20-JUL-2021, the subject experienced dry mouth. On 20-JUL-2021, the subject experienced hives. On 20-JUL-2021, the subject experienced unable to smoke as it makes him nauseous. Laboratory data included: Blood pressure increased (NR: not provided) Little high. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: tetryzoline hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from super drowsy, cold sweats, hot sweats, flu-like symptoms/fever/body ache/chills bumps/slight cough, eyes hot/on fire, thirsty, dry throat, couldn't get much sleep last night, hives, and dry mouth, had not recovered from no appetite last night and this morning, and unable to smoke as it makes him nauseous, and the outcome of blood pressure not high was not reported. This report was non-serious.

Mild fever around 100 degrees, severe chills, headache, fatigue, sore arm at injection site. Ongoing from around 7pm so about 2 hours at this point. Arm felt a bit sore for the first time around 2pm today.

Told to include this information in this box: Janssen COVID-19 Vaccine EUA Symptoms: Fatigue, nausea, body aches (entire body, but especially hips and injection site), and temperature between 98.5F-99.8F all day on the first day following the day of injection. Tylenol taken once and Advil taken twice throughout the day, which mostly relieved symptoms. Second day following day of injection, moderate fatigue in the afternoon, even after full 8 hour sleep with CPAP on all night.

No initial adverse reaction to vaccine and negligible localized pain at injection site. Sudden onset chills, severe tremors, and muscle spasm beginning +12h after vaccine administration, lasting ~2 hours followed by high fever (peak 103.6F), treated with acetaminophen OTC. Persistent fever (>100F) until +18h after vaccine administration. Fatigue, headache, muscle soreness persisting +24h after administration.

allergic reaction. Rash, itchy to BLE and BUEs x 2 days with swelling; pt reports mainly in joint areas, getting worse today and spreading; received J&J vaccine on 10MAR21. Rash with redness and itchiness to BUEs/BLEs; no pain; patent airway. MDM: Pt does not have anaphylaxis. The temporal relationship to COVID vaccine is suspicious. Will treat as allergic reaction. F/u and return precautions discussed.

Patient called and stated feeling some tingling on spots around my face. Nothing serious. Just like random small areas. Pt can still smile, talk and stick my tongue out normally. Pt states he had a red itchy spot over his eyebrow dime size but gone now, skin under his lower lip felt itchy and numb. He denies any chest pain pressure, SOB, wheezing, throat/tongue itching/swelling, diff swallowing, edema, GI sx. No hx of GB or Bells. He is able to move and talk, blink, stick tongue out w/o issues.

Shot at 9 am 4/2/2021 Back pain: 6pm 4/2/2021 Chills and body aches 7 pm Fever 9 pm( lasted about 12 hours) Body aches for the next 36 hours Arm pain and bruising

Confirmed Shingles outbreak. First time ever having shingles. Received prescription for Valaciclovir.

3/28/21 started to have jaw pain. 4/2/21 a lump started to form in neck. 4/3/21 lump in the neck and evening broke out with lesions on the left side of forehead, nose and temple. Went to ER for evaluation, CT scan with contrast. CT confirmed lump was swelling of lymphoid. ER thought maybe shingles, but it crosses over slightly over to the right with lesions.They determined maybe a virus and follow up with a dermatologist. 4/4/21 lesions now on left eye lid. ER visit again to ensure eye is ok, the ER dr. believes its shingles. 4/5/21 visit to dermatology and swab of lesions on face taken (still waiting on results). Dermatology believes some kind of herpes, but not sure. Went to Eye specialist to ensure eye does not have virus on same day. Eye dr believes shingles. Virus is not in the eye, but on left eyelid.

Soreness at injection site immediately after dose. About 9 hours after dose chills, headache, neck aches, and leg aches began. Fever was noticed around 1am pushing 101F. By morning, most were better.

