Johnson & Johnson

Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium

Patient describes pain and swelling at injection site that is spreading down the arm halfway to the elbow. Patient states that redness is continuing to get larger at 6 days out from vaccination.

The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a "rash" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area encompassing her entire breast. Axilla excluded. No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation.

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle and lower arm. After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three.

Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash.

At 9pm I started to feel tired and went to bed. At 3am I woke up with nausea, headache, and arm very sore at site of injection. I was also a bit dizzy when I got up. By 10am, I just had a bit of a heachache and fatigue.

patient had a hot feeling all over her body and her skin was red. . had no rash, no fever, no lesions. this resolved on its own.

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Frequent runny stools 11. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

The patient experienced a bright red rash that extended from her upper left ear to the upper chest that has not reduced in size. This began about 30 minutes after receiving her vaccine. She described it as broken capillaries. She has no other symptoms at this time. She spoke with the manufacturer and they told her to see her primary care physician. However, she said she does not want to do this. She still has the rash currently.

patient started reporting tingling in the throat and tongue after receiving vaccine. patient was given 25 mg of Benadryl and was then assessed by a physician. After 1st Benadryl, pt reported that tongue tingling improved but lips felt itchy. On exam, pt had a perioral rash. Benadryl 25 mg x1 given. 10 minutes later, rash was still present. Kenalog 40 mg IM was given. 30 minutes later, rash improved and patient doing well. she was discharged on prednisone 20 mg daily x 3 days.

initial and prolonged swelling with itching and hardness at the injection site which has escalated RT shoulder ache.

Awakened by itchy, red hives at about 4am or 5am every morning since administration of the vaccine. Most of the hives are on the torso, more severe on the front and some on the back. A few have been on my arms. After going back to sleep, the hives are gone when get up for the day. No hives during the day. Then awakened by hives again at 4am or 5am. Prior to receiving the one-dose Janseen COVID-19 vaccine, had only experienced hives three times in my life, several years apart. Now it has occurred early every morning seven times in a row and expect it will happen again, since the ones this morning were worse than the previous few times.

I broke out in itchy hives all around the left arm injection site, underarm, and left breast. This occurred one hour after injection and 45 minutes after I left the vaccination site. I took one Claritin OTC antihistamine and within 15 minutes, all reactions went away. No other symptoms occurred, not even soreness at the site.

severe chills, exhaustion, nausea, constipation, urinary discomfort, odor in urine - most symptoms lasted until Tuesday 3/16. However, that evening I developed a red bumpy itchy rash on both my legs (front only from knee to upper thigh). I took a Benedryl and it was gone this morning. The discomfort while urinating has returned this morning 3/17 and my primary doctor is sending me for lab work.

Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days. The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath. I was coughing up a lot of mucus. The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme. 8 days after the vaccine I started to have pain at the injection site. My upper hurt if I touched it. Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them. This seems like a muscle pain from the injection site to my shoulder.

Round raised blotchy 2 inch spot on arm that is sore and itchy. Began two days after shot, and is still continuing.

I noticed a rash on my right upper arm. At first it was small bumps (no color) & didn't itch. After a few days the bumps got larger & started to itch. They also appear to be turning red in color & possibly spreading. I have been putting anti-itch cream (Benadryl) on them twice a day. I didn't think much of it @ first since I got the vaccine in my left arm. With the weather being cold, I have only been wearing long sleeve shirts. I have not changed my laundry or shower soap either.

Day 7 notes slight "rash" but unsure it was issue Day 8 ( Friday) maybe slightly more- did not itch- didn't pay much attention Day 9 -trunk to breasts (no back) - small red bumps- on tummy appears as large red areas - larger bumps both legs- slightly less on both arms- they do get small and red near ankles- tried benadryl oral - no change Day 10- as above- tried witch hazel only some spots- 2% hydrocortisone cream only some pots and combo some sport- noted no change Day 11 ( 3/22) as above- no real change

Dizziness, vertigo, nausea3 days post vaccine 24 hour after vaccine chills shoulder pain on side of injection

Arm was a little sore after injection but exploded into searing stabbing pain at the 2 week mark. The pinpoint soreness was vague and lingering until the middle of the night last night when the intense pain woke me from my sleep. It isn't bursa pain it is deltoid pain more intense than I ever imagined it could be especially at the two week mark post vaccine!! It is pretty terrible.

Patient got vaccine on a Wednesday and still had swelling and fever in her arm at the site of injection on Monday. She went to see her primary physician for treatment on Monday.

Reason for Visit on 3/30/2021: rash and itching x 2days. Skin Comment: multiple excorations, erythem papules, few ecchymoses. ? due to Janssen vaccine. Take hydroxyzine 25mg bid.

I am covered in a severe rash that itches burns and tingles. First RX was a 4mg prednisone pack that did not help from an urgent care facility. I then went to Dr who gave me RX and the next day it was worse again so the current RX is described earlier. It is not getting any worse but I am struggling to not itch. I can not wear clothes for long periods of time and it is quite debilitating Clothes

Shot immediately started stinging. My upper arm swelled with a hard ridge about 3 inches long and 1 inch wide. Extremely painful. Could barely raise my arm and could not sleep on that side or tolerate even soft touch of my entire upper arm. No other reaction that seemed like an allergic response. I did get very sick for 2 days with severe flu symptoms and strange shooting pains in random parts of my body. Enough pain to wake me from a sound sleep. Bad chills, but no fever. I did. I give my legs seemed swollen for about 3 days. I got the J&J vaccine on 3-6-21 and my arm is still swollen with a slightly smaller hard and painful ridge at the injection site and it sometimes throbs and itches severely. Today is 4-2-21. Starting to wonder if it will ever go away. I still cannot sleep on that side. The pain overall is less, but it still throbs and itches periodically throughout the day.

I received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am on April 6th, I woke up hot and itching. I had a under the skin rash on my arms and legs with little pin prick spots my tongue was tingling. I took Benadryl. It was better in the morning but still visable and tongue was tingling. I took more Benadryl around lunch time.

RASH ON LEGS AND ARMS; SORENESS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced soreness. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 22-MAR-2021, and fever on MAR-2021, and had not recovered from soreness, tiredness, and rash on legs and arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

Fever of 100 for 2 days, muscle pain, chills 1.5 days after shot. swelling and painful arm from shoulder to elbow, bruise a quarter large at injection site for 5 days. Lymph nodes swollen along left clavicle and under arm. Felt fluish. Severe fatigue beginning in evening first day thru morning of 2nd day after shot.

1. Soreness at injection side immediately after administration, duration around 6 hours 2. Significant headache presented in front and sides of head (near temples), beginning day 1 after injection, with duration of 4 days. 3. Fatigue presented on day 1 after injection, duration of 4 days. 4. Mental health symptoms after day 1, with duration of 5 days, presenting as feelings of sadness and depressive ideation. The last symptom (#4) is difficult for me to correlate specifically to the vaccination, as I am a 60 year-old and in my first year in a rigorous doctoral program at a hospital. The negative physical symptoms experienced by the injection could have added an extra layer to the sadness that I reported from the daily app check-ins. I already operate (since fall 2020) in an overwhelmed state (while beginning a difficult academic program via Zoom). Could the physical fatigue and headaches from the vaccine lead to the feelings of sadness? Or were the feelings of sadness a third symptom of the vaccine? I cannot answer, and therefore cannot provide this correlation link with any reliability. I did speak to my therapist via Zoom, and reached out via email to my general physician (who recommended OTC meds.

7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided. Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.

Patient called after leaving the facility regarding the rash on neck left side and right side little bit going towards the both ears. No Itch or puffiness. recommended to take some over the counter Benadryl

Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - skin was sensitive to even my clothes. Headache started in the front of my forehead by late evening, and I literally couldn't even walk up to my bed. Restless sleeping with all the sweating and chills. Woke up with headache remaining and feeling very "wiped out" and still light-headed. No more chills or sweats the next day, but I was weak for about 48 hours. Honestly - I'm very healthy and getting Covid directly from another person couldn't have been worse than getting the vaccine. :( And I am even saying that as a 35 year professional Research Scientist. Thank you

-Within first day through 1 week: dry mouth, excessive thirst, thick mucus, skin sensitivity, dizziness, hyperactivity, hypervigilance, insomnia, irritability, -Persistent even 4 weeks after vaccine: confusion, increase in autism symptoms of sensitivity, "scrambled propioception sensory symptoms", "mismatch of emotions"

Sunday 04/04/2021 started itching on right side next to breast, no redness or rash. itch got more severe over nigh. 04/05/2021 morning lips dry and burni,g throat and back tongue scratchy. 04/06/2021 severe itching from head to toe still no rash or redness. took benedryl called fam. doctor, told me to continue benedryl till itch subsides. evening severe pain in upper stomach near breast, felt like big bubble /knot, started vomiting and diarhea all night . 04/07/2021 entire body rash and hives, went to ER. said it was severe alergic reaction. gave me prednisone shot, and told me to contact allergist. taking prednisone for 4 days also pepcid and benedryl. it is now 04/09/2021 still itching all over , and diarhea

Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking completed. Had mild reactions originally. Pain in arm, and fever next day that rose to 100.9. No chills, no major problems, no rash. A couple nose bleeds on second day which were not typical for me. Returned to work on third day. Now on day 10 I'm convinced I'm having a delayed reaction. Still mild but present. Low temp 99.5, headache, fatigue, feeling of not being normal. Not allowed to work today. Reason for report of such mild symptoms is my surprise of this delayed reaction 10 days later. There is a bruise on my injection arm now, opposite side of arm, that also is puzzling, but not really worrisome. Know to monitor for platelet issues.

Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen

I got an itchy rash on my right leg within the first 15 minutes, staff at the site tried to get me to belief it was from anxiety. The redness subsided though bumps remained when they let me go home. I also felt a bit "detached" on the drive home and really had to concentrate on my driving. Once home, I still felt odd but went about my day. About four hours later, I realized I was scratching my stomach and chest while watching TV. Upon raising my shirt, I saw a bright red rash on the top part of my belly that extended underneath both breasts and to the area directly over my heart, and up my left side into my left armpit. All of these areas were very itchy. I put Hydrocortisone cream on them, which helped reduce the itching quite quickly. I then took half a Benadryl tablet. When I awoke the next morning, the areas that had been bright red now had dark red dots but did not itch. However, I had lines of a bright red, itchy rash on both thighs near my groin. I again applied Hydrocortisone cream and took Benadryl, which helped abate the symptoms. Lymph nodes in my left armpit were quite sore as well, so I took ibuprofen.

Mild pain and redness at injection site. General wide-spread muscle soreness and fatigue after 12 hours and continuing into second and third day. Symptoms consistent with very mild flu vaccine reaction or very mild case of flu. Symptoms lessening on third day after vaccine with some continued muscle fatigue, particularly after activity.

Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.

Patient reports shortness of breath, fevers, chills, diffuse myalgias along with right-sided back and chest pain since receiving the COVID vaccine. Symptoms began a few hours after receiving the vaccine. She reports localized pain to the injection site but denies redness or swelling. She reports she had fevers for 2 to 3 days, highest being of 101. She presented to the ED on 4/10/21 because of worsening shortness of breath with mild cough and pain in her back. This is exertional along with pleuritic. She reports she has overall improved from the myalgias but is generally not feeling well and continues to have dyspnea.

Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs

Severe to moderate headache, fever (unknown first night and feverish feeling since), large joint and abdominal pain, very fatigued, thirsty, increasingly redness and tenderness at 8njection site and surrounding area over the past 2 days.

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

sore arm starting 4/10/21 - at injection site about 50 cent piece size - only when moving arm or brushing up against something, states that feels like immediately after injection but didn't start until 10 days later, nothing visually wrong

Client reported itchiness and redness in face during monitoring period post-vaccination. IV Benadryl was given and symptom resolved. Client was transported to ER for further evaluation.

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

Headache, neck soreness, Itchy all over, fever, and dizziness. Patient stated the headache started around 1:00pm on 4/12/21 and the itchy all over started about 4:00pm. All other symptoms started later that afternoon. Patient called to report this issue and stated he fever is now gone and so is it itchy all over feeling but the sore neck and dizziness are still present.

Started on Monday morning at 8:30 am started feeling cold chills. Took 800mg of Ibuprofen and after an hour felt better. When going to bed around 9:00pm I noticed that my skin was soaking wet and that I had a hot feeling. When I woke up in the morning (tuesday April 13, 2021) around 7am I could not fully open my eyes. I looked in the mirror and noticed that my entire face was swollen and was red in different areas. I took some benadryl as I thought this was an allergic reaction and went back to bed. A litter later I started getting cold chills and then hot flashes. Around noon time I took another benadryl. By 2:30 I was not feeling any better and I also had body aches and pains and called my doctor. I was able to get in to the office. I was told that I was having a reaction to the shot and that I was boarder line for the hospital. They gave me a shot steriod shot and prescribed Metheylprednisolon tablets (24) to be taken as directed and to continue to take benadryl. It's now Wednesday morning April 14, 2020 and the swelling has gone down but not fully gone and I have stated on the prescription. I now have redness in my chest area. I still have a some chills and hot flashes.

Starting the 10th, patient has had bad headache, severe muscle pains more than usual, SOB more than normal and severe fatigue. She thought it would go away but the symptoms got worse with each day. No fever. She had been taking Ibuprofen and Tylenol around the clock. Symptoms had not improved Also had been nauseated since Monday 4-12-21. The site was sore and her arm felt heavy and she could hardly lift it.

At time of injection:Burning and pain at injection site 11 hours later:Fever of 101, nausea, stomach pain, chills and other flu-like symptoms Appx. 8-10 days later: terrible deep /aching cramp-like pain in upper left arm. Limited range of motion due to pain. Sporadic head aches-unusual for me as i do not hget headaches unless it's sinus which this isn't.

on 4/11 she developed fever and chills, on 4/13 itching started at ankles, by morning she had a red rash from neck to toes. Appeared small raised rash, very itchy.

SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.

Warm, itchy red patch approximately 2 inches below vaccine site. Swollen, itchy, erythametous, and warm to touch, painful. Tired.

initial symptoms- rash, itching, elevated BP, headache, ankle swelling ultrasound on 4/6/2021 - bilateral DVT CBC low platelets - 16 thousand CT chest - moderate burden PE Pt. was hospitalized

Patient reported a "prickly rash" on their back, around side, and underarm 2 days after receiving vaccine. Patient reports is was itchy, she took Benadryl. Patient reports is has since improved.

Patient presented to ER with diffuse rash over body and minimal shortness of breath. Patient received Janssen Covid vaccine the day prior. Patient also on last day of antibiotic regimen (nitrofurantoin) for urinary tract infection.

Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied by chill, fatigue, body heaviness, Treatment was rest. Recovered by 3rd day. Vaccination shot site of arm extreme soreness the day after the shot for 2 days

Within in 2 hours of my vaccine my chronic eczema started to flair up and itch. After my next dose of Dupixant and use of Clobetasol the itching on my back subsided but my face continues to have issues with an eczema outbreak As of 4/16/21). Also by the evening of 3/8 (about 24 hours after my injection) my asthma symptoms appeared to increase (asthmatic cough) I have had to increase my Symbacort to 2 puffs 2x a day from 2 puffs once a day.

Felt some irritation near the upper middle of my back my spouse checked it out and it is hard to see.What I can see and my spouse is a 7x7 inch bumps spread across area.Some pain not much itching .I'm postive it's a reaction to shot first time iv ever had this happen.Im very healthy good skin no new products in used.Im feel like it's a reaction.Keeping Close eye on it.Useing hydrocortisone cream at this time.Thank you .I was asked by My local Health Dept to Contact you.

Immediate pain upon injection. Rapid heart beat . Sore arm at injection site. Later flu like symptoms: headache, chills, slight fever, body aches Later terrible leg cramps and numbness in both legs which sent me to emergency room 4/12/2021 Continued pain in nerves in arms and legs, muscle cramping. Nerve sensitivity on left side(shot arm) of face

A sore on leg which looked like a cut with 4 or 5 little blisters around it and created swollen knots close to the sore. Went to doctor, had a d-dimer test given was negative but knots remain in leg. Knots are not as prominent as before but still there. Doctor couldn't pinpoint the problem. Myself, husband and son all had the same thing happen, sons was on upper leg (33 years old), husbands is on right lower leg, mine is on left lower leg. All three took Jansen vaccine .

All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.

approx. 24 hours after receiving vaccine I began to have small hives and blisters on hands and wrists. with each passing day the rash, hives, urticaria has increased and worsened. It has been 11 days. Approximately 75% of my body is covered with lesions. Some are as large as my hand. it is on my chin, neck, chest, stomach, upper thighs, back, buttocks, shoulders. spreading more each day. I have severe itching

constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.

I took 1 Benandryl about 1 hour before the injection of the vaccine prior to leaving my home. My son took me as I would anticipate some type of reaction given my history. J&J was the one my doctor recommended in hopes that I could handle the response better and only need 1 dose. I had options to get pfizer or moderna, but my dr wanted J&J so I waited several weeks longer to get this one. Within 10 minutes of having the injection, my ears swelled up, and felt like I was on a bad plane and could not burst clear. Then my throat on left side, the same side I got the shot swelled. My face was full of red and rash and my son mentioned he was concerned how I looked. I told him my symptoms and then took another Benadryl before we left the store. I told the pharmacist that I was having a reaction, they wanted to call 911-I said please no. I am used to having reactions and would want to see if I can manage it with Benadryl at home. I came home and took my Alegra (as I take my alegra at night before bed to help with congestion). Going forward every 2-3 hours I would take another benadryl rotating the time frames and slept as much as possible. It took several hours for the swelling to subside, longer than I was used to. Over the next several days, I would have times when my ears, throat would swell, my face would be red and rashed, especially at night my face will get red, rash and ears and throat swell late at night. It waxes and wains depending on how I feel. After the main allergic reaction of 12-24 hours later, I stared with the COVID symptoms, fever, chills, body ache, the joints that I have trouble with hurt so much more (knee, foot, arms, hands) I was so thankful I did not catch COVID. I don't think I would have survived. On Friday, March 19, 2021 was the first day I started to feel better except for the late night episodes of allergic reaction. I take Alegra or when needed Benadryl. It seems to lower my swelling response.

SORE ARM AT INJECTION SITE AND FELT LIKE SOMEONE PUNCHED IN ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and 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 sore arm at injection site and felt like someone punched in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site and felt like someone punched in arm on 12-APR-2021. This report was non-serious.

ITCHINESS; SWELLING; REDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to tetanus vaccine. 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included citalopram for drug used for unknown indication, and ergocalciferol for drug used for unknown indication. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced redness. On 12-MAR-2021, the subject experienced itchiness. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness, and the outcome of swelling and redness was not reported. This report was non-serious.

Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place on right arm. Blood a lot when injection was done.

While I had nausea and fatigue Saturday morning after the vaccine, this report is about my nasty shingles outbreak. Rash started on left hand and calf and spread up my leg. Started with itching, not so much pain as in my prior outbreak which when I was 19 was local on my left arm. This is a bigger rash are, blistered red swollen, oozing, burning...the usual.

ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.

HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.

BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.

Itching, rubbing, nausea, dry heave, stridor, heavy breathing, cough, swelling of uvula Given Benedryl - Patient declined EpiPen, EMS and ER. Remained tired and itchy for the rest of the day.

Janssen COVID-19 Vaccine EUA Sloughing of skin of roof of mouth - has pealed off 3 times in 2.5 weeks white bumps on tongue - as if some taste buds have died Sensitivity of inner lips to acidic foods and mouthwash

SHINGLES BLISTERS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, penicillin allergy, and shellfish allergy. The patient was previously treated with gabapentin, vitamin b12 nos, salbutamol, fluticasone propionate, meloxicam, omeprazole, rosuvastatin calcium, levothyroxine, tizanidine hydrochloride, valaciclovir hydrochloride, estradiol, nystatin, amlodipine, hyoscyamine sulfate, ketorolac tromethamine, ondansetron, loratadine, and biotin; and experienced drug allergy when treated with ciprofloxacin, and trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced shingles blisters. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from shingles blisters on 30-MAR-2021. This report was non-serious.

DULL HEADACHE; INJECTION SITE ARM PAIN; FATIGUE; ACHY; DIZZY; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced injection site arm pain. On 09-APR-2021, the subject experienced felt fatigued. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine was not applicable. The patient recovered from achy, dizzy, injection site arm pain, and felt fatigued on APR-2021, and had not recovered from dull headache. This report was non-serious.

Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: recieved shot at 3:10pm, patient reported severe arm pain, nausea, blurred vision. 1st bp: 96/66 pulse 64 at 3:34pm, 2nd bp:102/68 pulse 62 at 3:50pm, 3rd bp 122/76 pulse 68 at 4:04pm. advised pt not to drive and left pharmacy around 4:10pm, observed patient for over 30mins due to use of epipen for cipr allergy in past

I experienced after my J&J vaccine headaches for two days. Then on 04-16-2021 upon waking up I had a red rash which was warm, hot sensation when touching my arm. This hot sensation radiated up to my neck, trachea and down my forearm. I got concerned about the red rash and because I felt my arm hot sensation and I went to see my doctor who asked me if I had trouble breathing or if I had any chest pain. I told him I could breathe and I was concerned about my rash. He prescribed Prednisone medication which I took several days to go away. To this day I still continue with the headaches that come and go and I take 2 acetaminophen to relieve the pain. I do not know if my headaches are related to the J&J vaccine and the rash has gone away.

Patient experience shortness of breath, hives, itching approx 8-12 hours post vaccination. No reaction reported within 4 hours post-injection

on or about 5/4/21 noticed a rash on both legs they had been itchy prior to that, the rest of my body is itchy w a few rash spots present. 5/8/21 noticed my left thumb twitching. As far as Item 20 rash is still still present and the thumb twitching is still present

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

Severe Headache, Triggered Trigeminal Neuralgia, Rash, Fever, Large swelling at vaccine site, Short of Breath

CHILLS; FEVER; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. 's medical history patient gave tylenol 500mg (a total of 2 tablets were given in the past day, 1 at 9am and 1 at 2am).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-MAY-2021 13:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced injection site pain left arm. Laboratory data included: Body temperature (NR: not provided) 99.4 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and injection site pain left arm. This report was non-serious.

Fever and cold-like symptoms on Saturday afternoon; woke to red itchy hives all over my neck, both arms, face, forehead, scalp, fingers, and ankle.

SPOTS THROUGHOUT THE BODY; BUMPS ALL OVER THE FACE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced spots throughout the body. On 12-APR-2021, the subject experienced bumps all over the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bumps all over the face and spots throughout the body was not reported. This report was non-serious.

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.

Hands have turned black inside palms and fingers. The knuckles and base of the palm and wrist looks burnt. Have no feeling in fingers, they feel very numb, If i make a fist ,It's very tight and can feel heart beating in the palm of hands. The black burnt look has moved to both inside and outside of hands

Patient stated that they started to lose their hair in chunks about 2 weeks after vaccination. Patient had to shave their head because of the amount of hair loss.

Patient states that about 1.5 to 2 weeks after receiving the vaccine she broke out in itchy hives over body. Most severe upper thighs and back,

2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my left arm swelled. The shot location in my left arm itched a lot. I scratched it, it bled. It became a large hole. 3 days later approximately, I start feeling very very tired. It got progressively worse . I then developed " brain fog". I have barely been able to work since then.. I believe I started to recover yesterday but not completely sure yet. I also developed a painful tumor in my right arm pit that lasted for a few days. It has since gone away. It was approximately 3/4 " in size. It developed overnight.

Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine

My big toes began hurting really bad. They got hot and reddish. They hurt for about an entire day. I put fungi with extra tea tree oil. That calmed it down. The right foot pain and discoloration completely stopped. On the left foot went to a reddish purple to an opal color. It then varied to a reddish purple again. It is discolored in my toenail. It lightens and gets darker. The pain and discoloration went on for about a week. The pain is gone but the discoloration is still present. The Tuesday after mother's day I cut my finger and received stitches. Along with the stiches I also received a tetanus shot. I received the tetanus shot in my right arm but I developed a painful knot in both my COVID arm and my tetanus arm. I put neosporin and a bandaid and massaged them which helped. The knots are going away but they haven't completely disappeared.

pt says she had bad migraines after taking the vaccine. Her left arm is still sore, red and inflamed at the injection site. (it has been months) Then she had itching all over. She took a shower and then noticed she had a bump on chest, then on her arms, and her both legs, stomach, back, and breast. These bumps appear like little blisters and then burst and scar her skin like a cigarette burn. Most are small but there are some larger ones. She says like look the measles. She went to her PCP Dr. She was told she was having a reaction to the vaccine and to come back if it got worse. Pt will reach back out to her doctor for medical advice.

I noticed a large lump, it started as a rush that was itchy and painful. I had some joint and muscle pain. The lump is still there and painful. I did have diarreha and fatigue.

When I received the shot I had no reaction at all not even a sore arm. Within a few days I started getting terrible pains in the calves of my legs. Then a few days later I got a purple line on my right calf that was painful. The next day I had 3 big yellow spots on the same leg. They went away in 2 days which I thought was odd. Next day I got a very large bruise at the vaccine location. After that I started with pains in all of my joints. Ever since then I have been having pains in all my joints. The pain level is not going away and has been getting worse

After my vaccine, I broke out in a rash, felt like someone was burning me, like if I was burning me alive, hard to explain. It was a rash then the rash turned into these big red mass, these lumps were nasty and I could not sleep for three days. They were on my arms and legs, stomach, back, parts of my face. The rash went away and came back, was on different parts of my body. I went to the ER to get checked out but at the ER they did not do any exams for me, they just told me I had hives. It took 4-5 days for my hives to go away. I still get these little bumps, they are small growing around my back, chest and legs and at the bottom of my legs and body and they do not itch.

Injection was extremely painful. Injection site was itchy and sore for a few days. Fever of 101 for about 36 hours starting day after injection. Round, hard lump (chick pea size) developed at injection site a week or so after injection. Lump faded over 3-4 weeks. Left a quarter size indentation about 1/4 inch deep. My primary physician said there is muscle atrophy and the chemicals in the injection likely killed muscle cells. Left arm is slightly sore.

PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.

LEFT ARM ITCHING AT INJECTION SITE; LEFT ARM PAIN AT INJECTION SITE; HARD KNOT AT INJECTION SITE UNDER THE SKIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 260 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced hard knot at injection site under the skin. On 11-JUN-2021, the subject experienced left arm pain at injection site. On 13-JUN-2021, the subject experienced left arm itching at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard knot at injection site under the skin, left arm pain at injection site, and left arm itching at injection site. This report was non-serious.

Right Hand and Arm feels tingling numbness ichy and major weakness. At times feels as though hand and arm are asleep. Lost functionality in hand at times.

4 days after injection patient had localized redness and itching. The area is slightly warm to the touch and whole arm had mild pain. hard to say if infected or cellular allergic reaction. Advised patient to take an oral OTC antihystamine and if signs/symptoms persisted or get worse, to seek medical attention.

Patients started complaining about feeling itchy on abdomen and legs. upon assessment of patient no visible redness, irritation, or bumps present on patient's skin. Vitals were taken at 0955 BP: 118/70, HR: 76, RR: 20, O2 Sat:96%. Offered patient water and called provider to request if Benadryl could be given to patient who stated itching was getting worse. Provider stated was ok to administer 10mL of Benadryl HCl 12.5mg/5mL PO at 1002. Patient was monitored for 15 mins after, vitals were rechecked at 1015 they read BP: 122/76, HR: 76, RR:20, O2 sat: 98%. Patient stated she felt better after given the medicine, the itch was going down.

Redness at the injection site and has swelled and became large over time, about the size of a quarter. Fatigue and dizziness. Severe pain under rib.

4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1month. Entire shoulder girdle burns and aches. Strong inflammatory reaction started on first night with many varied reaction symptoms for 10 days. Arm and shoulder pain remained and got worse daily for months, I now have nerve damage, weakness and loss of function. MRI showed damage, tendonitis, tears and much more, pain was severe for first 7 weeks, then I lost my job, I could no longer type for 10 hours a day. The pain progressed to pronounced weakness and poor coordination. Difficult to sleep for 4 months now. A steroid injection given for chemical bursitis by an orthopedic doctor did not help. Physical therapy, acupuncture and a home TENS unit have helped, progress of injury healing and nerve enervation is very slow. High medical costs. Symptoms are similar to Parsonage Turner syndrome, but two doctors said shot was given incorrectly, low and too deep, so possible SIRVA, or both. I progressively worsened for 4 months, now I am in slow recovery but I fear it will go on for years. This has affected all areas of my life. It has been difficult to get medical care and to care for myself. I live alone, there are so many things I can no longer do. I was self-employed, now I have no income and have lost full use of my left arm.

Immediately arm felt heavy but went away later. 5 to 7 days later covered with bumps and became nonstop itching, bruise easy

At approximately the 30 minute mark, patient began complaining of hot and itchy palms. Palms and fingers developed redness and there were faint red areas bilaterally on both arms. Patient's PCP consulted and 25 mg of Benadryl was given. PCP saw patient and determined she was safe to go home.

The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves). I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection. I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination. When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.

The patient was given the Janssen Covid vaccine on 7/1/21 and she called in on 7/15/21 to report her adverse event. She said she had been having awful shoulder pain ever since receiving the vaccine and it continued to get worse. She went to see her Doctor on 7/15/21 and received and x-ray and prescriptions for oral steroids and an NSAID gel. She said her Doctor diagnosed her with a vaccine related shoulder injury. The results of the x-ray are unknown as of now and the medication was just started today. I told her I would be filling out reports on the incident and that I would check back with her in a few days to see if the medication was helping.

LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm

Within 4 hours: extreme fatigue, headache, loose stools continued until 8am 3/7/2021. Itching all over body, without hives, from 2pm 3/7/2021 until 6:45pm 3/7/2021 - unsure itching is over.

-severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection

Received Janssen covid 19 vaccine 3/8/21 at 3PM. Twenty minutes after shot, felt skin flush pass over me and was directed to private area where paramedic took blood pressure and checked for hives. No hives but bumpy skin. Blood pressure spiked to 186/75. No history of such high blood pressure. Waited a while and blood pressure went down, flush and skin bumps subsided, and I went home. Blood pressure erratic in evening but never as high. Next day pulse higher than normal. Took homeopathic remedy. Pulse slowed down a bit. Better by next day.

Fatigue, Moderate body aches Intermittent Fever first 24hours Headache Red & soreness around injection site. Persisted for 48hours. Took Motrin, hot showers & herbal teas. Bed rest

Itching on shoulder and neck during first 15 minutes after Janssen COVID vaccine administration. Observed for additional 20 minutes by EMS. No treatment provided.

Chills, 103 fever, nausea, dizziness,aches, headache, fatigue. Came and went within 24 hours. Red face. On and off since vaccine Elevated blood pressure. Ongoing Tinnitus. Noticed last night, getting worse.

The day after I took the vaccine I awaken with a terrible headache and remained in bed all day. The next day I noticed a goose egg shape on my left arm in the area of the vaccine site, with soreness in my arm and shoulder throughout the entire week. Called the pharmacy who suggested I complete the form online and contact the doctor. Called the nurse line.

Hives started the first day on the back of my arms.Day two they were over half my body.Last night I had them from my ankles to my shoulders.Each lasted an hour or two.Immediately took Benadryl.

itching on forehead and neck, skin slightly pink. Both cheeks red and very warm to touch. began approx 48 hrs after injection. The redness and heat on cheeks intensified through out the night and into the next day. Called my primary care doctor who recommended Zyrtec which eased symptoms. After 48 hours symptoms had mostly subsided.

Received vaccine on Wednesday 3/17/21 @ 1250pm, pretty painful going in my R deltoid. Started feeling very tired on Thursday 3/18/21 around 7pm. Woke on Friday 3/19/21 with fatigue and diarrhea with body aches. Woke Saturday 3/20/21 with fever 101.7. (During this duration to include today I have taken Tylenol rotating with Motrin every 2 hours, this never broke my fevers). Fever continues on and off with body aches, nausea, the worst headache I have ever experienced and pain in the base back of my neck L side. These symptoms have continued since Saturday. It is now Friday, 3/26/21. I will say that during waking hours 8am - 10pm on Wednesday 3/24/21 and Thursday 3/25/21 I had no symptoms except absolute fatigue. The fever returned on those two nights at around midnight with it breaking about 4 am, waking up in a pile of sweat.

Four days after vaccine, muscles at injection site started getting sore. No symptoms prior to day 4. Continues to worsen day 5. Day 5 very tired despite adequate sleep. Mild diarrhea. Symptoms not bad enough to keep me home from work, but I thought it odd symptoms didn't begin to appear until 4 days after vaccine.

On 03-25-2021, at 7pm, I started to feel flu like symptoms with body aches but no congestion. In the morning it seemed getting better but then my symptoms got worse. I took two Ibuprofen which helped. I still continued to feel tired. After my vaccine, I also got a weird taste in my mouth. I was very tired over the weekend. My armpit itched and so I scratched it and I felt raised bumps under my armpit, under the pit of my arms on both sides, right greater than left. My left arm was the one vaccinated. I also had bad diarrhea on 03-29-2021. Today I still continue with the rash under my armpits and still feel very tired and fatigued.

The most severe reaction started the evening of March 26, 2021. It was a red patch on mid back and appeared to have a blister. It was extremely itchy. More patches developed over March 27, 28, and 29th.I self treated using Benadryl, Pepcid, cortisone cream and memetasone furoate cream. On March 27 at about 6pm I was able to secure a doctors appointment for March 29th. At the appointment I was given the regiment of one Claritin tablet in am, one 20 mg Pepcid in pm, Hydroxyzine 25mg at bedtime and to continue use of memetasone cream as needed. Rash has resolved. Still using meds as I felt itchy yesterday

Dolor, inflammation, heat and hardening, to palpation, in the muscle area where the vaccine was given, about 5 cm of radius that appeared 3 days after the vaccination. There was no color change in the skin, neither difficulty to make movement of the arm in any direction. After a day and a half the symptoms disappeared. It was not necessary to take medication for the pain only the application of ice compress symptoms improved

RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

The night of when I received my vaccine 03-25-2021, I experienced fever, chills. I took Tylenol for pain. I also developed soreness at the injection site and a red, rash on my left arm. I went to see my doctor, but saw a nurse practitioner who prescribed antibiotics and anti-inflammatory medication. My left arm is still sore at the moment and I have not completely healed.

The first night I had severe chills and an intense headache but that went away the next morning. Then four days later I broke out in hives all over my body. Still have hives on day 6.

Within 2 hours of the shot, I felt nauseous, somewhat dizzy, and very tired. I experienced this for over 24 hours. I still don't feel quite well. Also, my arm is still sore where the shot was administered, 3 days later.

Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.

patient reported full body hives one day after vaccination. No new foods or medications have been taken. Patient took diphenhydramine and reported that she would seek medical treatment of symptoms worsened.

My hair is falling in large amounts. Which before the vaccine i never had that problem. When i wash my hair i need to sweep the bathtub. Daily i have to constantly be removing hair from my shoulders.

Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.

Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot

Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallowing, hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS, patient was responsive when sent in ambulance to ER.

SCABS; ABSCESSES ON SKIN CLOSED (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included insect bite, and concurrent conditions included high blood pressure, and skin abscesses, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced scabs. On 09-MAR-2021, the subject experienced abscesses on skin closed (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scabs and abscesses on skin closed (unexpected therapeutic effect) was not reported. This report was non-serious.

on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour. Vaccine site also felt very sore. Arm remained mildly sore but becoming slight more painful each day. with some tingling in fingers the following week. By April 10 muscle sore and painful to lift lift for shoulder adduction at 90 degrees.

CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Burning immediately when the needle entered her arm before the vaccine was injected; difficulty raising her arm and opening the dishwasher since- loss of range of motion and weakness 1 week out.

Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning with bowel movement on 3/29, felt like a "habenero pepper." Also had itching and rash of chest wall, right breast, back. Received her shot in the left arm.

Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain radiating down under left breast, alleviated with Aleve every 12 hrs, lasted for over 1 week @8-9 days, actual bruising underarm pit, and pain and bruising down to the wrist and fingers. Did not seek medical attention.

Originally diagnosed as spider bite, then poison ivy. Self reporting as side effect of vaccine, due to similarity of other reports. Cellulitis spreading from left front ankle area to several areas on body; thighs, behind knees, between legs up buttocks. Surrounded by small blisters, some with yellow discharge. Large area of red skin patch beneath breasts. Itching around all areas. Sought help day 3 of onset started antibiotic (Cephalexin) and again day 6 when it was spreading more, added (Prednisone). Today, day 9 of onset, sores are starting drying out and red patches and measles-like blisters are starting to fade, though still having some itching. Some areas are scabbing.

Immediately after shot I felt pressure all over my body and my face tingled. The pressure eased off quickly but the tingling lasted until the next day then my face felt like I had been punched. I still have a little face swelling and itching with raised red spots on my face that move around to this day.

Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.

Swelling, tenderness at site. Headache within 5 hours. Muscle aches. Abdominal cramping and back pain all within 5 days (3/10-3/14 )of vaccine.Passed out on 4/10/21 while walking, noted fatigue on 4/8 until 4/13.

I had a bit of pain at the injection site for two days after the injection of 4/7/21 but after few days of no pain the arm started to hurt again and feels a bit swollen since 4/12/21

Shock down arm during shot administration, swelling, bruising, redness, heat. Cold compress, Tylenol and Ibuprofen. Benadryl cream. 6 days

My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches

SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.

Intense pain, hot from injection site, down entire arm immediately after given. Continued pain after two days into two weeks, shooting pains , crawling at injection site,and throbbing, even at elbow and wrist. Arm was also very weak, and still gets tired and throbs . Has been 4 weeks this week-end . Reported to nurse who tod me to see my Dr. which I did this week. No redness at injection site, just soreness, know something was off, according to side effects. Very tired feeling, still, and had some flushed color the first week in my face and like heat flashes for two weeks. Hope to get the normal feeling back in my arm. Not sure ? Maybe a nerve was nicked? But was not like a Bee Sting like tech described it would feel like that day. Had a ruff start.

WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate. On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.

Severe headache starting with 2 hours post injection lasting 6 days, severe nausea 6 days, diarrhea day 3 only. Red circular spot on hand, toes, shoulder area, day 2-4.

The left hand and foot developed bruising spontaneously at 2 pm, finger went numb and white., with tingling. Skin on hands reddened. These symptoms continue today, the day after, though lessened. Hands remain tingly and redness of skin is ongoing.

headache, light headedness, nausea, muscle aches, joint aches, lymph node swelling, fatigue, swelling at the injection site. All symptoms lasted about 48hrs. The swelling and bump at the injection sited lasted 1 week.

Tinnitus. Woke up with loud ringing in both ears, which has yet to subside. This has never happened to me in 61 years, so I'm very sure this is related to the shot. Prior to that, I had run a fever, and had my whole upper arm swollen and hot , which have both just started to subside.

Pain at injection site. What started as a small pimple sized bump has grown into a egg sized bump. Painful to touch

Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once while eating lunch. Left ring finger went numb, white and cold, with bruise appearing on the middle digit. Other finger tips turned pink. Skin turned red onhands with tingling sentation. Right hand blood vessels came to the surface and began to swell at intersections. Skin on rt. hand looked whiter and dry. The sudden onset sent me to the emergency room, the condition began to fade in 3 hours, not completely. The same reaction occured the next day at 12 noon. I took a hot shower and the condition improved followed by extreme tiredness. *At the time of vaccination, & on both of these events I had a stiff neck/red skin.

Horrible body aches, headache and chills for 12 hours. The following day I had horrible and painful shingles outbreak.

SWEATING; CHILLS; FEVER; HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sweating. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on MAR-2021, and had not recovered from headache, and soreness at injection site. This report was non-serious.

UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

NINE DAYS AFTER patient RECEIVED THE VACCINE SHE DEVELOPED A RASH ON HER SHOULDERS. RASH SPREAD TO 50% OF HER BACK, RASH CONTINUED DOWN HER ARMS. NO LYMPH NODE INVOLVEMENT. RASH WAS RAISED, RED, VERY ITCHY, WARM TO TOUCH. RASH IS STILL PRESENT AND NEW AREA DEVELOPING ON BACK OF UPPER LEFT LEG. patient NOTED SEVERAL DAYS BEFORE RASH APPEARED SHOULDERS WERE VERY ITCHY.

9 hours later began feeling a general "ick" like when coming down with something, then moderate headache and body aches, especially my back. This lasted less than 2 days. Other things, mostly starting 5 or 6 days later and some cropping up as late as 4/11. Random itchy red rashes on each shoulder and back of upper arm that would go away within an hour or 2. Itching and possibly bumps on buttocks and thighs. Intensely itching palms for a little while on 2 or 3 different days. Sudden appearance of a 4 x 4 inch patch of 15-20 bumps of various sizes in the crook of my left elbow (injection arm) with bright red skin. These looked similar to mosquito bites or blisters but didn't itch. It completely disappeared without a trace within an hour. Tingling tongue followed by tongue swelling on 4/6/21. I had eaten my bran flakes with some rice pudding a little bit before this, both of which I'd eaten every day for the past week or so and had had several times in the past. On the advice of my doctor's nurse, my husband drove me to an urgent care center. By the time we got there, probably 1.5 hours after this started, the swelling was some better. The nurse practitioner that I saw prescribed an antihistamine and 3 days of one 20 mg prednisone pill a day. I've never had a tingling or swelling tongue before in my life. I took only a half of one prednisone on 4/6, no Allegra. On 4/7 the random itchy red rashes mostly on arms/shoulders happened once or twice and disappeared fairly quickly, but my upper lip swelled. I could feel it happening as I sat in my recliner in the morning. I hadn't had anything to eat yet. The doctor advised I take my Allegra and prednisone I received at urgent care on 4/6, so I did. The lip swelling gradually went down over a few days, but it still feels irritated on the inside of the lip as of 4/11. Diarrhea beginning around 1:30 a.m. 4/8. Lasted about 3 days. I only very very rarely have diarrhea. Mild sore throat starting Friday 4/10. Better by Saturday. Sore throats are so rare for me that I can't remember the last one, possibly several years ago.

Patient received Johnson and Johnson vaccine on Saturday May 1st. I administered the vaccine. Today, 5/5 she came to the pharmacy to show me the circle rash that had developed around injection site. It was also swollen and felt like a bruise. I counseled patient on "covid arm" and that it was likely her immune system activating. I explained this can be a common reaction after getting the COVID vaccine. Patient had no other symptoms. I went over things to look out for in relation to blood clots and any warning signs and when to reach out to her doctor. I suggested she fill out Vsafe and I told her I would report to VAERS.

That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.

Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a bad headache. In the middle of the night my headache kept getting worse, my eyes started to hurt really bad and I also broke out in hives. About 6 hours later my headache felt like it wanted to explode. I saw a doctor through Tele-health by who prescribed a 6pk of steroids. Then on Day 6, my headaches came back along with the hives and I felt really tired and the hives broke out all over my body including my crotch and ear canal. He prescribed a 6pk of steroids and I started to feel and get better. On Day9, all of my symptoms were resolved except for the fatigue. To this day I still continue to have fatigue.

PT GOT MILD HIVES ON BOTH LEGS, PT ALREADY PUT ON SOME HYDROCORTISONE BUT STILL ITCHY. PATIENT SAID SHE IS DOING OK AND NOT TOO CONCERN ABOUT IT. PT ALREADY CONTACTED HER PROVIDER AND WAITING FOR A CALL BACK.

A few minutes after the patient received dose 1 of the Janssen Covid-19 vaccine, the patient started having trouble breathing, her throat felt "swollen and thick", was shaky, had itchy hands, and her lip was swelling. Her blood pressure was 174/86 and her pulse was fluctuating in the mid-high 80s. I administered 1 tablet of diphenhydramine (25mg) and 1 dose of the 0.3mg epi-pen. After about 7-10 minutes, she said her symptoms started to level out and were no longer getting worse. Her lip swelling started going down by the time EMS arrived. I continuously checked her blood pressure, heart rate, and heart rhythm while waiting for EMS to arrive and take over her care. They took her to the closest emergency room for continued monitoring.

I arrived home and my arm was throbbing really bad and broke out all over with hives (looks like measles).

With in 10 minutes of the injection my thoart closed, my lips swelled and I was having trouble breathing. Benaydyl was given and an Epipen was used, I was taken by ambulance to the local hospital ER where an IV was started, steroid was injected. I was kept several hours for observation and sent home. The following day I had attacks of itching and rashes as well as occasional numbness in my lips, by Thursday evening it was worse, returned to a different hospitals ER at 2am Friday morning, more steroid was given and I was observed, and sent home with an prescription for an epipen as well as steroids. Continued to take Benadryl often taking two with in a half hour, Monday May 24 went to my own docotor, as I had a new reaction of pressure in both ears with pressure in my cheeks and around the back of my head. She give me a prescription for additional steroids and is still monitoring me as I am still reacting.

Small number of hives two hours after shot that faded within an hour; small number of hives 24 hours after shot that faded within an hour.

When I got home, I had a headache. I felt tired. I took a nap. When I woke up, I was sick. I was nauseated, my stomach and body hurt all over. The headache was three days long. I felt achy and sore the next day as well. I felt like I had a flu. There were huge blood clot looking blisters, and red dots on both my arms. My left arm was worse than my right arm. I called the doctor and she asked me to come in, but I had to take pictures first of my arms before coming in. Then when I was able to go to the office, I took blood tests and the MRI. Everything came back okay.

5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.

swelling and bruising at the wrist area of the shot arm (was wearing a watch, during injection and during the night)

Sore throat, tingling on left top of scalp (usual site). Presented as another flare-up of Shingles, but Zoster sine herpete (ZSH). Two days later, I visited my PA, and she immediately started me on Valtrex (1g/3x daily) and gabapentin.

the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and had slightly labored breathing. Patient also said she was diabetic and was given apple juice. Vitals- TIME: 4:37 HR: 116 RESP: 14 BP:168/100 SP02: 94%

Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , muscle cramp at injection site resolved slowly over 3 weeks

Within an hour headache ,stomach ache, cough, exhaustion . After 10 days went in for Covid test per Dr.s orders. Came back neg. But had small bruise on arm below injection site that night. All symptoms resolved with in 2 weeks except bruising. Keep getting small bruises on arms and legs. Most are only about the size of a pea but now have one on forearm size of half dollar with 2 smaller ones just below it.

Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of injection. Skin itched all over, but no rash, no other symptoms. Took usual aspirin & Tylenol before bed. Also began probiotics and elderberry/zinc/C supplements recommended in Covid handout. That night: Slept on other arm, when rolled over in early AM, hurt to press on shot arm. Day 2: Woke up hay feverish - sinuses completely blocked but could breathe through mouth, so airway OK. Moderate headache, all over muscle aches. Took usual aspirin & Tylenol. Skin still itches all over. Took a Zyrtec. Sinuses cleared, muscles and head aches went from moderate to mild, skin itch also from moderate to mild. Took usual aspirin & Tylenol before bed. Day 3: Woke up with sinuses partially blocked and sneezing. Mild headache and muscle aches. Took usual aspirin & Tylenol, and when sinuses wouldn't clear on sitting up and blowing and kept sneezing, took another Zyrtec. Day 4: Sinuses draining so I'm going to try to do without Zyrtec. Body still very achy so taking usual aspirin & Tylenol. Day 5 and beyond: Symptoms gradually subsided without further Zyrtec. Higher than normal tiredness persisted longer than aches and hay fever symptoms. Overall, much milder reaction than I had to a flu vaccine many years earlier, so I'm pleased, but felt VAERS should have complete information.

Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. I could taste the vaccine. Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen. By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021. My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021.. on 07/02/2021 I had chills until approximately 5:30 pm. I carry Epi-pens should I need to self administer.

Immediate strong pain from injection that dissipated after 10-15 minutes; next morning low grade fever and moderate headache and moderate muscle/joint/body aches. Most symptoms dissipated after 3-4 hours after taking Advil.

Patient reported dark brown coloring in webs of fingers and spot on top of foot. This has occurred about 3 times since getting vaccine- approximately once weekly. No raised bumps or irritation. the discoloration has come off hands when scrubbed with soap and water, has been more difficult to remove off foot.

I sat in a chair for 15 minutes after getting my vaccine. One minute after sitting down, I had a headache, and I never get headaches. The headache got worse and worse. I had lunch, and I still had the headache afterwards. I then went home, and the headache got even worse. At about 2 AM, I got out of bed and tapped my head in the hope that it would help the headache and it didn't. I then started to get a fever. The following morning, I had a full-blown fever, and I still had a horrific headache. I ended up having the headache for a whole week. With my fever, the temperature was 102; I didn't take anything, because I thought it would run its course and allow my body to get used to the vaccine. I eventually took two acetaminophen tablets, and it only reduced the temperature by one degree. I then took Advil, which also reduced it by one degree. The day after that, I had hives all over from the knees up, even in my crotch, eyes, and ears! I called a doctor, who prescribed me heavy-duty steroids. I was on steroids for 6 days . On the 4th day, I began to show signs of improvement. On the 9th day, the hives started to clear up, the headache began to subside, and the fever was gone. I had terrible fatigue for a while afterwards. Now, I'm trouble breathing. I always feel winded whenever I do any activity. Before the vaccine, I was very high-energy and had no trouble with fatigue or windedness.

This was a Johnson & Johnson vaccine. No option was given on the website for this. Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95°. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated.

Rash - raised red and itchy all over face - mostly on left side of face (same side as shot given). On cheeks, forehead, nose, and neck

The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so. I really thought I was going to pass out. A woman with a tag that said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better. The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home. They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore. Could the shot have hit a nerve? I?ve never felt such acute pain.

PT HAS BEEN ON DPXT FOR ABOUT 4 YEARS FOR ECZEMA & HAS CONTROLLED HER SX WELL. SHE RECEIVED J&J COVID VACCINE ON SATURDAY & HAD DOSE OF DPXT ON SUNDAY & IS HAVING BREAKTHRU IN ECZEMA SX NOW. PT STATES AFTER GETTING J&J VACCINE ON SATURDAY, SHE HAD NO FEVER, FELT LITTLE TIRED IN AFTERNOON, MAYBE SOME CHILLS (BUT WEATHER WAS COLD), & NOTHING ELSE TO NOTE OF. SUNDAY WAS HER DPXT DOSE. SHE TOOK IT IN THE AM & ABOUT 5 HOURS LATER SHE STARTED TO HAVE BREAKTHRU IN SX. HER MOST SEVERE TROUBLE SPOTS PRE-DPXT TX WAS AROUND HER EYES, CHEEKS, FACE AREA. SHE STARTED TO FEEL INFLAMMATION AROUND EYES & UPPER CHEEEKS ON SUNDAY. THIS MORNING THE SX FELT VERY STRONG BUT SEEM TO BE DIMINISHING SOMEWHAT THROUGHOUT THE DAY. SHE IS HOPING THAT IT WILL CONTINUE TO IMPROVE & RESOLVE TOMORROW. SHE CAN FEEL THE INFLAMMATION UNDER THE SKIN - NO VISUAL SX YET. SHE FEELS LIKE THE COVID VACCINE SOMEHOW BLOCKED THE EFFECTS OF HER DPXT. PT HAS NEVER HAD THESE SX DURING HER TX OF DPXT. THE DPXT HAS CONTROLLED ALL HER SX WELL THROUGH THE PAST FEW YEARS. SHE WANTED TO INFORM US SO THAT WE CAN COLLECT DATA. ADV PT THAT IF SX DO NOT RESOLVE OR IF THEY GET WORSE, CONTACT MD FOR ADV. PT AGREED.

Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms. On 7th day, hives with raised red bumps and welts and intense burning itch appeared on lower legs. These gradually spread to upper legs and abdomen over several hours. After taking OTC antihistamine, itching subsided. Rash was gone the following day.

Body aches, fever 100.8, chills, loss of appetite, lasted about 24 hrs only. Nausea lasted about 1 hr Sore swollen arm at injection site sore for 6 days. They side affects put me to bed for the 24 hrs...slept through it.

Janssen COVID-19 Vaccine EUA I received the single dose at 10:40. In approximately 11 minutes I started to experience shortness of breath. I thought it was my N95 mask so decided to head to the car after my 15 minute wait period was completed. After sitting down in the car I started the following symptoms: shortness of breath, rapid heart rate, swelling of face, dizziness, weakness. I sit in the car for approximately 15 minutes then headed home. I had a driver (thank goodness). I continued to have symptoms and what felt like elevated blood pressure (I did not have access to a pressure cuff). After resting at my driver's house for about 5 hours I felt better and headed home. The next morning the symptoms were less but still present. In addition I had a slight rash on my stomach that wrapped around my back. After approximately 48 hours all of the symptoms subsided. My blood pressure had returned to normal also. All swelling went down.

pruritus Narrative: 61 y/o female received COVID19 vaccine (Janssen) on 03/18/21 @0906. Has prior history to Shingrix vaccine on 02/2020 documented as causing diarrhea/facial numbness, but also had been exposed to Shingles prior to vaccination. Prior ADR was reviewed with RN and pharmD; was given the vaccine and observed for 30 minutes. @0930, was observed to be itching to back, legs, and left side of neck. @0935, diphenhydramine 50mg PO was given. @0944 itching continued and reports lips felt funny. @0947 patient reports feeling better and itching resolving, was observed until all symptoms resolved. Patient denied any shortness of breath. Patient stated symptoms of numbness/tingling in lips resolved. Patient left @1007. Instructed to seek emergency care if symptoms worsen or have any difficulty with breathing.

first 2 days slight headache and body aches, third day through 10th day, nausea, vomiting on the days 9 and 10, stomach pain, hives. I went to the ER on March 19 for nausea and vomitting, was dehydrated and received IV fluids. I also had hives which I was prescribed Steroids for. The next day, March 20, I went to urgent care for severe hives and was given a steroid shot and epinephrine shot. I don't know if these symptoms are a result of the vaccine, but I did not have them prior to the vaccine so I thought they should be reported. Thanks

About a week after the vaccine, I came down with pain in my lower back which progressed to the front lower abdomen and two red spots showed up on my right lower back side.

As soon as I was injected I felt a burning sensation that went from the site up into my neck. Day 2, 7am I woke with a temperature of 102 degrees, Throughout the day I had fever, chills and arm injection site to neck continued to be painful, arm swollen and warm to touch with a lump about the size of a walnut, and lethargic. Day 3-4 symptoms continued same as day 2 with temperature decreasing to 100 degrees. Day 5 fever gone. Day 5 through today the injection site continues to be somewhat painful with some heat in the arm and lump has decreased to dime size. Called and spoke with doctors office this morning. Advised to treat with wet warm compress and Ibuprofen for discomfort. Call is worsen.

Day 11 .. right arm .. red splotchy rash, hot to the touch "Covid Arm" No prior symptoms other than sore arm.

Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away

Once the shot when in, no asperation done. Then I felt a warmth go around my arm in the area it was given, like someone grabbed my arm. This lasted about 5 hours. Only slight pain in the injection site for 4 days. I also had a rush of warmth and fast heart beat 5 min. after the shot. it lasted about 3 min.

7 days after vaccine skin rashes on chest, stomach and back. 14 days after vaccination visit to Dr. She most rash as Pityriasis Roses. Prescribed 400 mg Acyclovir 3 x day for 7 days.

Pt exited building, returned to complain of rash on face. Redness to cheek, chin, neck, and chest was found. Benadryl 25mg/10ml oral soln administered @1:18pm. Pt declined going to ER. Second dose of Benadryl given. Reported she will go directly to ER if she feels any worsening reaction.

Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the time I came back home I went to bed with all my cloths on and 2 more blankets I had a fever of 103 and was very hot to touch the shakes would not go away. The next day I started feeling a little better still cold and had a very sore throat and runny nose body ached bad very bad friday I feel better but feel like I was hit by a truck

Arm became sore on the left arm - I had a lump and my whole arm was like one giant bruise. That lasted about three weeks. I still have a lump but it isn't bruised looking anymore. The incident I went to medical care for - I saw the doctor on 4/2/2021 and he diagnosed I have shingles on my right leg. I thought it was spider bites. I did have the shingles vaccine. It is inflamed and I get nerve pain down my leg. It is very, very sore to the touch. Right now it is kind of dry - like blisters on it. It's a mild case. Doctor put me on Valacyclovir. He put me on it for one week and I have two more days after today.

Injection site bruising, rash, with creeping red rash that continued to broaden each day. Swelling, itchiness. Minor wheezing (Day 2 or 3) Extreme fatigue (Day 1, 2, 3).

SORENESS AT INJECTION POINT (SHOULDER); NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection point (shoulder), nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection point (shoulder), nausea, and fatigue. This report was non-serious.

UNABLE TO USE ARM AS SHE DID IN THE PAST; ACHING RIGHT DELTOID MUSCLE/ACHING ARM AT THE SITE OF THE INJECTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced unable to use arm as she did in the past. On 06-MAR-2021, the subject experienced aching right deltoid muscle/aching arm at the site of the injection. 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 aching right deltoid muscle/aching arm at the site of the injection, and unable to use arm as she did in the past. This report was non-serious.

RASH; This solicited report received from a patient: concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included macitentan. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and rash as possible. This report was non-serious.

Chest palpitations vomiting fever breathlessness rash on neck and face thickening of tongue palate lips blood pressure 174/106 spike tiredness headaches aches since Friday I had called nine times to this number

Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting with her head in her hands and alerted RN, then all responded at 1140. The client complained of shortness of breath and dizziness. Upon assessment, the client was pale, diaphoretic, and clammy, and her skin was cool and dry. The client stated that she is anxious about needles and vaccinations, and that her mask was making her feel "claustrophobic." The client was encouraged to practice deep breathing and her vital signs were obtained: blood pressure of 96/76, respiratory rate of 12. The client stated that she did eat breakfast that morning at 0930 and was offered some water to drink. . Per the client, she has a medical history of hypothyroidism and the only medication she takes is levothyroxine. The client also stated that she tends to have lower blood pressure and "110/60 is normal" for her. The client was alert and oriented. At 1145, the repeat vital blood pressure for the client was 97/63. She stated at this time that she felt like she was going to pass out, and was transferred to the reclining chair. At 1150, the repeat vital signs were as follows: blood pressure of 118/80, heart rate of 78, respiratory rate of 16, and pulse O2 reading of 95%. At 1155, repeat vital signs were as follows: blood pressure of 112/74, heart rate of 78, respiratory rate of 14, pulse oximeter reading of 96%. At this time, the client's color returned to normal and they were no longer clammy. At 1207, the client's blood pressure was 110/72, their heart rate was 73, their respiratory rate was 8, and their pulse oximeter reading was 97%. The client stated they "feel great" and left the facility at 1210, ambulating with a steady gait to their car, where they were driven home by an acquaintance.

