Moderna

Woke up that night feeling achy and run down. Had a low grade fever, headache, nausea for most of the next day after the injection. Two days later developed swelling and lymphadenopathy on same side for several days treated with NSAID's to help with inflammatory response. It is better now but some minor swelling still present but mostly resolved.

Myalgia 1) Arm stiffness, 2) Muscle soreness 3) Localized swelling 4) Small warm spot at injection site Narrative:

Headache, Myalgia, Fever, Rash, NauseaVomiting, joint pain, chills, and swollen glands, increased hip pain in replaced joint Narrative: Employee had COVID in March of 2020. 24 hours after receiving the vaccination states he got tested for antibodies due to not feeling well and that he was still IGG positive. on 1/6 his temp was 102.7, rash, headache, myalgia, nausea, joint pain, chills, and swollen glands. He had a hip replacement in September of 2020 and now has increased pain in that joint.

01/9/2021 sweats/fever like I had Covid 19 again. on01/10/2021 sore and swollen under right armpit and swollen neck.

Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.

60 yo with pruritic rash and mild lip and facial swelling the day after getting first dose of Moderna vaccine and lasting for 7 days, no throat pain, difficult swallowing or breathing; similar rash after either flu or shingles vaccine; pt nad Throat clear, no stridor, trismus, swelling or drooling, lungs clear, cvrrr, abd sof,t nt both arms with diffuse macular paular , blanching areas; Imp probable allergic reaction

Rash on inner wrists, upper thighs and scrotum along with 100 degree fever awoke me around 3:00am Feb 6. At 7:06 am I noticed left side facial swelling and slightly obstructed throat. Swelling worsened only slightly from 7am to 9am. At 9am I took 100mg Benadryl and withing 45 minutes swelling was subsiding and breathing was normal. Arrived at ER at around 11:am. Was treated with EPINEPHrine, methylPREDNISolone and saline IV. Released after a few hours

Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.

The arm where the shot was administered, underneath the armpit area was swollen (Lymph Nodes) also had body aches, slight fever.

Fever (102.7), headache, soreness of arm, lymphnode swelling (axilary), tea colored urine (prior to rehydration), cotton mouth. Tx: ACTM PRN over 3 days for fever, Increased fluids

60 y/o male presents to UC and reports itching rash on scrotum and swelling of both hands after he had the COVID vaccine two days ago. Patient denies chest pain, SOB, fever, chills, difficulties swallowing, testicular pain or other complaints or issues at this time.

Fever and diaphoresis 2/12/21, followed by neck pain starting 2/13/21. Hospital admission with sepsis with right-sided cervical lymphadenitis without abscess 2/17/21. Treated with Unasyn.

muscle/body ache, bad headache, pain, redness, and swelling at injection site approximately the size of a grapefruit, nauseated, neck swelling.

approximately 24 hrs after shot in left arm, IM, Left armpit swelling, assume lymph nodes. Slightly painful. Pain went from a 4 out of 10 to a 2 in 24 hrs, to 0 after 48 hours. Armpit is still swollen now. Visually obvious but no pain.

Injection site: tenderness and swelling of the lymph nodes in the same arms as the injection. General side effects: fatigue, muscle pain, fever (100.2)

Swelling on right side of face occurred 24-48 hours after injection. Feelings of anxiety of unknown origins 24 hours after injection. Soreness at the injection site.

Received vaccine on Thur 2/25/21 when woke up Friday AM lips felt swollen upper lower but not visibly noticeable. Saturday 2/27/21 when woke up noticed scattered red macular/papular rash on bilateral arms, chest, stomach and back -no itching rash even developed where a Freestyle Glucose patch had been days before and removed--rash followed in perfect circle of the patch and also around the outline of the bandaid from the shot but had also been removed and was not present when the rash started started taking Benadryl 25 mg q 4h during day and 50 mg at HS as of 3/4/21 rash fading some but still visible and beginning to itch Pictures available if needed

Patient had generalized weakness event, similar to MS exacerbation. It lasted approximately 24 hours, rapid recovery after overnight admission to the hospital.

Moderna COVID-19 Vaccine EUA About 5 or 6 hours after the vaccine was given I developed inflamed toes on both feet. Puffy and red. itchy and slight burning. Three days later still have the symptoms.

Day 1 within 4 hours intense burning in arm at site of shot lasting for 3 days. Day 2 to current time(day 6) swelling of hands and feet. Day 2 to current time (day 6) burning / itching / small red spots on face and behind ears that eventually dried up and peeled . Peaked at day 3. Still very irritated and raw but intense itching has subsided. Day 5 extreme fatigue and minor headache preventing me from working.

THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE. THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK. HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE. PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021. HE WAS DISCHARGED HOME IN STABLE CONDITION .

Injection was put in the fatty tissue and not in the actual muscle tissue - it may have been administered too low in my arm. Everything was fine for first five days - and I noticed where the shot mark was and I noticed a lighter ring around it and about 3 or 4 days later - ring around it that was four inches in size- it was warm to the touch; swollen. Inner part was bright red and about five inches out it was lighter - it looked like an infection. I sent a photo to my doctor and asked him and was put on antibiotic - about a week - just in case. It may have helped a little - after the antibiotics, I could still see it was there (although no swelling anymore).

Covid Arm swelled up about 3 inches on the 11 th day after first vaccine shot. Red and swelled around injection site. Very worried

08:20 am Received 2nd dose of Moderna. Hx of facial swelling to sulfa, so pt was to remain for observation for 30 minutes. At 08:45 am complained of feeling like her eyes were swelling. Pt's daughter was in the car with her and did not notice patient looking any different. No distress noted nor obvious swelling of face, eyes, lips, etc. O2 sat 98% pulse 72. Administered 25 mg benadryl chewable tablet and observed pt for another 30 minutes. At 9:30 am pt reported feeling better, no other problems noted. Pt was discharged to home and told to take benadryl q 6 hrs for the next day and seek emergency care if condition worsened. Call to pt on 03/26/21 revealed that pt had no further problems.

1. Fever ~101 for 48 hours, dropping to 99.5 next 24 hours 2. Very achy muscles for ~48 hours, slight to moderate achy next 24 hours. 3. Very fatigued 36 hours, gradual improvement for next 32 hours. 4. Painful skin on both arms and hands for ~36 hours. 5. Swollen lower right leg and ankle for 24 hours. 6. Water retention for 12 hours. Treated self with Tylenol initial 12 hours then Advil afterwards.

Elbow area started hurting then Shoulder and triceps area. Then it spread to lower arm. March 31 a rash started on lower arm and noticed swelling of arm and wrist. Rash continued until drying and started going away April 3. Arm is still sore, painful and swollen. Have taken Aleve for pain.

The night after my first vaccine, I awoke at about 3:45AM with extreme aches and pains all over my body for about 4 hours, then I was okay. Twelve days later, I tried to go for a short walk with my wife and the pain in my left leg was horrible at times. The calf muscle was swollen and pink and very warm to the touch. Also my toes were kind of purple and my ankles were badly swollen. I thought the toes and ankles might be related to my Bradycardia, but the calf muscle sent us to the ER to be checked for a blood clot. They did check the major arteries, as those are the dangerous ones, but did not check the calf as they said if one was there it wouldn't throw to the lungs or heart. I was discharged. The swelling went down in the calf. Still some aches in the back of both legs now when I walk very far - but really not bad. Having the purple toes and a possible blood clot... my daughter who is a nurse encouraged me to submit this information. Thank you.

I recieved the first Moderna Covid 19 Vaccine 1/08/2021 and there were no problems. The second Covid 19 Vaccine on 2/05/2021 went the same but after approximately two weeks I noticed soreness between my miidle and ring finger on my left hand along with soreness but thought nothing of it. the Pain eventually got worse. I went to my doctor on 3/25/2021 and was prescribed Naproxin and Voltaren Gel. The discomfort in my left had continues continues. There is selling above this area and the inside of my hand below those fingers hurts and my hand when I close it feels tight and this I atribute to the swelling. My doctor ran labs and all were negative even for Gout. There is a dense feeling in my left upper arm that comes and goes and some tingling. My left hand will have a burning feeling on the ring finger knuckle and experience pain when I fully open my hand. I have not injured my left hand in any way. I find it very unusual because I am right handed. I would appreciate any assistant if possible. I can send photographs if needed of my hand. Blood Work: URIC ACID 4.5 mg/dL 3.4 - 7.2 mg/dL General information Collected: 03/25/2021 11:39 AM from BLOOD Resulted: 03/25/2021 9:16 PM Result status: Final result

anaphylaxis requiring intubation, stable after extubation and discharged from hospital intubation required the morning after he got the vaccine at around 11am the previous day

Over the course of three days he had severe 10/10 pain at injection site. On the third day he developed a very large bruise that encompassed his entire upper arm distal to the injection site. Within a week the bruise moved down to his forearm and swelling began. He has never lost sensation or has had any tingling to the hand or extremity. To this day his health care professionals are saying to not let this prevent getting a second vaccine. He is a stubborn man and does not like hospitals. I am a critical care pediatric RN and I will not be taking him back for a second vaccine.

Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy. On 06-Apr-2021, the patient received first dose (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown. Treatment was not reported/ unknown. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Swelling of left side from clavicle extending up to jawline with lump that was movable. Redness and warmth at the site of swelling. Extreme fatigue and sweating spells. Redness and warmth have resolved but small lump and faint swelling remains.

Clinic visit 4/7/21: "60 y.o. year-old male who presents for left calf pain, swelling, and bruising that began on 03/27/2021. Patient states that 2 days prior to symptom onset he received the Moderna COVID-19 vaccine. He did have symptoms of fever 102 F for approximately 24 hours. After the resolution of his fever he notice swelling of the leg with tenderness any line of bruising going down the medial aspect of his leg. He noticed more prominence of varicose veins of the left leg and began using a compression stocking. His varicose veins seem to worsen with sitting as well as tenderness, and improves with walking. He notes a tenderness over the upper calf. He denies any history of DVT/PE. He notes that two brothers sustained blood clots, one he believes was in varicose veins which were ultimately stripped and the other he is not sure of the exact nature of the clots. He is unaware of any hereditary clotting disorder in his family. He denies any shortness of breath, difficulties breathing, or chest pains." He was sent home with aspirin 325mg daily. Hospital admission 4/11/21 " 60 year old male with no PMH comes in c/o LLE pain that originally started 2 weeks ago and intermittently getting worse. The pain started around the left calf and has moved its way up to his thigh/groin area. The pain is sharp, 7/10, worse when standing, slight improvement with aspirin. Pt denies tingling, numbness, CP, shob, N/V/D, blurry vision or weakness. Associated symptoms include erythematic rash around left inner thigh, tender to touch, and swelling of calf/thigh. He works with heavy machinery but is always sitting down 1-2 hours at a time. He does have family history of DVT/PE. He is not on any daily NSAIDs or other anticoagulation and denies smoking." he was started on a heparin drip then transitioned to Eliquis and discharged the next day.

Strong flu-like symptoms (chills, 100°F fever, muscle aches, swollen and achy glands including testicles, and headache) that lasted for ~24 hrs beginning 13 hrs after injection and ending about 37 hrs after injection.

3 Areas of site reactions on left arm and shoulder - warm, red rashes measuring 3 to 4" in diameter each swollen and painful lymph nodes in left side of neck

Patient claims 3 hours after receiving the vaccine his foot began to swell. It is now 24 hours after receiving the vaccine and he claims the foot has continued to swell.

After second dose 3/10/21 started having chills, myalgia. On 3/24/21 hospitalized with respiratory failure, kidney failure, heart attack, sepsis and liver malfunction. Had subsequent GI bleed

Patient called in and stated over the course of "a few days" both his arms and his neck swelled and later he developed sores all over both arms. It is now 3 weeks later and symptoms have resolved.

Started with hard to get up off of low seating area. weakness in chest muscles. legs,arms. severe pain in chest muscles,shoulders biceps, then radiating down in arms and hands.. trouble walking up stairs, raising arms above my head. getting dressed, washing my hair and general hygine issues. My hands started swelling very bad and continue. The amount of muscle weekness and pain i have i have never experienced in my lifetime. I have been to multiple doctors and have had many tests done. Prior to the Covid 19 vaccine i was a 60 yr old and now feel like a 90 yr old with many health problems.

Moderna COVID-19 Vaccine EUA: patient seen in emergency department two hours and seven days after vaccination for tachycardia and chest pain. First visit pulse 125 beats per minute, bloodp ressure 186/108 mmHg, rest of vitals within normal ranges. Patient administered intravenous fluids, Maalox + lidocaine, NSAID, and discharged to home stable when symptoms resolved and vitals improved. Second visit pulse 103 beat per minute, blood pressure 170/101 mmHg, rest of vitals within normal ranges. No medications administered and patient discharged to home stable when symptoms resolved and vitals improved with prescription for antihypertnsive medication.

Patient had anaphylaxis several minutes following injection. Received oxygen, benadryl and Epi. He was monitored following.

REDNESS SWELLING PAIN HARDNESS THEN BLISTERS; ER SAID TO TAKE BENADRYL 50 MG 3 TIMES DAILY CLIMDAMYCIN 150 MG 3 DAILY 10 DAYS. WENT BACK FOLLOW UP VA CHANGED TO 10 MG PREDNISONE 10 MG PROGRESSIVELY FOR 5 DAYS 5,4,3,2,1.

3" Hive at injection site. Swollen lymph node left arm pit and neck/throat which has still not resolved after 4 month's.

Right side Neck lymph node swelled shortly after vaccination now in process of ultrasound, ct. scan, biopsy performed and mass on right side of neck that they want to remove for further testing. This has all took place shortly after I received Moderna!

Slight swelling in my neck on the same site as the injection and one lump near the collar bone notice the day after the injection and a second lump noticed the next day in the same area. First lump is about 1/2 inch long by 1/4 inch wide. The second in about 1 inch long by about 1/2 inch wide. Swelling is still there and lumps have not changed.

Fever, Sweats, Chills, Nausea, severely swollen lymph nodes with soreness under left arm, neck, and shoulder blade. Swollen nodule at base of neck near left shoulder. Achiness in knees and elbow joints.

Several days after vaccine administration patient developed shortness of breath, orthopnea, tachycardia, leg swelling, cough. Seen by Cardiology outpatient, had Echo which showed EF 15%. Admitted to medical center. Patient diagnosed with myocarditis post vaccine administration by ID.

Extreme swelling and pain in left hand, saw doctor 4/26/21. Was thought to be gout and was given Prednisone for 10 days. Swelling/ pain minimized. Had scheduled chemotherapy on 5/6 and 5/7. Swelling/pain returned. Saw doctor on 5/13 and both primary and oncologist via video conference determined it could be cellulitis. Was given Doxycycline and was to follow up with doctor on 5/17 but I had an emergency visit with nurse practitioner on 5/15 with swelling from fingers to middle of my left arm. Was sent to hospital, then transferred to secondary hospital to see hand specialist, in case surgery was needed. It was not. Until my release on 5/19, I was on round-the-clock antibiotics and given pain meds as needed. Currently still do not have full use of my left hand. Chemo scheduled for 6/3 and 6/4. Oncologist will make determination whether to move forward or postpone.

He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.

chills, fatigue, throbbing headache, nausea, fever,no appetite, rapid heart beat, rt lymph node swollen,

ON 04/29/2021 HEAVY INDEGESTION, CHEST PAINS ACROSS FULL CHEST, CHILLS, FEVER 98-100 DEGREE RANGE SPENT 36 HRS IN HOSPITAL DID CARDIAC STRESS TEST AND LUNG IMAGING, DISCOVERED SWELLING IN NOGILES REALEASED ON THE 31st.

Within one hour developed golf ball size lump on side of face that continued to grow slowly. After second dose the next day lump grew to the size of a baseball and extended from mid-cheek to below jaw and ear. Work up is concerning for a vac stimulated, rapidly progressive malignancy

Fully vaccinated patient admitted to hospital with diagnosis of COVID per PCR. Patient admitted to the hospital on 06/21/21 for left sided upped abdominal pain. Diagnosed with pancreatitis. During admission testing patient has a detected PCR test for COVID. Patient remained asymptomatic for COVID throughout his stay. Discharged on 06/23/2021.

Stiffness in both hands and sharp Pain in the right hand !!! Index & middle finger swollen !!! Pain is still going on for 3 months till today so far continues !!!

This may just be coincidental, but developed polymyalgia rheumatica within one month after the second dose. Diagnosed with PMR on June 12, 2021. ESR 40 mm/hr, CRP 87.3 mg/L. Severe pain in hips and shoulders in the morning. Very difficult to get out of bed. Some stiffness in hands. Some stiffness in legs. Pain fades in late morning. Had been doing very high level of work/exercise during 3 months previous. Also got Shingles vaccine in January 2021. Currently on Prednisone 25mg/day. Pain reduced from level 7-8 to 2-3.

"swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown. the swelling and hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.

2:00 the afternoon of the day of the vaccine Pt started feeling bad and did not sleep much that night. Then about 7:00 the next morning he started vomiting and vomited all day until 3:00pm. He vomited so much he thought he was going to have a heart attack. Also, the gland in his underarm is very very swollen

Swelling in cheek. Patient states swelling was at the site of nerve in cheek. Nerve felt hard. Was not painful, just slightly tender if touched. Patient read online to take Benadryl. Swelling subsided in a couple of days.

Moderna COVID-19 Vaccine EUA ,,,,,eruption, pustule, area of right Axillary (pectoral) lymph node. Area of redness surrounds.

Softball size soft bursa like sac developed on the evening of the injection. Following morning joint pain was in left shoulder and elbow. Fatigue was significant 1 and 2 days post vaccine. Rest, massage and warm compress was applied and swelling is decreasing at this time.

Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open. Also some nasal drainage and feeling of unwell. Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out. Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here.

Three inch radius in size redness , with itch, and lump eight days after vaccination, dose 1. No symptoms prior to day 8.

Bilateral swollen forearms, numbness on left fingers, chest tightness; seen & cleared by EMS. Due to past medical history of asbestos lungs, client instructed to go to emergency room

Swelling of lymph nodes under left arm pit. Started sometime during Wednesday night. Didn't know about it until Thursday morning when I felt slight pain and tenderness in my arm pit. Checked with my doctor and she confirmed it.

Itching face and neck, hive on face, progressing to facial swelling. Bendaryl & steroid given. stabilized and monitored, sent home home with steroid pack and benadryl

Approximately 24 hours post injection-fever-102.4, and fatigue. Fever persisted for 24 hours then resolved. Fatigue persisted for 48 hours then resolved. Possible side effect-72 hours post injection-queasy stomach, malaise-Duration-approx. 6 hours all resolved. Also, cold sores erupted on lower lip for no reason. Being treated with Abreva.

approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling

Individual left a message 2/17/21 reporting that about day 5-6 he had erythema,warmness & itchiness around the injectyion site. He also reported swelling in deltoid region that extended midway down his arm, but did not travel to the tricep area. He applied a topical steroid cream and triple antibiotic ointment to the area. As of today, the swelling, warmth and redness are improving. He was advised to contact PCP for follow up.

Right side face swelling, right eye sore to the touch, dizziness on the first two days. Next day, sharp cramping in different parts of the body at different times lasted about a day and half and a little dizziness. Today, he's doing ok.

About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But about Friday, my right hand began to ache a bit. It became excruciating by Sunday. My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints. The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.

Moderna COVID-19 Vaccine EUA 100.4 degree fever, chills, sweats, severe joint pain in thumbs, swelling in left testicle, headache, gained 12 pounds of water weight over two days. Swollen legs with painful rash from knees down. Continuing joint pain in hips, knees, ankles

Client phoned; C/o face swelling; trouble breathing; dizziness and weakness. 911 phoned for client home address; client refused medical care/ambulance service.

patient said hand was swollen and side the shot was given, also other joints swollen and blood blisters formed on hands

Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vaccine. Each time the patient received the vaccine, he presented to the emergency department the following day with the following signs and symptoms: AMS, tachycardia, fever (Tmax 104.5), lactic acid 3.8, CRP 1.65, CPK 298, Troponin T 0.107, WBC WNL.

Received vaccine, and no reactions. Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye. General soreness around his mouth when he tries to eat or talk a lot. Limited movement of his face do to swelling, difficulty closing his eye, and headache. Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21. Was given corticosteroids for 9 days Prednisone 60 mg. The symptoms are slowly improving but still has the Bell's palsy.

Facial swelling and slight lip swelling and redness to skin which began about 90 minutes after the vaccination. He was seen in an emergency room and treated with diphenhydramine, famotidine and prednisone and discharged on the same. He improved in the ER but reports that he had recurrent facial swelling over the next few days when antihistamine wore off. Resolved after a few days. Seen in the office on 3/18/21 and doing fine off medication.

Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became. He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight". He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities. He had no trouble with his vision or cognition. He had no trouble with the previous vaccine. Presently the symptoms are resolving. Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23

He was given the Covid vaccine at a pharmacy and not at my office. 4 days after the vaccine he noticed discomfort in the right calf. Initially he dismissed it but then gradually the calf started to swell. Once he noticed some shortness of breath he decided to come into the office. He was seen on 4/12/21 and diagnosed with a pulmonary embolism. He was then admitted to Hospital for IV therapy and monitoring.

Patient received the first Moderna Covid-19 vaccine and a few weeks later he noticed jaundice and hematuria. He was admitted to the Hospital, and was noted to have dramatically elevated eosinophils (26.29 k/uL), elevated creatinine (2.36 mg/dL) and elevated LFTs (AST/AST/Alk Phos/Tbili all up, mostly direct). His eosinophils improved with pulse dose steroids and the diagnostic work up continues. There is diagnostic uncertainty about what caused this dramatic increase in eosinophilia, but it appears temporally related to getting the vaccination. Our working diagnosis is autoimmune vasculitis, but he is also being treated for possible parasitic infection, and will require very close follow-up. 61M with PMHx HTN p/w generalized fatigue, L flank pain, and decreased UOP. He was in his usual state of health until 5 days prior to admission with onset of general fatigue/sluggishness. This was followed by a few days of dull abdominal pain, watery bowel movements, and increased frequency which spontaneously resolved, though the fatigue persisted. Yesterday evening, he noticed new L flank pain, red urine, and decreased UOP associated with mild dysuria (he describes it as needle-like pain in his urethra) which prompted him to call EMS. Denies fevers/chills/night sweats, myalgias, respiratory symptoms, melena/hematochezia. He's never had pyelonephritis or kidney stones before, no recent urinary instrumentation, antibiotic use, or hospital stays. He recently received the first COVID vaccine and is due for the second COVID shot on Monday. He lives with his sister and works as a mechanic. He is not on any other medications or supplements. Not currently sexually active. ED Course Vitals: Temperature: 36.7 °C (98 °F) | Heart Rate: (!) 103 | BP: (!) 169/121 | Respiratory Rate: 18 | SpO2: 96 % | | FIO2 | Weight: 104.3 kg (230 lb) Exam: L CVA TTP Labs: Cr 2.34, bicarb 18, WBC 37, UA w/ 3+ blood, +1 LE, nitrates, >182 RBCs, 32 WBC, no bacteria, no casts Imaging: CT/AP with mild L hydrouretonephrosis, b/l periureteral and perinephric stranding, b/l urothelial thickening Interventions: CTX 1g, ketorolac, 1L LR, morphine ===================== Hospital Course 4/10-4/16 ===================== #B/l Pyeloureteritis with Eosinophilia c/f Eosinophilic Pyeloureteritis #B/l L Hydroureter/Hydronephrosis, B/l Perinephric Stranding and Pericystic Stranding #Profound Eosinophilia Pt presented with malaise, hematuria, decreased UOP and markedly leukocytosis with predominant eosinophilia to 26k and was found to have L hydroureter/hydronephrosis, b/l perinephric stranding and pericystic stranding on CT A/P (4/10). Notably has been afebrile and fairly well appearing. Symptoms were preceded by several days of watery diarrhea, cough with sputum production and subjective weight loss. Recently received moderna vaccine, and he was concerned it causes his symptoms. Underwent extensive workup as below with involvement of multiple services including Renal, Pulm, Rheum, Allergy, ENT, and Cardiology. Had one nasal lesion biopsied by ENT, which was non-diagnostic. Renal bx prelim without clear e/o vaculitis, although obtained after steroids. Negative testing for primary hypereosinophilic syndrome. Extensive w/u notable for ANCA positive at 1:80 with MPO only slightly elevated (20, uln 19) and PR3 wnl. cMRI with eosinophilic cardiomyopathy, for which cards was consulted as below. Additionally, toxacara ab positive and schistosoma ab indeterminate, although per ID both schistosomiasis and toxacara infection unlikely. Per rheum, overall felt presentation 2/2 hypereosinophilic syndrome, potentially the eosinophilic stage of EGPA (given low + ANCA, low + MPO) vs. End organ effects of idiopathic eosinophilia. Briefly received CTX 2g IV qd (4/10 - 4/12) until diagnostics returned. Treated with solumedrol 1g qd x3d (4/11-4/13) transitioned to prednisone 60 mg qd (4/14-) to be continued until rheum f/u, with rapid decline in eosinophilia. Received pre-treatment with PO ivermectin 20 mg before steroids. Treated with flonase nasal spray, symbicort and albuterol for respiratory symptoms. Deferred cyclophosphamide, with consideration of IL-5 or IL-5R targeted biologics as an outpatient. Treated with atovaquone for PCP ppx. Per ID, treated with praziquantel (for schistosomiasis) and albendazole (for toxacara) out of an abundance of caution, although low c/f visceral larva migrans given lack of compatible imaging findings and no known exposure to dogs and cats or schistosomiasis given remove travel history. Data - CT A/P (4/10): Mild L hydroureteronephrosis with b/l periureteral and perinephric stranding and b/l urothelial thickening. Pericystic stranding. - 4/11 CT Chest with parasinus mucosal thickening and sclerotic 1 cm lesion likely benign lesion or bone island - 4/11 CT Face with parasinus mucosal thickening and small fluid levels and sclerotic ovoid 1 cm lesion in neck of right mandible potentially representing benign fibro osseous lesion or bone island - PFT with severe obstruction and elevated FeNO c/w eosinophilic infiltration - Heme review of smear with normal Eos - Echo TTE with LVH nl EF 52% - Vitamin B12 >2000 - Urine Eos undetectable after steroids - SPEP with polyclonal hypergammaglobulinemia - Sinus Bx equivocal - ANA, ANCA (1:80; MPO 20, PR3 3), ESR (128), CRP (66), RF (<13), C3 (82, slightly low), C4 (10) - IgE 355 - Aspergillus IgG and IgE <19 - HIV non-reactive - RHP with CHIP mutation which will need f/u - FIP1L1 negative - Schistosoma ab equivocal - Strongy ab negative - Toxacara ab positive - Leptospira ab negative - Tryptase wnl - RHP notable for CHIP mutation as below - BCR-ABL negative - FIP1L1-PDGFRA negative - peripheral blood flow cytometry unremarkable #AKI on CKD #Nephritic syndrome #Urinary retention/hydronephrosis Cr 2.34 on admission. Baseline Cr unknown but Cr was 1.5 (OSH BI) and urine alb:Cr was elevated to 36 in 6/2018, at which time CKD was thought to be 2/2 untreated HTN. Now presented with persistent hematuria, HTN and proteinuria with UCx without e/o infection, all favoring nephritic process. Renal and urology consulted MALB/CCR 994.5. CT scan with hydronephrosis, felt to be eosinophilic pyelonephritis. Pt underwent uncomplicated renal bx 4/14 (after steroids) which showed preliminary very mild focus of interstitial nephritis with scattered eosinophils and immunofluorescence evidence suggestive of a mild immune complex-mediated disease without current activity. EM pending. He was treated with sodium bicarb 1300 mg bid. Hematuria improved but did not resolved by time of discharge. Cr on discharge 1.6, close to baseline of 1.5 in 2018. #Sclera Icterus #CBD Dilation on CT #Elevated LFT Sclera icteric and CBD dilation on RUQUS to 1.8cm with gallbladder sludge and small gallstones. MRCP with diffuse intrahepatic and extrahepatic biliary ductal dilatation to the level of ampulla, with associated ductal and gallbladder wall edema, complex material in the gallbladder lumen and CBD, and confluent periportal lymphadenopathy. No obstructing stone or discrete mass. Findings likely represent cholangitis such as eosinophilic cholangitis in light of severe eosinophilia.. No documented LFTs here, but OSH (BI) records indicate normal LFTs and viral hepatitis studies in 6/2018. Repeat Hep B non-reactive non immune, HCV non immune, HAV non-reactive. BIli remained stable and ALT and AST continued to rise after initiation of steroids. GI was consulted. RUQUS 4/15 with dopplers with persistently dilated CBD to 1.4 cm with sludge in CBD but with patent portal vein and hepatic veins. Anti smooth muscle ab positive on day of discharge; antimitochondrial ab pending. LFT uptrending at time of discharge, although patient declined to stay inpatient for further workup. LFT at discharge ALT 194, AST 114, ALP 262, TBili 6.3, DBili 5.3. ERCP to be considered as an outpatient. #HTN SBP on admission 160-180. History of HTN, not on any home anti-hypertensives. Per BI records, he was prescribed amlodipine 10/valsartan 160 in 6/2019, but pt reports self-discontinuation after ~2 doses. BP remains poorly controlled. Likely related to potential nephritic syndrome or renal infiltration by eosinophils, likely with contribution of high dose steroids. While inpatient, treated with hydralazine, labetalol, carvedilol, and amlodipine. BP regimen on discharge amlodipine 10 mg qd, carvedilol 25 mg qd. Avoiding ARBs and ACEI per Renal, although will likely need to add once AKI resolved. #Microcytic Anemia Patient with drop in Hct from 14.1 on admission to 11.4 4/14. Continues with hematuria, but denies current hematochezia. Suspect combination of blood loss and hypopoliferation given RPI 0.29, likely anemia of inflammation/acute illness given ferritin 1.010. Vitamin B12 >2000, Folate 11. Iron 151, unable to calculate TIBC. Noted to have persistently low MCV in low 70. Hemoglobin electrophoresis ordered. #Vitamin D deficiency #HyperPTH 25-OH Vitamin D 6. No e/o hypocalcemia. Phos slightly elevated on admission, but subsequently downtrending, likely iso renal dysfunction. Treated with ergocalciferol 50,000 U weekly x12 weeks #Right mandible lesion Sclerotic changes of the right mandible near the condyle noted on CT scan. Surgeon recommends outpatient follow-up, although patient declined. #Hematochezia #Hemorrhoids Patient with new bloody diarrhea 4/11. Some e/o hemorrhoids on exam. CBC stable. Treated with tucks pads, dibucaine ointment and hydrocortisone cream. #Little Medical Follow-up Pt reports that he has not seen a doctor in ~3 years.Cholesterol 124l LDL 73, HDL 10. HgbA1c 5.2. Will join Dr's panel on discharge #CHIP mutation RHP with DNMT3A mutation at low VAF. Will follow in cancer precursor clinic

Received Moderna Covid Vaccine on 3/3/21 and 4/8/2021. Nted onset 4/24 of right calf discomfort, swelling and firmess and at same time began to have exertional dyspnea with chest heaviness. U/S RLE - extensive DVT. CTA - multiple segmental vessels with clot, dilated right ventricle

Bursitis from vaccine. Poorly administered in wrong location with a needle that was possibly too long. Clinician did not roll up my sleeve and examine my arm before choosing needle size. Cannot lift or use left arm after 1 week.

Veteran contacted call center, Reporting LT Arm swelling from hand to above elbow, No redness reported around injection site. Veteran reports swelling has incresed over last 24 hours, painful to rest arm on object. No other symptoms reported, including No elevation in body temperature. Directed veteran to mission act urgent care for evaluation.

Covid-19 J96.90 - Respiratory failure (CMS/HCC) N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC) U07.1, J12.82 - Pneumonia due to COVID-19 virus

dizzy spells; swollen feet; frequent urination; vertigo/room was spinning around me; hypokalemia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (hypokalemia) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (ACETAMINOPHEN) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced HYPOKALAEMIA (hypokalemia) (seriousness criterion medically significant) and VERTIGO (vertigo/room was spinning around me). On an unknown date, the patient experienced DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet) and POLYURIA (frequent urination). At the time of the report, HYPOKALAEMIA (hypokalemia), DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet), POLYURIA (frequent urination) and VERTIGO (vertigo/room was spinning around me) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood potassium: 2.6 (Low) diagnosed with hypokalemia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event hypokalemia included 2 intravenous bag of potassium chloride. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

PATIENT RECEIVED 1ST COVID VACCINE WITH NO REACTION. PATIENT RECEIVED 2ND VACCINE ON 4/14/2021. ON 4/16/2021 PATIENT REPORTED HAVING A RASH ON HIS HANDS, CHEST, AND ARMS. HE SCHEDULED AN APPOINTMENT WITH HIS PRIMARY CARE PROVIDER ON 4/19/2021. PRESCRIBED PATIENT PREDNISONE TO TREAT RASH AND WANTED TO FOLLOW UP WITH PATIENT ON 5/3/2021. BETWEEN HIS 1ST APPOINTMENT AND HIS FOLLOW UP HE PRESENTED TO THE ER ON 4/29/2021 WITH INCREASED RASH, SWELLING OF ARMS, CHEST AND HANDS. ER DOCTOR PRESCRIBED PATIENT FUROSEMIDE AND BACTRIM. DURING FOLLOW UP APPOINTMENT ON 5/3 DAN WOLDT DISCONTINUED THE BACTRIM BUT ADVISED PATIENT TO CONTINUE ON THE FUROSEMIDE AND SCHEDULE AN APPOINTMENT WITH A DERMATOLOGIST. PATIENT HAD APPOINTMENT WITH DERMATOLOGIST 5/10/2021 AT 2:30 PM WHERE PRESCRIBER, MD PRESCRIBED PATIENT A TOPICAL TRIAMCINOLONE CREAM. HAD DIAGNOSED PATIENT WITH HAND AND FOOT SYNDROME AND WOULD BE CONTINUING TO MONITOR RASH. PATIENT HAS A FOLLOW UP APPOINTMENT WITH THE DERMATOLOGIST SCHEDULED FOR 5/25/2021 AND WAS ADVISED TO CONTACT DOCTOR IF ANY FURTHER RASHES COME UP DURING THAT TIME.

Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient wanted to report swelling and rash. He will use Benadryl and see his physician about swelling that continues to grow.

Additional History:. 61 yo M with a PMH HTN and HLD presents to the office with a mod-severe red itchy bumpy blistering rash that has persisted x 1 wk. Pt states he first noticed the rash on his right insole of his foot on 3/17 and over the course of the next few days the rash spread to both feet and got more red with large blisters forming and opening up. He went to the ER 3/20 where he was diagnosed with folliculitis and cellulitis and placed on PO doxycycline and topical Mupirocin. He has been using the meds as prescribed since 3/20. Pt presents to the clinic because the rash has persisted and the medications prescribed have not helped. Pt reports the blisters are now opening up and he's worried about them becoming infected. His feet are also swelling. Pt states that there are no relieving factors identified yet, but notes that water/sweating seems to make the rash worse.He does have a PCP but has not been seen anywhere other that the ER over the weekend. Of note, Pt states that he received his last Moderna vaccination 1/28/21 and had some rashes and swelling of his eyelid, then received his shingles vaccine "a few weeks later" and then the rash on his feet started about a month after receiving the shingles vaccine.1 . Toe rash location details: (all toes involved anterior/posteriorly B feet) Patient presents with rash, described as red, pale, tender, bumpy, itchy and weeping. The rash is located in skin folds, on the dorsum of both feet, on the soles, on the sun-exposed areas, on the extensor surfaces, on the flexural surfaces and in an asymmetric distribution on the toe(s). Associated symptoms include no abdominal pain, no arthralgias, no cough, no diarrhea, no fatigue, no fever, no headache, no lightheadedness, no malaise, no myalgias, no nail changes, no nausea, no neck stiffness, no shortness of breath, no sore throat, no swollen glands, no urethral discharge and no vaginal discharge. Onset was sudden 1 week(s) ago. The rash is spreading, becoming more red and becoming more pruritic. Changes have occurred over the last 7 day(s). Symptoms are moderate in severity. Precipitating and/or exacerbating factors include 2nd COVID 19 vaccine end of January, Shingles vaccine mid-February, but not carpeting, not exacerbated by chemical exposure, not exacerbated by cold exposure, not exacerbated by food triggers, not exacerbated by heat exposure, not exacerbated by humidity, not exacerbated by exposure to illness, not exacerbated by insect bite, not exacerbated by medication, not exacerbated by personal care products, no contact with pets, not soaps/detergents, not exacerbated by stress, not exacerbated by sun exposure and not exacerbated by tick bite. no recent contact with poison plants No relieving factors are noted. PE normal except for: Skin: (diffuse vesicular rash in various stages of eruption on B feet, not following dermatomal distribution. Rash is fluid filled vesicles with scattered bullae on bilateral anterior/posterior foot, extending onto soles, covering all parts of B toes, and spreading onto L calf area. There are several open bullae to R sole without evidence of active infection present. Sensation is intact to bilateral feet without current hypersensitivity or tenderness. Diffuse excoriation present without evidence of infection. NV intact) On exam, the skin was warm, has rash and was not diaphoresis. has drainage Rash(s): vesicular rash that was erythematous, that was becoming confluent, that blanched with pressure, that was excoriated, that did not have fine scales, that did not have thick scales, that had sharply demarcated borders and that was weeping on the lower extremities. Assessment 1. Dyshidrotic eczema (L30.1) Plan Calamine lotion may be used for itching.; Dermatology Referral Physician Referral See Referral Comment! Done: 24Mar2021 Ordered; For: Dyshidrotic eczema; Ordered By: Dr. Performed: Due: 07Apr2021 Laterality 1 : Bilateral Body Part 1 : Foot Reason for referral : Evaluate and Treat Plan: take otc antihistamine during the day, may start otc benadryl at night as needed. 4 packets Loratadine provided in office. Start otc barrier cream such as aquapor or eucerin cream. May use otc calamine lotion for itching as needed. 6 packets Calagel (topical diphenhydramine) provided to patient and applied in office. Ed on emergent s/s, pt verbalized understanding. If you experience and difficulty breathing or swelling of the face/lips please go to te ER. Please follow up with PCP for further eval/management of potential post-vaccine immune mediated reaction. Pt educated on reporting reaction to VAERS.hhs.gov website in order to help identify potential side effects with current COVID 19 vaccines. Referred to dermatology for new onset eczema to rule out alternate diagnoses and determine potential contributing factors.

