Johnson & Johnson

Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.

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.

Patient developed Severe INflammatory response syndrome . Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself

SWOLLEN LEFT ARMPIT (Swelling, Swelling) PAIN IN LEFT ARMPIT (Armpit pain, Axillary pain) This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine as26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.

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.

Swollen lymph nodes in neck, stiff and painful neck, headache,fever,chills, Excessive fatigue x 9 days and to present

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.

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.

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.

Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both legs.

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.

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.

I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my heart. Could not sleep on Saturday night extreme anxiety feeling. Extreme hyper active feeling!!! Felt like if I had a surge of energy. Very restless, legs felt jittery! Left lymph node in my neck was swollen and slight headache.

4/8/21- unable to walk with normal stride 4/9/21 severe pain in right hip making it difficult to walk or go up stairs 4/10/21 morning - unable to walk at all. Called my doctor, who after discussion, prescribed 5 days of prednisone for severe inflammatory response 4/11/21 able to walk again and complete course of steroid. 4/16/21 some inflammation in joints and hip persists.

SORE THROAT; SWOLLEN FACE; TINGLING LIPS; FATIGUE; FLUSHED 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 concurrent conditions included obstructive sleep apnea, hbp, bipap at night, non-smoker, abstains from alcohol, and seasonal 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included colecalciferol for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, hydrochlorothiazide/triamterene for drug used for unknown indication, loratadine for drug used for unknown indication, metoprolol for drug used for unknown indication, orlistat for drug used for unknown indication, and paracetamol. On 12-APR-2021, the subject experienced flushed face. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced swollen face. On 13-APR-2021, the subject experienced tingling lips. On 14-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen face, tingling lips, and fatigue on 13-APR-2021, was recovering from flushed face, and had not recovered from sore throat. This report was non-serious.

SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious

SWOLLEN LYMPH NODE; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; 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 the patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, 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 swollen lymph node. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-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 headache, body aches, fatigue, nausea, and swollen lymph node. 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.

Swelling and extreme pain in thumbs, index fingers and wrists as well as pain in right arm and both knees.

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.

DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; 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 blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time 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

LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PAINFUL KNEE/LEG; 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 blood pressure abnormal, knee disorder, and hand arthritis. 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 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid. On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.

Patient developed cold symptoms with heavy drainage on 4/15/21. Patient took a whole package as directed but continued to get worse. Used Vicks Vapor Rub and took a couple doses of sinus medication after the Coriidin was gone. Started severely hurting with difficulty breathing and chest pain on 4/27/21. Went to The Hospital on 4/28/21. Was diagnosed with pneumonia, pulmonary embolism in left lower lobe pulmonary arterial branches. Patient was admitted. Patient placed on Rocephin 1 gram IVPB daily and azithromycin 500 mg IVPB daily. Patient was started on therapeutic dosing of Lovenox and then transitioned to Eliquis 10 mg BID for 7 days then 5 mg BID. See hos.

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.

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.

Bad pain down leg , swollen leg, very sharp pain that move into foot . foot swells everyday since vaccine

HERPES FLARED; DAILY FEVER OF 100; REALLY BAD BRONCHITIS; ACHING; 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 past medical history included mono, and concurrent conditions included non-smoker, non alcohol user, and herpes, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient was previously treated with cannabis sativa. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, and COVID-19 virus test (NR: not provided) Negative, Negative. On MAY-2021, the subject experienced really bad bronchitis. On MAY-2021, the subject experienced aching. On MAY-2021, the subject experienced daily fever of 100. On 01-MAY-2021, the subject experienced herpes flared. On 17-MAY-2021, Laboratory data included: CBC (NR: not provided) Normal. On 20-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Laboratory data (dates unspecified) included: Epstein-Barr virus test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: budesonide/formoterol fumarate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really bad bronchitis, and had not recovered from daily fever of 100, aching, and herpes flared. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.

I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.

The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.

I received the J&J vaccine on Weds 6-23-2021 This is Friday 6-25-2021, ( day 3 ). I woke up this morning with a genital herpes outbreak and a herpes outbreak on my lip which I have only had ONE other time in my life ( after I had Covid-19 Feb 9th- 1st week of March 2020 in the very beginning of the pandemic). I have been trying all day to find out if it is ok to take my acyclovir anti-viral meds that I usually take at the first sign of an outbreak or if that will hinder the effects of the vaccine and no one has been able to help me with that question. To my dismay, it was never listed as a possible symptom and there doesn't seem to be any help for anyone without insurance to get assistance with the adverse health effects that the vaccine may cause, except to pay out of pocket if you don't have insurance because it is not affordable to a "spouse" of an employee, due to the "Family Glitch", with no subsidy available to spouses.

patient presented to ER with myalgias/arthralgias, flu like symptoms including fever, congestion, sore throat. Pt had COVID vax 6/9. In ER, noted to have leukocytosis of 36k with neutrophil predominance. Admitted and no infectious source identified. COVID negative on 6/22. Pt transferred to higher level of care due to concern for hematologic malignancy. All tests unremarkable so far. Ferritin was > 11k. Pt case reviewed by rheumatology who suggested adult onset Still's disease which could be vaccine related. Starting Anakinra asap in effort to see improvement

BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; 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 hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. 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, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. 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).

Within the first 6 days after taking the vaccine a bump appeared on the right thumb. Chronic pain increased, right shoulder, wrist and elbow sore. Has a cough currently.

11:30PM - Chills late that night and up for an hour for them - went to go to bed with a lot of clothes and lots of blankets but I fell asleep. Morning they were gone. Slightly after that, I had some fatigue but nothing major. I was pretty normal. Then I noticed a few weeks later some swelling under my arms - lymph nodes swollen. I was very aware that they were touching. That seemed to last for a couple of months. I have just become aware the last few weeks that those symptoms with the swollen lymph nodes are gone. About 6 weeks to two months ago - I have been getting pounding heart and a bit of difficulty breathing. May be related stress. It comes and goes and then about a month ago I started a stress reduction supplement protocol and started doing meditation but they were still there and so I went to the doctor. She did an EKG and general physical and she didn't find anything that showed up abnormal with heart. The heart pounding and the breathing issues I'm still noticing.

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.

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.

Could NOT breathe, Afib increased, could not walk 15 feet without stopping, gasping for air at night when trying to lay down, major edema in legs and feet - this lasted approximately 2 weeks. Then returned on 6/17 & 6/18.

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.

Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea

4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0

Janssen COVID-19 Vaccine EUA 3/11/2021 - 8pm very sore lymph nodes under armpits, sore chest muscles - sore all the way around my torse from one armpit to the other. Start getting the chills. Went to bed at 10pm. 3/12/2021 - 12am woke up with VERY Intense headache (forehead area and temples) - never had a headache this bad in my entire life, back of neck very sore, couldn't sleep, relax or focus. 3/12/2021 - 3am Diarrhea and nausea started, mouth very dry, tried to drink water but couldn't due to nausea, Headache still intense, haven't slept since midnight and couldn't relax or focus. In and out of bed, up and down stairs just didn't know what to do. 3/12/2021 - 7am diarrhea and nausea ended but still very intense headache. No sleep since midnight and just kept pacing , trying to sit, tried breathing learned in childbirth, but nothing was relieving the headache or letting me relax and sleep. Husband thought I looked like death. 3/12/2021 - 9:30am I finally broke down and took 2 Tylenol and was able to sleep for 2 hrs. 3/12/2021 - 11:30am body still ached and headache was now tolerable. Able to finally focus and relax. Symptoms were now tolerable as compared to 12am-9:30am, prior to taking Tylenol. 3/12/2021 - 5:00 pm beginning to feel better and eat a regular dinner. 3/13/2021 - 8:00 am woke up and felt 100% normal injection site was never sore or red, didn't have a fever

Was out shopping with friends and feeling fine but when driving home I noticed a high pitch sound in my left ear that abruptly started for no known reason. I have pollen allergies to trees and due to staying indoors and wearing a mask I was having no bad allergy symptoms and never had tinnitus on my worse pollen day. The tinnitus symptom was loud enough to notice over all other noise and very irritating in a quiet room. The high pitch sound was non stop and constant. I went to sleep that night and woke up Saturday morning still hearing it. I felt that morning like I was having a very mild cold with very mild congestion. I felt likeI had swelling under my ears I was not tired but I did feel like staying in bed and sleeping as if my body was mildly requesting it. I slept most of the day. Woke up with the high pitch sound but it seemed a little bit lower in volume. Around 8 pm the sound left as quickly as it came

6 days after vaccination I noticed tenderness in lymph nodes in both breasts and down sides of under arms.

The next morning, 09:00 am, I had mild flu symptoms which was full body aches and feeling feverish and unwell. I didn't register a fever on the thermometer. I was very tired; no appetite. I stayed resting all day. Slept a lot. It was easy for me to sleep - very unusual. By 9:00 pm that all lifted and I was feeling back to normal. The morning of March 28, I woke up with a very sore throat. And on 3/29, I had really continued sore throat on and off and Tuesday it got much worse. There was a really strange sensation of being extremely thirsty - I had never had experienced that before. Swollen gland on the right side of my throat - between the jaw and ear area. I had a little bit of an earache on the right side. I drove by the drive-in testing area. I am working in person each day so I get the drive by testing - I think Tuesday, the 30th. Called the dr and did the Telehealth visit - Wednesday - the 31st. I had in and out of laryngitis - raspy voice and headache. I looked in my throat with flashlight and could see a definitive red spot in back of throat and some white spots. They said it could be a blocked salivary gland and told me to eat something very sour to activate it. Over 6 to 8 hours it did clear the issue somewhat - thirst went away. I still had a sore throat. They told me that by the weekend, I could maybe start antibiotic. Saturday night I took first dose of Zpack - two tablets at first dose and then one tablet a day after that. By late evening Sunday (Easter) I felt some relief of symptoms. This week I still have a little bit of raspy voice and post nasal drip and clearing my throat at this point. I am recovering but not fully recovered.

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.

About 24-hours after getting the vaccination I started having pain and discomfort under my left arm. I got the vaccine in my left arm. Feels like a swollen lymph node. A little more than 48 hours after the vaccine I am now starting to feel a little bit of pain and discomfort in my right underarm area lymph nodes.

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.

The patient presented 3 weeks post injection with cardiac arrest from home. She had a 1 hour downtime. The day previous she had worsening leg swelling and SOB +DOE. Post arrest she was diagnosed with massive PE. She was treated for PE with thrombolytics and improved hemodynamically. She unfortunately at this time has anoxic brain injury.

4/12/21 12:30 pm began to feel fatigued, face felt flushed. No fever. Fatigue increased more in the evening. 4/13/21 2:30 am awoke and found entire face swollen and slight tingle in lips. Took Loratadine, Metoprolol and Triamterene/HCTZ and went back to bed. Awoke at 5 am, swelling better, but not gone. Still very puffy above and below eyes. Felt fatigue, no fever, went to work. Felt better by lunch time, swelling almost gone. 4/14/21 Slight sore throat, slight fatigue, no swelling.

Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.

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

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.

Not sure exactly when water retention began, but exactly 2 weeks after vaccine 03-27-2021 during middle of night, I woke to a bloody nose. Got it stopped. Next day felt a bit off but okay. At 9 pm 3-28-2021 had a huge bloody nose, just came out of nowhere. Looked inside was coming from not the nose walls but from way up inside sinus cavity? Tried to get it stopped, nothing worked, and 2 times it came out my mouth. Called our local Emergency room, went in. Blood pressure was at one time 220/110. They gave me 2 sprays of Affrin to reduce blood vessels, and tried to insert a nose plug (cotton gauze) to stop it, wouldn't fit, too small of nasal passage. Administered 2 pills, then drugs through IV then another pill form over 4 hours later blood pressure was still high some numbers while there were 204/94, 188/93 then when released and bleeding stopped 188/86. Next day 3-26-2021 immediately after taking my regular meds bleeding started again!!! So tried to get appointment with my doctor, they were full advised me to go /back to ER. Went about 1:00pm my BP was 181/73 Dr ran tests: EKG normal, Blood tests, good, and chest e-x-ray good. She also tried 2 diff types of meds, oral and iv, then I asked for losartan. and left.

patient came to clinic c/o right lower leg swelling on 4/6/2021, on 4/13/2021 she underwent a doppler us and was dx with right common femoral vein thrombus. her platelets are normal

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.

Patient states her joint pains were markedly worse the day after her vaccine dose, including new pain in the knees. Of note is that her rheumatoid arthritis has been worsening for the past 2 months since she stopped taking Xeljanz 3 months ago. (Her rheumatologist closed his practice and she was unable to establish with new one till 4/9/2021. Exam then showed now inflammatory changes in joints. Exam today by me also showed no inflammatory in joints, including knees. Labs ordered on 4/9 are just being drawn today.

April 12, 2021-Mild face swelling and light dizziness began about one hour after injection and lasted for about 2 hours. I took a Zyrtec-D the morning of the injection so I think that helped keep the swelling under control. April 15, 2021-around 6:00 pm I became very nauseous and dizzy. The nausea subsided by the next morning but the dizziness has continued to this day. Had to stay in bed all day April 17 and 18 due to dizziness.

FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; 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 fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.

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.

Acute Inflammatory Demyelinating Polyneuropathy/Guillain-Barre Syndrome, 6-day in-patient hospital admission, IVIG for 5 days, outcome undetermined as yet. Initial symptoms include severe low back pain for a week followed by bilateral leg weakness and ascending paralysis.

Developed a DVT in left calf on 5/10/21. Suffered a fractured metatarsal bone in left foot on 4/13/21 and a walking boot was prescribed. Foot healed excellently but developed a DVT .

ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. 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).

So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I also had cramping and pain in the back of my legs as well. I went to the DR and she put me on antibiotics, Cipro and something else I cannot remember. I went to the DR on Wednesday the 30th of June. The GI problems have been happening for about 2 weeks. I also saw my cardiologist on 4/8/2021 and he saw I was ok, the pulmonary DR also said my lungs looked fine on 4/26/2021.

2 Straight Days Headaches 7/20/21-7/21/21 I Don?t Get Headaches 7/22/21 cramps in stomach light blood through 7/23/21 heavy dark blood with light clotting. 7/25/21-7/26/21 large blood clots until 7/28/21. 0n 7/28/21 called Primary Physician for a Consultation it?s scheduled for Friday. I have enormous swelling in my Right leg in rear upper thigh. I have decided to go to Emergency Room. I have a slight headache and after Blood completely stop I am now seeing very light blood. I?m 61 I had stop having periods at 58!started back when I first took John & Johnson shot. I reported here before.

Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.

self-discovered sub-clavicular lymph node swelling in 1 node only-no pain. No issues with this and as a nurse I am reporting so this can be tracked as a side effect of this vaccine. Will be self-monitoring this.

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.

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.

Anaphylactic reaction 10 mins after shot - drop in blood pressure, swelling of lips and upper palate and throat. Treated with epi-pen. Symptoms subsided with some residuals for about 90 minutes.

Day 1: Received vaccine @ 2pm and about 15 minutes later lymph nodes in neck started to swell with right greater than left swelling. Notified nurse and told to wait another 15 minutes and contact if difficulty breathing. Took 25 mg benadryl orally, Symptoms remained the same. At 2:30 left vaccine site. At 2:35 took another Benadryl due to tightness in throat. No change in breathing, Swelling in Lymph nodes increased. No change in breathing. Went to bed for a few hours. Upon waking felt achy all over. Day 2: The next day about 20 hours after the receiving the vaccine felt chilled, increased body aches, feverish, temp 102.4. Treating with Tylenol and Benadryl, warm showers to try and decrease chills and fluids. Day 3 increased body aches and now mild headache, temp continues 100.2 treating with Tylenol, additional fluids.

Really bad headache, nausea, dizziness, fever, achy all over, arm swollen even in arm pit and really sore,diarrhea

After the shot i had slight swelling in my neck glands, not too bothersome. Severe insomia up from 10 pm to 5 am , really bad headache, pain pressure in my ears, { Couldl feel my heart beating in my ears } Took acetamiphen and cold compress to the head and eyes, seemed to help. Awake at 10 with no further symtoms so far.

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.

Swollen lymph nodes in groin (1 day)and underarms and under jaw (2 days), headache(2 days), loss of appetite (2 days), muscle aches(1 day), feeling very tired(1.5 days) Treated with acetaminophen and rest. Symptoms mostly resolved by end of 2nd day

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.

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.

Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J, March 20). Onset of sx approximately 15 days from J&J COVID vaccine. Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins. Tx: labs and imaging - see below.

The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021

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

On the day of the vaccination and for the next 3 days I felt tired, fatigued and on Saturday the 10th I noticed my gland under my jaw on that evening that it was swollen. Then on the 15th or 16th I noticed that the roof of my mouth was hurting, was sore. So I asked my husband to check it for me because I could not see it very well and he said there was a sore on the roof of my mouth. Yesterday I asked him to check again and he said it was even worse. I am going to see a doctor today, appointment today at 12:30PM. I also saw another Dr. also at the same clinic on 04/14/2021.

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.

RIGHT GLAND BESIDE THROAT WAS SORE AND TENDER TO TOUCH BUT TOLERABLE; SLIGHT AND INTERMITTENT HEADACHE; FELT LIKE WHOLE MUSCLE EXPANDED AFTER THE INJECTION; 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 rheumatoid arthritis, and sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced felt like whole muscle expanded after the injection. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced right gland beside throat was sore and tender to touch but tolerable. On 22-MAR-2021, the subject experienced slight and intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like whole muscle expanded after the injection, and right gland beside throat was sore and tender to touch but tolerable on 24-MAR-2021, and had not recovered from slight and intermittent headache. 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.

Guillain Barre Syndrome. Leg weakness one week following vaccine. Hospitalized. Treated with IVIG. Improved with leg weakness only sequela.

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.

Severe case of pink eye, in left eye, and a swollen lymph node in front of left ear. Started mildly on 04/15 and became much worse by 04/16. Both lids were swollen, itchy, discharge and RED. Started to get better by 04/23 and was almost gone by 04/25. Called the doctors office on 04/17 and they subscribed antibiotic eyedrops that I used for 7 days.

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.

Sun I woke in middle of night with pain in thumb. There was nothing there. When I got up few hours later my thumb on left hand had enormous blood blister. Which immediately grew, was infected, and whole hand swelled up. Wednesday night I had same pain under right eye. Again nothing was there. Few hours later my eye was all swollen. I have another Dr appt tomorrow with Dr. I had the emergency room take care of my thumb. That Dr, Dr , a few days later sent me to Dr.

Starting 3/21/2021 Pain, right knee, thumb swelled, terrible joint pain, muscle pain, tendon pains in legs and arms, knee is still swollen. Severe fatigue. In physical therapy

Swelling of the right foot and leg. Went to ER and they performed a doppler ultrasound and found a blood clot in the lower right leg. Prescribed blood thinner. So far, the swelling has gone down

It started with body aches, headache and sore arm at injection site. Left side -left leg started getting swollen - it started in middle on knee part - the swelling went down my leg to my ankle and up my leg; up my thigh . It was like there was fluid in my leg. There was no pain. It went like that for 1 1/2-2 months. Just had to let it run it's course. I was being treated for it and had tests run to test for blood clot. She prescribed 800 ibuprofen for it; that didn't work. That same day of the vaccine, I also broke out with a fever - 102. And fever blisters all over my mouth. I had those for about a week.

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.

Starting on or about June 16th - slight swelling noticed in left ankle, and left calf. Swelling continued in left ankle and left calf even after ice and elevating foot. June 21st scheduled doctor appointment with orthopedic thinking perhaps leg or ankle injury.

Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot pain, put I thought it was extremely painful. On my drive home it kept hurting. Finally on 04/17/2021, I was concerned because that was the time the media was mentioning blood clots from the vaccine. Because my arm, my shoulder hurt, and under my arm still continued to hurt I went into the ER. The doctor did not feel any abnormality in my arm. Till this day I still feel soreness in your arm and shoulder and under my arm. I can't extend my arm or use my arm. I use it cautiously, if I use it. I have had 3 or 4 visits with my doctor and she put me on methylpred 4 mg/ triage pack. It helped somewhat with the pain, but I still had soreness. So she prescribed Methocarban 500 mg. I just took it for 3 days. and it upset my stomach and gave me diarrhea . Now I have an MRI that is scheduled, but I don't know when at this point. I have to see if my insurance will cover it. I'm still pursuing to see why my soreness is persisting.

Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaws started aching, then they felt like they were swelling, along with my cheeks going down my neck, then I got a great deal of pressure, swelling, in my ear drums. I was speaking with a friend, who is a nurse, and she told me to take a Benedryl, so I ate a 12.5 milligrams children's chewable diphenhydramine. Twenty minutes later I felt normal again. Later that evening I noticed the palms of my hands were very hot. I did not have any fever. That passed the next evening.

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.

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.

March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflammation/chills/fatigue/pressure in ears/pain in teeth (upper back molars), swollen glands - just plain "ill" Week of March 8 - See above, the same March 9 - Appointment at Primary Care Clinic due to March 5th symptoms and a 1-day bout of diarrhea Diagnosis ?cold, sinus issues? - try Mucinex/Tylenol / Covid Test = Negative Mid-March: fever blister appears for a few days and ringing in my ears (noise) increases. Fever blister lasts about 4 days. Week of March 15 - Same Symptoms as March 5 plus another 1-day bout of diarrhea Sunday, March 21 - stomach cramps / diarrhea - chills/overwhelming fatigue - same sinus issues as March 5 Week of March 22nd - equilibrium is off and starts to become an issue - 3 nights of vertigo but not severe during that week. Last vertigo attack was in 2018. March 28th - sinus situation the same, diarrhea again, start Pepto Bismol regime based on past microscopic colitis issues Mucus is thin and clear, just started to discharge. March 31st - Schedule another appt at Primary Care Clinic due to ?status quo? - this doctor thinks inflammation and prescribes prednisone (2) 20 mg for 5 days - Covid Test / Strep Test / Influenza Tests = Negative March 31 - April 4 / Prednisone: Visibly more stuffed up. Tooth/nerve pain increased from a 3 to a 7; didn't take the final days dose. After stopping my head felt numb. Vertigo stopped; equilibrium still off. Increased tinnitus and increased pressure/burning under my eyes and around my cheekbones. April 5 - 6 - New symptom appeared approximately a week ago; tightness in throat, difficulty swallowing. Still experiencing tooth nerve pain (sinus cavities). Woke up soaked the last 2 nights. Noticed increased difficulty concentrating "brain fog".

DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; 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 concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. 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 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. 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

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.

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.

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.

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.

Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days. Finally feel somewhat normal on 9th day although tongue still heavily coated with white.

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

SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; 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 borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.

Had Janssen vaccine on 4/9 and within a day developed subjective fevers and dyspnea which progressed until admitted to Hospital on 4/11 and promptly intubated for respiratory distress. Found to be in sepsis and ARDS with multiple negative COVID tests including an extensive respiratory viral panel, we have failed to culture any bacteria from multiple sputum cultures, Legionella antigen and HIV negative. Have been treating as ARDS 2/2 atypical pneumonia, possible aspiration (although no aspiration event reported) with hospital course complicated by VAP. Concern remains for possible reaction to Janssen vaccine. Still admitted to ICU at Hospital.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

FEELING OF A LIGHTENING BOLT(ZAP) THROUGH BODY; CHILLS; LOW FEVER; HEADACHE; SWOLLEN GLANDS; 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Computerized tomogram head (NR: not provided) Normal. On 09-APR-2021, the subject experienced swollen glands. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low fever. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feeling of a lightening bolt (zap) through body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, low fever, swollen glands, and feeling of a lightening bolt(zap) through body. This report was non-serious.

63yr old female called into call center, stated she received J&J vaccine Friday 4/16 (external site; not with county), and today noticed swelling on her left calf, and 4/10pain above her left knee. Pt denied emergency symptoms at the time of call. Stated sunday night she felt her throat ""a little tight."" Drank water and felt better. Denied swelling of face, lip and throat at time of call. Pt denied SOB, pain/tenderness on calf, petechiae, new/easy bruising, abdominal cramping, backache or headache. Pt stated only other symptom she felt was on Friday 4/16 evening, a slight headache after the vaccine. did not experience any other symptoms. Pt Advised to call 911 or arrange for immediate transport to the closest ED. Pt verbalized understanding and agreed.

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.

The first symptom was the swollen lymph nodes in neck - that lasted a day and a half. About a week ago, same thing - swollen lymph nodes in my neck (or throat area) - that lasted about a day and a half also. Two and 1/2 weeks later, when I developed the swelling and pain in my paratoid gland in my left jaw. Severe swelling - could barely open my mouth. So I saw DR, on the 19th of March. She prescribed a Z-pak antibiotic and the swelling took about a good week to two weeks and maybe a little longer for the swelling and everything to go away. I was on antibiotic for seven days. Since then I have had no other problems.

I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors. I went to clinic on 03-26-2021 for evaluation. They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers. To this day, I am still having swelling and edema to both of my feet and ankles.

Severe leg swelling a couple of days after the Janssen vaccine. Can not walk very well now and does not drive so no access to a doctor or clinic. The vaccine was administered at her house by the fire department.

5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Diagnosis: Bells Palsy

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.

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.

brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet

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.

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.

Swelling in left lower eye and cheek within minutes of the injection. Has not resolved itself as of this reporting.

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.

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.

SWELLING OF LYMPH GLAND UNDER LEFT ARM (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 concurrent conditions included no alcohol use, non smoker, and antibiotics, and other pre-existing medical conditions included the patient does not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered in Left Deltoid on 31-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 10:30, the subject experienced swelling of lymph gland under left arm (armpit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of lymph gland under left arm (armpit). This report was non-serious.

I had no pain, swelling or redness in or around vaccine site. In the evening, my right hand and fingers began to swell, The next morning my hand and fingers were throbbing and I could not make a fist. I have iced it multiple times and the swelling is coming down today 4.11.21.

Jansen COVID-19 Vaccine EUA. Weight gain of 8 pounds overnight (water retention), glucose levels over 300 for several hours, elevated blood pressure (160/111). Doctor prescribed water pills for weight gain. Patient continues to monitor glucose levels.

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.

Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbow to wrists. Went to Dr. on 3-19-21 . Told to return in 3 days if not better. They said pulse was ok so prob not a clot. I had pain for two weeks but did not return. At end of two weeks swelling gone . Still some residual pain in right arm, but not constant.

Beginning 3/18/21: Initial headache. Fever greater than 103 F. Severe myalgias. Profound fatigue and lassitude. Drenching night sweats. E.R. visit followed by 5 day in patient hospitalization. Discharged from hospital approximately 3/9/21. Symptoms not yet resolved. Patient has persistent fatigue and severe occipital headaches.

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.

POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.

Fever, Headache, Nauseous, Severe Pain All Over, Extreme Tiredness, Shortness Of Breath. Swelling Of Both Feet. Onset - 9 Days Out. Still Ongoing 12 Days Out.

Pt has had left upper arm swelling and pain since the vaccine 7 weeks ago. Pt is being sent for imaging of the arm. Results not available yet.

CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; 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 poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. 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 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. 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.

One hour after getting the vaccine,my face and neck swelled,but I had no breathing problems. Then 4 days after vaccine I experienced a strange buzzing feeling in my brain,and Tinitus ring in my ears,with sinus pressure. It lasted less than 10 minutes,and stopped. On the fifth day after vaccine,I noticed High Blood Pressure symptoms,and went to ER. On 8th day after vaccine,I I went to hospital for High Blood pressure again,and was put on medication!

LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; FEVER; 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 colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. 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

Subarachnoid hemorrhage on 4/20/21. She began complaining of strong pain that caused vomiting, swelling, and hospital visits from about 3 weeks ago. We thought it was her blood pressure but it was consistently normal. She described it as the worst pain she has ever felt.

Anaphylaxis in the form of swelling of the tongue after eating pineapple. Patient had never had an allergy to any food prior to this.

3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling. She did not present to the office until 5/11/2021. She was sent to the ER which showing extensive acute DVT and bilateral pulmonary embolism.

Janssen COVID-19 Vaccine EUA: patient presented to outside facility one day after vaccination reporting confusion, vomiting,and abdominal pain. Found to be hypotensive (blood pressure 70/40 mmHg) in DKA with electrolyte abnormalities and ventricular arrhythmias requiring shocks. Patient initiated on blood pressure support, airway protection, insulin, intravenous fluids, antimicrobials, electrolyte management and transferred to this facility for a higher level of care. Patient improved, DKA and shock resolved, electrolytes normalized, and was discharged five days later medically stable.

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.

5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E. During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE: patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.

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.

SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; 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 asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

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.

SWOLLEN LYMPH NODES IN THE BACK OF NECK; STIFF KNEES; JOINT PAIN/KNEE WAS SORE; This spontaneous report received from a patient via (other manufacturer- Abbvie ) 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, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate for drug used for unknown indication. On 2021, the subject experienced stiff knees. On 2021, the subject experienced joint pain/knee was sore. On 16-MAR-2021, the subject experienced swollen lymph nodes in the back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in the back of neck on 2021, was recovering from joint pain/knee was sore, and the outcome of stiff knees was not reported. This report was non-serious.

LEG SWELLING/SWELLING WENT UP LEG TO KNEE; ANKLE SWELLING; 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 penicillin allergy, and multiple hernias, and other pre-existing medical conditions included the patient had no appendix and gall bladder. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced leg swelling/swelling went up leg to knee. On 07-JUN-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg swelling/swelling went up leg to knee, and ankle swelling. This report was non-serious.

Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.

Almost immediately these symptoms appeared: Extremely achy joints, swollen index finger on right hand, feet and hands hurt, facial filler in right side of chin dissolved completely. Approximately two weeks after vaccine feet and lower legs have pins and needles feel with nerves tingling. This is a 24 hour a day problem and quite concerning. My joints pop and creak like they suddenly aged and have no lubrication. These are all NEW symptoms/issues. I?m concerned that this is a long term and/or permanent medical issue for me! I WOULD LIKE SOME ANSWERS!!!!!

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.

dizzy, nausea, loss of appetite, headache, diarrhea, unable to leave bed for 2.5 days, fever, chills, body aches, swollen gland on right side of neck

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.

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)

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.

Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.

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.

Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.

pt says one of her toes on her left foot went completely number. Within a couple of days she started swelling between her left big toe and the toe next to it. Her entire left foot started swelling and then her leg started swelling. She went via ambulance to ER. They did an US of her leg and found 2 blood clots in the back of calve. She was given a RX for blood thinner. She went to 3 pharmacies and could not find it so she went home. She went home and then her right foot swelling as well. She went back via ambulance to ER. She was given blood thinner injection, and IV and took blood work. Pt was admitted where she stayed for 5 days. She was released and prescribed Eliquis. She has to take 20 mg a day for first week and then 10mg a day the following week for 3 months. She still has constant pain and her left foot continues to swell. Pt will have to have another US in 3 months.

I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.

Right arm sharp pains began within 1 week of receipt of the vaccine. Pain present with laying on the arm. Right arm pain persisted with swelling presenting on 4-26-21.

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.

4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.

Patient presented to ED on 5/12 with complaints on gradually worsening left leg swelling and pain for 3 days, no with difficulty ambulating. Patient reports she received the J&J vaccine 5 weeks prior.

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.

Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.

MAIN COMPLAINTS ARE VISION IMPAIRMENT AND HIGH BLOOD PRESSURE SINCE VACCINATION. PATIENT STARTED EXPERIENCING DOUBLE-VISION THE EVENING OF VACCINATION. IT HAS NOT SUBSIDED AND CAUSES CLOSE UP VISION IMPAIRMENT. SHE HAS SINCE RECEIVED PRISM GLASSES TO HELP. SHE NOTES THAT HER BLOOD PRESSURE HAS BEEN ELEVATED AND HER FEET SWELL SINCE THE VACCINATION. CURRENT READINGS ~142/87 MMHG (NORMAL READING ~114/72 MMHG). HER PROVIDER, DR. (LAST SEEN 6/4/21), ADVISED PATIENT TO CHANGE DIET BEFORE BEGINNING MEDICATION REGIMEN.

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.

Patient had normal side effects of low grade fever, chills, headache, but then developed a swollen lymph node under her right arm. (Right Axillary Node) Patient is retired healthcare worker. She said upon palpitation the node feels "golf-ball" sized. She stated it does seem to be shrinking in size by this morning. We felt it may be an important symptom to document due to her Lupus diagnosis and lack of studies in patients with this disease.

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

High fever of 102.8. Headache, cramping in legs, swelling in face. Lasted from 11:00 PM on 03/15/2021 to about 3:30 PM 03/16/2021.

Pt felt swelling on the right side of her neck(has went down) felt soar head hurt when turning but also going away, a little on left side very slight, brain fog on Friday night still very slight, and fatigued (still occurring), headache on first night no longer occurring

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.

Flu symptoms, weak, nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pulse, heart palpitations, malaise, rigor, a horrible experience lasted 36 hours.

Day 2 post vaccination, swollen glands Day 3 post vaccination Chills, aches Day 4 post vaccination dizziness, vomiting, headache Day 5 post vaccination headache, dizziness, flu-like, sleepiness Day 6 post vaccination glands still swollen, headache, tiredness Day 7 post vaccination, glands still swollen but much improvement overall Day 8, continuing to improve

hit me about 7:30pm - very tired, pain in my joints and fever during the night. Slept for 13 hrs Sat night and 10 hrs Sun night. Right arm has some swelling

BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADACHE RADIATING TO SHOULDER AND NECK; TEMPERATURE 101.4 F; MUSCLE ACHES TO BILATERAL BUTTOCKS AND BILATERAL THIGHS; LEFT ARM PAIN ALL THE WAY TO THE BACK OF THE SHOULDER; VERY BAD HEADACHE; NOSE SWELLING; LIP SWELLING; LEFT EYE SWELLING; FEELS NASAL PASSAGE CLOSED; LEFT EYE NOT OPENING COMPLETELY; LEFT EYE TEARING; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 218 pounds, and height was 62 inches. The patient's past medical history included anaphylaxis (closed throat) to sulfa, and concurrent conditions included asthma, sulfa allergy, corn allergy, non-alcoholic, smoker, hypothyroidism, seasonal allergies, and allergy to pcn, and other pre-existing medical conditions included the patient have allergy to caines. the patient did not have any drug abuse/illicit drug use. The patient was previously treated with epinephrine for anaphylaxis (closed throat) to sulfa. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm pain all the way to the back of the shoulder. On 24-MAR-2021, the subject experienced very bad headache. On 24-MAR-2021, the subject experienced nose swelling. On 24-MAR-2021, the subject experienced lip swelling. On 24-MAR-2021, the subject experienced left eye swelling. On 24-MAR-2021, the subject experienced left eye not opening completely. On 24-MAR-2021, the subject experienced left eye tearing. On 24-MAR-2021, the subject experienced feels nasal passage closed. On 25-MAR-2021, the subject experienced both eyes were irritated. On 25-MAR-2021, the subject experienced both eyes were red. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced feeling very bad. On 25-MAR-2021, the subject experienced temperature 101.4 f. On 25-MAR-2021, the subject experienced muscle aches to bilateral buttocks and bilateral thighs. On 25-MAR-2021, the subject experienced fell against sink. On 25-MAR-2021, the subject experienced headache radiating to shoulder and neck. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, had not recovered from nose swelling, lip swelling, temperature 101.4 f, left arm pain all the way to the back of the shoulder, very bad headache, left eye swelling, both eyes were irritated, left eye tearing, muscle aches to bilateral buttocks and bilateral thighs, both eyes were red, and left eye not opening completely, and the outcome of feeling very bad, feels nasal passage closed, fell against sink and headache radiating to shoulder and neck was not reported. 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.

Patient developed bilateral facial weakness starting on 4/3/2021, progressed over the course of five days until she presented to the emergency department on 4/8/2021. Exam with bilateral CN VII palsy and lower extremity areflexia. MRI brain shows enhancement of bilateral CN VII and VIII. Suspect GBS, treating with IVIG.

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.

COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 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, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.

presented to ED 3/22/21 with leg swelling that worsened over past 2 days. Diagnosed with Venous stasis ulcers & Thrombocytopenia

Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and DVT noted on ultrasound same day, started on Eliquis to manage clot.

BODY ACHES; INSOMNIA; ENLARGED LYMPH NODE IN LEFT UNDERARM; TINGLING IN ARM; CHILLS; HEADACHE; FEVER; FATIGUE; MUSCLE SPASM; PAIN IN ARM; 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 pre existing arthritis. The patient experienced drug allergy when treated with hydrochlorothiazide/methyldopa, cefalexin, and diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced pain in arm. Laboratory data included: CAT scan (NR: not provided) Pre-existing arthritis, and X-ray (NR: not provided) Pre-existing arthritis. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced enlarged lymph node in left underarm. On 01-APR-2021, the subject experienced tingling in arm. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No problem in lymph node. Treatment medications (dates unspecified) included: paracetamol, and oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia on 13-APR-2021, chills, and headache, and fever on 06-APR-2021, was recovering from fatigue, had not recovered from body aches, and enlarged lymph node in left underarm, and the outcome of pain in arm, tingling in arm and muscle spasm was not reported. This report was non-serious.

severe fatigue, sore throat, low grade temp off and on post-72 hours, ear pain, lymph nodes swollen under left jaw area, chest tightness and pain upon inspiration for the past 3 days. Reeived Janssen on 4/3/2021. Have white pus pocket on left tonsil for approximately five days

SWELLING OF LEGS; VENOUS STASIS ULCERS; THROMBOCYTOPENIA; 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 pre-existing medical conditions included the patient has chronic conditions like Patient Medical History of Hyperlipidaemia, hypertension, type II diabetes, coronary artery disease with recent segment elevation myocardial infarction left anterior descending s/p Percutaneous coronary intervention, low ejection fraction 30% from 60% s/p single chamber 6/202. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 10:29 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced swelling of legs, venous stasis ulcers, and thrombocytopenia. The patient on unspecified date was shifted in emergency room and later she was hospitalized. Number of days in hospital the patient was admitted was unknown. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Moderate to severe pulmonary HTN, and Echocardiogram (NR: not provided) worsening EF- 15% from 30%m Moderate MR. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of legs, venous stasis ulcers, and thrombocytopenia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: A 66 year old female, unspecified ethnicity, was diagnosed with venous stasis ulcers and thrombocytopenia 16 days after receiving the covid-19 vaccine ad26.cov2.s. The patient went to the emergency room for the leg swelling (start date unknown) that was progressing over 2 days. Medical history includes hyperlipidemia, hypertension, and type II diabetes. Patient also has coronary artery disease with recent segment elevation myocardial infarction left anterior descending (STEMI LAD) s/p Percutaneous Coronary Intervention, low Ejection Fraction 30% (from 60%), s/p Single Chamber ICD. Concomitant medications not reported. Smoking history not provided. Echocardiogram revealed worsening EF - 15% from 30%, Moderate MR, Moderate to Severe Pulmonary Hypertension. Thrombocytopenia was reported without a reported platelet count. The patient was subsequently admitted to the hospital for unspecified number of days and was reported to have recovered from all events. Given the patient's extensive medical history, there is a plausible alternate explanation for swelling of legs and venous stasis ulcers, and there is limited information to make a meaningful assessment of the report of thrombocytopenia. Additional information is requested.

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.

Swelling in feet beginning several hours after vaccine was admin. Continued thru ought that day 4/30/21 until completely subsided this morning (5/2/21) upon awakening.

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 .

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.

Okay so it started on the June 23rd 2021, I remember vividly because it was the day before I was supposed to take my sister out for her birthday and I could not. I first experienced a sore throat and aches throughout my body. Then on the 24th of June I continued developing the aches and checking my temperature, it got worse throughout the day. I canceled my plans on the 24th of June, the illness invaded me quite quickly. On the 25th of June I had the fever, was coughing up phlegm and was just not feeling well. I took my own cough syrup and such for the day and then it still continued, a lot of chills and headaches and even my neck was swelling a lot, my temperature got to about 101. I got a bit concerned because my neck was very swollen and under my neck I could feel my glands were very inflamed so I made an appointment to see my primary DR on June 30th 2021. He examined me and he said it seemed as though I had a cold, he put me on antibiotics, levofloxacin, and told me to rest and hydrate. He told me to alert him if anything got worse. I got better, but the neck inflammation and headaches are still present. I just wonder about the continued swelling and headaches so that keeps me concerned. I have a virtual appointment with my DR soon.

Pt remained in pharmacy 30 minutes after vaccination and then left. Returned within 5 minutes with left facial (upper/lower lip) swelling. Treated with ice pack and 25 mg of oral diphenhydramine (12.5 mg/5 mL oral solution). Swelling began to go down. Provided patient with famotidine 10 mg tablet to take home and take prn. Stated never had any tingling or trouble breathing. Advised to call us with any changes.

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

1 hour after vaccine, developed facial swelling. went to ER. Given Benadryl 50 mg. Next day better. Continued to take Benadryl and zyrtec for 3 days, controlled. 2 days after stopping, began to have facial swelling around the eyes. No oral swelling, shortness of breath, or hives.

Patient had onset on facial swelling while driving home s/p Johnson and Johnson vaccine after waiting in office for over an hour. No lip or tongue swelling or shortness of breath. Had zyrtec with her and took 10mg. Did not use epi-pen. Drove herself to ER, was given 50mg benadryl with improvement and was monitored. Continued on 50mg benadryl at night and 10mg zyrtec daily and doing better.

Acute bilateral lower extremity DVT found on venous duplex after reporting new bilateral leg swelling 7-8 days after receiving Janssen COVID-19 vaccine. No prior history of DVT. Brain MRA pending at time of report w/ concurrent history of new/moderate/persistent headache.

67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left hemiparesis and dysarthria in the setting of having received the Johnson and Johnson vaccine on Wednesday(48hours prior). Patient was found to have a right parietal multifocal parenchymal hemorrhage measuring 19x36x37mm and small right temporal lobe SAH. Subsequent CTA showed thrombosis of the superior sagittal sinus and the right frontoparietal cortical veins as well has nonocclusive thrombus of right transverse and sigmoid sinus. The patient was also noted to have focal seizure of mouth and tongue and was loaded with phosphenytoin. After discussing case with neurology, nuero IR, NSGY and family it was decided to transfer the patient to sunrise for close monitoring and consideration of cerebral venous sinus thrombectomy if she worsens. I had a long discussion with multiple sisters about the risks of anticoagulation with argatroban given the IPH but the necessity given the cerebral venous thrombosis. I also discussed that argatroban is not readily reversible and that heparin is contraindicated if there is concern about vaccine induced thrombotic thrombocytopenia due to possible PF4 ab related to HIT. The patients VITT modified 4T score is 4 and she is intermediate risk for this being VITT. #Right parietal IPH, right temporal SAH and Superior saggital sinus thrombosis with nonocclusive thrombus of right transverse and sigmoid sinus -concern for vaccine induced thrombotic thrombocytopenia given johnson and johnson vaccine 2 days prior -modified VITT 4T score of 4- intermediate -send fibrinogen, d dimer, consider IVIG 1gm/kg per day for two days if high dimer, low fibrinogen and falling platelets -will start argatroban, avoid heparin until HIT ab (PF4) is resulted, if HIT positive avoid heparin -neuro IR consulted for possible IR intervention if worsens -transfer accepted by sunrise ICU, appreciate transfer for IR evaluation -continue phosphenytoin -SBP goal <150 with nicardipine and esmolol gtts -monitor daily fibrinogen, dimer, coags #AKI- monitoring uop and cr, consider renal US if worsens #DM- ISS #HTN- nicardipine and esmolol gtts for SBP <150, target 140 Patient seen, examined, labs and imaging reviewed, agree with resident note

triggered considerable swelling from my lymph edema in both legs, ankles, and feet -- enough swelling that I couldn't even get my pants on, so it was much more than any other bout of swelling from the disease ... it's only just now starting to subside, and I believe that was helped along by the steroid shots I got in both knees and my left shoulder this past week. I have been told that this is something that could happen with all three versions of the vaccine, and while it put a great deal of weight on me for a while, I'm not in pain or suffering in any way from it. Just wanted you to know about it! I am currently in recovery.

RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; 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 pre-existing medical conditions included patient did not seek medical attention. 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-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. This report was non-serious.

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.

Severe pain in the arm muscle, followed by 3 days of headache, fever and intense pain in the arm, shoulder and right hand with pain and swollen knuckles and fingers, up to the right lung. Immobility from pain, I took TYLENOL, the discomfort was passing but the pain in my arm remained. I put hot water every day and applied the arnica cream after bathing to reduce the pain that intensified at the end of June along with the shoulder. I went to the doctor, she prescribed ibuprofen 800. To withstand the pain and regain mobility. She order Physical Therapy I had 10 sessions with physical Therapy. It has improved but I still have pain in my arm although I still have not finished with the sessions.

I?m a neonatal nurse practitioner, I have a high pain threshold . I had Covid in January 2021 I am a healthcare worker and did not seek medical treatment. This was not a normal reaction to a vaccine. Extreme headache Fever of 101° normal for me is 95.7- 97° Extreme joint pain, left hip still inflamed Sever chills, almost spasmodic, teeth chattering. Rigors Extreme Weakness Numb fingers and thumb on left hand Lymph node popped the size of a Cherry tomato

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.

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

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).

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.

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

Noted to develop ecchymotic area with swelling to R upper thigh with no adverse events noted or reported. X-rays completed 4/13, CBC, CMP, PTT, PT INR completed 4/14. No abnormal results. Daily ASA on hold, eliquis 2.5mg bid started, frequent monitoring in place. Repeat labs 4/16 and 4/19.

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.

SWOLLEN RIGHT PINKY FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.

(1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my Primary Care doctor, he examined my leg and immediately sent me to hospital ER because he was concerned that it might be a blood clot. They performed an ultrasound, but the results were negative and showed no signs of any blood clots. (2) Approximately three weeks after vaccine, I developed stiffness on the left side of my body in my arm, thigh and hip area. The stiffness was intense, uncomfortable and bothersome enough for me to take Tylenol for the pain the next 5 days and it lasted for about a week.

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.

Severe headaches started March 12, 2021 and lasted for over a month and a half, every day. Affected eyesight of left eye, Swelling in both legs, ankles and feet fore a week. Now every once in a while the sharp headache reoccurs and lasts for a few minutes. Mainly up the back left side of my head, up to the top of the head. Swelling has not occurred again.

Vaccinated in March, began having some mild shortness of breath and fatigue around mid April which she attributed to allergies. Fatigue and shortness of breath continued to worsen and she began having some lower extremity edema. She saw her family physician at the time, Dr., who did an EKG in the office which was normal, and recommended that she follow up with Cardiology. In May the shortness of breath and fatigue worsened and she began having pain between her shoulder blades. She saw the Dr. He did a cardiolyte stress test which was reported as negative, and an echo which showed a mild pericardial effusion and they recommended a

(1) Swelling behind left knee- approximately 1 month after vaccine (2) Pain inside left thigh and leg area - recurring since taking vaccine, nothing done, just noted (3) Wake up with stiffness in left side of neck approximately 2 times per week- recurring approximately 1 month after taking vaccine (4) Developed a dry cough - present and recurring everyday, approximately 1 month after vaccine (5) Severe insomnia noted after taking vaccine - developed approximately 2 months following vaccine (5) Severe lack of energy and body tiredness

The patient had her vaccine on 6/10 and then on 6/11 began to experience tingling throughout her legs and feet. She also complained of swelling in the feet in the mornings and shuffling gait. She also noticed joint pain and cramping in the legs. She still has these symptoms at this time.

Patient states she received J&J COVID19 vaccine today at clinic site at 10:30am. States she noticed facial swelling starting at 11:30am. Patient went out to lunch and returned home and called COVID19 hotline to report symptoms. States when the swelling was at it's worst, it was difficult to see facial structure of cheek bones which she can usually see. States symptoms are improving facial swelling has 'mostly resolved' with mild swelling around eyes persisting. No OTC medications taken. Denies vomiting/itching/nausea/rash/SOB. Talking comfortably on the phone. Denies need to clear throat.

Nausea for 24 hours, threw up overnight. Headache for 24 hours. Some swollen glands. Excessive aching around hips.

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...

Five hours after the covid vaccine shot, chills so bad my whole body was shaking, was running a temp , headache, aches all over.. these went away by the next morning but I continued to be very tired. Day three I was still very tired and developed a cold sore on the left corner of my mouth and sores in my mouth. Also had a left swollen gland near jaw line. I just layed low and rested. by March 23 the cold sore and sores in my mouth went away..

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.

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

Took Covid shot March 6 (J&J). Since then has felt fatigued and achy. No fever but has had joint pains. Feels SOB with walking. Feels it is worse since the shot. Having pain in the back of the neck, and her hands and knees are swollen (but not red or hot). Feels this is worse than it was before. Taking furosemide but swelling not going away. Taking spironolactone and potassium. Takes furosemide 4 days a week. No N, V, but has had diarrhea since taking vaccine. She says her husband has had very similar symptoms.

SWOLLEN LYMPH NODES (LYMPH NODES BLEW UP LIKE GRAPEFRUITS ); UNABLE TO PUT ARMS DOWN; PAIN UNDER HER ARMS ( PAIN UNDER HER ARMPITS); This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pain under her arms (pain under her armpits). On 31-MAR-2021, the subject experienced swollen lymph nodes (lymph nodes blew up like grapefruits ). On 31-MAR-2021, the subject experienced unable to put arms down. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph nodes (lymph nodes blew up like grapefruits), unable to put arms down, and pain under her arms (pain under her armpits). This report was non-serious. Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.

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.

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.

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.

patient vaccinated at another location. approx 7 days post vaccination was admitted to the hospital for increasing shortness of breath and leg pain and swelling.

ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; 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 temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest 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.

According to hospitalization discharge summary paperwork, patient presented to Hospital with bilateral leg swelling and calf pain shortly after receiving the Johnson and Johnson Covid-19 vaccine.

First adverse reaction was a headache behind right ear. This was a throbbing pain. Had low energy and a feeling of unwell. On 5/10/2021 had bad headache behind right ear. On 5/12/2021 I began swelling on the right side of my face with numbness on my right side lip area. On 5/13/2021 my face was fully distorted. On 5/13/2021 my neurologist diagnosed me with Bell's Palsy (G51.0). Neurologist ordered me on Prednisone 20mg three times per day for one week and initiate Physical Therapy. Ordered a blood test for Lyme disease.

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.

BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

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.

J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my right leg only. I thought it would go down and my leg and foot started swelling up and my foot got really cold. I went to the hospital on 4/11 and they said it was a DVT and they checked my lungs and said I had small blood clots in my lungs as well. They put me on Eliquis to keep my blood thinned out.

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

Patient presented to the ER on 4/10 with complaints of SOB. She has been SOB for a few days prior to admission. She is on 4L of oxygen at home. In the ED, WBC was 36.9, lactate 2.4. Admitted for acute on chronic respiratory failure with hypoxia. Possible trigger of COPD exacerbation could be COVID vaccine. patient also positive for 3/4 SIRS criteria on admission. She did test positive for COVID in February but did not require hospitalization. On 4/11, CTA showed tiny LLL PE. Eliquis began. Possible adverse event r/t clotting disorders after JJ vaccine?

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.

ON WEDNESDAY 14TH THE GANGLION BEHIND MY LEFT EAR SWELLD AT 8:30 AM IN THE AFTERNOON IT WENT DOWN. ON SATURDAY 17TH AGAIN AT BREAKFAST GOT INFLAMMED AND UNTIL NOW CONTINUES INFLAMMED.

FEET AND ANKLE SWELLING; DIZZY; 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 chemotherapy treatment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. Concomitant medications included potassium for swelling. On 08-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced feet and ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 09-APR-2021, and had not recovered from feet and ankle swelling. This report was non-serious.

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.

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

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.

Patient reports a burning pain in her right leg from the hip to the knee area; not pinpoint pain, more radiating; initial swelling but reports no longer swollen. Patient following up with primary care provider to see if this is related to history of back issues and radiating pain or something else.

The pt said she developed a blood clot on her posterior hand. I asked her if it was a bruise on the back of her hand and she said it was a blood clot. She said she slapped the bumb/clot and it subsequently went down/away.

Submandibular lymphadenopathy, severe bilateral temporomandibular joint pain started 4/19/2021. Patient went to urgent care and received cephalexin without improvement. Patient saw me 4/27/2021 and we are trying pain control with naproxen and hydrocodone?acetaminophen as needed for pain. Labs below were drawn.

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.

Extreme Swollen lymph nodes under both armpits; today, I still have swollen lymph nodes and very sensitive breasts/nipples. I just went to my OBGYN yesterday, and there are no lumps, but she confirmed swollen lymph nodes after 2 months. I will be getting a bi-lateral ultrasound on Friday.

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

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

My primary doctor did know what cause my vein going to my middle finger, left hand to roll to the left and there is swelling. She suggested I see a surgeon.

After vaccine I noticed I was having a horrible time sleeping, then I started having joint inflammation 10 days later. I was I excruciating down my legs, I had big knots on my as well. Days 12-14 the pain kept me up because it was bad. By day 15 I had extreme pain, water retention and I had to take something for pain. On 4/4 I had nausea and last Wednesday I was nauseated and started running a temperature and felt like the flu and chills. I went to get a covid test because of the way I was feeling and it came back negative.

Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine patient displayed no noticeable signs of deteriorating health. Over the next two days, friends of the patient attempted to contact her with no success. Finally after several hours of no contact, the grandchildren of the patients friend went to her apartment and found the patient lying on the couch unresponsive. When the patient was found, her leg was swollen. She was cold and not breathing. She passed away after receiving the Johnson and Johnson vaccine.

Patient with questions /concerns-said she had to get vaccine because of recent dx/tx for breast cancer. She said received vaccine on 3/13- then on 3/16 she was seen for one of her breast cancer therapy sessions- they have been treating her for lymphedema - she said she has been going for breast cancer in July- no chemo just radiation- surgery of breast with removal of seven surrounding lymph nodes. She was advised to wear a compression bra- on 3/16 and ever since then her left side of neck has been sore- thought it was likely related to compression bra not fitting correctly b/c too tight & was professionally fitted on her- the straps seem very tight over the collar bone area that was damaged/irritated by the radiation she received on that side up through Oct 2020 for cancer. Now when she saw story today in news she got concerned could the neck soreness really be from a blood clot? She as been going the week for tightness in neck to physical therapy which started yesterday for lymphedema. Again her radiation ended Oct 2020 but she has had persistent swelling in breast & fluid in lymph nodes on the left side. She still has pain in on collar bone- on same side of radiation- blisters, sore, red. As well as this new compression bra having two tight straps on each side. Her COVID vaccine shot in right arm but left side where breast surgery was She went on 3/16 for consultation on breast lymphadema - that was when told her to wear tighter bra for compression on 3/16. She is going today to be fitted for new one that is not so tight. She is approx. 4 weeks post vaccination & post when started wearing that tighter bone- maybe three inches from where had radiation injury is located.

TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). 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 09-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 itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.

Thyroid swelling Difficulty breathing--one week post vaccination Sore throat abdominal pain Swelling of face Constipation All started one week after vaccination

No events immediately following injection. Six days later I started to experience an allergic reaction for some unknown reason with red welts over body, swelling. and itching. On the 7th day, my tongue and throat started swelling and I went to Urgent Care. I was treated with prednisone and epinephrine on 4/18/21 and released. Prescription given for 5 days of prednisone. No further symptoms after 4/18/21. Physician recommended I file a report with VAERS.

Extreme fatigue, dizzy, foggy brain, disoriented, nausea, congestion, joints aching, extreme neck and shoulder pain on the left side . Feels like the Cortizone shot that I normally get for my joints stopped working once I got the J&J shot Shoulder doctor said the shoulder pain was caused from the shot being given to high in my arm

On drive home anaphylactic reaction (trouble swallowing, swollen tongue), went to Emergency Room, treated with benadryl. Returned to ER a week later with new symptoms, severe headache, nausea, tightness in chest, trouble breathing .

BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone 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: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real weak and watery mouth. Just didn't feel right, feverish, real thirsty almost like the flu and my body would ache, like going up and down the hill. For a while I was really totally upset and said I shouldn't have gotten the shot. All I wanted to do was lay down and I got so weak. I don't think I would take another shot again if they come out with a booster.

The medication that was injected stung me. My arm just kept stinging, I kept ice packs on it all day. After 3 hours I started feeling very tired which lasted for days. The next day my left gland in my neck was swollen, arm was hot. I felt like I was getting a sinus headache. The gland kept swelling on and off for about a week. The tiredness lasted for about three weeks. Developed a rash on my chest and lower back area. The doctor gave me a cream to use on the rash.

GOT UP LIMPING A LITTLE BIT SORE TO THE TOUCH; RIGHT HIP BOTHERING/ SORENESS; LEFT LEG SWELLING,PARTICULARLY AROUND AND ABOVE THE ANKLE BY 4 INCHES; 3-4 EPISODES OF DIARRHEA PER DAY/ LOOSE STOOL THAT HAS BEEN BOTH LIQUID AND SEMI FORMED/ STOOLS ARE NORMAL COLOR; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included leg injury, and darker skin discoloration, and concurrent conditions included asthma allergies, kiwi allergy, and reflux, 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: 2028A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included bismuth subsalicylate. On 27-MAY-2021, the subject experienced 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color. On 29-MAY-2021, the subject experienced left leg swelling, particularly around and above the ankle by 4 inches. On 30-MAY-2021, the subject experienced got up limping a little bit sore to the touch. On 30-MAY-2021, the subject experienced right hip bothering/ soreness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg swelling,particularly around and above the ankle by 4 inches, right hip bothering/ soreness, and 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color, and the outcome of got up limping a little bit sore to the touch was not reported. This report was non-serious.

Immediate swelling and bruising at injection site, size of golf ball, 09:55 Benadryl administered (50mg/ml) IM to L deltoid, 1010 ice pack placed, no report of itching or swelling at any other site. Swelling is reducing at 1030.

Received vaccine at approximately 1040. Patient then went to the self monitoring area where approximately 5 minutes later stated she felt "slight puffiness in lower lip and tingling on tongue". Patent was removed from the self monitoring area and brought to our First Aid room. Vitals remained stable BP 138/70 HR 80 and respiratory rate 16. After 5 minutes within the First Aid area patient stated " the tingling and puffiness of lower lip is extending to the back of my tongue and throat". EMS was called and patient was transported to SVMC ED.

Approximately 2 weeks after vaccination developed a red, itchy rash on left side of neck with mild swelling.

GIANT HIVES/HIVES STARTED; SEVERE CHILLS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 127 (pound), and height was 147.32 centimeters. The patient's concurrent conditions included sulpha allergy, latex allergy, heart disease, blood pressure, non-alcohol use, non-smoker, and cervical headaches, and other pre-existing medical conditions included the patient had no history of drug abuse. The patient was not pregnant at the time of vaccination. The patient did not have acute illness 30 days prior to vaccination and did not have history of any disease or allergy to vaccine or food. The patient did not have significant family history of diseases or hospitalizations. The patient was not breast feeding. The patient experienced drug allergy when treated with iodine. 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,1 total administered on 12-MAR-2021 10:00 to right arm for prophylactic vaccination. Concomitant medications included butalbital/caffeine/codeine phosphate/paracetamol for cervical headaches. On 12-MAR-2021, the patient experienced severe chills, muscle aches, nausea, fatigue, headache and itching. On 16-MAR-2021, the patient hives started and on 18-MAR-2021, the patient experienced dizzy spells. She also had upper body hives several hours later and had severe itching and shortness of breath. On 19-MAR-2021, the patient visited the ER. On 20-MAR-2021, the patient had rash all over the body, had giant hives and also experienced swelling and difficulty swallowing. The patient was hospitalized on 21-MAR-2021. Unspecified lab tests were performed for the patient. The patient received unspecified prescriptions to treat the skin eruptions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from giant hives/hives started, and the outcome of severe chills, headache, muscle aches, fatigue and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 06-APR-2021. The following information was updated and incorporated in to the case narrative: reporter details (physicians details added), patient demographic details (DOB, age, age group, height, weight, pregnancy information, date of admission and age at the time of vaccination), concurrent condition added (heart disease, blood pressure, sulpha allergy, latex allergy, abstains from alcohol, non-smoker, and cervical headaches), events added (severe chills, muscle aches, nausea, fatigue, headache, giant hives), no. of days hospitalized added for all the events (no information), other AE characteristics added (events giant hives/hives started), hospital address added for all the events, products added (Iodine and Fioricet with codeine), seriousness criteria added for all event (Hospitalization Caused / Prolonged). Upon review following information was amended (removed the event normal side effect and severe skin eruptions).; Sender's Comments: V1: This version is created to update regarding patient's demographic details, concurrent conditions, events added - severe chills, muscle aches, nausea, fatigue, headache, giant hives, dizzy spells and difficulty swallowing), other AE characteristics added (events giant hives/hives started and dizzy spells), products added, seriousness criteria added for event giant hives and difficulty swallowing (Hospitalization Caused / Prolonged) 20210351080-COVID-19 VACCINE AD26.COV2.S-giant hives. Follow-up received regarding Clinical 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). 20210351080-COVID-19 VACCINE AD26.COV2.S-severe chills, muscle ache, nausea, fatigue, headache. Follow-up received regarding Clinical Details. This event(s) is labeled and is therefore considered potentially related.

ITCHY RASH; SWELLING ON FACE; SWELLING ON LEGS; BURNING ON FACE ARM AND LEGS; SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash. On 13-MAR-2021, the subject experienced swelling on face. On 13-MAR-2021, the subject experienced swelling on legs. On 13-MAR-2021, the subject experienced burning on face arm and legs. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on face arm and legs, and sore arm, and had not recovered from itchy rash, swelling on face, and swelling on legs. This report was non-serious.

PAIN NEAR THE EAR AND UNDER THE CHIN; CANNOT SLEEP; FEELS SWOLLEN; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 72 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, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain near the ear and under the chin. On 25-MAR-2021, the subject experienced cannot sleep. On 25-MAR-2021, the subject experienced feels swollen. On 25-MAR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder, cannot sleep, pain near the ear and under the chin, and feels swollen. This report was non-serious.

BILATERAL SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced bilateral swelling in hands and feet. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bilateral swelling in hands and feet. This report was non-serious.

DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. 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 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.

I have had Rheumatoid for about 10 years and I am 73 yrs old. I have been on Methatrextrate and Enbrel 50 mg once a week for about 8 yrs. I was I guess what the doctors call in remission until I had a Johnson and Johnson Covid vaccine on April 2, 2021. Guess I should start with the side effects from the vaccine...2 days after receiving it I was very fatigued for 2 days then on day 7 my collar bone started to hurt, thinking I had slept wrong I just ignored it. On day 8 my lymph nodes under the arm that I had the shot started to feel swollen. After checking I did not feel any lumps but if it was still there the next day I was going to call my doctor. My niece and 2 of her friends were discussing it and all three had the same reaction (all had Modena) I started reading more on line regarding this and saw that it was just a side effect. Well 10 days after shot my hands and knees started to hurt by one month the pain was terrible. After going to both my primary doctor on May 24th and my RA doctor a week later and having had all the blood work done. My RA doctor stated all my bloodwork was fine and she believes that the Covid vaccine was causing the Enbrel not to preform like it should. All I could find in was one regarding a man with RA taking Enbrel and after having a Covid vaccine having the same issue. My doctor told me to try the Enbrel for another 2 weeks and if not better she no found one lady that takes infusions for her Rheumatoid and had flare ups also after her Covid Vaccination. There is also a man in his 50?s that went there the same thing. He was on Enbrel and had to end up with steroid shots. would try me on Humira. Well I read that didn't work either on the man I mention below. I am hesitant to change from Enbrel to Humira as I have had great success with Enbrel. Also I have Can you shed some light on why this is happening and have you had anyone else report this?

Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.

Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids

PATIENT REPORTED SWOLLEN FACE (JAWS) STARTING ON 04/09/2021. TREATED WITH BENADRYL AND SWELLING WAS GONE AFTER A 2 OR 3 DAYS. PATIENT REPORTED AFIB LASTING A 2 OR 3 DAYS STARTING ON 04/09/2021. PATIENT REPORTED ROUND RAISED RED CIRCLE ON SKIN OF RIGHT LEG WITH WHITE CRUST IN MIDDLE. START DATE NOT GIVEN. STILL PRESENT AS OF 04/17/2021.

4/8 vaccination 4/13 swelling both extremities. No pain, rash, nor fever. 5/4 Physical. Blood panel, Kidney function, and echocardiogram; neg. Unsure what is causing the swelling at this point. *Upcoming appt with endocrinologist at end of June for goiter. *unsure of Lot #; hard to read handwriting

The vaccine made my arthritis in my knees, and hips worst after two weeks. My Doctor order an EKG done because of the swelling in my feet related to my heart and kidneys. My hips and knees continued to ache whenever I stand up (still an issue).

LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.

IRRITATED JOINT; INFLAMED JOINT; ARTIFICIAL HIP INFLAMMATION ON LEFT SIDE; ARTIFICIAL HIPS AND KNEES PAIN ON LEFT SIDE; HEADACHE; CHEST PRESSURE; GRASPING PAIN AROUND NECK; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 210 pounds, and height was 158 centimeters. The patient's past medical history included gripping in neck/choked, and covid-19, and concurrent conditions included diabetes, high blood pressure, arthritis, migraine, sciatica, antibiotic allergy, msg allergy, compazine allergy, and avalide allergy and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 15:00 to Left Deltoid for prophylactic vaccination. Concomitant medications included meloxicam for arthritis, pitavastatin calcium for cholesterol, fluoxetine for clinical depression, metformin for diabetes, amlodipine besilate/hydrochlorothiazide/olmesartan medoxomil for high blood pressure, levothyroxine for thyroid, curcuma longa rhizome, magnesium, ubidecarenone, and vitamin d. On 16-MAR-2021, the subject experienced chest pressure. On 16-MAR-2021, the subject experienced grasping pain around neck. On 16-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced irritated joint. On 17-MAR-2021, the subject experienced inflamed joint. On 17-MAR-2021, the subject experienced artifical knee inflammation on left side. On 17-MAR-2021, the subject experienced artificial hip inflammation on left side. On 17-MAR-2021, the subject experienced artificial hips and knees pain on left side. On 17-MAR-2021, the subject experienced joint pain and sore joint. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and headache on 16-MAR-2021, and grasping pain around neck on 18-MAR-2021, and was recovering from joint pain and sore joint, irritated joint, inflamed joint, artifical knee inflammation on left side, artificial hip inflammation on left side, and artificial hips & knees pain on left side. This report was non-serious. Additional information was received from patient on 29-MAR-201. The following information was updated and incorporated into the case narrative: The patient's weight was 210 pounds, and height was 158 centimeters. The patient's past medical history included gripping in neck/choked, and covid-19, and concurrent conditions included diabetes, high blood pressure, arthritis, migraine, sciatica, antibiotic allergy, msg allergy, compazine allergy, and avalide allergy. Vaccination time to 15:00. Concomitant medications included meloxicam for arthritis, pitavastatin calcium for cholesterol, fluoxetine for clinical depression, metformin for diabetes, amlodipine besilate/hydrochlorothiazide/olmesartan medoxomil for high blood pressure, levothyroxine for thyroid, curcuma longa rhizome, magnesium, ubidecarenone, and vitamin d. Outcome of the events joint pain and sore joint, irritated joint, inflamed joint, artifical knee inflammation on left side, artificial hip inflammation on left side and artificial hips and knees pain on left side updated to recovering/resolving from Not recovered.

Instructed patient to wait 30 minutes due to previous history of allergic reaction of penicillin. Patient waited 30 min period with no apparent symptoms. Pt was asked if she was ok, pt stated she was. Patient was then instructed she could leave. Pt then returned in approximately 15 minutes and stated that when she removed her mask she noticed that her nose and around here eyes were red and possibly swollen. She removed her mask for immunizer and it was noticed that her cheeks nose and lips did appear to be red and possibly swollen. She stated that her nose felt tingly and her mouth and lips felt tight, but did not complain of a swollen tongue. Immunizer administered 50mg of liquid diphenhydramine . Pt also given one dose of Famotidine 40mg. Took blood pressure and found it to be elevated to around 200/90 with pulse rate of 65 bpm. Instructed the patient that we would need to call medics to come check her out. She begged immunizer not to call due to the anxiety it would cause her husband who has , possibly, some issues understanding. Pt was monitored for approximately with epipen on standby for approximately two hours by pharmacist immunizer. Patient began to feel better redness and and puffiness subsided patient went home. Pt returned on 4/7/21 with normal blood pressure and no issues. Pt state BP was high due to fear of going to hospital.

On Saturday, 04/10/2021 patient reported that she had a swollen leg that first appear with 24 hours of the vaccination which later disappear but reappear again on that day. The ankle area was a little swollen and red, Patient applied benadryl and took tylenol over the weekend, on seeing the patient on Monday 04/12/2021, the swelling and the redness has gone. We told patient to inform us and also refer patient to Doctor if the swelling come back again.

Patient woke up at 3am not feeling good and confused. Became increasingly confused and uncomfortable. Not very responsive to caregivers. Called an ambulance at 7:30am. ER ran tests that showed Sepsis with n o underlying infection. Patient had to be intubated. Admitted to ICU in hospital. Spent 3 days there and 4 days in regular room at hospital. Then transferred to a rehabilitation clinic where she is currently.

Mom started feeling ill on Tuesday, April13 with extreme fatigue and a headache. Then on Wednesday, April 14 she experienced: Headache Dizziness Swelling: Left side of face Swelling: Neck Swelling: Knees and legs (unusual swelling) Chest pain Right arm pain shooting up shoulder left arm pain back pain (unusual/more intense) We went to the ER and they treated her with: pain relief 4 aspirin IV Benadryl

04/19/21 TELEPHONE CALL: I was asked to call this patient who has been experiencing a rash and swelling since 4/9. She received the J&J vaccine 4/8. Rash described as very itchy, starting on extremities, especially wrists, hands, arms, legs, back. Not anterior trunk, not head or neck but head was itchy. She had swelling where the rash was/is, no asymmetric swelling. Much of it has resolved - she states it is "much better" now. Now the rash is mostly just on her hands and wrists, with a little swelling. Her joints do not bother her. No headache, fever, pain other than usual achiness from her medical conditions that include myasthenia gravis and DM. No flare or change in symptoms or state of her chronic illnesses. She has been taking benadryl at night, 12.5 - 25 mg, since 4/11, and using hydrocortisone cream on the rash. She has had a new puppy since 4/13. She gardens and works in her yard. She is active in walking, gardening, weeding, and her activity has not decreased since this began. Although she could have been exposed to weeds or plants in her yard that she might react to, she is covered when she goes out, long pants, shirt, boots etc. She has not used any new soaps, detergents, etc; cannot think of any new exposures. I offered medical evaluation here, but she is comfortable monitoring it at home since it is getting better. I advised her to come in for evaluation if rash or swelling became worse, asymmetric, or if new symptoms begin.

WHITE BLOOD CELL COUNT INCREASE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stage iii myelofibrosis, and penicillin allergy.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 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced white blood cell count increase. Laboratory data included: WBC (NR: not provided) 109.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count increase was not reported. This report was non-serious.

The day after the vaccination i had aches and chills, lasted about 24 hours and then went away completely. About a week after the vaccination i started to get pains in my joints and bones, especially the left elbow. I also had a swollen underarm gland in the left armpit. Now over a month later the swelling has gone away but I still feel achy at times. Recently, I have been experiencing a fatigue and real tiredness that prevents me from being as active as I had been. Not sure it is from the vaccine or my diuretic or my blood pressure medication, but I have been on those about one year with no problem. I am wondering if it is the vaccine. I never had joint pains prior to the vaccine.

SWELLING ON BOTH LEGS; RASH ON INTERIOR LOWER LEGS ALL OVER THE BOTTOM PART; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer, renal failure, non alcohol user, non smoker, fish allergy, and sulpha allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, Laboratory data included: Renal function test (NR: not provided) Abnormal. On 06-MAY-2021, the subject experienced swelling on both legs. On 06-MAY-2021, the subject experienced rash on interior lower legs all over the bottom part. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on interior lower legs all over the bottom part, and swelling on both legs. This report was non-serious.

Experienced pain within minutes in right kidney area and the right and left sides of her head. She then had a low blood sugar attack. For the following 3 days, she suffered from chills and many low blood sugar attacks. Also upset stomach and diarrhea for a few days, as well as headache and body aches. April 12th, left side of face was puffy and more headaches; continued into April 13th; also some sinus pressure/overall stuffiness June 4th- Vertigo attack; had another back in May Continues to have chills, body aches, and headaches, and tired with low energy

Patient reported some dizziness within 30 minutes of receiving the vaccine which went away prior to leaving the clinic, she experienced mild feeling of swelling in the cheeks, nose, and jaw after leaving the clinic

RED FACE; SWOLLEN FACE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 102 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 22-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced red face. On 22-MAR-2021, the subject experienced swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, and swollen face on 22-MAR-2021. This report was non-serious.

3 days after vaccination, patient had edema in legs, excessive bruising (9 spots) in legs, knots in forearms (5 total, one 9cm in diameter and one smaller), one knot initiated in wrist and moved upward on forearm; patient consulted with cardiologist who referred her to ER on April 28, 2021. Patient has not experienced shortness of breath or difficulty breathing.

I had vaccine on Friday noon and Monday morning woke up with a cold sore on/under my lip. I haven't had one in 25 years so I googled it and the CDC website said it could cause this for people suffering from autoimmune diseases such as I have, Sjogren's Syndrome.

Severe left knee pain at onset 10 days after J+J vaccine; better since onset; affecting daily activities. associated signs and symptoms: edema; warmth; stiffness; limitation of movement; weakness; instability; limp; fatigue.

SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism. On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen 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.