4/1 pt complained of not feeling well after Janssen vaccine. Patient had a syncopal episode while at monitoring tent, patient was trying to lay down on medical bay cot but ended up falling back and passing out. Pt was clammy and pale. Heart rate 42, spO2 99%. Pt oriented to self but not time or place. EMT arrive to further evaluate patient, BP 90/60. heart-rate 55, respirations 18. Patient refused to go to hospital, felt well enough to go back to work. Charge nurse followed up with patient later that day, patient was still at work and said he felt a lot better. One week later pt reached out on 4/8/2021 to inform on potential side effects. On the night of 4/7/2021 he began to develop hives/rash, and itchiness around the neck and legs. Next morning 4/8/2021 rash had worsened and pt had also developed swelling in the face and wrists. Pt was brought to urgent care where he was treated with prednisone. Pt was prescribed 20mg prednisone tablet twice a day. Charge nurse from day of vaccine followed up with patient, he will continue to take prednisone as prescribed and will follow up with allergist. Pt claims the itchiness is less, as well as, the swelling. Appreciates the follow-up phone-call and claims to feel better, will update us if any changes.

Rashes all over different parts of the body causing severe itchiness and some swelling. Randomly appears in places and disappears after two or so hours.

Tighten and sore at injection site. Arm pain when raising shoulder. Fever of 101 and chills about 24 hours after injection. Lasted for 8 hours after use of Tylenol and ibuprofen. Arm pain remains after 48 hours.

Fever of 100 degrees F. Chills and body soreness. No treatments. Fever broke the next day, Continued soreness at the injection site.

Felt dizzy/lightheaded for the first few days after vaccine. 4/9 he noticed the development of petechiae. 4/10 he went to the ER about it and his labs came back normal. He said it continued to spread after his ER visit. I reviewed with him there isn't a treatment option and it should clear on its own, but if it still continues to spread or spots get bigger, if he develops a fever, increased heart rate, or pulse changes to contact his doctor or go back to the ER and followup with us as well.

Started breaking out in red rash/ chicken pox- like break out on day 10 after vaccine on the arms. On day 11, it spread to all over body - legs, arms, stomach, back, and also started on the face by day 13. The red spots were very itchy. VIsited my primary doctor who said that it could be the vaccine. Gave me steroids and benadryl that relieved the itchiness, But when the effect of the meds faded, the itchiness was back. All red spots were yery itchy all over my body. They were not contagious as my children and wife did not get it. My wife got the same vaccine on the same day as me, but did not have a reaction as mine. . The red spots started growing in size and combining with other nearby spots on the legs. over day 12, and became brighter. They are fading now, but I still have the red spots all over my body.

After two days I start itching profusely with red bumps all over my body. This lasted for 10 days after the start

Patient stated that he got hives around the injection site and later it spread to other parts of his body - this is now resolved Patient stated that he felt a tightness in his chest on the evening he got vaccinated and that it has persisted until now. Patient refused to go to the hospital for evaluation

ITCHY RASH ALL OVER THE BODY; FEVER; This spontaneous report received from a patient concerned a 38 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced itchy rash all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from itchy rash all over the body. This report was non-serious.

pt developed a severe migraines and is still having them. He vomits every time he eats. He developed a rash on his chest, has shortness of breath, runny nose. Some confusion and brain fog. He went to ER in on 4/16/2021 for migraine headache and other symptoms. He was given a CT and a shot of Demerol and sent home to FU w/ neurologist. He continued having migraines so went back to ER on 4/18/2021. He had an EEG, ECG, and abnormal lab work. He was given another shot of Demerol, Phenergan and IV fluids. He was monitored for a few hours and released to FU w/ Neurologist.

SWOLLEN FACE; BAD RASH ALL OVER BODY; PASSED OUT; This spontaneous report received from a patient concerned a 38 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, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient passed out and had no symptoms until seven days. On 07-APR-2021, the patient experienced pretty bad rash. On 08-APR-2021, the patient experienced swollen face and rash all over body which made him to visit an urgency clinic where he was prescribed with prednisone for rash. The patient visited doctor or healthcare professional office for events passed out, swollen face, and bad rash all over body and emergency room or department or urgent care for events swollen face, and bad rash all over body. It was reported that, the medication had not eradicated the symptoms but only calmed them down. According to the patient, if he had stop taking the medications the symptoms would go back to the same intensity as before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 01-APR-2021, and had not recovered from swollen face, and bad rash all over body. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422310-covid-19 vaccine ad26.cov2.s -Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

BLOTCHY RASH ON THE TRUNK (STOMACH TO CHEST); RASH ON UPPER INSIDE THIGHS (BOTH SIDE); RASH FROM ELBOW TO WRIST (BOTH SIDES); SHOULDER PAIN (DULL); This spontaneous report received from a patient concerned a 38 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: 205A21A, 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 shoulder pain (dull). On 18-APR-2021, the subject experienced blotchy rash on the trunk (stomach to chest). On 18-APR-2021, the subject experienced rash on upper inside thighs (both side). On 18-APR-2021, the subject experienced rash from elbow to wrist (both sides). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain (dull) on 12-APR-2021, and had not recovered from blotchy rash on the trunk (stomach to chest), rash from elbow to wrist (both sides), and rash on upper inside thighs (both side). This report was non-serious.