I got the vaccine at around 11am on 6th April. By 8pm the same day I was experiencing very severe chills - I have never felt so cold before in my life, and the evening was not cold.. The next day, 7th April, I woke up with bad aches in various, seemingly random areas of my body: both upper arms, outside parts of both thighs, center of back between shoulder blades. Interestingly all the aches were symmetrical. I had not done any serious exercise to cause these symptoms, just a stroll around the park after getting the vaccine. I also experienced crushing tiredness and had to go back to bed in the afternoon. Today, 8th April at 5:30 pm my left arm at the vaccine site still aches, but all the other symptoms had vanished by the morning. I'm 5' 4" and weigh 114lbs. My husband got the vaccine at the same time and had no symptoms. We are speculating that my smaller size may have contributed to my adverse reaction. He is 5' 6" and weighs 180lbs. In spite of this discomfort I'm so relieved and pleased that we were able to get the vaccine. Thank you!

Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bumps on the same side as the shot was given directly above my left breast that was severely itchy. This rash is just now starting to dissipate but still itches; I used OTC cortisone creme and Benedryl to address the itching. The other major effect involved my left arm. For a full week, the muscle in which the shot was given was extremely sore to the touch and the whole arm ached. I still cannot fully extend that arm above my head without it feeling like an aching weight. Lastly, I had a pain in the center of my back as a hard ache that one week later still has not fully dissipated. It appears to be going away, but has lingered longer than I would have expected.

Fever 103.2 for 24 hours; Fever 102.1 for next 24 hours; chills for 6 hours; heart racing for 6 hours ; fatigue 1 week; diarrhea 3 days; headache on going; severe bruising to injection site about 1.5 weeks after the injection

RED LUMP ON ARM; RED MARK ON ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included leg pain, and other pre-existing medical conditions included the patient had received flue shot in the past but past reaction was not red. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 12:30 at right deltoid for prophylactic vaccination. Concomitant medications included ibuprofen for leg pain. On 31-MAR-2021, the subject experienced red lump on arm. On 31-MAR-2021, the subject experienced red mark on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red lump on arm, and red mark on arm. This report was non-serious.

almost two weeks later my arm is still very sore at injection site. the next morning after the vaccine when i was at work i had to leave my classroom because i felt sick. i felt nauseated, sweaty, light headed, short of breath and my heart was pounding like i had been running a marathon. i thought i was gonna have a heart attack. i HAD to go outside for fresh cool air and sit down. i was also applying a cold compress, drinking cool water and taking very deep breaths i was able to return to work in about 15 minutes. i continued to feel nauseated for the rest of that day and the next.

At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy

03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.

Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.

Day one: soreness at injection site, mild achiness and headache, brief episode of intense coughing/wheezing Day two: slight lightheadedness, episode of vertigo and nausea. All totally resolved by the end of day 2

Stabbing pain at injection site 20 minutes after injection. Stabbing, Aching and Throbbing pain intermittently since injection. I believe it was injected in the wrong area of the arm. Either the nerve, or tendon.

2 hours after I received the vaccination, I came down with severe chills. My entire body was shaking and I could not get warm. I got extremely fatigued to the point that I could not get out of bed. I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days). It seemed that every bone and muscle in my body began aching, from head to toes. My fever went up to almost 102. These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days). I alternated Tylenol, Advil and Alleve. They did not help hardly at all, unfortunately. 2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast. Today, these lymph nodes are still swollen and are painful to the touch. I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.

pt says that she has a big purple spot on her right arm around the injection site. Next day she said the warm red spot is growing so she had a nurse at her workplace draw a circle around the site. Within 2 hours the spot had grown bigger than the circle. The spot is now bigger than a 50 cent piece. Pt has taken Tylenol. Pt has an appt to see a NP today @ 2:45.

Tightness in throat, breathing problems, used my albuteral inhaler 2x, coughing, very itchy all within 10 minutes of the shot. I was taken back to a separate room and seen by paramedics.

Developed COVID arm. Injection site became swollen, red, hot to touch, hard in middle, and now a slight bruise. Also developed a skin rash on legs, arms, back, and mid-section on April 12, 2021. Rash lasted overnight.

BAD Dizziness, Rash & Bruising at injection site, (hot to the touch & Burning sensation .) Headache, spots in left eye, I fell due to dizziness ..

I am having hives on arms and legs seems to be getting progressively worse as time goes on I di not initially have them at the time of the vaccine no swelling or other symptoms but each week they seem to worsen itching and welts forming

Client became itchy after receiving vaccine, a rash was accompanied by itching sensation. Client has a history of developing a rash after getting vaccines. Client used inhaler (albuterol). EMS administered Benadryl and observed for 30 mins. No significant improvement, transported to hospital.

According to the patiens, she had hives and echiness the next day after receiving the vaccination. Today the 14th of April, she showed up to the pharmacy and complained of severe leg cramps and multiple bruises in her legs and thighs. I advised her to go to the emergency room. She picked up her aspirin 81 mg .

Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21. It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.

Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.

Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.

INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 180 pounds, and height was 62 inches. The patient's past medical history included aggressive breast cancer in 2015, lumpectomy, chemotherapy, and radiation therapy, and concurrent conditions included non-smoker, abstains from alcohol, and sulfas allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient experienced allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.

BRUISING; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 241 pounds, and height was 67 inches. The patient's concurrent conditions included multiple sclerosis, chronic obstructive pulmonary disease, latex allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included natalizumab for multiple sclerosis. On 08-MAR-2021, the subject experienced bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising. This report was non-serious.

Reports that she starting having leg pain in right leg. States that it starting out intermittent but has gotten worse. Especially at night. Did have some redness to that leg a couple days ago but has resolved.

NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.

HA, Itching all over, Rash (shingles like around neck), Itching ears, Swollen legs, Shortness of Breath

Patient developed a "goose egg" at the injection site 9 days after vaccination. Patient stated injection site was swollen, red, and warm to the touch. Patient reported these symptoms on 04/20/21 and was instructed to seek medical attention.

STABBING PAIN IN STOMACH; NAUSEA; INJECTION SITE SORENESS; FEVER; LOSS OF 5-6 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, and keflex, tylenol and asprin allergy. The patient experienced difficulty in breathing when treated with hydrocodone bitartrate/paracetamol, and hives when treated with naproxen sodium, erythromycin, and swelling of the face when treated with magnesium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of 5-6 pounds. On 01-APR-2021, the subject experienced stabbing pain in stomach. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and fever on 03-APR-2021, had not recovered from nausea, and stabbing pain in stomach, and the outcome of loss of 5-6 pounds was not reported. This report was non-serious.

MINOR HEART PALPITATIONS; HIGH FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at injection site. On 07-APR-2021, the subject experienced minor heart palpitations. On 07-APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor heart palpitations, and high fever on APR-2021, and was recovering from pain at injection site. This report was non-serious.

Woke up itching my lower left leg and by morning had a rash on both legs, upper thighs, inside of upper arms, and lower arms, a few days later also on front shoulder area on both sides, which is still not completely gone. Red bumps appeared in those areas as well. I treated the areas with calamine lotion and cortisone cream as needed, since it looked like an allergic reaction.

Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.

SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.

ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye was not reported. This report was non-serious.

I developed a nose bleed about an hour after injection. This lasted for about an hour. My arm was sore for a few weeks, with a red "bullseye". This lasted for 2 weeks.

RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone. On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.

MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.

I developed fairly intense itching throughout my body, primarily arms , legs and torso. I did not develop a rash or bumps. This lasted from Wednesday April 7 to Thursday night April 8. By Friday this had resolved. Other than that I was very fatigued the night of the shot and somewhat achy the next day.

HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.

HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04DDZ1D expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. This report was non-serious.

SHINGLES INFECTION (FEVER, CHILLS, BODY ACHES AND INTERNAL PAIN, FEEL UNCOMFORTABLE AROUND THE BREAST AREA AND ON BACK LIKE AN IRRITATION); This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included some breast issues, and other pre-existing medical conditions included 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles infection (fever, chills, body aches and internal pain, feel uncomfortable around the breast area and on back like an irritation) 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.

SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 19/MAY/2021) dose was not reported, administered on 06-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced crawling sensation. On 06-MAR-2021, the subject experienced cold. On 06-MAR-2021, the subject experienced sore arm at site of injection. On 07-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation, and cold on 07-MAR-2021, slight headache on 08-MAR-2021, and sore arm at site of injection on MAR-2021. This report was non-serious.

FLUSHED; WATERING EYES; SUNBURN-LIKE RASH; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd from 911 exposure, asthma, chronic rhinitis, thyroiditis, lipidaemia, codeine allergy, and levaquin allergy. The patient experienced drug allergy when treated with betamethasone, ciprofloxacin, and bupivacaine hydrochloride/epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flushed. On 10-APR-2021, the subject experienced watering eyes. On 10-APR-2021, the subject experienced sunburn-like rash. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, and sunburn-like rash on 11-APR-2021, and watering eyes, chills, and low grade fever on 12-APR-2021. This report was non-serious.

SHORTNESS OF BREATH; LIVER SPOTS; RASH LEFT THIGH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced liver spots. On 11-APR-2021, the subject experienced rash left thigh. Laboratory data included: O2 saturation (NR: not provided) 97 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from rash left thigh, and the outcome of liver spots was not reported. This report was non-serious.

ARMPIT SWELLING; ARMPIT PAIN; SORE ACROSS THE SHOULDER; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 (Vaccinated in left arm) for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced armpit swelling. On 28-MAR-2021, the subject experienced armpit pain. On 28-MAR-2021, the subject experienced sore across the shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the armpit swelling, armpit pain and sore across the shoulder was not reported. This report was non-serious.

ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthcare professional advised patient to visit emergency room but patient did not want to go. 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain at injection site. This report was non-serious.

Seven days after receiving vaccination I broke out in a rash that increased in severity for three days. It was located around my waist, down my legs and ankles. It started as raised red bumps that itched. By day four the clusters formed a flat mass of red- like blood pooling under my skin. The rash started Saturday night and I consulted with my healthcare provider in. I was in Denver for the week and she encouraged me to be evaluated. On Tuesday April 13 I saw Urgent Care. He seemed stumped - especially since the onset of rash was seven days after injection. He put me on a six day course of methylprednisolone. I began the course that day and that stopped the itching and the daily multiplication of spots and spreading blood like areas. Today, April 28 I am home in Portland and the spots are fading. Both health care providers went through list of common irritants and they did not apply. I was traveling with my husband who did not develop any rashes or spots.

The day after my J&J vaccine, I experienced left leg and knee pain with numbness sensation. I had a left knee replacement in September 2020. I experience numbness below and above my knee cap. I also experienced bad migraines , arm soreness at the injection site. I called my doctor and he gave me an appointment to see him and he did not think it was related to the vaccine but he was not sure since I do have history of rheumatoid arthritis. Today my left knee and leg still feel numb and I am taking my regular medications as instructed.

Shingles developed on April 14,2021- eight days after vaccination. Burning pain through left side back to left breast with rash left breast, enlarged lymph nodes left side and left neck, extreme pain which was treated with valtrex, gabapentin, two courses prednisone, Advil, capzacin cream. May 1,2021 pain continues. Seen in Hospital ER April 20,2021 for confirmation diagnosis.

Hives, rash, slight difficulty breathing, partial reduction in taste, fatigue, headache. 2 rounds of prednisone, benadryl, zyrtec

Major rash - neck, back, chest, stomach, some on thighs, left eyelid, major itching - saw doctor - took Benadryl at night and Zyrtec during day. Been 3 weeks and still have signs of rash and some minor itching.

Broke out in hives over entire body except the face. Large splotches, intense itch, elevated skin temperation. Took Benadryl, contacted pharmacy. Benadryl treatment for four days, on the fifth day symptoms began to subside. Came down with Covid sick in bed Sunday, April 11 after 4 p.m.

Patient says that on 5/13 her entire body (on both sides) broke out in large welps. They were also very itchy. She used benadryl tablets and topical hydrocortisone. I saw her on 5/16 and she still had a rash present but she says this was much improved.

First I had the itching and I came home and took a Benadryl and it subsided. The next day, I woke up stiff as a board. Everything hurt. Like I remember having the flu - feeling you get when joints etc. hurts all over. I took Tylenol - maybe took 1000 mg twice in that day. I have fibromyalgia and this was over and above that. The third day, the injection site on arm really hurt. The fourth or fifth day, the cough started - first a little irritation and then I started coughing and rattling and I have had the cough ever since. I have seen my doctor four times in the last month to get medications that work. I had to go to the walk in (Urgent Care at the clinic on Weekends) this Saturday (5/15/2021) and get this new medication that seems to be working - it's a steroid - it's Levaquin . Although, yesterday, I still had that overall body hurt (I was in bed all day) - could have been side affect of medication but today (after two doses) seems to be better and I'm not coughing as much.

patient developed extreme fatigue, rash, fever , chills and swelling of lower extremities within few days of receiving vaccine. Also had red rash scattered on lower extremities extending from knees down to her feet.

PATIENT STARTED ITCHING 10MINUTES AFTER INJECTION WITH 0.5ML OF VACCINATION- PHARMACIST ADMISTERED 10ML OF BENADRYL LIQUID- PT STOPPED ITCHING 5 MINUTES AFTERWARDS

I experienced the next day, had chills and slight fever, lasting 6 hours. Then on April 8 2021, I developed shingles and I went to urgent care on 04-12-2021, started with rash on my face. No medical tests were done. Today I am still dealing with shingles.

On 4/27 at 6:30 p.m., I became flushed and my skin felt hot. Next, I began itching EVERYWHERE, my arms especially. I scratched so hard I bruised my arms! My skin turned bright red. I chewed 2 Benadryl, and after about an hour it faded somewhat but I kept itching until about midnight. My family monitored me to make sure I didn't go into anaphylactic shock. The nest day I called my physician's assistant and he said just to monitor it, in case it happened again. It happened again on 5/4/21 at 10:30 p.m. It was not as severe, but I took 2 Benadryl immediately, since I recognized what was happening. I was better by about 12:30 a.m.. I had been in contact with my PA regarding my statins, and he said there wasn't anything they could do but to report it. He didn't think it was the statin that I had been taking, as I had discontinued the statin after the first incident, due to other concerns.

I am still experiencing pain at the injection site from when I received the vaccine. I have been experiencing heart palpitations that have been waking me up in the morning as well. I'm not sure if it's from the vaccine, or the nasal spray that I have had an allergic reaction to. My stomach still seems off. I'm not feeling right. I saw Dr. about my allergies and allergic reaction.

fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine going through entire body tiredness hoarseness, heavy breathing 6 weeks after vaccine

Rash and hives on entire face - took Benadryl, but that did not help Around 1:00 AM on 6/1/2021 - went to Emergency Room - lips were tingling and throat was closing up They gave me dexamethasone sodium phosphate injection 10 mg & famotidine 20 mg Rash cleared up on 6/3/2021 My known allergies are allopurinol and iodinated contrast media - IV dye

Reoccurrence of shingles in right buttock. Shingles occurred in this same site before when had 1st dose of Pfizer vaccine in April, which is why I switched vaccine.

I had a very bad headache and soreness at the site of the injection for a couple of days after the shot. Since then, I have felt tired and out of breathe. I also felt some angina. I had a cardiology exam and no problems were found.

Patient said they developed an itchy red bump at the injection site area and on her forearm. It was about the size of a dime and has not gotten worse since appearing the day after her injection.

JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. 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 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.

Severe, itching rash on arms, back legs & shoulder. Saw Dr on 6/9/21 because the rash was getting worse & more intense. The rash was similar looking to Shingles, not the severe pain but severe itching. I received a dermatological steroid injection & was prescribed Triamcinolone Acetonide Cream USP, 0.1%. The itching did not begin subsiding until much later that evening. My appointment with Dermatology was at 7:45 am on on 6/9/21.

Started as rash under armpits and torso. It has progressed to include arms, sides, elbows, crotch area, upper thighs & hips. It is slowly spreading farther away from my torso and seems to be aggravated by heat and rubbing against skin/clothes.

Allergic type reaction Itching on face, scalp, arms, legs, torso Started approx. 50 hours after injection Treated with OTC Benadryl, 2 doses thus far Patient continued with milder itching and a tingling sensation, similar to a Niacin "flush" on the skin Continued condition remains after 72 hours after injection

Swelling, redness and soreness and a knot in vaccine site for a month. As of today I still have a knot under the injection site and soreness. Cannot sleep on that arm and some pain with active or not. Achy joints and fatigue.

LOW PLATELET COUNT; BRUISING; RASH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and sulfa allergy, and other pre-existing medical conditions included patient was born with whole in the heart. The patient experienced drug allergy when treated with loratadine, and atorvastatin calcium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, one total administered in Left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, three weeks later the vaccination, patient started getting bruising and rash. On June-2021, patient went to doctor who put patient on steroids. Patient had blood work done which showed platelets were down to 7. The patient was given steroids in hospital and the platelets was 39 after patient got off the hospital. Patient was off of them too fast and platelets started to drop down, as of Wednesday 23-JUN-2021 platelet count was 304, week before that was 321 and lowered the dose of steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was serious (Other Medically Important Condition). ,; Sender's Comments: V0: 20210660892-covid-19 vaccine ad26.cov2.s-low platelet count. 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).

Ten days after the above vaccine, I broke out with shingles. I have never had shingles. I received medical treatment on June 16th. My doctor indicated that the vaccine played a part in compromising my immune system, and thus was a factor in the shingles breakout.

Pain to the muscle in the arm where the injection was given. Feels like the muscle is damaged and week. Pain in movement and when arm is used. It is now 4 months later and the pain is just as bad sometimes quite painful to move the arm

On June 14 I woke up with dry and sore throat the next day ears, eyes,head and body ache started. I waited 4 days and didn?t feel any better decided to visit my Dr. She didn?t find any infection she still gave antibiotics just Incase after two sets of antibiotics and pain medication I still feel the same I am hurting all over and am extremely tired all the time I have sharp pain shooting from back of my neck to the bottom of my scalp and my shoulders. My legs are heavy and tired. Over all I don?t feel good at all. It has been a month and not much improvement. I tested negative for covid about two weeks ago.

Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue 03/07/2021

Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.

At 1346 pt c/o itching around face and head. Benadryl 25mg administered PO. Referred to pharmacist supervisor. At 1350 BP 142/78 P 82 R 16 O2 98% (room air). At 1400 pt states itching has decreased at this time, At 1415 pt discharged home.

Around 430pm my right upper began to get red also my chest began to get red (blotches) I began to feel my heart racing also slight tightening in my throat approximately a half hr later all symptoms went away.

Patient felt light-headed and dizzy 15 minutes after receiving the vaccine. She also felt like her hand was shaking. Her forehead and cheeks appeared to be red and flushed. Her symptoms did not improve, she was evaluated by the ID physician and was transferred to the ER.

I developed a vasculitis rash mostly on my lower right leg. I had a tiny rash of he evening before the shot. That was a Thursday. The shot was Friday night. Monday evening I had a huge rash on my lower right leg and a very tiny rash on my lower left leg.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported to our store 5457 about a vaccine she got at 5434 last monday. She broke out with a rash the thursday after getting the vaccine and after a few days of vaccine she decided to go to urgent care since the \"burning wasn't stopping\" and it spread to her chest. She was discharged with a script of prednisone and the rash seems to be getting a little better. I will follow up with her in 2 days to make sure it has cleared up.

March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues. 1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb. 3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.

At the time of injection I felt a pressure pain radiating diagonally downward toward my armpit. Where she injected me was very high up on my arm almost close to the top. The pain at injection site was quite sore for the first few days and then went away for the most part for a day or two but has now come back much worse. It hurts to lift my arm or move it and feels like I've lost strength to raise my arm. I am in constant pain now and my arm around the injection site is painful when I press down especially on the bony area.

Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea; I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night. Felt very drained and tired with myalgia all of the next two days. Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head (and I have not had a cold since November 2019). I had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.

itching 5 min after the injection, then developed a rash that has been coming and going daily, Benadryl has helped she is still itchy daily and is having intermittent rash now 6 days later though every day is better

Low grade fever the night of the vaccination. Redness, tenderness, and swelling just below the vaccination site began day following vaccination. The redness eased a bit but developed into a hard lump the side of a quails egg in the same location.

Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down. Patient went to ER for evaluation. Started on prednisone. Dx: Vasculitis On Monday 3/22/21 evaluated by PCP. Follow up blood work and office appointment in 8 to 10 days. Report to VEARS. Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call. Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen. Purple skin discoloration remains on lower extremities but decreased pain. VEARS form submitted.

Started with chills, fever ,Nausea aches and pains for 2 days went into full sinue infection, weal and its been 5 days,

I had my shot at 3:45 pm on friday, the 26th of March. at around 6:30 I started to feel nauseous and started to get body aches. Lot of congestion and a runny nose. I also got a stomach ache later in the evening. by the time I went to bed around 10 pm I hurt all over and was very sick to my stomach. I felt like if someone touched my skin my bones and muscles would all shattered. I did not sleep much that night and woke up on Saturday, the 27th with the same symptoms but not quite as bad. I still had nausea and a stomach ache and was very tired and drained. I did start to get diarrheic around 3:30, 4:00. I still hurt and have diarrheic and am very tired today, which is Tuesday, the 30th of March at 5:15 pm.

C: Hives Had vaccine on wed and broke out with rash on Sat HPI: Patient presents with recent onset of skin rash. Rash has moved to different areas of the body. Rash is erythematous, raised and very itchy. Patient is not sure about what caused the rash. Denies an insect bite, recent exposure to new meds, cloth, cologne, food or other allergens. No recent use of new meds. No trouble breathing, no wheezing, no cough, no chest pain, no palpitations, no dizziness. No problem swallowing or swelling in the tongue or throat. No recent Hx of upper respiratory infection or other illnesses. under sterile conditions the the buttock was prepped with alcohol prep and patient was given a combination of decadron 4mg im with depo medrol 40 mg im Patient tolerated the injection well witho side effect prescribed for steroids to take benadryl and zyrtec will repeort possible adverse effect to regulatory authority.

Pain injection site since day of vaccination, still have pain. Slight fever and chills, body aches, fatigue for 12 hours.

LOSS OF CONSCIOUSNESS, FAINTED; HEART WAS RACING; DIZZY; VOMITING; CANKER SORE UNDER TONGUE; HEADACHE; NAUSEA; FATIGUE; INFLAMMATION ON LEFT EYE; FALL ON BED; SMALL HIVES UNDER EYE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included seasonal allergies, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, after vaccination, she felt fine all day and night. The next morning she woke up and felt sick. She had nausea, headache, hive under eye. She laid back down and tried to sleep. A few hours later, she woke up to use the bathroom. She was very nauseous and dizzy. She lost consciousness and fell trying to get to the bathroom. She fell on her bed and was uninjured. The paramedics took her to the hospital. She was given medication for nausea, headache, and IV fluids. She gave blood for lab tests and they came back normal. No COVID test was administered. When she felt better, she was released. A few days later, she discovered her tongue was sore and red. She called her primary care physician (PCP). PCP said the red and sore tongue was probably related to allergies. Two weeks later, her tongue was not sore, but still red. They advised her to get a second opinion with another HCP. She was going to visit her allergy specialist.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, fatigue, inflammation on left eye, and small hives under eye on MAR-2021, and vomiting on 07-MAR-2021, and had not recovered from canker sore under tongue, and the outcome of fall on bed was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from the patient on 23-Mar-2021. The following information was updated and incorporated into case narrative: Patient's medical history added as seasonal allergies and codeine allergy, Vaccination site as left arm added; Additional events as small hives under eye, fall on bed; lab test of blood work added; Event outcome of loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, and fatigue was updated to recovered/resolved.; Sender's Comments: v1: Follow up information received updates patient's medical history (seasonal allergies and codeine allergy), Vaccination site as left arm; Additional events (small hives under eye and fall on bed), laboratory test (Blood Work); Event outcome (loss of consciousness, fainted, heart was racing, dizzy, headache, nausea and fatigue was updated to recovered/resolved). This updated information does not alter prior causality assessment of reported events 20210323730-COVID-19 VACCINE AD26.COV2.S-headache, nausea and fatigue. These events are labeled and are therefore considered potentially related. 20210323730-COVID-19 VACCINE AD26.COV2.S-loss of consciousness, fainted, heart racing, dizzy, vomiting, canker sore under tongue. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are no information on any other factors potentially associated with the events.

Area around injection site firm, red and tender and remains that way as of 04/04/2021. Also had joint pain and fatigue.

2 days post vaccine, woke up with a rash to bilateral palms and arms that stop at the shoulder. small maculopap bumbsular from palms to shoulder, skin is sensitive to hot and cold, rash is "itchy and painful," denies skin peeling, took zytrtec with no relief, also complains of low energy/fatigue, appetite is ok, denies fever, approximately 12 hours later noticed rash to abdominal region, same maculopapular bumbs across bilateral upper abdoment, denies shortness of breath

PT GOT HER JANSSEN VACCINE ON 4/3 SATURDAY 10:30 AM. AS PER PT, AROUND 6PM THAT DAY, SHE STARTED GETTING ITCHY HIVES ON HER FACE, AND IT STARTED GOING DOWN HER CHEST.

My neck started itching gradually more annoying by last week of March. I started exp redness below my neck looked like eczema.

Patient is found with secondary provider reporting the patient had an episode of syncope and hypotension. Patient reports that she is hot, diaphoreticand dizzy after receiving J&J Vaccine. A 12 lead ECG is completed as noted in chart. Patient's vitals are taken as noted in chart. Patient reports that she is beginning to feel better, patient continues to be monitored by EMS. Patient is found A&O x4, flushed warm and diaphoretic. Patient has no noted neurological deficits, pupils are PERRL. No trauma is noted to patient's face. Airway is patent, respirations are as noted. No JVD is noted, trachea is midline. Patient has equal chest rise/fall, lung sounds are equal bi-laterally. Patient denies chest pain, shortness of breath. Abdomen is soft/non tender. Patient denies abdominal pain, no GI/GU Symptoms are noted. Patient has no deficits noted to extremities, pulses are strong. Patient denies covid 19 concerns, other injuries or illness. 12 lead ECG is taken showing sinus rhythm as noted in chart

Blood glucose 158 mg/dL; Blood pressure 177/102 mmHg; Heart rate 92 bpm, Sp02 98%; Per spouse her head, arms, and chest hurt; arms have itching and tingling. Client's spouse reports she had a similar reaction and it is "less than last time" and was recommended by her PCP to receive a dose of Janssen instead of a second dose of the Moderna (received 1st dose on 01/16/21 Moderna 013L20A).

woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.

Slight chills and headache on the day following the vaccination. My two adult children were vaccinated at the same time and had hard lumps and more pain at the injection site than I did. My daughter's arm stayed that way for more than a week and then looked bruised. My son has complained of mental fogginess while my daughter and I have suffered frequent light-headedness, chills and fatigue. My lightheadedness seems to be becoming worse by the day.

Immediate moderate pain at injection site. 6 hours post injection: severe body aches, chills, tremors, weakness lasting 36 hours. Generalized fatigue and weakness continuing for 4 days.

Patient reported itchiness all over body while in the after vaccination monitoring area. No hives, redness or swelling present. Symptoms improved after 15 minutes. Patient reports she will take an antihistamine at home. Patient reports using a new detergent that could have caused this.

Received the shot at 11 am and had felt fine all day. Arm was sore a vaccine site but that's it Then around 10 pm I started to get chills. Within 10 minutes of this I felt violently ill. The chills amd shaking were intense. I began vometing and had severe intestinal issues. This attack came on fierce and lasted until 4 am. I was sweating and shaking at the same time and for at lease 6 hours. My body felt tired and drained. I never expected to be so sick. The following day my symptons had began to go away for the most part, headache and feeling drained continued for a few more hours.

BLISTER ON LEFT ARM BY THE SHOULDER/BLISTER ON LEFT SIDE OF THE BACK/BLISTER ON BREAST AREA ABOVE STOMACH; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm 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 blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. This report was non-serious.

I had fever, chills, headache, dizziness, loss of appetite and extreme fatigue for 24 hours. I was in bed from 5pm 3-27-2021 to 6 pm the next day 3-28-2021. The dizziness lasted for one more day and I had injection site pain for 3 days.

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past. I had a little itching at the shot site. That went away in about 15 mins. Late afternoon I had a slight headache. 4/1/21 Day 2: Morning was normal. Afternoon I started feeling a little sluggish. I had a little headache. 4/2/21 Day 3: Morning was slow. I noticed that I was tired. Headache was stronger. I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day. My body was telling me to rest. So I did.

4/4/21 Swelling below waist, including buttocks, hips, thighs, and knees. Severe itching and pain. 4/7/21 Swelling spread to calves and ankles. Severe pain and itching. PCP prescribed 50 mg Benadryl every 6 hours and was told to go to Urgent Care if symptoms persist. 4/9/21 Went to Urgent Care Clinic due to excruciating pain in legs. Admitted to accompanying ER. Received IV and had blood drawn, showing extremely low platelet levels (37k). Discharged with prescription for antihistamine, steroid, and hydroxyzine HCL. Ultrasound taken but did not show blood clots. 4/11/21 Pain and itching spread to both arms. Extreme pain when standing and walking. 4/13/21 Went to ER. Ultrasound confirmed multiple blood clots. Discharged with prescription for Xarelto.

