Johnson & Johnson

8 hours later bad chills then fever of 101. It was over within 12 hours Three days later had a strange like feeling of flittering near heart area...has happened 3 times since Blood pressure has increased at least 20 points or more since vaccine Swelling in fingers and toes

Pain, reddness, swelling in right leg, below the knee, when I got up in the morning. Symptoms continued over the weekend. Called Dr. on Monday, April 5, 2021 and got an appointment for the following day. Dr. diagnosed it as phlibitis and sent me for an ultr sound. Prescribed Xarelto 15 mg twice a day for 21 days, then decrease to 20 mg daily.

Right leg swelling below knee , feels like needles around right ankle, call heart doctor had a scan of both legs found no blood clots have tried using a extra water pill to bring down swelling but it comes back the next day.

Pain at left side of head, neck and ear with tender lymph nodes and "throat feels funny", few days later "legs feel funny" with numbness sensation

The patient is a 76 y.o. female who presents to the Emergency Department with three days of left ankle pain and swelling status post mechanical GLF. Patient reports that she fell onto her left side three days ago. She is not anticoagulated and denies striking her head or any LOC. Since then she has had constant dull left ankle pain which is acutely worsened with ROM and weight bearing. Patient reports a history of fracture to this ankle. Patient notes that she is able to shuffle when wearing her compression stocking, but this elicits pain. She has pain radiating up her LLE, into her buttocks, and up her back "all the way to my neck." Patient has not taken any pain medications symptomatically. Patient reports feeling chills last night.

patients left neck , jaw, is exremely swollen and hurts to swallow. Recommended for patient to go to urgent care and I followed up with her primary care doctor within a hour of her reporting.

Pt received Janssen vaccine on 4/5/21 and did complain of arm soreness on 4/6/21. Arm assessed small bruising noted. Pt working with therapy on 4/8/21- she was complaining of pain, nsg assessed arm and found the RUE was blue in color and hard to touch. NP made aware, ordered warm compresses as needed to arm. MD assessed pt on 4/9/21 for a poss. UTI- IV Rocephin ordered and adm. Pt had an allergic reaction to IV Rocephin, pt sent to ER for eval and treatment. Pt was adm on 4/9/21 and returned to health on 4/15/21. When pt arrived her entire rt arm/hand is black in blue in color. Per patient and daughter- the bruising continued to get worse day by day after she had received the vaccine

Kidney transplant on 4/11. Immediately after surgery severe R groin pain. Within 7 days, leg continued to swell, pain continued, and clots (DVT?s) were found via ultrasound in the R groin, R calf, L calf. Readmitted to the hospital where anticoagulant therapy found unsuccessful. Clots continued to grow. Pt was put on heparin. Pt has no history of blood clotting disorders.

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

SWELLING OF BOTH EYELIDS- UPPER AND CORNER; SWELLING OF LEFT SIDE OF FACE; HEADACHE BEHIND EYES; DIZZINESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included dust allergy, allergy to cats, antibiotic allergy (hives), diverticulitis, alcohol intolerance, and drug intolerance. The patient was previously treated with calcium for hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802025, and batch number: 1802025 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of both eyelids- upper and corner. On 09-MAR-2021, the subject experienced swelling of left side of face. On 09-MAR-2021, the subject experienced headache behind eyes. On 09-MAR-2021, the subject experienced dizziness. Treatment medications included: achillea millefolium/aconitum napellus/arnica montana root/atropa belladonna/baptisia tinctoria/bellis perennis/calendula officinalis/echinacea spp./hamamelis virginiana/hypericum perforatum/matricaria recutita/ruta graveolens/symphytum officinale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-MAR-2021, was recovering from swelling of both eyelids- upper and corner, and headache behind eyes, and had not recovered from swelling of left side of face. This report was non-serious.

LEFT ARM SWOLLEN; PAIN AT LEFT ARM/ HURT ON MOVEMENT; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart attack, and concurrent conditions included breast cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced left arm swollen. On 23-MAR-2021, the subject experienced pain at left arm/ hurt on movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at left arm/ hurt on movement, and left arm swollen. This report was non-serious.

INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious

78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery.

TEMPORAL ARTERITIS; CHILLS; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced temporal arteritis. On 13-MAR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporal arteritis, swollen lymph nodes, and chills on 2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

PAINFUL FACIAL SWELLING ON LEFT SIDE OF FACE; DIFFICULT TO OPEN MOUTH; SWELLING IS UNDERNEATH THE EAR LOBE, ON THE NECK AND JAWBONE; This spontaneous report received from a patient concerned a 78-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and phenobarbital and ciprofloxacin allergy. 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 28-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced painful facial swelling on left side of face. On 28-APR-2021, the subject experienced difficult to open mouth. On 28-APR-2021, the subject experienced swelling is underneath the ear lobe, on the neck and jawbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful facial swelling on left side of face, difficult to open mouth, and swelling is underneath the ear lobe, on the neck and jawbone. This report was non-serious.

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

At 8:05 am on 05/12/2021 temperature of 102.8 was noted and Tylenol was given. The nurse did not did not document any other symptoms and stated that the patient denied any pain and felt fine. CBC, CMP, Flu swab, chest x-ray and UA with culture were obtained. The resident had a low grade temperature of 99.9 at 2:04 pm on 05/12/2021 and no other symptoms were documented. On 05/13/2021 at 12:15 pm, Nurse noted that resident wasn't 'acting like herself'. Nurse obtained a rectal temperature of 99.6 from resident and the resident had a blood pressure of 159/80, pulse of 66, respiration of 18, and an O2 sat of 95% on room air. Nurse noted that the resident was trying to speak but could not get

INFLAMMATION OF THE BALL OF RIGHT FOOT; BRUISING OF THE RIGHT FOOT AND TOE; TINGLING IN THE BALL OF FOOT; SWOLLEN BALL OF FOOT; THE BALL OF FOOT WAS DISCOLORED/ DISCOLORATION (DEEP RED AND PURPLE) HAD SPREAD TO THE WHOLE BOTTOM OF FOOT AND BIG TOE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included fractured vertebra, and concurrent conditions included no alcohol use, non-smoker, mast cell activation syndrome, seasonal allergies, and drug allergy, and other pre-existing medical conditions included the patient had seasonal and atypical (gastric and dermatologic) sensitivities to medications. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced inflammation of the ball of right foot. On 25-MAY-2021, the subject experienced bruising of the right foot and toe. On 25-MAY-2021, the subject experienced tingling in the ball of foot. On 25-MAY-2021, the subject experienced swollen ball of foot. On 25-MAY-2021, the subject experienced the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation of the ball of right foot, had not recovered from bruising of the right foot and toe, and the outcome of tingling in the ball of foot, swollen ball of foot and the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe was not reported. This report was non-serious.

bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting

Patient was in store and top of chest started hurting and down left arm. Patient states that they called 911 and ambulance took her to the hospital. She was tested and found to have mild heart attack with blood clot in vein of her heart. Had procedure to remove clot was put on blood thinner and is now wearing a heart monitor for the next 30 days. Is on Brelinta for the next 30 days as well. Patient went back to ER on Tuesday night (4/13/21) due to SOB spent 12 hours at ER before being transferred back to hospital. She spent another day and half before discharge diagnosed with fluid buildup.

SWELLING IN CALF; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, joint pain, macrobid iv dye allergy, and bowel impacting. 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 oxybutynin for bowel impacting. On 30-MAR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced swelling in calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, and had not recovered from swelling in calf, and nausea. This report was non-serious.

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

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

Pt received vaccine on 4/8/2021. Pt was diagnosed with COVID-19 on 5/17/2021. Pt was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19.

While waiting the 15 minutes after shot was given, noticed a tingling sensation that traveled from my left arm, across my left shoulder to the back of my neck. It subsided about 15 minutes later. April 22 - Started mild symptoms of stiff and sore neck; ache in lymph nodes below left ear; pimple at the hairline at the nape of my neck. Discomfort moved to different areas near my left ear. May 5 - Discomfort moved up above my left ear- all other symptoms remained. Became a full blown headache above my ear to my temple. Headache was a sharp, stabbing painwhich moved around on left side. At one point, I timed it at every 16 seconds. May 7- Went to emergency room. Had a full workup. All tests

ANGIOEDEMA; This spontaneous report received from a pharmacist concerned an 81 year old female 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 administration was not reported, batch number: unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021 (1 hour after vaccination), the patient developed angioedema and was hospitalized. She did not experience respiratory distress. The patient was discharged on 31-MAR-2021. The number of days of hospitalization was 6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from angioedema on 31-MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210408678-covid-19 vaccine ad26.cov2.s - Angioedema. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.

CLIENT HURT HER ANKLE COMING OUT OF HER BED ON 4/10/21 AND DEVELOPED A BIG BRUISE, SWELLING, AND COOL TO TOUCH THAT DIDN'T HEAL AND REQUIRED A UREGENT CARE VISIT ON 4/21/21. SYMPTOMS HAVE STAYED THE SAME , NOT PROGRESSIVELY GETTING WORSE. CLIENT WENT TO SEE HER PRIMARY AND HE SAID IT WAS 'ANGRY' AND NEEDED A VISIT TO URGENT CARE FOR AN ULTRASOUND TO RULE OUT A BLOOD CLOT.

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

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

81 year old female admitted to healthcare facility for deep vein thrombosis and pulmonary emboli. Hospitalized x 14 days; treated by healthcare provider. Patient sought care after Chiropractor noted her right leg was swollen and he told her she should investigate this problem. Patient was then seen by healthcare provider who sent her for diagnostic testing - Doppler of lower extremities, and CT scan of Lungs. Pt was referred to a pulmonary specialist; Pt was hospitalized and treated with Heparin and Coumadin, and Oxygen.

Since receiving immunization over 2 weeks ago, the patient has been experiencing on and off soreness and swelling in arm. Patient has been directed to contact doctor for treatment.

Resident received J & J vaccine on 4/10/2021, on 4/13/21 noted to have mild pain and edmea to left lower extremity. 4/14/21 MD ordered doppler which showed DVT to left popliteal and left posterior tibial veins, orders for anti-coagulant given. 4/15/21 resident stating mild pain, no other adverse effects noted.

Patient after taking a nap and applying ice to swollen cheek. Also c/o red swollen tongue and swelling of Rt cheek last night at 2 am. The tongue is no longer swollen but it is still red and her cheek swelling has decreased. She also has a hoarse voice. No Benadryl in the house. Patient urged to go to ED immediately to be evaluated.

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

patient reports development of peroneal vein thrombosis about 1-2 weeks after J&J vaccine. patient was on a flight at this time. she saw her PCP for swollen legs are was diagnosed with superficial thrombophlebitis. patient started asprin 325mg BID. after an ultrasound was done, it was revealed that the patient had right peroneal vein thrombosis as well as superficial thrombophlebitis of the medial right thigh. she was started on Xarelto 10mg daily. since taking Xarelto "tender lumpy spot on right upper thigh has gotten much better". patient has been referred to hematology to follow up.

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

LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.

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

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

Pt reports fever; BLE edema; H/A - on & off with dizziness; Abdominal cramping; looses stools w/ offensive odor; fatigue started on 4/6/21

86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8. Patient's last known well was at 10 AM on 4/8. GCS on arrival 15. NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria). In the EMS blood glucose was 122, no meds were given. Patient is not on any anticoagulation. Patient's blood pressure was elevated at 233/78. Patient denying any headaches, nausea, vomiting. Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit. Neurology contacted in the ED for stroke code. Patient outside of TPA window. CT head was negative. CT head negative for acute intracranial infarction. Chest x-ray negative for any acute cardiopulmonary findings. Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off. CBC showed mild leukocytosis (14.8) likely reactive. CMP unremarkable. PT/INR was also obtained. After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke. After discussion with family and the physicians the patient refused admission. Upon reexamination no further worsening of her initial symptoms, blood pressure controlled. Patient was discharged in a stable condition. She was discharged AMA. Patient was thoroughly explained the risks and benefits of leaving AMA. Patient said she understood and was advised to come back if the symptoms worsen. Patient was discharged with aspirin, Plavix and atorvastatin. Recommended to follow-up with the PCP tomorrow soon as possible. Also advised to return to the ED if any of the symptoms return.

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

Patient complains of lymph node enlargement in her breasts, armpits, and neck. She also claims both arms and legs are swollen.

4/12 3pm patient went to get up from recliner, body was very stiff and had severe muscle spasms and cramps from back, stomach, pelvis, thighs and legs down to feet. Legs swollen (enlarged veins) patient said. Patient slumped over and went down to floor. crawled to bathroom and applied Hemp Vana every few hours until some relief. 4/13 moring took 2 tylenol -muscles from hips down burning, stinging and sore. Called doctors. 4/14 patient continued applying Hemp Vana but then switch to Arnicare pain relief. Patient mentioned diarrhea and nausea with headache(she did not mention before) seemed little better(on and off) 4/16 up at 8am diarrhea and throwing up -muscles very sore -spent day exhausted and resting 4/17 patient used warm wet towels and arnicare. 4/18 diarrhea and nausea stopped 4/19 muscles beginning to relax. leg and thigh swelling going down 4/20 Saw dermatologist for other issue. He lower back and thighs and recommended patient to see ultrasound vascular surgeon for pelvic ingestion syndrome and recommended doctor.

BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.

Patient presented to the ED 5/18/21 with voice slurring, headache, leg swelling. Patient with symptoms starting on Friday 5/14/21. Patient with profound weakness of her lower extremities, unable to ambulate around the house which is new. Patient also reporting she feels "different/wrong." While here in the Emergency department, patient fell onto her rear while at ultrasound, did not hit her head. Unable to stand on her own after. Patient was found to have an acute left lower extremity DVT on 5/17/21: Acute deep venous thrombosis throughout the left lower extremity with most proximal extension of thrombus into the common femoral vein noting that the external iliac vein could not be visualized