PINCH IN HEART; BURNING SENSATION; PIMPLES ON CHEST; ITCHINESS IN CHEST AREA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included confirmed covid-19 infection, and concurrent conditions included non smoker, non alcohol user, and benadryl intolerance, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the subject experienced pinch in heart. On 02-APR-2021, the subject experienced burning sensation. On 02-APR-2021, the subject experienced pimples on chest. On 02-APR-2021, the subject experienced itchiness in chest area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pimples on chest, pinch in heart, burning sensation, and itchiness in chest area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

MIGRAINE TYPE HEADACHE; PAIN IN NOSE; FEELING OF PIMPLE INSIDE NOSE; PAIN IN EYES; PRESSURE IN LEFT EYE; BLINKING LIGHT AURA IN LEFT EYE; NASAL PRESSURE; FEELING OF BUMPS INSIDE NOSE; PAIN IN FOREHEAD/A LOT OF HEADACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient have no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol. On 05-APR-2021, the subject experienced migraine type headache. On 05-APR-2021, the subject experienced pain in nose. On 05-APR-2021, the subject experienced feeling of pimple inside nose. On 05-APR-2021, the subject experienced pain in eyes. On 05-APR-2021, the subject experienced pressure in left eye. On 05-APR-2021, the subject experienced blinking light aura in left eye. On 05-APR-2021, the subject experienced nasal pressure. On 05-APR-2021, the subject experienced feeling of bumps inside nose. On 05-APR-2021, the subject experienced pain in forehead/a lot of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in nose, feeling of pimple inside nose, and feeling of bumps inside nose on 07-APR-2021, had not recovered from pain in forehead/a lot of headaches, migraine type headache, pain in eyes, pressure in left eye, and blinking light aura in left eye, and the outcome of nasal pressure was not reported. This report was non-serious.

Symptoms: Fever, tiredness, body aches, joint pain, soreness around eyes, and soreness at injection site. Symptoms started approximately around 7:00 P.M. , which is approximately six hours after receiving the vaccination.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: close to fainting several times-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Specifically tingling in Hands. Patient was very disoriented and appeared close to fainting a couple of times post vaccination. Was closely monitored for 30 minutes. He did not think it was due to being nervous, he was slightly nervous before the vaccine, but nothing of concern.

Patient presents with a diffuse rash on his back and what appears to be hives on his shoulders and chest.

my arm got hard at the injection site almost immediately and sore, the feeling and hardness has persisted for more than 7 days.

Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild

Pain and swelling at the injection location. Extreme tiredness, headache, muscle pain/soreness, chills and intermittent (minimal) nausea. Felt like my body was working harder than normal, with slight tightness in my chest.

red warm and sore left upper arm ( vaccine was administered in Right arm - hours after - next day warm to touch - painful swollen with are of rash

Rash developed on neck, and the next day has spread all over body in red splotches. Rash is mildly itchy.

Patient came to the pharmacy 3 days after receiving the vaccine and complaint of red rash all over the body. Advise patient to seek care at the emergency room. Followed up with patients 2 days after, per patient the emergency room gave him medication for the allergic reaction and that he is doing well after the medication.

SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. 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).

Soreness at injection site immediately and lasting afterwards at least 24h. About 6 hours after vaccination, general aches, headache, fever (~101 oral reading while taking ibuprofen), chills, insomnia; all of these symptoms lasting (so far) about 16 hours and continuing.