Discussed that pt is prone to allergies and that I would monitor her 30 mins after her vaccine. 1310 pt received the vaccine. 1324 Pt c/o itching to upper extremities, chest, head and torso. No c/o breathing issues or a feeling of her throat ?closing?. No other symptoms reported. 25mg liquid Benadryl administered PO. BP 160/95, Pulse 92; 1329 Itching improving, administered another 25mg liquid Benadryl PO. No c/o breathing issues or feeling of throat thickness. Discussed treatment options with EpiPen and calling 911. Pt. felt comfortable to the treatment of Benadryl since it was helping her symptoms of itching. 1334 BP 141/97, Pulse 98. Assisted her to recline in the lounge chair she was sitting in. Observed her closely. No other complaints of symptoms, itching improving. Instructed her to call her primary physician. She called and described her symptoms to the person that answered the phone. They will discuss with her physician and call her back. 1405 Pt feeling much better. States she feels comfortable to leave. I gave her the bottle of Benadryl and let her know when she could take it again if needed. She is going back to her orthodontics office and will be around several people to assist her is needed. 1815 Called pt., she heard from her physician. He told her to continue the Benadryl if needed and that she could add Zyrtec. No other recommendations given. She has slight itching.

Approximately 3 weeks after getting the shot, I had really bad lower back pain and a fever of 100.2. The fever lasted one day and the back pain for about a week until it started feeling better. I also had pain on the left side of my stomach area and a rash under my breasts. Rash and stomach pain gone.

She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states that she went to work on Saturday, she is a food server, she started to feel not herself and felt like she ?snapped?. She states that on the way home in her car she was nearly struck by the train crossing barriers. She states that she went home and sat in her recliner on Saturday and did not get up until Wednesday at around lunchtime. She states that she did not get up to eat or drink. She used incontinence pads and depends. She did not get up to use the restroom. She did continue to take her medications. Patient states that she was motivated to get up today because her friends were concerned for her and 1 of her friends came over to take her out for lunch. Elevated D Dimer History of DVT - mild leg pain, no swelling or erythema. No chest pain, cough or SOB. Low suspicion for PE - full dose lovenox - BLE duplex in the morning

RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.

Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea and fatigue since receiving the vaccine. Patient also advises that she used to be able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient also states that the foot that is painful is also a blueish gray in color.

Extreme Diarrhea, Fever 103 degrees, Chills, Sweating, Muscle Weakness, Fatigue, Muscle Pain, Nausea, Uncontrollable Diarrhea, Incontiness, headache, injection site welt, swelling, shoulder pain, unable to lift arm due to shoulder. Lasted 72 hrs for most extreme symptoms: headache, ongoing fever, extreme weakness (unable to walk without help). Did not return to regular strength until 8 days after administration of vaccine. Liquid Diet, Bedrest (4 days), Pain medication, Tylenol

1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site

SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING; PRESSURE CHOKING; VERTIGO; Facial pain; SUSPECTED PRODUCT CONTAMINATION; FEVER BLISTER; Foggy feeling in head; DIARRHEA; SEVERE STOMACH CRAMPS; SINUS INFLAMMATION; Sensation of pressure in ear; Injection site lump; CHILLS; FELT ILL; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, upon vaccination the patient woke up and experienced sinus inflammation, sensation of pressure in ear. On 05-MAR-2021, the patient experienced injection site lump. On 05-MAR-2021, the patient experienced chills, felt ill, injection site pain and fatigue. On 11-MAR-2021, the patient experienced severe stomach cramps and diarrhea. On 22-MAR-2021, the patient experienced foggy feeling in head. On 23-MAR-2021, the patient "believes the vaccine is contaminated", fever blister and facial pain. On 24-MAR-2021, the patient experienced vertigo. On 28-MAR-2021, the patient experienced pressure choking and difficulty swallowing. The patient visited 2 clinics and an ear, nose and throat (ENT) specialist but they were unable to diagnose and they felt there was some autoimmune effects (onset date unspecified). The patient suspected that the vaccine was contaminated based on the news report. On 02-APR-2021, the patient experienced stomach burning sensation. On 04-APR-2021, the patient experienced night sweats. On 05-APR-2021, the patient experienced tooth pain. The patient has been visited two clinic Treatment medications (dates unspecified) included: famotidine for 14 days for pressure choking and difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps, vertigo on 28-MAR-2021, night sweats on 06-APR-2021, stomach burning sensation on 05-APR-2021, and injection site lump, and injection site pain on 16-MAR-2021, had not recovered from felt ill, sinus inflammation, chills, fatigue, sensation of pressure in ear, tooth pain, foggy feeling in head, pressure choking, and difficulty swallowing, and the outcome of diarrhea, fever blister, facial pain, some autoimmune effects and suspected product contamination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a patient who experienced sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Approximately a week later, the patient experienced stomach cramps and diarrhea and 1.5 weeks later she had foggy feeling in head and "believes the vaccine is contaminated", had fever blister, facial pain and vertigo. Approximately 3.5 weeks after being vaccinated the patient experienced pressure choking and difficulty swallowing. A throat (ENT) specialist was unable to diagnose and they felt there was some autoimmune effects. A month after being vaccinated the patient experienced stomach burning sensation, night sweats and tooth pain. Given the close temporal relationship and the nature of the events, the events of sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue are considered related to the vaccination. The insufficient information precludes a meaningful medical assessment of the remaining events, including "autoimmune effects". The events will be assessed further when additional information is received.

BLOOD WENT OUT ABOUT 4 INCHES AT INJECTION SITE; POSSIBLE PARTIAL DOSE ADMINISTERED; PAIN AT THE INJECTION SITE (HURTS SO MUCH)/VERY BURNING SENSATION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced blood went out about 4 inches at injection site. On 07-APR-2021, the subject experienced possible partial dose administered. On 07-APR-2021, the subject experienced pain at the injection site (hurts so much)/very burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the injection site (hurts so much)/very burning sensation on APR-2021, and the outcome of possible partial dose administered and blood went out about 4 inches at injection site was not reported. This report was non-serious.

1. severe headaches that are not going away 2. severe abdominal pain that is not going away 3. Swelling in legs & belly 4. nausea (but not throwing up) 5. Diarrhea (comes & goes) 6 100.3 temp (today) 7. body itching all over comes & goes

24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above the knee cap. There was a soft bump in that area. At work the next day I felt more sharp pains and bumps developing around my knees on both legs. The backs of my thighs were also beginning to burn. I contacted the hotline set up at my work for adverse reactions when I got home from work that night. They were concerned and had me call my doctor. My work is onboard an aircraft and she did not want me to fly again without an ultrasound. I had an ultrasound perform on my left leg and the thigh of my right leg. It was normal. Over the next week I would get stinging , painful bumps and used NSAIDS to help. Approximately six days after the shot the burning sensation on my thighs got worst. It spread for the back of my thighs to the front and then to the calves, arms and shoulders in that order, I started taking Benadryl to release the burning. I went to my doctor who sent me for another ultrasound and blood up. Three weeks after the injection the painful stinging bumps are still happening and the burning is on my legs, arms and shoulders. I am going back to the doctor today and talk about prescribing Gabapentin.

Later that evening I began having severe chills, nauseous, my body was achy and I was very tired. The skin of my upper body begin to itch and burn and got worse over the next couple day. It continued to get worse so I went back to the pharmacy on 15th but the pharmacist knew nothing regarding what I was experiencing and advised I used Aveno and swithch from Allegra to benedryl to help with the itching and if it didnt get any better to go to the dr. Within the next couple weeks I reached out to my PCP a couple times but all he could provide it that I continued to take the benedryl because topical ointments wouldnt work. Its still here but not as bad as it originally was. I have a dermatologist appt on May 6th. It had gotten better over the next few weeks but I am still experiencing the skin sensitivity.

leg pain, used ice pack x >12 hours, when removed had rash, patient, went to ED on 4/12/2021 and diagnosed with shingles

Rash with red spots on the lower legs, itchy. started 5 days after vaccination. starting to self resolve now with purpura that are fading.

FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.

15 minutes after vaccine - eyes were getting puffy; lip and tongue - tingly and numb. I took Benadryl and the symptoms went away. That night of the shot, I had a headache - (Like a bus hit me) at 07:00 PM. The headache never went away after that. 24 hours later, I had a full body itch - I took Benadryl for that and that helped the rash. Since that first headache - I have had headaches every day. I have had to manage it with Tylenol and Ibuprofen and I still do. I saw my doctor 2 weeks after vaccine. My vision was going blurry about two weeks after my vaccine is when I really noticed it. My doctor sent me to an Ophthalmologist - I was told I had cataracts. I had my regular Optometrist - in January 2020 and nothing was noticed with cataracts. The doctor told me to try to manage the headaches and if I have any extreme pain then to go straight to ER.

Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.

LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.

I now have mini little eczema patches on my face - two or three of them; I use Fluticasone (steroid) on them which I was using for the original adverse event with red patches on/below my neck. I had a health report today primarily related to a different health issue but I asked her if I should use the Fluticasone cream on them. She cautioned me to use the steroid cream minimally on my face. The eczema I have on my hand - that is what I always there in dry, bad weather - seems worse than it normally gets. The rash on my neck is gone. Also, two weeks after the Vaccine, I have noticed that my eye sight is different. I am going to the eye doctor tomorrow because of this.

Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past. I had a little itching at the shot site. That went away in about 15 mins. Late afternoon I had a slight headache. 4/1/21 Day 2: Morning was normal. Afternoon I started feeling a little sluggish. I had a little headache. 4/2/21 Day 3: Morning was slow. I noticed that I was tired. Headache was stronger. I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day. My body was telling me to rest. So I did.

About a week after my shot I began to have an itching sensation from my shoulders to my ankles. No rash except for that caused by my scratching. The itching was not medically serious but quite uncomfortable and lasted almost two weeks.

CYST LIKE OVAL LUMP AT THE INJECTON SITE ON LEFT ARM; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 63-year-old White female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported,1 total, administered in left deltoid on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced injection site pain, fatigue. On 11-APR-2021, the patient experienced cyst like oval lump at the injection site on left arm that was painful to touch. It continued to be there two weeks later. The patient had an appointment with healthcare professional today (as reported,28-APR-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fatigue on 11-APR-2021, had not recovered from cyst like oval lump at the injection site on left arm, and the outcome of drug allergy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit disorder, back pain, cigarette smoker, and cough, 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.

Itching that was like pinpricks all over the body, including the ankle, face, legs, and nose in particular. (No itching at the injection site.) Developed a rash on face. These all developed within 15 minutes of receiving the vaccine. Took a benadryl to be safe shortly afterwards. Itching lasted for approximately 2 days. The rash is still about the same. There was also swelling at the injection site, plus a rash that developed at the site about a day later. Other symptoms, such as fatigue, tiredness, and achiness, seem to be more typical outcomes. Also developed a swollen lymph node under the arm that received an injection. This occurred two days afterwards.

PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 29-APR-2021. This report was non-serious.

Severely chapped lips, particularly at edges. Center of upper lip feels a bit swollen and numb. Staying hydrated, but skin on lips sheeting off at times. Also, using Chapstick. This is not normal for me and I can only connect it with having received the vaccine. I think the symptom is improving, but it very slow and minimal. This started shortly after receiving the vaccine a month ago and continues to this day. Other side effects were very temporary: Headache, fatigue. No arm soreness at all. Mild body aches within 24 hours, but diminished rapidly.

I had a rash appear around 3 to 4 days that was raised and very itchy and grew in size.Y ou could still see the injection site. I went to my Dermatologist last week and prescribed a topical cream to put on it twice a week for 2 weeks.

ARM IS VERY SORE AT INJECTION SITE AS WELL AS PAIN TRAILING TO UPPER SHOULDER AND NECK. PAIN IS VERY INTENSE AND CONSTANT AFTER ONE MONTH OF INJECTION. I DONT KNOW WHAT KIND OF DOCTOR I NEED TO SEE FOR THIS. I FEEL THAT THE PERSON THAT ADMINISTERED THIS HIT A NERVE IN MY ARM,AS IT WAS VERY PAINFUL AT TIME OF ADMINISTRATION.

RED SPOTS ON BOTH THIGHS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy, betadine allergy, abstains from alcohol, non-smoker, and latex allergy, and other pre-existing medical conditions included the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced red spots on both thighs. The action taken with covid-19 vaccine was not applicable. The patient recovered from red spots on both thighs on 14-MAY-2021. This report was non-serious.

Fever (99.80), Nausea, Headache, Low back pain, Intestinal cramping x 36 hours; left arm pain around site of injection x 5 days.

UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.

ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.

As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad that I wanted to scream. I felt lightheaded and needed to sit for awhile after the shot. The next night I started getting pain in my right arm and I couldn't move it. My nerve endings in my arm, shoulder, and clavicle felt like they were on fire. The lymph nodes under my right arm and neck were swollen. I had three swollen lymph nodes in my neck, but one went down, and I still have two swollen nodes in my neck. My quality of life has suffered because the pain in my arm is so bad.

About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.

I had a case of shingles. Started with rear upper thigh leg pain. It turned into a right side rash and moved all the way up to my rear - mainly the back side of my leg. It was very severe and painful. The doctor gave me Valtrex (Valacyclovir tablets), Tylenol, and Methylprednisolone. I had some relief after a week, but the rash started to scab up.

Patient stated that that within 20 in 30 mins of receiving the vaccine her left eye started to itch and burn. She lost sight for about 3 or four hours. Mouth was dry and burning back was swelling and had a rash. Vaccine administrator had to call 911.

It started with my left palm exp warm to touch(felt like slight fever around some areas) and itching all over skin.The symptoms will come and go after touching items causes whelps to appear. Around a week ago it was hard to make a fist(both hands) from the continuous itching on my hands. I have went to the doctor was prescribed Cetirizine and prescribed hydroxyzine by the ER. I have appt on 7/12 to see a Dermatologist.

The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the vaccine I had severe flu like symptoms of fever, nausea and sweats for six days. The next week on 04/15/2021 I started to get pain over my left eyebrow and my Diverticulitis was flared up. My doctor sent me to get the headache checked out because it was very painful. The headaches were there all day every day and localized to the left side over my eyebrow. Migraine medicine made it worse Sumatriptan. The pain persisted but I was checked up for Glaucoma. My Neurologist advised that I take Indomethacin and it worked to relieve the pain. Regular pain killers did not work. It slowly improved over the course of two months. It had been twelve weeks and I am still getting headaches intermittently, It is more like a twinge.

FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS

At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21- I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain. It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year. My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for hormone/menopause and I have been taking the hormonal supplements a month before the shot.

Instant right fingertips numbness, Breast itch and have for days, the numbness in fingertips have not gone away. Shortness of breathe on and off. Headache the evening and next day after the shot.

Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side). Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.

Symptoms from improperly administered vaccinations - known as SIRVA, for "shoulder injury related to vaccine administration'' - include chronic pain, limited range of motion, nerve damage, frozen shoulder (the inability to move the shoulder) . I received a COVID-19 vaccination (2nd dose as part of the Janssen study ).. When the nurse injected the needle into my arm it HURT. I started to leap off the table but she told be to stop and 2 nurses stepped forward to steady me. I told her it hurt extremely bad but she didn't withdraw the needle. Another nurse handed me a tissue to wipe the tears from my eyes. The injection hurt, more so than the usual injection. In the days that followed, the pain in my right shoulder worsened. Initially, I dismissed it as typical post-shot soreness. But it didn?t go away. Months later, it still hurts. The sports medicine doctor says I have excess fluid buildup in the bursa. He withdrew the fluid. I'm still going for physical therapy 3 times a week to get back range of motion and strength in my arm. I?m convinced this occurred because the nurse injected the vaccine too high on my arm. I had no symptoms before the shot, and pain has persisted since.

Continued pain in upper left arm where given the shot. Never had pain there before until given the shot. Pain sometimes wakes me up at night. No pain in right arm. Is difficult to get dressed in the morning and loss of strength in the upper arm. Pain started day after the shot in upper arm and has not gone away. Is tender to the touch at the location the shot was given in the arm.

SHINGLES; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 87 pounds, and height was 60 inches. The patient's past medical history included hives, and concurrent conditions included lymphedema in left leg, bronchiectasis, abstain from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, clarithromycin, and doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced flu like symptoms. On 09-JUN-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 12-MAR-2021, and had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.

severe leg and foot cramps/spasms. every night and sometimes during the day time. toes point downwards like a ballerina's foot, calf muscles get hard and very painful. sometimes my foot shakes when this happens

Just under a week after getting the J&J vaccine, I started to develop a rash, along my waist and under my breast. Then is appeared on the back of my legs from pantie line down to the back of my knee, also along the inner thigh, and after a few more days in the anal area, and vaginal area. The rash is both very painful, and itchy, I saw my primary doctor who then referred me to a Dermatologist, who said it was Lichen Sclerosus, and there is no cure for it. He prescribed 2 medications that both have steroids in them, but I am still having pain and itch. Pain feels like my skin is being ripped off me or will tear. Life is not real enjoyable dealing with this

Every few weeks since the vaccine I experience a sharp stabbing pain at the vaccine site. Another symptom that that began slowly (every week or so) until now when it is several times daily-feeling a prick and then a burning sensation on one of my toes or fingers like a fire ant is biting me. The pain lasts for hours-no red marks. I have also experienced the same sensation on my arms, over ribs, abdomen and legs. I have not spoken to my Dr. about this, but will if the frequency keeps up.

Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness Took ibuprofen and drank lots of water... cold compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red.

Stinging, burning pain in upper right thigh, at the site of where I developed shingles about 3-4 yrs ago. I will be watching that area and if it looks like a shingles outbreak, I will go see my PCP, Dr.

Patient developed hives the day after receiving the vaccination 3/6/2021. Hives come and go, very itchy. Continues to have sporadic hives on 3/10/2021. She is using Benadryl PRN. Recently prescribed prednisone for Hives. She also had a swollen throat day after receiving the vaccination without difficulty swallowing. Took Benadryl PRN, this has since subsided.

at injection, arm was not opperable, too weak to pick up coat or purse. After about 15 minutes the full use of arm was back. The muscle is still affected and strained after 6 days. I waited a half hour at the site and got into my car at 3:45. On the drive home within 30 minutes my face started to itch and turn red, then my mouth inside started to itch, then my eyes started to itch. After that my throat started to feel gravely, so I took 75 mgs of gel cap benedryl. This is what I feel and take upon getting stung by a bee. I also took my albuterol inhaller two puffs which I also always have on me because of my asthma. I was sleepy but had dinner and went to be. I did not feel that I had to take more benedryl during the night.

One week after vaccination, patient awoke with intense generalized itching (she described as a "internal burning itchiness" that was "all over"). She saw no rash or hives. Continued for remainder of night, difficult to sleep. Next day her husband found what he described as a few "faint, non raised patches of very light hives" on the patient's back. She looked more carefully and found a few small similar patches on both arms and legs. Treated with OTC lotion, CeraVe Itch Relief Lotion from store. Patient says 12 hours after onset that the "insane burning/ itching has subsided for now." Patient reports no new foods, clothing, washing machine detergent, illnesses, or other exposures. I am a physician, and the patient called me (her brother) to ask me whether this was a known side effect of the Janssen COVID vaccine. I did not see this described in the FDA advisory committee data package, but just a general reference that urticaria would be an expected side effect to a vaccine.

Day 6 after Injection: Hives/rash on arms, legs, hands, feet, torso. Itchy and raised. Treated with 1 Benedryl around 1.5 hrs after rash first appeared. Also used some cortisone cream on the worst areas. Symptoms mostly relieved although some rash still present. Took 2nd Benedryl before bed (10 pm). Day 7 after injection: Hives returned at 4am slightly worse than when it first appeared. Took 1 Benedryl and after 2 hrs the rash started to go down and itchiness greatly reduced. 1 Benedryl around 11am. By evening only a few bumps remained. Residual itchiness lingers. No more Benedryl taken. I have never had a rash or hives like this. There have been no changes to detergents, soaps, diet.

Saturday night around 9:45 my hands and arms began itching. Then i noticed they had broken out in a red rash with whelps beginning on my arms. It then began breaking out on my face and legs. I took 25 mg of benadryl. The rash continued to spread so I went to the ER. They administered prednisone, pepcid, and benadryl. After about 1 hour the itching was better and the rash began to fade but it didn't go away. The ER sent my home with a predisone dose pack for 6 days and to take 50 mg benadryl every 6 hours. When i awakened this morning I had the rash on other sites on my arms, legs and stomach and in my right eye, it was red and a little swollen. I took the first day's dose of prednisone and 50 mg benadryl and 20 mg of famotidine. After about 30 mins to 1 hour the itching and redness improved but has not completely gone.

Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tongue was swelling and her face was getting red and hot. Following the reaction protocol patient received 0.5mg of epinephrine IM at 15:26 and was moved to a stretcher. EMS was called, again per protocol. EMS recommended patient be transported to hospital but patient refused. Patient ambulated out of clinic independently and drove home.

11:00 am - very mild rash on face - 2 spots started at 4:15 pm - peeked at 5:45 pm - temperature 100 degrees, sever chills, violent shaking, bad body aches especially back area, headache. Took Advil which reduced violent shaking, chills and body aches by 6:30 pm. Remained fatigued rest of evening.

3/8/2021 - 9 hours after vaccine had severe chills for 4 hours, headache, nausea - stayed in bed for 1 day and then seemed fine. 3/16/2021 - late afternoon - developed swelling in left foot along with rash on both legs from the knee down to toes. on 3/17, swelling on both feet with rash and swelling of left hand.

Chills and fever as high as 101 started at 10:30 pm along with skin sensitivity and then deep pain in muscles, joints, & tissue throughout my body & very bad headache. Had mild nausea. Took Aleve for pain, was unable to sleep through the night. Pain better by next morning, mild fever continued until approx 5 pm the following day. Some headache pain lasted about 20 hours.

My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy.

In the same area as my shingles virus, which is well on its way to healing, I developed a rash about 6 or 7 hours after the vaccine. The rash is small red markings that look like hives and it is unbelievably itchy. I took benadryl which reduced the itching within 4 hours, but did not appear to impact the rash. Today is day 1 after my vaccine, so I am watching the rash to see if and how it progresses over the next 48 hours.

Site: Pain at Injection Site-Mild, Systemic: patient stated \"palpitations\"-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient received Janssen covid vaccine 3/12/21 at 5:04pm to her left arm. Due to patient's response on the screening questions, patient was to be observed for 30 min. At 5:30pm patient complained of numbness to arms and face. At 5:34pm patient state she had palpitations. Rph on duty advised husband to take her to ER asap. For next 3days, rph on duty attempted to call the patient multiple times throughout the day but the phone would go straight to busy signal.

Bad headache that Tylenol was able to handle, drained feeling the next day, arm sensitive at site. Fine later next day and into the next no problems.

Blotchy, red area to lower abdomen and right thigh, pruritic at times Recommended an antihistamine cream or pill, if symptoms worsen suggested for her to see primary provider Symptoms are subsiding. Recommended to see provider if symptoms worsen.

Pain radiation from injection site down arm to elbow, extreme headache (migraine like), nausea staring 24 hours after injection, no solids only liquid.

3/17/21-Pattern of red bumps (rash) in a circular pattern, itch and I applied alcohol at 9:30pm 3/18/21-Contacted Physician because of welping that occurred on the site Dr viewed via Zoom session and sent in a prescription of Prednosone (5) pills, suggested benadryl and hydrocortisone cream 3/26- No improvement asked the doctor to prescribe a cream of Triamcinolon Acetonide cream 0.1% 3/26- Visit with Nutritionist and made her aware of the incident relative to Chronic condition of Diabetes Prednosine makes blood sugars high 3/31- Vast improvement of site but not completely clear but shrinking in size

Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided. Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.

On the morning of March 15, I developed a red rash on throat, lower facial cheeks, and chin. Lips tingled a little bit. Rash did not itch. Took 2 Benadryl three times that day, contacted doctor via email. The rash was better the next day (March 16) but took 2 Benadryl again three times that day. Sent photo to doctor who had an allergist in the clinic look. He said it was a reaction to the vaccine. March 17 rash was completely gone and have had no other reactions since.

Headache, fever, bone and bodyaches. Inflamed red area at site of injectionwith itching, painful and hot to the touch started within 24 hours after injection. Still red inflamed hot and itchy as of day of report. Fever has resolved, bone and body ache diminished. No betterment as of yet at injection site

On 4/4/2021, I developed a red rash on both arms at approximately 3 pm. As the evening progressed, the rash spread to both legs, tops of both feet and lower back area. I took a Benedryl dose in tablet form before going to bed. As of 4/5/2021, the rash is still present. My physician was notified. I have taken another Benedryl tablet to help with the rash.

30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receiving the vaccine-- stiff neck on the left side which after a night's sleep, moved to my right side of neck. No big deal. Tired & 'drunk' after the vaccine which lasted until mid-afternoon the next day. No big deal. The worst of all happened at 3 1/2 days, a rash started in the evening, went to bed, woke up the next day with rash almost everywhere. Red, swollen, & itching like crazy. The next day- Sunday, along with Monday & Tues. was horrid. I am covered from my scalp to the tops of my feet, my crotch hurts, as do my breasts. Used Benadryl cream, aloe vera to no avail.

3/29/2021 metallic taste in mouth, 15 min after leaving the clinic. Tingling in lips and chin. 3/30/2021 hives, mouth sores on roof of mouth. went to ER received steroid and magic mouth wash. patient is at home recovering at this time.

From March 8 th through March 18, I experienced very severe level 10, out of a scale from 1 to 10, migraine pain and related usual symptoms day and night. I also experienced swelling of a 5 in area ,,soreness and redness ,around the injection site for the same amount of days. I normally suffer from chronic migraine.

FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.

Pain in arm at injection site x 2 days Fatigue on day 2 Headache on day 2 Fever of 100 on day 2 Muscle soreness on day 2

NO medical intervention required. For reporting purposes ONLY. Within about five minutes, throat swelled but not to the point of concern. Don't remember reactions to previous vaccines but not surprised considering allergies. Left side of face felt strange but didn't look any different when a selfie was taken. Sometime during the afternoon/evening, experienced a headache of short duration. Approximately six hours after shot, experienced chills and low grade fever. Simply went to sleep. Better the following morning, though very tired. Probably unelated rough itchy patch on RIGHT arm the day following vaccine. Went away with no treatment.

BRUISING AT THE SITE OF INJECTION; SORENESS AT THE SITE OF INJECTION; LETHARGIC; FATIGUED; SLEPT THROUGHOUT THE WHOLE WEEKEND; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included von willebrand disease.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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced slept throughout the whole weekend. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced fatigued. On 04-APR-2021, the subject experienced bruising at the site of injection. On 04-APR-2021, the subject experienced soreness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, was recovering from lethargic, and fatigued, had not recovered from soreness at the site of injection, and bruising at the site of injection, and the outcome of slept throughout the whole weekend was not reported. This report was non-serious.

About an hour or so after the shot, continuing until now, only 36 hours later: A general sense of feeling quite ill, headache, extreme fatigue, weakness and sleepiness, muscle aches over the past 36 hrs since the shot occurred. I have been in bed sleeping off and on feeling ill in waves. I feel less ill for hours at a time, during which I get up out of bed and function relatively normally. I felt completely fine (except for injection site achiness) until about an hour and a half after the shot, after which I went to sleep for several hours after which I felt better. The major symptom is the general feeling of 'being sick'.

A couple of weeks after my covid 19 shot, I had soreness at the injection site. After a week I took some Advil several times but the soreness did not go away. While the soreness is less severe today, it is still very noticeable even without my rubbing at the site of the injection.

Patient called on 4-10-21 at 4:10p to report what she believes to be a delayed hypersensitivity to the vaccine. She got the Janssen Covid-19 vaccine on 4-6-21 at 1:37pm. She said she was fine but 4 days later at the site of injection it was very red, swollen and about 2 inches in diameter. She has been taking Benadryl around the clock and it seems to be helping she just wanted to have Vaers report filled out just in case. She doesn't believe it serious to require a visit to the emergency room.

Patient reports check tightness, anxiety. Patient was treated by EMS and nurses on site. Patients symptoms resolved and patient left site via personal vehicle.

Awakened earl y morning 12:00 am of April 9th with horrible pain in left calf of leg. Pain continued throughout the night, until I finally got up and just walked around house to try to get some relief then laid down and try elevating leg on pillows. The pain continued so got u p and walked around more and pain finally subsided enough to get some rest. Then felt like just had a bruise in that area of the leg for a day.

Nine days after vaccination developed pain and swelling in lower right leg, ankle and foot. Red discoloration of lower leg and purple and blue discoloration on ankle/foot. Went to ER suspected blood clot. Ultrasound and blood work were done. NO blood clot was found.

2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain. After two days gradually improved. Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm. Gradually improving to pain over the deltoid near injection site; as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements. No treatment except restricting use of arm and time. 10 hrs post inoculation developed chills, myalgia and headache. Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache. This reaction was not unexpected. Did not have pain at injection site until 2 weeks post injection.

Nausea, headache that increased to monstrous proportions throughout day and lasted 3 days; severe joint and muscle pain., incoherent thinking process, fatigue, some dizziness. Presently have shortness of breath. Surprisingly, injection site only hurt the first day.

Patient states she developed the typical flu-like symptoms over the first 2 days after receiving vaccine (achy, fatigued, sore arm) and improved after these first 2 days. On day 8 post vaccination, she began to develop a whole body rash that she describes as itchy and irritated. They are still present today 4/14/21, 2 weeks after vaccine administration

Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant other diagnosed with Stage 4 inoperable NSCLC ) and had been attributing the often present headache to that, but they were also accompanied by a butterfly pattern red flush across my nose. Acid reflux which I was attributing to stress or alendronate. Woke in the night 4/12 to severe acid reflux, nausea, headache, flush, thought maybe I was having a heart attack (I have no cardiac/BP issues); then last night, 4/14 about 6 PM, weird numbness tingling in right arm from center of my chest passed in about 5 minutes. Significant Other said I had the pattern flush on face at time of attack which faded as I began to feel better. I have not consistently felt at 100% since vaccination, but I have a lot going on and attributed it to that.

I have developed a hard very sore lump starting on day 5 after my vaccine. The lump is below the injection site to the right of my bicep and it is about the size of a large grape and very sore. I have heard of others developing a lump in the area of their lymph notdes under their arms but my lump is not in that area.

The next day I had swelling at injection site, and aches and pains . Yesterday I woke up with hives on both arms between elbows and wrists and legs above the knees. I haven't eaten anything or been anywhere or changed soaps or detergents.

For the 1st 10 days it felt like my brain was swollen too big for my skull. Not like any headache I have ever had. I did take some acetaminophen but it didn?t seem to quell the pain. While still at vaccine site I got a weird taste in my mouth, dry mouth and my voice started going hoarse. I stayed a while longer to be watched as I also had itching. I did not go into hives. I had pain in my body from time of injection ? the ?typical? sore arm didn?t set in until day 3-4. I had hot spots all over my body ? but not fever or rash. On 4/11/21 I broke out into a rash on my forehead that lasted about 4 days. What I want to specifically report is I like these zinger/sharp traveling pain from my temples to posterior head. Still having this sensation but not as frequently. They don?t last long but are noticeable at the time they are happening. The only way I can explain the pain is that it felt like when you break a blood vessel in you finger and it really, really hurts for a short while and then pain subsides. I started having these pin prick sensations within the first few days all over my body (arms, legs, back) but the frequency has decreased. Days 2-6 I was just wiped out and rested. I am still feeling lack of energy still today.

Celiac and probe to rashes, but got odd, very little blister rash. Blisters were far apart on my stomach, a few more on my right side. Did not bother me except when flu-like symptoms flared up in the afternoon for 4 days. The rash then itched and stung a bit. I used a cannabis ointment on it for comfort. I still have a few small dried scabs from the rash.

BODY ACHE FELT MOSTLY ON KNEES, PELVIS AND HIPS; NAUSEA; INJECTION SITE PAIN; FEELING VERY TIRED; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and concurrent conditions included bactrim allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was previously treated with lorazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21A or batch number: 043A21A, 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 ache felt mostly on knees, pelvis and hips. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and feeling very tired on APR-2021, and was recovering from body ache felt mostly on knees, pelvis and hips, and injection site pain. This report was non-serious.

Under my Chin and Neck turned scarlet red. A rash or hives covered my chest. On the left side of my neck hives or a rash developed and crossed my shoulder down to the injection sight on my left arm.

APPETITE LOST; SORE THROAT; ACHING JOINTS; MUSCLE PAIN; HEADACHE; INJECTION SITE PAIN; UNABLE TO SLEEP; ITCHY RASH; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 03:24 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced unable to sleep. On 09-APR-2021, the subject experienced itchy rash. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Fever (NR: not provided) 100 increase body temperature (units unspecified). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced aching joints. On 10-APR-2021, the subject experienced muscle pain. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced appetite lost. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, itchy rash, and fever, was recovering from muscle pain, headache, and injection site pain, had not recovered from fatigue, and the outcome of appetite lost, aching joints and unable to sleep was not reported. This report was non-serious.

VOMITING; RATTLING COUGH; NOT SLEEPING; TEMPERATURE-FEEL FOREHEAD WARM; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 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 vomiting. On 10-APR-2021, the subject experienced rattling cough. On 10-APR-2021, the subject experienced not sleeping. On 10-APR-2021, the subject experienced temperature-feel forehead warm. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, rattling cough, not sleeping, nausea, and temperature-feel forehead warm. This report was non-serious.

April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest

SORE IN ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient previously had vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072/1402072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 09-MAR-2021, the subject experienced sore in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore in arm at the injection site on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210319996.

PAIN IN RIGHT EYE COMING FROM BACK OF HEAD STOPS FOR A WHILE AND THEN REPEATS; EYE ITCHING; TIREDNESS; PAIN AT INJECTION SITE; STOMACH PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 05-APR-2021, the subject experienced stomach pain. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced pain in right eye coming from back of head stops for a while and then repeats. On 15-APR-2021, the subject experienced eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and pain at injection site, and tiredness on 07-APR-2021, had not recovered from pain in right eye coming from back of head stops for a while and then repeats, and the outcome of eye itching was not reported. This report was non-serious.

BURNING AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and fibromyalgia, 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: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at the injection site on APR-2021. This report was non-serious.

SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain. I was unable to sleep more than a few short spurts the entire night as the pain was so intense. I read online that Benadryl was to be used for the pain, as well as ice. Originally I had used heat, before finding the information online. Nothing seems to help at this point.

Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness Aching legs Heavy feeling in chest Vertigo following day Increase HR-as though heart was pounding in my chest

The day after the vaccine I got the usual symptoms for 36 hours. Four days after the vaccine I developed a slight cough. The cough got worse, and I had green sputum. After ten days I contacted my doctor and he prescribed antibiotics. It cleared up a little, but it was persisting. I was tested for Covid-19 and the test was negative. I had the cough for almost three weeks. I developed a weird bruise on my right forearm the size of a silver dollar. It was round and it took a couple of weeks to go away. My arthritis in my hands was also worse than normal for the three weeks.

BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hours. The morning after the vaccine I felt lightheaded and weird. I had heart palpitations and I was queasy. I started to walk back to my bedroom. The next thing I knew I woke up on the floor after passing out. After that I felt like my body was crumpled and I was disoriented. I could barely walk but I made it to the couch, and I had bumps in the front and back of my head near my ear. I was in a lot of pain and I think I was in shock. My foot was painful, and I saw a foot doctor. I had a doctor?s appointment and they did an EKG and they sent me to a Neurologist. It has been seven weeks I still have dizziness and nausea and it is hard to focus. I also have pain in my knee and my right arm.

I received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking out in hives all over my body 24 hours later. I was lethargic, wanted to sleep all the time, and had no energy. This is gradually getting better, but still occurs. I periodically have headaches. After two full months I continue to have regular eruptions of hives on my arms. Prior to taking the vaccine I had no health issues, ran daily, and worked out regularly. I have just recently started walking, but have not been able to run.

VEIN WAS TURNING PURPLE APPEARING BLACK AND DARK (BLACK GROWTH ON THE WRIST); RAISED SMALL BUMPS ON LEFT WRIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042B21A, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced raised small bumps on left wrist. On 10-MAY-2021, the subject experienced vein was turning purple appearing black and dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein was turning purple appearing black and dark, and the outcome of raised small bumps on left wrist was not reported. This report was non-serious.

I woke up two weeks after the vaccine to cold symptoms, despite not being around anyone without a mask. I had a cough and an extreme stuffed nose that I had to take Musilex in order to breathe. The cold lasted 11 days, but I still wake up with a cough and stuffed nose. I also have hives on my face. Sometimes I see them and sometimes I just feel itchy. At first I thought it was a side effect to the Atenolol I started taking -- and it might be -- but my face continues to itch despite having stopped taking Atenolol over a week ago. I wonder if these side effects are the vaccine, especially the cold symptoms since the vaccine has a cold virus in it.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.

HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.

Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine

A lump appeared shortly after the vaccination was given and remained for six weeks. After this time the lump started to decline and pain in the arm started. This pain ran all the way down my arm to my fingers from the injection site. At times the pain is unbearable and requires that I take Tylenol and put on a Lidocaine 1% patch.

Right after receiving the vaccine my thumb started to swell. I took a picture of it because I couldn't believe the size. For the next three mornings I woke up with a headache. I took Tylenol and it helped get rid of the headaches. I started to see unexplained bruising on my arms and legs a week after the vaccination. To this day, I still have bruising, but it is going away. I noticed that I was getting Petechiae (tiny red, flat spots that appear on the skin). I noticed a bruise on my breast ( I am a breast cancer survivor and have had reconstructive surgery on my breasts.) After the bruise started to disappear, my skin was already thin from radiation, but the skin started to open up and expose my silicone inside my breast. I had to go to the surgeon and my implant had to be removed. Now I am flat chested on that side. This is going to take several weeks of recovery to get through this. The surgery for the removal of the silicone was 9PM PST, Emergency Surgery.

I had symptoms of fatigue for a week. My arm hurt a lot where the injection was. I was given an anti-inflammatory medication 10mg for fourteen days. My arm and shoulder are still sore and its hard to cross over. I have limited range of motion. I had double hip replacement ten years ago but after getting the vaccine, pain started to arise in that area where I had the surgery. I have to go to physical therapy now because of this.

I had a slight fever, the highest was a 100 it didn't last long. The site where I got the vaccine swell up and became very sore.

I tested positive for Covid-19 with no severe symptoms in February of 2021. One week after the vaccine on 04/09/2021 I broke out in hives after eating a meal. The hives were mostly on the right side of my body but there were some on the left. I also had some numbness and tingling in my mouth. I used some anti itch cream, and the hives were mostly gone the next day. Twelve days after the vaccine I started to unusual vision symptoms which included wavy zig-zag lines in my vision. My doctor advised that they were Ocular Migraines. I had a headache at the same time, but I have never had Migraines before. I was also fatigued with a little dizzy and nauseous. The headache lasted for one day, but I still felt a little nauseous the next day. The feeling of fatigue and tired ness lasted for about six weeks. Two to three days after Ocular Migraines I started to notice a bright red rash on the right side of my back. It quickly spread around my side to the midline and then up my right side to my Bra line in front. I consulted my doctor on 04/19/2021 and he identified the rash as Shingles I was prescribed Acyclovir 800mg for 7 days and then an additional 5 days. I saw my Dermatologist on 05/06/2021 and he said that the Shingles were still active so I was Prescribed Valacyclovir. The Shingles lasted about six weeks total with some fatigue before I felt normal. I still have some visible signs of the rash on my back. Dr., PCP, 04/21/2021 Dr. Dermatology. 05/06/2021 for Shingles

Patient became ill after J and J vaccine. She was seen in the ER on 5/1/21. C/o were temp > 100, headache, fatigue and myalgia. She presented to the ER on 5/2/21 with multiple complaints. Since that time she developed cellulitis, elevated LFTs and was seen by GI/hepatology. She developed peripheral edema and has been treated with diuretics. Her h/h dropped and hematology referral made. She did not receive the vaccine at this clinic.

She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't dizzy but wasn't herself, felt off. Then she got petechia in both legs and she took it easy, drank a lot of water. She took it easy, but ever since then her energy is not there, she is "zapped". She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue. She is now really concerned as it is lasting. She feels like she is mentally confused. She could not tell me her address without looking it up first. It has started to subside some the feeling of being off. She feels like that she has no blood in her. She feels like she's out of iron, and zapped of energy. She has not called her doctor.

By the evening on the day of the shot I noticed my arm getting red and swollen. It continued swelling until I went to the doctor today June 4th. He said I was having an allergic reaction and to take Benadryl. Started Benadryl at 4:45 this evening.

For the past six weekends patient gets severe fever of coldness shaking and lies on a full length heating pad to warm up. Then experiences fever of hotness sweating and cannot cool down. Muscle aches, joint aches and hurts to touch the skin and exhaustion. The aches and fever last 4 - 6 hours and the next day all she can do is sleep.

This is my second time contacting the CDC. I have had hives since receiving the vaccine in April. The hives are only on my face, inside of nose, and lips. It is not going away, despite taking antihistamines such as Benadryl. Is this permanent.?

COUGHING ALL DAY WITH DRY COUGH; FEELING DIZZY; FATIGUE; FEVER; NAUSEAOUS; SHARP PAIN IN THE UPPER RIGHT SHOULDER NEAR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and gall bladder taken out, and concurrent conditions included long covid hauler.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 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sharp pain in the upper right shoulder near injection site pain. On 03-JUN-2021, the subject experienced coughing all day with dry cough. On 03-JUN-2021, the subject experienced feeling dizzy. On 03-JUN-2021, the subject experienced fatigue. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced nauseaous. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from coughing all day with dry cough, and had not recovered from fatigue, nauseaous, feeling dizzy, and sharp pain in the upper right shoulder near injection site pain. This report was non-serious.

Urticaria - extreme itchiness all over body. Welting with any kind of pressure from clothing or carried items; also if contact with skin by any external item or scratches. Usually subsides within half an hour but then arises elsewhere on body.

PT states vaccine caused shingles to occur and the shingles are resistant to antiviral and steroid treatment. PT developed shingles about a week after vaccine and has had them ever since. She states she has taken two rounds of antivirals and steroids. PT has been to doctor and per the patient the doctor says she has never seen shingles respond to treatment like hers. Pt asked pharmacy to report this adverse event incident.

EXTREME FATIGUE; EXTREME MUSCLE PAIN; JOINT PAIN; PAIN IN SHOULDER; SWELLING IS WORSE IN RIGHT ARM; PAIN ALL OVER BODY MORE IN HANDS AND ELBOWS; NOT BEEN ABLE TO SLEEP; PAIN IS WORSE IN RIGHT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 220 pounds, and height was 62 inches. The patient's concurrent conditions included fibromyalgia, bipolar polar i, hypothyroidism, reactive hypoglycemia, abstains from alcohol, non smoker, and preexisting hand pain, and other pre-existing medical conditions included the patient had known allergies antidepressant drug had agitation allergy and narcotics drug had itching allergy. the patient did not have any drug abuse/illicit drug use. the patient is taking eye drops for unknown indication. The patient was previously treated with risperidone for bipolar disorder; and experienced vomiting when treated with dexamethasone for drug used for unknown indication, and drug allergy when treated with erythromycin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acarbose non-company for drug used for unknown indication, calcium citrate for drug used for unknown indication, colecalciferol for drug used for unknown indication, colestyramine for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, fluticasone furoate/vilanterol trifenatate for drug used for unknown indication, iron for drug used for unknown indication, lamotrigine for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, lithium non-company for drug used for unknown indication, melatonin for drug used for unknown indication, nortriptyline for drug used for unknown indication, pancreatin for drug used for unknown indication, phenytoin for drug used for unknown indication, tegretol non-company for drug used for unknown indication, vitamin b12 nos for drug used for unknown indication, vitamin c for drug used for unknown indication, oxycodone/paracetamol for pain, and vitamins nos. On JUN-2021, the subject experienced pain all over body more in hands and elbows. On JUN-2021, the subject experienced not been able to sleep. On JUN-2021, the subject experienced pain in shoulder. On JUN-2021, the subject experienced swelling is worse in right arm. On JUN-2021, the subject experienced pain is worse in right arm. On 10-JUN-2021, the subject experienced joint pain. On 10-JUN-2021, the subject experienced extreme muscle pain. Laboratory data included: Pain scale (NR: not provided) 7-8/10. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue, had not recovered from extreme muscle pain, swelling is worse in right arm, pain is worse in right arm, pain all over body more in hands and elbows, and joint pain, and the outcome of pain in shoulder and not been able to sleep was not reported. This report was non-serious.

RASH ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; HIVES ON LEFT SIDE OF TRUNK OF BODY LOOK LIKE MOSQUITO BITES AND ON MIDDLE OF BODY; LOW GRADE FEVER; CHILLS; ACHINESS; LAGGY; LETHARGIC; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced achiness. On 18-JUN-2021, the subject experienced laggy. On 18-JUN-2021, the subject experienced lethargic. On 18-JUN-2021, the subject experienced chills. On 18-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: paracetamol. On 22-JUN-2021, the subject experienced rash on left side of trunk of body look like mosquito bites and on middle of body. On 22-JUN-2021, the subject experienced hives on left side of trunk of body look like mosquito bites and on middle of body. Treatment medications included: camphor/diphenhydramine hydrochloride/zinc oxide. On 23-JUN-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, laggy, lethargic, chills, and low grade fever on 19-JUN-2021, and was recovering from hives on left side of trunk of body look like mosquito bites and on middle of body, and rash on left side of trunk of body look like mosquito bites and on middle of body. This report was non-serious.

Pt. received Johnson & Johnson vaccine 05/24/2021 suffered flu-like symptoms following. Diagnosed with Shingles 07/02/2021. Doctor called in prescription for Shingles. Stating Physician informed her to let them "scab-up" and let them go away.

LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. 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: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

Patient reported swelling to left wrist are, no itching or pain. Area looked puffy and feels boggy. Patient given 50 mg of Benadryl Po. After 30 minutes, swelling improved. Patient advised to take Benadryl 50 mg ever 6 hours x 24 hours. no driving while taking Benadryl. Follow up with nearest ER if symptoms worsen. Follow up in office for recheck in 48 hours

Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible. This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days. I took Advil and Tylenol without any relief. Called the nurse at physicians office who told me to increase the dosage and to use only Advil. If it got worse to go to urgent care to get Tordal and/or steroid injection. I didn?t want anymore side effects of medication so I just toughed it out. The injection site became the size of a half of a tennis ball, was red and hot to touch. It is now 18 days later and there is still a small knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night. I felt like I was in a dark hole for the first 3 days and was then in a fog for a week. I had blurry vision off and on for the first 3 days and then again on day 5.

Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.

Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.

I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotches (no hives) and feels more like a sunburn . There is a burning sensation with mild itching and red blotches/spots. I contacted my physician who recommended OTC treatment at home and advised me to report it to VAERS. It is mild in terms of impact but not expected four days after the vaccination date.

I developed a few hives on arm and torso within an hour of receiving the vax. Other than minor soreness at injection site, I've had no other adverse reactions.

Bad chills/shaking for 2 hours. Headache (took tylenol several times, gone by noon next day) Tired and general achiness through the next day (gone by 3-13-21) Light red rash under arms and across rib cage area (gone by 3-14-21)

I started to get headaches a few days around the vaccine but briefly got a bit worse after the vaccine. My arm only got sore five days in the area of the vaccine.

pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice.

Excessive itching at scalp, face, neck, and upper back and chest. Persisted for 12 hours, very minor effects after that point to about the 24 hour period. Redness but not a full rash. Treated with benadryl and prednisone.

Shingles- on head, scalp, face - treatment valacyclovir, lost of 10 teaching days, Atrial fibrillation - irregular heart beat, 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol

Patient reports itchy, swollen hives over legs between waist and knees, and buttocks. Topical oatmeal bath, and ice pack. Hives almost completely clear on day 3, just a few left.

I had gone to see my Dermatologist and showed her the injection site where it spread. The Dr. told me they have seen a lot of these, and stated it was an allergic reaction to the vaccine. She have me steroid cream to put on it, also told me it would take about 6 weeks to heal. It's still read and very itchy.

Patient reported urticaria, she was noted to have erythematous hives upper and lower extremities and torso. Airway clear, respirations even and unlabored, HR 101. Patient administered 25mg PO Benadryl. Vital signs @ 5:58pm BP 152/98, HR 101, O2 sat 94%, Resp 22. Patient was then observed for 10 minutes , vitals then were 125/86, HR 101, O2 sat 94%, Resp 18. Additional Benadryl 25mg PO administered at 6:19pm. Patient reevaluated at 6:30pm- Improvement noted. Reassessment completed. Patient reports she is better and no longer itching all over. Hives improved. Patient was advised to follow up with her PCP as needed. Call 911 or report to nearest ER if emergency. Patient left at 6:45pm.

First day developed a headache, and a bad rash on my chest that was very itchy for 2 days, rash was visible for approx. 2 weeks. (took a picture), second day had flu like symptoms, headache turned into a migraine 24 hours after initial headache began. Had joint pain, slight cough and lower back ache as well as headache until Saturday morning 3/13/2021. Took Tylenol at home and got extra rest until all symptoms went away.

Bad rash all over body. Symptoms included wheals, swelling of skin, and itching. Symptoms relieved with Caladryl Clear lotion (applied as needed) and oral Benadryl (50mg/q 6hrs) . Symptoms subsided after 5 days.

Within minutes of getting the injection, became faint with a severe drop in blood pressure. Under observation at the site by Health professionals for 50 minutes. On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER. They suggested fluids and prescribed Benedryl and waiting nearby. When symptoms did not worsen, left and arrived at home around 2 p.m. Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.

BLOOD PRESSURE SLIGHTLY HIGHER THAN NORMAL; DIZZY AND LIGHT HEADEDNESS; SWOLLEN ARM; REDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 12:20 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced dizzy and light headedness. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced redness. On 02-APR-2021, the subject experienced blood pressure slightly higher than normal. Laboratory data included: Blood pressure (NR: not provided) 157/72. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and redness, and had not recovered from dizzy and light headedness, and blood pressure slightly higher than normal. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

3/18 vaccination 3/19 4am woke up I felt sick I had a HA, Nauseas, dizzy, hard to stand, hard to keep eyes open to even go to the bathroom. I tried to go back to sleep. When I woke up, I took it easy. I did get the chills and sweats thru the day; skin turns really red (MCAS). That symptoms still comes and goes. The chills, regulating body temperature, has flared back up after being dormant for years. 3/30 I saw MD. She wanted to defer for 4-6 weeks after vaccination to see if symptoms were still persisting or leveling out. I have since canceled every sort of appt since then as I don't have the energy. *I am on the very tail end of an opioid withdrawal; tramadol. I have taken for 6 years, 400 mg weened down to 100 mg this last year, down to 12.5.

Vomitting, Wretching, Dry Heaving, Diahrrea, Mild Fever, Beet Red Face, Body Aches, Cough, Lethargy starting the evening of the vaccination 4/10/21 9PM. Continued until 4/11/21 Midday.

web like red pattern on right inner thigh NOT a rash. I did take a photo of it but cannot transfer to this page. I took benadryl and the symptom faded away and did not come back.

When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow and About 2 AM on 4-7-21 I tarted feeling very very cold and trembling and delusional I could not recognize my home I had muscle spams on both legs and fever finally got up and took some Advil put on extra PJ's and socks and turn on the heater finally fell asleep about 4 AM about 8 AM on 4-7-21 woke up with a headache and very very tired lot of pain on my left arm so stayed home from work and rested on 4-8-21 came to work at 7 AM and was seeing everything blurry as the day progressed it got worse finally went home about 3 PM took more Advil and rested some more my left arm hurt me for 6 days and I felt very tired and a bit confused I did not call my doctor or any one at Health Department I just took care of myself

ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.

anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues, aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations. 8 benadryl in first 30 min. kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)

4days post injection she developed a full body rash, ears are "swollen", and throat has a funny sensations in it. Breathing normal. Treated on 2 successive days with a predinsone injection, but then was admitted for observation the next day. Treated as an inpatient for 24 hours with Solu-Medrol every 6 hours. Recovered and was released. Patient reported that she had been previously vaccinated against COVID-19 in January, but we have no record of that (all vaccinations in Louisiana are required to be in our State Immunization Registry).

INDIGESTION; GENERALIZED JOINT PAIN; FEVER; RAISED RASH ON RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, mitral valve prolapse, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced raised rash on right leg. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 15:00, the subject experienced generalized joint pain. On 06-APR-2021 19:00, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-APR-2021, and had not recovered from indigestion, generalized joint pain, and raised rash on right leg. This report was non-serious.

SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchiness to my scalp with left top pf head very warm to touch. Flush feeling to entire face. Woke up with this the Saturday morning after the injection and lacey rash over entire body w/ rash gone Sunday morning with lesions to my left forehead still visible. Lesions began to weep on Monday morning.

Rash, hives: legs, back, belly, arms, face, eyelids, around mouth, neck, genital area. I had 3 episodes of hives/rash. one daily after day of vaccination. I had to go to ER the day I received vaccine. (i received the vaccine at the Hospital where I work ( in the Lab), went that same night to the ER where I also work in the Lab . I was given i.v. benadryl and 2 other medications. Later I was given a prescription for Prednisone 5 days and Atarax after being released. The second day I got worse. Third day symptoms subsided. Now it is 8 days after, I have only a small rash in my leg.

65-year-old female presenting with reaction to the Johnson & Johnson Covid vaccine. Received vaccination in her home, about 5 to 10 minutes later, developed redness and swelling of the face. Thought she had some stiffness of the tongue and tightness of the throat. No chest pain, shortness of breath.

Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade fever, which ramped up quickly. Fever-topped out at 101.4 by 3:00am, body aches, repeated vomiting, repeated massive diarrhea, severe headache -crushing, squeezing vise (in the top 10 worst of my life -including migraines!), bright pink/red fingers and toes, racing uneven heartbeat. Couldn't sleep. In tears from headache pain. In desperation took an 800mg Ibuprofen pill at 4:00am. Finally got to sleep. Woke up 5 hours later. Fever mostly gone. Other symptoms receding, except headache. Took 2 aspirin at noon. Still have minor headache. Yuck!

CHILLS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non smoker, non alcohol user, mold allergy, cat allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced injection site pain. On 06-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 headache on 07-APR-2021, and injection site pain on 06-APR-2021. This report was non-serious.

INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:10 for prophylactic vaccination. Concomitant medications included naproxen. On 12-APR-2021 13:15, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.

POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.

ITCHINESS; REDNESS OF ARM; SORENESS OF THE ARM; SWELLING OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, mild asthma, sinusitis, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use and the patient had bad allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced tiredness. On 04-MAR-2021, the subject experienced redness of arm. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of the arm, swelling of the arm, tiredness, and itchiness, and the outcome of redness of arm was not reported. This report was non-serious.

Large rash on back with pustules that opened and bled, other area of bright blotchy spots that remained flat and did not bleed

Vomiting for 24 hours starting at noon 4/02/2021 and ending late 4/03/2021. Intestinal cramping yellow, watery diarrhea started 2:30PM 4/08/2021. Diarrhea continues, but getting better, more normal color. Injection burned. I did not experience any serious soreness, but my arm still burns if something touches it. No swelling, redness, rash.

COLD; RUNNY NOSE; CHILLS; FEVER; HEADACHE; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site redness. On 29-MAR-2021, the subject experienced cold. On 29-MAR-2021, the subject experienced runny nose. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, runny nose, chills, fever, and headache on 30-MAR-2021, and injection site redness on 10-MAR-2021. This report was non-serious.

MUSCLE ACHES; FEVER; RASH; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and ciprofloxacin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included levothyroxine sodium. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced rash. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 11-APR-2021, and muscle aches, and fever on APR-2021, and had not recovered from headache. This report was non-serious.

HIVES; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ciu.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included omalizumab. 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.

The injection site has become increasingly painful as time goes on. It feels l like my shoulder muscle is 'dying' if that makes sense. definite increasing weakness in my shoulder and arm , pain radiating out deep in the muscle right at the injection site ,

At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Monday, the 15th, I had the worst flare-up of sciatica that I have ever had in my life. Left leg - it had a tremendous swelling. It was crippling. I am still using a pain. I cried because the pain was so horrific. I was able to get into the doctor early on Tuesday - prescribed Prednisone; hydrocodone; muscle relaxer. None of which touched the pain. I was unable to sleep for three days. I slept upright in a chair. I used an office chair as a wheel chair. I wasn't able to lay down. I've improved but I still can't walk to the mailbox - could walk down there - two houses down but couldn't get back. I am using a cane still. I have to elevate leg on a recliner to sleep so it will help with the continued swelling. There was nothing I did that triggered it.

HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deteriorating disc disease (c4 and c5 in spine), pain in hand, tingling in hand, neuropathy, and varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, fosinopril, ibuprofen, metformin, and simvastatin. On APR-2021, the subject experienced knot/lump in left leg. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced tender left arm. On 19-APR-2021, the subject experienced red spots / rash in left arm. On 20-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot/lump in left leg, tender left arm, red spots / rash in left arm, and headache on APR-2021, and had not recovered from swollen left arm. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

ITCHINESS; REDNESS OF ARM; SWELLING OF THE ARM; SORENESS OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, mild asthma, sinusitis, seasonal allergies, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 04-MAR-2021, the subject experienced redness of arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the arm, soreness of the arm, and tiredness on 17-MAR-2021, had not recovered from itchiness, and the outcome of redness of arm was not reported. This report was non-serious.

Very high fever for 3 weeks; Shivers; Extreme fatigue; Lethargy; GI problems; Increased level of traponin; Very dark and itchy red rash; Very high blood pressure

pt experienced flu like symptoms beginning 6-7 hours after receiving the vaccine. She reported headache, body aches, chills, sore arm. Significant bruising the size of a tennis ball appeared 18 hours later around the area of injection and persisted for 10 days.

Broke out in rash (very small bumps not red but raised) on legs along with blotches on legs . slowly moved up my body, rash now is on chest and back, legs are clear. very itchy.

Ten days after the vaccine I woke up in the morning with little lumps on my ankles and the top of my feet. By the end of the day ,they were pointy hard lumps with heads on them. They spread to other parts of my body. They would rupture and they were huge. They were very itchy and painful. They were on my thighs, arms, back but they were worst on my feet ankles and calves. I took Benadryl and Epsom Salt baths which helped but they were there for a week. The first three days were the worst. They were popping up a few at a time for another month. They later ones were mostly on my thighs and I never had any on my arms. I have never had hives that ruptured so easily and were so big.

FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.

No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.

SLIGHTLY HOT TO TOUCH AT INJECTION SITE; DELTOID MUSCLE TONE LOSS; SWELLING BELOW INJECTION SITE; PAIN AT THE INJECTION SITE, PAIN IN BELLY OF LEFT DELTOID, LEFT DELTOID PAIN AT THE TIME OF INJECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vascular necrosis of the hip, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection. On an unspecified date, the subject experienced slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection, slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. This report was non-serious.

She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThing short of breath, she said no. I ASKED IF SHE WANTED A BENADRYL AND SHE SAID NO. MY TECH WAS AN EMT AND CAME OUT WHILE I WENT TO GET BLOOD PRESSURE CUFF, WE WATCHED HER AND SHE STARTED GETTING ITCHIER BUT BLOOD PRESSURE WAS FINE. WE CALLED EMS . SHE WAS RESPONSIVE, DIZZY, AND ALERT WHEN SHE LEFT WITH EMS.

Early evening of 5/20/2021 large red rash appeared bilaterally on calves, with spreading of rash overnight of 5/20 to 5/21/21 to the front of right leg. Affected areass hot to touch with minimal itching. No exposure to possible irritants. It should be noted that patient had also started on tricor 4/20/2021. The rash is a known symptom of both the covid vaccine and tricor therapy in some cases. Blood tests ordered (cbc, complete metabolic panel and liver enzymes) but results not yet available. PCP has seen similar rashes in other patients after covid vaccine so recommended filing the report to vaers out of an abundance of caution.

4 weeks after the vaccine. I'm a doctor and my patients started telling me my face was red. 4 weeks and 1 day my face was swollen and red. for a week. My sister found out through Google, swollen face and red was normal symptoms. ONly on the face no where else. Benadryl for 1 day was getting better. It took about 3 days after the benadryl to disappeared.

Little brown, purple, and red spots (lots of red spots) allover the body. Little blood vessels broke. Pt has not been feeling good since receiving the shot. Pt did not hit her legs but had a very painful legs and when she looked down she had blood vessels broking. Has red blood vessels on face and legs only. Pt has been feeling tired and no energy and was not able to work some days.

I had a slight ache where the needle was placed after I was given the shot. It was not severe. Next 10 days I did not have any symptoms. At the night of the 10th day, I had a little chill, fatigue and joint pain on the fingers and the toes. Next 14 days, My joint pain on the same area and fatigue continued about at the same rate from the 10th night. On the 15th day, my joint pain was almost gone, a little bit of tiredness remains, I would not call this fatigue anymore. On the 16th day, joint pain was gone. and after 30 minutes of nap, the tiredness is gone.

Six and a half weeks previous to my vaccination (April 26) I had 2 basal cell carcinomas removed from my right lower leg; one by Mohs and one by simple excision. These were fully healed. On June 12, the day after my vaccination, both excision sites became red, hot, swollen and painful. I called Dr, the physician that performed the excisions and he prescribed Clindamycin. The sites became increasingly red and painful with purulent drainage so I was seen at my PCP for a culture which came back positive for staph aureus. I was changed to Doxycycline for 10 days and completed the full course of antibiotics. I was also seen by the Dr. and he injected the sites with a steroid to reduce the inflammation. Approximately 48 hours after completing the Doxy, the excision sites began worsening again. My PCP started me on Bactrim and I was seen again by Dr. on July 12 where he removed the surface tissue and re-injected the sites with steroid again. Both are still notable red but improving.

Janssen COVID-19 Vaccine EUA Uncontrollable, severe itching of upper arms (both right and left) and sometimes nape of neck. Upper arms become extremely hot. I have to use ice packs to cool down.

Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later. Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday. I took a Zyrtec tablet around 6:00 p.m. on 3/9/21. Also used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time. I also had a resting pulse of 111 with fast heartbeat. My blood pressure was 136/84, my oxygen was down to 93.

Rash on chest. Swollen lymph nodes. Swollen lymp nodes particularly worse on injection side and still persistent. Periods of hot and cold chills

Caller c/o hot flashes twice a day since receiving the vaccine on 3/13, states that her skin feels "hot", however reports no fever. Takes cool showers to feel better. No other symptoms

First day: I swelled up like the Pillsbury Dough Boy. I had high blood pressure, (which I normally do not have), migraine like headaches for three days and now I have a rash all over my face and arms. The rash is very itchy and annoying.

Broke out in Hives, 4 days after injection from the Johnson & Johnson Vaccine, Took Antihistamine, gone 6 days outbreak.

RED SWOLLEN INJECTION SITE WITH PAIN THAT INCREASED A FEW DAYS AFTER THE INJECTION. SHE WAS GOING TO GIVE IT A FEW MORE DAYS AND IF IT DIDN'T GET BETTER OR GOT WORSE SHE WOULD THEN CALL HER DR.

RASH ON THE LOWER RIGHT ARM THAT WENT TO THE LEFT ARM AND UPPER PARTS INCLUDING ABDOMEN, BREAST, AND FACE. ( ONLY UPPER EXTREMITIES ) SEVERE ITCHING, SHORTNESS OF BREATH,

3-13-21 Shot, soreness in arm and knot nothing else notable except maybe mild headache 3-23 start with itchy rash mid back, arm still sore knot smaller 3-24 Rash continued to spread up back extremely itchy 3-25 Rash continue to spread to stomach area , major head ache, vomiting (one time) temperature 97.1 3-26 Rash continue to spreading to left breast headache, no appetite 3-27 Rash continued spreading to buttock cheeks, apatite improving 3-28 Rash continued to spread arms, Knott in arm getting small feeling itchy all over. 3-29 Rash continued to spread to lower limbs. knot in arm almost gone, visit to doctor . Prescribed steroids for 7 days follow up in one week.

On Saturday 3/20/21, Patient developed a circular rash below injection site on left arm. She had swelling and pain from left shoulder to elbow and radiating pain up to neck and down to hand with numbness in hand. Patient said the rash lasted about 2-3 days. On 3/27/21, Patient went to ER due to pain and was given naproxen. She went back to ER on 3/29/21 due to continuing to have pain. She is to follow up with PCP this week.

Five days after my vaccine, I experienced itchiness to my skin and body. I talked to my doctor about my symptoms and he does not know what caused my skin itchiness. He recommended for me take Benadryl and allergy medication. He also gave me a steroid but I could not take it since I am allergic to the steroids. I want to find out why after my vaccine, my whole body and skin is itchy. I still have the itchiness today and it does not want to go away.

Approximately 8 hours after being injected, I broke out in an itchy rash. The raised rash covered my abdomen, my back, and the backs of my legs. The rash persisted for about 4 hours and then subsided.

Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient's current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.

The patient reported feeling tired and "spacey" 2 hours after the immunization. She also reported the following day, bumps (possible oozing, she indicated they feel wet but cannot see it) that itch on her back; right of her spine about an inch below her bra strap. She was unable to see the reaction site but said they feel like her shingle flare ups. She believes this to be another flare, possibly triggered by the immunization.

Immediate pain at injection site as expected , as well as fever, headache, chills, fatigue. Towards evening these symptoms worsened. (not adverse). I hardly slept. (all these not worrisome to me) I'm so glad my vaccine provider warned me that with underlying conditions, the vaccine could make them flare up. Which they did. In the morning I had widespread pain all over. Severe headache, and shortness of breath. Because I already have near emphysema hypoxemia oxygen levels, I checked my Oximeter and my blood oxygen was in the dangerously low 70's. It stayed there until I put my oxygen concentrator on. Monitoring oxygen levels all day, I was able to keep it in the 80's to 90's, which helped. 40 hrs after injection , symptoms already fading away. All my adverse events were related to underlying conditions responding to the inflammation of the immune response. I feel protected, glad I had the oxygen handy, and I feel great about the J & J vaccine!

About 7 hours after vaccine delivered had severe chills that lasted for 3 hrs. Difficulty sleeping that night. Next day tired but overall feeling fine. A slight bruise at the injection site but not very painful. No other adverse conditions after the initial ones.

A LITTLE BIT OF LIGHT PINK INFLAMMATION RIGHT BELOW THE INJECTION SITE IN MORNING; SORENESS AT INJECTION SITE; SWELLING RIGHT BELOW THE INJECTION SITE IN MORNING; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 approximately at 17:15 on left arm for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive COVID-19 Test. On MAR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 19-MAR-2021, the subject experienced a little bit of light pink inflammation right below the injection site in morning. On 19-MAR-2021, the subject experienced soreness at injection site. On 19-MAR-2021, the subject experienced swelling right below the injection site in morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little bit of light pink inflammation right below the injection site in morning, soreness at injection site, and swelling right below the injection site in morning on 20-MAR-2021. This report was non-serious.

SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.

Patient has been experience pain in the arm of the site injection still after the injection on 04.01.2021 when reported to pharmacy on 04.12.2021 by phone.

Patient ran low grade fever the night she received the vaccine.The next day she woke up in hives all over her body. Her whole body itched. She stated she took Benadryl every 6 hours and applied benadryl cream. The rash disappeared around 4/12/21 but her whole body still itches. She did not receive medical attention.

PAIN BELOW THE INJECTION SITE; LOSS OF APPETITE; SHAKY HANDS; FLU-LIKE SYMPTOMS; SLEPT ALL DAY; TERRIBLE CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis, high bad cholesterol, and varicose veins. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced shaky hands. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced slept all day. On APR-2021, the subject experienced terrible chills. On 06-APR-2021, the subject experienced pain below the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and pain below the injection site on APR-2021, was recovering from loss of appetite, shaky hands, and terrible chills, and the outcome of slept all day was not reported. This report was non-serious.

I noticed a rash on my left front thigh about 1 day after vaccine. It then spread to my left front thigh. No itching or pain. It is one week later and it is almost gone. I was not sure if it was related to the shot as I had been doing yard work during that time. Then I saw an article this morning which described the rash accurately. So it is probably related, however that being said, given the choice, I would take it again. Had no pain at injection site, no other issues, and I feel safer for the experience. Pharmacy sent text.

Patient developed hives from upper thigh up to her neck bilaterally. These were more localized in the torso area, to the point they overlapped. These lasted for 3 days heavily but decreased in size and quantity over time. They continue but are now much smaller and less frequent. Claritan has helped to calm the hives. Patient also noticed minor swelling of lips two days after vaccine. No swelling of throat and no shortness of breath per patient. The lip swelling would come and go and has disappeared.

I reported to my doctor that around 2 weeks after receiving the J & J vaccine, a large bruise appeared on my right thigh. Their office recommended that I inform you of this. Bruising is rare for me and I had not, to my knowledge, done anything to cause it. I have been in the system for follow-up reports regarding the vaccine and have always reported doing well. I have no other symptoms. This bruise, however, caught my attention after the latest news. So, I am reporting it, as directed.

Dull headache for several days. Excruciating abdominal cramping off and on for almost a week. Arm soreness appeared about a week later severe enough to keep me from sleeping on that side of my body. Lasted about a week. At the same time, large bruises appeared on the "shot arm" from the shoulder down almost to my elbow. Soreness in my right calf developed after four weeks and still comes at times.

CHILLS; TIRED; INJECTION SITE PAIN; HEADACHE; FEVER; PAIN; FELT MISERABLE; BACK HURTING; LIGHTHEADED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, pollen allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use and was healthy individual at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced felt miserable. On 08-APR-2021, the subject experienced back hurting. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 08-APR-2021 18:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, chills, and headache on 08-APR-2021, and fever on 09-APR-2021, was recovering from felt miserable, and back hurting, and had not recovered from pain, tired, and injection site pain. This report was non-serious.

INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced injection site swelling. 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 pain, injection site swelling, and injection site redness. This report was non-serious.

HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Developed burning in and around ear, ear ache, then rash after a couple of days , was out of town, so not diagnosed till the following week with Shingles. I still have it, it has not gotten any better after a month

Patient presented one week pos vaccination with 2 days of easy bruising and petechiae. Platelets were 4K. Seen by doctor of hematology. Started on steroids with improvement to 21K and discharged. Came back a week later with presyncope and chest tightness. Platelets again 4K. Treated with IVIG

BUMP ON TOP OF RIGHT INDEX FINGER; HEADACHE; This spontaneous report received from a consumer. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced bump on top of right index finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from bump on top of right index finger. This report was non-serious.

I can't say for sure but 9 days after receiving the vaccine, my condition called Erythromelalgia flared up terribly, which involved uncomfortable to intense burning of the outer ears 24/7 with no relief. It calmed down for a couple of days and then came back with other symptoms, including the burning ears, and parts of my neck and face. In addition to that, my eyes were bloodshot and had drainage coming from them and in the morning, it appeared that they had like a lining of film over them. Skin is peeling due to all the burning in the areas described. Several different treatments were tried but none has slowed down the flare-up. After another trip back to the NP, she said that it was inflamation and gave me a steroid shot along with prednisone tablets. I also went to an optometrist who found some things wrong with my eyes and prescribed some steroid eye drops. Before the vaccine, we pretty much had the Erythromelalgia under control with meds but this time, it's been hard to get things under control and more tolerable.

SORENESS IN LEFT ARM AT INJECTION SITE; FEELING TIRED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, anxiety, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. there were no drug abuse or illicit drug usage. the patient was on anxiety medication. 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 16-APR-2021, the subject experienced soreness in left arm at injection site. On 16-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in left arm at injection site on 19-APR-2021, and was recovering from feeling tired. This report was non-serious.

The evening after the vaccine Developed severe abdominal pain and joint pains This lasted about a week Also developed mild rash and itch the day after the vaccine Had extreme fatigue for about a week The second morning developed what appeared to be swollen blood vessels in both forearms This lasted several hours and went away Went To dr and received fluids and vitamin iv

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. 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 to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. 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.

STOMACH HURTS; BODY ACHES; HIVES ON BOTH LEGS; BRUISE ON LEFT WRIST; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 107 pounds, and height was 61 inches. The patient's past medical history included cyst on pancreas, and concurrent conditions included severe asthma, high blood pressure, non alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207421A, and batch number: 207421A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for drug used for unknown indication, omeprazole for drug used for unknown indication, ibuprofen for pain, budesonide/formoterol fumarate for severe asthma, and diltiazem. On 02-MAY-2021, the subject experienced bruise on left wrist. On 03-MAY-2021, the subject experienced hives on both legs. On 04-MAY-2021, the subject experienced stomach hurts. On 04-MAY-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on both legs, bruise on left wrist, stomach hurts, and body aches. This report was non-serious.

SWELLING OF LEFT ARM; LEFT SIDE CHEST BROKEN VEIN; LYMPH GLAND CLOSEST TO VACCINE SWELLED UP; SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, dermatomyositis, antisynthetase syndrome, interstitial lung disease, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any known drug history. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced soreness. On 12-MAY-2021, the subject experienced lymph gland closest to vaccine swelled up. On 13-MAY-2021, the subject experienced left side chest broken vein. On 16-MAY-2021, the subject experienced swelling of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, lymph gland closest to vaccine swelled up, left side chest broken vein, and swelling of left arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious

Patient presented to pharmacy with a red blister that was raised, inflamed and pussing on right arm that she received J&j vaccine in on 5/2/21. She reports pain started 5/20/21 and blister open overnight. Recommended patient go to urgent care to be seen by a medical doctor right away .

tiny blood spots under the skin beyond the site of injection both arms and front and back of upper body

HOT SPOT SENSITIVE; ROUND BUMP RED CIRCLE ABOUT AN INCH ON ARM NEXT TO THE INJECTION SITE; FELT TIRED; MILD HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, fibromyalgia, non hodgkin's lymphoma, and sulfa allergy.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042172117 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced felt tired. On 18-MAY-2021, the subject experienced mild headache. On 19-MAY-2021, the subject experienced round bump red circle about an inch on arm next to the injection site. On an unspecified date, the subject experienced hot spot sensitive. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild headache on 18-MAY-2021, was recovering from felt tired, had not recovered from round bump red circle about an inch on arm next to the injection site, and the outcome of hot spot sensitive was not reported. This report was non-serious. This parent/child case is linked to 20210540029.

I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a little lightheaded which subsided but did not go away completely. The next day I was better, but I had soreness around the injection site. I also had diarrhea.

Got a rash like I used to get when I was a kid in the bend of my arms. Looks like eczema, and it itches. I called the doctor and had a phone visit. The doctor prescribed a cream, and I'm going to pick it up today.

Waited 30 minutes after shot at clinic, just sore in upper arm. About 45 min after vaccine in car, shooting pain in upper arm that went down my forearm, and up neck, stopped and then started up again... - lasted for about 10 min. thought I was having a heart attack, but it all subsided. My husband felt it was anxiety - Happened again when we got home on and off, we thought sore muscle - subsided. Wakes me up at night sometimes, happens occasionally during day, happens when golfing - asked a PA friend in heart department at hospital and she said it may take time to heal from vaccine bruising. Past 3 days got another cold virus and yesterday my vaccine site and forearm was killing me all day off and on, a couple of times up same side neck. Got me concerned enough today to call Tri-county who scheduled vaccine to see if anyone else had similar symptoms - told me to fill this form out. I was concerned it was a blood clot. Better today- dull pain off and on.

Upper extremity DVT same side of vaccination Left upper arm pain, bruising, swelling Symptoms started approximately 2 days after injection

More severe: Low back pain starting 06:40 AM Thursday June 10, continuing into present. Made same-day appointment with clinic. Tests normal. Mild to moderate: Site soreness (no redness swelling) starting June 7 continuing to present (6.5 days at present).

That next day, the injection site pain was with me for over a month. I couldn't move my arm; felt like someone was jabbing me. I can finally touch my arm now without feeling pain. The brain fog - it feels like - in the front of my forehead right above my eyebrows - like there's something the size of orange that is just sitting there. It stops my thoughts and word processing. I was fine the day before the vaccine. That has not gone away. The doctor does not know what to do about the brain fog. I was having horrific full body muscle pain - especially in my legs. Like someone had put 20 lbs weight on each of my ankles. That is sort of resolved. But the fatigue - hasn't resolved. I always have a little bit of low level fatigue but this is worse - I have to have two naps a day now. Brain fog is the most troubling to me - hard to function - it's like instant Alzheimer's - my words are stuck in my mouth and I feel like I'm trying to think through a veil or fog.

SWELLING OF THE FACE; GENERALIZED ITCHING; HIVES ALL OVER HER BODY; FEVER; CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, 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 chills. On 09-APR-2021, the subject experienced fever. On 15-MAY-2021, the subject experienced hives all over her body. On 19-JUN-2021, the subject experienced swelling of the face. On 19-JUN-2021, the subject experienced generalized itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from hives all over her body, swelling of the face, and generalized itching. This report was non-serious.

A PINECONE SHOVED DOWN HER THROAT; SEVERE HIVES; RECURRENT URINARY TRACT INFECTION; CHEST PAINS/HEART PAINS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock, anaphylaxis, and urinary tract infection, and concurrent conditions included penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included allergy to 20 unspecified drugs. The patient was previously treated with doxycycline for urinary tract infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest pains/heart pains. On APR-2021, the subject experienced recurrent urinary tract infection. Treatment medications included: doxycycline. On an unspecified date, the subject experienced a pinecone shoved down her throat, and severe hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains/heart pains, a pinecone shoved down her throat, and severe hives, and the outcome of recurrent urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home. 7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.

injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is all very unusual for me.

Shaking chills, headache, subjective fever, stuffiness starting 6 hrs after Johnson and Johnson vaccine Noted bumps day after vaccine around a superficial vein along L lateral forehead associated with soreness. She had some hyperventilation which also subsided Had HA for 2 days. No clear vision changes, wears contact Had R ear redness briefly but also resolved

Localized headache starting the afternoon after the vaccine. Shingles outbreak near and marginal in right eye as of March 16 (4 days after vaccination.)

15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.

24 hours after vaccine, hard lump, swollen and pink, moderate chills. The next day, bigger lump, swollen, all just below injection and red, moderate chills, a bit itchy, nausea., and painful. Same on 3rd day but much bigger redness spreading down arm, 2 1/2 by 2 1/2' hard mass and red, itchy, painful, chills and nausea. Next morning called Dr. I am taking amoxicillin-clav 875-125ng tab. Three days later mass is turning from red to pink and retreating. Still hurts and now bruses show around the injection site, which I thought was strange. The vaccine actually hurt when given (I get injections every three months, so I know what they will feel like, but this hurt and went very deeply and then burned). I felt warm afterwards for about 10 minutes.

Fever, chills, sweats, huge red and swollen arm at injection site, headaches, can?t hardly move that arm! For, 3 days +

Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went to bed and had muscle aches, pains and headache. Next morning felt flu like symptoms, malaise especially. Tried to work and could only work 3 hours. Arm remained sore. 14 days later still experiencing soreness in injection site (does not appear swollen), tender to the touch. If arm is lifted up then feels like it is "pulling on something."

March 18 , 2921:Fever 100.9,9:40 p.m. Chills 11:30 p.m., Fever 101.9, 12 a.m. Took 2 Tylenol March 19, 2021: Fatigue all day, sore arm getting worse, injection site getting redder and larger, hot to touch, Fever morning: 100.2, Fever afternoon 101.8. Sore all over body. Took 2 Tylenol in afternoon March 20, 2021: Fatigue until afternoon. Then mostly better. Fever 99.9. Injection site still very red and hot to touch

Patient received vaccine on March 11, and reports that she began experiencing arm soreness immediately afterwards. She was reporting soreness with pulsating pain for the first 2 to 3 days, now reports a constant dull and achy pain that is worse with activity and movement. She has been using Tylenol, which she reports does help reduce pain symptoms. She denies any reduction in her range of motion, but states pain symptoms are more prominent with movement. She is also reporting daily headaches that occurred starting the day after getting the vaccine. Patient reports headache is bilateral in nature with a dull, aching quality. She states headache starts within 10 to 20 minutes of waking up. She takes Tylenol to help with headache symptoms, which does seem to relieve the headache. Some days, she reports headache comes back in the afternoon or evening. She denies any nasal congestion, vision problems, tinnitus, postnasal drip or sinus pressure. No balance, near syncopal, or syncopal problems. Denies any sensory or motor impairment accompanying the headaches.

I got the shot they had to clean up my arm because I was cleaning and put pressure on the arm. I sat for 30 mins. My chest felt a little funny. about 9am my face was really red, I got my BP checked 188/85 Oxygen was good and Dr said to take benadryl and took two right away and I took 2 more after 6 hours, symptoms subsided that evening. My BP stayed high and I felt not good, I had pressure in my chest and some pressure on the left and right side of my breast, BP was 177 at 4pm. I went home to bed I woke up with pressure again in my chest. I went to the Dr and he said come back in two weeks and see how you are, I went in this last monday and he put me on medication for high blood pressure

When administering vaccine to patient she complained of intense burning pain. The medication was easily injectable into the site. She complained of intense pain to her left shoulder above the injection site all the way to her neck. She had pain when moving her arm at first. We monitored her for 30 minutes and before she left she was pain free and able to freely move her arm.

On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night. I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued. I had to stay up all night, any attempt to lie down triggered more vomiting. By 3 in the morning I was ?on empty? and by 6 am could lie down. Nausea took three more days to leave completely. Muscle pain is resolving, almost gone. I am resuming my meds [everything that went down before came right back up]. The only tummy pain was after hours of vomiting [muscle strain]. Today is the 25th and I?m still tired and a bit foggy but otherwise feel better. I had a call with my doctor about this and she said I should report it so that?s what I?m doing.

Developed hives all over my torso and arms that continued through today (3/25). Went to ER and was given IV steroids, Benadryl and Pepsid and steriods to take at home for 4 days. Have never had a hive episode like this before.

Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with blurred vision and eye pain, light sensitivity and swelling of face, the base of the neck and at the site of injection and behind shoulderblade, Numbness of lips and burning mouth, Ongoing nausea, and upset gastrointestinal issues. Low-grade fever and chills, tremors in both arms and hands, upset stomach Still have nausea and headache, body pains,, tremors, and strong fatigue. issues

Immediate bruise at injection site when received, moderate nose bleed 48 hours after vaccine. Bleeding stopped. No medical attention needed.

11:05 injection-burning sensation at site, assumed to be normal, sat down, within 17 min. top of hand began to prickle. Drawing cramping pain followed in forearm, prickling turned to numbness. Mentioned this to one attendant, who recommended sitting longer. Sensations continued, another nurse/attendant checked on me, also mentioned I sit at least 30 min. All other sensations normal-no nausea, no headache, etc. Small finger, finger next to it,-and their part of the hand to the wrist -were first numb, with occasional tingles, now still numb.[7:30 pm.] Slight cramp from top of arm to neck, is off -and- on from injection wait-time til now. I left at 11:55, took temperature at 12:20, =99.4 (my usual basal is 97.6).

Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg

3/6/2021- received vaccination. 3/9/2021 didn?t feel good 3/12/2012 went to q clinic and got a Covid-19 test and flue test. Both negative and was sent home. 3/15/2021 Doctor sent me to get a x ray, diagnosis pneumonia. Symptoms: Fever, Headaches, rash under both breast, muscle aches, nausea, fatigue, loss of appetite As of 4/12 2021 I am still nauseated , and fatigued

Severe left arm pain / throb at injection site since March 31, 2021. I have been wearing a pain patch to try and sleep at night. Will not subside.

I woke up on Sunday morning with tingling in my left arm from my shoulder to my fingertips and my right leg by the shin area. My left ear was itchy and hot to the touch. I took half a Benedryl. I did a telemed visit with my MD about my arm. She ordered a STAT US of my left arm and prescribed me prednisone.

The first day after the shot. headache and a bit tired... 2 days later the vaccine triggered my SHINGLES reactions... BLISTERS on the back of my head! Way more than my normal. My ear is pealing off more than before the shot. I am losing parts of my left ear every since the SHINGLES shot. This lasted for a couple of days then went back to my NORMAL(?) reactions i have had for many years from the shingles shot.

LETHARGIC; ARM PAIN/SORE ARM; FEVER; HURT WHEN WAS INJECTED; FELT HAVING FLU; FELT HEAVINESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt having flu. On APR-2021, the subject experienced felt heaviness. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 98 F. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced arm pain/sore arm. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced hurt when was injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and fever on 11-APR-2021, had not recovered from arm pain/sore arm, and the outcome of felt having flu, felt heaviness and hurt when was injected was not reported. This report was non-serious.

HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included non smoker, and non alcohol user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hard knot at injection site. On APR-2021, the subject experienced flushing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced red swelling at injection site. On APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, hard knot at injection site, flushing, dizziness, and red swelling at injection site. This report was non-serious.

ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.

She got the vaccine and had no pain at all. She was in her recliner on 3/29/21 and noticed red dots (petechia) on both legs that were red, itchy. She took Benadryl and within 3 days the reaction was gone.

2 days fever - 101 degrees, aches in joints similar to flu with headache. 3 weeks after injection blood vessels burst in left arm leaving lower arm/wrist with very large bruise or venous flood.

TINY BRUISE AT RIGHT ARM AT INJECTION SITE; RIGHT ARM AT INJECTION SITE HURTING AND IT IS HOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included overweight, and concurrent conditions included arthritis, penicillin allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced tiny bruise at right arm at injection site. On 10-APR-2021, the subject experienced right arm at injection site hurting and it is hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny bruise at right arm at injection site, and right arm at injection site hurting and it is hot. This report was non-serious.

RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills 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.

Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy. Arm now aches continuously and is very weak. Mobility without pain is limited. Have not contacted my doctor yet - but will do so soon. No doctor visit planned yet. (Suspecting this is SIRVA????)

DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.

12 hours after vaccine started to have congestion, hives/welts (50-cent piece size) on head, neck and chest, itching, difficulty breathing, "bronchial asthma-type symptoms", GI cramping, throat felt like it was closing. She is still having difficulty breathing, congestion, itching, and hives are still present.

HIGH BLOOD PRESSURE; HEART PALPITATION; SEVERE DIARRHEA; HEADACHE/THROBBING IN THE TEMPLES; TIRED; INJECTION SITE PAIN; VOMITING/THROWING UP; SICK; FELL ASLEEP; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included adverse reaction to beta blockers, and concurrent conditions included blood pressure, and hypersensitive to drugs, and other pre-existing medical conditions included the patient had adverse reaction to beta blockers. The patient had 15 medicinal allergies and reaction to drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: nebivolol hydrochloride (form of admin, route of admin, and batch number were not reported) 5 mg, frequency was not reported, from 2021, and 2.5 mg, frequency, and therapy dates were not reported for high blood pressure; and losartan (form of admin, route of admin, and batch number were not reported) 25 mg, 2 times every 1 day, from 2021 for high blood pressure. No concomitant medications were reported. On 03-APR-2021 (on the day of injection), the patient had injection site pain on the day of injection. On 05-APR-2021, the patient starred to getting tired. On 07-APR-2021 or 08-APR-2021, the patient woke up with heart palpitation, throbbing in the temples and diarrhea. Were on vacation, left and came home, still did not feel good, went to urgent care on 11-APR-2021 and blood pressure was 190/100 mmHg. The patient have had blood pressure before, but had been controlled for years until this. Went to cardiologist twice, gave her another medication (carvedilol) which did not bring it down. Carvedilol increased her blood pressure. She was taking 3.175 in morning and 3.175 at night. The patient was tried another medication Bystolic 5 mg that did not bring it down. Cardiologist said they could not do anything else for patient. Referred to a nephrologist that she was not seen yet. No tests from the nephrologist yet. Kidneys were working fine. Meanwhile went to her primary care 3 times, tried on 2 other medications but blood pressure didn't come down. primary care physician lowered the Bystolic to 2.5 mg because she was getting sick from it. Started Losartan 25 mg morning and 25 mg at night, started getting headache. Last night she started getting headaches and throwing up which she said were side effects of the losartan. She went to emergency room on 09-MAY-2021 blood pressure was 215/105 mmHg and kidney was fine, heart was fine, all tests were good (coded as unspecified lab test) and emergency room physician gave her clonidine 0.1 and blood pressure went really low to 129 mmHg over something and she got really sick. They gave her a prescription of clonidine. Family physician told her to take 1/2 of the clonidine if her blood pressure was over 190. On 15-MAY-2021, the patient went to emergency room again because the heart rate was higher (95 ) usually was 60 and blood pressure was 210 over 99 mmHg. She took 1/4 of clonidine and it did drop it down to 160/79 mmHg. She took 1/4 of Xanax and fell asleep. She woke up with severe diarrhea and threw up. Medications included 1/4 Losartan last night. 20 mg Enalapril (original medication) and Hydrochlorothiazide 25 mg and xanax and blood pressure didn't come down. She was taking a 3 course medication therapy all along. For 5 weeks she had been housebound, tryied different medications, throwing up, diarrhea, and xanax tried to bring it down blood pressure right now 188/ 86 mmHg. The patient had been taking the blood pressure medicine and diuretic and a quarter of the Xanax . Her usual BP was 130/140 over 70 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nebivolol hydrochloride, and losartan was not reported. The patient was recovering from high blood pressure, and the outcome of injection site pain, headache/throbbing in the temples, heart palpitation, severe diarrhea, vomiting/throwing up, tired, sick and fell asleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529638--High blood pressure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.

4 hours after the vaccine, a dull headache; restless sleep/insomnia throughout the night. 24 hours after the vaccine two rashes appeared (upper back behind left shoulder; and on the underside of left breast); they are suspected as herpes zoster. Rx is 800mg acylovire 5x/day for 7 days with advil or tylenol for pain, caladryl for itching and ice. Pain is localized and severe. No fever.

PAIN AT SITE OF INJECTION; SLEPT THROUGHOUT THE DAY; FATIGUE; FELT LIKE NEEDLE HIT THE BONE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 109 pounds, and height was 61 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A201A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced felt like needle hit the bone. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 23-MAY-2021, the subject experienced slept throughout the day. On 23-MAY-2021, the subject experienced fatigue. On 24-MAY-2021, the subject experienced pain at site of injection. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fatigue on MAY-2021, pain at site of injection on 24-MAY-2021, and fever on 23-MAY-2021, and the outcome of felt like needle hit the bone and slept throughout the day was not reported. This report was non-serious.

Janssen covid-19 vaccine EUA - side effects 1. head 'fog' 2. voracious hunger [i've NE:VER had a flu vaccine] 21 hours in i'm still starving . what's the cure? 15 hours later I woke up at 6 a.m. because I was starving I had to make myself eggs and toast. 17 hours " I had a bagel. 18 hours " I made meatballs I was eating them like candy. [albeit my meatballs are delish carmelized onions, roasted garlic, basil, pesto...yum] I feel drugged. [ it's like a trip from the 70s flashback]. I feel weird. closest thing is dizzy but not dizzy just weird, very weird. head/brain fuzzy . The munchies continue. I never heard of these side effects before we'll see how long they last. only a pale yellow bruise where the injection went in. minimal arm soreness if any , no rash. I got a 12-page booklet for taking the vaccine yesterday I'm going to report the symptoms to the CDC, Johnson & Johnson janssen and whoever else wants to hear about them there's a big long list in the pamphlet they gave me. Maybe there's a cure. I hope it doesn't last too long I'll run out of food. 6 hours later I've got the munchies I'm eating everything in sight for dinner I had soup, two salad,s a steak, dessert and pretzels. I've never eaten that much ever. 4 hours down I started getting super hungry but I thought it was cuz I barely ate breakfast and lunch cuz I didn't know how this was going to react. I still don't feel a thing in the arm. yay hope it sticks. I can't even see where they gave me the shot. I will admit the shot did hurt a little when it went in, I don't know if it's cuz she pushed the plunger fast, or if it was cold from the refrigerator or what but I definitely felt a little something with it going in but not since. I realized that when I went into the hospital out building to get the vaccine I was talking to the nurse for a while because they had to go get my vaccine and she was telling me that three of her family members got the Johnson & Johnson and they didn't feel a thing, no sore arm no fever no nothing so I'm hoping that subliminally I absorbed that and that's why I'm having such a favorable results cuz I think I was really expecting something or other. Even though I know someone who got the jnj & didn't have a problem. I did my own research and nobody under 50 has had a problem and even those people had medical conditions and we're taking prescription drugs and so on which is not my case we'll see. The first hour has passed no rash, no soreness of arm nothing I'm a little bit surprised happily.

TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.

inflamed psoriatic arthritis, Very sore muscles , chills, rash, fatigue, stomach upset since march 10, 2021

Called the clinic on 6-16-21 and reported she had some inflammation, redness, and itching to left arm where shot was given. Unsure when symptoms started.

Patient received vaccine on 6/19/21. She came into the pharmacy on 7/10/21 to ask about side effects she had been experiencing from the vaccine. She stated having severe pain in her arm at the injection site. I asked questions to determine the type of pain and when it occurred. She stated it started a week or two after the injection, there was localized swelling, tenderness, and difficulty with mobility. As I asked more questions she also mentioned swelling in her knee and leg and that she had gone to her orthopedic doctor to be checked out and they couldnt determine the cause. They asked if she wanted a scan done because she was concerned about a clot she declined. I asked if she told the provider she had recently recieved the J&J COVID-19 vaccine she said no. I suggested she return to the doctors office and let them know that as they may be more apt to do more thorough testing and examination to rule out possible clots.

Patient states she had unexplained swelling in her knees and legs. She was concerned about a possible clot so she went to the orthopedic doctor to be examined. They couldn't determine cause of swelling asked if she wanted a CAT scan she declined. Also stated sever pain at injection site that doesn't go away, tender to touch, limits mobility. I suggested she return to providers office and let them know she received Janssen COVID-19 vaccine and that additional test may be warranted.

LITTLE BLOOD SPOT UNDER SKIN ON RIGHT ARM; A LUMP AND POOL OF BLOOD INSIDE BEND OF RIGHT ARM TO THE RIGHT SIDE; FRESH BRUISING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. This report was non-serious.

LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal. On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.

Still have Pain in upper arm where vaccine was given now more than 4 months later. Difficult to sleep on my left side. Hurts. PCP did ultrasound and asked a lot of questions. PCP did an ultra sound at about 2 months to be sure there were no blood clots. There were not. PCP wants to see me again next week specifically to address pain in arm at site of injection. PCP is considering putting me on prednisone to see if that helps. NOTE — this is unresolved so difficult to answer question 21 — hopefully this is not disability or permanent damage.

On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday morning I awoke with a bad headache and had body aches all day as well as tendonitis- like pain in both lower arms. I felt somewhat better on WED but I did notice that my compression sleeve on my right arm (lymphedema arm) felt more snug than usual. That night I had severe chills and fever of 101. I slept until 11:45am on THU and felt aches all over. Very fatigued. Went back to sleep from 2:00pm until 6:00pm. Temp was down to 99.8. When I woke and removed my compression garment, my arm was red and swollen, also rash-like bumps, and was very warm to the touch. FRI morning it looked worse, so I contacted my lymphedema specialist and then my PCP. This is NOT a good situation for anyone who has lymphedema and will necessitate months of treatment.

Patient states she has a knot between the injection site and her elbow. The knot is about the size of an egg according to the patient's description.

as of this report, it is day 9 and I still have sore muscles in my arm where shot was given. midway between shoulder and elbow, when using the arm. It gets worse overnight. calms some after rising.

Started three days after vaccine. 3/18/ the itching -3/19/ swelling 3/20/ seeping (redness and itching as soon as the ban-aid fell off. itching at site. swelling at site, slight seeping, redness now today, scaly No Pain, no soreness

About one hour after vaccine she developed itch of the face. She came back to be seen about two hours later (three hours after vaccine) because symptoms were stable and not resolving. No cough, dyspnea, rash, GI SX, dysphagia, etc. Seen in clinic and looked well. No rash or redness. Given Benadryl 50mg PO which she has used in the past for similar symptoms. All symptoms were resolved about one hour after PO Benadryl (four hours after vaccine). Never had any abnormal signs.

Within 5 minutes of the shot, my skin began to itch all over (legs stomach, arms, neck) and my tongue went numb. I have had this reaction before with exposure to wet polyurethane. The doctor looked at my leg to see if if there was a rash (there was not) and she gave me a bendryl. The symptoms subsided. I stayed at the clinic for a total of 2 hours. Later that evening, the itching came back so I gave myself one benedryl and the itching subsided. The following morning the itching was gone and my tongue felt better.

3/14/21 woke up with Rash/Purpura below knees, both legs. Fever in evening of 102.5, resolved with aspirin. Rash/Purpura faded by the time I followed up with PA on 3/22/2021. Some light discoloration remains.

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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).

Irritation on left hand at base of 2nd & 3rd fingers and general itchiness on day 1; continued itchiness and headache day 2 & 3; injection site most sore on day 3. Treated with soothing cream, ibuprofen, and rest.

Red flushing face, neck chest and arms. Felt like my face was on fire. It lasted maybe 30 minutes and then started to go away on my arms, chest and neck. My face got better, but felt hot for maybe 2 hrs. after.

NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.

ITCHY SKIN ALL OVER THE BODY; NUMBNESS IN TONGUE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included hyperactive immune system, environmental allergy, food allergy, pharmaceutical allergy, alcohol user, non smoker, inflammation, hiatal hernia, seasonal allergies, and insulin resistance, and other pre-existing medical conditions included there is no history of drug abuse or illicit drug use. The patient experienced 2 anaphylactic events when treated with urethane. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 13:00 for prophylactic vaccination. Concomitant medications included famotidine for hiatal hernia, metformin for insulin resistance, and levocetirizine dihydrochloride for seasonal allergies. On 13-MAR-2021, the subject experienced itchy skin all over the body. On 13-MAR-2021, the subject experienced numbness in tongue. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy skin all over the body, and numbness in tongue on 14-MAR-2021. This report was non-serious. Additional information was received from patient on 29-MAR-2021. Following information was updated and incorporated into the case narrative: other reference numbers, onset date for event numbness in tongue updated, Vaccination time updated. Upon review, following correction was performed in the case: Anaphylaxis to urethane coded as past event past drug format.

A SORE THROAT; GLANDS ON HER NECK WERE MORE SWOLLEN; TIRED; SOME TENDERNESS ON THE SITE OF INJECTION FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, lupus, connective tissue disease, penicillin allergy, and sulfonamide allergy. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1005018, and batch number: 1005018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate. On 16-MAR-2021, the subject experienced some tenderness on the site of injection for a couple of days. On 20-MAR-2021, the subject experienced a sore throat. On 20-MAR-2021, the subject experienced glands on her neck were more swollen. On 20-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some tenderness on the site of injection for a couple of days on 18-MAR-2021, and had not recovered from a sore throat, glands on her neck were more swollen, and tired. This report was non-serious.

HEAVY BREATHING/SHORTNESS OF BREATH; MILD CHEST PAIN; INCREASED FATIGUE; ITCHINESS TO RIGHT LEG; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalisation, and blood transfusion, and concurrent conditions included cardiac blockage, non smoker, non alcohol user, and low hemoglobin (3/10), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAR-2021 15:00 for covid 19 prevention. Concomitant medications included fexofenadine hydrochloride for drug allergy. On 18-MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported. On 18-MAR-2021 15:00, the subject experienced itchiness to right leg. On 19-MAR-2021, the subject experienced heavy breathing/shortness of breath. On 19-MAR-2021, the subject experienced mild chest pain. On 19-MAR-2021, the subject experienced increased fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchiness to right leg on 18-MAR-2021, and had not recovered from increased fatigue, heavy breathing/shortness of breath, and mild chest pain. 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.

Tried and headaches for 3 days. Swelling, rash, pain , 8 days. Redness, 10 days. Slight swelling, Pain, Blue/redness skin around area 4 days. Skin peeling at the swelling site 2 days

Later the day after the vaccine I developed severe chills and a really bad sore throat. I developed hives in my throat and mouth which cause hoarsness and was hurting really bad. On that Monday I visited my PCP who prescribed an antibiotic which did help and took antihistimines also. I developed a fever an was really tired and after about 3 day the symptoms subsided. My arm was really sore for about 2 days also.

All tendons and muscles throughout entire body aches. Gradually getting worse each day. Face has irritating itching like I was allergic to medication.

Patient reported headache, hive on her face, tongue swelling. She reported that she took Benadryl for few days but it did help that much. She went to Urgent care and was referred to ER where she was prescribed Prednisone for 5 days. She reported feeling better after she started taking Prednisone.

1 week after injection experienced low platelet levels and bruising. Those resolved within another week of time. Patient has also been more tired since vaccine, has been experiencing prolonged sinus issues and has been having sensations of needle pricking all over her body in various places since injection.

Pain at injection site, 16 days. Dizziness. Fever. Chills. Muscle ache 72 hours. Depression. Suicidal Ideation. 4 days. Excessive Fatigue 15 days.

On Saturday, I started itching in the inside of my lower arm between my wrist and elbows (both - mainly my right arm but left arm was itchy too). I had splotches like a rash and light red bumps. My arms puffed up a little (both). It looked like corduroy fabric - red like line indentations. I started using aloe vera. That helped a little bit. I had some Cephafil cream (OTC). I thought I had a reaction to something in the soil from yardwork I was doing. I had redness and a rash in my knuckles - between palm in my hand and my knuckle of where it bends - they were red; rough and raw. There was a little rash on the tops of my hands. I went to the doctor on the 12th and he prescribed. I used it for four days: Trimethadione cream with an acetate name on the end of it. My right arm did have a little swelling around the elbow joint.

Patient with "easy bruising" went to PCP who sent patient to ED. Platelet count found to be 9000 when two months prior was 200,000

STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE PAIN; PRESSURE IN THE CHEST; RIGHT BREAST (FROM CENTER OF CHEST) UNDER THE ARMPIT STILL FEEL DISCOMFORT; HEART BEATING FASTER; FELT LIKE HEART WAS JUMPING OUT OF THE CHEST; STOMACH PAIN/SHARP PAIN; FELT THE URGE TO GO TO THE BATHROOM; REDNESS OF THE FACE; PAIN IN THE JAWS (BOTH SIDE); FELT LIKE HAVING A HEART ATTACK; PAIN SHOT UP TO RIGHT SIDE OF NECK TO SHOULDER AREA, THEN ELEVATED TO THE EARS; HARD TO BREATHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included x-ray dye allergy, prednisone allergy, amoxicillin allergy, non alcoholic, non smoker, fibromyalgia, and lymphedema in the legs, and other pre-existing medical conditions included the patient had allergy to an unspecified pain medication. the patient had 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pressure in the chest. On 10-APR-2021, the subject experienced right breast (from center of chest) under the armpit still feel discomfort. On 10-APR-2021, the subject experienced heart beating faster. On 10-APR-2021, the subject experienced felt like heart was jumping out of the chest. On 10-APR-2021, the subject experienced stomach pain/sharp pain. On 10-APR-2021, the subject experienced felt the urge to go to the bathroom. On 10-APR-2021, the subject experienced redness of the face. On 10-APR-2021, the subject experienced pain in the jaws (both side). On 10-APR-2021, the subject experienced felt like having a heart attack. On 10-APR-2021, the subject experienced pain shot up to right side of neck to shoulder area, then elevated to the ears. On 10-APR-2021, the subject experienced hard to breathe. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021 13:00:00, the subject experienced migraine-like headache. On 13-APR-2021, the subject experienced stuffy nose. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced faeces has really bad odour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating faster, and chills on APR-2021, redness of the face on 12-APR-2021, and pain in the jaws (both side) on 11-APR-2021, was recovering from migraine-like headache, pressure in the chest, and hard to breathe, had not recovered from stuffy nose, and diarrhea, and the outcome of stomach pain/sharp pain, injection site pain, felt like heart was jumping out of the chest, felt the urge to go to the bathroom, faeces has really bad odour, pain shot up to right side of neck to shoulder area, then elevated to the ears, felt like having a heart attack and right breast (from center of chest) under the armpit still feel discomfort was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

Excoriated face; nose cheeks forehead and chin .. today also neck, chest and right shoulder. 4/22/2021

Injection site felt like a heavy material was injected. Started feeling ill shortly after. Slept fitfully with fever chills, next day body aches. 16 days later still have a constant headache, and stiffness in my neck.

Patient was aware she might have a reaction to the covid vaccine as she reports a reaction to influenza and tetanus vaccines in the past. Patient received Janssen vaccine today. Patient brought along her own EpiPen and Benadryl as a precaution. Pharmacist advised patient to wait in the observation area for atleast 30 minutes to monitor for signs of an allergy. Patient's appointment was for 1355 and after vaccination around 1410 patient complained of a mild rash insides of both arms. Pharmacist advised her to take a Benadryl and continued to monitor for signs of anaphylaxis. After 20 minutes, patient left with no additional harm. Mild rash was still present but patient felt ok to leave home.

INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) once a total dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 16-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210349960.

EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RASH TROUGHOUT BODY; CHILLS; SWELLING AT SITE OF INJECTION; FEVER; NO STRENGTH TO STAND UP; ITCHING; BODY ACHES; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included sepsis, and concurrent conditions included no alcohol use, and non-smoker, 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced no strength to stand up. On 18-MAR-2021, the subject experienced extreme break out of cold sweat. On 18-MAR-2021, the subject experienced bee sting-like pain. On 18-MAR-2021, the subject experienced nerve pain. On 18-MAR-2021, the subject experienced low blood pressure. On 18-MAR-2021, the subject experienced irritable. On 18-MAR-2021, the subject experienced rash throughout body. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced swelling at site of injection. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Low. 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 19-MAR-2021, had not recovered from extreme break out of cold sweat, chills, low blood pressure, swelling at site of injection, rash throughout body, bee sting-like pain, nerve pain, and irritable, and the outcome of itching, no strength to stand up and body aches was not reported. This report was non-serious.

BRUISING ON BODY AND FACE; This spontaneous report received from a consumer concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and lymph nodes removal. 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 02-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, linaclotide for drug used for unknown indication, sumatriptan for drug used for unknown indication, tramadol hydrochloride for drug used for unknown indication, and acetylsalicylic acid. On an unspecified date, the subject experienced bruising on body and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on body and face was not reported. This report was non-serious.

PAINFUL NECK; SORE FROM HEAD TO TOE; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: 23-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 burning during injection. On 09-APR-2021, the subject experienced sore from head to toe. On 24-APR-2021, the subject experienced painful neck. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore from head to toe on 10-APR-2021, and burning during injection on 08-APR-2021, and had not recovered from painful neck. This report was non-serious.

RASH ON RIGHT ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, heart murmur, diastolic dysfunction, osteoporosis, gastric reflux, mitral valve insufficiency, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced rash on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on right arm was not reported. This report was non-serious.

Almost 3 1/2 weeks later broke out all over with red body rash. It is very itchy. Took two benedryl just now.

SWOLLEN AREA BELOW THE SHOT/ SWELLING IN ARM; REDNESS IN PROXIMITY OF INJECTION SITE; SORE ARM; HEART FLUTTER; This spontaneous report received from a patient concerned a 68 year old White (Not Hispanic or Latino) female. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, heart flutter, and severe hives with antibiotics, and concurrent conditions included non-alcoholic, non-smoker, sulfer allergy, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, cefdinir, and ibuprofen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 on left arm as prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the patient experienced heart flutter. On 01-MAY-2021, the patient experienced sore arm. On 15-MAY-2021, the patient experienced swollen area below the shot/swelling in arm. On 15-MAY-2021, the patient experienced redness in proximity of injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from heart flutter on 30-APR-2021, and had not recovered from sore arm, swollen area below the shot/swelling in arm, and redness in proximity of injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine heart flutter. 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.

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium

I have a major history of blood clots Muscle Aches Im never real chill was unable to get warm Rash on half my body Tired When I ate I felt a flushing feeling I felt like a pile of crap But it has lighten up Still dealing with core temperature problem, still cold

SINUS INFECTION; JOINT ACHING ON BOTH FEET AND ANKLES; LUMP ON INJECTION SITE; SORE INJECTION ARM; REDNESS AT INJECTION SITE; REALLY ROUGH LOWER BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies and also has no covid in past and not tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced really rough lower back pain. On 17-MAY-2021, the subject experienced lump on injection site. On 17-MAY-2021, the subject experienced sore injection arm. On 17-MAY-2021, the subject experienced redness at injection site. On 18-MAY-2021, the subject experienced joint aching on both feet and ankles. On an unspecified date, the subject experienced sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate/clavulanate potassium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really rough lower back pain on 16-MAY-2021, and was recovering from sore injection arm, lump on injection site, redness at injection site, joint aching on both feet and ankles, headache, and sinus infection. This report was non-serious.

FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported. The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands. The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient called and reported redness at injection site that extended from the injection site down to close to the elbow. Patent reported it was a red band about 3 inches wide and possibly warm to the touch.

LIP SWELLING; GENERALIZED ITCHING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced generalized itching. On 10-JUN-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and lip swelling. This report was non-serious.

Had immediate severe pain in arm, head rush, hives, dizzy, sick to my stomach. Sick all week and missed 3 days of work.

RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.

HAIR FALLING (HAIR LOSS); This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid with pneumonia, and intensive care unit.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced hair falling (hair loss). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair falling (hair loss). This report was non-serious.

I had an upper respiratory infection on 05-17-2021. I went to see my doctor who tested me for Covid and my test was negative on 05-19-2021. Post vaccine reaction I did have fatigue lasted longer than I thought I would. One week after my vaccine I had fatigue. On 04-11-2021, the fatigue was less than it had been, also had nausea. On 04-12-2021, I had dizziness during the night and I could not babysit the next morning because I was still feeling light headed. I also developed shingles after my upper respiratory infection and diagnosed on 05-31-2021, diagnosed on the 5th cranial nerve and had to go to the eye doctor to make sure my eye was not affected.

RED SPOTS ARE ITCHING AND BURNING; RED SPOTS ON LEFT KNEE LEFT ANKLE AND LEFT ARM; SLIGHT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced red spots are itching and burning. On 18-JUN-2021, the subject experienced red spots on left knee left ankle and left arm. On 18-JUN-2021, the subject experienced slight fever. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, red spots on left knee left ankle and left arm, and red spots are itching and burning. This report was non-serious.

Developed cough 12 hours after shot. Developed severe indigestion, chills, fever, and exhaustion 24 hours after shot. Stomach problem continued and developed hives 3 weeks after.

Since receiving the vaccination, I have lost work due to flu symptoms a few days a month. On 20 June I began a slught Shingles outbreak. I was prescribed Valcyclovere. On 2 July, I experienced what felt like a sinus infection accompanied by cough and fever. I was prescribed Amoxicillin and prednisone. The discomfort in my sinus area, accompanied by headache, runny nose and fatigue, has not gone away. I reported these symptoms on the wellness check-in and was contacted by phone. Unfortunately, I was unable to properly understand the message and phone number to return the call.

mild itching, headache, and very tired. I di not take an antihistamine or pain med for the headache. I di sleep about 10 hours.

Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future.

patient had lightly red/pink, slightly swollen area about 0.5 to 1 in circumference from injection site. patient reports warm to touch. reports no fever. reports has been getting slightly worse everyday since 3/12 (so for 3 days). let patient know that injection site reactions are common with the vaccine and can commonly last 3 days (1-3 days median per trials). also let patient know that if it continues to get worse over the next day or two, report to doctor.

The evening of my vaccine I had severe chills. The next day I had a headache, body aches and fatigue. The second day just didn't feel well, lethargic. My arm where vaccine was given was tender for several days.

Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart. Rate measured at 100 bpm. Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.

2nd day I woke up at midnight, with uncontrollable severe chills and 102.8 fever. It took 2 Tylenol, 2 Advil and a washcloth on my forehead all night, to control the fever. Next day had a bad headache. 3rd night same exact thing, chills & high fever. Next day I was good. Day 5, arm swelled and was swollen red from shoulder to elbow and warm. That lasted for 3 days and then I was fine...

Injection site redness and swelling that occurred days after the vaccine. Bell palsy that developed approximately 5 days after receiving the vaccine.

On March 23, four days after the vaccine injection, I developed a burning pain in my Left arm and temperature of 100.2 . An area about 5 inches in diameter was dark red and hot to touch. This area was well below the injection site, approximately 6 inches below the injection site. My doctor advised a cold compress and Benadryl. The area remained hot, red and itchy for 5 days. Temperature elevation lasted 24 hours.

Skin rash manifesting on limbs and face as small red spots, non itchy. Still present at moment of reporting.

Patient is a 69-year-old female who reports a history of hayfever who is coming in today after recent Covid vaccination with concerns of facial swelling also complaining of the rash and itching to her chest. On exam the patient has obvious facial swelling. She has what appears to be an urticarial rash on her chest. While she does have swelling around her lips and face otherwise she does not appear to have any obvious signs of airway involvement with no swelling of her tongue or uvula, she has good phonation with normal respirations without difficulty. Does not appear to be having reactive airway disease exacerbation at this time. Does not appear to have impending respiratory distress. She otherwise does have some skin changes in her bilateral lower extremities that she reports is baseline with her history of eczema. Primary concern at this time is for possible allergic reaction. Patient appears to have angioedema. Does not appear to have anaphylaxis. Other abnormalities are considered. Patient will be connected to cardiac and respiratory monitors. IV access will be obtained. The patient will be given a 1 L IV fluid bolus. She will be given Benadryl, Solu-Medrol, and famotidine. Patient be monitored for response. Labs have been ordered to evaluate. EKG as well as chest x-ray will be obtained. We will file VARES report. Chest x-ray obtained. There is no acute cardiac no acute pulmonary pathology on my interpretation. Laboratory evaluation has returned. The patient's CBC is reassuring. CMP shows a glucose of 78, otherwise reassuring without significant abnormality. Troponin within normal limits. Covid, influenza, RSV testing is negative. On repeat evaluation the patient is resting comfortably. She reports that the itching has resolved. Her face feels less uncomfortable. She has had no progression of the swelling. On repeat examination she continues to have facial swelling as well as swelling around her lips however she has no tongue swelling, no swelling within her posterior oropharynx, and her phonation continues to be normal. She and her friend were informed of the initial findings. Plan at this time is to admit for further evaluation and treatment.

On day 9 felt both sides of neck tender under ear by jaw line. Upon palpation both sides painful however left side more. Paid no attention to it except on day 10 because pain still felt with left side more painful. No lump or bump felt just very sensitive and painful upon palpation. Left side more painful when palpated. It seems to be going away slowly. Did not put this on my daily report because I chalked this up to being maybe a cold or something coming on. After thinking about this symptom I realized it is slowly going away and as an R.N. contributed to it now as a side effect. Below I put "No" regarding recovery because the pain is still there however not as bad. It seems to be going away slowly. Hoping it will be gone in a few more days.

Rash and itching on neck and chest in V-shape Looks like sunburn from V-neck tee-shirt Itchy and rough little bumps some neck swelling taking Benadryl April 6 April 7 taking Hydroxyzine 25mg applying cold pack to reduce swelling

injection site bled but no band aid was offered. following day a large knot appeared in my arm at the injection site, approximately the size of a golf ball. other reaction was feeling cold and tired, but not until the day after the knot appeared in my arm

As soon as she injected the vaccine into my arm I immediately felt a burning sensation go down the inside of my arm to my wrist. It lasted about 5 minutes. I felt fine the rest of the day. The next day I developed a burning sensation in my tongue, mouth throat and chest. Then weakness in my chest and dificulting breathing. It is Saturday April 10, 2021 and the symptoms still come and go. The burning sensations mostly at night. The chest weakness and breathing issues seem to be in the morning and when I exercise. These symptoms are not as bad as they were initially but still present. I am unable to get an answer when I ask if the burning down my are is normal when getting a vaccine. No one else that I have talked with has experienced this symptom. I emailed my doctor she suggested taking tylenol.

Slight light headed ness, but major flushing and the beginnings of hives. I got myself up and ate 2 Benadryl. Made it home, fell asleep for 3 hours, seems okay now.

Tinnitus starting approximately 10 days, two weeks after vaccine.This is very intrusive, and the lingering adverse affect I am reporting in this form. Initial adverse reaction starting +/- two days after vaccine; sore arm at injection site, lasting 10 days, still somewhat sore.. took Tylenol extreme tiredness. Low appetite. Feeling ?buzzed? ?high? , ( not lightheaded.) these reactions lasted for 10 days.

Left Popliteal DVT Edema, pain, increased warmth Starting Eliquis 10mg po bid x 7 days f/b 5mg bid x 6 months

Fever...low grade...99.3 highest Body aches...everywhere on my body. Very tired for several days. Nauseated.....on and off for 10 days Feet very hot....purple bruised like appearance under big toes, both toes ached for 11 days...thumb nails also had purple under the nails Blood vessels all over my body were larger then normal

Left arm became extremely inflamed, itchy & swollen. Started as a small area on 03/16/21 then expanding to cover my entire left forarm from my elbow to my wrist by 03/18/21. I sent a phot to a friend that works for a doctor & was told to have it seen ASAP. My doctor was out of the office that day (Friday March 19th) my insurance company told me to go to the ER. I went , They diagnosed it as cellullitis on my left arm and also an allergic uticaria on my right arm. I was prescribed Cephalexin 500 mg & Prednisone 20 mg & Claitin D. The area cleared up, however it is coming back. I currently have an area of red, itchy and a little swollen of approxiamately 3" x 3 1/2" on my right arm.

Rash - Papular purpuric lesions to arms and legs, some surrounded with erythemia. Some noted raised with vesicle appearance. Sed Rate and liver enzymes elevated, Heachache

Approximately 21 days after receiving vaccine I started to have symptoms of what was later diagnosed to be shingles. My skin was very sensitive to even wearing clothes and I thought I had bites on the back of my neck into my hairline because we had been on Nantucket. But I could not see it. I was feeling very fatigued and had pain from my left ear down my left arm and side. I did not think it could be shingles because I received the Shingrix vaccines in 2019. Finally I had my husband take a picture of it and sent it to me PCP ON 4/8/2021. She informed me it was shingles and put me on a prescription (not sure of name for 1 week). Because nerve pain in neck and ear still continues I was prescribed Gabapentin which I am still taking.

This spontaneous report received from a patient concerned a 69 year old female (local case ID# 002498740). The patient's height, and weight were not reported. The patient's concurrent conditions included giant cell arthritis, polymyalgia rheumatica, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included tocilizumab. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers On 16-MAR-2021, the subject experienced nerve issue. On 16-MAR-2021, the subject experienced throat ache. On 16-MAR-2021, the subject experienced pain. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced left arm swollen. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced little red around injection site. On 16-MAR-2021, the subject experienced swollen around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat ache, tired, pain, sick, nerve issue, left arm swollen, little red around injection site, and swollen around injection site. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

BILATERAL UNDERARM LYMPH NODE SWELLING; TIREDNESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, non alcohol user, and non smoker. The patient was not pregnant at the time of reporting. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site swelling. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced bilateral underarm lymph node swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and injection site swelling, and had not recovered from bilateral underarm lymph node swelling. This report was non-serious.

CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM; TINGLING IN LEFT FINGERS; SHARP HEADACHE; TWINGE OF PAIN IN LEFT SIDE OF TONGUE; LIGHT HEADEDNESS; BURNING SENSATION AT ADMINISTRATION SITE/ TENDERNESS AT INJECTION SITE; LEFT-SIDED NUMBNESS THAT SPREAD FROM HER JAW, FACE TO TOP OF HEAD; LEFT SIDED FACIAL NUMBNESS LASTED FOR AT LEAST 5 HOURS DESCRIBED IT AS WAS SIMILAR TO DENTAL ANESTHESIA, BUT MORE EXTENSIVE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and concurrent conditions included seasonal allergy, vision damaged, and sensitivity to alcohol, and other pre-existing medical conditions included azithromycin allergy (headache, rash, hives, swollen lips, tongue and throat , breathing problems, chest pains, raises blood pressure), sulfadiazine allergy (headache, rash, hives, swollen lips, tongue and throat), omnicef allergy (headache, rash, hives, upset stomach), cefdinir, clonidine allergy (headache, rash, hives, upset stomach), cipro allergy (headache, rash, hives, upset stomach), aspirin allergy (upset stomach), cortisone allergy (feels like shards of glass), lisinopril allergy (cough), amlodipine allergy (swelling of legs &feet), hydrochlorothiazide allergy (headache, upset stomach). The patient experienced drug allergy when treated with amlodipine, acetylsalicylic acid, azithromycin, cefdinir, ciprofloxacin, clonidine, cortisone, hydrochlorothiazide, lisinopril, cefotaxime sodium, and sulfadiazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:05 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On 06-MAR-2021, the subject experienced left-sided numbness that spread from her jaw, face to top of head. On 06-MAR-2021, the subject experienced left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive. On 06-MAR-2021, the subject experienced allergic reaction. On 06-MAR-2021 14:25, the subject experienced light headedness. On 06-MAR-2021 14:25, the subject experienced burning sensation at administration site/ tenderness at injection site. On 06-MAR-2021 15:05, the subject experienced twinge of pain in left side of tongue. On 06-MAR-2021 15:15, the subject experienced sharp headache. On 06-MAR-2021 16:00, the subject experienced constantly cleared the throat. On 06-MAR-2021 16:00, the subject experienced felt kind of swollen throat. On 06-MAR-2021 16:00, the subject experienced and had a lot of coughing. On 06-MAR-2021 16:00, the subject experienced numbness in left arm. On 06-MAR-2021 16:00, the subject experienced tingling in left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly cleared the throat on MAR-2021, and and had a lot of coughing, numbness in left arm, burning sensation at administration site/ tenderness at injection site, and sharp headache on 06-MAR-2021, had not recovered from light headedness, left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive, left-sided numbness that spread from her jaw, face to top of head, tingling in left fingers, and twinge of pain in left side of tongue, and the outcome of felt kind of swollen throat and allergic reaction was not reported. This report was non-serious.

CLIENT REPORTS THAT 4-5 DAYS AGO SHE STARTED HAVING EXTREME FATIGUE, AND RIGHT NECK, SHOULDER, PAIN THAT IS POUNDING AND REQUIRES TYLENOL PO Q 3 HOURS. ICE HELPS A LITTLE BUT ONCE MEDICATION WEARS OFF SHE HAD SEVERE PAIN IN THESE AREAS. IT STOPS AT THE LOCATION OF THE SHOT ON HER RIGHT SIDE/ARM.

10 min. post inject Lt upper arm started swelling. No pain. 5min. later intense pressure/pain/surge to nose & sinus's. Couldn't breathe thru nose. Within 15 sec sinus/nose rush went to entire head with dizziness & passing out intensity. Did not loose consciousness. RN on scene. 10min later made comeback. Beads of sweet on forehead. Lt. upper arm swelling gone. Felt fine for 3 days. On 3rd day rt & lt knees to ankles began off & on sporadic (static electricity like) shocks concentrated to one area at a time. Coming & going in daytime, not at night. Continuing for 10 days. On 9th shocks lessening but then started experiencing pressure in lt. leg calf. Went to ER & had lt leg doppler. Neg. for clots. Now 4wks. later shocks gone but pressure in rt. & lt. calves continue off & on.

First 2 weeks no symptoms at all. After about 2 weeks I noticed 4 small bruises on my L forearm. About a week later I noticed a huge black bruise on my L hip with a knot in the middle of it - it is still there but much lighter. Some days later I noticed a bruise on my R knee. Today I noticed a bruise on my R forearm. I do take a low does aspirin every day. I did get a little dizzy a couple of times and when I look up I get vertigo - not sure if that is related.

No problems immediately - took 2 Benadryl given me at the vaccination clinic 2 hours later (after driving home.) No sore arm or other obvious reactions until woke up on day 5 with hives. Raised itchy individual bumps on face, back and both arms.

The injection site felt "achey" immediately after the injection and this discomfort lasted several hours despite my gently massaging the band-aid site. My left arm felt "heavy" for the rest of the day. Within 18 hours of vaccination, I was awaken from sleep shaking violently. I thought that someone was shaking me violently. When I realized that my body was shaking so, I wrapped myself in a comforter; then I passed out or went back to sleep. When I was aware of myself again, I was too hot wrapped in the comforter and removed it. I was very concerned about what had happened to me so I moved slowly getting up and starting my day. I live alone so there was no one to help or advise me. For the next few days, I rested often, not sleeping, just feeling the need to lay about. By week 2 after the injection, I was "dragging" but not sleeping. When I laid down, my mind roamed about, when I tried to read or engage in meaningful activities were not successful. By week 3, I have full-blown insomnia. I go to bed at 4 am to be awake for hours while in bed, then being exhausted during the day. I am normally active, but I do not have the stamina to do what I love such as mowing my own lawn and working in garden. My heart rate jumps to 122 after 10-20 minutes of activities when in the past I could work steadily for 40 minutes and my heart rate never get above 90 beat per minute ( I wear a charge 2 watch that monitors exercise parameters.) I had to stop to rest up to 4 times to complete the yard work that I could normally complete in less than 40 minutes. Currently, I have "hay fever" symptoms: itchy runny nose, tickle in the throat with dry cough, tired, runny eyes and frontal headache; I take benadryl and other allergy medicines. I have poor sleep habits.

+ Homan?s Sign Right upper LE localized tenderness Warm to touch No MCR part A until 7/1/21 so not sought tx Taking ASA 325 mg qd Thigh high compression Leg elevated/ bedrest

PATIENT DEVELOPED A RASH ON FACE AFTER INJECTION 2 HOURS LATER...WENT TO URGENT CARE AND WAS ADVISED TO TAKE BENADRYL. PATIENT TOOK 25MG DOSES ON HAND AT HOME AND SEEMS TO BE EFFECTIVE.

The weekend after the shot, I noticed deep purple coloring at the top of my thighs, pubic area, arm pits. There are also welts on the top of my thighs, where coloration is more blotchy. After a couple days I realized I was having small episodes of near-fainting. I would have the sensation that I was was going to faint, and it went away without any fainting or dizziness. It was a warning sensation. This occurred 10-15 times a day. It would grab my attention & be gone just as quickly. The same weekend I started with the rash, my anxiety level rose very high. I felt a motor in my chest all the time. Sleeping was very difficult. This anxiety & motor are indicative of a thyroid rage, which I have experienced p

On the day of the vaccine, participant just had a minor sore arm. A week and 2 days later, participant woke up with hives. The hives were located on both arms from shoulder to wrist and around the waist line. Participant went to Urgent Care. Participant was prescribed a shot of Prednisone, Prednisone 5mg 6 day Pak, OTC Benadryl twice a day, OTC Claritin twice a day and OTC Pepcid. If not improved, she was to come back in 3 days. Participant went back to the doctor in 3 day since her rash has not improved. Participant got another shot of Prednisone and told to D/C Prednisone 6 day and D/C Claritin and D/C Benadryl. Participant was prescribed Prednisone 12 Day Pak, Zyrtec, hydroxyzine 5mg 2 tablets 4 times a day, Singulair 10mg once a bedtime. Participant noticed her rash was improving with the new drug regimen and started clear up. After 2-3 days after finishing the medications, she started to break out again. Participant contacted her PCP via MyChart who referred her to an allergist specialist. She is awaiting an appointment with the allergist. Her rash is sporadic and will come and go andshe is currently taking Singulair, Zyrtec and Benadryl for the rash.

FLU SYMPTOMS; ACHING BONES; HEADACHE; INTERMITTENT SWEATING; PAIN AND SORENESS IN THE LEFT ARM AT INJECTION SITE; REDNESS IN LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 214 pounds, and height was 65 inches. The patient's past medical history included lumpectomy of right breast, radiation therapy, and colon resection, and concurrent conditions included breast cancer, non-insulin-dependent diabetes mellitus, asthmatic, second hand smoke, chronic obstructive pulmonary disease, neuropathy, iodine allergy, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient cannot take certain antibiotics because it upsets stomach. The patient experienced bad reaction with colon when treated with prednisone for drug used for unknown indication, and ministroke when treated with midazolam hydrochloride, and blood pressure problems and headache when treated with celecoxib, stomach upset when treated with erythromycin, and blood pressure increased when treated with salbutamol. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 7808980 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced intermittent sweating. On MAY-2021, the subject experienced pain and soreness in the left arm at injection site. On MAY-2021, the subject experienced redness in left arm at injection site. On 13-MAY-2021, the subject experienced flu symptoms. On 13-MAY-2021, the subject experienced aching bones. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain and soreness in the left arm at injection site, and the outcome of flu symptoms, aching bones, headache, redness in left arm at injection site and intermittent sweating was not reported. This report was non-serious.

Pain, pain, pain, and blisters, itchy and soreness. I went to the Clinic ER because I was in so much pain in my chest and back and they kept me over night and ran test. I was sent home and returned in a couple of days cause I was still in pain and was diagnosed with Shingles.

observed injection site that afternoon when removing bandage: my upper arm was full of tiny pinpoint dots, injection site was swollen/hard. I was busy that day finishing payroll and preparing for trip . I did not notice so much in the morning, I drove to visit family for a few days. Upon return home, I read the paperwork provided by the clinic after I had received the shot...and began examining my body for tiny blood spots. Now, with each shower etc I would notice random spots and try to remember if they had been there before... My doctor was retiring and called last weekend to followup on a lab test he had previously ordered to take in May. During that conversation I asked him about the random spots, and he made an appt for me to see the PA the next day and do my urine sample for the lab order. PA ordered bloodwork for low platelet counts, which I had had previously, and urine test for abnormal immunofixation.

couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had one on my hip. I was not concerned as I have them on occasion. I felt fine. Went to bed that evening and woke up with extreme burning and itching in my index finger and thumb of my right hand. Also a very large hive on the inside of my arm about 2 1/2 inches from my wrist bend. Intense itching. I took a Benadryl tablet and felt better almost immediately. Later in the day about 6 1/2 hours later, I had more itching on my hip where the high was located. I took another Benadryl. I am fine. I also call my doctor and reported it.

Patient described a shingles flare the day after her injection and also described intensification of chronic pain, above and beyond normal pain, for the two days after her vaccination.

Patient complained of a shingles flare the day after receiving vaccine and also described intensification of chronic pain, above and beyond normal, for the two days since her vaccine.

Metal taste in mouth Swollen face bright red. Later tinnitus rash on legs and arms a few racing heart beats. Itchy face. Headache Today (3/17) face swells and itches then better headache tinnitus but much better than last night.

Fever of 102F, Derma, between 11:30 PM to 2:30 AM, Chills at same frame, Sore Throat, Headache, pounding continuing from 11:30, 03/23/21 until 9:45 03/24/21, Several hours of weakness and dizziness, Injection site, Left arm, continues to be sore.

Pt reported developing slight bruising and a "bump" at the injection site, starting 3 days after receiving the vaccine (received vaccine on 3-11-21, developed symptoms on 3-14-21). Pt still had those symptoms on 3-27-21. Pt did not report any arm or injection site pain.

pts left arm became very sore and she has a red hard painful knot. The arm is in alot of pain at times and does not seem to be getting any better at this time and it has been more than two weeks. Pt will contact PCP.

RASH ON HER WRIST; TIRED; This spontaneous report received from a patient via a company representative concerned a 70 year old female (Patient 1). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced rash on her wrist. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her wrist on MAR-2021, and the outcome of tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210342307.

SINUS SYMPTOMS; DRYNESS; SORE ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 29-MAR-2021, the subject experienced sinus symptoms. On 29-MAR-2021, the subject experienced dryness. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 30-MAR-2021, and was recovering from sinus symptoms, and dryness. This report was non-serious.

I had the Johnson and Johnson one shot vaccination on March 15, 2021 and Initially had no adverse reactions .. However , 18 days after my vaccination, around April 2, 2021, began to have deep muscle pain radiating around the injection site, which was in my upper right arm, in the muscle at the top of my arm.. It was SO painful, the pain was deep in the muscle but not painful to external touch., that I had to take Tylenol for three days. Today is April 7, 2021, and the deep muscle pain is barely noticeable, but once in awhile, I will still get a jab of pain..

EARACHE; SINUS BLOCKAGE; FACIAL PUFFINESS; ITCHY; RASH ON FACE; RED SPOTS ON FACE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included rosacea, and concurrent conditions included osteoporosis, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received COVID-19 VACCINE ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at 10:40 to right arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced earache. On 19-MAR-2021, the subject experienced sinus blockage. On 19-MAR-2021, the subject experienced facial puffiness. On 19-MAR-2021, the subject experienced itchy. On 19-MAR-2021, the subject experienced rash on face. On 19-MAR-2021, the subject experienced red spots on face. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from earache, sinus blockage, and nausea on 20-MAR-2021, had not recovered from rash on face, facial puffiness, and red spots on face, and the outcome of itchy was not reported. This report was non-serious.

Intense itching and burning and breakout on neck, right side of face, and nose after 12:30 am Thursday am. By Thursday afternoon, eruptions began on chest from shoulder to shoulder. Pain still persists where the rash presented. Diagnosis-Shingles

BUMP UNDER THE SKIN (KNOT AROUND 1/4 INCH BIG AND A LUMP); RED PATCH (RED SPOT); SWELLING; SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included high blood pressure, type 2 diabetes mellitus, high cholesterol, skin cancer, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no 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, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced bump under the skin (knot around 1/4 inch big and a lump). On 03-APR-2021, the subject experienced red patch (red spot). On 03-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and swelling on 04-APR-2021, and had not recovered from bump under the skin (knot around 1/4 inch big and a lump), and red patch (red spot). This report was non-serious.

She got the vaccine, and where she got the shot it turned red, about the size of two silver dollars, very sore. Right above that a very big red spot popped up. She had itching and bumps on her feet and then over her whole body. she had red spots and a rash on her stomach, and a big rash on her back and all over her face. She had diarrhea, headache, flu symptoms with aches all over her body. The aches went away except in her feet and her toes, it hurt to walk due to the toe pain. She still has the bumps and the itching, but took the Benadryl, but cannot take that as it gives her restless leg syndrome, and is now takin Claritin. She now has itching in her lips, has allergies in her eyes, She has not call her doctor. She talked to the person who gave her the shot and also Wal-Mart pharmacist who told her to take the Claritin. These symptoms have continued.

deep vein thrombosis, swelling, pain in both legs and lower abdomen. warm and red skin. red swollen veins.

SLEEPINESS 30 MINUTES AFTER VACCINATION; INJECTION SITE TENDERNESS; SLIGHT HEADACHE; STONED FEELING; DECREASED RINGING IN RIGHT EAR (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ringing in right ear only from approximately 15 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sleepiness 30 minutes after vaccination. On 09-MAR-2021, the subject experienced injection site tenderness. On 09-MAR-2021, the subject experienced slight headache. On 09-MAR-2021, the subject experienced stoned feeling. On 09-MAR-2021, the subject experienced decreased ringing in right ear (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sleepiness 30 minutes after vaccination, stoned feeling, and slight headache, had not recovered from injection site tenderness, and the outcome of decreased ringing in right ear (unexpected therapeutic benefit) was not reported. This report was non-serious.

FLUID RETENTION; INJECTION SITE REDNESS; BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and 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 generalized aching. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced fluid retention. 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 recovered from generalized aching, fatigue, and injection site redness on 12-APR-2021, and had not recovered from fluid retention. This report was non-serious.

ITCHINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced itchiness. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-MAR-2021, and nausea on 07-MAR-2021, and had not recovered from itchiness. This report was non-serious.

OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE

Patient reported a sore arm directly after receiving the vaccine. She called the pharmacy to report the sore arm and concerns that she didn't think her arm should be that sore. The pharmacist went over the vaccine technique used by the technician who remembered the patient. Technique seemed appropriate, so we recommended patient follow-up with her PCP if the discomfort continued. Pharmacy let the patient know that discomfort in the arm for up to 7 days can occur and is not unusual. On 4/19/21, patient reported that she followed up with PCP, tried taking a Medrol Dose Pak and was then referred to doctor with sports medicine. The pharmacy called doctor for more information for the VERS reporting. Doctor had determined patient had injury of left shoulder with bursitis relating to vaccine administration and is a "well known phenomenon" per doctor. Patient continues to follow-up with doctor and will begin PT to help with the condition.

MUSCLE ACHES; INJECTION SITE SORENESS; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced injection site soreness. On 11-APR-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and was recovering from injection site soreness, and injection site redness. This report was non-serious.

Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.

March 5th I received Johnson and Johnson vaccine March 8th developed fatigue and chest pains March 12th I developed blisters on one half of my torso, March 15 my PA diagnosed me with shingles Today, about 6 weeks later the rash is almost gone but I still am being treated for chronic nerve pain

Knot still in my arm/04/23/2021 still warm to the touch. Extreme itch more on scalp. Swelling . Arm still have the blue/greenish color at the site of the injection

ACHE (ACHIE); DECREASED APPETITE; HEADACHE; NAUSEA; FEVER; RASH ON INJECTION SITE; WARM INJECTION SITE; DIARRHEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient didn't had any pre-existing medical conditions and no known allergies. The patient was previously treated with paracetamol. 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 21-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced rash on injection site. On 21-MAR-2021, the subject experienced warm injection site. On 21-MAR-2021, the subject experienced diarrhea. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced stomach pain. On 21-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced ache. On 22-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from rash on injection site, and warm injection site on 22-MAR-2021, was recovering from headache, and had not recovered from diarrhea, fever, stomach pain, nausea, ache, and decreased appetite. This report was non-serious.

COLD SORES IN NASAL CAVITY; PAINFUL IN NASAL CAVITY; BUTTOCK CHEEK BURNING SENSATION; BUTTOCK CHEEK ITCHING SENSATION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold sores in nose.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, once a total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced buttock cheek burning sensation. On 05-MAR-2021, the subject experienced buttock cheek itching sensation. On 10-MAR-2021, the subject experienced cold sores in nasal cavity. On 10-MAR-2021, the subject experienced painful in nasal cavity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from buttock cheek burning sensation, and buttock cheek itching sensation on 05-MAR-2021, and had not recovered from cold sores in nasal cavity, and painful in nasal cavity. This report was non-serious.

ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-TO-TOE; RASH; FREEZING; HEADACHE; TIRED; NAUSEA; FEVER (101F); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bowel obstruction, hernia, diabetes, non alcoholic, non-smoker, penicillin allergy, and levaquin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced freezing. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever (101f). On 20-MAR-2021, the subject experienced itching of legs. On 20-MAR-2021, the subject experienced swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe. On 20-MAR-2021, the subject experienced rash. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tired, nausea, and fever (101f) on 18-MAR-2021, was recovering from freezing, and had not recovered from itching of legs, swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe, and rash. This report was non-serious.

TENDERNESS AROUND SITE OF INJECTION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, kidney disease, high blood pressure, high cholesterol, bipolar, and glaucoma. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tenderness around site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tenderness around site of injection. This report was non-serious.

My skin became very sensitive to touch 4-5 days ago, then I noticed some pain in my left leg like muscle overuse, then I woke up yesterday and found a rash. Dr. said its Shingles and said it is likely due to the vaccine.

BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Redness at Injection Site-Mild, patient called back about 8 hours after injection. Reports small bumps on her stomach, thinks it is a rash/hives, has no other symptoms.

First, the injection was far more painful than anticipated (and it bled down my arm). My arm immediately ached intensely. Approximately 10 minutes after injection, I began to sweat profusely, followed by intensifying extreme lightheadedness. I could not stand, or lift my head, as I would have definitely passed out. My shoulders and neck became extremely painful, as if ?frozen?, also preventing me from lifting my head. After about 35 minutes I very gradually began to recover. It was about an hour before I began to move around normally. Pharmacy and store staff debated calling the paramedics, but I refused. FYI, I had not been especially anxious about the vaccine, and I have never experienced such a reaction to anything in my life. It was a traumatic experience I would not wish to repeat.

I had an event where my blood pressure was very high and the left side of my body became tingly and weak. I went to the doctor and stayed two nights for observation. They ran many diagnostic tests but nothing was diagnosed. I continued to have the tingling and weakness and began to feel it could be a pinched nerve in my back/shoulder. I went to a chiropractor and was treated twice for adjustments to my back, neck area and the tingling, weakness has not occurred again. I am monitoring my blood pressure at home and have a doctor check up scheduled for the end of this month. Confident it was not a medical event due to the Covid vaccine but still following up.

First night had chills, very slight nausea and low grade fever (99.3) the next two days. On the morning of April 7th I woke up with a swollen lip. Throughout the day the swelling continued on the left side of face, then on bottom of right foot and later on top of both feet. Went to emergency room and was treated for hives. Over the next five days, the hives kept moving around, the right side of face, and then to upper lip. I followed up with my Primary Care Doctor, who did extensive allergy testing. All came back negative. I felt that it was a result of my body reacting to the vaccine. In addition, I was feeling weak muscles and joints that kept moving around.

PAIN IN LEFT ARM AT AND AROUND INJECTION SITE AND MUSCLE PAIN AT INJECTION SITE EXTENDS INTO SHOULDER AND BACK; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. The action taken with covid-19 vaccine was not applicable. The patient was recovering from pain in left arm at and around injection site and muscle pain at injection site extends into shoulder and back. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

Patient went to urgent care on 5/30/21 with a rash on her upper arm. This appears to be shingles with the distribution and vesicles that were fluid-filled. She was given prednisone orally. I am seeing her 5 days later and she has a scabbed over rash in a dermatomal distribution that still stings and burns. No other contact dermatitis risk factors. I think this is Herpes Zoster.

25 hrs after injection non itching dermatitis on both legs and arms. It appeared to be a rash but there was no itch. It disappeared about 2 hrs later.

CONSTIPATION LASTING OVER A WEEK, STRONG HEADACHES FOR A WEEK, SINUS CONGESTION, RASH TYPE SKIN ERUPTIONS ON FACE, REMARKABLY SIZED AND A TYPICAL BOIL TYPE CANKER SORES INSIDE MOUTH.

Had severe rash and itch. With time it got worse. Got blisters . Used over the counter lotions for months. Went to Urgent Care hoping for relief June 17/21. I did remember I had Darier's disease. Prior rash minor no blisters. This flare up worse in 30yrs. Covered both lower leg left side. Then and now both lower legs blisters. Triamcinolone 0.1% made it worse.

STIFFNESS IN THE NECK; HEADACHE; TIREDNESS; SORENESS IN THE INJECTION SITE (LEFT ARM); MUSCLE ACHE; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-JUL-2021, the subject experienced stiffness in the neck. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced tiredness. On 01-JUL-2021, the subject experienced soreness in the injection site (left arm). On 01-JUL-2021, the subject experienced muscle ache. 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 stiffness in the neck, headache, tiredness, soreness in the injection site (left arm), and muscle ache. This report was non-serious.

on March 14, 2021 that evening, chills, fever. the next day, my face was completely flushed. It faded by the next day. On March 27 at 3:30 in the morning I work up with pain in my right leg , on the inner side of the leg by knee. later in the morning I notice a large bruise. On June 11, the same thing occurred on my left leg. I took a picture of the bruise on the right hand side of my knee. On July 3rd, the pain the back of both legs wall painful all day.

Raised red & itchy spots (hives?) on my chest and stomach which lasted for about 2 1/2 months. The severity of the rash varied throughout that time. I was mostly able to resist the urge to scratch I contacted my Dr who recommended Benadryl, but I never felt the need to take it.

Patient said she is experiencing a high level of fatigue. She discovered a on 7/09/2021 she went to the DR and found out she had shingles.

1. first day swelling and pain 2. queasy, headache for 2 weeks, 3. Blisters reoccurring, 4.Inflammation in joint escalated. 5. Severe Angina (7) times 6. Tendonitis in knee, shoulder, elbow 7. Pressure in Back and hips then spread.

fever ,swelling of face and throat, red rash all over upper body. intestines swelled. epipen, benadryl, prednisone starting at 4pm. still taking benadryl and prednisone

Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and "red flush" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.

Pt developed a rash on her finger that spread to her wrist. Benadryl 25mg was given.. the rash improved. Pt blood pressure elevated 195/113, repeat 207/117. Pt developed nausea and abdominal pain. Pt was transported to the ER

Red rash about 1" wide by 3" long. No raised areas, no itching, tenderness or soreness. Appeared almost 1 week after injection. It is on my right side below my neck and slightly toward my right arm. I received the vaccine in my left arm. Area is not as red after about 36 hours of first appearance but still quite visible.

Pt got vaccination at waited 15 minutes before leaving. She called me 4 days later to let me know that she fainted approximately 1 hour after getting the vaccination resulting in a trip to er and stiches to her face.

Day 1: no sx, Day 2: extreme fatigue . Dizzy lightheaded Day 3: profound lethargy + dizzy & lightheaded . bedridden Day 4: profound lethargy dizzy + lightheaded bedridden Day 5: visit to urgent care. rx for keflex for injection site sub cutaeneous lump. c/o right arm swollen, petechia, right torso petechia. dizzy lightheaded. Patient reports she is blood type AB negative Day 6: visit to PCP

Patient reports developing a rash 1 week after receiving Johnson & Johnson vaccine. Patient describes rash as bright red spots on bilateral legs from knees to ankles. Majority of spots are around the ankles on the inner aspect of leg. Spots are the size of a pinky finger tip and are not bothersome in the way of itching or hurting. Patient reports contacting PCP who instructed patient to contact the local health department. Patient spoke with a pharmacist who recommended she use a cream that she was unable to remember the name of when speaking with the reporter.

1st day of symptoms. Hands started itching. Felt like I had placed my hands in scalding hot water. Slightly red blotchy look to palms of hands. 2nd day I have additional Symptoms, I woke up with strange feeling in my mouth. Feels like i drank scolding hot drink. Mouth is also Tingly feeling, I am definitely having some kind of allergic reaction i-week after the Covid vaccination.

Achiness in legs, then chills, and then my legs felt like they were on fire. The next day I had a terrible headache and very tired.

Large rash on chest. Itching that began after the second week. Treated with Benadryl cream with some relief. Rash continues to remain after 7 days of starting.

Shot was put in the very top of my arm, in my shoulder. Excruciating pain when given and for some time thereafter. Able to drive home one-handed. Taking extra celecoxib, heat, resting has provided some improvement but still having problems 3 weeks later.