He just told me yesterday that the day after he got his second moderna injection both feet swelled up. Severely ! He complained of not being able to move his toes etc. There is no pain or trauma. just ironically it happened the day after his injection. He will not go see a doctor yet because he thinks it will go away. He started wearing compression stockings the day before last and it has helped. I am worried that he has a blood clot but he thinks that it woudn't be in both feet. Not sure if it matters but he is a 61 year old man . with no known co morbities. Is this a side effect that has been recorded? I am concerned but dealing with a stubborn man.

The first Moderna shot on 4/6/2021 was fine with no reaction. The second Moderna shot on 5/5/2021...the arm one week later was red/sore... By the 11th of May, I had chills, joints were sore, slight fever, fatique....then within days... a head ache from my forehead that wrapped around down my left side of face (which was quite swollen under my eye (red) as well as cheek and painful to my left ear and back of head. This has lasted since the llth of May.. Went to doctor (primary) on the 18th of May and he took notes and gave me the antibiotic Azithromycin 250 mg. Today, the 20th, when I woke up my eye was still looking like it was pushed back. When I look in the m;irror, one eye looks bigger than the other and one looks like is has receded in my face..

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-141559 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

About 1month afterward starting having facial swelling and tingling from jaw/lips to eyeball on the right side, with eyeball pressue. I also have tingling, numbness, burning to both lower legs from the knee down to the feet. I can have burning and sometimes my feet are freezing at the same time. Lower back pain also. The burning and sensations have gone on for awhile now. Also tinnittis which is currently off the charts with pain, lost 30 lbs as I get so ill from the noise I cannot eat---have nausea when the symptoms are to bad.

My husband received the vaccine approximately 4:00 pm. He was told to wait at the site for 15 mins and he did. On his way home he called and said he had a very bad headache. Once home his shoulder swelled and he just didn't feel like himself. By the next morning he started running a fever that was between 100.1 and 102.1. I continue to take his temp and give him cold liquids and popsicles in an effort to control the temp. He has yet to start feeling better and it has been over 24 hours since the vaccine.

DVT- developed leg pain and swelling for several days. Presented to ED for evaluation. Found to have RLE DVT

Timeline was exactly the same as that of the first dose. Day one, nothing, day 2 very sore arm, days 3,4,5 nothing. Day 6 reaction. After the first dose I developed high fever, body aches and lethargy on the sixth day and it lasted several days. On the second dose, it followed the same timeline, but on day 6 my lips and cheeks swelled and kept swelling for 7 hours even though I was admitted to the hospital emergency room within the first hour and they gave me 4 drugs by IV to counteract the swelling. The doctors told me I was having an allergic reaction, but I had not eaten anything out of the ordinary and I've never had an allergic reaction of any kind. They were reluctant to admit that it was a Covid vaccine reaction, but they couldn't find any other answer and I knew it was... the timing was too coincidental. Also, the drugs they gave did nothing and it took several days for my facial swelling to diminish.

From the evening on 2021-06-11(Fri), of the 2nd shot of Moderna CoVid-19 vaccine, the whole body was knocked out until the late morning of 2021-06-13(Sun), with pain all over the body, headache, sore throat. Had to be in bed. The reason for this report is that the symptom is contrary to the listed side effects. The 1st shot of Moderna Covid-19 vaccine was taken on 2021-05-12(Wed). After the 1st shot, the side effect symptoms are within the listed. Injected arm was swollen and pain there lasted several days. Except the side effect on arm, other side effects were not noticed. === continued It is understood that the side effect is less after the 2nd shot. However, in my case, after the 2nd shot, the side effect symptoms are far beyond the listed, as described earlier. FYI, the 2nd shot was given a different healthcare worker(LVN?), who was a receptionist for the 1st shot. She used unprotected(disposable dry cotton piece) to clean injection spot and the disposable bandage after shot. Subject suspicion goes for overdose. Please advise.

started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination; slept a lot after the shot; covid like flu symptoms; very weak/very weak feeling; terrible diarrhea; Zero appetite now for 3 days although eating once a day; no longer able to sleep at night; pain in my heart/pain moved from left side heart area and slid toward my left side; neck glands swelled last week/2swollen neck glands; very tired/very fatigue; Bad headache; chills (no fever); heart attack-like pain; lost 20 pounds of his body in the next 24 hours,weight was 184/185; sweat really bad/terrible night sweats; I had pain which I felt like was in the right kidney and lower right abdominal area; I had pain which I felt like was in the right kidney and lower right abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart attack-like pain) and POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after shingles vaccine. February 2020 second dose. October 2019 first dose.) on 24-Jun-2008. Previously administered products included for Shingles: Shingles vaccine in February 2020. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included HIV disease since 18-Feb-1988, Renal agenesis, Drug allergy (Allergy to Floriquins), Allergy to chemicals (Contrast dye allergy), Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhoea (Improved with daily morphine ER.) since 01-Oct-1996. Concomitant products included RITONAVIR, DOLUTEGRAVIR SODIUM (TIVICAY) and DARUNAVIR ETHANOLATE (PREZISTA) for HIV disease, AMLODIPINE BESYLATE, ACYCLOVIR [ACICLOVIR], PRAVASTATIN, FINASTERIDE, ABACAVIR SULFATE (ZIAGEN) and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185) and NIGHT SWEATS (sweat really bad/terrible night sweats). On 17-May-2021, the patient experienced ANGINA PECTORIS (heart attack-like pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area), ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)). The patient was hospitalized from 09-Apr-2021 to 14-Apr-2021 due to POLYURIA. On 10-Apr-2021, POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) had resolved. At the time of the report, ANGINA PECTORIS (heart attack-like pain) had not resolved, WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185), NIGHT SWEATS (sweat really bad/terrible night sweats), SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)) outcome was unknown and RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area) and ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. On an unknown date, Blood creatine: high (High) high. On an unknown date, Electrocardiogram: unknown (Inconclusive) unknown. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications included blood pressure medication. Follow-up received on 11-May-2021 included the completed ADR form with significant information about the patient's medical history and new events. Follow-up received on 12-May-2021 included additional details of lower abdominal pain experienced by the patient. The patient reported that he sought medical care from a doctor's office from 09-Apr-2021 to 15-Apr-2021. significant follow-up received on 03-june-2021 This is a report of a 61-years polymorbid male under multiple chronic therapies; who presented various adverse events after receiving the second dose of the product. For the event heart pain/angina pectoris, the patient was not hospitalized. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-073550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up included additional details about the adverse event reported in the initial SD of pain right side abdomen. On 03-Jun-2021: Significant follow-up added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

On June 1, I was hospitalized for pancreatitis although I had none of the preexisting conditions for it such as a history of drinking alcohol or anything else that the hospital could find. Next on June 16, I began feeling lightheaded. I went to an internal medicine doctor who referred me to a specialist. After some testing, Doctor informed me that my heart was beating lower than the normal range. I just had a heart stress test done a few years earlier and my heart was more than fine. It is hard for me to understand how my heart health could have such a dramatic reversal so quickly.

My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila

Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bipolar disorder. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient reported that the adverse events started immediately after the first shot. Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered. This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.

Discomfort and soreness at the injection point and left elbow joint about 2 hours after vaccinated. Similar to my 1st vaccine 4 weeks earlier, except this time my elbow joint had some soreness. The soreness and swelling continued to get worse throughout the day and could not sleep well that night. The following day I woke up with a painful and swollen elbow joint, and still had soreness around the injection point. By the afternoon I could not move or extend my left arm with severe pain. The swelling and pain increased and Advil or ice was not effective in reducing these symptoms. The pain and swelling got so severe and I could no longer tolerate the pain and went to Urgent Care. I continue to experience left elbow joint pain, and now experience similar joint swelling and pain in my ankle and knee. It's not as severe and painful as my left elbow joint. I am making this report now because 2 days ago I started to develop the same symptoms in my right elbow joint and leg/hip joint, and now I can barely walk. The joint pain is severe so I will seek medical treatment today.

Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.

At work 24 hours after vaccine administration - Lip swelling, jaw swelling increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.

Onset yesterday (1/21/21) after stretching left shoulder. Felt like itching and mild burning in left deltoid. Rapidly increased to mild pain/discomfort/aching. Went for walk. Upon return, muscle tested and stretched arm to see if I had injured arm. Afterwards, there was onset of pain, swelling, redness, increased itching. Redness generalized over left deltoid with pronounced scarlet redness at site of injection, about 3mm diameter. Today (1/22/21, Day 2 of flare-up, about 22 hours after onset of symptoms): increased aching over entire left shoulder/trap/scapula with pronounced redness over slightly greater area on deltoid, itching at deltoid, hardness and swelling of deltoid. Almost a burning sensation over the deltoid, but not quite. Tissue feels irritated and hot. Limited loss of range of motion. Pain increases with use of left arm, pushing arm through ROM movements. Moderate headache at waking, relieved with 25mg Sumatriptan. Still mild headache. Mild lethargy and fatigue.

Two weeks after the vaccination, the vaccination site is red, itchy, and swollen. The itchy red patch is about 3 inches in diameter and hard.

Bruising and minor swelling. Bruising down entire upper arm. 2nd shot given on 1-26-2021 and bruising did not appear until 1-31-2021

Red rash about 4-5 inches on my left arm at injection site. Some itching associated with rash. Some minor swelling/raised area where rash is. Also some soreness in the area of the rash. The soreness is similar to what I experienced the day of, and the couple of days after the injection. Area of left underarm (perhaps lymph nodes) were tender a day before the rash appeared.

Good night of the injection about 11 hours after I got the injection I started to feel very achy and very sore and then led to shiver passing and turning headache and all of the above the next morning I woke up feeling okay I ate a very small portion of yogurts and oatmeal took two sips of coffee and had to go to the bathroom it was very intense I would stuck in the bathroom for an hour intermittently going number 2 and vomiting very sick and scary the rest of the day I was weak and miserable with a temperature and the temperature lasted all the way until last night it range from one hundred and one point eight two last night at a hundred and 128 I had severe muscle aches after I tip my prod element injection yesterday it which is a Statin anyway that today I feel much better but it was very intense I also developed a swollen lymph node under my left armpit the same arm where they did the injection and it was hot and painful I'm afraid to take the second injection but I want to complete the process if possible

Swelling at site of injection of dermal filler under and adjacent to eyes. Swelling was prominent 44 hours post injection and has not resolved.

Ten days after the first injection of the Moderna vaccine I developed a red rash on my right arm at the injection site. The red rash is round, about 3 inches in diameter, has bumps and itches. The arm muscle is also sore and swollen.

Extreme fatigue, swollen lymph node on left side of neck, sore jaw, sore nasal cavity, headache. No treatment and still recovering. Feeling a little better each day.

Swollen arm at injection site; swollen hands, fingers, and feet; headache (forehead); painful joint inflammation in fingers, shoulders, knees.

Fever, malaise, joint pain, headache, and pain for two days. Injection site swelling for four days so far. Red, tender hemispherical mass the size of a softball in my left axilla.

I don't have the lot number for the second dose so i listed the lot number from my first dose. Second dose left arm Feb 4th 930am. A few days later i noticed an itchy spot left temple slightly red. Persisted and slowly spread. Left side face, scalp neck shoulders chest, back and eventually entire body. Very itchy, red rash. Went to ER FEB 27TH. treatment with 7 day prednisone. Sx improved but did not resolve. Went back to ER March 13 due to increasing sx swelling and numbness in face. Back on prednisone follow ups scheduled

The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The stiff neck and headaches and general malaise has persisted throughout even until now. As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.

Fever headache chills muscle aches redness on left arm and swelling took about 40 hours to get over it

Follow up report: Severe left shoulder joint pain. I have had two orthopedists trying to help me - had a shot of steroid in that joint and that didn't help. I have severe bursitis. The injection was given in the joint and not in the muscle which is what is causing this. I take Motrin and Tylenol for the pain. Limited use of shoulder joint because of it. I communicated with the Health Department. have not heard a word back from anyone.

On day 6 after getting the vaccine I have developed Covid Arm with considerable swelling, hardness, a red rash and extremely itchy.

Lymph gland on left side under armpit swelled up for four days then returned to normal size. No other symptoms or effects noticed.

Itching in 10 minutes followed by reddening of skin and red splotches, extreme headaches, body aches, fever, sweats, chills, cough, nausau, swelling of lymphs nodes in chest and groin, shortness of breath, and light sensitivity.

Had worst headache I've ever had in my life. Arm was swollen and super sore. Joint aches everywhere and had diarrhea. It lasted 48 hours Took Tylenol every 4 hours.

Itchy, painful red rashes all over body. The rashes continued after the 2nd dose (date: 04/13/2021, Moderna Lot # 037B21A). Over the counter antihistamine help to reduce swelling and itchiness temporarily.

Lymph node on the left clavicle became inflamed and enlarged sensitive to touch CAT scan and sonogram performed

Extensive DVT requiring surgery. Received second Moderna vaccine approximately one week prior to admission, presented with acute onset of left leg swelling and pain. Left lower extremity ultrasound demonstrated an extensive deep venous thrombosis extending from the common femoral vein into the peritoneal and posterior tibial vein with a patent IVC. He was given a treatment dose of enoxaparin and admitted to the hospitalist service. Overnight he developed diminished sensation in his toes and vascular surgery was consulted. On 3/31/2021 he underwent mechanical thrombectomy of the left superficial femoral and common femoral veins as well as stenting of the left common iliac vein stent. Of note he was noted to have May Thurner physiology with compression of the left common iliac vein by the external iliac artery on the right. Post procedurally the patient's swelling and edema was significantly improved. He did not have any significant pain or difficulty ambulating. On postoperative day #1 he was evaluated and found to be hemodynamically stable with improvement of his symptoms and stable for discharge home. Prior to discharge it was discussed with the patient that he will need to be on a loading dose of Eliquis for 7 days, followed by a maintenance dose of 5 mg twice daily. No h/o COVID.

Within a few days stiffness and swelling in left knee and leg; stiffness and soreness in both shoulders, stiffness in hips, stiffness in hands, particularly left. After about 3 weeks, swelling of right foot.

Left acute axillary lymphadenitis, swelling at injection site, mild bi-frontal headache. No fever, body aches or other bodily symptoms noted.

On 3/4/21 noticed my left calf was swollen. I did not think much of it at first. A week later the swelling had progressed to include my ankle. Saw Dr. and ordered an ultrasound on both of my legs. Right leg was normal & left lower leg had a clot(s) in it. Dr. ran blood work then prescribed Eliquis. Saw him in follow-up on April 14. Swelling down but not gone. Renewed the prescription for Eliquis and set a followup visit for Friday June 18. He ordered additional blood work to be drawn on Wednesday June 16 to have results at the next visit.

Initial presenting symptoms upon awakening four days after his shot were muscle spasms, "felt things in his chest," and dark urine. Within 48 he was confused and was unable to state his last name, which progressed to unresponsiveness by ~7 days after the vaccine. He has since become comatose and his brain MRI is notable for hyperintensity involving the deep gray nuclei as well as the periventricular and subcortical white matter diffusely, bilaterally. The etiology of his comatose state is still under investigation, but a detailed infectious, autoimmune, and malignancy work up at 2 different medical centers and have since been unrevealing as to alternate causes.

Throat infection swollen lymph glands neck Shingles outbreak right ear Difficulty breathing and swallowing

I was typing in this section when I was timed out due to "inactivity". Pls change your definition of "inactivity". I do not believe that I will be able to duplicate what I previously wrote before being timed out. I will do the best I can. To the best of my recollection and ability. NOTE: Automatic Wrist BP readings (also takes pulse) closely follows manually-taken Stethoscope Sphygmomanometer readings. 4/22/21 Doing active range of motion pre and post injection. 7:45pm Signs & Symptoms (S/S) Mild - arm discomfort w/swelling, fatigue, lightheadedness, and body ache. Ice- alternating periods of 15 minutes on, then off - done several times. Lessen arm discomfort, no redness noted. Slow increase S/S through night. 4/23/21 mid afternoon- marked increase S/S plus start sporadic flush feeling, noted 1 x 1 inch oval red area over site. 8pm- Increased & more constant flushed. Temp 98.9 F. Noted marked increase body ache, first moving across chest, then descending to both toes/feet. 9pm- Temp 100.4 F. Monitoring temp, hoping peaked. 9:30pm 99.9 F- 9:50pm Felt very dizzy, self-palpated pulse- felt weaker than my normal, noted more distended veins on arms. Asked wife to get pulse oximeter- sat/pulse ranging 93-97, depending on finger, hand, how long on each; noted amplitude lower than my normal; 82-86 range pulse. 9:53pm Obtained BP R wrist supine 105/61 Pulse 82. Felt too dizzy for BP to be done in sitting. BP confirmed by second reading. BP wrist supine sys about 30 -35 & diastolic about 10-20 below baseline. 9:56pm Took 1000mg Acetaminophen. 11pm Temp less than 99, marked decrease head to toe pain, more towards my mild lightheadedness at times due to my mild TB baseline. Able to ambulate. 4/23/21 4-5 am Temp low 98 range (more my normal). 7am BP L wrist supine 135/70 Pulse 69. Sat 98 reading obtained very quickly, pulse amplitude more my normal. Feeling better but not to Pre-vax. Repeated BP & Sat readings twice during the rest of date. Don?t recall time of 1st BP 135/70 Pulse 70 & Sat 96/Pulse 69, noted injection site redness. 9:30pm- started having headaches, pain on L side head (near site of my head wound/mild TBI site), slight increase lightheadedness, injection site red area increased in pain & size to covering almost full deltoid area. BP 125/73 Pulse 65 Sat 97/ Pulse 65. Both Sat numbers obtained very quickly, as per my normal. Ice used. Alleviated pain to tolerable. Monitoring size of red area & intensity/duration of lightheadedness. Recall a strong tingling sensation going down my left arm once. Noted change in sensation afterwards. Slight increase lightheadedness felt due to what usually happens in change in weather, like rain coming. Rain occurred. 4/25/21- Basically the peripheral of deltoid showing redness with some scattered redness centrally. At 8pm redness fully covering deltoid area. Will continue to monitor ("Covid arm"). Other than fatigue thought due to vax, NO S/S of markedly reduce platelets. If need be, will contact Teledoc. Have prior training as a respiratory therapist & occupational therapist.

Patient reported to his primary care provider, Dr, on or about 4/2/21, that he was experiencing swelling in his left arm. He was advised that he could be seen in the office the following Monday, 4/5/21, or may report to the nearest emergency department. He opted to wait until 4/5/21, and was evaluated in the office. Dr's staff reported to the pharmacy that a Doppler was ordered for patient, which revealed an "acute DVT in the left proximal / mid-subclavian vein and axillary vein", and it was suspected that the Moderna 1st dose may have been related. Pharmacy was contacted by the County Health Department ( nurse), and staff from County Office of Epidemiology , and instructed to obtain further information from Dr's office to file this VAERS report. Pharmacy was NOT able to successfully contact patient for further clarification on medications/prior conditions/allergies, as calls were not returned prior to completing VAERS report.

Patient developed left leg swelling and pain. Ultrasound performed showing superficial thrombophlebitis of L posterior tibial vein.

from the second day after vaccination -> itchy, swollen, aching feet and fingers, hard to walk (does not pass). On the third day -> chills, cold as with a fever (has passed).

swelling of throat on both sides of lower neck base and slightly to the side on right and left side -- swollen and puffy -- does not go away , stays about the same in size .... and bad rash all over body that does not go away - sever itch ... doctors have no idea about swelling on base of neck and suggested we watch it ,,, so I have no confidence in what they say -- the same is true of the persistent rash that will not go away -- they prescribed some sort of cortizone cream and zyrtek ... another wrong diagnosis and treatment -- and my insurance does not cover these doctors visits because I have a high deductible and my employer does not offer health insurance -- Looking back , I wish I had never taken the vaccine .

Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.

Persistent fever began on 4/6/21 and persisted until diagnosis of acute pericarditis with pericardial effusion on 4/24/21.

patient developed lumpy rash on both arms neck and side. Dr prescribed hydroxyzine hcl and triaminolone cream . patient reports the medication helped itching but rash increased with lumps the diameter of golf balls

reports that the patient called her over and informed her that he was experiencing left head pain and the he had a bump there that was not there before and he just felt after he had received his vaccine (5/19/21 at 1102am)." escorted pt to triage area and stayed with pt until ARNP was able to assist him 3-5 minutes later.reports that pt was unable to concentrate or answer questions appropriately when she spoke with him. pt sitting upright with both arms on knees, appears to be in pain. pt reports the same situation to ARNP as what was reported to. Vitals obtained 1110: 119/76 BP, 75HR, 98%. pt A&OX3, Pt denies a hx of DM2, HTN, and anxiety. Lesion on L forehead was appreciated and was erythematic along with his L cheek. pt denies any previous trauma or bug bites this AM states " I came home, took a shower and then came to get my shot." visual acuity test performed and PERRLA present and pt able to follow without issue. B.F.A.S.T. completed to r/o stroke symptoms and it was negative. Lesion on L side of head continued to grow and pt's L eye visually was closing (or getting smaller). pt then reports that L side of face began to be numb and L arm with pain. he then agreed to be seen at ED; EMS called at 1115. Second set of vitals obtained 121/86 BP, 75 HR, 95%. pt given 2 tabs of benadryl at 1122. EMS arrived at 1130 and pt left with them.

Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: mild redness and singular hive/bump appeared on left arm 1 - 1 and 1/2 weeks after injection, 3 inches away from injection site. Arm felt bruised, sensitive and had a bump that is stillon the arm. bump appears like a big bite

No initial reactions or side effects from the first dose on April 12, 2021. Three weeks later on May 3, 2021 if felt fatigued by evening time and had chills and sweats all night. No energy on May 4, 2021 and slept all day with bouts of chills and sweats but never had a temperature over 98F. Woke up the morning of May 5, 2021 and discovered a large red patch centered over my left hip THR incision scar. The incision scar was very sore and a dark purple. I had a dull dehydration type of headache and had to urinate about every 20 minutes on May 4th. Went to the emergency room and was diagnosed to have cellulitis and given a 7 day dose of antibiotics and 10 day dose of antiviral medication. The rash never was very itch and started to subside immediately after taking the first dosage of these two medications. Went to see my primary physician on May 10, 2021 and he believes I had vasculitis and not cellulitis. No signs of any insect bites or cuts to have started the infection/inflammation. He noticed that blood vessels in and around the red patch which was about the size of a dinner plate were elevated to the surface. Followed up with Dr on May 25th via telemedicine visit and he ordered another series of blood lab and urine tests on June 10, 2021, to make sure my ESR, CRP, and urinalysis results were continuing to decline.

Excessive swelling of face and eye lids;tingling sensation on face-immediatly the morning aftervacination Discoloration of cheek and texture change to skin at cheek-continuous through next three (3) weeks

I had pain in my arm and it was swollen up. I was really tired. I had a headache (low grade), dizziness, and an hour or 2 later I started getting chills really bad. The next day I felt dizzy and kind of foggy. I did not take my temperature.

After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.

Pt developed itchy feeling in arms and hands/but states not stomach issue/no swelling in throat/no sob/no difficulty swallowing. Patient needed a dose 50mg of liquid benadryl due to swelling in hand and feeling of itching @1518; checked patient again @ 1523 stated still feeling itchy; @1526 timer went off after waiting 30 min.; asked if patient wanted to stay around a little longer (told him have epi-pen on hand could use if felt needed-patient stated didn't feel needed/no stomach issues or swelling in face or swelling in throat stated), he said no should be fine. Patient purchased some diphenhydramine to take home to use. Pt has hx of RA in hands-felt maybe vaccination was triggering that some. Will take more diphenhydramine soon; told him max 300mg per day; if gets home and has any of the above sx's needs to contact EMS asap; patient did not want to stay around any longer. Tried to contact patient prior to close-no answer on phone call. Followed-up with patient next day-stated doing better but still some itching from time to time. Event Details

It was Saturday morning Jan.30th 7:00AM. I laid on my back and I felt a awkward feeling on my growing and it was a lymphoid. It was the size of a pickle.

Initially started with the common known left underarm lymph node pain and mild swelling. After a couple of weeks the lymph node pain continued and intensified with additional pain radiating up and around the entire left shoulder for about two more weeks. Then at about 4 weeks later, the ongoing pain continued, with an additional burning nerve pain and numbness radiating down the upper arm, across the elbow and down the lower arm into the wrist. No relief of pain, now at 11 weeks post second vaccination.

Pancreatitis; Flank Pain; Allergic reaction; Abdominal Pain; Pain; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PANCREATITIS (Pancreatitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia and SEMAGLUTIDE (OZEMPIC) for an unknown indication. Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), EMPAGLIFLOZIN (JARDIANCE) and METOPROLOL for an unknown indication. On 20-Dec-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day and SEMAGLUTIDE (OZEMPIC) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criterion medically significant), FLANK PAIN (Flank Pain), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash). At the time of the report, PANCREATITIS (Pancreatitis), HYPERSENSITIVITY (Allergic reaction), ABDOMINAL PAIN (Abdominal Pain), PAIN (Pain) and RASH (Rash) outcome was unknown and FLANK PAIN (Flank Pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Had a really swollen, sore arm - and under arm pits it was really swollen too. I toughed it out for a couple of weeks. I called the clinic when it was still sore. I was not able to lift weights when I exercise - I was dropping them. I called the clinic and talked to a nurse. On June 22nd, around 1:00 or 2:00 - my whole left side went numb. I couldn't speak. Left side of face was drooping. I had blurred vision. But then it got a little better within an hour or two ( I could communicate) and I called the clinic said to come in on 23rd - doctor thought I was still having a stroke due to symptoms observed. I have an optometrist is going to check my eyes. I am going to get a physical done next month (August 9th) at the clinic. I work out and tried to do some neck exercises - and dr noticed a past injury of left side of face -that happened 45 years ago - on the CT. Dr wonders if it's related to that . I decided to do some neck exercises on Monday and yesterday I was bedridden after doing those exercises - lymph nodes swelled up. I still have some blurry vision; my face is still drooping but just a little bit. I do jumble my words.

a couple days after the second shot his arm swelled up; After his whole upper torso swelled up; has no strength in his arm; pain in his muscl; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) in a 62-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) , while the parent received the product for COVID-19 vaccination. No Medical History information was reported. In 2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the adult was diagnosed with PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up) (seriousness criterion hospitalization), SWELLING (After his whole upper torso swelled up) (seriousness criterion hospitalization), ASTHENIA (has no strength in his arm) (seriousness criterion hospitalization) and MYALGIA (pain in his muscl) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to ASTHENIA, MYALGIA, PERIPHERAL SWELLING and SWELLING. At the time of the report, PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) outcome was unknown. The action taken with mRNA-1273 in response to the event was not applicable. The patient had been in the hospital for a week due to symptoms. couple days after the second shot his arm swelled up and then after his whole upper torso swelled up. The patient had no strength in his arm and pain in his muscle. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Person had a fever of 102.4, pulse rate of 118, he was non-responsive with edema of the right calf & ankle this morning when he was assessed.

Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Was fine after receiving shot. Woke up at 4: 00 a.m. next morning with 101.5 fever. Took Tylenol but would not go down. Called primary doctor. Told me to take ADVIL. Still would not go down. After hours and very weak, called 911 and ambulance too me to the hospital. Arrived and they too vitals. Still high fever. Blood work showed high white blond count. stayed at hospital until late at night. Fever went down. Told me some people have thee type of issues with Moderna. Checked brochure Moderna provided says fever but not High fever. Doctor dismissed me from ER and told me to rest the next two days. I had Covid in October 2020. They wnet ahead and did another test. Waiting on results

The second day after I got the vaccine shot, I started to have pain on my left shoulder. I thought it was the normal adverse reaction and I kept watching it until the pain continues with tingly sensation on my left middle finger. I called my family doctor and schedule an appointment to see him. My doctor advised me to take Aleve or Ibuprofen for one week and also go to Community hospital employment office which I did and they noticed I have swelling on my left neck ( lymph nodes ) I have pain on my left shoulder and Tingly on my left middle finger hence am submitting this report.

Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination. He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A). He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies. He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome. He was ultimately discharged to outpatient care with ongoing supportive care for his fevers. His liver associated enzymes were improving at discharge.

Have had off and on swelling of my lips and face for the past seven days. First time was full face swelling about 51 hours after vaccine and and 20 hours after eating lobster and other shellfish pasts dinner. (63 and never been allergic to shellfish before) on Saturday. First swelling went down slowly and gone within 24 hours. Following Tuesday, woke to swelling/numbness of lower right mouth & lip. Lessened throughout day. Thursday, woke to upper left and upper right lips numb and swollen. Lessened throughout day. Today, woke to lower left lip numb and swollen like I?d been punched in mouth. Wife insisted I go see doctor immediately.

PER PT DAUGHTER. RECEIVED VACCINE AND HAD NORMAL SORENESS OF SITE. AFTER 5 DAYS, HAD SEVERE PAIN IN LOWER EXTREMITIES AND HAD TO GO TO HOSPITAL ER 3/5/21. WAS GIVEN STEROIDS AND NSAID AS WELL AS PAIN SHOT DURING VISIT BUT DIDN'T HELP PAIN MUCH. FELT A LITTLE BETTER NEXT DAY BUT WENT TO PRIMARY CARE AND WAS TOLD TO STOP MEDICATIONS FROM HOSPITAL. NOW WAITING FOR ULTRASOUND. DURING THE COURSE HAS EXPERIENCED SEVERE PAIN, SWELLING, HOT FLASHES, NAUSEA, AND LOSS OF APPETITE.

Evening of was sore shoulder muscle, lasting for 3 days. Starting on 2nd day, soreness down into upper arm, almost to elbow. 3rd day sore and itching. Upper arm, just below shoulder muscle appears red like sunburn. Area about 3 inches, shaped like upside down heart. This area still sore and very itchy. No blisters or noticeable bumps, but slightly raised and harder than surrounding areas. Still prominent on March 9th.

The next day after the vaccine. the injection site was swollen about the size of a golf ball. It was hot to the touch and kept getting bigger day by day. By the 4th, it had spread over my whole upper arm. I went in on the 5th to see a doctor.

Moderna COVID?19 Vaccine: I was recovering from a mild sprained ankle/foot for about a week. At the time of vaccination I had very little pain and could easily put full weight on the foot. About 13 hours after the injection, I awoke to a throbbing foot and severe pain in that foot. I could no longer apply any weight to it and it exhibited considerable swelling. I visited the doctor and am now resting, icing, compressing, and elevating the foot. Diclofenac Sodium was prescribed for pain. Vaccine induced stimulation of an inflammation response is a possible explanation.

Pt received 1st moderna vaccine on 3/15/2021 and was admitted with sudden hypoxia , sob , low grade fever and pleuritic chest pain 10 days later. Pt is lifelong non smoker. no recent travel or recent illness. no new medications.

rash in his throat; boils in his tongue; swelling in his face and throat; swelling in his face and throat; headache; joint pain; A Spontaneous report was received from a consumer(patient) concerning himself a 63 year old male patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister and boils in tongue/tongue blistering. The patient's medical history was not provided. Concomitant medications included blood thinner and meloxicam. On 25 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:001A21A) intramuscularly in the left arm for prophylaxis of covid 19 infection. On 25 Feb 2021, within the first 24 hours he had a headache and joint pain. Then, a couple of days after he experienced swelling in his face and throat, a rash in his throat, and boils on his tongue. Rash in the throat/oropharyngeal blister was considered medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache, joint pain/arthralgia, swelling in face and throat, rash in the throat/oropharyngeal blister were unknown. The outcome of the event boils in tongue/tongue blistering was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

3/26- small itchy spot in middle of forehead 3/29- Large red inflamed rash center of forehead and swelling on jaw at left ear, 3/30- appointment with VA. N.P. thought it to be Shingles w/ cellulitis and swelling from drainage. Prescribed 500MG Keflex 3 times daily. 4/2- rash and swelling have diminished, rash a little larger than 50 cent piece w/ a 1 inch vertical scab? in center.

pt reports bilateral feet swelling without pain 4 days after receiving moderna vaccine. No pain, erythema, warmth, SOB. spoke with pt day 7 after vaccine- pt reports improvement.

Arm sore 48 hours. Day 4 post shot lymph nodes became very painful. Saw Primary Care Doctor at 7 days after shot - Dr. ran blood tests, did not indicate vaccine could be the cause. Bloodwork normal. Day 11 (Sat Apr 3) and 12 (Sun Apr 4) experienced cold chills and shaking about midnight. Day 13 (Apr 5) at about 5:30 p.m. experienced cold chills and shaking and 101.5 fever - controlled by Tylenol. Followed by sweats when Tylenol wore off over night. Shaking lasts about 5-10 minutes, cold until heating pad applied - about 30 minutes. Day 14 (Tue Apr 6), 15 (Wed Apr 7), early evening chill and shakes - Tylenol stops it. Pt. feels FINE during the day - with just sore lymph glands and some fatigue. There has been only one episode of chills/shaking per day, always in the evening. Experienced sweats overnight only on Day 13 and 15, so far. Symptoms are alarming, and uncomfortable at night. Daytime symptoms of fatigue and sore lymph nodes do not impair daily activities. He continues to take Tylenol as needed.

Patient got 1st Moderna Covid vaccine on 3/24/21. On 3/29 patient started getting a runny nose. By 4/2 patient started getting fatigue with loss of appetite and on 4/3 started getting right sided abdominal pain with movement. Seen in the clinic on 4/5 with tachycardia 112 apical and temp 99.1, abdominal pain was feeling a little better and only reproducible with use of abdominal muscles. No resp symptoms except intermittent runny nose. Patient appeared very dehydrated on exam, IVF were offered but patient declined. Labs were done and patient was encouraged to aggressively hydrate at home. US abdomen was ordered STAT. Patient declined US on 4/6 because he was busy so it was scheduled 4/7. Covid test scheduled for next available apt. On 4/6: Labs showed mild increase in WBCs and dehydration but otherwise no major abnormalities. Patient reported new onset swelling, redness, and pain in his R leg and concern for DVT. He reports family history of DVT in his mother. US of the leg was added to his testing on 4/7. He also reported on and off chills. 4/7: Report called for US Abdomen was negative but patient did have extensive DVT in the right leg. Eliquis was called in and patient instructed to pick up and begin immediately. He denies any respiratory symptoms today but still intermittent chills. He reports that abdominal pain has resolved.

Axillary swelling of the lymph nodes on the left side of breast bone, which was also the side of the vaccine injection. I didn't treat it because I read on medical websites that it was a possible normal reaction to vaccinations, although I've never had it happen with any other vaccinations. I also read that it normally dissipates in a few weeks, but it's been 4 weeks now and I still have the swelling.

"cold sores"/HSV-1 on lower lip encompassing left two-thirds associated with significant swelling and development of single multiple vesicles to larger more coalescent ones. Also swelling and sensitivities to left upper and lower gum line and palate with minimal focal nodular mass effects.

Patient received the 2nd dose of Moderna COVID Vaccine on Wednesday 4/7/2021. He called the office today 4/12/2021 at approximately 9:00AM. He stated that his left arm was swollen from the shoulder, down to the his fingers. He said that the swelling started on Thursday 4/8/2021, and has not improved. I scheduled him to come into the office for an appointment with PA, at 10:20AM today, 4/12/2021. Patient was sent him to have an ultrasound, which showed DVT in the left subclavian vein and internal jugular vein.

Arm became red, hot, swollen and itchy down to elbow. Experienced worst fibromyalgia flare I have ever had for approximately 24 hours.

1/21 vaccination 1/22 pain at urination; possible dehydrated. Mild flu like symptoms. 1/23 subsided 1/24 By 4am I woke up in pain. The pain in urination came back very painful; blood in urine. I called immediately to clinic as it was painful. Drank a lot of fluids. The NP called back; 2 weeks of cipro. Might have been a particle; stone, low level. But was gone with hydration.

The patient came in this evening and wanted to report his adverse reaction to me. He stated that the day after he received his second dose of the Moderna COVID-19 vaccine on 3/26/21 he had several severe side effects start that are ongoing. He had a large red lump appear on his arm that was swollen, sore, and red. His arm is still sore. He also began to have severe body aches and weakness. He stated that the weakness has not gone away and he is still having difficulty performing daily tasks. He stated that he reported the reaction to his physician.

Severely swollen neckline lymph nodes, particularly large on injection site side (2 days after injection, til current ). Bulging along clavicle area, and swollen nodes. Fever (one day after shot, only) and significant redness and soreness around injection site (2 days after injection)

Woke up on 4/15/21 w/ "stinging to lips", generalized facial swelling present. No rash, SOB, or hives present.

Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021. On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient came to pharmacy today w/ his wife to pick up Rx for XARELTO. He has developed multiple DVT's in his leg. He reported symptoms started the day after (Saturday) his second dose of Moderna COVID 19 vaccine on Friday 4.9.21. His leg was swollen by Sunday 4.11.21. Symptoms would get worse and then get better. He finally went to see Dr. today 04.20.21. They found several blood clots in the leg via doppler. Patient was therefore prescribed Xarelto. Pt wife advised that Dr said clots were due to Moderna vaccine and they should let pharmacy know also. Their next appointment will be in 2 weeks.