BEFORE GIVING THE JANSSEN COVID VACCINE (LOT # 1805025 EXP 5/25/21), THE PATIENT HAD STATED THAT THE LAST FEW TIMES HE GOT A SHOT OR HAD A BLOOD DRAW HE GOT REALLY SICK AND EVEN PASSED OUT. THE VACCINE WAS GIVEN WITHOUT INCIDENT AND PATIENT SAID HE FELT OK. HE TRADED PLACES WITH HIS GIRLFRIEND AND SAT IN A CHAIR IN THE EXAM ROOM. IT WAS NOT UNTIL AFTER I HAD ALREADY GIVEN HIS GIRLFRIEND HER VACCINE THAT HE SAID THAT HE WAS FEELING FUNNY. HIS COLORING CHANGED AND HE WAS DIAPHORETIC. I GOT A PAPERTOWEL WITH COOL WATER ON IT AND PLACED ON HIS NECK AND ANOTHER ONE FOR HIS FOREHEAD. AFTER A MINUTE OR SO, HE DID PASS OUT WHILE IN THE CHAIR. HE WAS OUT FOR ABOUT 30 SECONDS AND THEN CAME BACK TO AND WAS ALERT AND ORIENTED X 4 BUT STILL FELT VERY WEAK. I GAVE HIM A WATER TO SIP ON. HIS GIRLFRIEND STAYED AT HIS SIDE THE WHOLE TIME. HIS O2 WAS 100% AND HIS PULSE 53. HE SAID THAT HE HAD EATEN SHORTLY BEFORE COMING TO GET HIS VACCINE BUT THEN LATER ASKED FOR AN APPLE BECAUSE HE WAS ON A CLEANSE DIET AND REALLY HAD NOT EATTEN MUCH. THE PCT WENT TO GET HIM AN APPLE. AFTER EATING THE APPLE AND SITTING FOR AN ADDITIONAL 20 MIN HE FELT WELL ENOUGH TO LEAVE. STILL WITH HIS GIRLFRIEND AND HIS GIRLFRIEND COMMITTED TO DRIVING HIM SO HE DID NOT HAVE TO. HE LEFT WITH NO ASSISTANCE.

Janssen COVID-19 Vaccine EUA 3/15 12:30pm -Rash developed on injection arm and down right side of upper body.

Received vaccine at 7PM, and by 1:30AM had severe chills/shivering; Fever reached 103, and continued throughout the day. Finally dropped to 99 by 3PM the next day. Continued throughout day to have body aches, head ache, chills. Around 3PM had hives on both sides

Evening of vaccination: fatigue, sensation of feeling hot Day after vaccination, AM: mildly sore arm at injection site, sore joints elsewhere, continuing fatigue Day after vaccination, PM: continuing fatigue

Chest fluttering Dizzy/nauseous/fatigued 1st day Fever/chills/tension headache 2nd day Mild chest tightness 3rd and 4th day Sweaty/clammy hands and feet every day since vaccine Waking up sweaty every night Mild left ear Tinnitus 4th day Forehead Neck/throat/chest/stomach warm no fever 3rd and 4th day Some loose stool 4th day, vertigo Imbalanced feeling chest quivering elevated heart rate 4th day constipation 5th day and insomnia along with severe vertigo when lying flat severe tension headaches mild hearing imbalance and popping both ears 6th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 7th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 8th day pressure on head, stomach burn, heartburn weak legs vertigo 9th day

The night of 3/23/21 at 5pm I had chills in my Brady and numbness and tingling in my toes. I looked at my toes and noticed they were turning very pale. One minute later the bottoms of my feet started turning yellow and within one more minute the bottoms of my feet souls were completely yellow. I have never had this reaction before. It was shocking and looked like I had stepped in yellow paint.

Sweats, chills, tired, nausea, aches, sore arm where shot was given - most adverse events have subsided. Still a little achy, drowsy and sore arm shot was given. Sweats still at night but not as bad as the 2nd night after the shot was given.

PATIENT REPORT MODERATE RASH AND SWOLLOWEN BUMP ON NECK. I ADVICED PATIENT TO TAKE IBUPROFEN AND BENADRYL. I RECHECKED AFTER 2 HOURS AND PATIENT HAD IMPROVED IN SYMPTOMS

Felt a little hit after shot and was asked to stay 30 minutes cause was a little red and heart rate was a little elevated. The following 2 days had a 103 fever shivers muscle pain and fog in head 4 days later still don't feel 100 percent

PATIENT WAS VERY ANXIOUS AT THE TIME OF THE INJECTION. INMEDIATELY AFTER THE FACT PATIENT FELT STINGING PAIN AT THE INJECTION AREA AND FELT LIKE A BRACHIAL PLEXUS LESION . HE was unable to fully close his hand for a few hours. WE CONTACTED HIM THE DAY AFTER AND HE IS FEELING WELL. PATIENT PUT ICE ON THE HAND.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild

Chest pain, fever, body aches, headaches, blurry vision. All seemed to last about 5 days. Pain at injection is still sore. Wife had same exact adverse effects.

After 18 days of vaccine I feel itchy body and cramp legs at night. Also I still feel soar throat and stuffy nose.

That evening patient developed rash on legs. Progressed over the course of several days to include severe rash (red/purple bumps) on legs, red spot at injection site, itchy all over. Rash spread to include trunk by 4/11/21. Patient was using hydrocortisone cream and benadryl over the counter. Advised patient to see medical doctor. Patient went to hospital and was discharged on Prednisone.

Within a few minutes of receiving the vaccination I lost consciousness. It was a drive-through vaccination clinic by the Health department. My vehicle rolled into a cement and metal bar/side of the building's exit at a slow speed. The EMS at the scene stated that my heartbeat was irregular, varying between bradycardia and tachycardia. When they checked my blood pressure inside the ambulance they stated it was very low. About 15-20 minutes later I tried to sit up and was still unstable and unable to keep myself upright without assistance. I was then taken by ambulance to the nearest hospital's emergency department. Nothing notable or unusual was found when I was checked out there. Within a couple hours I felt well enough to go home. Once home I had a headache, fatigue, mild dizziness, and nausea with physical activity. The following day I had a headache, muscle aches, pain at the injection site, and nausea with extended physical activity. Today I have pain in the arm where I received the vaccine and a mild headache.

Developed within 10 hours and lasted 36 hours Severe body aches Fatigue Metallic taste in mouth Injection site pain that lasted 1 week Fever of 104.3

5:30PM on Saturday 4/10/21 began chills and slight headache. Arm very sore. 7:00PM fever was 101, chills and headache worsening 9:00PM fever was 102.1, chills, massive headache and bones of legs hurt. 11:00PM fever was 102.7, all same symptoms except now whole body hurt and very cold. 4/11/2021 12:00AM fever was 102.9, all same symptoms, started Tylenol 2:00AM fever was 103.1, all same symptoms 4:00AM fever was 102.9, woke up nauseous 5:30AM fever was 102.7, threw up. 6:00AM fever was 102.9. Took more Tylenol 10:00AM fever was 101.1. Was able to sleep for 4 hours 12:00PM fever was 100.5. Took Advil (2) for headache. 5:00PM fever was 98.3. Took more Advil (2)- headache was still pounding. 9:30 PM fever was 101.5. Chills returned. Went back to Tylenol. 4/12/2021 1:00AM fever was 98.9. Chills were gone. Felt better. 7:00AM fever was 98.3. 9:30AM Feeling foggy. Left work to come back home. 9:45AM fever was 99.5. Took Tylenol. Head still hurting but manageable. 11:00AM fever was 101.1. Headache returning. 1:00PM fever was 100.9. Same general weakness. 3:00 PM fever was 101.4. Took Tylenol. 6:00 PM fever was 99.5. 9:00 PM fever was 99.0 11:00 PM fever was 98.2 4/13/2021 Slept through the night. Stopped taking medicine. 8:30AM fever was 98.6 11:00AM fever was 98.8 As of right now, I feel better outside of just general weakness from previous fever. At injection site is still extremely sore and today has developed to look a bit infected. It is itchy and sore to touch.

ITCHING; RASH ON ARMS, BACK AND LOWER TORSO; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 39 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: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced flu-like symptoms. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced rash on arms, back and lower torso. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 08-APR-2021, and had not recovered from itching, and rash on arms, back and lower torso. This report was non-serious.

Pt notes he had J&J covid vaccine on 4/8. He states that immediately, he had L arm pain and low grade temps for 2 days. He notes in the past few days he started having a rash around his ankles and left wrist area. He has also had some intermittent tingling in the first 3 fingers of his L hand. He states this is worse with use of his computer. No weakness. The rash on his legs are b/l. He hasn't had any allergen exposure that he knows of. He tried benadryl which did not cause any change. He notes that the triamcinolone that was prescribed seemed to wrosen the rash. He currently has no tingling in his arms.

Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: major pain right arm-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: someone spoke to patient. He is complaining severe pain down his right arm to the point where he had to take an LOA. He is not physically capable to flying a plane at this time. He is not a citizen and cannot collect unemployment, so he is out on unpaid LOA. He attributed this injury to be caused by the immunizer injecting too high on the deltoid, and possible hitting the radial nerve. He went for an MRI which he had to pay out of pocket for and is awaiting results.

I got the vaccine and chills, fever, nausea, diarrhea and dizziness. I was kind of our of breath and fatigue, I wasn't able to life anything and constantly out of breathe. It was hard for me to do anything, I had to rest all the time and take off of work. I was driving to work and had to keep pulling over because I felt dizzy. I ended up going to the Dr. and had test ran and they said I was extremely dehydrated and I didn't understand because I drink a lot of water. they hooked me up an IV and gave me fluids. They said I was Healthy just extremely dehydrated it. My injection site was kind of tender but nothing more. I'm still having issues. I'm just always thirsty no matter how much water I drink.

I developed a very itchy rash on my back, hands, feet, arms and what felt like everywhere. The just today stopped. The rash lasted about 8-10 days I would say. It got worse over the course of a week and then started getting better. Someone suggested I take an anti-inflammatory, because my hands were swelling and it was difficult to work at the computer. That seemed to help immediately or it could've just started to go away on its own. Regardless, I've kept the twice daily naproxen for the past 4 days and things seem to be all better now. My wife suggested I report my reaction. The small red bumps were scattered mostly on my back, feet and hands. They looked very similar to shingles but without the big red splotches only the small red bumps. As they were forming they appeared to be sun blisters and then turned bright red. Extremely itchy and kept me up scratching at night and scratching all day.

Right eye twitch, right side of face swelling, pressure right side of face, shingles like rash up left side of torso. The rash lasted a week the face swelling and twitching non stop since about day 7 and has not let up

Hives, swelling in lips, face, metallic taste in mouth. Continuing even after ER visit at 4 am Wednesday morning and taking meds to control reaction

4/10/21 - I took 4 low dose Bayer aspirin about 11:45 AM on 4/10/21. I received the Janseen COVID19 vaccine about 12:45 PM on 4/10/21. I cleared the 15 minute monitor period at 1:05 PM. About 8:00 PM on 4/10/21 I felt slight chills and left wrist was achy. About 9:00 PM on 4/10/21 chills persisted and I felt fatigued. About 9:45 PM on 4/10/21 I felt more body aches and took 4 low dose Bayer aspirin at 81 mg. About 10:15 PM I had a temp of 100.4 F and body chills. 4/11/21 - About 2:35 AM I had a body temp of 101.6 F with body chills and night sweats. About 11:25 AM body temp decreased to 99.9 F and had a headache. I took another dose of 4 low dose Bayer aspirin. I slept a total of about 3 hours from 10 PM on 4/10 to 10 AM on 4/11. About 9:00 PM body temp was 99.6 F. 4/12/21 - About 8:30 AM body temp was 97.9 and slept more than 5 hours with light to moderate night sweats. Experienced injection site pain from 4/10/21 to 4/13/21.

Chills and Fever the first day a few hours after injection along with Fatigue, Multi-day Headache, Slight Body Ache, and Injection Site Pain all for about 2 or 3 days. Some leg pain was noticed the 2nd or 3rd day. And I have experienced ear ringing randomly about a week and a half after vaccination. Those may or may not be related. Also I feel it important to note in March of 2020 (before testing was available) I experienced a very similar set of symptoms: fever, chills, fatigue, multi-day headache, body ache, 6 weeks of slight cough, leg pain, and a day a few weeks after the coughing started where I had shortness of breath. I wasn't tested back then as it was not available. But based on the symptoms I experienced, I truly believe I had COVID-19 last year prior to vaccination.