Lump on left collarbone, visit to PCP who referred to General Surgeon, lump was enlarged lymph node that surgeon removed on 4/20/2021. Result was benign.

I received my second dose of Modena vaccine last Thursday (4/15) morning at 9am. No initial reaction occurred. Later that Thursday my arm got the expected tenderness, muscle ache. Towards evening, I got pretty tired and was starting to get some body aches, took 2 tylenol and went to bed at 9pm. Slept in late and was tired. Started to feel like mild flu which is what I expected. Friday took some naps and continued mild flu symptoms. Went to bed about 8pm and got up at 5:00, feeling a bit better. Saturday I continued to improve, arm was much better, less flu symptoms, didn't need tylenol, had turned the corner. Cont'd... Saturday evening was going to go to bed at 10pm and noticed my left cheek was kind of pressing against my gums - it was swollen. It continued to swell some but was not hindering my throat or breathing. I decided to stay awake, keep an eye on it and if necessary would go to an emergency room. The swelling increased only slightly more over the next couple of hours to the size of maybe a golf ball (a bit less) on the left side and a much smaller amount on the right side. No airway effects. I did apply some ice but not sure if that had an effect. I slept for a few hours. Sunday morning I did not take my medications as a precaution. Sunday the swelling was slightly less and seemed to be going down a bit. I took 2 Benedryl at 11:00 am which really knocked me out, slept. Sunday evening the swelling was noticeably improved but not gone. Took 1 Benedryl at 10:00pm bedtime. Monday still had a bit of swelling on left and right swelling is nearly gone. No other symptoms.

Rush ( red and swollen skin rush ) around the stomach area, under groin area, and down the inner parts of the legs all the way to the knees; warmth and very itchy.

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment drugs were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Rosacea -like rash .swollen ,bumpy raised wheal bilateral cheeks and sides of nose. started about seven days after vaccination and began to resolve after 4-5-days.used OTC benadryl 25mg PO in the evening and topical steroid clobetasol 0.05% ointment to reduce swelling and itch.

1.) 5/13 Sore Arm....no concerns 2.) 5/14 Minor enlargement of glands in neck 3.) 5/15 Increased enlargement of glands in neck....felt minor constriction of throat by 11:00 PM 4.) 5/16 Glands in neck swollen....breathing constriction is increasing. Will take Benadryl and monitor .....if no better by afternoon then I will head to emergency room

Pt states that he woke up the next morning and his entire left arm was swollen and numb. The following day, two days after the vaccination, the entire left side of his body was swollen and numb. The patient went to the hospital on April 6, 2021, and was hospitalized for ten days. Upon admission, he had bloody urine, swelling and numbness on the left side of his body, and was short of breath and coughing up blood. Pt was diagnosed with pneumonia while admitted to hospital.

Started with swelling hands during moderate exercise (3 mile walk). Tingling started in hands shortly thereafter and continues. Secondarily, muscle tightness especially in legs (quads very tight). Coincidentally perhaps is development strained calf muscle during a run. Finally, and related to tingling. I experience my arms "going to sleep" at night depending on which side I'm sleeping on. Summary: Tingling in fingers persists. Arms "going to sleep" at night. Tight muscles (seems to be subsiding)

left leg pain and swelling developed on 5/26/2021, did not seek treatment until 6/9/2021 as not resolving. Evaluated in ER 6/9/21, identified on ultrasound left popliteal and calf deep vein thrombosis. Started on anticoagulation therapy, Eliquis 10mg BID, ongoing treatment, reduced to 5mg BID after 7 days and will continue to monitor renal function.

Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose; Swelling in my face; Redness in my face; Itching in his face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced SWELLING FACE (Swelling in my face) (seriousness criterion medically significant), ERYTHEMA (Redness in my face) (seriousness criterion medically significant) and PRURITUS (Itching in his face) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 03-Apr-2021, SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product use was not provided by the reporter. Treatment information was prescribed antiallergic medicine and Prednisone but the patient took only prednisone. The patient was supposed to get the 2nd dose on 01May2021 but the healthcare provider on duty refused to give the shot as he had previous allergic reaction to the 1st dose. Action taken was no change. Company Comment: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Hives/rash first appeared near injection sight on 6/1/2021, becoming more severe through 6/9/2021. Medical intervention was sought from primary healthcare provider on 6/9/2021, whereas the hives became severe and facial swelling on the right side of the face appeared and lasted from 6/10/2021 through 6/14/2021. It was during this time that eye irritation appeared. As of this reporting the hives are still persisting, coming in 'waves' of almost unbearable itchiness, varying between a few minutes to 3 hours, with the duration varying between a few minutes to 3 hours as well. Disrupted sleep cycles have been a peripheral side affect, caused by the hives

Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.

Foot swelling due to Blood clot in left leg. Went to hospital ER on 2/22/21, received ultrasound showing clot. Prescribed Eliquis.

Pt stated that he has had swelling, tingling, and pain up and down his arm. He is also reporting mild pain down one side of his chest which is not going away. The second shot of Moderna was give 05-03-2021.

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

Admitted to the ER complaining of 103-104 fever, extreme fatigue, headache, weakness, and nausea. Initial diagnosis was inflammation and sepsis from unknown origin. Patient was slightly anemic and had borderline enlargement of the heart on Xray. Pulse Ox levels were 91-93 prior to giving 02. Patient had traces of blood and protein in urine. WBC levels were normal. Blood cultures failed to reveal a bacterial, viral, or fungal infection. IV Antibiotics were administered and patient was discharged with no fever after 5 days. However, patient began experiencing mild afib onn the 5th day. Metoprolol was prescribed and patient scheduled a follow up echocardiogram. No infection ever located.

Inflammatory arthritis, systemic. Stiffness, swelling, immobility, pain; persisting. Onset 24 hours after covid vaccination, unresolved. Unable to write, sit in boat, grip, disability of other ADLs. Treatment: marked improvement with prednisone, no improvement with 7.5mg methotrexate / week

Massive PE with R heart strain. Possible RA thrombus. Duplex LE with extensive residual B/L lower extremity clot. Was given heparin and needed tPA due to high risk for decompensation. Transitioning to Eliquis

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

I have had chronic diarrhea since receiving the Moderna vaccine. This is the third week experiencing the symptoms.

On day #2 after second dose, I got a pain under my left arm (injection arm) in my arm pit area. It is painful and swollen, and appears to have fluid build-up.

After 9 days I had vaccine, I had red rash on my arm, it is about 1-2 centimeters below where they aurally gave vaccine. It became itchy, little swollen, slightly pain, it get redder and little bit bigger.

Slight pain at injection site, slight swelling of lymph nodes in left arm, slight body aches. Took Tylenol and all self resolved in 48 hours.

Right side Lips, face became numb. Right eye drooped, along with corner of mouth right side Right side of tongue became numb, swelling of right jaw lymph node, ear ache, dry mouth.

C/O abdominal fullness and unable to burp. C/O soreness in bilateral lymph nodes. EMS review, VSS, Patient burped and reported improvement in symptoms

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

Chills started within five minutes then within an hour fever of 104. Patient taken by ambulance to Hospital and patient diagnosed with sepsis and cellulitis and shortness of breath

I had night sweats starting on Day 2 thru Day 6. from 2 to 3 times per night I had to change my night shirt. On day 5 I woke up to fever blisters/cold sores under/in my nostrils and fever blisters around/inside the corners of my mouth.

Chills (big time, could not stop shaking), body ache, sore injection site/arm. Swelling of arm that got the shot. Treated with Tylonal and rest

6 hours after injection had severe flushing of skin. Moderate to severe itching minor swelling of face and throat. Started to subside in 30 minutes or so. Went home took a Benadryl and slept for two hours. Had severe tiredness and some minor nausea.

On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot. The site were I had to shot was burning like it had been branded. I had brain fog couldn't remember what i was doing up. Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area. the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch. Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.

Patient states he had his 1st moderna vaccine 2 weeks ago on March 16, 2021. His left arm was sore for 1 and half days and this has resolved. He had some left groin pain shortly after this but this is gone Since the vaccine he has felt achy all over in his arms and legs He does not take a statin medication The last 3 days he has had neck pain on the left without radiation to his arms or associated numbness, weakness tingling or rash He denies any head trauma Patient works on a computer and has been blowing snow with a snow blower He denies any falls or trauma or new pillows He does not take any medications including over-the-counter herbs or other over-the-counter medications except for recently with his neck pain ibuprofen 2 pills every 4 hours He states heat does not help his neck and he cannot tolerate ice He had 1 day of a fever up to 101 on March 27th but since has had temperatures of 98-99. He denies constant shaking chills, ear pain, headache, cough, postnasal drainage, shortness of breath, wheezing, dyspnea on exertion, chest pain, UTI symptoms, change in sense of smell or taste He states his urine color changes from clear to yellow depending on how much he drinks Patient had a flu vaccine this year He has been very careful during COVID and has no known COVID exposures but would like to be tested for COVID

Swollen lymph node in neck on same side as shot given High fever of 102 with chills for 12 hours the day after shot Lymph node is still swollen two days after receiving shot

Shingles; Sore throat; Swelling of the left side of his face; Ear infection; Rash on the side of his face, inside his ear, and on his scalp; Loss of hearing; Drooping of his left lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Loss of hearing) and FACIAL PARALYSIS (Drooping of his left lip) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included AMOXICILLIN SODIUM (AMOXYCILLIN [AMOXICILLIN SODIUM]) for Laceration. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DEAFNESS (Loss of hearing) (seriousness criterion medically significant), FACIAL PARALYSIS (Drooping of his left lip) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp). On 27-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, DEAFNESS (Loss of hearing), FACIAL PARALYSIS (Drooping of his left lip), HERPES ZOSTER (Shingles), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Swelling of the left side of his face), EAR INFECTION (Ear infection) and RASH (Rash on the side of his face, inside his ear, and on his scalp) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient went to urgent care center for the events experienced. Treatment for the events included ciprofloxacin 0.3%, dexamethasone 0.1% suspension and cefdinir. Treatment for shingles included valacyclovir 1mg, gabapentin 300mg, and prednisolone 4mg. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Significant follow up appended.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Right Arm DVT and superficial venous thrombosis on ultrasound done on 3/30/2021-Pt noticed right arm soreness and discomfort then he started to have firmness which continued to get worse.

There was slight soreness in left arm where shot was given for a couple of days. This was expected and explained as a potential side effect by health personnel. Next day or so, the lymph nodes (?) in left armpit began to be tender to touch and became inflamed or puffy. Has continued to get more sensitive and more inflamed/puffy as the week has gone on. Not real painful, but definitely can tell that is there, especially when showering and putting on deodorant. Hoping that it will subside in the next week.

On April 7, 2021, upon waking noticed Right lower leg swelling from the knee down to the ankle. No pain however is swollen, slightly red and firm. Also has been lethargic since April 3 to present, April 7, 2021 but this is getting better.

Fever between 99 and 101 on second day. No fever on subsequent days. Swollen upper arm, red rash, pain in arm for the next 5 days. 6th day the swelling and pain dissipated. Still have the rash and some itching.

Moderna COVID-19 Vaccine EUA: patient presents to oncology clinic with four days of fevers (maximum temperature 103 degrees F), dry cough, left arm erythema and swelling and tachycardic after vaccination. Admitted to unspecified hospital for management of neutropenic fevers.

Patient reported headache and swelling and itching of his face. He declined treatment (diphenhydramine) or staying longer to be monitored. Noted itching was decreasing before leaving at end of 30min monitoring - left clinic alert and otherwise well enough to contact someone familiar to him should symptoms become worse per clinic nurse.

Swelling in my right cheek that has persisted for two days. No other signs of an allergic reaction and no pain with the swelling.

Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER

Site of joint replacement swelled for a week. By 7 days it did not support weight. 9 days is was 80% normal.

Covid vaccine administered on 3/31/21. 4/3/21- pt reports sore arm; muscle aches; swollen lymph nodes on Left side of Neck (Lymphadenopathy). 4/8/21 - d/t these complaints pt went into PCP office for evaluation. Pt was Dx w/ Active Shingles virus w/ out complications.

Please note the patient did not receive the vaccine at this hospital so lot # is not available. Submitting to VAERS since patient had an anaphylactic reaction and unsure if vaccination site submitted. 64 y.o. male who arrived to the emergency department for Allergic reaction. Patient developed airway, tongue, lip swelling 5-10 minutes after receiving his second Moderna COVID vaccination today. He was given 2 IM Epipens at site where the vaccine was administered then transferred to ED by EMS. EMS gave him Benadryl and a DuoNeb treatment. Patient reported mild relief. He still reported tongue, oral floor, and throat swelling. Discharged from ED in stable condition after 4 hours of observation

Severe pain to lower left leg without injury hx. Went to doctor on 3/17/21 and was examined and doppler to left leg showing no blockage. Dr prescribed nsaid as needed for pain and monitor. Monitored and pain continued until approx 4/9 and noticed swelling starting and some redness to skin slightly warm. Returned to dr on 4/13 and was placed on antibiotics. On 4/14 noticed slight shortness of breath on exertion and on 4/15 shortness of breath worsened and some irregular heartrate. I went to hospital. Bloodwork, EKG, Chest xray and CT showed multiple pulmonary embolisms and several DVTs in left leg. Admitted to hospital and placed on Heparin drip and monitored for three days. Released from hospital on 4/19 on Eliquis and advised to follow up with personal physician and report severe breathing problems or CP.

Lump under left arm pit. Lump is about the size of a quarter. Lump is not sore when touch. Lump appears to be shrinking. Noticed the lump 30 Apr 2021. Contacted my Primary Care Physician on 3 May 2021.. Physician stated if the lump gets larger or is sore to touch to go to an Urgent Care or Hospital Emergency

2 days after receiving dose #2 on 4/7/2021, patient developed left side arm, shoulder and knee pain. He developed bilateral hip pain and bilateral hand swelling. Seen in Urgent Care 4/28/2021 and 5/8/2021. Seen by primary care 5/10/2021.

17 days post vaccination as the first step in prep for a colonoscopy I experienced a reaction to the laxative Miralax, a 17 gram dose. First sneezing, the a flushed feeling accompanied by tingling and itching in hands and feet, the swelling of the lips, nose and tongue. The flushed feeling turned into a cold sweat and shaking. These symptoms started within 20-25 minutes from ingesting the Miralax and lasted for about an hour and 30 minutes before they began to subside. The puffiness and some pain continued in my face until after midnight, the Miralax was taken approximately 5:45pm I cannot say for certain whether I have ever taken Miralax before, I think so as prep for another colonoscopy over 10 years ago but not certain on that. I am reporting this per my doctor's request.

Initially developed earache, fever sore throat so went to Urgicenter on 3/19. Diagnosed with ear infection and given prescriptions for Cefdinir and Dexmethasone. On 3/27 had not improved & had a rash on left side of face, in/out ear and scalp. Earache had intensified to a stabbing pain. Returned to same Urgent care and was diagnosed with shingles in my left ear. Left side of face had started to droop, particularly left side of mouth and jaw was sagging and swelling. Had lost hearing in left ear. This was if most concern since I already have hearing loss and wear hearing aids. Follow up visit with Audiologist revealed no additional hearing loss from previous tests. After changing medications

Right off the back with fever and super tried. Started having swelling in my throat. Went to my cancer doctor an had a CAT SCAN and it came back abnormal with enlarged lump nose. So, we understood with the cancer and went back the next month an did another CAT Scan and it came by with other things in my lungs. He don't know if it's from the vaccine. I go back to my cancer doctor on 06/09/2021. He also did a PET Scan on 06/04/2021 to see some other things. Hopefully, tomorrow's test will tell the outcome. I had a total of three CAT Scan's and One PET Scan done. A lot of different things is starting to happen to my body since the vaccine. I will know more on tomorrow 06/09/2021 to be able to report more finding, if any by my PCP.

Severe chest and left shoulder pain, worse on breathing and leaning forward. Five physicians heard a rub. Responded to Motrin and Colchicine. Lasted two weeks.

Arm pain developing into joint and neck pain. Swollen gland in left side neck. Not improving after 1 week.

Had 1st vaccine on 3/30/21started feeling ill on 4/2 on 4/5 went to hospital for fever, aches & pains, loss appetite shortness of breath, etc. Was back in hospital 4/9 ? 4/14 for weight loss, fever, aches & pains, headache high white count

red,hard knot on it; Rashes and hives all over the body; Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow; He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles; Patient was wondering who he should to go to, so someone can can write "Do not give the second dose; Upper lip was really swollen; Upper lip was really swollen; Puffiness around the eyes; burning sensation on his upper lip on the inside; Felt pressure on his face; Swollen eyes; Feeling exhausted; Swollen face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the second episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), FATIGUE (Feeling exhausted), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The patient's past medical history included Stroke (he had a mild stroke 2 years ago on August 27th and his right arm, right leg, and right foot were paralyzed.). Previously administered products included for No adverse event: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EYE SWELLING (Swollen eyes), SWELLING FACE (Swollen face) and FATIGUE (Feeling exhausted). On 15-Apr-2021, the patient experienced the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face) and the second episode of LIP SWELLING (Upper lip was really swollen). On an unknown date, the patient experienced MASS (red,hard knot on it), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDINE ACID REDUCER) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 15-Apr-2021, PERIORBITAL SWELLING (Puffiness around the eyes) had resolved. At the time of the report, BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the last episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow) and FATIGUE (Feeling exhausted) was resolving and GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other non drug treatment include Ice pack to alleviate the Rash. The patient experienced just felt different. The patient rang his HCP who advised him to go to emergency room. The patient was discharged a few hours later.Patient mentioned that he is not allergic to anything and found it strange that he would have severe allergic reactions from the vaccine.During the month of May, there were a couple of times where his face was swollen, upper lip was swollen, rashes and hives on the upper arms and upper thighs. On 07 Jun 2021, his face was swollen again. Patient noticed there were rashes under his arms about two inches long and on the left arm inside of the elbow, there was a very red, hard knot on it. Patient put a cold compression to alleviate the rash. Patient is concerned because he had never been allergic to anything in his life until this incident happened. He received other vaccines like the flu vaccine and he did not experience any side effects from the vaccine. Patient also reported that he has been feeling exhausted everyday.He has not taken any allergy medications since his last allergic reactions. He was currently not experiencing any symptoms.Patient is concerned about exhaustion and the swollen face that he had woken up to three times from 14 Apr 2021- 07 Jun 2021. Healthcare professional advised patient not to take the Second dose. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, Updated events outcome to recovering and Seriousness criteria in events tab,reporter information updated, Historical vaccine in other relevant history updated,Vaccine route of administration updated in events tab and added event (Gait inability) and reporter information.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded

I had brief episodes of atrial fibrillation lasting about 30 seconds; I woke up with tachycardia of a heart rate about 130 to 140 beats per minute; my arm had some swelling; I felt a little fatigue; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 250202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) (seriousness criterion medically significant), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue). On 28-Feb-2021, ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Patient received vaccine in left non-dominant deltoid. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Swollen glands in neck, left side (fairly significant swelling) Extremely sore throat, difficult to swallow Fever around 100 - typical issues that with fever (tired, achy, etc.) Rash on chest

Patient presented with angioedema. He stated the day after his second shot, he had what appeared to be 2 cold sores, one on each corner of his mouth. He says each day the swelling has gotten worse. (Presenting from vaccine almost 6 weeks ago) He was advised to seek medical advice, to which he declined. He was then advised that if he would not do that, he should take benadryl and ibuprofen.

What started everything was that I had gall stones. It caused an infection in my gall bladder and it spilled over into my blood stream. They treated the infection with antibiotics. I was in the hospital for about a week. I'm having surgery around 07/20 to have my gall bladder removed. They found that I have diabetes. They said that it could be from the gall stones and it may go away after the removal of my gall bladder.

Beginning 1.5 hours after the 2nd Moderna dose, my hands began shaking, and my arm was sore. These symptoms continue today and have not gotten better. Beginning 2 days after the shot, my left foot from my toes to my ankle turned black and green. Beginning 1 week after the shot, my toes turned purple; this has continued on and off since May 5, 2021. Beginning 2 weeks after the shot, the lymph nodes in my neck, roof of my mouth, nose, and ears were swollen and tender. At random times, I would get hot and begin to sweat profusely 2-3 times per day, and my ears would get extremely red. At this time, my temperature would be between 100F and 101F, and my blood pressure was elevated. These symptoms lasted about 4 weeks. Beginning 3 weeks after the shot, I developed a walnut-sized, squishy knot on the inside of the joint of my left elbow. I also began losing the hair in my armpits and have since completely lost all the hair in my armpits and on my legs. Beginning 4 weeks after the shot, I developed a golf-ball-sized, squishy knot on the inside of my right knee, similar to the one that appeared on my elbow. I also developed a walnut-sized, squishy knot on my left knee just below the kneecap. Beginning 5 weeks after the shot, I developed shin splints but had not completed any running or other activities that could explain the tenderness in my shins. Beginning 6 weeks after the shot, I noticed a loss of muscle mass in my arms and legs. Beginning 7 weeks after the shot, I have had severe chest pain three times. Each felt like I was having a heart attack; 2 times were in the middle of the night and 1 time was early in the morning. Beginning 8 weeks after the shot, I began getting lightheaded at random which has caused me to fall multiple times. In addition, I have begun bruising very easily; the bruises take weeks to heal. My left eye is also extremely tender and waters more than normal. Beginning 9 weeks after the shot, I notice that I have begun drooling even though I have never drooled in the past. My gums occasionally feel tender when I brush my teeth.

Since date of vaccination (12/29/20), the adverse events, symptoms and side effects patient has experienced are the following: Pain, tenderness and swelling in the same arm of the injection. Fatigue, headache (on the second day only), muscle pain, chills. He is usually a very active person but now he has been sleeping a lot. He is also experiencing lack of appetite.

I got my injcetion on the 'top' of my shoulder. I didn't see it go in, but noticed entry point at home. Into the evening I started getting beyond normal reaction. I had a very stiff shoulder joint with pain, beyond that of my existing condition. It was severe the next day. Saw my doctor, for the first time meet, and mentioned the reaction I got, but he said it will go away. During the doctor visit I had elevated BP identified, which wasn't normal for me either. That evening I had additional symptoms that included swelling at the proximal points on the thumb and index finger, this also included the wrist. All symptoms have since subsided to normal. No other symptoms.

- sore shoulder at injection site for two days (mild); - red rash after 24 hours on arms, thighs (no pain or itching); - after 4th day, headache, swollen neck glands, chest pressure, dizziness, sore throat, fatigue - ongoing

Moderna COVID-19 Vaccine. Reaction began that same night with redness and swelling, tenderness, itchy, possible rash. By today, February 10, the redness and swelling has moved down towards the elbow. Still sore and feels warm to the touch and still itchy.

Shoulder pain in the injected shoulder radiating to the posterior scapula with paresthesias and numbness in median nerve distribution of the hand associated with axillary lymphadenopathy and tenderness for the 5 days so far since the injection. No signs or symptoms at the actual injection site. No other systemic signs or symptoms after some malaise on the day following the injection. This shoulder was asymptomatic before the vaccination and is the shoulder for the non-dominant hand. The self-reporting patient is an orthopedic surgeon.

I am experiencing redness, itching and swelling . Started in hands and moves to face, legs and torso. It happens about three times a day.

1) Tinnitus - The principal adverse event was a significant increase in my tinnitus, to levels I hadn't experienced since I originally developed the condition following a viral infection in May 2006. I first noticed mild tinnitus the day after the injection and it gradually became worse over two weeks. [not recovered] 2) Sore arm - I had a hard time lifting my arm the evening of the injection. I recovered in a day. [recovered] 3) "COVID arm" - My right arm became red swollen and itchy for about three days, starting a week after the injection. [recovered]

Anaphylaxis, hives, whips around waist and butt, itching ,swollen lips . Was given epic Pen and Benadryl , Pepsi?s and steroids 24 hours and it returned when to doctors office and received another steroid shot

02/16/2021 3PM, firm lump in arm and some itching 02/17/2021 11 AM, Swelling, red rash 2 1/2" to 3" diameter, warm to touch, itching, started taking Benadryl 02/18/2021 8 AM , stopped taking Benadryl 02/18/2021 2 PM, minimal swelling, some redness, some itching, warm to touch 02/19/2021 , all day, no swelling, a little itching, a little redness in the morning but gone by evening 02/20/2021 , AM, no swelling, redness, or itching

I am allergic to polyethylene glycol ? it actually put me in the hospital for years ago. I had no idea it was in the vaccine, although a smaller amount than I had taken before. I started experiencing severe and awful anxiety and panic that night I got the vaccine. I had other minor side effects that were expected but they went away within a day. Several days later, I began experiencing pain in both my bilateral Achilles tendons and bilateral knee pain. A physical therapist examined both and said that I was swollen. I have had both of those problems under control for a very long time. I am improving somewhat but nearly 2 weeks later I am still having some repercussions. I am now scared and don't know if I should get the second injection done because the previous adverse symptoms were awful. Thank you.

Raised area approximately 1" x 3" hard to the touch. Initially red, then Discolored as a bruise would appear...... also on L forearm what appear as dots (like a hive) multiple and itchy. This rash resolved after 2 days, using hydrocortisone cream, then returned on 2.25.21. Some relief but still a visible rash.

Hives and swelling of front, side and back of neck, severe itching, rash across shoulder and collar bone. Saw doctor 2/11 and received steroids for 5 days. Swelling and itching reduced then flared back up. Returned to the doctor.

I developed a swollen lymph node in my right side neck just under lower jaw at rear. This presented itself as strong jaw pain like a bad cavity and soreness at the lymph node. I have a sore throat and have not been able to hardly chew or swallow without pain. This is still going on as of 3/3/21 but seems to be easing up a bit. I have a Dr. appointment on 2/9/21 to check it out.

2/24 -Facial redness, minor swelling, nose peeling. 2/25 -Hands dark red, forearms red raised rash, hives on upper chest. 2/26- hands very swollen, almost had to cut ring off, rash progress to upper chest, hives resolve 2/27-3/4- rash continues, itching, face looks better, rash starting on lower legs with pitting edema 3/4-3/12- Rash less red on body and starting to dry up, face resolved, rash still on neck, legs improved, extremely dry and scaly skin on hands and forearms, still red patches on hands and neck, starting to peel skin on finger tips. much improved at this time but not back to normal yet. Never had a fever, cold symptoms, difficulty breathing or any other symptoms. Tried treatment with Benadryl and hydrochloride cream but no improvements.

my underarm at my armpit is very swollen and over into my chest. my chest is starting to swell. my wife says she sees swelling in my arm and I feel soreness in my back. its all annoyingly painful. wife also sees swelling on the side of my face ( left side)

Pt stated he woke up with a swollen arm- called the hospital and they had him be scheduled with PCP. Pt came in 03/17/21 at 1:00PM with a swollen left arm and was warm to the touch. Provider ordered a Dexamethazone injection, I gave pt injection in right deltoid- pt wait x15mins and left with no adverse reactions from injection. Provider instructed pt "if not better by tomorrow (03/18/21) get Rx for Cephalexin.

Swollen right lower leg. Doppler study revealed multiple blood clots. Stared on Eliquis. Continues on Eliquis at this time and leg still swollen

65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.

Seen at the walk-In clinic on 3/9/2021 where he presented with complaints of right leg weakness, numbness, and tingling. He was transferred to ER for further evaluation and management. The symptoms (numbness in his hip and thigh) began around 1400 while he was working. He went about his day. The symptoms progressively worsened while he was ambulating around the hardware store. In the ER, his sensation of his right leg was dulled as compared to the left. The numbness extended from his hip to his toes. Felt a pressure-like sensation in his thigh and calf. Denies pain. Felt as though his right foot is floating 2 inches off the ground when standing with both feet on the ground. Reported his right leg is 1-2 inches shorter after a femur fracture many years ago. Nothing made his symptoms better or worse. Did have an episode of feeling generally hot and then cold the evening prior to admission. Denied any trauma. Denied any dizziness, lightheadedness, headaches, shortness of breath, cough, chest pain, palpitations, vomiting, diarrhea, constipation, blood in stools, urinary habit changes, hematuria, dysuria, pyuria, myalgias, arthralgias, recent illness, or fever. MRI showed T2 changes on the right side of the cord down of the thoracic spine concerning for her transverse myelitis. Patient did have Covid vaccine 7 days prior to onset of symptoms, one dose mRNA vaccine. He is on day 3 high-dose methylprednisolone thousand milligrams IV ×3 days. He has noticed an improvement in the pressure sensation from the knee up the thigh on the right, no longer having tingling in the right lower leg or the left foot. He is still having numbness over the anterior right thigh. Yesterday when he went to bear weight on the right heel, he had a sharp pain with increase in weakness. That has since settled down. He did have a few involuntary myoclonic movements as described yesterday. This writer reached out on 3/22/2021 for information on his Vaccine lot number. He stated "At this point I am attending physical therapy, I am walking with the aid of crutches or a walker. There is improvement in the foot and lower leg regarding the numbness, but the upper thigh is still pretty much completely numb yet."

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium

pt called clinic for advice regarding swelling of Right arm on 2/18/21; pt was traiged on 2/18/21 - Pt verbalized that he has Right arm swelling since the vaccine. RN advised pt to ice the arm at least 2-3x per day. if swelling has not gone down in the next 2 days to please call for an in-person appt or stand- by list ; pt verbalized understanding.

Deep Venous Thrombosis, 5 days of calf/leg swelling, diagnosed 8 days later, treated with Xarelto. Currently being treated.

Swelling of capillaries of my retina. I did not realize that the Covid vaccine caused this and, so, I received my second does on 02/17/2021 and my condition worsened.

Slowly progressive tingling, imbalance, and mild weakness, with loss of reflexes, elevated CSF protein, and slightly elevated WBC in CSF. Current diagnosis is probable AIDP/GBS (Guillain Barre Syndrome) beginning about 12 days after vaccination. EXAM: Mild weakness, imbalance, absent reflexes in legs, trace biceps reflexes

Next morning after shower notice tennis ball size lump that is water filled and a little painful on L lymph node on axillary and neck. Applied head to the area for 2 days with decrease in size and pain.

patient is complaining of bursitis with his 2nd dose - he is stating that his doctor thinks the shot hit his bursa sac -

COVID-19 Arm: redness around injection site, area large as tennis ball and warm to the touch, slight swelling (lump on arm at injection site). Also experienced mild sweating like in a fever.

Extreme cellulitis in the left leg; swelling; was warm to the touch; severe redness; Pain in his joints; Developed a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Extreme cellulitis in the left leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LTH037A213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, SEVELAMER CARBONATE and FERRIC CITRATE (AURYXIA) for Dialysis, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever). On 20-Mar-2021, the patient experienced CELLULITIS (Extreme cellulitis in the left leg) (seriousness criteria hospitalization and medically significant), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch) and ERYTHEMA (severe redness). At the time of the report, CELLULITIS (Extreme cellulitis in the left leg), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch), ERYTHEMA (severe redness), ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment of the events included, vancomycin 1.25 g IV

Patient presented to local ED on 4/8 after having symptoms ~0400 with right sided numbness unable to move fingers on right hand. Patient also unable to use right leg properly to walk. Later ~0800 weakness, numbness progressed to left side and patient had worsening paralysis to all extremities, trunk, and to face. Patient was transferred to our facility for concern for guillain-barre syndrome. Once admitted, patient was intubated for airway protection and remains on ventilator receiving plasma exchange sessions for presumed diagnosis.

Swelling in lower right leg, ankle, foot; Venous Doppler ordered; blood clot detected; doctor examination; Eliquis prescribed.

Thumb joint on right hand. Severe pain and swelling. Unable to grip anything with right hand due to inability to bend thumb.

Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist and reports he began training again for the spring season approx. 1 mo ago. He had L calf tightness present for a few weeks as well as slightly painful knees which he attributed to his age and mild deconditioning over the winter. He traveled with infrequent stops on 4/2/2021 to visit family. He continued to have discomfort and increasing ankle pain, thus presented to ER. LE ultrasound venous dopplers performed showing extensive DVT: L femoral, popliteal, posterior tibial and peroneal veins. CT also demonstrated acute PE w/in distal R and L main pulm artery and w/in bilateral segmental and subsegmental pulm arteries involving all the lobes. Patient had remote history of LE DVT in 2017 after mild bumping of leg and placed on Xarelto for 6 mo. Had genetic testing completed at that time which was negative. He has had no clotting issues since. ( Received Moderna COVID-19 vaccines on 2/3/21 and 3/3/21. Reports brain fog and fatigue approx. 20 hours after vaccination followed by the above.) Patient discharged on rivaroxaban.

When patient came in on 4/10/2021 for second dose of Moderna COVID-19 vaccine he reported that after first dose he experiences swelling from shoulder to hand, so much he could barely take watch off. Swelling occurred 1 day after the first vaccine, which was administered on 3/6/2021. Patient took Benadryl at home and did not notify Health Center facility or his physician at the time of occurrence. Swelling resolved by next day.

Moderna COVID19 EUA chest tightness and shortness of breath, covid negative per rapid test, tachycardia and HR in 180s-190s. elevated BP and hypoxic, narrow SVT found through EKG, adenosine ineffective, admitted for pneumonia later developed chest pain and transferred to Hospital

Pt presented with lingering mild cough and dyspnea after his home diagnosed COVID-19 from 2 mos prior, that seemed to improve with his Moderna vaccine series 2/23/21 and 3/23/21. But he also had new LUQ abdominal pain and painful breathing. On exam he had a firm tender enlarged spleen versus several cm abdominal mass. WBC was > 185, 000, peripheral smear (by lab director) was "full of blasts". I sent patient same day to ER, he was admitted, prelim diagnosis: CML, awaiting pathology results but has started chemortherap as of today (4/19/21).

Left lower leg swelling which onset Sunday morning after getting his 2nd COVID-19 Vaccine (MODERNA) on Saturday.

Patient developed sweilling his left calf about 10-14 days after second dose of his vaccine. He had an ultrasound which demonstrated deep venous thrombosis of the left calf.

On 3/8/21 65 y/o M received his first Covid-19 vaccine (Moderna) and states on 4/2/2021 he had a myocardial infarction with 2 stents placed. He discharged to home and was doing very well. Tuesday, 4/6/2021, he received the second Covid vaccine. The following morning, he had pain in his right ankle. It progressed and involved his left foot and ankle. Over the next few days his pain progressed to involve his legs, but stopped at the knees. He had leg weakness and associated diarrhea, fever and chills. He thought his symptoms would pass and tried to wait it out over the weekend. When he awoke on Monday morning, 4/12/21, he could not move his feed. He went to the ER and was diagnosed with Guillain Barre Syndrome.. He received 5 doses of IVIG with very good response. Patient states his leg strength is improving, but is not back to baseline. His arms are unaffected by his Guillain-Barre. He is in Rehabilitation now.

Moderna COVID-19 Vaccine EUA: patient presents to emergency department one day after vaccination reporting shortness of breath and left flank radicular pain. Found to have widely metastatic urothelial cancer involing the chest, abdomen, and pelvis. Patient admitted to the hospital for medical management. Discharged to hospice care.

Patient states on 4/14/21 to the facility that he the following issues following his second covid vaccine that started around 22:00 on 3/26/21. Facial swelling, lymphnode swelling, severe malize and weakness, increased sleepiness, unable to urinate or with extreme difficulty. He called his PCP and was treated in the outpatient office.

3/18 Initially aches and chills. 3/20-29 Progressed on to more severe pain in muscles, joints, tendons and ligaments. 3/30-4/3 pain became debilitating, difficult to get out of bed without using arms to move legs, sitting and rising from a sitting position required extensive use of arms. 4/4-4-26 pain gradually diminished but was not eliminated. Remaining pain is mainly in shoulders, hamstrings, buttocks and hips. 4/23- some breathing difficultly started, only when taking deep breaths. Appt with PCP tomorrow to diagnose and for potential EKG.

He had the vaccine, had gravely scratchy sounding voice that does not go away, and swollen glands which he felt was due to allergies on the right side and lump on the right side of his throat which appeared on 4/25/21. He has called an ENT and has an appointment tomorrow to see about that nodule that he has.

2 weeks after vaccination, patient developed swelling in legs and feet, shortness of breath, left pleural effusion, ground glass opacity on imaging of lung

DOSE 1: MILD FATIGUE 72 HRS. SWELLING/SORENESS/REDNESS INJECTION SITE 72-96 HRS DOSE 2: MILD FLU SYMPTOMS--MUSCLE STIFFNESS/ACHE FATIGUE 99.3 FEVER LASTED 48 HOURS AFTER VACCINATION. SWELLING/REDNESS INJECTION SITE SAME AS DOSE 1 CONTINUES. BUT NOW ALSO SWELLING IN LARGE AREA LEFT ARM PIT INTO PECTORALS NOW GOING ON 96 HRS (5 DAYS AFTER VACCINATION). PHARMACIST ADVISED COLD COMPRESS ON SWOLLEN AREA WHICH HELPS REDUCE SWELLING.

5/4/21- vaccinated with second Moderna 5/5/21- Patient reported fatigue and lethargy, slept a lot, "felt like someone punched me in the nose" 5/6/21- Patient reported fatigue and lethargy had subsided, but facial swelling had begun in nose and around eyes, patient reported he was able to complete shopping trip this day and other ADL's. 5/7/21- Patient awoke early in the AM with cold chills and overall not feeling well, had temp of 101, and increased facial swelling patient stated he was unable to wear eyeglasses due to swelling of nose. Patient contact PCP who referred them to the ER where he was diagnosed with cellulitis given antibiotics, steroids, and decongestant. Patient was informed by ER to follow up with PCP and return to ER if swelling progresses or does not subside by 5/9/21. Patient reports airway patent throughout time post vaccination

I had severe pain in the entire both legs and pain in the trochanteric bursa at 4:00 AM with a fever. It resolved quickly with over-the-counter naproxen 440 mg

Left Patellar and peri Patellar Severe pain, swelling, point and generalized tenderness, no weight bearing, questions re. Reaction to vaccine triggering severe Gout versus septic joint - no fever improving course over next 6 days with increased hydration and typical treatments for a Gout flare. Have had X 2 the past five years w/ this being the most severe - low purine/low NA diet no triggering traumatic event. Resolving course.

Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs Erratic heart rate Outcome: death 3 days after. Heart failure

Patient stated, " Sometime in February and has had some type of problems with his legs since then". He gets left ankle cramps and has noticed increased swelling in left leg. Patient is now in acute renal failure.

auto immune disorder; both wrist started swelling\Swollen Knee/swollen ankle; Swollen hands\swollen feet; muscle pain every night\Pain became persistent and wont go away.; Joint (and muscle ) pain; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included QUINAPRIL for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle) and MYALGIA (muscle pain every night\Pain became persistent and wont go away.). an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain). At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle), PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain) outcome was unknown and MYALGIA (muscle pain every night\Pain became persistent and wont go away.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) extremely high but no visible sign of infection.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included steroids. It was reported that, side effects from both doses were alike and started on the night of vaccination. Two weeks after 2nd dose of vaccine, both wrists started swelling followed by the joint and muscle pain every night. Pain became persistent and won't go away. Pain only subsided 5-6 hours after taking steroids. It's been 6-8 weeks of extended inflammation. The laboratory exams performed to further understand the event included number of drug test and results pointed to an auto immune disorder. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

2-3 days of swelling of throat/neck with a sensation of a foreign body in throat then lost voice or raspy voice for weeks.

1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired.

Sore arm 5 hours after shot, low grade fatigue and fever and blood shot eyes 10 hours after shot, at 12 hours ever to 100.1, body aches, chills, joint pains, sore swollen neck glands, heart rate increased to 98 from 64 and O2 saturation dropped to 93% from 98 %. After 24 hours, aches and pains were 80% better, heart rate and O2 saturation the same and fever 99.3 orally.

Patient reports that his arm was red, swollen, warm to touch for six days. Reports his blood pressure was high and he had readings of 200/90 at times. Patient was extremely fatigued for three days. Patient had COVID 19 >120 days ago, was hospitalized and had heart issues at that time. This reaction occurred after his first vaccination.

2 hours after shot, severe and fast angioedema in left hand and 4 hours later, mild angioedema in left foot. Swelling stabalized and appears to be going down slowly - 6 hours after shot.

About 36 hours after the vaccine during the middle of the night the patient woke up with swelling of the R side of his face and pain. He went to the dentist the next morning who diagnosed him with parotiditis. He also saw a NP at his PCP office that afternoon. He was started on Augmentin and took ibuprofen with improvement of symptoms. Symptoms were mostly resolved by 1/31. It is unclear if this was related to the vaccine, but given the timeline decided to report it.

on Monday night/early Tuesday morning after the vaccine on Sunday, swelling of the left side of face/neck concertrated in the jaw area. Called the vaccination site. They said to take 2 Benadryl. Called primary doctor, he called in a steriod. On Wednesday after the vaccine, swelling of both feet. Took another Benadryl. Will start the steroid on Thursday.

The joint at the base of my little finger swelled up rapidly, starting at about 2pm. It became extremely painful. Due to swelling and pain, I could not grasp with that hand. That evening, I used ibuprofen and Aleve. The swelling and pain was better in the morning of the next day. Forty-eight hours after onset, the hand was essentially back to normal.

Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021

Facial swelling noted approximately 24 hours after the first injection was administered. Oral Benadryl administered upon onset of symptoms. Prescribed medication treatment resolved the adverse reaction.

Body aches, fatigue, swollen face/eyes, rash all over body, with welts, cough, itchy . Headache. I still have swollen bilateral eyes!

Woke up 2/13/21 with lypmh node swelling on both sides of body and moved into right peck which was very painful and swollen; got a bump on the right side that was bluish and 3 in by 4 in by 2/14/21; elevated heart rate;felt fatigue and overall not well; 2/15/21 gout attack in right toe and finger along with other symptoms, took medication for gout; swelling decreased some in lymph nodes. 2/16/21 swelling going down more; patient has been taking ibuprofen which has helped with some relief.

Tested 1/14/2021 positive, fever & malaise 1/19-21/21, admitted with severe CoVID pneumonia 1/22/2021 – 1/25/2021, required supplemental O2 1/22-24.

pain down length of L arm swelling L arm nerve pain as if carpal tunnel syndrome L arm shooting pain at times in L forearm muscle numbness in tips of fingers L hand sometimes soreness in knuckles or bones of L hand sometimes bone pain in L arm sometime muscle pain in L arm similar to "charley horse" in calf i had gotten when younger Never had any of this before , nor any prior vaccine reaction

Rash and Hives began at 12:30 Pm 3/11/2021. Started at ears then abdomen and in 6 hours spread over entire body. Went to Urgent Care approx 6:30pm. Rec'd Diphenhydramine (25mg) tablets, Prednisone (20mg) if this worsens and 2 Epinephrine pens. Diphenlhydramine provides temporary relief. Woke up this AM with rash head to toe and slight swelling of hands and feet. Experiencing mild chest discomfort (not pain), it is now 12;52 am, 3/12/2021.

Swelling and discomfort in joints and hands, dizziness, extreme fatigue for 24 hours, pain and pressure in center of chest and upper back strait across from chest pain( lasted about 6 or 7 hours.

Beginning approx 36 hours post inoculation, had glandular swelling in neck under jaw, arm pits, (both sides), the concerning thing was the rear of my tough swelled and felt like it had canker sores on it, both sides back my my molars, both sides, down into my throat. Benadryl relieves some of the swelling which would be quite bad without.

3-4 days after vaccine, developed asymmetric, localized edema in both ankles along with neuropathic-type pain in both lower extremities. Flare-up of epididymitis also with headaches. Nausea, malaise, which continues now, two weeks later. Started spiking high-grade temps every night up to 102.8 degrees. Weakness, fatigue. These symptoms are atypical for me!

Moderna Covid-19 Vaccine EUA Persistent rash on both arms, hands, fingers, and face Swelling behind left ear, swelling around left eye on face, severe swelling on both hands, and fingers. Severe itching on arms. Treatment used cortizone cream, and Tylenol. Allergic symptoms persisted for 8 days, gradually improving after day 6.

Patient came to the ED with angioedema of the lips/face that started about 54 hrs after vaccine administration. no other clear triggers were obvious other than the recent vaccine administration.

Developed sore throat on March 3, then had negative strep test. Sore throat persisted and saw ENT with normal exam. Lost sense of smell and taste on March 7th. Negative Covid test on March 10. Developed swelling in left leg on March 9, and had ultrasound on March 10 that showed DVT. Was hospitalized on March 10 and had second negative Covid test by PCR.

Patient reported pain in his arm with swelling. He also has axillary lymphadenopathy with severe pain in the right arm post vaccine

joint pain, swelling arm/feet/legs/neck, headache, lower back pain, blurry eye, insomnia, neuropathy in arms and legs, itchy

On 3/22/2021, 7 days after I received the second shot, after supper at ~6:00 PM, I felt pain from right feet below the ankle. The pain got worse by 8:00 pm. I though I might somehow got it hurt somewhere. I massage the pain area and place the foot and lower leg in a bucket filled with warm water. Those did not help. I went to bed at ~8:30 pm and felt the whole right leg very uncomfortable. The dull pain came from the foot and extended to the whole leg, I felt the foot and leg were swelling but they were not. By 12:00 am the pain became less and totally gone by 7:00 am, I urinated four times over night and had severe sweating in the second half of the night. I feel alright the next day, just some kind joint/musel uncomfortable.

5 days after second Moderna Covid vaccination, patient had sudden onset severe right leg swelling and pain, found to have extensive right lower extremity DVT and bilateral pulmonary embolism

Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up. The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded

AFTER FIRST VACCINTION: SEVERE SHOULDER PAIN , TOTAL IMMOBILIZATION OF ARM , LEFT LEG SEVERE PAIN FROM HIP TO ANKLE ,CURRENTLY STILL OCCURING. AFTER SECOND VACCINATION: PREVIOUS SYMPTOMS CONTINUING,ALSO RIGHT LOWER BACK SEVERE PAIN , DOWN RIGHT LEG.,CAN NOT WALK ON RT. LEG . BOTH SIDES OF FACE HAVE SWELLED UP IN AREA OF PRIOR FACIAL FILLER INJECTIONS

3 days after injection, severe myalgias and arthralgias in bilateral joints. Headache on and off. Excessive fatigue. Lasting weeks. His CRP was extremely elevated. Prednisone dose pack given and symptoms improved after 1 dose but then recurred when dose pack was completely. CRP came down after dose oack done, but symptoms recurred in full. Another dose pack given and symptoms resolved after 1 dose again. Concern for PMR.

Caller states that he had his first Moderna vaccine on Tuesday 4/5/21. Since getting the vaccine, has notice swelling in both calves. Denies pain or redness or tenderness to touch in legs. He states the swelling has decreased over the past 3 days, but is still present. Encourages to rest and elevate legs as often as possible and to notify his PCP regarding this new occurrence.

I had almost identical problems even after the first injection which lasted 2 1/2 days that time. This time, the second dose, affects were even worse. Injection site was sore almost immediately and started to get muscle pain in back of neck,gradually started aching with headache over time. About 8hrs after injection temperature started,my normal temp is 97-97.6 it went up as high as 102.8 & stayed above 99.4 for approximately 36hrs. Also had swelling of left side of face,left had noticeable swelling under it. At same time aches & pain got worse including chills & sweating which made sleeping impossible. Took aspirin to break fever which didn?t come down till 2 days after shot. By third day was still achy and extremely rundown. Will absolutely NOT go through this ever again:especially with the Moderna vaccine!

On 4-1 2021 My husband started with lightheadedness and unsteady on feet went to AAGH ER in Annapolis MD ruled out a stroke and diagnosed with ataxia and given antivert. Two days later 4-3-2021 he developed right side of face drooping . MRI was re-done with contrast and without and no stroke. Diagnosed with possible Bell Palsy started on prednisone and antiviral drug. Is now 4-14-2021 he feels better but right side of face still drooping. But he feels better. Only reporting as saw Bell Palsy was seen in trials for Moderna.

First shot had Covid arm. 7 days after shot started with itching around site. Next had a dark red circular area around injection site. Arm more sore than right after shot. Went away gradually over 4 day period. Just used cortisone cream. Second shot was sick with flu like symptoms 12 hours after shot. Got shot in my right arm since I had experienced Covid arm in my left arm with first shot. Symptoms lasted exactly 24 hours ( fever broke). Also noticed swollen lymph nodes in my neck on the sane side as shot. This occurred about 5 days after and went away after few days. Also started to have pain up the back of my neck on both sides. Also tingling sensation around right shoulder area. Slight occurance of Covid arm but not significant

The patient presented to our clinic with left calf pain and swelling, shortness of breath without chest pain, low grade fever. He was slightly tachycardic with elevated blood pressures to 160s/90s but had O2 saturation of 99%. DVT US showed extensive thromboembolism of left superficial femoral vein down to popliteal vein and calf veins. CTA chest showed bilateral sub-segmental PE. He was transferred to the the ED for PE workup and treatment.

The patient woke up on 03/22/21 at 7:30 with multiple symptoms. He had a fever of 100.5, both hands were swollen to the point he couldn't make a fist, a rash from wrist to elbow on right arm, chills and overall hurting from head to toes. By the evening he had a rash on both legs from ankles to hips. He lost his appetite for two days. Also, for two days his glucose levels were between 300 and 408. Patient took acetaminophen but it didn't relieve his fever. His wife called his primary care provider, on 03/22/21. She was instructed to call a hot-line, which ended up being our county health department. She was told by them to contact his primary health provider. She didn't call the primary provider again. The patient's symptoms had resolved by 03/25/22 except for the rash on his right arm. The wife called Care physician on 04/09/2021 to talk abouth what happened to her husband. This time provider called the state hot-line. The state hot-line advised the patient not to take the second shot because the symptoms could be worse or fatal.

Pt came down with severe headache on 4/15, started vomiting, complaining of "worst headache of his life, very lethargic, can't stay awake." Sent to ED on 4/21. Diagnosed with subdural hematoma with midline shift and hypertensive emergency and admitted to the ICU. Emergent craniotomy with hematoma evacuation with subgaleal and subdural drains placed on 4/21

Severe muscle and joint pain primarily in hands, arns. Shoulders. Seems to me that the vaccine triggered Polymyalgia Rheumatica. Currently being treated with 20mg Prednisone daily.

Left arm just distal to site of injection started getting erythematous, edematous pruritic and mildly tender patch. My thoughts were allergic skin reaction versus cellulitis and treated as such.

He got his vaccine, within 24 hours later he had hives, his lips and face swelled up, he had a low grade temp of 99.8 having chills and wanting to stay warm and lay in bed with multiple blankets. After his daughter noticed it about 2 hours later they went to the ER, and they gave him a steroid, Benadryl and a steroid and gave him IV Pepcid until the swelling went down and he felt better. They gave him 6 days worth of Benadryl, and steroids which he did take for that. After 6 days and after 24 hours he broke again in the same manner and they told him that it was okay as long as he was breathing well. He then went to the UC and he bought OTC Benadryl which he continued. Then exactly 30 days after he went to the ER on 4/24/21 he broke again with the lips swelling, hives, temperature was normal but feeling achy and the same symptoms he had from the beginning. He went to his PCP and he has him now on steroids, Benadryl and the Pepcid when needed as well. He takes the Benadryl as needed and then the symptoms subside and the reaction comes back. If he does not do the Benadryl until later this evening then his lips will start tightening and then swell.

Next day mouth and lips swollen, eyes puffy, top of tongue swollen up. Ate breakfast, cheeks swelled up again, today 5/6/2021 still cheeks a bit swollen. Has not had this reaction with moderna shot only second.

Patient is a 66 y.o. male who presents to the ED for onset of substernal chest pain associated with nausea and weakness. Pain onset around 6 PM. Has been nauseous and weak all day. Relates this to second Covid shot obtained on Monday (5/11/21). Reports feeling fine yesterday. As the morning and afternoon progressed he noted that he was just more and more weak and was really not able to get around which he normally does with a walker. Endorses a past history of both pulmonary embolus and pancreatitis for which his chest pain feels like. Is not currently anticoagulated. Last PE 2 years ago. History of Parkinson's disease. Denies any fever. No other symptoms reported.

Left neck gland connecting to left ear is swollen and earache. Has lessened everyday. Almost gone at this submittal. Self care, 325 mg aspirin first day. Nothing taken since.

persiseant hypoglycemia, cardiomyopathy with pulmonary edema, encephalopathy, elevated inflammatory markers, (ddimer, crp, esr)

Awoken with circumferential ecchymosis to L upper arm Also experienced mild lymphedema .5 to 1 of L extremity Reaction symptoms cleared in 36 hours I suppose it?s COVID arm .

Pt called call center to schedule a J&J vaccine instead. Pt stateswhen he got first dose of moderna on 2/5/2021 and then got severe reaction with skin rash on entire body and water retention gained 30 lbs in 5-7 days after 1st covid vaccine. Pt saw outside PCP and allergy MD for follow-ups and evaluation. [Pt reports his allergy MD advised for patient to take J&J vaccine instead. Pt will follow-up with PCP to schedule J&J vaccine.

He had numbness in face and lips that started 15-20 minutes after the vaccine. The altered facial sensation lasted for the remainder of the same day. Altered sensation was bilateral and described as his tongue and lips felt heavy and swollen. Did not see any swelling, however. Had difficulty talking, eating and drinking and compared it to having the face numb after having dental work done. This altered sensation resolved by the next day and pt. reports back to 100% of normal. He has always had tinnitus but states his ears have been ringing a lot more since his first Covid vaccine.

Pt was healthy prior. Approx 4-6 weeks after the 2nd vaccine injection the pt was noted to have joint stiffness in the R shoulder which then progressed to knuckles, wrists, and legs with weakness at his artificial knees. Stiffness was initially worse in the am and was without relief with NSAIDS. Pt had trouble with ambulation and getting up and down from chairs/sitting. He became significantly debilitated and f/u with MD ensued. Steroid dose pack helped but after several days post completion the s/s returned. C-RP & ESR were elevated but all other RA and autoimmune markers were neg on his labs. Repeat f/u with MD a Ketorolac Injection was given that didn't touch the s/s. As the s/s continued the pt was then put on Celebrex 200mg bid and instructed to f/u with Rheumatology. The pt gets relief with the Celebrex bid but if the dose is decreased to 200mg x 1 q day > the pt has immediate return of s/s. Repeat C-RP and ESR were again elevated on the second set of labs also. We are in the process of follow up with Rheumatology who after first visit said he didn't know what was wrong with him. We are pending additional labs and xrays this week. The pt has always been very active and healthy with no medical problems other then slight hypertension. His body has gone into a systemic inflammatory response acutely for no reason.

Anaphylactic reaction, Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of, eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP, STEROIDS, MULTIPLE MEDS

Swollen lymph nodes neck, (L) armpit + shoulder Rash - Red blotchy rash all over chest, Abdomen + Back

Received the Moderna COVID-19 Vaccine EUA on 01/21/2021 @ 10:30am in my left arm. On 01/25/2021 in the evening I noticed a soreness in my left collarbone and felt what I think is a swollen gland. I have not pursued any additional medical assistance from my primary care physician or my healthcare specialist.

Sore arm with mild swelling, starting 2 hrs after administration, lasting 36 hrs Generalized muscle aches and fatigue, starting 4 hrs after administration, lasting 36 hrs Shaking chills but no fever starting 6 hrs after administration, lasting 10 hrs

PATIENT EXPERIENCED ISSUES WITH SOME LIP SWELLING AND PRESENTED TO THE PHARMACY ON FRIDAY JANUARY 19TH IN THE MORNING. HE HAD VISIBLE SWELLING ON ONE SIDE OF BOTH LIPS . HE PURCHASED SOME DIPHENYDRAMING 25MG OTC AND LEFT. ACCORDING TO HIS WIFE VIA PHONE TO US (ON JAN 26 6PM) HE HAD BEEN ADMITTED TO THE ER AND WAS ON A VENTILATOR DUE TO SEVERE SWELLING OF HIS LIPS, NECK AND TONGUE. HIS AIRWAY HAD BECOME COMPROMISED AND HE WAS STARTING TO EXPERIENCE NAUSEA AND VOMITING. HE WAS IMMEDIATELY INTUBATED AND PLACED ON A VENTILATOR EVEN THOUGH HE WAS STILL CAPABLE OF BREATHING ON HIS OWN. DRS WERE FEARFUL OF MORE SWELLING AND WANTED TO SEDATE HIM AND BEGIN TREATMENTS.

Pt presented to ER via EMS at 1556 3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate, Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt, CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive.

This is a follow up report to VAERS report 259546, and is regarding the second shot of COVID vaccine. The first shot I had a bad rash 14 days after receiving the vaccine. This was treated with Benadryl and hydrocortisone and within two weeks, it was almost gone. Therefore, I was advised by my doctor to get the 2nd shot in the other arm. Within 24 hours of the second shot, the same rash broke out from shoulder to elbow that happened after the first shot. In addition, at the same time, my right armpit gland became very swollen and sensitive to the touch. Doctor advised to again use Benadryl for 48 hours and hyrdocortisone.

Patient states that about 8 hours after receiving vaccine his arm started to hurt. Approximately 12 hours later he states that his arm went numb from his shoulder down to his elbow and he states that his fingers in that hand are freezing cold and appear to have poor circulation. Upon visual, his hand looks swollen. Patient states that he gets some relief with acetaminophen. He does not have a primary care provider and does not intend to follow up with any physician.

Fever, body aches, weeknesss,temperature of 100.3, swollen neck, shortness of breath and chest pain.nousea Tylonal, phenergan, Benadryl Waiting to see if this helps

Client anxious about receiving first dose. Said he checked with his doctor as he has multiple antibiotic allergies. His doctor told him to get a COVID vaccine. He received the vaccine and was asked to wait 30 minutes. After a 15 minute wait, he stated he felt chest tightness, swelling in his eyes, face and neck. His blood pressure was elevated at 180/100 and his heart rate was 150. He felt hot/cold and felt he was going to pass out. Cool cloth to forehead and comfort position. after 5 minutes his blood pressure back to 140/80 and pulse down to 100. He continued to state his face/neck and chest were swelling and felt tight. He continued to talk without lack of oxygen. He asked an ambulance be called. He was taken to a local hospital for evaluation and was released home. No medications were given and no face/neck swelling were noted by healthcare workers. Family states he is home and doing well.

These reactions started 15 days AFTER the 1st Moderna vaccination: Feb 1, 2021 Left eye swollen shut; within hours - right eye & face swell, hives form on neck, arms, trunk. By noon, jaw was tight. Went to ER, prescribed diphenhydramine 25 mg, famotidine 20 mg & prednisone 20 mg for 3 days. Feb 2, 2021, large welt like (some bigger than dollar-size coin) swelling on head & right arm. Ears swell Feb 3, return to ER, given liquid corticosteroid in higher dose said to last 52 hours. Feb 4 hands swell, heartburn feeling in chest, light headed, overall body weakness. Begin running temp (under-arm) (between 100.5-100.8) which lasts until afternoon the following day (Feb 5) Feb 6, feet swell, Feb 7, upper lip swells; visi

Baseball sized red circular rash appeared at the site of injection 2 days after 2nd vaccine. The area is reddish, a little swollen and warm to the touch. The shot was given to the right arm. The same type of rash appeared at the site of injection a week after the 1st vaccine dose. (Moderna Lot 029L20A) It took about 6 days for the rash to disappear after the first vaccine dose. The first vaccine was also given in the right arm.

Patient states that he found a 2 to 3 inch lump in his left armpit. He found it when showering. It was not tender and not red

pt stated that later the day after receiving the vax that he started having pain on the left side of his head. The pain went from jaw to temple. He wasn't able to speak for 3 days. On 2/17/2021 he went to the hospital. They thought he may have Bell's Palsy so the they did a XRAY and CT. They were not able to find anything other than facial swelling so he was discharged and told to come back if he did not get better and they would make him an appt w/ an ENT. He started taking Aleve. He no longer has constant pain but his mouth still hurts when he opens it. He will contact his PCP to let her know what happened and to let her know that he will not be taking his 2nd covid vax dose.

Started with pain in left arm and then the pain increased around 5pm on saturday. At midnight the pain increased and went down the left arm and across the shoulder and neck , down the right arm, down the back and ribs and into the legs. His hands and knuckles swelled up. From 1am to 5am he couldn't hardly walk, he felt almost paralyed. Around 6am(Sunday) he was starting to move more but the swelling in his hands lasted into Tuesday.

Very fatigued, numerous naps taken over day 2 and 3. Are swelling first 2 days the swelling in lymph node area and pain day 3.

50 minutes after covid vaccine patient reported coughing up a small amount of blood while at dialysis center. Dialysis was delayed a day. Patient reported low BP, swelling on neck and mild shortness of breath.

Day after vaccine received, tenderness and swelling of lymph nodes in the same area of injection. Each day, swelling and tenderness lessening.

Patient is experiencing left axillary lymph node to size of golf ball as well as swollen left arm. Left arm swelling and increasing by day. Started swelling at injection site and has now progressed to his whole arm.

I got an immediate headache in my temple from the shot. That evening I developed fatigue, chills, sore throat, swollen (throat) glands. Woke up the next day feeling all of those plus coughing and sinus congestion/draining. Went to urgent care the following day and tested negative for Covid and flu. Returned to urgent care on Saturday for a chest xray and was diagnosed with pneumonia.

The morning after first vaccination I noticed tightness and inflammation in the lymph nodes in my underarm area. Days later muscle inflammation throughout my arm progressively worst accompanied by occasional tingling in the fingers, After the second week I had a virtual office visit with my PPC doctor who said this was a common side effect and so I just let it take its course. After my second shot (2/15/) the same feelings have occurred but even more acute. Keeping me awake at night etc.

Soreness in left shoulder & arm, nausea, vomiting, headache Initial soreness lasted 3-4 days then savaged. Currently, pain soreness & swelling in left hand & wrist. This has persisted for past 3-4 days.

Injection to shoulder went in vein rather than muscle; bleeding. A week later left ankle swelling, turned worse, calf starting cramping and swelling. On next Monday went to Hospital for ultrasound. Diagnosis: 2-foot long blood clot, DVT. CT Venogram taken February 11 no cause found. Went to hematologist did full blood panels. No cause found. Diagnosis: only alternative cause: COVID-19 vaccine.

Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic. At 8pm he could not get up out of his chair and was disoriented. Wife call an ambulance. He was admitted for altered mental status. Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%. BP 171/96, pulse 85, temp 37.3C. Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet. THe infection control doctor told wife he is critical.

March 7: After 3-4 days or worsening dyspnea, pt requested ambulance transport to our ED. Upon arrival, pt was very SOB so full workup ensued. Pt was found to have elevated BTNP at 2240 pg/ml with fluid overload, and Biofire Respiratory Panel showed Coronavirus PCR positive. At that time, his COVID markers were also elevated. CRP 91.4 mg/L, D-Dimer 2340 ng/mL. Patient was admitted, diuresed, and started on inpatient COVID protocol which included Ivermectin. March 9: EKG was performed and patient was found to have a heart block. All labs had improved over the past 48 hrs. BTNP reduced to 1530, D-Dimer reduced to 1700, CRP reduced to 47.9. Due to the heart block, patient was transferred to a care center to a cardiologist. Just prior to transfer, a follow up Biofire respiratory panel showed Coronavirus PCR NEGATIVE. PCR positive and negative results were relayed to accepting facility - facility and they were going to refer to epidemiology for follow up.

He got the vaccine and the first two days he had very little reaction, had a small swelling, then it went away. Yesterday, 3/11/21 the injection site area went to itching, and then he noticed a pretty good swelling in that area, and now the swelling is fairly deep, 3/4" high and about 3" across, about as big as 1/2 the size around as a baseball and sticks up about an inch. It's red to touch. His son is a nurse and told him some remedies for the symptoms. He has taken some ibuprofen for it as well, which did not do anything for the swelling.

started with minor swelling in glands, then tightness of chest, breathing difficulty, then eyes began to swell,

you got second Moderna vaccine on March 10, Wednesday. Saturday night began with left leg swelling and pain. Thought it was a side effect of the vaccine. Tuesday, march 16 the pain got so bad he went to ER. Has bleed clots in main artery in leg femoral artery. Pt. was transferred to larger hospital.

Pt reports that by the morning after the 2nd dose of Moderna, his left arm was feeling more tight and swollen. Pt denies any c/o itching. States that this shot seemed "like it hurt more" than the first shot. Pt reports that he did apply ice to the injection area as well as OTC steriod cream and that nothing was helping. He was also elevating the left arm to try and reduce the swelling. RN

Site: Itching at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium

First dose went fine. Second dose resulted in swollen left arm at outside of elbow the next day. Now just over 2 weeks later swelling has gone down some but still present. Suspect lymph node involved.

Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and went into respiratory failure with sepsis due to COVID19. He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found. HE required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ failure. His level of cognition decreased until he was no longer responsive and he died on 2/24/2021.

Moderna COVID- 19 Vaccine EUA: patient reports to emergency department five days after vaccination with left arm from shoulder to mid-hand diffusely tender, swollen, and erythematous with lymphadenopathy. Vital signs within normal ranges except for blood pressure 163/100. Patient given intravenous fluids, steroids, antimicrobials, analgesics, antihistamines, and treatment for abnormal electrolytes and discharged to home with follow-up in place.

scabs on my forearm; itching really badly; extreme swelling; redness from the shoulder down to my fingers; hot to the touch; cellulitis; it tingled; blisters on my forearm; blotches of about 6 inches x 4 inches, purplish blotches on my forearm of 1 inch x 5 inches; lymph node about the size of a Ping-Pong formed in my armpit; pain in my left bicep; redness in my left bicep; A spontaneous report was received from a consumer concerning a 67-years-old, male patient who experienced cellulitis, lymph node about the size of a ping pong formed in my armpit, it tingled, extreme swelling, blisters on my forearm, blotches of about 6 inches in to 4 inches, purplish blotches on my forearm of 1 inch in to 5 inches, hot to the touch, scabs on my forearm, redness in my left bicep, itching really badly, pain in my left bicep and redness from the shoulder down to my fingers. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 25 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient started getting redness and pain in his left bicep. He had a lymph node about the size of a ping pong formed in his armpit. He reported that the swelling was getting worse daily. On 06 Mar 2021, the patient had redness from the shoulder down to his fingers of his left arm. There was extreme swelling, blisters on his forearm and blotches of about six inches by four inches. The site was hot to the touch and it tingled. He went to urgent care where he was diagnosed with cellulitis (Medically significant). On 15 Mar 2021, the patient reported his forearm started itching really badly. There were multiple cabbed over blisters to that forearm. He also reported that he had purplish blotches on his forearm of one inch by five inches. Treatment for the event included cephalexin and allegra. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Some fatigue for a few days after injection. Swollen Lymph nodes in armpit of the arm receiving the injection. Swelling has not subsided yet.

Tuesday 3/16/21: Woke up with headache and had excruciating pain in both knees and bottoms of both feet. Extreme difficulty in getting out of bed due to the pain. Feet felt like I was walking on nails. My left hand, finger joints and thumb were badly swollen and painful. Pain and swelling persisted in knees, left hand, finger and thumb joints, but bottoms of feet improved. Sunday 3/21/21: Woke up and right wrist, fingers and thumb on right hand extremely swollen and painful. Could not use right hand for two days until the swelling and pain decreased. Headache every morning when I woke until Wednesday 3/24/21.

4 hours after injection, my left arm from my bicep to my elbow was giving me excruciating pain (10+ on a scale of 1-10). Impossible to sleep despite Tylenol to try to relieve the pain. By morning, 30 March, the pain subsided to a 1 on the same scale, but my arm swelled up from my bicep all the way to my hand and today, 4 1/2 days later, it is still swollen. My primary care doctor is sending me for a sonogram on Monday or Tuesday to discern if there is any underlying damage.

Onset variety of symptoms approximately 3/29, 10 days after 2nd covid vaccine: fever, chills swelling in his axilla, ear pain and discharge, headache, body/joint aches. Seen in clinic 3/31 and treated with augmentin for otitis, which he took with some improvement but return of drainage 3 days later. Intermittent urinary discomfort, which improved briefly then returned and culminated in passage of a small amount of blood. Was seen in ED for that, and confirmed to have RBC in urine, but CT abd/pelvis negative, CBC normal. Was told evaluation normal but may need to see urology. He thinks may have passed small kidney stone. Ten days later, continues with fevers (subjective - has no thermometer), chills, body aches, joint pain, headaches. Axillary swelling has decreased in size but he feels a pain deeper inside at that area. Pain & fever improve with tylenol but both return when it wears off. No further urinary symptoms. No rashes No recent travel Feels a little pressure in his chest to breathe, but no difficulty breathing. Never had cough No contact with COVID positive (or suspected positive) person - has only been at home. Was offered COVID test in ED but declined due to did not feel he was at risk of having come in contact with it.

He started developing right shoulder pain a week after the 2nd dose of the Moderna shot in his right arm. The pain persisted for another month and spread to both shoulders, both hips, and the muscles of his arms and legs. Tylenol and flexeril did not help much. He went to the ER on 3/15/21 where he received an IV fluid bolus and had his levothyroxine dose lowered a little. Since discharge from there, he then followed up in clinic on 3/23/21 where he said his pain and weakness were bad enough that he was having difficulty lifting his arms, grabbing objects especially at/above shoulder level, and holding objects in general to perform his daily activities of living. He was placed on a 2-week tapered course of prednisone on 3/23/21 and again required another 2-week course on 4/8/21 because when the prednisone wore off he was back to having pain and weakness.

Woken up around 2am the following day by arm pain at injection site, Arm was very sore and involved all the upper arm at the shoulder. Treated with Ice pack and acetaminophen so I could sleep. At 7am the same morning, arm was still very sore, slightly swollen and hot to the touch. Also experienced body aches and high fatigue. Ended up resting and napping for the balance of the day . Today 4/11 only have a slightly sore arm at injection site and no fatigue or body aches.

Chief Complaint Patient presents with ? Fatigue C/o feeling like he was going to faint since yesterday. Is feeling very weak. C/o still coughing and spitting up some green phlegm. Admitted to hospital

24 hours after 2nd vaccine, usual injection discomfort, low back ache, felt not well, minor, resolved quickly. 3 weeks after 2nd vaccine, onset of new bilateral lower extremity 3+ pitting edema. No previous episodes. Very active, healthy exercising/running life style. some relief with self administered HCTZ and leg elevation. Very unusual, not expected, no obvious explanation. Waxed and waned. No fever, SOB. No risk factors for DVT. Painful due to new acute stretching of skin around ankle up to mid calf. consulted ab PMD 4/11/21, suspecting side effect of amlodipine or lisinopril, however, I've taking these meds for years. This is very unusual. Lab. tests are ordered. My concern is clot.

He got the vaccine, when she gave him the shot if felt like liquid fire going in, it was then fine. Two hours later the arm started swelling up and got so swollen he could hardly move the shoulder. Then it started moving into the shoulder quadrant, as far as your fingers can spread, all the way back onto the back itself. It then traveled up to the neck, to the spine to the ear in that quadrant and stops at the knot behind the ear. The pain is so bad that you press on the knot behind the ear the headache will go away. The headache is so intense it feels like it's going to blow off and takes migraine headache medicine which does not help it. It now has caused vision issues, he cannot read/blurry vision with large print things close up. He can see fine 5' or further with no problems, but nothing up close and he can't drive due to this or use the computer as he can't see the keyboard to type. The pain has continued even up until today, 4/14/21. The shot area is fine now. Originally when the symptoms started he could not turn his head as it hurt so bad, and has taken all this amount of time to actually turn his head some, but cannot turn it to the left much. He can gently and slowly turn his head but it is painful. He has gone to his doctor and went to the COVID clinic with the first vaccine who want to see him to a neurologist.

The patient had his second Moderna vaccine on 2/18/2021. Around the same time he actually mechanically injured his knee. On 3/8/2021 he went to a care clinic for knee pain but had also developed severe bilateral shoulder, bilateral hand and hip girdle pain with stiffness a few days after receiving the vaccine. At the time he was told that this pain was likely related to compensating for his knee pain. He then presented to see me (primary care provider) in my office after having the knee repaired on 4/5/2021. Reported he was able to bear weight and walk as usual on his knee but was not seeing any improvement in his shoulder, hand and hip girdle pain and stiffness. Ultimately was diagnosed with polymyalgia rheumatica, started on prednisone and referred to rheumatology.

3 days after 2nd Moderna vaccine developed fevers, chest pain, shortness of breath. Now found to have probable constrictive pericarditis without clear etiology.

Moderate swelling of the axillary lymph node in the left arm and slight pain, on the second day after vaccination. Slight headache, chills and drowsiness from the day after vaccination.

Patient hospitalized Hospital Admission Diagnoses: Severe sepsis (CMS/HCC) [A41.9, R65.20] Discharge Diagnosis: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 Discharge Diagnoses: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 *Acute respiratory failure with hypoxia (CMS/HCC) 03/24/2021 *Acute pulmonary edema (CMS/HCC) 03/24/2021 *IVH (Intraventricular hemorrhage) (CMS/HCC) 06/06/2018 *Brain edema (CMS/HCC) 06/06/2018 *Brain compression (CMS/HCC) 06/06/2018 *Benign essential HTN *Coronary artery disease * Type 2 diabetes mellitus with hemoglobin A1c goal of less than 7.0% (CMS/HCC) *Nontraumatic right thalamic hemorrhage (HCC) 06/05/2018 Consults: IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY INPATIENT CONSULT TO PHARMACY INPATIENT CONSULT TO PHARMACY IP CONSULT TO NUTRITION SERVICES IP CONSULT TO NUTRITION SERVICES Procedures: Intubation Catheterization Significant Diagnostic Studies: Cardiac Catheterization

Achy and sore all over, his arm is sore and red. He noticed he has a buldge in the arm pit, it may be swelling. It is the size of half of tennis ball. He has monitored the symptoms only, no meds

50 days after 2nd shot, severe injection site nerve pain. (Severe Radiculopathy) also experiencing moderate bilateral swelling from knee down through foot.

Acute idiopathic pancreatitis. Symptoms included tenderness and tightness in the center-left portion of the upper abdominal region. After 24 hours of discomfort, patient went to ED at. CT, ultrasound, and blood panel were conducted at that time. Ultrasound was negative for gallstones, blood panel showed highly elevated lipase (~600), slightly elevated WBC. Recommended admittance and abstinence from food for 36 hours. Treated with IV hydration, and IV antibiotics for potential diverticulitis. After 36 hours, put onto a liquid diet for 24 hours, then was allowed to eat a normal meal and was discharged without restrictions or modifications to diet or lifestyle.

lymphadenopathy Narrative: Patient received COVID-19 Moderna vaccine doses on 2/27 and 3/27/21. During both doses patient was observed for 15 minutes post-vaccination and not noted to have any adverse events immediately following vaccination. On 4/19/21 , patient messaged provider to report that developed 2 lumps on his collarbone area since receiving the 2nd dose of COVID-19 vaccine. Patient denied any pain, redness, or other symptoms from reaction with the exception of fatigue. Patient reported on 4/21 that smaller lump appeared to be dissipating, while the larger nodule had no change unless he manipulated it. When patient manipulated the larger lump he reported dull pain. Patient stated he is checking the lumps daily and was advised to keep the clinic up to date with any changes. Lumps were likely lymphadenopathy which is a known adverse effect from the COVID- 19 vaccine.

extremly high blood pressure; severe headache; DVT to right leg starting at the groin and going down to the foot; worsen edema with 4+and 5+ pitting edema in right leg; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included DUPILUMAB (DUPIXENT) from 09-Mar-2021 to 06-Apr-2021 and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg). On an unknown date, the patient experienced HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache). At the time of the report, DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot), OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg), HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound Doppler abnormal: abnormal (abnormal) Causative extensive occlusive thrombus", DVT in the right leg starting from the groin going down to the foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had an ultrasound of the leg performed. The diagnosis showed "causative extensive occlusive thrombus". Patient reported taking heparin and acetaminophen(Tylenol) ad treatment for the symptoms. This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-079102:1st dose

Right middle finger became blue and very painful to touch. Swelled up and became very hard and crusty. Tip of finger very cold

Significant left axillary lymphadenopathy, not resolving after 6+ weeks. Patient presented to family practice physician with large axillary swelling and lymphadenopathy. Patient had several follow ups with providers and was eventually diagnosed with B-cell lymphoma.

03/09/21(2:00PM):received dose 1 moderna vaccine - no ill effects; 04/07/21 (10:00AM): received dose 2 Moderna vaccine; 04/11/21 (11:00PM): experienced what seamed muscle cramp in left upper calf muscle; 04/19/21: cramp diminished, some swelling left upper calf, slight swelling left inner ankle; 04/22/21: swelling entire left ankle and top left foot; 04/22/21: visited primary care, diagnosed possible Baker's cyst or venous thrombosis - sent to hospital for ultrasound; 04/22/21: ultrasound revealed deep venous thrombosis, upper left calf vicinity (popliteal vein); 04/22/21: hospital performed blood tests, prescribed Xarelto 15mg (2 daily) for 21 days; 04/26/21: primary care follow up, prescribed Xarelto20mg (once daily) for 90 days. 05/22/21: slight swelling inner left ankle persists, slight fullness upper left calf persists, otherwise no other ill effects; 05/22/21: further blood tests pending (as per primary care physician): cbc with differential, pcrp, ante, esr, 83891, cmbp, tshr, ptp, leid, misc, acab, lupus; NOTE: Moderna dose 1: lot # 048A21A, intramuscular, left arm

Rash of increasing severity, treated beginning 04/05/21 by PCP with prednisone 20 mg 1x/daily. Referred to dermatology; diagnosed by PA on 04/13/21 as Seborrheic Keratosis and treated with IM steroid and begin triamcinolone acetonide. Rash worsened. On 04/20/21, seen by dermatologist and diagnosed as Urticaria. Prescribed loratadine 10 mg 6x daily/famotidine 10 mg 2x daily/hydroxyzine 25 mg 1x/daily. Seen again 04/27/21; confirmed continued Urticaria and continue loratadine/famotidine/hydroxyzine regimen. Condition persisted; on 05/24/21 dermatologist observed severe erythematous patches on trunk, arms and legs. Another IM steroid, continue loratadine/famotidine/hydroxyzine and referred to allergy clinic (cont)

4/19/2021--About a week after 1st dose of COVID-19 Vaccine patient experienced lymph node swelling in axillary area on L side (the side he received vaccine). He came to get 2nd dose and was still experiencing this swelling and decided to get the vaccine in the same arm - the swelling did not worsen after the 2nd dose although he did experience body aches and chills. Now about 5 weeks later patient is still experiencing lymph node swelling and it is very uncomfortable for him - it in painful and achey if he puts any pressure on it so sleeping has been miserable. He has followed up with his provider and had an ultrasound - his waiting for those results. Will report to VAERS, RN.

About 2 weeks after the vaccine, a knot lymph node appear on the right side of my neck. I also had swelling lymph nodes under my arm with the first dose. It was about the size of a large grape and felt painful, no fever. I went to the doctor to get it check out. I was advise to wait and see. I was not prescribed any medication. It did take 3 weeks for it to go away. It has not reappeared.

Acute myocardial injury/ Myocarditis; MIS-A; Hypertensive; Worsening shortness of breath; Orthopnea; Fever; Chills; Nausea; Increasing fatigue; acute exacerbation of CHF; hypoxia; tachycardia; tachypnea; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocardial injury following COVID-19 vaccination: a case report and review of current evidence from vaccine adverse events reporting system database. The patient's past medical history included Stent placement and Coronary artery bypass graft. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, Congestive heart failure (with preserved ejection fraction), Chronic obstructive pulmonary disease (without any home oxygen requirement), Hypothyroidism and Gastroesophageal reflux disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE MONONITRATE, LEVOTHYROXINE, LISINOPRIL, METFORMIN, METOPROLOL TARTRATE, POTASSIUM CHLORIDE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and TIOTROPIUM for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocardial injury/ Myocarditis) (seriousness criteria hospitalization prolonged and medically significant), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (Hypertensive) (seriousness criterion hospitalization prolonged), DYSPNOEA (Worsening shortness of breath) (seriousness criterion hospitalization prolonged), ORTHOPNOEA (Orthopnea) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), FATIGUE (Increasing fatigue) (seriousness criterion hospitalization prolonged), CONDITION AGGRAVATED (acute exacerbation of CHF) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criteria hospitalization prolonged and medically significant), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and TACHYPNOEA (tachypnea) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHILLS, CONDITION AGGRAVATED, DYSPNOEA, FATIGUE, HYPERTENSION, HYPOXIA, MYOCARDITIS, NAUSEA, ORTHOPNOEA, PYREXIA, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, TACHYCARDIA and TACHYPNOEA. The patient was treated with FUROSEMIDE (intravenous) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency; CEFTRIAXONE for Sepsis, at an unspecified dose and frequency; AZITHROMYCIN for Sepsis, at an unspecified dose and frequency; Physical therapy (BiPAP (12/8 cm H2O setting)) for Dyspnoea and Physical therapy (BiPAP (12/8 cm H2O setting)) for Hypoxia. At the time of the report, MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bilirubin: 1.9 (High) mg/100mL. In 2021, Blood culture: negative (Negative) negative. In 2021, Blood gases: abnormal (abnormal) pH 7.294, HCO3 21 mmole/L, PaCO2 39.9mmHg. In 2021, Blood lactate dehydrogenase (135-225 units/l): 239 (High) units/L. In 2021, Blood lactic acid: 5.7 (High) mmol/L. In 2021, Blood potassium: low (Low) hypokinesis of the ventricular wall in 2 regions on TTE with an acute presentation. In 2021, Brain natriuretic peptide (Unknown-124 pg/ml): elevated (High) 43134 pg/mL, elevated (High) 39813 pg/mL and elevated (High) 4796 pg/mL. In 2021, Breath sounds: abnormal (abnormal) coarse crackles in both lung bases. In 2021, C-reactive protein (0-0.5mg/dl): elevated (High) elevated 15.5 mg/dL and elevated (High) 11.5. In 2021, Chest X-ray: abnormal (abnormal) cardiomegaly and pulmonary edema without any focal conslidation. In 2021, Echocardiogram: abnormal (abnormal) mildly dilated left atrium, a left ventricle ejection fraction of 50%-54%, mild hypokinesia in the mid-septal and mid-anterior walls and grade 2 diastolic dysfunction. In 2021, Electrocardiogram: abnormal (abnormal) sinus tachycardia with non-specific ST/T wave cganges. In 2021, Fibrin degradation products (Unknown-500 ng/ml): 2010 (High) ng/mL. In 2021, Haemoglobin: 18 (High) g/dL. In 2021, Influenza virus test: negative (Negative) negative. In 2021, Oedema peripheral: 1+ (High) pitting edema in his lower extremities. In 2021, Oxygen saturation: 86% (Low) on lL/min of oxygen via nasal canula. In 2021, Red blood cell sedimentation rate (0-20 mm/h): elevated esr (High) 41 mm/h and 34 (High) mm/h. In 2021, Respiratory rate: 40 breaths/min (High) tachypneic. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Serum ferritin (30-400 ng/dl): 550 (High) ng/dL and 454 (High) ng/dL. In 2021, Sputum culture: negative (Negative) negative. In 2021, Troponin (Unknown-19ng/l): 180.8 ng/l (High) elevated high sensitivity troponin, 117 (High) ng/dL and 85.2 (High) ng/dL. In 2021, Urine analysis: normal (normal) normal. In 2021, Venous pressure jugular: elevated (High) elevated. In 2021, Vital signs measurement: high (High) BP, mmHg= 169/96 HR, beats/min=141 Temperature (degree F)=101.2 RR, breaths/min= 26 oxygen saturation, %; oxygen requirement=92% 15L oxygen by NRB mask, high (High) BP, mmHg= 134/61 HR, beats/min=92 Temperature (degree F)=98.6 RR, breaths/min= 21 oxygen saturation, %; oxygen requirement=99%; BiPAP (12/8); 40% FiO2 and borderline (Borderline) BP, mmHg= 129/73 HR, beats/min=87 Temperature (degree F)=98.3 RR, breaths/min= 22 oxygen saturation, %; oxygen requirement=96%; 2L/min by NC. In 2021, White blood cell count: 17.86 x 1000/µl (High) leukocytosis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) to be possibly related. Patient denied history of previous COVID infection or contact with a patient with known COVID-19 infection. Acute exacerbation of CHF was treated with diuretics and supplemental oxygen therapy. Tachycardia and Tachypnea improved with bronchodilators. A literature case with some reported events approximately 6 hours after the second dose of vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.; Sender's Comments: A literature case with some reported events approximately 6 hours after the second dose of vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.

Pain in back of neck, down arms to fingers, hip. Swelling and or lumping of both bilateral bicep muscles. Flu-like feelings, low grade fever and stay in bed most of the day. My Eryth. Sed. Rate, C-Reacitve Protein and other bizzare levels show a lot of inflammation. My other lab reports (back from Fall of 2020 to 2011 are normal). This has been going on since March 2021. I cannot perform caretaker duties for my wife who has Parkinson's Disease;

Not sure if caused by vaccine but growth double golf ball size on rt side neck. Family doctor not sure. could not see ENT until Aug 4th.

After shot dizzy and light headed; Had shot Tuesday Friday night left side jaw pain and teeth misaligned due to jaw not closing due to pain and swelling.

Ongoing issues with migrating joint and muscle aches. Initially I took advil. After 2 weeks my GP prescribed a medrol dose pak that got rid of symptoms immediately and for the duration of the treatment. When the meds were over the symptoms came back to a lesser degree. The symptoms are persistent to this day. I presently take 2 tylenol usually twice a day and I am comfortable but still have slight malaise. I am due for second shot on the 29th. A little worried

Swelling (puffiness) of Lymph gland in armpit of vaccinated arm site. Occured about 3-5 hours after vaccination and is still present at 8 days.

The patient noted weakness starting in the legs on January the 19th, 10 days after receiving the first dose of the vaccine. The weakness progressed to the point that he was able to ambulate only with assistance. He was seen in my neurology clinic on January 28th and his evaluation suggested an ascending, painless weakness of the legs with rapidly progressive symptoms. He was admitted to Hospital on the same day. His evaluation is consistent with Guillain Barre Syndrome and he has been started on plasmapheresis to treat the condition.

HCP was called to a patient with "tongue swelling". HCP asked MD for an Epi Pen and the paramedics are O2. O2 was applied at 2L per NC. . HCP approached vehicle where a 68yo white male was sitting in his vehicle on the driver side. Quick assessment revealed erythema of the face and angioedema. Pt was able to speak clearly, was CTA and had RRR. 911 was called. BP 160/90. EpiPen dose 1 was injected into right vastus lateralis and pt reported improvement at 1057. HCP asked for injectable diphenhydramine. HCP continued to monitor pt with RRR and CTA but erythema and angioedema began again along with swollen tongue so EpiPen dose 2 was injected into right vastus lateralis. 50mg IM diphenhydramine was injected into the right deltoid while fire rescue began to arrive on scene. Pt did not report difficulty breathing. Pt did report previous anaphylaxis to fire ant bites/stings and did report being allergic to bee stings. Fire rescue transported patient without difficulty. HCP called pt later that night at 2030 who reported doing better but still having tongue swelling.

Pericarditis with pericardial effusion. Treatment: Pericardiocentesis, Colchicine, Aspirin, Ibuprofen, Omeprazole Symptoms began (syncopal episode, retrosternal chest heaviness and aching worse with inspiration, fever, chills, lymphadenopathy for a for 9 days following vaccination) Outcome: Patient discharged home after 3 day hospitalization. Currently feeling better at 1 week follow up.

During welfare checks pt was found to have ALOC and swollen lymph nodes. Pt's VS 200/107 P 144 R 16 T 98.1 O2 sat on RA 99

patient developed headache, myalgia and nausea around 8-9 hours post injection. He felt he was having a sickle cell crisis. He worsened overnight and developed acute respiratory failure with respiratory distress and diaphoresis. EMS called around 7am on 2/9 and placed on BIPAP and admitted to ICU

4 hours after shot, patient's underarm lymph node swell. He is continuing to see his doctor regarding the lymph node. The lymph node is still swollen with not much improvement per patient.

Pt admit 2/16 with angioedema after receiving Moderna COVID-19 vaccine 2/4/21 given at store. He was treated with benadryl, pepcid and solu-medrol and symptoms improved. 2/17 solu-medrol dose decreased from 60mg bid to 40mg daily. ADR admitted to VAERs and Moderna. Pt discharged in stable condition.

Symptoms started within 3 days of getting the shot. As per Hospital : severe UTI - cleared up completely severe Pancreatitis - cleared up completely Severe diabetes - placed on high insulin severe kidney failure - placed on dialysis

Pt. had facial swelling, and difficulty breathing the night he received the vaccine. Difficulty breathing resolved by morning and facial swelling resolved the next day. Patient also had redness, pain, and swelling at injection site. Patient never sought treatment for reaction and feels it has completely resolved

Woke up at 2:00 AM and every joint, every muscle, every tendon in my body was in excruciating pain. It was like it triggered an attack of Polymyalgia Rheumatica (PMR). I could not get out of Bed for 2 days. I had the shot on a Thursday and today is Monday and I am still exhausted and not back to normal. My arm was swollen for 48 hours with a big lump.

Vaccine manufacturer and lot number unknown, vaccine given at alternate location. 2/23/21 8:27 PM: The patient is a 68-year-old male comes to the emergency department by paramedic ambulance for altered mental status that, began at around noon in association fever temp 102.9. PMH of myelofibrosis (on Jakafi and hydroxychloroquine), depression, anxiety, OSA, and history of AVR. Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors. Patient has a MOS procedure 14 days prior - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission. ED physician indicated mild facial cellulitis. 2/23/21- WBC 16.1 on admission. ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine. He did not feel the patient has a source of infection upon admission. Questionable given wounds on forehead Dr. (CMO) review of case- his impression was septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse

Within 48 hours of second vaccine, I developed a red spot on my right foot that was tender next to my small toe. This area became very soar and I am unable to walk on that part of my foot without extreme pain and swelling. I have not seen a physician yet, but doctor ordered an x-ray which he said showed no fracture. I am waiting to see a podiatrist . My foot has shown no signs of improvement so far.

The patient's arm became very swollen and warm immediately after the injection. He said it was pretty painful as well. We applied ice and monitored for 30 minutes. By the end of the 30 minutes the swelling had gone down.

exactly 3 weeks after my first vaccination (I am going for my second one on 3-16-21) my left hand became red and very swollen. I was vaccinated in my left arm. The swelling extended a little beyond my wrist as well.

severe fever after 7 hours-103-104 lasted 11 hours-reduced fever 15 more hours, chills, accelerated pulse, rapid breathing, nausea-no food or water 15 hours, enlarged lymph gland under right jaw (did notice an enhanced sense of smell during both 1st and 2nd shot reaction period)

Enlarged right lymph node (opposite of injection arm), Headaches, Fever, Body aches, Chills, Sweating ,Fatigue, Tiredness,

Offer 4 hours development Cardiac anaphylactic shock with. Blood pressure dropping to 90 when sitting and would not read pressure when standing. Heart rate at 133 bpm throughout the nest 48 hours then slowing dropping. Was at 92 after 72 hours and normal 62 the next day.

Sore arm 2 days/3rd day started with pain right side lymph nodes, next day pain on both sides of lymph nodes and then couldn't swallow having a hard time eating and the pain was really hard the swelling got real large underneath my chin and bottom part about my neck, had to go-to my doctor today for swelling in pain and both sides of the throat look like white pus on inside of my mouth and also just wanted to note my wife after the first day she felt like she had the a fever for two days chills and everything and eventually that went away for her. My doctor put me on amoxicillin today or no it was a penicillin and it's $875 milligrams twice a day. She thinks it was just tonsillitis but still having problems doing a lot of salt water ibuprofen aspirin drinking lots of chicken noodle soup so I hope that helps you out

Angioedema; Difficulty breathing; A spontaneous report was received from a pharmacist, concerning a 68 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced angioedema and difficulty breathing (dyspnea). The patient's medical history was not reported. No relevant concomitant medications were reported. On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection. On 16 Feb 2021, approximately 12 days after receiving vaccine, the patient was hospitalized for angioedema with swollen oral cavities, swollen lips and difficulty breathing. He was treated with diphenhydramine, famotidine and methylprednisolone. The patient was discharged from the hospital on 19 Feb 2021. The patient did not have any changes in his diet or at home medications. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of events, angioedema and difficulty breathing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of these products and the start date of the event, a causal relationship cannot be excluded.

Fever (103.7) with rigors 1 PM Mar 16, 2021 Night sweats Mar 17, 2021 Left Foot tenderness and swelling Mar 18-19, 2021 Left calf swelling with pain Mar 19, 2021. 5 PM Left leg DVT diagnosis Mar 19, 2021. 8 PM (UltraSound) despite warfarin treatment with INR 3.1 measured Mar 19, 2021. at 8 PM Admitted Medical facility Mar 19, 2021 with fever noted in chart through Mar 21, 2021 Switched from Warfarin to Lovenox anti-coagulation therapy due to warfarin failure Mar 21, 2021 Released from hospital Mar 21, 2021 Seen in clinic by Nurse Mar 25, 2021 for follow up Phone visit Mar 24, 2021 Coagulation specialist

Sensation of chills and shivering began approximately 15 hours after injection. Symptoms worsened and broadened to include generalized body aches, headaches, loss of appetite, and overall listlessness which persisted for approximately 30 hours but were ameliorated with Tylenol. Reddened area appeared on left upper arm, approximately 10cm long by 8cm wide and separate from the site of injection. The closest point of the reddened area to the site of injection was separated from it by approximately 2cm. The reddened area was neither painful nor manifested itching. Gradual reduction in redness and swelling noted as time progressed, but is still visible five days post-injection.

-2/8/2021: received Dose #1 of COVID-19 vaccine (Moderna) -2/10/2021: received pembrolizumab 200mg IV for metastatic sarcoma (has had excellent response over last two years with almost no side effects) -2/13/2021: 5 days after receiving Dose #1 of COVID-19 vaccine (Moderna) - fever, body aches -2/14/2021: COVID PCR test negative -2/15/2021: presented to emergency room with fever (103.4F), body aches, epigastric pain; admitted to hospital for pancreatitis (CT: acute insterstitial edematous pancreatitis with moderate peripancreatic inflammatory change); Lipase, SGOT, SGPT, WBC elevated. Infectious work up negative (no antibiotics given). No previous history of pancreatitis. Discharged from hospital on 2/18/2021. -2/19/2021: presented to oncology immediate care with rash (torso, back, scalp, arms) ? mildly itchy; started on prednisone taper -2/23/2021: returned to oncology immediate care with worsening rash, abdominal pain, vomiting; continue prednisone (80mg PO daily) -2/26/2021: dermatologist consult for generalized pruritic erythematous edematous eruption on face, torso and extremities; rash improving on prednisone, advised to start topical triamcinolone ointment. Elevated SGOT, SGPT. -3/17/2021: received pembrolizumab 200mg IV; pancreatitis and rash resolved. SGOT, SGPT slightly elevated.

He got his vaccine and had no problems other than arm soreness. Then yesterday, 4/4/21 in the groin area he has itching, swelling and redness on both legs, worse on the left leg. The right arm has a rash that started off as welts with redness just to about the elbow. The areas are not hot to touch, just itchy. He had some anti-itch spray that he has been putting on the areas, which seems to be helping.

Parotitis - Primary Very swollen face on my right side (apposite side from injection site) On Thursday 3/11/21 (after injection Tuesday morning 3/9/21) woke with swollen right side of face. Eating painful. Friday extreme swelling, externally visible and very painful. Saw Dr. who started course of rimethoprim-sulfamethoxazole (Bactrim DS) 160-800 mg TABS. Over weekend swelling and pain went down, but it was a full 2 weeks before I felt almost all of the symptoms were gone. This is not a condition I have ever had before.

Severe Pain, both knees... Swelling about LEFT knee... Swelling down to LEFT ankle foot... Blood Panel Dr Consult Ultrasound LEFT Leg... Checking for DVT. Beginning Prednisone 20mg for 5days, 4/7/2021.

Monday morning at 08:00am I experienced a short dizzy spell lasting 3 to 5 seconds while walking in my home. At about 09:30am the same morning I had another dizzy experience for the same duration. The remainder of the day I experienced a light headed feeling all day. The next day (today) started out normal but by 10:00am I experienced dizziness again for about 8 to 10 seconds and as I write this report I have a light headed feeling again. Note: one week ago I had a sore gland under in my jaw on the left side just below my left ear which lasted for 3 days and went away without treatment. I have not seen a Doctor in reference to this condition yet.

24 hours after vaccine swelling to throat and face, shortness of breath, dizziness, weakness, headaches-symptoms lasted 3 days

My doctor says there is a good chance the Moderna vaccination trigged a polymyalgia rheumatica reaction. I am currently being treated with Prednisone.

Since 2 days after the first vaccine in Dec 2020 I have experienced migrating discomfort in muscles and joints. I had to take medrol dosepak on 2 separate occasions to allow me to function. The symptoms go away completely with the steroids. Otherwise I take Advil 2 tablets BID (I did TID for a while). I never had to take anything before in my life. I never had these symptoms prior to the vaccines. I took the second dose with persistent symptoms from the first vaccine.

DVT leg leg: leg pain started around 3/24, then he developed swelling on 4/2 and a DVT was diagnosed on 4/3. He had been on Xarelto 10 mg daily for history of recurrent DVT (had never had one while on anticoagulation) at the time this was diagnosed.

Dose 1: Arm soreness, Dizziness, Fatigue starting 20 minutes after dose and lasting 2 days. Dose 2: More severe soreness, swelling at biceps and progressing to forearm Lasting from 2 days post to 7 days post. Chills, aches muscles and joints (flu-like) no fever, for 1 day, day after shot. ****Dizziness, balance unsteadiness, brain fog starting 2 days post to present (1 month) Standing only. This last one is worrisome. Doesn't really show signs of improvement.

Arm pain with redness and swelling at injection site, headache, severe shaking/chills, fever of 102.7 for 2 days, numbness on left side of face including tongue and gums with a slight facial droop lasting for 3 days, night time hallucinations lasting 6 days.

Currently experiencing severe intractable nausea and vomiting (unable to drink even a sip of water), fluctuating blood pressure, a severely racing heart (130bpm), overall weakness and fatigue. Started the evening of April 20 and became so severe by the evening of April 2021 that had to come to the local emergency room.

abdominal pain; lymphadenopathy; Nose bleed again for 1 to 2 days when he sneezed or coughed; Awake hallucination; Shaking chills; Feet were red; Myalgia; Arthralgia; Chills,Teeth were chattering; Headache; Nausea; Violent vomiting, vomit was coming out of his nose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (Awake hallucination) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (The patient received monoclonal antibodies.) in January 2021, Myelosuppression (As a result his platelets and white blood cells count were dropped.) in January 2021 and Nose bleed in January 2021. Concurrent medical conditions included Asthenia, Walking difficulty, Pituitary apoplexy (makes him high risk patient) and Panhypopituitarism (makes him high risk patient). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CORTISONE, FLUDROCORTISONE, CABERGOLINE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81), TESTOSTERONE and VITAMIN E NOS for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HALLUCINATION (Awake hallucination) (seriousness criterion medically significant), TREMOR (Shaking chills), ERYTHEMA (Feet were red), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), CHILLS (Chills,Teeth were chattering), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Violent vomiting, vomit was coming out of his nose). On 20-Mar-2021, the patient experienced EPISTAXIS (Nose bleed again for 1 to 2 days when he sneezed or coughed). On an unknown date, the patient experienced ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymphadenopathy). On 20-Mar-2021, HALLUCINATION (Awake hallucination), TREMOR (Shaking chills), ERYTHEMA (Feet were red), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), CHILLS (Chills,Teeth were chattering), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Violent vomiting, vomit was coming out of his nose) had resolved. At the time of the report, EPISTAXIS (Nose bleed again for 1 to 2 days when he sneezed or coughed), ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymphadenopathy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to events was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-076797 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-076797:first dose

The patient is experiencing pain and swelling of the neck on the left side. The patient had the vaccine on his left arm. He said his arm is sore but his neck is sensitive to the touch. We discussed using warm compresses. He indicated he would seek medical care if it got any worse. He was not having any other symptoms.

Painful Swollen Lymph nodes; then Prednisone for six days (symptoms relieved), but symptoms returned two days after Prednisone course completed. Symptoms persist still after 5 weeks; now on 6th day of 7 day course of antibiotics (Augmentim) with no relief (as of 5/3) Scheduled for ultrasound and soft tissue scans on 5/7. This duration of swollen lymph nodes seems is longer in duration that what is reported on line.

Patient presented to the ED via ambulance with fever, nausea, vomiting. Patient noted to have 103 degree temperature at home. Patients heart rate was elevated in the 110s. Patient has rigors. Fever increased while at hospital. Patient admitted to the hospital for sepsis. Started on numerous antibiotics, fluid boluses.

Patient received 2nd dose of the Moderna Covid vaccine on 4/24/21. On 5/3/21, patient called office complaining of redness, swelling, pain in left lower leg/calf. Patient was seen the same day and did have a STAT Ultrasound performed that did diagnose a DVT in the left leg.

Clot; Stroke; Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back; Problem with walking; Got mad and walked out of hospital byhimself; Nauseous; Pins and needles sensation; Felt chilly; Dizzy; Whole body(left side) went numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back) (seriousness criterion hospitalization), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), PARAESTHESIA (Pins and needles sensation) and NAUSEA (Nauseous). On 07-May-2021, the patient experienced THROMBOSIS (Clot) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (Problem with walking) and TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself). The patient was hospitalized on 07-May-2021 due to CEREBROVASCULAR ACCIDENT and THROMBOSIS. At the time of the report, SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot), CEREBROVASCULAR ACCIDENT (Stroke), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), GAIT DISTURBANCE (Problem with walking), PARAESTHESIA (Pins and needles sensation), TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Blood test: unknown (Inconclusive) Unknown. On 07-May-2021, Computerised tomogram: unknown (Inconclusive) Unknown. On 07-May-2021, Magnetic resonance imaging: unknown (Inconclusive) Unknown. On 07-May-2021, X-ray: unknown (Inconclusive) Unknown. Company comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded. The causality assessment for the event of Treatment noncompliance remains Not applicable. This case was linked to MOD-2021-133656 (Patient Link).; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded. The causality assessment for the event of Treatment noncompliance remains Not applicable.

Neuromuscular weakness, tingling/numbness, and fall prior to admission. Progressed to acute hypoxic respiratory failure requiring intubation.

patient developed pain and swelling in the shoulder that later spread all the way across his back to his other shoulder. It has improved, but it still feels like he has a tight muscle in the shoulder what was injected. i was the one to give his vaccine, and i know for sure that i gave it in the most central, thickest region of the medial deltoid and did not give it too high. I told him that as well, and he confirmed that i gave it in the muscle. he said a long time ago, he received a shot that was too high, and he knew i didn't give it too high.

pt states that approx. one week after receiving the vaccine his left hand went numb and he has numbness throughout his arm. His hand is also swollen. Pharmacist advised that he see is PCP or go to the dr. Pt stated he doesn't have a doctor and that he has never hand any medical issues or problems until he got the vaccine

Patient reported pain in the area of injection that required a trip to the doctor. The patient reported that the physician diagnosed this as bursitis.

Non-severe diarrhea began on April 10th, continued until visit to clinic on April 21st. Diet changed to bland and diarrhea stopped. Vomiting a couple hours after eating began around that time and lasted for another 7-10 days

Previously reported 4/7/2021... Knee joint PAIN, and swelling... (2) Blood Panels... (7) indicators tested... 3/25/21 and 6/4/21 Untra-Sound on LEFT Leg... 4/6/21 Right Knee X-Rayed... 6/23/21 Swelling, adverse effect to Lymph Nodes behind knees... Deep Vein Thrombosis was ruled out by ultra-sound... X-ray to Right Knee indicates medial compartment narrowing... I recommend contacting Dr.... these events have been very uncomfortable, and their time frame has more than been an inconvenience. P.S. I have been in good shape, healthy, through of my days. Thank you.

After the second Moderna Covid shot patient had fatigue, malaise, his symptoms never improved they became worse. Since then he has been light headed, dizzy, some peripheral eye issues. He falls asleep in less than two minuets. He was told to give it some time that these were side effects from the Covid shot. He made an appointment with his primary doctor on June 10th, had several blood test done, many came back with extremely abnormal results. He was sent to an oncologist, the bone marrow aspiration revealed PH+Chronic Myloid Leukemia. Patient was very healthy prior to this, had had blood work within the previous year that was 100% normal at that time!!

In March 2021 was "putting in vinyl flooring and had issues with lower legs". Early April 2021 noticed pain/swelling in bilateral feet. June 7, 2021 saw PCP to rule out gout. Negative for gout. Was being treated for possible nerve pain. Decreased PO sodium intake. June 21 prescribed gabapentin for 3 weeks; did not complete course due to increased swelling in feet. Asked PCP if this was a Moderna side effect, reports PCP was unsure. Patient now as an EMG ordered to rule out neuromuscular etiology.

3:00am-CN noted resident awake sitting up in bed verbally responsive, encouraged to lie down and sleep, resident complied. 4:00am- resident noted sleeping in bed, unlabored breathing, same sleeping position as of 3am. 5:15am- Charge nurse went into resident's room to give him his routine breathing treatment. CN found resident in bed unresponsive, pupils fixed and dilated, facial swelling, drooping noted on left side of face. 911 called, resident transferred to hospital.

itching all over, puffy eyes. started 1/23/21, still present 1/25/21. On 1/28/21, resident reports he has been short of breath since the vaccine, joint pain, body aches, swollen lymph nodes, and resident's right eye is visibly swollen. Injection was done on the right arm, which is the side all symptoms have been on. Resident going to see doctor.

69 YO M CARDIAC ARREST. PT HAD JUST RECEIVED HIS COVID VACCINATION AND WAS PULLING INTO THE OBSERVATION AREA WHEN HE LOST CONTROL OF HIS TRUCK, BECAME UNCONSCIOUS AND CRASHED INTO A LIGHT POLE. THIS OCCURRED IN FRONT OF THE STANDBY MEDIC UNIT AND OTHER FIRE DEPT STAFF. PT WAS IMMEDIATELY REMOVED FROM THE VEHICLE AND THE PATIENT WAS DETERMINED TO BE IN CARDIAC ARREST. CPR WAS INITIATED WITHIN SECONDS OF BEING REMOVED FROM THE VEHICLE. EMS WAS IMMEDIATELY AVAILABLE AND THE PATIENT WAS DEFIBRILLATED FOR WHAT APPEARED TO BE A SINE WAVE VT/COURSE VF WITHIN ONE MINUTE OF HIS ARREST. PT WAS PLACED ONTO A BACK BOARD AND MOVED TO AMBULANCE IN A PULSED VT AND WAS AWAKE AND RESPONSIVE. ONCE IN THE BACK THE PT WAS WIRED INTO THE FOUR LEAD AND WAS SYNCHRONIZED CARDIOVERTED AT 100 J WITH A CONVERSION TO A PULSED JUNCTIONAL RHYTHM WITH A RATE OF ABOUT 58. THIS RHYTHM CHANGED INTO A SINUS TACH AT ABOUT 100 BPM. IV ACCESS WAS OBTAINED AND 100 MG LIDO BOLUS WAS ADMINISTERED WITH A 2:1 LIDO DRIP HUNG. AMBULANCE BEGAN TRANSPORT TO ER. OVER NEXT SEVERAL MINUTES PT BEGAN HAVING VENTRICULAR ECTOPY IN THE FORM OF PVCs COUPLETS AND EVENTUALLY 4-5 BEAT RUNS OF VTACH WHILE ON PHONE WITH ER MD. DISCUSSED GIVING ANOTHER BOLUS OF LIDO AND INCREASING DRIP TO 3:1 DUE TO INCREASING VENTRICULAR ECTOPY. THE ER PHYSICIAN CONCURRED AND ANOTHER 75 MG LIDO BOLUS WAS GIVEN FOLLOWED BY INCREASING THE DRIP RATE TO 3MG/MINUTE FOLLOWING THE SECOND LIDO DOSE AND DRIP ADJUSTMENT THE PATIENT'S VENTRICULAR ECTOPY RESOLVED AND THE PATIENT REMAINED IN A SINUS RHYTHM / SLOW SINUS TACH THROUGHOUT TRANSPORT AND TRANSFER OF CARE TO THE ER. A 12 LEAD WAS OBTAINED JUST PRIOR TO ARRIVAL IN ED THAT SHOWED SINUS TACH WITHOUT VENTRICULAR ECTOPY BUT WHAT APPEARS TO BE PACs, FLIPPED T WAVES IN a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

The day after the vaccine, pt. awoken on 02/04/2021 @ 0700 with swollen right and left hands and wrists. On day 8 after the vaccine 02/11/2021, pt. started to get a red rash that started on his chest and moved to the upper back then to the arms and legs. The rash did not itch. No treatment per pt. Today 02/18/2021 pt. states that his left wrist is slightly swollen and the rash is still present but fading. Pt. states that he did not have any difficulty with breathing. Pt. did not seek medical care.

Had normal light S.E headache, 100 fever, jt & body aches over within 30 hrs, approx 10 hrs after these SE disappeared got angioedema side effects of the face & lips, decreased gradually hrly

Around 9:55 pm on 2/27/2021 client took Afrin nasal spray for nasal congestion. About 5 minutes later (10:00 pm) client states he went into anaphylactic shock. The ambulance was called by his wife. Per client, her received infusions of epi and Benadryl from ambulance staff. Client was taken to Hospital for further treatment. He was subsequently transferred to Heart Hospital for overnight observation due to possible heart issues. Note: Client has take Afrin nasal spray for over 30 years and has never had a reaction.

Patient had swelling of left arm index finger. It was difficult for the patient to move the finger. The following day it did resolve.

Two week after the shot, I came down with a case of Shingles ( I received both doses of the Shingles Vaccine) last dose towards the end ofJuly My glands under my are at the injection site saw swelling and 2inch area around the site swelled up

There was a marked flare of symptoms in a pre-existing inflammatory condition (RIGHT shoulder bursitis) in an area remote from the vaccination site (LEFT deltoid). The flare began 24 hours after injection and subsided 72 hours after vaccination. Symptoms went from "2" (on a scale of 10) to 10, then returned to "2". The patient's wife, also an MD, also noted an identically timed flare of her own pre-existing inflammatory state with the same time frame.

Chills beginning 4 hours after 2nd dose. Extreme swelling in right lymph node in neck. Severe rash up neck, over the right ear, across right cheek, around right eye and across right side of nose. Our family doctor examined patient on Thursday, 2/25 and said it would get better on it's own. It continued to worsen and he was very ill with vomiting, low grade fever and chills. On Monday 3/1 he went to the ER was put on Kefflex antibiotics. The diagnosis was cellulitis. After 7 days of treatment he is much better, the rash has dried up and only red scabs are left to heal.

69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology. Outside Hospital: Seen at ED where a stroke code was called for headache, RUE weakness, dysarthria with a CT and CTA that were negative for any acute changes. He he was febrile to 102.2, tachycardic to 130s, hypotensive with pressures in the 80s systolic unresponsive to fluids, leukocytosis to 15 and lactate of 3.5. He was started on vancomycin, ceftriaxone, ampicillin, acyclovir, and dexamethasone. Additional workup including an LP, UA, and CXR were all unremarkable. He was transferred here due to a lack of beds. Of note, the patient received his second COVID-19 vaccine dose on 3/10 and had been febrile since the morning of 3/11. Hospital ICU: Patient is hemodynamically stable and has been fully weaned off pressor support. His hyperglycemia is decreasing satisfactorily to insulin and is receiving IVF. Repeat lactate for PM of 3/12 and workup for TIA initiated. Assessment and plan : 69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology requiring vasopressors, antibiotics, and TIA workup. I have personally reviewed the daily labs, imaging studies, cultures and discussed the case with referring physician and consulting physicians. My assessment and plan by system for this patient is as follows: Neurology/Psychiatry: # RUE Weakness, headache, dysarthria Presented to Hospital with RUE, headache, and dysarthria with negative CT and CTA. The patient has a known hx of diabetes and hypertension with a recent elevated A1c. His hypotension as a result of sepsis may have revealed territories in his cerebrum particularly affected by his likely vascular disease. Will initiate TIA workup. Pending results, will consider Neurology Consult. Plan: - ASA 81 mg PO daily - Echocardiogram - Fasting lipid panel - Bilateral carotid artery ultrasound Cardiovascular: # Hemodynamics, Rhythm, Ischemia # Septic Shock Weaned off NE, still on Vasopressin 2.4. Monitor shows NSR in the 70s. Has now been weaned off vasopressors. Plan: - Weaned off pressors # History of hypertension Plan: - HOLD PTA lisinopril Pulmonary/Ventilator Management: # Airway, Oxygenation, Ventilation, Mechanics: No airway in place. Unlabored breathing on room air without assistance with sats in mid-90s. Plan: - Monitor GI and Nutrition : # BMs/Gas/Feedings: Reports having diarrhea. No enteral feeds. Plan - Monitor electrolytes Renal/Fluids/Electrolytes: # Electrolytes, Acid/Base, Volume Patient is septic and requiring pressors. He is also having diarrhea, so monitor electrolytes, creatinine, UOP. Glucose responding to insulin, most recently 159. If this afternoon's lactate and creatinine normalize this afternoon 3/12/21 and the patient continues to eat/drink ok (which he has been), then we can turn off his IVF. Plan: - HOLD Metformin given elevated creatinine and risk of metabolic acidosis - Lactated Ringers at 75 mL/hr continuous - Trend BMP - Monitor UOP - Venous Blood Gas - Electrolyte replacement per ICU protocols - Generally avoid nephrotoxic agents such as NSAID, IV contrast unless specifically required - Adjust medications as needed for renal clearance - Follow I/O's as appropriate Infectious Disease: # Septic Shock # Leukocytosis # Lactic Acidosis # Recent Covid-19 Vaccine Patient was tachycardic to the 130s, hypotensive with systolic pressures in the 80s, and febrile to 102.2 F. Worked up extensively at outside hospital with the following perfomed: Negative CT/CTA, unremarkable lumbar puncture, unremarkable CXR, and unremarkable UA. His pressures were not fluid responsive at that time, so we will continue some further workup here as below. In addition, there remains the possibility that this patient's current status may be a result of the Covid-19 vaccine and cannot be ruled out given its temporal relationship to his presentation. Will document this potential reaction with the Department of Health. Patient's most recent lactate returned at 6.5 and likely reflects his critical illness in combination with decreased clearance (given that his creatinine was 1.7, unclear baseline). Plan: - MRSA Swab, nares - Stool Ova and Parasite - CSF Culture - CSF HSV (from outside hospital, pending) - Continue piperacillin-taxobactam - Trend procalcitonin - Trend lactate - Report possible Covid-19 reaction with DH Endocrine: # Hyperglycemia # Recent Diagnosis of T2 DM not on Insulin Was found to be hyperglycemic in the high-500s on arrival. At least part of his hyperglycemia is a result of receiving dexamethasone at the hospital. However, his most recent A1c on 3/12 was 8.8 and his diagnosis of T2DM is recent. Plan - Diabetic diet - Nutrition consult - Insulin bolus 5 U - ICU insulin protocol with goal of BG <180 - HOLD PTA metformin Hematology/Oncology: # Hgb, Platelets Within normal limits. - Monitor as appropriate # Leukocytosis Leukocytosis to 15.4 here. Plan as above. Plan - Trend CBC MSKL/Rheum: # Right Shoulder Pain Reports having some right shoulder pain over the last few weeks, exacerbated by shoveling snow. Pain with right arm abduction. Pain is greater in arm and forearm than shoulder itself. Plan: - Tylenol PRN for pain - Outpatient f/u as needed. IV/Access: 1. Venous access - Left brachial PICC, left wrist PIV 2. Arterial access - None ICU Prophylaxis: 1. DVT: Hep Subq/ LMWH/mechanical 2. VAP: Not applicable 3. Stress Ulcer: Not indicated 4. Restraints: Not indicated at this time 5. Wound care - per unit routine 6. Feeding - Diabetic Diet 7. Family Update: Updated wife who was at bedside on AM 3/12/21. 8. Disposition - ICU pending further workup, treatment, and continuation of vasopressors.

Sore throat, swollen/sore glands in neck, morning temperature 1.9F higher than MY normal, sore lower back

Rash and swelling on neck at collar line. Swelling approx 1 inch high at peak and three inches long and wide Itches , some pain in shin on touching vaccination arm, left side

BOTH HANDS BEGAN TO SWELL, VEINS IN HANDS STARTED BULGING AND HANDS TURNED ORANGE/RED COLOR UP TO WRIST ON BOTH HANDS. PT STATED THAT THIS WENT AWAY WITHIN AND HOUR.

Swelling, itching on left arm. Hives spreading to face with swelling, itching. Hives appearing on right arm, chest (itching). Neck pain, joint pain, headache, fatigue. Called Dr. after Benadryl and hydrocortisone not effective. Ibuprofen relieved headache. Rx: Methylprednisolone initiated on afternoon of 3/15. Itching relief allowing me to sleep but hives on right arm (opposite of injection) has worsened. On second day of 5 day protocol.

Morning after vaccination body aches, headache, low fever, tiredness. Second day after vaccination same as above with additional symptom of difficulty swallowing, right side of throat feels swollen internally. these symptoms are continuing for several days up to and including date of this report, Tuesday 3/16/21

Major rash lower legs; major swelling all of right foot with pain in right big toe; increased sciatica that had been much improved with pain in lower back

Patient did not tell that he was not feeling well. Later that day, he had to go to ER for heart related fluid issues. He stated that he was give medicine to get the fluid off his chest and that he had difficulty breathing. His doctor stated that this was most likely not related to vaccine.

Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).

I was breaking down existing blood clot in my right leg when after getting the 1st shot got a red rash & my right leg swelled up producing a blood clot in my right leg .

Vomited once on 3/15. Then had left upper chest burning radiated up to his left jaw for few days that started 3/15. Since 3/16 he has had generalized weakness, fatigue, difficulty walking, and chills. On 3/17, he had one episode of urinary urge incontinence. Fever on 3/18 and 3/21. Imaging showed paraspinal myositis from suboccipital region to upper thoracic region. Main continued symptom now is generalized weakness and difficulty walking.

Swollen and slightly uncomfortable sub-mandibular glands for about 2 weeks. Did not initially pay attention so exact dates of onset and resolution unknown. Just thought it might be related. Thus the report. No known sinus or dental problems that would cause same.

I think the injection may have been subcutaneous and not IM. Is there a test to find out if it was effective? I did not feel the shot AT ALL, and now four days later my arm is hot and swollen on the side closer to the body.

Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure. Possible Rhabdomyolysis.

Jaw very painful and sore, swollen badly, can't eat, very painful, side of neck and throat swollen painful and hurts badly, fever, cold chills.

Pt had fever the first night after getting the second vax but it went away by the next day. Pt stated that he developed severe sweats so bad that he has to change clothes about two times per night. These symptoms lasted several weeks. Pt had been to the doctor after getting the first covid dose for having these same symptoms. He had blood work that showed SED Rate was 101 and C reactive was 33. The doctor wanted to rule out cancer so he ordered a head, chest, abdominal xray, abdominal US and abdominal and pelvic CT w/ Contrast. These test did not show anything. He had a small bowel test that was negative. He had more blood work on 4/1/2021 that was normal. SED Rate was 20 C Reactive was 2. His doctor seem to think that he had some type of reaction to the vaccine.

Wrist pain and top of hand swelling (on left arm vaccine side). Confusion as to whether this is a reaction to shot thus prompting cellulitis like symptoms. Being treated for cellulitis. Outcome to be determined

Swelling , redness and tenderness in the second DIP joint of the middle and ring finger of my right hand and left hand. Gets worse at night and recedes somewhat during the day. I had mild serious at time of injections. Only using topicals to treat. Had no swelling of joints before vaccine.

Soreness in R thigh above patella developed in mid March Acute Flaring of R knee in late March 3/31/2021 with pain, heat, and swelling that progressed over two days to inability to flex knee, raise leg against gravity when supine. Symptoms in leg resolved over 2 weeks with PT. R-foot began to swell 2 weeks later with pain over and below base of R toe that progressed with heat, swelling, and redness over lower R-foot. Physician thought knee problems may be due to gout because of presentation so a prescription for a methylprednisolone was made available (6 day taper (21, 4 mg tabs) instituted within 24 hrs of severe foot symptoms). Pain, swelling, and temp. elevation of foot began to resolve within 8 hrs or steroids.

He noticed a slight rash within 2 days of 2nd vaccine and has gotten worse until the present time. Rash has spread all over the body including the chest, back, genital area, and upper thighs. Skin feels tight, itchy, and stings when touched. Also is areas of rash are swollen.

Swollen lymph nodes and slight rash under both arms 12 days after vaccine, lasted 5 days; Severe pain in left knee 13 days after vaccine and lasted one day.

patient received 1st Moderna dose on 4/30/21. The next morning on 5/1 he felt pain on his left leg. He waited to see if would get better or worse. On the afternoon at an unknown time, his leg had gotten worse. He had severe pain on his left leg; it was painful to the touch; it was swollen and was hard as a rock. He called 911. He was taken to Hospital. Pt wanted me to report that he did not receive any treatment for his blood clot. He received a Lidocaine patch on his knee and was given a prescription for Voltaren Gel. (he was expecting to receive TPA to dissolve the clot like a few times before when he had blood clots but this particular time he did not)

Persistently intermittent high-grade fevers with associated chills since 4/14/2021. On 4/20/2021, patient reported to his PCP for further management, and blood workup did not show any acute abnormalities. On the morning of 5/5/2021, patient woke up with a 101F fever and appeared to be confused as per wife and niece, which prompted ED visit.

Took 600mg of Ibuprofen (200mg x3) orally at 7:45AM, 30 minutes later while viewing a medical webinar at my desk at home, I suddenly noticed significant itching of my entire hands which quickly became reddened and progressively swollen as the itching sensation become more generalized within 10-15 minutes. I got up from my chair to go tell my wife but as I walked a few paces, I became extremely weak with visual 'closing in' as I barely prevented myself from collapsing to the floor / losing consciousness. At the same time my tongue was now thickened and malfunctioning making my spoken words to my wife almost unintelligible - all consistent with a CLASSIC ANAPHYLAXIS REACTION. My wife helped me to the couch to recline where I carefully swallowed CHLORPHENIRAMINE 8MG, FAMOTIDINE 20MG; and 15 minutes later DIPHENHYDRAMINE 50MG (I did not have any Epinephrine available from prior 'bee sting kits'). At no time was my breathing impaired nor was there any audible wheezing or dyspnea. After ~45 minutes I was improving noticeably, and after ~2-3 hours I had made a 100% recovery with no sequelae thereafter. Although I had taken my routine morning medications several HOURS PRIOR, nevertheless, (after purchasing several vials of Epinephrine 1mg/1mL for protection in case of another reaction), after this event and over the succeeding days I re-added each of those medications separately / one-at-a-time to ensure that NONE of those was the offending agent - NO problems ensued. For obvious reasons, I have 100% AVOIDED ingesting Ibuprofen or other typical NSAIDs since this episode (although my routine single daily aspirin tablet has presented no problems). BOTTOM LINE: DESPITE HAVING USED IBUPROFEN 400MG OR 600MG PERHAPS 1-2 TIMES WEEKLY AS NEEDED FOR MUSCULOSKELETAL DISCOMFORT OVER MANY YEARS, NEVER UNTIL THIS ANAPHYLACTIC EPISODE 11 DAYS AFTER MY SECOND DOSE OF MODERNA'S COVID-19 VACCINE HAD THERE EVER BEEN ANY TYPE OF ADVERSE REACTION TO IBUPROFEN WHATSOEVER.

The patient received the first dose of vaccine on March the 1st and the 2nd dose of the vaccine on March 28th. Patient had difficulty breathing with swelling feet and ankles that did not begin until April 12th. Patient had no history of breathing problems. Cardiovascular history is unknown at the pharmacy as we had only ever performed vaccinations on the patient. Patient was discovered in his house deceased. Exact date is unknown. The pharmacy was contacted by the patient's prescriber which requested we file this report. I apologize for the lack of precise information.

four 2 liters of pee flushed out of body; A-fib; 25 pound water weight gain; dry cough with phlegm; feeling tired; Water blisters on leg where skin was coming off; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A-fib), FLUID RETENTION (25 pound water weight gain), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and PRODUCTIVE COUGH (dry cough with phlegm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 5A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included IBUPROFEN, POTASSIUM and OMEPRAZOLE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Water blisters on leg where skin was coming off). On 13-Jun-2021, the patient experienced PRODUCTIVE COUGH (dry cough with phlegm) (seriousness criterion hospitalization prolonged). On 23-Jun-2021, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criteria hospitalization prolonged and medically significant) and FLUID RETENTION (25 pound water weight gain) (seriousness criterion hospitalization prolonged). On 27-Jun-2021, the patient experienced FATIGUE (feeling tired). On an unknown date, the patient experienced URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 23-Jun-2021 to 26-Jun-2021 due to ATRIAL FIBRILLATION, FLUID RETENTION, PRODUCTIVE COUGH and URINE OUTPUT INCREASED. The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) for Cough, at an unspecified dose and frequency. On 26-Jun-2021, FLUID RETENTION (25 pound water weight gain) had resolved. At the time of the report, ATRIAL FIBRILLATION (A-fib), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and BLISTER (Water blisters on leg where skin was coming off) outcome was unknown and PRODUCTIVE COUGH (dry cough with phlegm) and FATIGUE (feeling tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information included blood pressure medication. Treatment information included Blood thinner (not specified) for A-fib. The patient reported four 2 liters of pee flushed out of his body where he went from 259 pounds upon admission to 226 pounds on 27June2021. The patient had an appointment with his cardia doctor for the A-fib 06july2021. Action taken with M-RNA-1273 (Moderna Covid-19 Vaccine) in response to the event was not applicable. Company Comment : Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.

DVT; MRSA; Left leg swelling; Pain; Hardened leg as hard as a rock; Skin is tight; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and STAPHYLOCOCCAL INFECTION (MRSA) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy and Blood pressure high. Concomitant products included CARVEDILOL (COREG) for Blood pressure high, GABAPENTIN for Neuropathy, DIGOXIN and SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (MRSA) (seriousness criterion medically significant), PERIPHERAL SWELLING (Left leg swelling), PAIN IN EXTREMITY (Pain), LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at a dose of UNK dosage form; VANCOMYCIN ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form and CEFEPIME ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT), STAPHYLOCOCCAL INFECTION (MRSA), PERIPHERAL SWELLING (Left leg swelling) and PAIN IN EXTREMITY (Pain) outcome was unknown and LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. For the last 6 weeks, patient was being treated with vancomycin and cefepime for MRSA infection. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Atrial fibrillation; Water rentention; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and FLUID RETENTION (Water rentention). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and FLUID RETENTION (Water rentention) outcome was unknown. The concomitant medications were not reported. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital and treated for worsening AKI and hypotension.

No immediate adverse effects. Very little soreness. I was told to rub/massage the injection site to reduce any pain or swelling. Red area, swelling, and itching appeared on the fourth day following the vaccination. Current size of area is approx. 12 cm by 6 cm. The long side of the area runs vertical on my arm. The vaccination site is about 1 cm down from the top of the swelling, so the swelling, redness and itching mostly extend down my arm from the injection site

Extreme redness and rash starting in the groin area and spreading over entire body. After the doctor visit and taking Doxycycline 100 mg for 10 days the redness and rash cleared up. My hands were swollen and later the skin pealed from both hands.

when i first got the shot i could feel a difference in my body immediately. i started hurt on my left side of my throat, then started getting puffy face and eyes. was given some Benadryl pulse 45 blood pressure 90/54 and did an EKG , then medic didn't like what he was seeing and called 911 . Medic gave him an epi pen because his throat started swelling. Went to the hospital where he was there for 5 hrs.

Hospitalization- admitted on 2/14 for appendicitis and peritonitis; had appendectomy. Discharged on 2/18

Extreme swelling of lymph nodes under right arm noted just over 72 hours after vaccination. Swelling lasted about 36 hours, then subsided.

Had Covid in April of 2020 and was in hospital for 5 weeks. not sure if this is why i experienced what i did After vaccine i kept a fever the night after shot and it got to 101.3 and remained for 48 hours i had substantial swelling that got worse with my fever and began going down after two days and by the 3rd day it was gone. Over all body ache, and splitting headache behind my eyes.

Palm of left hand red, Extremely sore, lump. Redness has dissipated, soreness and lump still present.

Patient was given his injection in the right deltoid. Tolerated this well. Approximately 10 to 15 minutes later, his care provider brought him to me and stated that his face was " red and splotchy". It was noted that Patient had red, raised areas on his face. Patient is non verbal and developmentally disabled, so I was unable to assess if these were itchy. I assessed his neck, chest and arms, no red raised areas noted. I placed a pulse oximeter onto the patients finger, oxygen saturation 95% or greater, heart rate 90-100's no visual signs of distress.

Delayed allergic reaction on day 8, following vaccine #1. Sudden onset of HUGE induration (thick, hard, hive-like plaque) measuring 5cm x 10cm with additional fingerlike projections, hot, red, swelling with itching. Treated at home with diphenhydramine.

Patient came to the pharmacy and stated that he had experienced severe and painful swelling of the legs the morning after receiving the vaccine. He states that it was painful for him to walk for a few days. He also let me know that as the last month has passed, the swelling has gone down, but he states that there is still some residual swelling in his legs that is not normal. He did not voice any treatments to me. He did say that he had talked to his doctor and they had asked him to visit the pharmacy where he had received the vaccine.

Presented to the ED with rigors, rash vomiting, and diarrhea. He was found to be mildly hypotensive in the ED. He also had a WBC count of 20500 and a diffuse maculopapular rash. He was admitted for probable COVID vaccine allergy.

2nd dose of Moderna on 3/9/2021 at 8:30am. At 9:00pm started having upper respiratory distress leading to vomiting and diarrhea (every 10 to 15 min) on 3/10 at 10:00 pm. Went to ER on 3/11 at 1:00am. Admitted to ER with initial diagnosis (following lab work, x-rays, etc.) of Anaphylactic Shock. Symptoms were allergic reaction, chest pain, hypotension, acute kidney failure, diarrhea, DM2, hives/rash/itching. Multiple IVs of saline, antibiotics, steroids were administered. Remained In critical care/ER for ~12 hours until stable and transferred to hospital room. Discharged on 3/12/2021 at 11:00 am.

3 days after vaccination, noticed joint pain in right arm and hand. By 5 days after vaccination experienced immobilizing pan in both shoulders, hips, knees and hands.

Breathing difficulty, fluid retention, upper respiratory congestion and flu like symptoms. No fever or chills.

Swelling, Rash & persistent itching & sensitivity on both arms & hands continuing now into the 13th Day. I have had no headaches & no fever. I'm concerned about having the 2nd injection..

3-13-21 WIFE STATES PT WOKE UP ON 3-10-21 7AM WITH 'RT SIDE OF FACE SWOLLEN AND BLOODY DISCHARGE WHEN HE BLOWS HIS NOSE'. STILL SWOLLEN TODAY (3/13) BUT A LITTLE BETTER. HE HAS A ROUTINE APPT WITH HIS HEART DR THIS TUESDAY. 3-17-21 8:45AM TC: PT STATES 'HAS BEEN IN THE HOSPITAL X 2 D TO HAVE BALOON ABLATION FOR HX OF A FIB AFTER ROUTINE APPT WITH CARDIOLOGIST (HAS NOT BEEN IN A FIB SINCE ADMMISSION)'. ALSO STATES HIS FACE IS NO LONGER SWOLLEN, STILL HAS BLOODY NASAL DISCHARGE WHEN HE BLOWS HIS NOSE 'LIKE A SINUS INFECTION'. WILL ASK FOR ANTIBIOTIC.

Tongue feels funny; Chewing is hard; His left eye and face are changing shape, smiling is hard; Possible Bell's Palsy; Numbness on left side of face; Swelling arm; Painful arm; Headache; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible Bell's Palsy/facial paralysis, numbness on left side of face/hypoaesthesia, tongue felt funny/paraesthesia oral, chewing was hard/mastication disorder, left eye and face were changing shape, smiling was hard/ facial discomfort, sore arm/pain in extremity, arm swelling/peripheral swelling, and headache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient initially had pain, swelling, sore arm and headache. Patient stated on 15 Feb 2021, he had some numbness on left side of face, chewing and smiling was hard. Patient stated a couple days later, he had numbness and on 01 Mar 2021, his left eye and face were changing shape, tongue felt funny, and it was hard to brush teeth. Patient spoke with doctor and MRI was scheduled on 12 Mar 2021, according to patient there was a possibility for Bell's Palsy. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, facial paralysis, hypoesthesia, paraesthesia oral, mastication disorder, facial discomfort, pain in extremity, peripheral swelling and headache were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Lips and face swelling on 1-25 and then hands swelling , r ight wrist on 01-29 21 /left wrist red and swelling on 01/31/21 and swelling continued on Feb 1st and visited to see healthcare provider. On Feb 3rd /FEB 17- Saw DR - suggested I go to hand specialist and suggested taking Advil/Feb 24, saw PA with Hand specialist, he gave me shot in both hands and said it may be arthritis/March 1st, swelling of left hand and trigger finger/March 8th, left hand and wrist swelling and red /March 9th, saw healthcare provider/March 18 and 19, pain in both legs above knee caps.

Swollen Glands (Lymph nodes?) in ear/neck thoractic area - very painful - now March 23rd and easing up but not back to normal yet

Sore Arm, Headache, temperature, irregular heart rate, chills, night sweats, loss of appetite, extreme fatigue, weakness, cloudy thought, swollen lymph node under left arm (size of tennis ball), labored breathing which has continued to date of this report.

Approximately 24 hrs after vaccine I developed a rash on lower right forearm. The rash worsened over the next 4-6 days spreading over most of the right arm, also in neck area, and around waste band area. Right arm became swollen. Treated with topical cortizone 10 cream and aloe vera. On begining of week notified Dr that rash was getting worse and arm swollen. He prescribed Benedryl 25 mg tablets 3 times daily and prescribed MethylPrednisolone tablets 4 mg per tablet in 6 day taper pack. That treatment started today Wed 3/24 at 3PM.

Severe pancreatitis with no specific cause identified followed by complications of peritonitis, fluid in lungs of 80%, deep leg vein thrombosis, and multiple episodes of coronary arrest and systemic inflammation.

I have painful swollen glands under my neck area. I went to my primary doctor, ran a cbc and came back negative but my glands are painful, mostly on the right side where the vaccine was administered.

Lower Jaw and lower Lip Swelled up overnight. Took 50Mg of benedryl and iced the area. Symptoms subsided 75% within 6 hours, but still active on lower left jaw and lower lip. Took 50Mg. more of Benedryl and iced again. Results are pending.

03/31/2021 - Swelling, rash and hardness of the right buttock and groin 04/04/2021 - Angio Edema of the face, cheek and lip. All after the second vaccination

This is a follow up to an earlier report. Following the request for a key just took me in circles. Following the injection, and within 24 hours, I began experiencing severe vasovagal, with severe bloating, severe headaches, severe weakness and mental cloudiness. It is difficult, and at times virtually impossible to urinate and defacate. Any tissues with columnar linings are severely swollen, from the eustachian tubes to trachea and esophagus, including all intestinal organs. In fact all organ systems are involved. It is very painful, and has forced my retirement from practice, as I cannot provide the care that is needed for my patients. Severe fatigue continues, with severe headaches, cloudiness, inability to concentrate.

Patient's wife called 3/22/21 and stated patient had a cough, fatigue, and low grade fever running around 99 starting 3/20/21. Patient went to airport testing center on 3/23/21 to have a rapid COVID test performed. Patient tested positive. Patient called PCP office on 3/29/21 to notify PCP that he had been admitted to Hospital. Patient was admitted for COVID pneumonia and acute respiratory failure with hypoxia. Patient was treated with Remdesivir and dexamethasone while in the hospital. Patient was discharged from Hospital 4/10/21. Patient was discharged home with home O2 of 1lpm.

Pt as admitted to the hospital with severe b/l pneumonia and hypoxia requiring high flow oxygen on 4/10/2021. He received his 2nd covid vaccination on 4/4/2021 and began to have shortness of breath 3 days later. He is still hospitalized with severe pneumonia as of 4/14/2021 and his condition has progressed to left upper lobe collapse which will require a pulmonary interventionalist as out pt.

COVID arm - 4 inch circle on left arm after shot #2. Vivid dreams continuing for three weeks as of this date.

7 days following vaccination patient reported swelling to right lower extremity with pain and shortness of breath. 10 days post vaccine, patient admitted to hospital with pulmonary embolism as well as very large deep vein thrombosis.

Stared evening of shot sore arm some swelling, Middle of night symptoms increased headache, sore muscles, aches malaise. Nausea. Very flu like symptoms

ABOUT 2 WEEKS AFTER VACCINATION, Patient started with GI symptoms-constipation, diarrhea. The lower GI bleeding started. He was hospitalized twice-sepsis and GI bleeding requiring transfusion and Remicade. Patient had had a colonoscopy in May of 2020 and he was fine-no problems. Not sure if any of this was related but it won't be known until we investigate. No one can say why he was so acute

THE SHOULDER WAS SWOLLEN RIGHT AFTER ON THE DAY OF THE SHOT, THE PAIN EXTENDED TO THE SIDE OF THE CHEST AND THE BACK (SHOULDER BLADE) THE NEXT DAY, TO ALL ACROSS THE CHEST TO THE OTHER SISDE INCLUDING THE TIGHTNESS AND CRAMPING THE NEXT DAY, RASH FOUND ON THE BELT LINE AND TAILBONE LATER, PAIN ALL OVER THE BODY WHERE HE WAS INJURED BEFORE, COULDN'T GO TO WORK FOR DAYS, SAW HIS DOCTOR TWICE FOR THIS BUT THE DOCTOR SAID "IT IS A GOOD SIGN, THAT THE VACCINE IS WORKING"

70yo Male. with no significant PMHX. Presents with LLE swelling. States swelling started 1 day after his first moderna covid vaccination. He was found to have extensive DVT LLE. He denies recent travel or prolonged immobilization, he denies injury to the leg, he denies previous blood clots/blood disorder/cancer. This is sooner than I would expect patient to begin having symptoms after DVT after covid vaccination however I have no other clear etiology at this time.

Fever to 100.8, Nausea and vomiting, Pleuritic chest pain which was worse when supine and improved with sitting up. Symptoms started within 24 hours of the vaccination. Symptoms improved a few hours the initiation of treatment with anti-inflammatory agents.

Patient was actually being seen in our hospital as an outpatient for Procrit injection and lab work. The Top care nurse felt the patient should be seen in the ER so she directed him to sign in as an ER patient. Patient had a mass on the right deltoid that started on 5/8 after receiving the second Moderna vacation on 5/6. The swelling peaked a few days later and now it has been getting better for the last week. No fevers, no nausea or feeling ill. Patient stated he would not have signed in to the ER if not for being asked to do so by the top care nurse. He receives weekly Procrit and lab work.

Severe muscle and joint pain that began a few days after the second dose of the Moderna COVID-19 vaccine.

lower leg was swollen and started to get bigger and bigger; blood clot in the right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the right leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history were reported. Concomitant products included PANTOPRAZOLE for GERD, TRAZODONE for Sleeplessness, SIMVASTATIN and CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (blood clot in the right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger). The patient was treated with RIVAROXABAN (XARELTO) for Thrombosis, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot in the right leg) and PERIPHERAL SWELLING (lower leg was swollen and started to get bigger and bigger) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication includes Benapraxine for to simmer down. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Blood infection; Sick; Didn't feel good; chilling; Patient received both the doses on smae month; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEPSIS (Blood infection), ILLNESS (Sick), MALAISE (Didn't feel good) and CHILLS (chilling) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20 and 035J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. The patient's past medical history included Aortic valve calcification in 2011, Alcohol use (6 bottles beer/week) from 1964 to 2000, Ex-smoker from 1964 to 2015, Eyes red (while on Humira) in 2020, Back surgery in 1996, Open heart surgery in 2003, Carotid endarterectomy in 2006 and Cataract in 2013. Concurrent medical conditions included Diabetes (DIABETES TYPE 2), Blood pressure high, Acid reflux (esophageal), Cholesterol, Plaque psoriasis and Bladder cancer (bladder cancer cells) since 25-Nov-2020. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ACETYLSALICYLIC ACID (ASPIRINA) for Anticoagulant therapy, METOPROLOL and LISINOPRIL for Blood pressure high, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for Digestion impaired, HYDROCHLOROTHIAZIDE for Diuretic therapy, NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Pain. On 17-Dec-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML(40 Milligram, Solution for injection in pre-filled. In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both the doses on smae month). On 12-Apr-2021, the patient experienced SEPSIS (Blood infection) (seriousness criteria hospitalization prolonged and medically significant), ILLNESS (Sick) (seriousness criterion hospitalization), MALAISE (Didn't feel good) (seriousness criterion hospitalization) and CHILLS (chilling) (seriousness criterion hospitalization). On 17-Apr-2021, ILLNESS (Sick), MALAISE (Didn't feel good) and CHILLS (chilling) had resolved. At the time of the report, SEPSIS (Blood infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both the doses on smae month) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Catheterisation cardiac: aortic valve calcified (abnormal) Aortic valve calcified. In April 2021, Computerised tomogram: aortic valve calcified (abnormal) Aortic valve calcified. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the event included ertapenem for the blood infection. Company comment: This report refers to a case of inappropriate schedule of product administration for mRNA1273, lot# (035J202A and 030L20) with no associated adverse events, however the patient experienced some reaction approximately. three months later. Based on available information, there is no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patient's advanced age and co-morbidities are strong confounders.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA1273, lot# (035J202A and 030L20) with no associated adverse events, however the patient experienced some reaction approximately. three months later. Based on available information, there is no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patient's advanced age and co-morbidities are strong confounders.

1st dose of the Moderna Covid-19 vaccine on 3 months ago; Itchy Sensation/ itchiness near injection site; Soreness near injection site; Redness near injection site; Rash near injection site; Swelling near the injection site; Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful; Stiff neck/stiff neck on the side where the vaccine was given; Mild Itchy/Tingling Sensation in Extremities; Anaphylactic reaction/ unusual severe reaction; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021. The most recent information was received on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced MUSCLE SPASMS (Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful) and VACCINATION SITE ERYTHEMA (Redness near injection site). 27-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck/stiff neck on the side where the vaccine was given), PARAESTHESIA (Mild Itchy/Tingling Sensation in Extremities), VACCINATION SITE PRURITUS (Itchy Sensation/ itchiness near injection site), VACCINATION SITE PAIN (Soreness near injection site), VACCINATION SITE RASH (Rash near injection site) and VACCINATION SITE SWELLING (Swelling near the injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 3 months ago). On 28-Feb-2021, MUSCLE SPASMS (Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction), MUSCULOSKELETAL STIFFNESS (Stiff neck/stiff neck on the side where the vaccine was given), PARAESTHESIA (Mild Itchy/Tingling Sensation in Extremities), PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 3 months ago), VACCINATION SITE PRURITUS (Itchy Sensation/ itchiness near injection site), VACCINATION SITE PAIN (Soreness near injection site), VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE RASH (Rash near injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Event of anaphylactic reaction added. Outcome updated to recovered. Treatment information was added.

Mild-mod muscle/tendon/joint aches at bilat anterior hips beginning 1 week after 1st injection and exploding in intensity and breadth one week after the 2nd injection. Areas currently involved: pan-pelvic, bilat shoulders, lower neck, L knee and R Achilles. Symptoms worse with immobility/cooling (PMR-like). Partially respond to NSAID's on which I've been dependent since 01APR2021 to accomplish ADL's. Symptoms have slowly decreased in intensity in recent 2 weeks but show no sign of completely abating. Can't sleep in a bed due to pain; often need a narcotic Rx to quell pain to allow sleep at night.

Patient had redness of the arm and warmth in the arm. He had a very swollen lymph node about the size of a baseball. He had no pain, but it was uncomfortable. The swollen gland never went down so he went to the doctor's on 6/18/2021 and they prescribed 2 antibiotics and an ultrasound.

I was having extreme difficulty walking for a week. Wobbly legs (muscle and nerve impairment) severe fatigue and weakness. Vestibular dysfunction and Auditory issues. I suspect a Guillain-Barre type immune system response to second injection? I verified this on CDC website. I am trying to get in to a neurologist ( 3 month wait) My Primary care Dr. is aware of issues. Original response was to give it time. I have started PT as of 6-8-21. I need to have a Neurologist investigate and I believe doing an NCV test will "reset"{ the nerves. This worked several years ago after neck surgery issues.

couldn't breathe; swelling of his whole body; whole body was red and rashy; seeing flashes and black dots in his vision; vision was blurry; he lost 11 lbs of water weight; headaches; dizziness/dizzy; His legs ... changed to red and ankles swollen when he dropped them to the floor; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body) and ERYTHEMA (whole body was red and rashy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 017B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs ... changed to red and ankles swollen when he dropped them to the floor), VISION BLURRED (vision was blurry), WEIGHT DECREASED (he lost 11 lbs of water weight) and HEADACHE (headaches). On 28-Apr-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization), SWELLING (swelling of his whole body) (seriousness criterion hospitalization) and ERYTHEMA (whole body was red and rashy) (seriousness criterion hospitalization). On 07-Jun-2021, the patient experienced PHOTOPSIA (seeing flashes and black dots in his vision). The patient was treated with FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) at an unspecified dose and frequency; PANTOPRAZOLE at a dose of 40 mg at bedtime; HYDROCHLOROTHIAZIDE at a dose of 45 mg in the morning; LOSARTAN POTASSIUM at a dose of 50 mg twice a day; CLOPIDOGREL at a dose of 75 mg once a day; VITAMIN B12 NOS at an unspecified dose and frequency; VITAMIN B3 at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body), ERYTHEMA (whole body was red and rashy), DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs .. changed to red and ankles swollen when he dropped them to the floor), PHOTOPSIA (seeing flashes and black dots in his vision) and WEIGHT DECREASED (he lost 11 lbs of water weight) outcome was unknown and VISION BLURRED (vision was blurry) and HEADACHE (headaches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure increased: 179/110 (High) increased. On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Weight decreased: decreased (Low) Decreased. On 08 Jun 2021, a consumer reported that he took simvastatin for high cholesterol and baby aspirin and fish oil prophylactically. He got his first Moderna dose in his left arm on 01 Apr 2021, lot 017B211A. The next day his blood pressure skyrocketed from 100/50 normally to 179/110. He went to a heart doctor (cardiologist) on Thursday, 22 Apr 2021. His left arm had a higher blood pressure than the right arm. The doctor sent him to the emergency room as he thought he had blocked arteries. They did a computerized tomography (CT) scan and magnetic resonance imaging (MRI). The tests came back negative and he was sent home. He had headaches, dizziness and his vision was blurry. His blood pressure came down to 167/106 and stayed around that level. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events. This case was linked to MOD-2021-213198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events.

I had the second dose on 3/18/2021 and on 06/14/2021 I noticed I was extremely short of breath and my left lower leg swelled up. I went to the doctor?s office and they had me do some tests and the D dimer came back very high, they sent me to the ER right away and they put me on heparin, I stayed there for 2 nights and then they sent me home with a prescription for Eliquis. They found a clot in each lung it was called pulmonary embolism and in my lower left leg they found a DBT.

Sever inflammation of heart/ heart congestion; Abdominal area down to legs fluid retention/ weight gain 30 pounds; Horizontal and vertical rash at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Sever inflammation of heart/ heart congestion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FLUID RETENTION (Abdominal area down to legs fluid retention/ weight gain 30 pounds) and VACCINATION SITE RASH (Horizontal and vertical rash at the injection site.). On an unknown date, the patient experienced CARDITIS (Sever inflammation of heart/ heart congestion) (seriousness criterion medically significant). At the time of the report, CARDITIS (Sever inflammation of heart/ heart congestion), FLUID RETENTION (Abdominal area down to legs fluid retention/ weight gain 30 pounds) and VACCINATION SITE RASH (Horizontal and vertical rash at the injection site.) outcome was unknown. Concomitant medications were not provided. Treatment included fluid pills (details not provided). On an unknown date, the following tests were performed but results were not provided: Cardio scan, computerized tomogram, and ultrasound. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-032565 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated event Carditis. Case upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

one week after shot patient states he has swollen lymph node in neck the same side as the vaccinaton arm. Patient has not been seen about the reaction. The swelling is still present at this time, the time of his second shot.

71 yo M admitted for sepsis from perforated gangrenous cholecystitis c/b E coli bacteremia, s/p lap chole 1/14 then found to have post-op collections now s/p drain placement of medial collection and aspiration of lateral collection. CT evaluation for pulmonary emboli on 1/22/21 discovered, "Bilateral upper lobe segmental/subsegmental pulmonary emboli. No evidence of pulmonary infarct or right heart strain."

Moderna COVID-19 Vaccine EUA - [ ] Lymph nodes soreness - [ ] Large knot in left shoulder, progressively more sore each hour - [ ] Tightness in chest - [ ] Tight jaw - [ ] Teeth aching, left side of face, lower jaw - [ ] Slight nausea - [ ] Slightly tired (but did play men?s night)

"Covid Arm" - slightly red and swollen. Appeared on Saturday (1/30) evening. Size about the diameter of a baseball. No treatment given. By Monday, 2/1, grew in size; shape now oval, length approx 6 inches, width varies from 2 to 3 inches. Started to itch slightly at approx 9:00 PM. Took2 Benadryl liqui-gels at approx 11:00 PM. At 10:00 AM on 2/2, size remained the same, and red coloring started to fade. By 10:00 PM on 2/2, the size grew about 1/2 inch in both length and width. Took 2 more Benadryl liqui-gels at 10:00 PM. By 1:00 a on 2/3, there is no change.

Terrible pain in the lymph nodes on the left side of the neck. Terrible pain in the lymph nodes in the groin area. Acid Reflex in the middle of the night for 7 nights.none

02/03/2021 The next day after the Covid 19 (Moderna) injection my dad felt chills thru out his body around 7:00 pm he took a Tylenol we assumed it was just a side effect from vaccine. At on or around 8:45 PM my dad called my sister that he was having trouble breathing and felt very short of breath. My sister was there in about 7min by the time she got to him my dad was gasping for air he would lift his head up trying to breath. They got him to the hospital shorty after about a 7 min drive. My dad was taken into hospital we were not able to go in due to restrictions.

injection site pain, swelling and redness Narrative: Patient received the vaccine at a non- COVID vaccine clinic. Called the call center 2.5 weeks after receiving the COVID MODERNA vaccine dose #1 on 1/21/2021. Patient reports he experienced fatigue and arm pain 2 days after receiving the vaccine. Then on day 12 he noticed localized red area and swelling accompanied by more pain. States on day 14 his symptoms resolved. No intervention or active treatment noted and thus noted as mild severity.

about 30 hours after first dose of covid 19 vaccine, the patient had a bad stomach aches and diarrhea for an hour. after that he went into anaphylatic shock-had itching, hives all over body, his tongue swelled up, and he couldnt talk. he went to the ER and received benadryl, decadron, and fluids

First night (Monday) had a slight numbing in my tongue, second night my tongue was starting to fill my throat and I called 911, Thursday night my left side of my lip and cheek/face swelled up took a shot of children's Benadryl and a adult pill.

Within 24 hours of vaccination, pt developed soreness in R arm (where vaccine was given), generalized weakness and difficulty ambulating, and became nonverbal. Presented to BMC ED with temp 102.5, HR 119, BP 112/62, 97% RA.

About a week after getting my second dose I developed a severe, very itchy, swelling and raised bumps on my front and back torso, my face and my arms. My doctor put me on hydroxyzine and Pep-Cid because they felt Prednisone would suppress my immune system. Two weeks later he has put me on Prednisone because the first course of action did not work. I've gotten through two days worth of Prednisone.

Red, swollen, painful redness over a large area of arm. It started out as about a nickel-sized round redness around the injection site. Grew to a 3? x 3? Red patch by the next day. Approximately 4? x 4? red patch now, 24 hours later.

severe COPD; could not breathe; chest pressure; pressure in the neck; rapid heartrate; premature ventricular contractions, extra heart beat; face swollen a little; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face. No prior medical history and concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient experienced the events like severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face on 12 Feb 2021. The reported case is serious as the events, severe COPD, could not breathe, had chest pressure, pressure in the neck, rapid heartrate (have extra heartbeat), premature ventricular contractions and swelling in face lead to hospitalization and resulted in prolonged hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were considered not resolved and the patient is still in.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Onset was simple cold sore on lower lip, few days later sore inside left nostril, week later sore inside right nostril. Three days fatigue as of yesterday. None have healed at this point. Bloody and oozy. Ouch. No fever.

Nausea, headache- constant pressure, feet feel like blocks of ice, temperature is 2degrees above normal, chills, fever blisters inside mouth, sore arm at injection site, pins and needles feeling in my fingers and fingers are swollen- can close my fingers but tight and lightheaded .

Deep red rash about 3cm in diameter with hardness underneath about 5-6cm and swelling. Also swelling in lymph under arm. Dr. was seen who ordered a course of antibiotics and steroids after which the swelling and redness resolved.

Nearly immediate onset of throat tightness, facial swelling, difficulty breathing. Became unable to talk. Epinephrine, benedryl and zofran were immediately administered by on-site paramedics. Was able to talk after administration of Epi. Was transported to hospital via ambulance. We later heard that he had another episode within the hour and was admitted for observation.

Swelling and red with spots and Itching. Becoming worse each day. started 4 to 5 days after injection.

Swollen lymph nodes; raised rash on upper chest, throat, neck; some pain in throat. Rash is red, painful, and itchy. Has persisted for for at least 5 days with little relief from medication (Advil, Benydryl).

Swollen left arm. Sinuses inflamed with heavy mucus. Throat infamed. I was afraid the mucus would travel into my lungs. Went to health facility the 25th of February to phyician`s assistant for medical care.

Tenderness pain, swelling size of a tennis ball, pain and muscle soreness same after 72 hours itching, warm to the touch

Moderna shot 2/10/21. 2/16/21 left arm injection site got large welt, rash left arm and ankle. OTC benadryl and hydrocortisol 2% cream. By 2/22/21 rash eventually spread to whole body. Burning and itching. Bright red skin on forearms. Attacks of flush face, bright red body, intense burning of skin 2 or 3 time per day for three weeks. Vertigo. Hard swollen stomache. Sore swollen lymph nodes. Fatigue, fog. 2/23/21: Treated with Prednisone 60 mg/day for 2 days, 40 mg/day for 3 days. 3/09/21 Hyroxyzine HCL 20 mg 4 x day for 1 weeks plus zyrtec at night, 2xday for 1more wk, currently 1x/day plus zyrtec at night. 3/11/21. Clobetasol Prop 0.05% Oint 60 mg 2 x day to areas for two weeks to date. Improving to date.

fainting spells or passing out; severe stomach pain, abdominal pain; nausea; Swollen lymph nodes in three places like a triangle; low blood pressure with faint pulse; faint heart beat or rate with flutters; lightheadedness; blurry vision; right ear ache; face flush or red face; burning sensation on his hands; red rash on under arm; HEART FLUTTER; A spontaneous report was received from a Consumer concerning himself as a 72 Years-old male elder patient who experienced severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm. The patient's medical history was low glycemia and atrial arrhythmia.His concomitant medications were reported as Vitamin D31000 IU as supplement, Prevacid 30 for acid reflux prevention and Magnesium 400mg as supplement. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced fainting spells which is medically significant and the other events are severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand and red rash on his under arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of the event(s) severe stomach pain, nausea, abdominal pain, swollen lymph node in three places like a triangle, low blood pressure with a faint pulse, faint heartbeat or rate with flutters, dizziness, lightheadedness, fainting spells or passing out, blurry vision, right earaches, facial flushness or red face, burning sensation on his hand, red rash on his under arm were Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Fatigue, headache, rash and swelling upper leg, occasional high temp of 99, night sweats, dark urine, swollen lymph nodes(gone now)

left arm from deltoid down the arm painful with extensive swelling/erythema and possible cellulitis so prescribed cephalexin. fever, headache, nausea and vomiting.

I spoke on 03/09/2021 with a question from him. He received his first dose of COVID-19 vaccine as Moderna on 02/16/2021. He reports he did well with his shot initially and didn't really even have a sore arm. About 6-7 days after his vaccine, however, he started getting some significant redness, warmth, tenderness and then swelling in his arm that continued to worsen. became concerned that his reaction was more than would be normally expected so he was seen by a doctor who diagnosed him with cellulitis and started him on antibiotics and steroids. He had completed his antibiotics at the time of our conversation and said his arm felt better but was still slightly red. His doctor recommended that he not get a second dose of Moderna, but suggested that he might get a Pfizer or a Janssen vaccine instead, and was wondering about our recommendation for this? I let patient know that there are no specific studies for the interchangability of these vaccines but there is a statement from CDC that says if an individual is unable to get a 2nd dose of an mRNA vaccine due to a contraindication, they could consider getting one dose of Janssen vaccine at least 28 days after the first dose to have a complete valid J&J dose. I encouraged to speak with his provider about this possibility and any further action. I did some education on potential causes of cellulitis and let him know that per immunization guidance, cellulitis isn't necessarily a contraindication to a second dose of vaccine but more of a precaution as it can be difficult to know the exact cause and a second dose may not result in the same side effect. Several times reported no respiratory symptoms or other symptoms than the cellulitis. I again recommended him to speak with his provider for the best plan of action and he agreed to this.

Swelling and tenderness of lymph node in left armpit. This was first noticed on 01/31/2021, 10 days following the first Moderna vaccination. It may have started sooner, but was not noticed at the time. Two days later it was gone.

Local swelling & redness, nausea, headache, tiredness & fatigue, muscle aches, chills, low grade fever

Right ankle swollen; could not walk for several weeks; Leg cramp; pain in right leg that comes and goes; right leg swelled up; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not walk for several weeks), MUSCLE SPASMS (Leg cramp), PAIN IN EXTREMITY (pain in right leg that comes and goes) and PERIPHERAL SWELLING (right leg swelled up) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fall from high place (fell off a roof 20 years ago), Coma (for 23 days after a fall), Clot blood (in left leg after being in coma for 23 days) and Nerve damage (left leg). Concurrent medical conditions included Depression (mild), Acid reflux (esophageal) and Disability. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ST. JOHN'S WORT for Depression. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (right leg swelled up) (seriousness criterion disability). On 26-Feb-2021 at 8:00 PM, the patient experienced MUSCLE SPASMS (Leg cramp) (seriousness criterion disability) and PAIN IN EXTREMITY (pain in right leg that comes and goes) (seriousness criterion disability). On 27-Feb-2021, the patient experienced GAIT INABILITY (could not walk for several weeks) (seriousness criterion disability). On 01-Apr-2021, the patient experienced JOINT SWELLING (Right ankle swollen). At the time of the report, GAIT INABILITY (could not walk for several weeks), MUSCLE SPASMS (Leg cramp) and PERIPHERAL SWELLING (right leg swelled up) outcome was unknown and PAIN IN EXTREMITY (pain in right leg that comes and goes) and JOINT SWELLING (Right ankle swollen) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, X-ray: normal (normal) no blood clots. Treatment for the events included diclofenac sodium cream and paracetamol. On 06 Mar 2021, a physician told the patient that it was okay for him to do leg presses so he did 350 pounds x100 and he also walked in a pool. He went home and after sitting for a half hour, his leg cramped up again and he needed a crutch to walk. The patient also reported using a cane. The patient stated, stated "now I just exercise leg with movements that seem to help." Very limited information regarding this event/s has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: City, state and zip code updated; patient's date of birth and race updated; medical history and concomitant medications added; events updated.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Fever, chills headache, fatigue , swollen fingers and joint pain in both hands, soreness at injection site. Felt as if I had Covid again . Had Covid end of March with double pneumonia just antibiotics . 2nd Moderna injection March 30th just injection site pain.

Body rash. Itchy, red and swollen on both arms, both shoulders, neck and face. It's almost 3 weeks and the rash is still going, and repeatelt at the same place. I visited my PCP doctor 3 day ago, and doctor gave me "Triamcinone Acetonide 0.1%". I also got fever, headaic and tirenese for couple days afer second shot.

Nine days after receiving injection: 3 1/2" x 4 1/2" area; red, swollen, warm to touch, itchy Benadryl taken orally, Hydrocortizone cream topically, and ice packs

Dizziness; weakness; dyspnoea; throat swelling; Swelling face; Eye swelling; fever; vomiting; muscle pain; joint pain; Tiredness; Not moving so much due to the healing broken ribs; Broke 3 ribs; Hurt his left arm and forearm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), DYSPNOEA (dyspnoea), PHARYNGEAL SWELLING (throat swelling), SWELLING FACE (Swelling face), EYE SWELLING (Eye swelling), PYREXIA (fever), VOMITING (vomiting), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (Tiredness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included End stage COPD (stage four), Emphysema (stage four), Kidney disorder, Heart disorder, Rheumatoid arthritis (severe) and Dependence on oxygen therapy. Concomitant products included METHADONE, OXYCODONE and PREDNISONE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSPNOEA (dyspnoea) (seriousness criterion hospitalization), PHARYNGEAL SWELLING (throat swelling) (seriousness criterion hospitalization), SWELLING FACE (Swelling face) (seriousness criterion hospitalization), EYE SWELLING (Eye swelling) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), MYALGIA (muscle pain) (seriousness criterion hospitalization), ARTHRALGIA (joint pain) (seriousness criterion hospitalization), FATIGUE (Tiredness) (seriousness criterion hospitalization), RIB FRACTURE (Broke 3 ribs) and LIMB INJURY (Hurt his left arm and forearm). On 19-Apr-2021, the patient experienced MOBILITY DECREASED (Not moving so much due to the healing broken ribs). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ARTHRALGIA, ASTHENIA, DIZZINESS, DYSPNOEA, EYE SWELLING, FATIGUE, MYALGIA, PHARYNGEAL SWELLING, PYREXIA, SWELLING FACE and VOMITING. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (weakness), DYSPNOEA (dyspnoea), PHARYNGEAL SWELLING (throat swelling), SWELLING FACE (Swelling face), EYE SWELLING (Eye swelling), PYREXIA (fever), VOMITING (vomiting), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (Tiredness), MOBILITY DECREASED (Not moving so much due to the healing broken ribs), RIB FRACTURE (Broke 3 ribs) and LIMB INJURY (Hurt his left arm and forearm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: high high. This case was linked to MOD-2021-080362, MOD-2021-080525 (E2B Linked Report).; Sender's Comments: MOD-2021-080362: MOD-2021-080525:caller's case

Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown. This case was linked to MOD-2021-080525 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-080525:caller's case

Patient reported that the evening of his vaccination he started to get cold sores. Overnight he got several more cold sores. These are located on his lips and inside his mouth. Looks to be around 5-10 cold sores currently.

swollen cheek and tongue; severly swollen tongue; swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (severly swollen tongue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0394209) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Proctitis from 01-Jan-2021 to 01-Apr-2021. On 08-Feb-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021 at 7:00 AM, the patient experienced LIP SWELLING (swollen lip). On 10-Feb-2021, the patient experienced SWOLLEN TONGUE (severly swollen tongue) (seriousness criterion hospitalization). On 11-Feb-2021 at 7:00 AM, the patient experienced SWELLING FACE (swollen cheek and tongue). At the time of the report, SWOLLEN TONGUE (severly swollen tongue), LIP SWELLING (swollen lip) and SWELLING FACE (swollen cheek and tongue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

2 months after second Moderna vaccine into L deltoid, I developed constant dull ache 6/10 in same shoulder 2 days after a trivial injury. Pain affected very little by movement. Full ROM. Pain much worse at night when supine. tender lymph node behind L clavicle. No improvement or worsening over next 6 days. disrupting sleep. No benefit from topical diclofenac. No other analgesia used. Neg x-ray. not behaving like injury induced pain. I began taking prednisone 40mg qd on 5/7/21 and improving.

Possible Guillain-Barre; Weakness in his legs up through his abdomen and lower back; Numbness in his legs up through his abdomen and lower back; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure abnormal and Blood cholesterol abnormal. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre) (seriousness criterion medically significant), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back). At the time of the report, GUILLAIN-BARRE SYNDROME (Possible Guillain-Barre), ASTHENIA (Weakness in his legs up through his abdomen and lower back) and HYPOAESTHESIA (Numbness in his legs up through his abdomen and lower back) outcome was unknown. Concomitant medications included blood pressure medicine and cholesterol medicine. Treatment information was not provided. The caller stated that although they are still running some tests, his doctors believe that he developed Guillain-Barre after receiving the vaccine The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Approximately 2 to 3 weeks after my second Moderna injection, I experienced a burning sensation in my thumbs and noticed a large lump on my left thumb along with a small wart. Rubbing the painful thumbs for several minutes reduced the burning sensation and shortly after stopped hurting. The burning sensation reoccurred a few more times during the week or two following the initial occurrence. Subsequently, the large lump has reduced in size but the small wart is still present.

Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections.

headache; tiredness; Convulsion; Severe chest pain; Breathing problem; Swelling of his whole body; Severe Allergic reaction; significant drop in blood pressure; Shaking and Tremor all over the body; Pain all over the body; exaggerated pulse at 92 bpm; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B214 and 03114211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Malaria (Had 2 types of Malaria.) and Sick child (Sickly as a child). Concurrent medical conditions included Rheumatic fever and Drug allergy (Allergic to sodium Pentathol). Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASPIRIN [ACETYLSALICYLIC ACID], TRIAMTERENE, HCTZ, ATORVASTATIN, TERAZOSIN and DICLOFENAC SODIUM (FENDER) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), TREMOR (Shaking and Tremor all over the body), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 16-Apr-2021, SEIZURE (Convulsion) had resolved. On 17-Apr-2021, TREMOR (Shaking and Tremor all over the body) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement (120-90 mmHg): low mmHg (Low) 107/65 Significant drop in Blood pressure. On 16-Apr-2021, Heart rate: abnormal (abnormal) Exaggerated pulse at 92 bpm. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Ascending paresthesias, loss of distal reflexes, gait unsteadiness, progressed over 3 weeks. Diagnosis of Guillain-Barre Syndrome.

rash on right arm shoulder to wrist. next day left arm. was in sun 2 to 3 hours and the left arm became swollen almost twice it regular size . Burning feeling. a little oozing . Left torso affected also . inner legs hives.

Pain in left bicep initially. :Pain and stiffness gradually spread to both shoulders, both hips, and both wrists. Increasing pain and stiffness. Diagnosed with :PMR (polymyalgia rheumatica) Began treatment with :Prednisone

Pain, stiffness, and swelling in left hand. Next day, it moved to right hand. Very intense pain. Went to ER on Hwy 290 on 03/30/21 and doctor said I had cellulitis, and prescribed an antibiotic. After about four days it wasnt't any better and went to ER. They did some blood work and X-Rays and said it was Osteoarthritis. Xray showed some mild to moderate arthritis to both hands. Until that second shot, I never had any pain in my hands or anywhere else. I asked the doctor if he thought I had ever had cellulitis and he said "no". I still have the pain and swelling in my hands but sometimes it migrates to my knee, my foot, or my shoulder. I am currently taking 3 advil in the morning to cope with the pain.

Pt advised received first Covid Vaccine on Friday (Moderna) and began having shortness of breath, dry non-productive cough, BLE edema 3 days ago. He does admit to increased salt intake over the past week as well. He presented to ER in April with CHF/COPD exacerbation with TTE showing EF 30 to 35%, moderate MR with posterior jet impingement on wall, mild TR, bicuspid aortic valve, mild pulmonary hypertension. He underwent IV diuresis and steroids. He initially thought the level of shortness of breath he was experiencing was caused by his first Moderna COVID-19 vaccine because it became acutely worse after receiving the vaccine. He saw his outpatient cardiologist who ordered stress test which showed severe lateral wall and inferior wall ischemia, infarction in circumflex territory, EF 38%. He was then referred for left heart catheterization with diagonal 1 90%, LAD 75%, circumflex 100%, RCA 60%, PDA 75 to 80%, PLB 100%, DFR of the LAD 0.80 then 0.66 which is significant, EF 30 to 35%, mild MR. Since his hospitalization, he admits to shortness of breath while working in his yard but states that his shortness of breath improved. He underwent PFTs which showed FEV1/FVC 77, FEV1 3.11, FVC is 4.03, DLCO 49.5. Other past medical history of diabetes (A1c 9.2), hypertension, spinal stenosis. He is a former cigarette smoker with 35-pack-year history. Family history of father with heart disease.

right side of his cheek swollen; right side of his lips swollen; right side of his cheek swollen; right side of his lips swollen; tongue swollen; tongue swollen enough that his speech was different; Right side of cheek swollen; Swollen lip to the cheek on left side; Tongue was swollen three times the normal size; Unable to breathe; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue was swollen three times the normal size) and DYSPNOEA (Unable to breathe) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039420a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 09-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue was swollen three times the normal size) (seriousness criterion medically significant) and DYSPNOEA (Unable to breathe) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced SWELLING FACE (Right side of cheek swollen) and LIP SWELLING (Swollen lip to the cheek on left side). On 22-Feb-2021, the patient experienced the first episode of SWELLING FACE (right side of his cheek swollen), the first episode of LIP SWELLING (right side of his lips swollen), SWOLLEN TONGUE (tongue swollen) and SPEECH DISORDER (tongue swollen enough that his speech was different). On 24-Feb-2021, the patient experienced the second episode of SWELLING FACE (right side of his cheek swollen) and the second episode of LIP SWELLING (right side of his lips swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue was swollen three times the normal size), DYSPNOEA (Unable to breathe), SWELLING FACE (Right side of cheek swollen), LIP SWELLING (Swollen lip to the cheek on left side), SWOLLEN TONGUE (tongue swollen), SPEECH DISORDER (tongue swollen enough that his speech was different), the last episode of SWELLING FACE (right side of his cheek swollen), the last episode of LIP SWELLING (right side of his lips swollen) and ARTHRALGIA (Sore shoulder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Allergy test: unknown (Negative) Negative to food he ate (pistachios, tomatoes, shellfish, prawns). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had a tongue swelling and reaction on the night on 09FEB2021 and was taken to the ER after calling 911. They released him in 3 hours and patient visited an allergist, who drew blood to check for a rare disease. Also did allergy testing for the foods that had eaten just prior was negative for them. The patient has never had allergy problems prior to this. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

sweating, fever, lightheaded at first. I thought it was just a reaction to the shot. 5 or 6 days later I ended up in the hospital with a bad infection (Sepsis) and while in the hospital went into fibrillation that would not stop. They rushed me down to the OR to shock my heart back to a normal rhythm. I was in the hospital for 8 days. Now I am on blood thinners and a drug to stablize my rhythm so it can't happen again. I have a new heart doctor who is doing much testing. I have never had a heart problem before I took the shot.

Swelling in lymph node and pain in left chest. Thought it was a heart attack , went to urgent care and then on to ER. Nothing showed up as it being a heart attack.

I felt a lump on the right interior part of the neck about 2 cm, I had an ultrasound, CAT scan, and removal of 2 lymph nodes. I was diagnosed with swollen lymph nodes and follicular lymphoma. I had scheduled a biopsy and a CAT scan confirmed the two lymph nodes and PET scan showed an enhancement in the rectum and sacrum. I have recovered from the surgery but not from the adverse event since I was diagnosed with cancer (Follicular lymphoma) and I am still under evaluation to see if it is stage 4.

Pt received dose #1 Moderna COVID Vaccine 1/12/21 Clinic. 1/15/21 presented to ED for left upper arm redness/swelling, fever, body aches, new cough, decreased appetite, and fatigue . Had been treating w/OTC Tylenol. Developed sepsis, leukocytosis from LUE cellulitis, currently admitted to hospital for treatment. Entered by PSS for tracking.

Patient received the first dose of the Moderna COVID19 Vaccine on 1/8/21. He reports he had a sore arm for about 2 days, but soon after developed shortness of breath, generalized body aches and extreme fatigue, most of which lasted for 6 to 7 days. The shortness of breath worsened during this time and he also developed a bump in the right neck area. Upon admission his oxygen saturation was 91% and he had a 10 L nasal cannula placed, increasing saturation to 93%. As of 1/27/21, oxygen saturation has improved and pt is now on 5 L nasal cannula, saturating at 99%.

Patient previously was diagnosed with COVID-19 and recovered in 12/20. Patient received MODERNA COVID-19 vaccine 72 hours PTA. Patient developed soreness and achiness and fevers 48 hours PTA. This was followed by progressive redness of the skin on left upper arm at vaccine injection site. Patient was then admitted with left upper arm cellulitis with sepsis criteria.

prior covid patient in march developed transient sob for fifteen minutes with subsequent three days intermittent chills and swollen painful red arm for six days

Patient went to bed totally fine and woke up saying he could not see in one eye. I rushed him to the emergency hospital they ran cat scans, MRI, heart tests etc. He stayed overnight while they checked. The next day we went to eye doctor who told him he had a eye stroke. He would regain some of his site not all of it. Something to do with blood clot or loss of blood to the eye. I was not satisfied with that so made another drs appointment for the next day with a different eye doctor. The first eye doctor gave us some blood test to do so we did it then. Later that evening we got an emergency call form the first eye doctor to get back to the hospital right away he could lose sight in the other eye.. They found some high c-reactive protein. Normal is 8 his was over 40. They put him on heavy steroids and did biopsy on both temples of his eyes. This started last Wednesday morning. He was released from the hospital Monday Morning to see his regular doctor that afternoon. Test results for the eye would be Tuesday and all other vital tests came back fine thank goodness. On Tuesday the biopsy tests also came back negative so they are stopping steroids. I think they were looking for auto immune issues. Today we are going to Rheumatologist

Woke up to swollen upper lip and face, itching of hands and rash around beltline, abdomen, inner thighs and groin. Taking Benadryl.

Swollen glands left side of neck. Soreness in joint of left shoulder ,elbow ,hand .Tingling in hand .Soreness down left side and the hip area .

Weakness, swelling , fatigue joint pain mild fever chills for 4 days; Most worrisome is impact on two artificial knee joints; Can?t stand without assistance.

Redness, slight swelling, warm to touch, itchy, approximately four inch diameter, very irregular shape. Persists since onset. No treatment.

Patient reports noting bilateral lower extremity swelling and redness that started after vaccine and has persisted. He obtained care today at the clinic. There are many other possible causes but reporting due to patients report this began after 2nd dose of vaccine. No rash, no itching

patients wife calling to report that the patient had his first covid shot on 2/ 11/21. 2 days later the patient broke out in hives on top of his head, forehead, back of neck cheek bone area on the LT side swelled up only lasted 2 days.

MODERNA COVID-19 VACCINE EUA 48 hours after receiving the vaccine, patient experienced extreme pain, sensitivity, and swelling in his left wrist and fingers. Approximately 24 hours later (72 hours post vaccination) patient reports that his right wrist and fingers were experiencing the same reaction. He is unable to make a fist, grip a water bottle, or open his medication bottles without assistance.

Muscle aches arm, legs Headaches, chills Glands in neck (left side) swollen, continues to enlarge and is sensitive to touch.

Two days after patient received second dose of Moderna COVID-19 vaccine, he presented to the emergency department with complaints of abdominal pain radiating to his back. He denies alcohol use or fatty meals recently, does not smoke, denies nausea/vomiting/diarrhea, chest pain, shortness of breath, fevers or chills. In ED he was mildly tachycardic, otherwise hemodynamically stable.

Swelling in lymph node in rt armpit. Swelling and redness of arm and chest. Prescribed Clynimyocin and Benadryl. Symptoms subsided in 10 days.

Severe face and throat swelling; difficulty swallowing; rash (shingles-like) across chest and back. Swelling subsided after 2 days; Rash is still present, though lessened in intensity

1600 day after vaccine presented with N/V and chills. Small bowel obstr-partial. NG tube, fluids. resolved. Admit 3/3 DC 3/8

Very itchy rash all over the body. beginning 2 days after injection. Felt like flea bites. They were not. Exterminators called and treated house on 03/04/21. Rash kept getting worse, and swelling in right calf was detected.. Monday 03/07/21 went to emergency roon. Visual examination diagnosed allergic reaction to vaccine.. Began prednisone and benadryl treatment that day.. As of today, it is better, but still some rash left and swelling id down in right calf.

24 Hours after the first vaccine shot a rash appeared on my left leg. Experienced severe itching and scratching and the rash became raw. Within 48 hours rash had spread covering a larger area on my leg and then I developed numerous random blisters on both arms , right leg and back, causing severe itching and mild burning pain. The rash on my leg became extremely red and caused pain and swelling. None of these symptoms have abated.

I have oral herpes. I get it 2-3 times a year. Valicyclovere is taken and it goes away without exception. It came up the day after receiving the vaccine and has lasted 5 weeks and the Valicyclovere isn't working. it went away by 03/10/2021. I also experienced fever and weakness 03/06/21 and then when it resolved the herpes came up. Went to the doctor at a walk in clinic on 02/24/21 because I had high fever and nausea and weakness for about 10 hours. I got an infected tooth(root canal and crown on this tooth) and an infected jaw. Dentist put me on antibiotics and I have to have the tooth pulled. I went to the dentist on 02/11/2021.

Patient experienced Muscle aches, Elbows ached and were swollen along with his knee's and thigh's. Patient states his neck hurt so bad he could not turn his head from side to side. Also states that his left eye would twitch. Patient saw Primary Care doctor and was given Advil, Tramadol and steroid taper dose pack.

Besides expected head ache and slight fatigue, I woke up on the night of 3/17 (day 2 following 2nd vaccine dose) with extreme pain in my right big toe and foot, with some cramping in the right calf. It was difficult to walk. I stayed in bed most of the next day with right leg elevated, and using ice to help pain and swelling. My wife and I suspected Gout, however it would have been a first for me to have it. By 3/19 it felt a little better, but right foot still swollen, and my wife and I noticed a pronounced vein from the right knee down. She got scared that it could be a blood clot, so we called Dr and he ordered ultra sound, which was done on 3/19 in afternoon, but technician said that saw "nothing". Today (3/20) foot still sore and it's hard to put wight on it still.

fatigue, chills, sweats; lasted four days, starting on the 14th. Got tested - negative. Swollen glad on left side of neck lasted only a day.

PLEASE HELP. I have had moderate to severe pain at upper left arm injection site starting approximately 1/15/2021, a day after the injection, until the present. It manifests itself mostly during sleep and awakes me with significant constant pain while in a reclining position. When I sit up, it is somewhat alleviated and I have to take extended release tylenol (650mg) to get back to sleep. I wake up most mornings with the same left arm pain at the injections site. On March 16, 2021, my internist examined it and found the same bump in my upper left arm and said it is definitely from the 1st vaccination. He suggested heat on and off for 20 minutes. I tried it two evenings in a row and the pain got worse in bed. Since I cannot take any NSAIDs due to my aspirin regimen for Coronary Artery Disease, there seems nothing else to do, but I am worried that some long lasting detriment is happening to my body. PLEASE HELP. I did not have any such symptoms from the second Moderna vaccine received 2/11/2021.

Vaccine #1 received on 2/11. On 2/13 experienced polyarthralgias (wrists, shoulders, knees, ankles, hips), headache, scalp tenderness, and swelling and pain of testes. These had resolved by 3/4, after receipt of ceftriaxone, azithromycin, doxycycline, and ibuprofen. But on 3/10 he developed loss of vision in his right eye and new frontal headache and was referred to Ophthalmology on 3/11 where he was diagnosed with Giant Cell arteritis (GCA) and prescribed corticosteroids. Within 1-2 days of receiving the latter, his headaches and vision loss had resolved.

3/26/21 HPI: 72 y.o. male who presents with SLURRED SPEECH, WEAKNESS AND CONFUSION. PT SENT OVER FROM DOCTOR'S OFFICE WHERE WAS NOTED TO HAVE ACCUCHECK OF 59. PT STATES HAS NOT EATEN SINCE 7 AM AND HAD EGGS AND SAUSAGE. PT HAD SECOND COVID VACCINE TODAY AND HAS TAKEN ALL HIS MEDS INCLUDING INSULIN AT REGULAR TIMES. PT DENIES ANY RECENT ILLNESS. PT WAS RECENTLY HOSPITALIZED 3/5/2021 FOR CELLULITIS AND DECONDITIONING AND IS GETTING HOME HEALTH FOR PT. 3/26/21 Transferred to HOME MEDICAL dx: inferior MI, hypoglycemia, right middle lob pulmonary infiltrate 3/30/21 returning to HOSPITAL for swingbed admission

Client has history of COPD and CHF. Three days after the 1st COVID Vaccine, client had some SOB and he called 911. When the ambulance arrived they had to do CPR on him and got him to the hospital and at the hospital they got him breathing on his own. From the ER they transferred him to Facility. He spent 23 days in the hospital and Rehab. He was told he could take the vaccine. He was out of the hospital for one week before his 2nd COVID Vaccine. His friend/neighbor is the historian and she states that since he was out of rehab that he was having a lot of extremity swelling. He then came to the Health Services on 03/29/2021for his 2nd COVID Vaccine. On 3/30/2021 at 5:45 pm, client went to Pharmacy to pick up his medications, and after 9 pm was found by friend deceased in his car at Pharmacy. This information was received from friend/neighbor, no local family available.

pt states when he went to bed on 4/1/2021 he had a headache, fever and a sore right arm. He woke up w/ headache, body aches, face is swollen. His right eye is almost completely swollen shut and the left eye is swollen. He states it looks like he has angioedema. He is not taking any medication for his symptoms at this time.

3/23/21 Medical Group note: dx pleuritis Chief Complaint Patient presents with ? URI c/o sob, tired, chills, headache, achey. symptoms started today. 72 y.o. male Pt has had both COVID vaccines. URI :This is a new problem. The current episode started in the past 7 days. The problem has been unchanged. There has been no fever. Associated symptoms include abdominal pain and chest pain. Pertinent negatives include no congestion, coughing, diarrhea, dysuria, ear pain, headaches, joint pain, joint swelling, nausea, neck pain, plugged ear sensation, rash, rhinorrhea, sinus pain, sneezing, sore throat, swollen glands, vomiting or wheezing. He has tried nothing for the symptoms. The treatment provided no relief. Review of Systems HENT: Negative for congestion, ear pain, rhinorrhea, sinus pain, sneezing and sore throat. Respiratory: Negative for cough and wheezing. Cardiovascular: Positive for chest pain. Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for joint pain and neck pain. Skin: Negative for rash. Neurological: Negative for headaches. Objective Vitals: 03/23/21 1604 Weight: 120 kg (264 lb) Comment: pt. reported Height: 69" Body mass index is 38.99 kg/m². Diagnoses and all orders for this visit:Pleuritis Chest wall pain Pt was advised to go to ER if symptoms persist or worsen. Pt was advised to come to office tomorrow for CXR and recheck. 3/24 sih med group dx rib pain: Patient presents with ? Chest Pain c/o chest pain/initially had chills, sob. symptoms started yesterday. Patient is a 72 y.o. male. Pt states he has gained 20 lbs in last few months. Pt sleeps in a recliner. He states he has to reach over the arm of the chair to adjust the reclining lever. Pt has pain to right ribs and abd. Abdominal Pain The current episode started in the past 7 days. The onset quality is sudden. The problem occurs intermittently. The problem has been unchanged. The pain is located in the RUQ. The pain is moderate. The quality of the pain is aching and dull. The abdominal pain does not radiate. Pertinent negatives include no anorexia, arthralgias, belching, constipation, diarrhea, dysuria, fever, flatus, frequency, headaches, hematochezia, hematuria, melena, myalgias, nausea, vomiting or weight loss. The pain is aggravated by palpation. The pain is relieved by nothing. He has tried acetaminophen for the symptoms. The treatment provided no relief. There is no history of abdominal surgery, colon cancer, Crohn's disease, pancreatitis or ulcerative colitis. 3/26/21 Admitted to Hospital, dx: elevated troponin, sepsis, acute renal failure, streptococcus bacteremia HPI: 4/5/21 Admitted to Hospital, swing bed status dx sepsis, physical deconditioning

Onset of Guillain-Barré syndrome. Admitted and still inpatient in the hospital being treated. Admitted to the hospital 4/7/2021

Lymphadenopathy; A Literature Non-Study report, was received from a physician concerning a 72 year old male patient who developed Lymphadenopathy/Lymphadenopathy. The patient's medical history included Mantel cell lymphoma, completion of chemotherapy with complete metabolic response to the therapy 10 months prior to immunization with mRNA-1273. Concomitant product use was not provided by the reporter. Prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of Covid-19 infection. After receiving a dose of mRNA-1273, (onset date and time not provided), the patient developed Lymphadenopathy. Treatment information was not provided. According to the literature abstract, two days following the patient's immunization, he underwent a FDG PET/CT examination. Per report abstract, "Series follow up FDG PET/CT scans have been negative for lymphoma". "Current FDG PET/CT scan showed a new cluster of subcentimeter left axillary lymphadenopathy with avid FDG uptake. There was also focal FDG uptake in the left upper arm deltoid muscle and adjacent subcutaneous soft tissue, with no other abnormal FDG avid lesion or suspicious CT image findings". Action taken with mRNA-1273 in response to the event was unknown. The event, Lymphadenopathy, outcome was considered unknown.; Reporter's Comments: This case concerns a 72-year-old male with PMH of Mantel cell lymphoma S/P chemotherapy with complete metabolic response, who had a serious unexpected event of lymphadenopathy, with FDG PET/CT 2 days after first dose mRNA-1273 showing new cluster left axillary and upper arm deltoid muscle nodes. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

None at time of moderna vaccine 1 or 2 but on the 3rd day after vaccine 2, 02/11/2021, I was given the degarelix injection in the stomach which resulted in an allergic reaction with hives and difficulty breathing. and swallowing. The second degarelix injection on 03/11/2021, was no reaction but on the third injection on 04/08/2021, 911 was called at the Urologists Office to take me to ER in Medical Centre with a severe life threatening allergic reaction, difficulty breathing, hives, swollen face, hands arms, body., sickness and wanting to clear my throat. I have been having degarelix injection on a monthly basis since 2017, with no adverse reaction.

Diarrhea next day, Fever of 101.6 5days, Large Fever Blister 2 Weeks, Headache, No Appetite 8-9 days, Weak 10 days, loss of balance 10 days On 6-7 day joint pain in every joint much worse than Covid-19. Right shoulder felt like a long nail shoved down the top of my snhoulder. Back, knees, elbows, ankles hurt worse than Covid-19

Significant tongue pain, swelling, blistering and bleeding. Patient reports minimal swelling after dose #1. Significant swelling, bleeding, pain, erythema and open wound after dose #2; requiring 2 urgent care visits.

fevers; joint pain; chill; muscle aches; intermittent hallucinations; swelling in bilateral feet; unable to use the right arm; difficulty performing ADL; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (intermittent hallucinations) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches). In April 2021, the patient experienced HALLUCINATION (intermittent hallucinations) (seriousness criterion medically significant), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL). At the time of the report, HALLUCINATION (intermittent hallucinations), PERIPHERAL SWELLING (swelling in bilateral feet), HYPOKINESIA (unable to use the right arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty performing ADL), PYREXIA (fevers), ARTHRALGIA (joint pain), CHILLS (chill) and MYALGIA (muscle aches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient is taking unspecified medications for treatment of the events. This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of hallucination, and nonserious unexpected peripheral swelling, hypokinesia, loss of personal independence in daily activities, and expected pyrexia, chills, myalgia, arthralgia. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Started with numbness and lack of being able to move thumb of left hand. Later had swelling in most of rest of arm although mostly lower in arm than injection site. Swelling in arm is starting to go away, but patient is still unable to move thumb well.

Right leg burning, red, swollen. Doppler showed XL blood clot and numerous small clots in right leg. Put in Eliquis for2-3 wk. brought to hospital on 5.6.21 with worse swelling, red, and right foot very painful. CT showed clots in legs and in lungs. Still in hospital as of 5.8.21

LYMPH NODES SWOLLEN LEFT AXILLA, STILL HAS 20 PERCENT SWELLING PER PATIENT . PCP SENT HIM TO HEMATOLOGY, ONCOLGY AND HEMATOLOGY, DOCTOR. PATENT STATED HIS WBC WAS HIGH, OVER 18. IS TO HAVE REPEAT CBC END OF MAY 2021 AND FOLLOW UP WITH HEMATOLOGY. ALSO HAS DEVELOPED SWELLING IN JOINT OF LEFT TOE. STATED GOUT TEST WAS NEGATIVE BUT IS NOW ON PRESCRIPTION MED FOR GOUT WHICH SEEMS TO HELP PAIN. ADVISED HIM TO FILE A VAERS REPORT OF HIS OWN SO HE CAN PROVIDE MORE DETAILS. OCCURED AFTER SECOND MODERNA SHOT. IST SHOT WAS 2-12-21.

developed large lump under left armpit the day after shot had an ultrasound done and results was enlarged lymph nodes; received second dose on march 15-- swelling still present--after 3 weeks lymph node swelling increased--- had another ultrasound and biopsy performed on May 3rd-- diagnosed with b-cell lymphoma-- awaiting visit to doctor for further results and treatment

Forearm elbow down to hand has been swollen/puffy; Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Pacemaker insertion (cardiac). On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Sore arm). On 15-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy). At the time of the report, CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling), PAIN (Sore arm) and PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy) outcome was unknown. No concomitant medications mentioned. Treatment for the events included Clindamycin hydrochloride 300mg. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The Urgent Care, diagnosed patient left upper arm swollen twice the size from elbow down to finger, as Cellulitis of Unspecified cause left upper limb. The Urgent Care prescribed Clindamycin HCL 300mg antibiotics every 6 hourly for 7 days and patient symptoms improving after starting the treatment, according to the patient. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Mentioned confirmation of visiting Urgent care and diagnosis from Urgent Care; Events updated. 2nd dose information mentioned; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

2 days sick with aches and weakness. Arm swelling and rash with pain, headaches, fever, chills, tired.

pt felt fine while in store. He went home and felt good enough to mow lawn a few hours later. After mowning lawn his arm started to hurt and felt tingly. When he woke next morning, his are was swollen from top of shoulder to fingertips/ very red and itching. He went to see his physician and she started him on Keflex 4/19. He later took prednisone 20mg 5/5. he states swelling gone, but arm still very red/itchy

Per client, "I received the second dose of Moderna in my right arm on 03/19/2021. The next morning on 03/20/2021 around 9:00 AM, I noticed my left arm swelling. I got to feeling real bad. On 03/25/2021, I was feeling so bad that I went to Family Medicine to see my doctor, MD. He sent me straight to the Emergency room. They gave me the clot buster for my left arm. I was in there for 3 or 4 days. I was discharged. I have blood clots in my lungs. I had a follow up appointment. I also started seeing a new doctor, a pulmonologist, for the blood clots in my lungs. I lost a lot of weight, 32 pounds.

Following vaccination on 05/18/21, WBC elevated with circulating peripheral blasts suspecting disease progression. Bone marrow biopsy has been requested.

On May 9th my father started to not feel well. On May 16th he was admitted to the hospital with sepsis. He had 2 MRIs which concluded he has an infection in the bone of one of his toes. He was sent home after 5 days in the hospital with a PIC line where he has to be on 2 antibiotics and a blood thinner for 6 weeks. If infection doesn't resolve he will have to have toe amputated. Prior to Covid vaccines my father was very active and healthy. He could do things without distress. He can now barely walk too far because he is so weak.

4/20. Painful lumps in temples, Head swollen. Temperature 101 to 102. 04/30. started a week of Clindamycin. 150mg/3 times a day By 5/5 developed dry hacking cough, bad headaches, night sweats, aches in lower joints. 05/06. Started a week of Sulfamethoxazole-Trimethoprim 800, 160mg, 2 times a day By 5/12. head has gone down, sweats, temperature late in the day, cough continued. Some vision changes. Food tastes OK but no liquids taste right By 5/24. cough, temperature some days, night sweats aches in lower joints continue. Taste of liquids still not right.

Became a bit dizzy, BP dropped significantly, and he fell while walking into the doctors office (he had no ambulatory issues before this). Legs became weak, couldn?t walk on his own, could barely walk with a walker, legs were beginning to get atrophied, arms began to shake. He had 5 falls total after receiving both Moderna shots. While in hospital, received IVIG for possible Guillan-Barre Syndrome.

Development of PolyMyalgia Rheumatica Diagnosis delayed as first thought to complication of Lipitor. When persistent was diagnosed

Red blotches on both arms at bicep and minor blotches at groin (itchy) lasted approximately 1 day. This occurred twice in a period of 3 weeks. Severe swelling of the right hand lasted approximately 3 days. Severe swelling of left-side of face. Lasted approximately 3 days. Severe swelling of entire face including lips. Lasted approximately 3 days. The doctor prescribed a Medrol Dose Pak 3 times to correct the 3 events of swelling.

Blood clots formed in the portal veins to the liver blocking the blood supply to the liver causing necrosis. Symptoms included fevers, chills, weight loss, lethargy. Ended up spending 7 days in the hospital with a liver drain inserted to drain off infection. Pic line for antibiotics inserted along with oral antibiotics. Sent home to recover with drain, pic line and antibiotics.

lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death

Left Heal became gradually painful especially to weight bearing about 3 hours after vaccine. No other symptoms. 24 hours latter it seems reddened somewhat compared to the right heal. It is made worse with dorsiflexion of the foot or weight bearing. It also appears a little swollen. It does not feel warm to touch. No sign of foreign body or history of any injury or new increased activity.

same day of vaccination, left side of face/ears swollen, didn't feel right, back pain, arm pit sore, went to walk in clinic today 1/27/2021

On day 23 post vaccine I began with mild influenza like symptoms including aches, chills, sweats, general malaise and mild sore throat. Within the next 24 hours a raging gingivitis and swollen submandibular lymph nodes followed. No cough, chest congestion. . At this time my flu like symptoms remain at gradually reducing levels - mostly resolved. My gingivitis symptoms also re reducing but it is still very painful to attempt brushing my teeth.

dizziness, extreme increase in blood pressure/hypertension, upset stomach, swelling on left cheek, feel flush, lot and cold flashes

Received Covid vaccine at 4:00 PM. At 4:45 developed sharp, acute, shooting pain behind right ear near bottom. At about 6:15 PM contacted a relative who is an active nurse at a local hospital. She said problem was a swollen lymph node and to ice it and take Tylenol if desired. I iced it for 15 minutes and took two high strength Tylenol at about 6:30 PM. Pain stopped at 7:00 PM. Pain returned at 10:00 PM and I reapplied ice for 25 minutes (did not take any more Tylenol). When ice was removed, pain had stopped. Went to bed and awoke at about 12:30 AM and 3:00 AM with no pain. No more pain throughout today.

On January 19, 2021 (4 days after the vaccine injection) I developed severe itching in the palms of my hands. By the next day, January 20, 2021, I had developed severe hives bilaterally from my groin areas down to almost my knees, as well as on my buttox. I also had severe hives in both armpits. Both hands (palms) and wrists had become swollen and fire-engine red and the itching was maddening. I saw a Physician who gave me an injection of Depo Medrol and a 7 day prescription of Dexamethasone, 4mg , take twice a day and a prescription of Hydroxyzine HCL 25 mg, 4 times a day as needed. The hives began to fade after 18 hours of medication and got fainter and fainter each day, along with relief from itching. Hives were completely gone by the time I completed the 7 day cycle of Dexamethasone. I have not had a recurrence.

(1) Face muscle, left side, along the lower jaw, feels swollen, about 3 inch diameter circle. No swelling visible from outside. It is not num, feels like num. Has been that way for last five days, no improvement. No pain, (2) Minor rash, about two inches diameter, middle of the lower back. Has lasted more than 5 days now.

Approx. 24 hrs after vaccine, Felt sore arm, general weakness, lightheadedness,. Fainted. Hospitalized, Couldnt speak and eventually went into a coma type sleep for approx. 24-48 hours. Hospital Diagnosis was: Encephalopathy, History or intracranial hemorrage, hypertension, stroke like symptoms, hepsis. 5 days in hospital. Medicines after discharge added: Norvasc 5mg 1 day, Plavix 75 mg, 1 day, Listopril 1 day 5mg.

Patient recieved 2nd Moderna Dose on 2/4/20221. No symptoms other than sore arm until 2/10/2021. On 2/10/21, patient developed what was described as "covid toes on both feet." Patient's great toe, 2nd, and 3rd toe is purple, the 4th and 5th toe is red and swollen. Patient is awaiting a call from PCP for evaluation. No other symptoms noted.

I received Moderna vaccine. First vaccination - 1/4/21. Second - 2/1/21. No significant reactions to either: no fever, chills, myalgias, fatigue, etc. However, about 1-2 weeks post the first vaccine, I developed mild distal finger joint stiffness and slight pain and swelling. Both hands. R>L. Involving 3rd - 5th fingers. Not symetrical. No other joint pains or spine pain. There has been slight reddish soft tissue swelling of distal phalanges of involved fingers. Nails look normal. Also, few punctate red spots - sl painful; they look like punctate hemorrhages. No systemic symptoms. Not requiring medication. Findings persistant till now. No involvement of toes. No generalized body rashes. I do not have psoriasis, but these findings are reminiscent of findings one would see with Psoriatic Arthritis. I am an MD (Internist). I thought this may be interesting since it looks to me like a possible immune-mediated reaction. I do have photographs available.

I awoke at 2:00 AM on 2-14-21 with severe chills and copious perspiration. After that I slept only intermittently. When I arose at 10 AM, my left arm was swollen and throbbing with pain. I took Aleve with breakfast and that helped the pain, but not the swelling. However, this morning, 2-15-21, I noticed hives in the crook of both elbows and on my chest under both pectoral muscles. The hives don't itch or cause any discomfort except for causing some anxiety due to the fact that I haven't heard of hives being mentioned as a side effect of the vaccine.

Resident getting rehab therapy in the facility and has a long history of Parkinson's Disease. On 01/29/21, he received the COVID vaccine on left deltoid, resident was recently hospitalized due to Pneumonia and was on antibiotic IV and was recently placed on GT feeding due to severe dysphagia from his Parkinson's disease. On 01/31/21, started having increased congestion. On 02/02/21, started having increased temperature and WBC went up >20,000 on 02/03/21, started on Vancomycin IV on 02/04/21 but was transferred to the hospital. Facility was notified today (02/18/21) that resident expired in the hospital.

Herpes hv2 groin outbreak approximately 3 days after first Moderna shot. Resolved within 5 days of onset.. "Covid-toe" swelling and red and blue on left foot, middle and adjacent toe approximated 2 weeks after first Moderna shot. Treatment with fungicide and antibiotic creams did not resolve. Appeared to worsen after second Moderna shot on Feb 17, 2021. Treating now with cortisone ointment.

The rash on back of left lower leg at ankle height as a red itchy spot about 29 hours after shot. By 24 hours later a heavy painful rash had erupted on both lower legs around the ankle. The rash has eruptions that are red and the size of a pencil eraser. Very painful to the touch and very significant burning sensation. Cold water used to flood the affected area feels warm on contact, and gives a temporary relief.

Death within 30 days: Admit 2/8/21-2/13/21 s/p fall with left hip fracture (repaired), severe debility with recurrent falls discharged to SNF. Not doing well postop at the SNF, brought to ED due to failed foley insertion with bright red blood upon arrival to ER febrile, hypotensive, tachycardic, severe sepsis. Gran negative bacteremia likely from chronic ascites, family decided on comfort care and he expired within hours of admission.

swelling and pain began in left elbow, (bursa sac area) pain and swelling continued to get worse till unbearable. could not bend or straighten left arm, could not sleep throbbing pain I rated at 8 on scale to 10 day later same swelling and pain started in base of left thumb and forefinger area. today is sunday and elbow is still swollen but not throbbinghave been applying menthol spray and like hand are which is greatly swollen.

Sore left arm, severe headaches (3-4 per week), extreme swelling in feet-from first shot to present - inside mouth left cheek lining disintegrated into a bloody mess after 14 days after 2nd shot

On February 18th - My dad started with fever/chills within the next day after getting his second shot, stopped eating/lost appetite, couldn't eat anything - couldn't eat any solid food - only had liquids and Ensure for 10 days. He has also experienced pain in his chest pain (unclear if muscle pain). He is still experiencing discomfort. Has lost weight. Then got a little better for 2 days, then lost appetite and unable to get out of bed. Then arm and legs swollen on 3/9/2021 but swelling has gone down today. He is conscious but is having a hard time getting out of bed and has no energy.

Immediate recurrence of GBS post vaccination. This time around on Tuesday pt got a COVID vaccine and 6 hours after pt started feeling nauseous and 3 days after the vaccine had numbness in his feet b/l at first. Numbness travelled upwards up to the knees. Next the weakness started extending upwards to his mid thigh. Pt will not put any weight on his legs because he knows he is very unsteady. Today he has numbness in his hands b/l. Pt had no symptoms before Tuesday. He lives at home (independent senior facility) and is coming from there. Pt woke up this morning and went from his bed to his chair and since then pt was not able to get up from the chair.

1 week post vaccine patient reported swelling in the left lymph nodes in neck and at jaw line. Advised him to seek medical treatment due to swelling, pain, general feeling of unwellness, night sweats

extreme fatigue then patient passed away while asleep Narrative: Unclear if the vaccine is connected to his death. Chart reviewed. He has medical conditions which could have caused his death. Unclear who completed his death certificate. Death was close to a month ago. Whether he had an autopsy or not is unclear. We can report as a suspicious death after vaccination.

Severe chills, fever(100.9) severe Headache (lasting 3 days) mild headache still on day 5, severe body aches (3 days), under arm lymph node swelling, nausea. Fatigue

I am writing this to let you know that two weeks after receiving my first COVID 19 vaccination I developed a severe blood clot from my right ankle to my right groin. I am Factor 5 deficient, and believe that the vaccine caused the clot. I had no symptoms at all until I noticed my right calf was swollen (no pain). My wife insisted I go to emergency because I am Factor 5 deficient and inclined to thickening of the blood. I have not been on a plane or taken a long trip by car. I walk 3 miles a day, play golf and am very active. I strongly believe the vaccine caused the clot. I will be on blood thinners the rest of my life..

The morning after immunization patient had fever, rigors and chills. He then had progressive weakness to the point of being unable to stand resulting in him contacting EMS. In the ED was found to have SIRS physiology and lactic acidemia. Hospitalized for 2 days without clear source of infection, was not treated antibiotics and improved.

patient developed shortness of breath , headache , sore throat and swollen lymph nodes in right neck two days after receiving vaccine, He had has developed progressive sob. he presented to PCP 34/6/21 HRCT shows decreased lung volumes and development of bronchiectasis. Pulmonary function test show severe restrictive lung disease. He denies any covid symptoms or positive test. He has been exposed to wife who is a er nurse. He states normal cxr last year. He was riding his bike in dec.

On 2/7/21 RIGHT great toe developed a hang nail and 2 small blisters noted to 5th digit. 2/13/21 black/blue discoloration was noted to RIGHT foot 5th digit. 3/22/21 Dr. (surgeon) diagnosed patient with dry gangrene and trimmed the nail on RIGHT great toe. 3/25/21 RIGHT foot 5th digit amputated. 3/27/21 black discoloration noted to RIGHT foot 4th digit and RIGHT great toe. 4/5/21 blisters noted to LEFT foot. Black discoloration noted to LEFT great toe and LEFT foot 3rd and 4th digit. After right digit was amputated patient continued to have other digits of the opposite extremity develop necrosis after several months. Patient is currently awaiting appointment with a surgeon.

1. On 4/21/2021 at approximately 3:00 p.m., Patient experienced severe pain in his right side under his rib cage, followed by vomiting. The next bowel movement was abnormal in color (white). He has been experiencing pain day and night until last night when the pain subsided. 2. Pain in foot - He started having pain in his right foot on 4/21/2021 in the evening. The pain has become progressively worse as days go by. Last night 4/24/2021 the foot started to show pink color in the lower half of the foot. This morning, the foot showed swelling and pink on the top of the foot. By the end of the day the foot pain is so severe he can hardly walk on it. 3. Blood in urine - He started having blood showing up in his urine on 4/21/2021 in the evening.

RPh called the patient on 4/25/2021 to verify receiving second dose. Patient's wife reported he developed a rash, hives, and swelling following his first vaccine dose. He was treated twice at the ER over a two week period. Both treating physicians advised that he not receive the second dose of the COVID 19 vaccine.

After 1 day, headache, low grade fever, and fatigue. Day 2 aspirin taken and symptoms improved. Monday started with cold sore on lip and sores on hands. Sores then spread up arms, legs, and on buttocks. Went to Urgent care and received prednisone which improved sores.

Feb. 26-2 days after 1st shot, unconscious, blood sepsis, nausea, on a ventilator, severe pneumonia in right lung. In ICU for 3 days, normal ward 3 days, treated with antibiotics Mar. 26-2 days after 2nd shot, unconscious, blood sepsis, blood clot, heart failure, kidney & liver damage, treated with Eliquis and antibiotics. At hospital in ICU for 2 days, normal ward 3 days. Continuing with Eliquis, increased Metoprolol. Follow-up with kidney specialist and Cardiologist PA.

Moderna COVID-19 Vaccine EUA: Case of COVID-19 that resulted in Hospitalization post vaccination. Patient received Moderna COVID Vaccinations on January 14, and February 11, 2021. On May 17th patient requested a Telemedicine visit for chest congestion, painful cough, tightness in chest since May 14th - diagnosed with acute bronchitis and provided prescriptions for prednisone BID, Doxycycline BID, and Benzonatate Q6H prn cough. On May 18th the patient presented to the ED for evaluation of confusion upon waking. Upon arrival patient was febrile (102), CRP was 224. Evaluation was significant for acute respiratory failure with hypoxia secondary to COVID pneumonia. CT scan demonstrated multifocal pneumonia consistent with COVID. He was started on 2L oxygen via NC, dextamethasone, remdesivir (2 doses given), & Duo Neb treatments. He initially did well on 2L. On the 20th, he began to decompensate. He went from 2L to Airvo 55L 70% at 11am. Procalcitonin went from 0.26 to 0.96. Ceftriaxone & doxycycline was initiated. He maintained saturations on the Airvo, & was even weaned down to 55%. On May 21st, he has decompensated further, with saturations quickly dropping to the upper 80's with minimal activity. RR has been 28-32. Airvo settings were increased to 60L/95%. Saturations are now 88-93%. ABG was 7.45-38-60-27-92%. He was given an additional IV dextamethasone. Patient will be transferred to Medical center for a higher level of care. Patient was treated with tocilizumab on May 21st.

pneumonia; Sepsis; CMV virus and a lot others; he never got second shot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization prolonged), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant), CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (he never got second shot). The patient was hospitalized on 04-Mar-2021 due to CYTOMEGALOVIRUS INFECTION, PNEUMONIA and SEPSIS. At the time of the report, PNEUMONIA (pneumonia), SEPSIS (Sepsis) and CYTOMEGALOVIRUS INFECTION (CMV virus and a lot others) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (he never got second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was reported. No treatment information was provided. The patient was coming back home on next Wednesday 2-Jun-2021.The patient was a part of a clinical trial which went completely wrong. The patient had number of diagnose like pneumonia, sepsis, CMV virus and a lot others. Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use, the start date of the events and the evaluation by HCP's the events of Pneumonia, Sepsis and Cytomegalic virus infection is unlikely.

Pt diagnosed with Guillain- Barre syndrome pt was hospitalized 3 weeks after receiving first dose of Moderna vaccine. Pt did not receive second dose d/t being hospitalized. Pt was hospitalized for 91 days. Pt was vented for over a week. Pt is wheelchair bound and unable to walk. Pt states feet are numb and can't move them

2nd Covid shot (Thursday 2/18 AM) , Sudden pain (Monday 2/22/21 PM) Bad pain in left Leg (Calf) after walking <2minutes or 2 flights of stairs. Started suddenly Monday pm. I was walking about 1 to 1.5 miles a day and did a big walk that morning. Call to Cardiologist led to test next AM (Tuesday 2/23) for DVT. US=> NO DVT but reduced blood flow left leg. UltraSound & PVR on Saturday ( 2/26/21) showed reduced blood flow left leg below knee. CT-scan and Runoff (3/12/21) showed Left Poplilteal Artery 100 % blocked behind left knee. All other arteries both leg wide open. Consultation with Vascular Surgeon (04/01/21) suggested blood clot from heart!. Holter Monitor for two weeks (4/19/21) showed no Afibs. Continuation of what happened. Cardiac Calcium score on 5/24/21 which was a total of 13. All arteries clear except LAD at 13. All leg arteries clear and all heart arteries clear & no afibs!!! TEE (6/4/21) showed blood clot in Left Atrial Appendage. I was placed on Eliquist 5mg 2x day on Friday 6/5/21. On Friday 6/11/21 I didn't feel well and went to Emergency Room at Hospital. Was admitted with high white cell count and low PB, fever 101F Only visible thing was red area under left armpit. I was placed on IV antibiotics Vancomycin 1gm/bag and Ceftriaxone 1gm/bag, several bags over 4 days. Next morning Saturday 6/12/21 developed very large red lesions on both side of my trunk each about 10"x8". No one in hospital knew what it was or how to treat it. Areas were red, warm, slightly itchy. The Arm pit lesion eventually turned to a target and eventually went away with the IV antibiotic treatments over 4 days in hospital. Dx: Possible Tic bite. Monday 6/14/21 I was released from hospital, with no one knowing what was going on with rash on body. One Doctor decided that the newest medicine (Eliquis) might be the cause and changed it to Zoralto. I had an Emergency Apt with Dermatologist (6/15/21) who was stumped and had to consult with 3 other doctors in the group to finally decided it was probably "Fixed-Drug-Eruption" and recommended topical Steroids (Clobetasol 0.05%). I have results of all test and photos etc if interested. At this point in time, no one knows 1) why the blood clot developed 2) what or why I got these big red areas on my body which I am now actively treating. All or some may have to do with the immune system and possible activation or stimulation or whatever possibly from the Covid shot? I am still trying to track down the blood clot and may get an implantable Loop monitor to conform never any afibs. You can call me for any questions. The sudden blood clot 4 days after covid seemed to come out of no where as I don't have afibs, as far as we know, I don't have blocked arteries, either in legs or heart. Big mystery to me and my doctors at this point. I still have appointment with vascular specialist in Philadelphia on July 1. Please stay in touch with me.

BILATERAL HAND/WRIST PAIN AND SWELLING, POLYARTHRALGIAS REPORTED HE EXPERIENCED AFTER RECEIVING 2ND DOSE OF THE VACCINE

Death LEG SWELLING N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism K92.2 - GI bleed K92.2 - Upper GI bleed

Unusual swelling. Pr referred by PCP to rheumatology and nephrology for elevated ESR and ANA w/ concern for poss vasculitis or nephritis.. While work-up in process, pt experienced cardiopulmonary arrest. Hospitalized and ventilator supported. Remained encephalopathic, presumed anoxic, w/ seizure disorder and shock liver that precluded proceeding w/ planned coronary/cardiac catheterization. CT chest showed no pulm emb, CT brain showed multiple punctate infarcts suggestive of embolic etiology. Neurology felt infarcts could not explain his encephalopathy. Echocardiogram neg. Family declined trach and PEG and pt was compassionately weaned to comfort from ventilator support, extubated and transitioned to hospice care. Pt passed 6/22/21. Autopsy declined.

Patient stated that about a month after getting his vaccine, he fell down the step bc his legs felt numb. Once he went to doctor, he was guillain barre syndrome. Patient did not get his 2nd vaccine bc he was in the hospital at the time. Patient stated that he can't walk and that he's in a wheelchair now.

Second day (Tuesday 1/5/21) swelling and some soreness on inside of throat right side. Wednesday 1/6/21 swelling had spread significantly to inside the right side of mouth and tongue also affecting right jaw. By 3 Pm that day my tongue was numb and swollen on the right side as well as the right side of my mouth and jaw. I could only chew, eat, and swallow effectively on the left side of my mouth using the left side of my tongue to negotiate eating. I could only this with small amounts of food. By that evening about 4 hours later I could eat , chew etc. pretty good but the swelling & discomfort remained but reduced to a functional level. Today, Thursday 1/7/21, the soreness and discomfort remains inside throat, mouth, tongue and jaw all on the right side.

24 hours after presentation patient had developed high fevers 104. He presented to the emergency department with symptoms of severe sepsis and respiratory distress. He was intubated, suffered cardiac arrest with return of spontaneous circulation, requiring vasopressors.

Headache Chills Sweating Nausea Pain in injection site Swelling Loss of appetite Joint Pain Lethargic Dry Cough

15 days after injection, very very large red patch appeared (in the evening). It was itchy. Next morning, it was elevated, hot, with peeling eczema flaking skin. It was still itchy. Now, 24 hours later, it is still red, itchy, elevated, hot to the touch, with peeling eczema flaking skin. It is not clear if Benadryl would be helpful and/or safe to take for this so no medication is being used at the present time. More information about this would be helpful.

Abdominal cramps, followed by diarrhea that lasted 8-12 hours. Reporting this because I don't see it among listed common side effects. Other family member shared same food and had no symptoms Do have mild site discomfort and probable axillary lymphadenopathy but see that these are not uncommon

Began with redness around injection site 6 days after injection. Continued to grow to cover upper arm and began to experience swelling around elbow and forearm. Went to urgent care clinic six days after onset of symptoms. Diagnosed as cellulitis infection, prescribed antibiotic. One week after starting antibiotics, symptoms 95% gone.

Extreme swelling of upper arm and shoulder extending to forearm . Redness and pain entire shoulder and arm. Temperature elevation to 102.4 lasting 5 days. Lethargic and no appetite. Contacted Md/oncologist on day two....tylenol and ice. Started amoxicillin-clav 875-125 mg 02/22. Saw dr.on 02/24 at hospital.. continuing to monitor.

loss of consciousness;febrile Narrative: Patient received his 2nd vaccine at 10am 2/17. That evening he felt subjectively febrile and then suffered a ground level fall at 0400 on 2/18. He did not lose consciousness or injure his head. EMS was contacted and assisted him into bed. At 0600, wife noted increased work of breathing, which prompted another EMS call, who found him hypoxic with fever of 106. He was transported to a community hospital, where he was found to have temp 102.9 and blood pressure in 70s-80s systolic. He was transferred to hospital at 1300 on 2/18/21, requiring norepinephrine for pressure support after fluid resuscitation. He c/o stiffness and soreness all over but presenting ROS was otherwise negative. Patient was treated with 4L IV fluids and vancomycin and piperacillin/tazobactam at the outside ER. Here at the hospital he was treated with vancomycin, piperacillin/tazobactam and levofloxacin along with IV fluids and norepinephrine. Despite this he had several fevers with Tmax 103.5F the night of 2/18-2/19 and he required norepinephrine plus vasopressin overnight to maintain blood pressure. Piperacillin/Tazobactam was discontinued in favor of meropenem. His last fever was at 6am on 2/19. ID consult was obtained 2/19/21 and vancomycin and levofloxacin were weaned off. Ultimately his blood pressure improved and he was weaned off of all vasopressors the morning of 2/20. Notably, he never developed severe hypoxemia at rest while in the ICU, but did require BiPAP non-invasive ventilation at night instead of his usual CPAP to keep his oxygen levels > 90% while sleeping and additionally had desaturations into the low 80% range with exertion from which he was slow to recover. His oxygen saturation was >90% on 30-40% FiO2 via aerosol mask overnight and 3L (his current baseline) NC during the day. He was transferred out of the ICU on 2/21 based on hemodynamic improvement, stable oxygenation, and improved mentation and symptoms. Unfortunately, on the morning of 2/22/21, patient had an abrupt change in status and was found to be unresponsive with hypercarbic respiratory failure and hypotension. ABG during this event was 7.16/121/65. BiPAP was initiated as patient's code status was DNR/DNI. CXR with no significant change from 2/18/21. CT of head without contrast was negative for acute processes. Based on lack of rapid improvement, the decision was made by wife to transition to comfort care. Patient died at 1446 on 2/22/21. **Of note: patient was admitted for 1 week for covid 19 pneumonia November 2020. During this hospitalization he was found to have chronic R sided PE, no acute PE.

Patient states he had arm swelling, headache and chills that started roughly 24 hours after his second vaccination. Forty-eight hours after his vaccine, Patent states he felt "hypothermic, really really cold and then had the sweats." This lasted for approx 12 hours

Left arm became extremely sore down to fingertips. Patient could not hold onto anything as fingers hardly could move. After two days his hand swelled up. I almost took him to Urgent care but said he was getting g a little better.

Pt woke this morning 2/12/2021 at 8:30 and he had swelling to his lips and rt side of face (cheek area), Pt reported at 3:30pm still noted lip swollen and rt cheek swollen but not as much as when he awoke at 8:30

3/15/21 ER HPI - Transferred to Hospital, remains inpatient as of 3/16/21 74 y.o. male who presents with near syncopal episode. Patient states he was getting ready for his doctor's appointment this morning and when he started walking outside he fell dizzy.Wife states that before leaving for his doctor appointment this morning the patient complained of not feeling well, was sweaty and complained of upper chest pressure radiating into both arms. This symptoms have pretty much subsided on arrival to the emergency room. After initial dizzy episode, he almost collapsed, stood up, recovered and then felt dizzy again and was helped down by his wife and denies any injury except for some redness on his left knee. Patient denies chest pain or palpitations. He does not have any prior history of syncope. He is diabetic and hypertensive. Recently underwent bladder surgery due to cancer and now has a urostomy(ileal conduit). This was performed by Dr., urologist at Hospital He is on clindamycin postoperatively due to incisional infection on 03/08. 3/15/21 Hospital H&P: The patient is a 74 y.o. male with history of bladder cancer s/p open radical cystectomy resection with ileal conduit urinary diversion, type 2 diabetes, hypertension, diabetic neuropathy and chronic back pain presented to ED at Hospital because of dizziness and weakness in addition to chest discomfort. He stated that he was walking in the parking lot of his doctor's office when he suddenly felt dizzy weak and started falling on the ground. His son helped him and the ambulance was called. He stated that he felt pressure in his chest with radiation to the shoulders. He also felt short of breath. Stated that the symptoms lasted for about half an hour. He stated that he has never had any similar episodes in the past. He is not known to have any heart or lung disease. He was treated for bladder cancer and had open radical cystectomy with ileal conduit. He has been diabetic for the last 16 years. He has diabetic neuropathy. He stated that he gets out of breath walking a notice increasing swelling in the lower extremities

Patient is a 74 Y male with a past medical history of hypertension, paroxysmal atrial flutter, COPD, diabetes mellitus type 2, schizoaffective disorder, depression, pulmonary embolism, pulmonary nodules, asthma, tobacco dependence, alcohol abuse and urge incontinence who presents to the Emergency Department today with complaints of shortness of breath and leg swelling for the past few days. He has also been having cough which is productive of clear sputum and has been wheezing.He has been using his albuterol inhalers with relief. He has also noted increased leg swelling more and decreased urination. He tries to be compliant with his salt and fluid restriction but does not always follow through. He had just been hospitalized at hospital from February 21 to March 2 for COPD exacerbation, CHF and hypoxia. Patient has a history of COVID B infection last October and was hospitalized for it. Yesterday he got a 2nd COVID shot but denies any fever, chills, chest pain, nausea vomiting after that He presented to the ED where he was noted to have temperature of 98.4°, pulse of 76, respiration of 32, blood pressure 19477 and O2 sat of 95% on 3 liters. Labs showed a white count of 8.8, hemoglobin 12.9, bicarb of 35, creatinine 0.57, potassium 3.6, magnesium 1.6, BNP of 2675 and 2 serial troponins of 55 and 50. Chest x-ray with chronic vascular prominence unchanged. Some minimal infiltrates or atelectasis at the left base are improved. EKG with normal sinus rhythm, heart rate of 76, few PVCs and PACs. Patient was given a dose of IV Bumex and is now admitted to the hospitalist service

BURSITIS in right shoulder (NOT the injected left shoulder!), knees (particularly right knee), possibly in right hip. Clearly a systemic reaction to the vaccine. The bursitis in my right shoulder precipitated a cascade of adverse effects that became quite debilitating, and from which I am still recovering. The bursitis in my right knew made squatting difficult for about a week, but that symptom is substantially gone. Here is the sequence in more detail: Vaccinated (Moderna) on Feb 4; went to play tennis on Feb 10; had discomfort raising my right arm (racquet arm) when hitting my topspin backhand which has a high follow through ; decided to instead practice slice backhand. Developed acute pain next pain. Could not raise my arm ab ove shoulder for weeks now.

patient reported swelling of the left side of the face 1.5-2 days after receiving the second Moderna vaccine which was administered on 3/13/2021. The swelling started after he got injection of Eylea to the eye from his ophthalmologist on 3/15/2021.

Fever, chills, muscle aches that lasted for 36 hours. Soreness at injection site, swollen axillary lymph node on side of injection.

DVT Narrative: Patient received 1st shot of Moderna vaccine; two days later (w/n 48 hours) developed left leg swelling with discoloration (purple) from upper leg to ankle. Went to local ER diagnosis: extensive DVT of the left lower extremity with occlusive intraluminal thrombus extending from the common femoral vein with contiguous distal involvement of the entire deep venous system down to the level of the distal popliteal vein. No identifiable provoking factors aside from timing of symptoms post moderna vaccine. Was stated on DOAC apixaban 5mg bid.

Swelling started in left wrist on the day after the vaccine. The swelling extended to his entire left arm then to his left arm and shoulder and neck. Later that day the swelling continued to right neck then arm then wrist. It then receded back over several days the way it came. Swelling in left wrist lasted a week.

March 31st 2021- 11 days after the second COVID vaccine patients hands became achy and swelled. His wrist and elbow were stiff and sore. (He felt this could have been from working on tractor and straining to hard. He also painted that day.) April 1st 2021- Patients hands and elbow became increasing worse. His bilateral shoulders started to hurt. He was unable to bear weight on right foot. He began to run a fever t-max 101. April 2nd 2021- Went to primary care doctor who ran some lab work and noted elevated wbc and glucose and sent to the ER were he was admitted for fever of unknown orgin with leukocytosis.

Angioedema; Both legs were swollen from knee to ankles/ hands were swollen; rash on both legs; A spontaneous report was received from a consumer concerning a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hands, both legs were swollen from knee to ankles, rash on both legs, and angioedema. The patient's medical history was not provided. Concomitant medications reported were atorvastatin, lisinopril, amlodipine and clonazepam. On 20 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 031M20A) in the right arm for prophylaxis of COVID-19 infection. On 22 Feb 2021, the patient experienced hands, both legs were swollen from knee to ankles, rash on both legs. The patient went to his doctor and the doctor thought it to be angioedema. Treatment details included antihistamine. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events hands, both legs were swollen from knee to ankles, rash on both legs and angioedema were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

2nd dose administered 4/10, Pt now presenting with diffuse macro-papular rash to upper torso and extremities, peripheral edema, resipiratory distress, tachypneic, tachcardia. r/o Sepsis

He tested positive for COVID-19 on April 7 2021. He qualified for monoclonal antibody therapy and presented for that therapy 4/9/2021. After starting the infusion he developed sudden onset shortness of breath. He is noted to be wheezing. He was given Solu-Medrol and benadryl prior to transfer to ED. Acute hypoxic respiratory failure in patient with recent Covid diagnosis with sudden worsening during monoclonal antibody infusion. Differential includes allergic reaction/anaphylaxis, flash pulmonary edema, worsening Covid. Given the wheezing he was given a DuoNeb with no significant improvement but may be slightly decreased wheezing. Patient was placed on BiPAP given concern for pulmonary edema and increased work of breathing. We were able to titrate down the FiO2 to 40%. He was transitioned to high flow nasal cannula. Will admit to the hospital for further supportive cares given Covid and hypoxic respiratory failure.

Moderna COVID-19 Vaccine EUA: patient presented to emergency department (ED) lethargic, confused, and hypoxic two days after receiving vaccination reporting fatigue and malaise. Initial vital signs: blood pressure 120/64 mmHg, pulse 65 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 15 breaths per minute, oxygen saturation 92% on oxygen 1 liter via nasal cannula. Patient reports cocaine use and non-compliance with medications for Parkinson's disease. Admitted to hospital for acute hypoxemic respiratory insufficiency- currently still hospitalized.

Right arm swollen up twice it size, Right hand swollen up twice it size, Left arm swollen and left hand swollen with rash and red bumps up and down arm Infection type rash on both arms and hands Red ash on right side of upper chest area with red bumbs Left leg had rash wih red bumps