Fever, severe chills/violent shivering, extreme fatigue, loss of appetite, diarrhea, muscle/body aches, prolonged pain at injection site

Three days and continuing since onset Fevers of above 100(Tylenol sometimes controls fever) 2 every 6 hours Muscle aches Extreme fatigue Dizziness Shivering /hot and cold flashes Loss of strength Mental confusion Coughing Shallow breathing Loss of taste and smell Loss of appetite Nausea Sensitive skin(pins and needles)

I have had headaches every day since I received the vaccination that last most of the day. There is a constant pressure in my head that moves around all areas, from the back base of the head, to the sides, temples, forehead/sinus regions. It is from waking until sleeping. Not incredibly intense, but constant. I have difficulty sleeping through the night and have not slept well since, either. I have also experience blurred vision. I have also experience bruising on various parts of my body including my arm, abdomen, and toe nails. My quality of life has suffered tremendously and I wish I hadn't gotten the vaccine.

maculopapular rash on arms, legs and trunk when evaluated on 5/11/21 and 5/14/21 Symptomatic treatment started 5/12/21 with benadryl and hydrocortisone no improvement per patient when seen on 5/14/21, so was started on medrol dose pack and vistaril

day followimg shot: i awoke to extreme pain in all muscles and joints, profuse sweating, blurred vision, headache just behind my eyes muscle/joint pain lasted approx 24 hours; ibuprofen offered some relief. sweating lasted 3 days and resulted in dehydration to the point where my kidneys ached; i drank as much water as i could but my urine remained dark headaches/blurry vision lasted 2 days 5 days after the shot, the soles of my feet began to feel itchy, and the itchiness has been ongoing even up to now (7 days after shot) 7 days after shot, itchiness has also begun affecting the palms of my hands

Headaches started within 1 day of vaccination and persisted for 3 weeks before ending; Lightheadedness started 3 days after vaccination and has not subsided; periodic tingling and short bursts of pain in feet and hands started ~4 weeks after vaccination and have been decreasing in intensity but are not gone; small yellowish bruises have unexplainedly shown up ~4 weeks after vaccination (top of right foot), ~5 weeks after vaccination (left forearm), ~8 weeks after vaccination (right side upper back), ~9 weeks after vaccination (lower left abdomen); occasional instances of chest discomfort started 6 weeks after vaccination and still occur infrequently No specific diagnosis; treatment has included increased daily walking, increasing water intake, occasional wearing of compression socks (knee high)

Slight ache where vaccine was. I woke up the next morning and it felt like I couldn't sleep. I worked that day but had extreme fatigue. Couldn't get up for work the next two days - extreme fatigue. It was a little better on Saturday and by Sunday it felt like I was getting my energy back. IF I hadn't been working at home, I probably would have missed my Wednesday work day that first day. I had at Hospital Hemorrhoid Surgery (outpatient surgery) on the 22nd of April. My recovery had been going well for the first week or so but now I am having an issue with hard stools. I am taking liquids every and I am having a bowel movement every day and I can't get them soft - they are all hard. I am taking two stool softeners a day. and I'm taking fiber. I am being impeded my recovery of my surgery - I'm a week or two behind in recovery because of this.

Was fine at the time and shortly after the injection. Woke up the next morning to a 103 degree fever, chills, sweating, disorientation, headache, vertigo. several days later developed a "shingles-like" rash around the injection site which is now radiating down the arm and back of shoulder. Rash is only in that area and no where else on the body. no previous history with vertigo or shingles rashes

Night of the vaccination had a fever of 102., body aches, chills and fatigue one night tired for a couple of days then three weeks later three weeks after vaccination had a fever body aches, chills, fatigue lasted 9 days, 3rd short ness of breath, 5th day head aches,6th blistered and body swelling, face swelling lips, neck and antiphallic type. A week into the symptoms Tele visit was told to take Benadryl next day, Emergency room a week into the symptoms, after taking Benadryl and was not seeing relief. Right wrist blister and both arms and legs was swollen feet and ankle was swelling and over the weekend the swelling. 5lbs of water swelling. Cold sweats through the symptoms.

AE: patient felt warm pain on the right arm after 1 minute of vaccine administration. As per the patient, never felt this kind of pain before. there was no numbness, no tingling. it did not hurt upon palpitation. Treatment: patient was offered water to drink and kept under observation. Approximately 10 minutes after observation, patient symptoms improved. Outcome: Patient was discharged to POV/Home.

Probable shingles (herpes zoster) outbreak on top/bottom of right forearm. Had chicken pox but no prior history of shingles.

I got a very strange rash all over my back - went to urgent care - they gave me a steroid pill - still hasnt gone completely away - Ive also have had pains in my nerves in my left leg and up to my chest [ heart] tightness in my chest and tingling in my arms and legs. Still having those. But about a week or so later went to urgent care for that and felt like i was going to faint.

Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone