Moderna

101 degree temperature, headache from day of injection which was a Saturday, Sunday and Monday, severe body aches,. tender nodes in neck, felt very ill, slept 24 hours, no appetite, itching.. I have improved but still itching and have hedache

severe pain in neck and shoulder area, slight fever, swollen glands, affected vision for over five days

Day 1-3: Fatigue, sore arm Day 4-6: None Day 7-9: Injection site red, swollen and hot, fatigue, vertigo, dizziness, weakness, facial swelling---experiencing now.

Employee received vaccine on 12/29/2020, was diagnosed with COVID-19 on 1/12/2021, had ED visit, received the Bamlanivimab infusion, returned to the ED on 1/16/2021, was admitted with dehydration, currently remains inpatient receiving Remdesivir infusion.

Five minutes after the vaccine was injected, I became dizzy, my eyes teared and face swelled up and throat tightened. The EMT's came, checked my lungs, etc. and talked me through the episode which lasted about 15 minutes. Then the swelling subsided. I suspect it had, because I had dermal fillers approximately a year ago. I had no other adverse affects, except for tiredness that evening. People should be warned about this because it is a frightening event. I have never had an adverse reaction to a vaccine before.

Delayed rash on arm at injection site. On the 8th day following vaccination, I developed a circular red rash, slight swelling, hot, vaguely itchy. The circle was about 2 inches diameter. Over the next two days, although the swelling abated, the rash expanded down and around my arm. I am now in my third day of having the rash. Now , the rash is about 6 inches down my arm Like her, I am wondering whether I should have the second dose of the vaccine.

COVID-19 Vaccine EUA Ten days after the injection of Covid 19 injection my arm swelled up, and became very red and itchy at the site of the injection. It just came up out of nowhere it seems as I had no reaction at all to the vaccine during the prior 10 days since the vaccination. This continued for two days. The first day after it happened I felt tired and weak in the morning. I got into work here at the house and the weakness went away. I treated the itchy situation with Clobetasol Propionate Cream which I had here and was prescribed by my dermatologist for poison ivy. That took away the itchy situation that was very annoying. Two days into it the swelling began to go down. Today is the 4th day since the problem occurred and there is no swelling and only a slight redness. I am assuming that I can take injection #2 on February 9 as scheduled.

Sore left arm, day 2. Swelling, redness, inflamation (heat), itching on day 8- a week after the injection. This required Acetaminophen and cortisone cream. Surface area (4" by 6") still red on day 10.

Moderna COVID-19 Vaccine EUA Swelling, redness, itching started on the 9th day after vaccination. Area of redness expanded on 10th day and again on 11th day (today).

Itchy rash at injection site, started one week after 1st Covid inoculation (Jan 24). Still present as of Jan. 29, 2021. Lymph node under arm is swollen and sore. Rash is not infected, only itchy. Saw doctor Jan 26 who said it was either cellulitis or shingles. Saw second doctor Jan 27 recognized it as Covid arm. I wish this had been noted as a side effect on the web. I could have saved myself both the cost and potential Covid exposure from two different doctors' visits. Also, it would be nice to know if this is a delayed allergic reaction to vaccine components or a beneficial reaction by the immune system.

Injection site became more sore a week to 9 days after vaccine. Arm was red and swollen about 6 inches down and 4 inches wide. After 2 days of observing it, it was no better so I went to urgent care to get it checked 01/16.

RIGHT ARM SWOLLEN ABOUT 5 INCHES IN DIAMETER. HUTS AND ITCHES. ASL EYES WERE VERY DRY AND LEFT EAR LOB HURTS

Day 1 to Day 6: painful Left arm Day 3 to current Day 7: area red, hot, swollen and intense itching, w/redness increasing in diameter each day. Now the size of a baseball, and waking me frequently during the night w/ intense itching. Lethargy, nausea on Day 7

Red rash, both itchy and swollen, first noticed to be about 2 inches in diameter and which doubled by Feb. 3.

left arm redness started several days after receiving the vaccine, slightly swollen and itchy. c/w delayed hypersensitivity response.

About a week after receiving the vaccine soreness in my arm which lasted for about 3 days. About 5 days after the soreness went away I developed a rash on my arm. My arm was hot and swollen. I went to an urgent care the same day I noticed the rash, they put me on steroid and antibiotic Cephalexin. They also sent me to the ER for an ultrasound to make sure I didn't have a blood clot. It is normal now. Besides the rash I felt fine otherwise.

Had itching off and on since injection. Did not have soreness until 2 days after injection and itching off and on. Became progressively worse until Sunday, February 7. Noticed very red rash, slight swelling, "knots" in area but only slightly swollen overall. "lumps" in arm.

Fever up to 101 degrees 4 hr after the injection followed by chills and a headache, followed the next day by a sore throat and then by 3rd day by swelling and pain of left side of the face

started on the 8th day my arm started itching i saw that it was swollen about 3 inches around and it was red and very warm to the touch and had red bumps on it, took about 3 days to recover

Swelling the size of an apple which lasted for 11 days Strong joint pain left wrist and both knees still present 3 weeks after the injection Throbbing pain in all past scars from surgeries including my skull (40 years ago) abdominal sutures ( 6 years ago ) and right thigh ( 4years ago). The pain started within hours after the injection in scars which never hurt once they healed after the surgeries but now the pain is hard to bear. The strangest pain is the site of vein ablation in the right thigh where the tissue looked normal before but now it looks hollow and throbbing.

When I woke up the next morning my arm was super red and itchy, throughout the day it got swoller, redder and developed a fever. About 12n my daughter took the temp of my arm and it was 102 so we made ice packs to help with the pain and swelling. Later she went an bought Cortisone and used the ice packs and Cortisone for about 3 or 4 days when the arm finally begin to get better. My arm was so painful it was almost unbareable to touch.

The next day after I was so weak and fatigued I couldnt get out of bed. I was literally stayed in bed for 36hr because I was so weak and tired. My arm swole up just as bad as from the previous arm did from the 1st vaccination but this time when healing it was like red and pink streaks were up and down my arm.

Severe itching, redness, rash, and swelling; 7 days after injection. Still continuing 48 hours afterward

Beginning 7 days post-injection there was itching, a hard bump and redness in a circle form, measuring approximately 3", gradually lessening until gone 10 days after noticing this.

-swelling (5" x 3") red, sore for 7 days - chills and temperature 2/2/2021 starting at 4:00 p.m. and lasting approximately 12 hrs. Temperature 101.2 reduced with Ibuprofen

On day eight following vaccination itching on upper arm at site. Day nine redness at site. Redness and itching expanded down arm. Day 12 swelling in arm and lymph nodes?? above crease in left arm swollen. One slightly and the other golf ball size. Contacted doctor on day 13 (Friday morning) . Due to weather conditions advised to see him on the following Monday (today day 16) if not improved. Currently the redness and itching has stopped but swelling in one of the lymph nodes is still visible but much better than before. My concern is about worse reaction to second vaccine and if I should receive second vaccine in same arm.

Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot Chest pains New left axillary Adenopsthy -CT scan 2/11/21

Syncope 18 hours post injection, Feb 13 left eye irritation with tearing, Feb 14 mild case of Bell's Palsey right side of face, along with headache, herpes on left corner of mouth, fatigue and ?Epstein-Barr. I was exposed to the virus by my hairdresser on 2-11-21 and she developed symptoms and tested positive 4 days later

Sore injection site first two days (slight difficulty laying on that side), then Day 9 developed a rash and itching close to injection site, Day 11 noticed swelling on the upper arm and tenderness in armpit; Day 13 rash about doubled in size and some itching returned Applied Cortizone-10 to relieve itching - it helped

Patient said the day of the vaccination she developed a red patch about 1/2 inch in diameter that was red and swollen and a little tender. Patient reported that it was periodically itchy and she has been scratching it. She stated that yesterday (day 9 after vaccination) that she noticed the size of the redness had increased. She said it was still periodically itchy and only slightly tender to the touch. She said she felt otherwise fine no systemic effects reported. Patient had not taken anything. Recommended benadryl and icing the area. Treatment outcome unknown at this time.

Slight fever, loss of strength, headache, extreme difficulty breathing. Oxygen, steriods, antibiotics for UTI, Cyanotic according to EMS and saturating at 80s at home. No accute pathology but hyperinflated WBC was 19. Sent home with oxygen

The day of the vaccine she had no problems. Then 9 days later on 2/20/21, her arm started itching, she scratched it, it swelled up, hot to the touch and sore. It is getting better, but still has some color in it, reddish, and does not itch as bad. It looks like the picture on the website. She took some Tylenol, but nothing else.

I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had another onset of diarrhea. that evening I had chills so bad that I could not get warm. Left arm is sore and swollen but mobile.

day 1-3: take 4 Advil for pain for one day day 4-6: start swell ( red) and itch. Use ice pack day 7: minimum pain and itch remain. Much less adverse events than first time. One week after vaccine, I have no problem to do house work.

headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat, 02/22 thru 02/25/2021 Doctor prescribed PredniSONE 20 MG TAB CADI beginning 02/25/2021 for 5 days, on going, no outcome

Have a soreness in the armpit of my left arm as well as a small lump at the base of my neck on the left side. I had the same type of reaction 40 years ago to a Tetanus vaccination.

Soreness, red swelling--growing from 3"x3-1/2" red raised spot hot to touch to 3" x 5" raised red spot hot to touch.

Anaphylaxis shock, was given a shot of benadryl, put on an ambulance and taken to the nearest hospital. I was on oxygen therapy at the hospital for several hours then sent home.

I have an elbow (left arm which vaccine was given) with fluid in it and am not sure what to do about it. I have never had this before I got the Covid Vaccine.

On February 14, I had used the handlebar rotation exercise of a stationery bike for 5 minutes. The next day I noticed a large swelling about the size of half a pear on the muscle where my Moderna injection was done. It was as hard as a nut, red, and warm and itchy with a red rash around it. I saw an urgent care medical person and was told it was probably a reaction to the exercise and that sometimes that happens after an injection. I was told to use cold compresses, hydrocortison cream, and rest it. I did this, for 5 days, but though the swelling subsided, the rash continued to move around and down my arm. I went back to urgent care on February 19 and was told that it looked better. I was offered prednazone for it, but declined since I was still on Budesonide . I was told it would probably clear up over the weekend. On February 22 it hadn't cleared up so I saw a PC. She noted the rash had spread, but swelling had gone down. She checked my lymph node under my left arm and noticed it was swollen. She said it was most likely due to a mild infection in the arm where I had received the vaccination. She prescribed a Zpack and after 2 days, all symptoms were gone and I felt so much better. This event happened 10 days after my vaccination.

Patient presented to the ER ON 2/25/21 with symptoms of elevated blood pressure, severe lymph node swelling in her left axillary region and on her left shoulder. It was determined she also had cellulitis of the left shoulder. She was started on antibiotics.

After 10 days, noticed a large reddened area; painful; tenderness; heat; itchy; off-centered from injection hole in deltoid muscle; and swollen lymph nodes; with difficulty swallowing. This lasted for 2 days. Now on 14 days post first injection, site is still slightly red. No treatment was necessary

Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard. Hairstylist removed her mask and she then passed out. Called 911. They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy. After several minutes she came out of it. Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am. Her color was still pale and she was still incoherent. While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled. I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75. She stayed with me for the rest of Saturday. Her sugar was still high Saturday evening and Sunday morning. Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.

February 23 large left axillary lymph node. February 24 rash to left deltoid area at site of vaccination. February 26 supra clavicular and anterior cervical lymph node. February 23 through February 28 left posterior shoulder and scapular pain.

Chills, 101 fever , headache, body aches, swollen arm at injection site Symptoms present for 16 hours Tylenol taken - 2x500mg twice at 6-hr. intervals Sore arm lasted 5 days

The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I woke up and the rash was there, and spread over the different areas of body. I was sweating bad, muscle pain, joint pain, and nauseated for about 3 days. I had knots in my arms. I went to the doctor last week, and she gave me a shot in the hip, it helped with the swelling. Then I called her back and she called in a cream for me. The other symptom remaining is the rash at the injection site, I have been putting the cream on it twice a day, taking Benadryl and Tylenol for pain

Having itching red swallowed arm cant stop itching to the point i want to take my skin off.. took so many antihistamines, rash medication nothing is calming it down... my both arms are having fever it's red and sever discomfort.... it's been over a week I still have the same symptoms

In the evening lots of pain in left arm. during night chills including teeth chattering, pain all over, no sleep but slept through most of the next day, ate nothing. Was quite concerning but did not call doctor although I sure thought about it. I was wondering if I was actually infected with Covid- 19. Shot was Tuesday 2: 30 PM, felt a bit better by Thursday but arm still hurt even on Friday arm was red and swollen down to my elbow. Saturday fine. I thought someone should know about this as lost of my friends also had difficult reactions. But this was the first time I saw an opportunity to respond.

Three days after second vaccination developed red, itchy rash covering large portion of outer upper arm,. Was swollen. Also, diarrhea that day. Later in day of shot was fatigued, during night chills and severe muscle aches. Aches and low fever the next day.

Aside from the expected sore right arm, I developed painful welling of underarm glands (right side) which I've NEVER had before even as a child; also developed itching and some redness and swelling at injection site,. These occurred in late afternoon on 3/5/2021 - a day after 2nd Moderna vaccine injection. I also developed a low fever for part of the same afternoon (3/5) into early eve. I also had some ache in center chest (gone now) which I never had before (angina?). It is now 3/6/2021 and I still have swollen underarm glands (right arm), right arm soreness at injection site, and some itching there as well. But no fever just now. I'm VERY CONCERNED the swollen glands will not go away in time for my aortic valve replacement surgery on 3/15/2021.

Instantly felt shot material go through veins on L side of chest, 15 minutes later extremely light headed, 10 min later L side of face become numb, headache, 30 min later L arm swelled to side of 1/2 of baseball, lymph nodes under L arm and on L collar bone became enlarged. Arm swelling lasted 4 weeks, Lymph nodes have not gone down and it has been 5 wks, Advised by Nurse Practioner at Pharmacy advised me not to get 2nd shot. I am extremely healthy and work 5 days/wk, workout at gym 3x /wk Weights and Total Body Lift classes. Sided effects were a major surprise!

The patient developed severe arm pain, redness and swelling one week after the vaccine. She was treated with benadryl and steroid. Since that time she has continued with some arm pain, had new onset pain in her espohagus, rash and diarrhea.

Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes. Next day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.

Patient received vaccine on 2/19/2021. On approximately 3/3/2021 patient developed redness( size of a palm) , swelling , pain. and itching

swelling of L arm's inner aspect; tenderness in entire arm especially around the inside elbow; some red areas that have diminished; fatigue. continues.

she had delayed rash, redness, swelling, and itching. it took several weeks for this to subside. started ~ 8 days after first vaccine near injection site.

my arm was very sore but I was concerned with a lump on the back of my skull of my left ear, after 3 days the lump had not subsided and it hurt, I went to urgent care. I was prescribed a painkiller cyclobenzaprine 5mg but I didn't take any of it and provided information regarding lymph nodes and that it was normal . lump went away after a few days and came back after the second shot.

Sudden significant nausea 7 hours after vaccine. Lasted an hour. Suddenly went away. Muscle and body aches and headaches, beginning about 5 hours after vaccine, lasting for 60 hours. Swollen lymph glands in neck and under jaw on both sides, 26 hours after vaccine. Significant fatigue, beginning about 6 hours after vaccine, ongoing at hour 52. LARGE RED HARD BLOTCH on vaccinated arm, one inch+ UNDER the vaccine site (which still has bandage on it), TENDER, ITCHY, ABOUT 32 HOURS AFTER VACCINE. ONGOING, although the hardness is decreasing, and the redness isn't as angry at hour 52.

Eight days after injection, my arm had a hard red rash about the size of a 4 x 4 inches. Itched bad. I put Benadryl spray on the place as well as Benadrly by mouth. Next day the rash went all the way to the elbow and was swollen. Today at 11 days it is still red but doesn't itch as much. It seems to be getting better.

tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwell,swollen,throat swelling,lost appetite.

"Moderna Covid-19 EUA" Admitted inpatient after ground level fall when she fell after attempting to get out of bed. right hip pain, headache Lab worrk showed stable eectrolytes, but significantly elevated myoglobin, CK, and CKMB and troponin, WBC elevated, admitted for rehydration PT/OT evaluation and pain management

Redness, sharp pain, shot area lump, redness swollen arm lump which went down to the elbow on left side. Doctors appointment who prescribed clindamycin. To take for 7 days 3 daily.. started 3/16/21.

Swollen upper arm, redness, very warm to the touch , itching, sore arm muscles (difficulty holding anything using left arm. Pain extends to the wrist.

Patient c/o extreme fatigue, pain and swelling to right neckline onset 3/4/21. She states the pain and swelling increased over the next 4 days, swollen area was now the size of a golf ball. She was seen and evaluated on 3/9 by her PCP, DR. CMP, Thyroid Profile and Lipid Panel were completed, all results were within normal limits. Pain began to ease up on 3/11/21. On 3/17/21 she is still c/o extreme fatigue, no change in the swelling to her neck. She is calling her PCP to schedule another appointment for next Friday 3/26.

Sore/tender arm at injection site beginning in about 2hrs after injection. Entire upper arm hot, red, swollen about 10 hrs - very itchy at 24 hrs. Remained extremely tender and red, itchy for a week. Still slightly sore, tender at 9 days. Had a fever of almost 100 starting next day following injection and continued for a total of 3 days. Fever accompanied by chills. Decreased appetite and extremely fatigued. Appetite now back to normal but still somewhat fatigued.

30 Minutes after receiving the vaccine, patient began having a self reported allergic reaction. Complaining that her nose and face was beginning to swell. + nausea. When I arrived to assess the patient, she was tachypneic and trying to self administer benadryl

Headache 10 mins after shot, muscle spasm in left arm & left shoulder 15 mins after shot, pain lower back, weakness in both legs, aching all over, tired, started about 20 mins after shot, large raised area, red, itch, slight soreness shortly after shot

Pt states that she developed a dozen lumps underneath her right arm the day after her second shot of vaccine. She also developed an eye infection and a sore on her lip the day after as well.

Approx. 20 days after 1st Shot, and about 10 days prior to second shot, I felt a nodule in my neck below the mandible on the left side. It seems to have gotten larger and currently is approx 1" in diameter. My physician is having me follow-up with tests as to what is going on with it and to determine whether it is a swollen lymph gland resulting from the Covid 19 immunizations, or something else. She has assessed it as a "Submandibular lyphaedenopathy" thus far as of unknown origin and the tests are to "evaluate the submandibular node", I am setting up for testing tomorrow and she will receive reports of their evaluations and any further actions to be taken.

Troponin over 4000; Blood pressure over 300; Flushing beet red/erythema; Feeling groggy; Difficulty with cognition; Arm swelling; feeling hot/overheating; A spontaneous report was received from a consumer who is a 76-year-old, female patient who experienced blood pressure over 300 (blood pressure increased), troponin over 4,000 (troponin increased), flushing beet red (flushing), overheating (body temperature increased), grogginess (somnolence), difficulty with her cognition (cognitive impairment) and arm was swollen (peripheral swelling). The patient's medical history included breast cancer in the right breast. Products known to have been used by the patient, within two weeks prior to the event, included cholesterol medication and once weekly Fosamax with calcium and vitamin D. On 10-MAR-2021, the patient received a dose of mRNA-1273 (Batch number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Mar 2021, immediately following the vaccination, the patient reported she experienced overheating, became beet red and her blood pressure was over 300. An ambulance took her to the emergency room. She had her troponin levels checked which were over 4000 that lead to a hospital admission and required a unspecified catherization. The patient was discharged home on unspecified date. She reported still feeling groggy and having difficulty with her cognition but it was improving throughout the day. The patient also reported her arm was still swollen, but improving. Treatment for the event included diphenhydramine and other unspecified medications and treatments. Action taken with mRNA-1273 in response to the events was unknown. The events, blood pressure over 300 and troponin over 4,000, were considered recovering. The events, flushing beet red, overheating, and grogginess were considered not recovered.; 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.

Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jerks, headache, irregular heart beat, joint pain, muscle pain, itchy area under the shot, swelling of upper arm, red rash under shot-4"X6", continued "brain fog"

The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a black eye and cheek bone swallon. extemely tired, light headed nausea .

Giant cell arteritis. Symptoms started 2 days after COVID with upper back and neck pain, lymph node enlargement and tenderness, TMJ pain/trimus. After second dose of Moderna vaccine, worsening sympotms with intermittent sharp lancing pain behind right ear, right >left frontal headache, lancing pain on forehead that radiated to back of head, scalp tenderness, no vision changes or temporal artery tenderness. Labs, exams, CT head and MRI/MRA head done. Video, telephone, office visit, ER visits. Prednisone started. Temporal artery ultrasound negative. Temporal artery biopsy consistent with temporal arteritis. Symptoms improved with prednisone.

She had 102 temperature for next three days, accompanied by severe headache, extreme nausea (still a bit nauseous today), face red and swollen, jaw hurt, stomach pains-she couldn't eat.

Swelling at vaccination site spreading to full upper arm from shoulder to elbow. Slight hacking cough, rapid heartbeat, miscellaneous pangs around body, earaches, edginess, swollen feet and face. Started about 4/06/21 and beginning to subside around 04/11/21

complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,

Provided Moderna COVID-19 Vaccine EUA. Adverse Reactions are as follows: Elevated heart rate, Shortness of Breath, Severe Pain throughout entire body, Extremely Cold and Uncontrollable Shaking of her Body through the night and over the next two days. (The shaking would come in waves over the three days). Fever. Fatigue that lasted a few days. Diarrhea, Lost Appetit. Swelled/Sore Arm. Diarrhea, Fatigue and little apatite is still an issue as of today 4/14/2021. All symptoms are identical to when my mother had the virus in 2020. She is not getting the 2nd shot as a result; too risky for her health.

Just wanted to know if cold sores was part of side effect as several of us broke out with cold sores! Didn?t go to a doctor. Just thought you should know..

Face / tongue / throat swelling sensation without problems breathing or swallowing or speaking Prescription medication needed

3/19/21 2:30 am Fever lasting aprox 3 days 3/30/21 8:00 pm 100.5 Fever & aches lasting 4 hours 3/31/21 7:30 pm 101.1 Fever & aches lasting 4 hours 4/1/21 2:00 am Fever & Aches with EXTREME chills lasting 1 hr. 4/1/21 Cold sores and cankars lasting 1 week 4/10/21 very mild cold

Patient developed rash and swelling on her arm the night of her vaccination. She said they area remained itchy over the couple few days. The swelling does seem to be going down slightly.

Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency department following a syncopal episode. Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10). She was admitted and treated for PE and possible pneumonia. She was discharged 4/5 on warfarin anticoagulation. She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.

@ 10 PM, I STARTED GETTING HIVES BEHIND MY LEFT KNEE. THEY GOT WORSE, SPREADING AROUND MY ENTIRE LEG & @ 12" HIGH. I TOOK A BENADRYL TABLET, APPLIED TOPICAL CORTISONE MULTIPLE TIMES, USED BENADRYL SPRAY MULTIPLE TIMES. I DID THIS TIL @ 11:30 WITH NO IMPROVEMENT. I WAS AFRAID TO GO TO SLEEP, SO WE HEADED TO THE ER. @ 20 MINUTES LATER, THE REDNESS & SWELLING STARTED TO SUBSIDE. WE GOT TO THE HOSPITAL, BUT DECIDED, SINCE THE AFFTETED AREA WAS NOW NORMAL, THAT WE WOUD GO HOME. mY ONLY GUESS, IS THAT THE MEDICATIONS HAD FINALLY TAKEN EFFECT. I DO HAVE A PHOTE, IF YOU ARE INTERESTED IN THAT.

Cellulitis; Arm started swelling; Arm was red; Arm was tingling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling). On 22-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis), PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Arm was red) and PARAESTHESIA (Arm was tingling) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 16 Jan 2021, the patient's arm started swelling, and it was red and tingling. The redness started traveling down her arm. On 22 Jan 2021, the patient went to urgent care and was told she had cellulitis. She was told it was bacteria getting into the skin from the way it was administered. She stated the physician who gave her the injection, cleaned the area before the shot was given. She reported that she was to pick-up antibiotics that day (22-Jan-2021). The patient states she definitely has an infection in the arm. 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.

Covid arm got 7 days after shot hot swelling red upper arm with rash,very itchy lasted eight days but still have tiny itchy spots on thighs,very few.

Pt came into our pharmacy complaining of her arm still hurting after receiving vaccine more than 15 days ago. The pt's right arm was red and irritated in a large 2 inch circle around her whole arm. Pt complained of arm itching, warm to touch, swollen and inflamed.

First I had two bumps size of half a dollar on my upper left arm and, like, a mass or swelling about the size of a silver dollar on my left arm right above my right wrist on the upper side. The two bumps on my upper arm have gone away, but the mass or swelling above my wrist is still there.

Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to other joints and muscles. Intensity varied. Applied ice to back of knees and legs when movement was affected. As the weeks progressed, fatigue, weakness and pain became more intense. It became difficult to stand from a sit position, walk, turnover in a lying position, bend-over and sit-down. PCP ordered labs on 3/08, which resulted in ESR and CRP showing elevated, inflamed condition. Referred to rheumatology. Diagnosed on 4/21 with polymyalgia rheumatica. Prescribed prednisone 15mg/day. Symptoms relieved and strength returned. Gradual tapering off of prednisone is planned.

Unstable dizziness; Constant swishing noise in left ear; Wite blood cell at 10.8 and should be 10.2.; head aches.

I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first time occurred on 03/09/2021 for severe sepsis, tachypnea. The second time occurred on 3/22/2021 for Acute cystitis without hematuria.

Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night, nap in day. June 2 start of stomach or gut hurt, constipated, until June 9, June 2, beginning of all leg, ankle, knee, hip lower spine pain could barely walk. Lasted until June 10. June 15,soreness and roughness inside cheeks, June 16, Terrible pain in left knee ,the leg with varicose veins. Feels like nerve knee, up to hip. Leg swelling. Can only walk for a little. Still happening. Also, drinking water goes right through me, comes out almost clear.

Tingling in feet and hands, numbness in feet, loss of balance 2-3 weeks prior to ER visit on 6/12, was admitted to hospital Guillame Barre Syndrome was diagnosis MRI of brain and lumbar Lumbar puncture to confirm high protein IVIG infusion for 5 days

Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.

Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel flu-like though. and within the first few hours I had "Moderna arm" - right near the injection site - big red splotch and the arm was sore. The redness in the arm lasted a good week. It was a red blotch but not itchy or swollen. I didn't feel well for a few days after the vaccine. The symptoms came and went as far as how I felt - chills, weak, not feeling terrific for those first few days or so. A month after the second shot, I had a rash on my neck. It came and went - a little itchy and then not itchy. (This happened for a month.) And then at the same time, I felt the same original symptoms - chills and not feeling good. It lasted about three days - the chills and weakness. And then it went away. Even since, April, I get this periodically - I feel weak in the knees, I get the chills and I have to take a Tylenol or something. The middle of May, I was taking off my makeup and I felt a burning on my face (same stuff I've been using for 20 years on my face) red splotch from top of nose and all around and on cheekbones and down the face - it was puffy, swollen, red and caused bags under my eyes and redness under my eyes- and it still is. He gave me a cortisone lotion (my dermatologist) - It's not as red as it was but if I press on it the redness comes back. I have not changed anything with make-up; lotion or food. I have photos of it that I can send of my face. It's still here - maybe not as bright - and I'm not sure that I notice difference using the cortisone cream. It's been a good six weeks since it started on the face.

On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchiness, and muscle pain in both legs starting on 7/6/21, Tuesday night. She took Tylenol around 8pm, which helped. The next day the chills resolved, but she is still experiencing itchy and swollen legs. She tried Cortizone 10 cream and Bactine Max spray, but neither helped. She received her 2nd COVID-19 vaccine on 6/28/21, and she has experienced an allergic reaction when taking Tylenol previously.

fatique, headaches (still have them. They go from one side of head to the other), swollen hands (continuing issue), bone spur on foot (7/10/21), sores in mouth (June 2021), bulging left eye ( June 2021). None of these issues have been resolved. Something new every week. Body's immune system is under attack. I had none of these issues prior to the 2nd vaccination. The first vaccination I got severe covid arm.

on the the day right arm warm was itching, large knot on arm, red and raised up and hot, continued to spread down her arm for the next 7 days, became very weak, unable to eat and very sick for the next 6wks. very weak couldn't get out of bed.

March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital

A few hours after receiving 2nd Covid vaccine patient began feeling nauseated then started vomiting. She denies blood in the emesis. She also endorses feeling "chilled to the bone." Triage temp is 103.1. Patient denies chest pain, shortness of breath, cough, numbness, tingling, falls, headache, abdominal pain, diarrhea, constipation, changes in diet, recent travel. No dysuria, hematuria, rashes, bruising or bleeding. She states she has had at least 6 or 7 episodes of emesis and is on her fourth emesis bag in the ER. She states she feels very dehydrated and week. I was informed that the patient was admitted and was under the care of a hospitalist who I could not reach.

hot, red, itchy and felt like bees stinging me 2nd day severe Vertigo and vomiting 3-4 days severe diarrhea (with nausea) 9 days later arm swelled and got very red and sore for over a week Still hurts 6 months later

Itching on left arm. Red swollen hard lump. On Monday Jan 11. Itching on Tuesday red on arm Swelling gone still itching Wed. Itching Thursday itching Friday red itching less

Lightheaded nausea swelling headache chills itching. Swelling continues spreading around injection site and is hard as a tick. Sensation of stinging

Red swollen arm. Temperature up to 101-8 Terible headache. Today is the third day of not feeling well.

Significant Swelling and redness with itching. NOTE - small amount for a day or so, then went away, reappeared two days ago much more pronounced

covid-19vaccine EUA received shot on Monday on Wednesday expierenced swelling of lymph noid in groin left side applied hot compress went down but has not disapeared tuesday Jan 26

One week to day, January 28 , 2021, woke up with itching and huge swollen area on left arm at injection area, area red and feverish. Health dep closed that day. Called them next morning, told to me call my primary care doctor. Went to doctor that day, told allergic reaction, put on 800 mg Motrin every 8 hours plus a Zyrtec for pain and swelling. Knot started going down, turning to fluid filling entire arm, into left breast. And under arm Into back area.

After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up and my balance was completely off and I almost fell into glass table. I felt very foggy and my head wasn't right. I had to hold on to things and I sat down and I kept saying I just didn't feel right. I called my daughter and my arm was hurting and I figure that's what happens, I was getting so tired and really bad headaches. My daughter asked somebody and they told me to take extra strength Tylenol (500 mg ) 2 at a time 6 hour intervals. Which i did i got up the next morning and i had to go back to bed i had no energy. I felt horrible. When i did get up in the afternoon all of a sudden i had horrible chills and that day in Florida it was 82 degrees and i put the heat on 84 and i was extremely shaky and cold. I went back to bed and later i did have a fever, not highs, it only went to 100.8 but during the evening it did break because my sheets were almost saturated. Yesterday morning 1/27 Wednesday i felt better, fever had gone down, pain was still there in my arm and swelling. I thought that was natural. In the afternoon i decided to take a shower and i noticed my left arm around the injection site was a red rash about 7inches long and 4-5 inches wide which i had to seen before i called my primary doctor just to make sure this was normal around injection site and talked to the nurse and she thought it was normal. But if there was no changes to call her back on Friday. Last night not able to sleep i saw an article that said COVID arm rash seen after Moderna vaccine, annoying but harmless it was a large article and it made me feel better but there were only 14 examples but they believe there were more because they were younger people with the health dept. that received this vaccine. It said in 1week it should go away. I still have it, its still red and sometimes itchy and i am happy to say now that i know it will be a week i feel better. it should be on the list of side effects for all.

PT RECEIVED VACCINE ON 1/25/21. UPON COMPLETION OF HER ADMINISTRATION FORM, SHE HAD NOTED THAT SHE CONTRACTED COVID OVER THANKSGIVING. I HAD WARNED HER THAT SHE MAY STILL HAVE ANTIBODIES WITHIN THE 90 DAY TIMEFRAME AND SHE MAY POSSIBLY HAVE A STRONGER RESPONSE TO THE VACCINE, HENCE MORE REACTION TO IT. SHE CALLED THE PHARMACY ON 1/28/21 STATING SHE HAD STARTED PRESENTING SYMPTOMS OF A REACTION 24 HOURS LATER ON 1/26/21. SHE COMPLAINS OF SWOLLEN AND ITCHY ARM AND GENERAL BODY ACHINESS. SHE TOOK ACETAMINOPHEN TO RELIEVE ANY PAIN EVEN THOUGH HER SYMPTOMS STILL PERSIST. I SAID SHE COULD US COLD COMPRESSES AND BENADRYL TO FACILITATE. I TOLD HER TO CALL HER PHYSICIAN AND TO ALSO CALL US BACK IF NO BETTER.

I received my injection on 1/25/2021 I had my second COVID shot, everything went well, I just had a little pain and swelling and was fine. About 7 hours later i got up from chair and i was dizzy and my balance was off and i almost fell into table. I didn't feel right. I went and sat back down and i was very tired and i started getting headache. I called my daughter and a nurse she knows told me to take extra strength Tylenol 500 mg take 2 every 6 hours. I started at 730 and went until 130. I slept on and off and got up Tuesday and my arm was still hurting. I was very tired and had no energy. When i got up later in the afternoon i had extreme chills. It was 83 degrees in Florida nd i turned heat up to 84 and i was still shaking. I got under covers and had a fever it was 100.8. Went to sleep that night and fever broke. Got up Wednesday and felt a little better, still had headache and tired. Decided to take a shower. I noticed my left arm where the injection was was all red. 6-7 inches long and about 5 inches wide which i never saw before. after shower I called my PCP I contacted the nurse said she thought it was normal and if there was no change to call her back on Friday. my arm is still red and warm i went to sleep but couldn't sleep. I saw an article about COVID arm rash seen after Modern vaccine and now i know that's what I had. I feel better after I read it in the magazine today and it said it will only last a week. This should be listed as a side effect so nobody else wonders what it is. I drank so much water because it said to drink plenty of water and i tried to use arm as much as possible.

24 hours s/p receiving a vaccination in the R deltoid, the patient noted R distal ulnar redness, swelling and discomfort. The next morning the swelling got worse and she also noted similar swelling around her Left Hallux Longus (similar to a pseudogout reaction). No intraoral swelling. Speaking clearly in full sentences. She has never had similar reactions such as this nor has a h/o pseudogout or polyarthritis.

?COVID arm? Rash developed 15 days after first shot at site of shot. Large patch about 2? X 5?. Itching, swollen, warm to touch. No treatment given. Awaiting resolution.

Pt reported feeling like she was going to pass out at around 10pm on 1/26/21 and lowered herself to the floor in her bathroom. Was discovered on the floor around noon, 14 hours later, by staff after noticing her food tray was untouched . Arrived in ED via EMS. Pt was febrile with rectal temp 100.7 c/o weakness. Pt had a WBC count of 11.2, absolute neutrophil 9.9, and creatine kinase 3214. Pt was alert and oriented and reported having been hospitalized for a few weeks in November 2020 with Covid-19 and having received her first dose of covid vaccine at approximately 11:30 on 1/26/21. Hospitalist voiced concerns that this may be a reaction to covid vaccination.

Swelling of Left upper from top of arm to 1/2 way to elbow. On 1/31/21 the swelling decreases but redness started from mid upper arm to elbow with itching..

Upper right arm became swollen, red and painfull 10 days after the shot was given. Went to urgent care doctor and was told there was an infection from the shot or a reaction from the shot. Doctor gave my an injection of Rocephin 1g IM. I was prescribed 500MG of Keflex PO 3 times per day. Symtoms got worce and went back to primary care doctor. Doctor stated that I should continue with the same treatment and return for further tests if the condition did not get better.

Her arm began to get very sore that night, then the next day it was swollen, she also had a horrible head ache for two days, the third day she slept most of the day in bed(highly unusual for her). She has experienced fatigue every since the shot. and she has had some digestion issues a couple of days; upset stomach and diarrhea.

Swollen face and eyes with deep redness and areas of purple coloring; nausea, multiple herpes zoster outbreak on lips, low grade fever.

I awoke on 1/23/2021 (Saturday) morning to find my face and especially my lips swollen. Contacted doctor's office for the on-call; he strongly suggested I visit the ER. Was kept there for 2-3 hours for observation. Was considered "hypertensive," routine blood work done (CBC, metabolic panel) all of which were normal. Was given Prednisone and ZyrTec. After no change in my condition, was discharged with instruction to contact primary physician and continue to take Prednisone and ZyrTec for the next four more days. The reason for the facial and lip swelling could not be determined......It was indicated that the swelling could be one of several things including an allergic reaction to something topical like a lip balm (I used a Blistix application before bed), a reaction to one of my medication (BP med-Olmesartan, which they told me to discontinue) or less likely a reaction to the COVID vaccine.

SEVERE ITCHING, HIVES, SWELLING, REDNESS, SHE WENT TO THE DOCTOR WHO DREW A CIRCLE AROUND THE REACTION AREA TO MONITOR SPREAD, PRESCRIPTION MEDICATION WAS GIVEN FOR REACTION

Left deltoid IM injection on 1/26/21 Left upper extremity swelling on 1/28/21 Presented to clinic on 2/2/21 and was found to have an acute LUE DVT and an acute PE on CTA chest

Fatigue Muscle aches over back, arms, legs Red area on arm Day6. Jan 28-Hip pain and difficulty walking: ongoing feb 2 given cortisone I hip for bursitis of hip. By feb 2 fatigue and generalized muscle pain and arm redness gone. Feb 3 arm redness recurs, swollen, red, itchy and scaly. 3 and 1/2 inches by 4 inches

On January 29, my arm swelled, turned red, was hot and sore. Lasted till February 2. Took photos. Patch was 4" long and 1-1/2" wide

an extremely itchy, red, sore, slightly swollen patch on my upper left arm (but not the exact site of the injection) about 2" x 1". So far, symptoms have subsided after 22 hours except for redness.

phone call from patient on 2/5/2021 who states that her arm is swollen and very and unable to lift arm.

Left arm pain starting the day after administration, progressed to redness and swelling and has continued to worsen over 10 days. No improvement over that time. Has no fever or oozing at site. Has not had any treatments.

2/4/2021 fever/chills/ fatigue/headache/body aches. Most symptoms gone 2/5/2021 2/6/2021 painful, blistery rash on both palms pads and index fingers peripheral. Swollen hands. Still symptomatic 2/8/2021

Approx 39 hrs. after vaccination woke to swelling on bottom left lip. Thought is was the beginning of a cold sore. Approx 2 hrs. later woke again to right side of face swollen. Felt like when you get novacine at dentist office. About 2 hrs after that got up and felt top lip swollen, bottom right side had gone down. At about 3PM face then begain to swell on left. All swelling stayed except where it began on bottom right lip rest of day. Throughout the day on Sunday, swelling started to go down. Still swollen on Monday going down as the day went on. at this time 6:47PM is it about 90% gone. Just on bottom of cheeks and the right one is noticeably less swollen than the left.

patient arm was red, swollen, and warm to the touch. Injection site was hard to the touch. Symptoms started the evening of shot and continued the next few days. As of today, (2-9-21), she still had symptoms as stated above but stated she was improving. She also stated that she was going to the Dr. today for an unrelated issue and would get them to look at her arm.

Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and soreness of whole left side of body. Body aches and tiredness

Client reports having a headache over left eye about 1 1/2 hours after injection. Client woke up on 2/9/2021 to a swollen face. Swelling to both eyes and "bruising" under both eyes. Client is experiencing light sensitivity. Continues to have a headache and discomfort over left eye. Denies respiratory distress and reports no rash. Recommended follow up with PCP.

Got the shot on 1/26/21, the next day 1/27/21 her arm was a little red and sore and was nauseous. Then about 8 days later, just over a week she woke up and her arm was red again and more swollen and looked like a black and blue area where the needle went in. There was a red rash around that point. The rash was larger than the palm of her hand. She was tired that day and it did go away after 2-3 days. She took Tylenol one night due to the pain to help sleep. She did not call her doctor. It has now totally resolved as of today, 2/10/21.

I took the first shot of Moderna?s COVID-19 vaccine the middle of January. Two and a half weeks later, I developed a two inch rash above my right breast even though it didn?t itch or burn, if pressed, it hurt. I treated it with antibiotic ointment and calamine lotion. During that time, I experienced tiredness, exhaustion, sluggishness as well as aches around the right shoulder. I went to get a mammogram where they told me my lymph nodes were swollen on the right side under my arm. They had seen adults who had taken the shot develop swollen lymp nodes which made it necessary to retake the mammogram. I also went to the dermatologist to see what the inch rash was, he took a biopsy, and it turned out it was shingles even though I had had the shingles shots a year before.

After about 7 days she looked at it and it was a quarter or larger area that was red, raised, inflamed area. Around it had some little smaller redness, not raised that were blotchy all over. It was a little itchy and when she touched it it was a little warm. It was not a real bad reaction, but did not feel sick just the redness. The next day it itched more and took a Benadryl, and about 2 days later it started to fade, but did merge together and got lighter and lighter in color and is almost completely gone. it is not itching anymore and is light pink.

This event , because so many elderly people have the fillers in their knees should be widely publicized! We have fillers that help so much to be able to walk without pain, but this vaccine has caused me to have extreme pain and burning and not be able to walk without pain for 4 days now. NO ONE has said anything about how this Moderna vaccine would affect us because of the Hyaronolic Acid injections to our knees. We should have been allowed to get Pfizer!!!! I am so upset about this and extremely disappointed in our government's lack of disclosure.

Rash, swelling, itching, some lethargy and slight headache, Tylenol, Rash and itching diminishing, other symptoms gone

Got the vaccine, went home and got home around 3:00, and all of a sudden she was extremely cold, put another blanket on, and got a heating pad and put it on her feet. She was lying in bed, her heart was hurting to the point that she could not move it. Around 8:00 she put the electric blanket on, got warm but she would still get a cold chill like she had ice water in her veins. Was this way all night. She had a fever, the swelling on her arm. She did not throw up but just the chills, fever. She tossed and turned all night until about 3:30 this morning. She then took 1/2 of Tylenol, dozed off. She is still cold, not as cold as she was. The arm is also still sore.

Red, bull's eye rash that grew over time, swollen and lumpy arm, hot and itchy. Lasted about 10 days.

Covid Arm. Red, swollen and itchy. Lethargic. Started approximately 7 days after Moderna vaccine injection.

COVID-19 VACCINE EUA; MY ARM SWELLED REAL BAD TURNED A DEEP RED, VERY PAINFUL, AND AS OF YESTERDAY 02/16/2021 HAD PURPLE SPOTS.

2 days after the injection She started swelling on her cheek bones up high- like she got Botox. Still there currently today, called the Dr to let them know about it, but havent heard back yet

2/15: Red rash, swelling, firm, itchy, warm to touch. Approximately 3 inches in diameter; 2/16: red rash spreads, doubling in size, still itchy. no medication taken; 2/17: no significant change. Late afternoon, experience left shoulder ache, headache. 9:00pm 1 tablet 500mg Tylenol taken; 2/18: red rash spread; itchy along edges. 2:00pm 1 tablet Benadryl taken; Headache 10:00pm 1 tablet Tylenol taken; 10:30 pm 1 tablet Benadryl taken 2/!9: swelling, red rash diminished by 60%. Slight itching. Still not resolved.

Acute nontraumatic pain in neck, left side, and upper left extemity(shoulder). Acute left cervical lymphadenitis. Still have discomfort in shoulder blade, some swelling yet of lymph node. Tingling in two fingers on left arm, had swelling over same two knuckles but that has receded just have like my hand is asleep, more at night time. Fullness feeling inside of arm at bend, vein area. Injection site is high - about 1 1/2 fingers down. Have had no x-rays or tests. Went to Urgent Care - prescribed Predisone for 5 days - no help. Nec k, now, has less swelling. Mom

bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken

Seven days after first shot, the area of my upper arm under the vaccination site became quite itchy and a bit red and swollen. Hydrocortizone cream stops the itchiness. Still swollen but it's not a problem

Patient reported a week after she received the vaccine she started feeling a lump above the injection site, then the lump moved down to her left hand. She reported than now the top of his left foot is swollen. She reported that this has never happened before. Patient reported that she has taken Advil, warm compressed her left foot nd she is not getting better or worse. She was advised to go to the doctor or urgent care ASAP

First Day arm sore, fatigued and cough. Second day Chills and Fever, Body Aches, Headache, Nausous, couldn't eat or drink, Arm sore and swollen, very fatigued, slept all day. Third day a little better, Fourth day fine.

5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.

4x4" area increasing to 3x6" red with circle changing to mostly red. Warm. Swollen. From slightly painful first 2 days to just a little itchy by 5 day- today. Painful arm a few hours after injection, which mostly ebbed, with the redness starting about 7-8 days after injection, becoming somewhat tender, with that ebbing by 5 day. On third day ( 8 days after vaccine) Urgent care diagnosed it as a seondary infection and prescribed doxycycline. Dr. said had never seen anything like it. Took the antibiotic for 2 days and stopped. Med seemed to make no difference.

Chills, fever, weakness, aching for about 36 hours, Sore, painful arm, then 3 days post injection, swollen area covering a 2-3 inch on arm with severe itching, redness lasted about 2 days.

6 inch red raised red patch that itched and pained so far for 5 days. It is not at site of injection but in the inner crease of my elbow. I used ice and benydrel.

muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared excepto for swollen lymph nodes after 2 days

Received vaccine on 2/17/2021 at the healthcare facility. States about 6 days later on 2/23/21, her L arm became extremely sore, itchy and swollen. Also, looked severely bruised from just above the site the vaccine was given down below the elbow. Saw MD on 2/24/21. Reports taking Plavix and doctor told her the Plavix could be a contributing factor to the severity of the bruising. MD advised pt. that the pain to the L arm and the bruising was likely related to the COVID-19 vaccine.

2-19-21: sore arm; 2-20-21 sore arm sniffles, sometimes tingling around mouth and on left side of face; 2-21 - tired, tingling along jaw line; 2-24-21 - sniffles,intense tingliness on and under tongue, feeling of numb lips; 2-25-21 numb lips - called Facility, talked with advise nurse: 2-26-21 swollen gland, slight headache. Video visit with Dr,; She said if symptoms continued for another week to call back and that an MRI might be considered. . Symptoms of tingling, sense of numb lips primarily on left side have continued daily through today 3-5-21. Called advise nurse today and am waiting for a call back from Facility.

Moderna COVID-19 Vaccine EUA Freezing cold, headache, arm swollen & hurt, fever, dizzy, Memory loss, chest pain, fatigue. No treatment. These symptoms lasted 4 days. (not all at once)

One week after receiving the vaccine, patient woke up with her face badly swollen. It has slowly gotten more swollen over time.

One week after receiving the injection, her face suddenly became very swollen and quite red. Despite visits to two emergency rooms and an allergist, she has gotten no relief from the swelling, which continues to increase over time.

A red spot appeared on my back. I thought it might be ring worm but it was gone in a week. Also my shoulder was sore for about a week. After my second shot a lump formed in my arm pit that was extremely sore. It was gone in two weeks

Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21; used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.

Moderna COVID-19 Vaccine EUA. Chills, fever, swollen throat, sore-red-itchy arm, headache, swollen sore lymph nodes, mild nausea, generally felt TERRIBLE.

chills, fever, headache, joint pain all over, red swollen arm with severe pain starting morning after injection and continuing for 2 day. Arm still red swolen, sor to the touch and hot to the touch

Soreness at injection site. Substantial swelling, soreness and tenderness of the Lymph node in the area above the right collarbone (Clavicle) Some aches.

Body was extremely hot and red, and I also had chills. Arm was very hot and sore and swollen. Entire body ached (like I have never had before) , nausated, bad headache, very weak. My urine was a different color (kinda of peach/pink). I took Tylenol to help with fever etc., for a couple of days. I still fatigued from the ordeal.

fever, nauseous, redness itch lower injection area, fatigue, headache, urinated 10 times that evening, tired, chills, itching, swollen arm

"Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, increased swelling,

Anaphylaxis reaction; A spontaneous report was received from a consumer concerning a 77 year old, female patient who developed Anaphylaxis reaction. The patient's medical history included allergies. Concomitant product use was not provided by the reporter. Vaccination details are not provided by the reporter. After she received vaccine developed Anaphylaxis reaction. Treatment for the event included steroid shot. Now her doctor says the shot is ineffective and she can't get the second shot. She wants to know whether that information true and she is willing to take second shot despite her doctors advice. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event Anaphylaxis reaction 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 the event, a causal relationship cannot be excluded.

I was fine with no noticeable reaction until sometime around 4:00 am when I felt my arm was itchy. Then upon getting up about 6:00 am, my arm was swollen and warm and I had a red rash at the shot site. It get more and more painful to touch but then after three days the swelling started to go down but i also notice that my neck glands and under my arm were also feeling discomfort. I thought it was almost gone except for the glands in my neck but then, last night, March 16th I realized I still had or that a new rash was again on the same area and is still a bit swollen and sore but not as bad as on the 10th. I am really worried about taking the 2nd shot I have a daughter who is having a heart transplant and deaf and she needs me to be in the hosp. with her to interpret for her.

One week after injection, my arm was swollen with a rash and pain up to my shoulder. It is still painful to use my arm and shoulder. I have had Rotator Cuff repair twice on Rt. Shoulder and the pain I feel there is like it is in my rotator cuff. I cannot lift my arm up above my waist without feeling the pain. When I do not use my arm, there is not pain. I do not have a rash any longer but feel there must be swelling in the shoulder. Ocassionally I have some itching in injection area but try not to scratch at all.

day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intestinal tract upset slight nausea and diarrhea. Next day...arm better, lightheadedness better, very tired and slept a lot. Next day: not bad during day. in evening had shooting pains in calves, and sweated a lot at night. Arm much better. Today: arm almost painless, still a bit lightheaded, intestinal tract still "busy". no pains in legs.

At 11:50 pm on 1/26/2021, I could not swallow even a sip of water. My Esophagus appeared to have closed. I debated calling 911, but had sick animals I couldn't leave. Went to bed and when I woke, I could swallow again. However I had severe hives as well as debilitation itching and swelling of my fingers, hands and later, my toes and feet as well. These symptoms have continued in varying degrees ever since I received my first Moderna vaccination.

still having problems breathing; anaphylactic reaction; A spontaneous report was received from a consumer concerning a77-year-old, female patient who developed anaphylactic reaction and still having problems breathing (dyspnea). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received the unknown of two planned doses of mRNA-1273 (Batch number: 030M20A) on 24 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection. On 24 Feb 2021 the patient experienced anaphylactic reaction (lips went numb, face went numb, blood pressure went up, heart rate went up, her throat closed, and she couldn't breathe or talk). An ambulance was called and the patient was transferred to the ER (emergency room) where they administered intravenous diphenhydramine. Five hours later, the patient was okay, but reported that as of 25 Feb 2021, they are still having problems breathing. Treatment of the events included prednisone and diphenhydramine. Action taken with mRNA-1273 in response to the event was not provided. The event anaphylactic reaction was considered resolved. The outcome of the event, still having problems breathing, 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 the events, a causal relationship cannot be excluded.

One of her eyes and mouth were dropping a little bit/Bell's palsy; Broken out with fever blisters; Rash and itching all over the trunk; Itching all over the trunk; A spontaneous report was received from a patient's spouse in the concerning a 77-year-old female patient who experienced one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus and broke out with fever blisters/database: oral herpes. The patient's medical history was not reported. Concomitant medications included metoprolol, lisinopril, acetylsalicylic acid, omeprazole rabeprazole sodium, vitamin D, duloxetine, folic acid, vitamin A, balofloxacin, vitamin B12 and amlodipine. On 25-Feb-2021, one day before the start of symptoms, this patient received the planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 012A21A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection. On 26-Feb-2021, the patient developed a rash and itching all over the trunk. The events resolved on 27-Feb-2021. On 28-Feb-2021 the husband noticed one of the patient's eyes and her mouth were drooping a little bit. He took her to the ER (Emergency Room) because he thought she was having a stoke. She had also broken out with fever blisters. They ran tests NOS and everything was normal. The treating Physician said it was Bell's palsy and it was due to the vaccination. The events were treated with prednisone 15 mg and valacyclovir 1 gram. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the events, one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis and broke out with fever blisters/database: oral herpes is unknown. The outcome for the events, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus is recovered.; 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.

Allergic reaction with bright redness and swelling of face, tingling, itching and swelling of tongue, mouth, gums, tingling, heat and itching in hands and fingers, feet,insoles, between toes, in crook of arms, behind knees, itchy eyes, ears, scalp, increased itching throughout body

After DOSE 2 had swelling of several body parts, lip, ear lobe, arm and ring finger( had to have rings cut off), lasted close to a month

After more than two weeks, I still have a large, swollen red arm at the site of the injection, which has been painful and now itches terribly. I also have swollen glands in my neck, on the left side. Reading on the internet indicates This is a rare reaction, ?covid arm? and that a doctor?s intervention with antibodies or steroids are not especially helpful and that the issue is eventually resolved.

I had no initial reaction but exactly a week after my inoculation site began to itch, I had a red area that was swollen and was warm to the touch. Initially the spot was approximately 2x3 inches, as time passed it spread and became less red. It was gone a week later. I had no fever with it. I took antihistamines. I called my doctor and we agreed that I would get back to her if my reaction became worse.

allergic anaphylaxis; A spontaneous report was received from a consumer, concerning herself a 77 years old female patient, who received Moderna's COVID-19 vaccine and experienced allergic anaphylaxis reaction in which the throat is swollen and could not eat and drink liquids. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08 MAR 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030A21A) via Intramuscular route for COVID-19 infection prophylaxis. On unknown date, she experienced allergic anaphylactic reactions which the throat was swollen and could not eat and drink liquids. She took Benadryl (diphenhydramine) as the treatment. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was considered to be unknown at the time of this report.; 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 event, a causal relationship cannot be excluded.

first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - sore arm, sore back of neck from headache (muscles seemed frozen for days), really cold from 8pm to 4am with debilitating headache. left side of body was without coordination, hip, knee, ankle didn't work. Went sideways with all joints when walking. 03/18/2021 - passed out in bathroom due to pain. Hit door frame and had large lump on forehead. Bowel mess to clean up. 03/21/2021 - didn't dress, still wobbly stomache upset, neck sore, dizzyness, ate squash and beans. 04/01/2021 - still have stomache upset and though day temperature is over 70 degrees, am very cold, tired as soon as do just one thing. continues

pt says her left arm was swollen and had fever in it for almost 2 weeks. The swelling has gone down now. She had fatigue that lasted almost 2 weeks. She developed diarrhea a couple of days after getting the vax and still has this today 4/7/2021. She says every time she eats she gets diarrhea. She has taken Pepto Bismol but it has not helped. Pt will contact her PCP regarding her symptoms.

When I woke up the day after my vaccine my injected arm had a large red circle it is swollen and itchy.

Patient was seen at healthcare clinic 3/5/21 for complaints of abdominal pain and diarrhea x 1 week, no fevers. Admitted to the hospital for IV fluids and Zofran. Lab work shows elevated WBC and patient was given x1 dose of Metronidazole IV and discharged to home with appointment to f/u at healthcare clinic 3/6/21. On 3/6/21 patient was not improved and was sent back to hospital for IV fluids. Lab worked showed further elevated WBC, CRP and PCT so CT abdomen was done and found to have inflammation throughout the colonic wall. She is then admitted to for further evaluation and antibiotic treatment. Patient remained afebrile and WBC, CRP and PCT all trended downward. During hospital course she was also treated for hypokalemia due to diarrhea. She was started on Budesonide for colitis and was discharged on 3/11/21. On 3/25/21 patient is again seen at healthcare clinic for N/V/D with dehydration and is sent to hospital for IV fluids. Lab is again elevated and patient improves and is sent home with instructions for f/u at healthcare clinic on 3/26/21. On 3/26/21 patient is then admitted to hospital for N/V/D with dehydration and fatigue with headache. CT again shows pancolitis. On 3/26 patient then experiences A.FIB with RVR and is stable but as the day progresses becomes unstable with elevated heart rate and low BP. Due to patient?s unstable condition she is flown to another hospital for increased level of care.

put on 30 pounds of water weight; Fainted; blood pressure dropped so low that she fainted; Moderna COVID-19 Vaccine reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, WARFARIN, TADALAFIL and DILTIAZEM for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction). The patient was hospitalized on sometime in February 2021 due to SYNCOPE. At the time of the report, VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) outcome was unknown. 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. On an unspecified date in Feb-2021, the patient reported that she became very ill and hospitalized for 12 days after receiving the Moderna vaccination. She reported that her blood pressure dropped so low that she fainted. She also had had put on 30 pounds of water weight, which she is trying to get off. She reported that her doctor was aware of the hospitalization. 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. Reporter did not allow further contact; 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.

explosive loose bowel movements with burning anus for two weeks (burning elemenations continue still); head ache on top of head - several days; puffy face; Brief Chest pain on 4/4/21 with fatigue following for several hours and balance problems. pain in left plantar fascia and discomfort in right Siatic nerve area and upper thigh 4/13 Cough - productive; patient is mostly recovered from adverse reactions with exception of burning bowel movements

FEVER, Wheezing, Shortness of Breath DX Fever, unspecified fever cause R50.9 Pulmonary infiltrate R91.8 New Prescriptions DOXYCYCLINE HYCLATE (VIBRAMYCIN) 100 MG CAPSULE Take 1 capsule by mouth 2 (two) times daily for 10 days.

on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking medications as prescribed. Documentation from MD in ED uncertain if pt. taking her amiodarone, torsemide and elquis. Noted to have O2 sats on RA of 81%. Pt. was in respiratory distress upon arrival to ER. Pt. was transferred to higher level of care, another Hospital on 4/15/2021 placed on Bipap.

Approx 10 days after shot - severe pain in muscle part of arm, neck gland protruding , swelled, neck pain going all way to ear- previous to this time could not lift arm above waist- not concerned at first but kept getting worse and extending to neck, shoulder, upper arm. Some swelling in hand as well numbness - fullness feeling in inside of arm especially at bend and hard lump in muscle of arm. I had this w first shot, filled report, met w 3 doctors, each prescribed different rememdoes. First time went to UC - prescription for steroids & ice. Family dr back from seminar visit - said should never have prescribed steroids -- prescribed heat, topical cream. 2nd shot effects mush later showing - this time dr prescribed xtra strength Tylenol, ot ibuprofen. Do not want to talk meds, want to know why this is happening. Since last major surgery, 2019, after 2 others in 6 years, only take low dose aspirin & vitamins pills.

Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9.

Laparoscopic Appendectomy 2/27/2021 (Miniperforation) Never had any previous trouble with appendix symptoms came on (mild) 1 week after first Moderna vaccination, to ER for CT scan following evening: surgery 1:30am. No idea I?d this is related. Only reaction to first vaccination was sore arm.

March 8th thru March 29 swollen ankle and left calf. Treated by patient with compression socks. Seemed to relive swelling April 13th Emergency Room at hospital, after extreme shortness of breath + coughing up blood at home. Admitted to hospital

Client received 1st dose of Moderna vaccine at 1:30 pm and at approximately 7:00 pm she experienced loss of muscle strength/weakness of her left arm along with edema from the left elbow down to the left wrist. No pain was associated with the event. The swelling and weakness resolved itself the next day, within 24 hours of the onset of symptoms.

arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-year-old female 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 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved. No concomitant medications provided. Treatment included doxycycline and prednisone. 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 stated that about a week and a half after she got the vaccine, her arm became swollen, warm, red, and puffy. It went away the next day.

(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of "just not feeling right" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed "water pill" and told to "lay off salt,". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter "water pills" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative.

She got her vaccine, about a day and a half her arm was sore and itchy. Then later on it was red, splotchy kind of redness, but not at the point of the injection, just a couple of inches below towards the elbow. This lasted for about a week. The soreness went away but could see redness in the area, which took about 4 weeks for this to disappear completely. She had a headache which lasted for a short period of time, and disappeared. She also had a swollen lymph node along her waste that were sore about 2 days after the vaccine, which also disappeared and had it only for a day or two. She started noticing a sound, thinking it was in her old house the 2nd week of April, but moved to a quieter neighborhood and still noticed it. She was reading an article this morning in the paper and realized the sound that she was hearing was tinnitus. She was only born with one ear and it sounds more like a beeping sound than a ringing, but it continues to bother her. She does not notice it when she's out driving around from the other noises in the environment but when it's quiet due to the one ear she can hear it. With only one ear she cannot determine the direction of where the sound is coming from, but does notice it during quietness. She puts her ear up to the wall to determine where the sound is coming from and plugged her ear, and determine it was from the ear itself. She is worried about it getting worse or not getting any better with only having the one ear.

Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.

Redness, swelling and itching of arm and reactive lymphadenopathy, persistent arm pain lingering months after initial reaction

Night of second shot had low fever and diaphoresis lasting 3 nights. On 5th am post injection had severe upper abdominal pain. Upon arrival in ER had bloodwork, CT, and MRI (results below) Diagnosed as idiopathic pancreatitus since no reason could be found. No alcohol at all, no stones, and no routine meds known to cause this. Admitted NPO and on IV fluids. Discharged next evening after pain resolved and tolerating po fluids. Hospital physicians told me they did not think the vaccine could have been the issue but I still feel this was such a coincidence that it should be reported.

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

Patient presented to the ED and was subsequently hospitalized with Sepsis without acute organ dysfunction within 6 weeks of receiving COVID vaccination.

PAIN AND SLIGHT SWELLING IN INJECTION ARM. NO REDNESS, NO RASH. STARTED IN AFTERNOON AFTER 1ST DOSE OF MODERNA. CONTINUED TO TODAY (6/29/2021) AND PATIENT STATED THEY WERE ON THEIR WAY TO THE PHYSICIAN TO BE EVALUATED. PATIENT WAS AMBULATORY AND, OTHER THAN PAIN AT INJECTION SITE, SEEMED TO BE IN GOOD HEALTH.

Cough, sore throat, swollen glands, weakness, tiredness After about two weeks the symptoms lessoned substantially. I was given a Covid-19 test and a strep test. Both were negative. The PA prescribed lots of liquids and lots of rest.. That is what I have been doing and the symptoms have gradually lessened.

fever (103.9) one day after last vaccination. 10 days after vaccination, visit to cardiologist who had precribed verampamil for palpitations a few days before my vaccination - my legs and feet were swollen. She told me I had mild purpura and edema from the verampamil, and she discontinued it. I told her I suspected it was from the vaccine. I quit taking verampamil, and I still have the rashes and edema in my legs and feet, and also on my arms. I had to go to the ER for severe leg pain, I believe in March orApril, where they tested me for a blood clot, which was negative, and went away a few days later. I still have the swelling and edema and rashes. I do not have a doctor's appointment until September with the cardiologist NP, and in October with my PCP. I am sure my situation is from the vaccine.

on 7/12/21 patient noticed swollen gland in right submandibular region, with mild fever off 100F last night. Patient noticed an increase in the size of gland overnight.

Fever , chills, tireness, redness and swelling after 6 hours. took tylenol every 4 hours for 2 day, then starting taking 2 times daily.

DECEMBER 30 2020 BUMP , SWEELING AND ITCHING AT INJECTION SITE AND HALF DOWN MY ARM. USE SARNA AND FELT BETTER IN ABOUT A DAY JANUARY 4TH 2021 SWELLING AND INTENSE ITCHING ON MY RIGHT ARM AND CHEST ACCOMPANIED BY A RED RASH. USED SARNA AND ICE PACK. FELT BETTER AFTER A DAY OR TWO.

Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sniffle. This morning woke up about 4:30 a.m., has some nausea but did not vomit. Had some lightheadedness. Has had vertigo in the past.

One week after the injection my are swelled and bcame very warm to the touch the doctor prescribed warm soaks and an antibiotic. It seems to be improving

Patients left arm is slightly swollen and red-warm to the touch. Patient received vaccine on 1/8/21. Symptoms started on 1/15/21. Reported to pharmacy on 1/19/21. States antibiotic cream has been helping.

Glands below the right ear swelling with infection. Thought it was a tooth problem. Went to a dentist. After his xray, he said the infection was not from a tooth. He prescribed Amoxicilin . This is the 3rd day. glands are still swollen. Ice packs are helping. An unexplained infection!

1/21 Significant itching at injection site. Refrained from touching. By evening progressed to small area of redness and swelling. 1/22 Much larger area, rosy red, swelling and felt hot. Applied ice. Area affected continued to spread. 1/25 Presently extends from shoulder to arm pit, but not under arm. About size of very large orange. Tender, but not painful. Very itchy, still red, hot feeling, and puffy. Hopeful it is safe to receive 2nd dose around 2/14/2021

Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and joint pain, chills, nausea, dizziness (for about 18 hours) oxygen level: averaged 96 but dropped to 93 one time (but that might have been equipment error)

patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a severe headache and fever, unknown exact temp, nausea and vomiting. Fever stopped on 1/20/21 per patient. She reports her eyes seemed blurry for several days, like haziness. States she felt like her heart was racing for a few days beginning on 1/18/21. She did have a routine doctors apt on 1/22/21 and her physician completed bloodwork, unsure of labs or results. Her physician said that she should report her symptoms after the vaccine. She also had swelling and redness to her left upper arm all the way down to her elbow area after the vaccine.

My forehead felt like it was swelling. Lips were tingling. Took 2 Tylenol. Stayed home and rested. Disappeared in a couple of hours, around 1:30PM. Felt fine thereafter.

One week after my injection on 1/15/21, on the evening of Friday 1/22, my left arm felt warm, was reddened, somewhat swollen and itchy. It has continued for the past 5 days, with the itching and reddening decreasing a little bit each day. I was surprised that this reaction occurred a full week after vaccination. Should I still take the 2nd dose?

Patient had small localized reaction for 2 days after injection that cleared. At approximately 7 days post injection she began to have another localized reaction that included reddness, swelling, pain, heat, and a dry skin tecture that progressed to cover the lateral aspect of upper left arm from shoulder to elbow. At time of examination by RN, the patient reports that size and intensity have been increasing for about 7 days. Patient finds relief in hot shower. No other treatments attempted at time of exam. Patient reported area may be improving, but she is unsure. Area was outlined with marker by RN and patient was advised to see PCP for treatment if area increased in size and was not continuing to improve. Counseled on using OTC benadryl cream if there was itching.

after the shot, red swollen line going down elbow and around my arm about 8 inches wide. went to the ER on the next day, and was diagnosed with cellulites and the spot is infected both ER and the Physician said the same thing. Advised to get the second Shot on the other arm and to take one hr before Zyrtec and famotidine and again 4 hrs later. The inflammation is still spreading as of today.

The patient received the vaccine on January 20, 2021 uneventfully. She did not develop soreness at the site. Approximately 3 days later, she noted a bump that was sore to touch and slightly itchy. It slowly got better. She did apply clobetasol ointment on January 24 and 25. It seemed better. On January 28 the evening and 8 noticed some redness. She saw me, her doctor, on January 29. She had a 7 x 7 cm round pink area that was slightly warm and minimally tender. This was at the site of injection. It was slightly swollen. I did not give her the vaccine. She got it through the health Department.

Extreme pain in jaw. Lump tmj and in throat. Swollen glands on left side. Sharp pain when swallowing and ear ache.

My arm is red and tender. The doctor gave me a prescription for Triamcinolone Acetonide Cream to put on the site 3 times a day.

pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appetite, dizzy, weak and felt like she needed to faint. She was experiencing angina type symptoms w/ short frequent episodes of AFIB. She went to bed and woke up around 11 PM on 1/31/2021 sweating and had a temp of 103. She took extra strength Tylenol and went back to bed. Next morning her temp 101.5. but had returned to normal during the day but had gone back up to 99 later that night. On 2/2/2021 states there was no temp but her arm is swollen, itchy and red with pain. She was able to eat and get hydrated. Pt is still dizzy and light headed at this point. On 2/3/2021 patient woke up feeling some better and able to focus but still has itchy, painful and pink arm that is hot to touch. She is going to call her PCP and Cardiologist today on 2/3/2021.

24 hours following vaccine arm very sore and red. Beginning 24 hours later arm continued to swell to size of tangerine, very red, hot to touch. Unable to sleep or lay on side. No lymph node swelling. Unable to use. arm. Took Tylenol first day only. Took Ibuprofen for arthritis but not for arm. Did find some relief from the over the counter meds. Seen by private doctor who diagnosed cellulitis. Told to take second dose but in different arm.

Day #1 Intense itching, swelling and redness within 3 hours after injection Day #4 Swollen tongue, itching, difficulty swallowing, coughing, wheezing. Called 911 and transported to Hospital. Received Prednisone 20mg for 5 days, Famotidine 20mg Day #9 Tele-visit with Dr. Received Azithromycin 250mg for coughing. continued Azithromycin Day #10 Symptoms returned. Swollen tongue, difficulty swallowing, breathing difficulty, left arm is swollen, red and itching at injection site. continued Azithromycin Day #11 Woke up with same symptoms in addition to nausea. continued Azithromycin

2 inch by 3 inch reddened, itchy and swollen area to left arm. Was encouraged to use cool compresses 2/3 times per day and monitor. She was also encouraged to seek medical attention if needed.

25 minutes after receiving her 1st dose of Moderna, the patient complained of having a sensation of swollen lips and tasting the vaccine. Her lips did not appear swollen, she had no shortness of breath, no rash or hives. The patient has a prior history of allergic reactions to shrimp and other injectables (not specified). Per the patient, by the time I spoke with her, her symptoms were already resolving. Her vital signs were recorded and reported to Doctor on duty. Instructions were received to continue monitoring the patient and she could be discharged when her symptoms were completely resolved. After an additional 20 minutes, per the patient, her symptoms were all gone and "felt fine". The patient was discharged to home. Patient left the clinic by wheelchair accompanied by her family member. She was instructed to call 911 if her symptoms worsened and/or contact her primary physician. The patient was asymptomatic upon discharge.

Injection site very hot and hard and tender. Chills and aches for a full day. Nodule in lymph area in neck.

Swollen upper right arm 3-4 inches in diameter, raised, bright red, itchy and the onset was Thursday, 2-11-2021...8 days post injection. Adverse symptoms beginning to recede today, 2-15-2021

Redness, slight swelling, achy muscle, This occured immediately after vaccine, went away on its own. Reoccurred 10 days later with itching off and on

patient indicated she noticed swelling in entire left side of face and neck no redness or rash swelling including lips not tongue

Did NOT occur until 1 week AFTER injection: pain, tenderness, swelling in upper arm & pain, hardness and redness; these were preceded by diarrhea and fatigue. Better in 2/3 days.

After Dose #2 Muscle swelled and red mark just below vaccination site same day. Next day fatigue, chills, sweats, diarrhea, low grade fever, burping Next day pain above stomach below breast bone, nauseau, vomiting, indigestion, burping. Next day arm still swollen, red spot much larger, itchy, hot.

Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.

Four days after injection right foot became inflamed and hugely swollen. Top of foot and all along the outside side of it both on top and at bottom of foot all very painful. Ankle and leg very swollen and painful. Can't walk on foot. As of 2/26/2021 swelling is not as bad and not so discolored but still some swelling and redness burning and very painful and still cannot use the foot. Also have noticed places where I have had surgery or injuries is hurting and being stiff. Am questioning whether or not I should get the 2nd shot. Concerned it will make situation even worse.

On day 10 following injection, red rash at injection site, (shoulder) about 2" diameter. Also rash on both hands, especially both forefingers, like poison ivy: itchy, red , some swelling, also other spots scattered on hands. Treated with Cortisone cream On day 14, the redness at injection site measured about 4" x 6" - not itchy or rashy, more just a red area By day 17, symptoms were gone.

About 45 minutes after injection, funny feeling in face (can?t explain, maybe tingly, puffy), muscles in throat tightening. Both of these were fleeting. Following two mornings had no voice (laryngitis) first thing in the morning. Voice came back as day went on. No further issues

7 days after second dose I began to get what seems to be hives. 9 days after multiple large red itchy swellings on both cheeks, on butt, on non-shot upper arm

itchy, red, swollen reported start of symptoms on 02-23-21 still having symptoms on 03-01-2021 (7 days)

12 hours after 1st covid vaccine she began having swelling of the left side of her face, cheek, eyelid. She also noticed tender lymph notes in her neck on the left side. Denied any recent illness, no rash/hives. Denies problems breathing, no swelling of tongue. Seen on 2/25/21 at PCP office. Assessment by Dr. on 2/25: "mild residual soft tissue swelling noted in the cheek laterally and into the chin and skin above the left eye. There is tenderness to palpation along the left side of her neck with mild fullness of the lymph nodes.

Ran a fever at night the first 2 days, the second day my arm started getting red, swollen and painful

March 3, 2021 Arm started itching, Arm has been sore for 3 days, warm to touch and swollen. Rash appeared around injection site and below. Size of rash 6" long x 3" across. Applied ice throughout day and evening. Found information online regarding COVID Arm reactions and pictures which looked like my rash. March 5, 2021 - rash is less but arm still swollen

For 8 days following the injection I had a sore arm, on the 9th day the area became bright red about the size of a drinking glass lid, was warm to the touch, hurt and itched. and was hard maybe slightly swollen.. It remains that way.

Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation). The patient's medical history was not provided. No relevant concomitant medications were reported. On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection. On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was not reported.; 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.

First dose was on 01/12/2021 at 9:30 am. No reaction until Feb.7. 2021, when left leg began to swell, but not seriously. Feb.8, 2021 leg was continuing to swell. went to doctor's office where he prescribed an ultrasound. Was told there was a clot behind my left knee and in some of the smaller veins. I had the chills, joint pains all over, which lasted about the three weeks, but was slightly different every day. When I began the 20 mg dose of Xarelto, every symptom cleared up and I felt great. I am continuing on the 20 mg Xarelto.

Arm became red and swollen day after shot. Arm is still red and swollen day 5. Have taken ibuprofen each day after shot. Not sure if I should wait longer to see dr.

Patient visited pharmacy a few days after administration to report slight redness and irritation. Pharmacist informed patient to apply ice and take Tylenol or Ibuprofen to help with redness/swelling. Patient called today 03/16/2021 to state that the redness spread to the upper and under arm. Patient is still experiencing pain/discomfort from vaccine. Pharmacist suggested patient to seek medication attention and to inform us of outcome.

Not serious, but the fact that it didn't happen until eight days after the vaccination seemed unusual. Sore arm at the site, redness, some swelling and itching and a rash Faded after about three days.

3 days after vaccine experienced fever, extreme muscle pain, extreme bone pain, head ache, chills. 13 days after vaccine experienced extreme swelling in glad under left ear and down the neck under chin. Ear ache in both ears but worse in the left ear. Visited physician next day and was prescribed an antibiotic. Was better in 14 days.

Per patient's son, the patient developed a rash at the site of vaccination 4 days after the vaccine. She also began developing swollen, cracked lips and swollen hands and feet with a blistering rash. The symptoms were reported to our pharmacy by the patients son 28 days after her vaccine, on 3/15/21. The patient was due for her second dose on that day, and he wondered if she should still get it. We instructed him to call her Dr. After seeing her Dr for an appointment today, the patient was told not to get the second dose of the Moderna vaccine.

Redness that became swollen and itched. Today 3/17) is day 2. It looks worse than yesterday. I had the same reaction to the first shot and it was diagnosed as cellulitis. Now I see it wasn?t.

On January 27th, 7 days after injection of the vaccine in my right arm, below the site of injection my arm became red and swollen. The red swelling spread down the arm almost to my elbow. On January 28th, I took Benadryl and the itching and swelling cleared up in 3-4 days.

Pain at site of injection. Swelling of arm down to elbow, chills, aches especially in fingers and wrists, temp 100.2, nose bleed (minor).

very cold the night after shot. very tired the next day. a few days later had blood pressure and heart rate fluctuating. sore red swollen arm. md says infected.

Patient notified pharmacy that on 3-23-21 she woke with red spot at injection site. Two days later it increased in size and became swollen and itchy. Patient attempted cold compress which made it worse and Allegra. Advised to try Benadryl and Cortisone cream and speak with physician if it continued to progress further.

Both arms, and only the arms, became swollen, red with rash, itchy and painful. Other more common side effects included fatigue, chills, nausea, severe headache, which occurred in the evening of the day vaccine was administered

The day off there was alot of pain similar to a bruise, nauseous throughout day of and night, swelling in right hand,

29 days after patient's second Moderna dose, she had sudden onset significant pain where she couldn't stand or walk, her left leg became swollen twice it's size, and blue. She went to the ER with no treatment. About 5-6 hours after discharged she returned with her leg turning purple and uncontrollable pain. She was diagnosed with venous thromboembolis and transferred to a larger facility where she underwent lytic therapy and venous angioplasty. She is having to go for venous stenting in the next two weeks. She continues to have pain in her leg, chronic fatigue and weakness, as well as being lightheaded with a stable BP (no orthostasis). She has been diagnosed with anemia since vaccination and is being worked up for that.

Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Event outcome 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 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Event outcome 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.

Patient called in to report that she had severe left arm pain. Stated that she went to the Emergency Room due to the pain and was told that she had fluid in the subcromial space in left shoulder (thought to be the vaccine). She states she is a retired nurse and thought that the nurse giving the vaccine gave the injection too high. She stated she was to have a MRI on 3/29/2021 but have not heard back from her with results. She stated she is also to see an Infectious Disease Physician to consult on if her vaccine is effective or she needs another vaccine. Patient did not give names of physicians to this nurse.

Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. Pt went to the hospital and was later called to come back to the hospital because she had a blood clot. Pt was sent to clinic and had a procedure by to remove clots. Pt states that the clot was "2/3 size of thigh." Pt states that she is scheduled to have a second procedure in May to remove blockages from iliacs.

22 days after the second shot my feet swelled and itched and were reddened for 4 days. it was worse at night.

Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 78-year-old female 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. Concurrent medical conditions included Cholesterol (Tressor for cholesterol), Stress (Takes "stress pills") and Drug allergy (azithromycin (Zithromax)). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 05-Mar-2021, LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10-Apr-2021, she experienced right-sided facial paralysis and was unable to keep her eyes closed. Her doctor subsequently diagnosed Bell's Palsy. The patient inquired if there were patients who have experienced the same thing. Action taken with mRNA in respect to the events was not applicable. Concomitant medications included stress pills and tressor for cholesterol. Treatment included prednisone, unspecified antiviral medication and eye drops for the right eye. 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.

Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Tiredness in leg) and GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction (no reported medical history). On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Tiredness in leg) (seriousness criterion disability), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) (seriousness criterion disability), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath). At the time of the report, MUSCULAR WEAKNESS (Tiredness in leg), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. The patient was treated with prednisone and Percocet (oxycodone/paracetamol).; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh. The patient scheduled to have a second procedure in May to remove blockages from iliac. Action taken with mRNA-1273 was not applicable. 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. Prior medical history of blood clot is considered a significant risk factor.; Sender'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. Prior medical history of blood clot is considered a significant risk factor.

After second injection, arm site was red, hot, sore, and itchy for 8 days. 5 days later, my legs and feet started swelling considerably and became tight and blush colored. Have not had this before. May not be associated with vaccine, however unusual.

1st Dose: 10 days after vaccine my left arm and right breast swelled and reddened for a few days. I had a masectomy and breast reconstruction on my right breast in 05/1998. Breast cancer 2nd Dose: The day after the shot I had chills, fever, etc which is normal but my right breast got swollen, hot and red. as of this date, 2 month later my breast still is slighty red but not as bad as in the beginning . I know this probably from the shot but is a little scary.

Unsure of cause/effect. Patient developed idiopathic thrombocytopenic purpura with platelets of 4000 from normal the month prior. With most recent different events being the COVID-19 vaccination and starting prolia twice yearly for osteoporosis. She developed purpura on left arm starting on 4/18 which enlarged and coalesced throughout the week. She then developed oozing from known wound and purpura on chest. Entire left arm developed diffuse bruising and swelling by 4/22. Left side of face also with spontaneous bruising. Developed mucosal bleeding of mouth and throat on 4/22. Presented tachycardic and mildly hypotensive.

Patient presented today to the pharmacy (4/22/2021, 11:05 AM) with various bruises on the arm that received her second dose of the Moderna COVID-19 injection (left deltoid) both at the injection site and further down the upper arm. There was also redness and swelling, slight skin mottling as well. Patient did not report pain, but did report itching of the affected area. Patient said that this has been going on for the last few days. Patient was consulted to seek medical attention if there was any worsening of the affected area or if it did not seem to be healing within the next 2-3 days. Patient was also advised to let her primary care provider know about the reaction.

Left arm swelled, became warm to touch. The swelling and red spread across my whole arm. 4/9 was diagnosed with an infection at the injection site. Was put on antibiotics- Cephalex 500mg ever 12 hours for 10 days.

Within about 45 mins . after I received the shot (and had left the facility), I was driving home and began to feel the left side of my mouth (my lips) swell up (as if I had been give novacane at the dentist), then the area under my left cheek bone began to swell up as well; nothing hurt, I had no chest/back pains (had a double by-pass 16 yrs. ago, no further heart problems), no pain, tingling, in arms, legs; my doctor's office is closed Friday afternoons, so went to Emergency Medical office where was diagnosed with Bell's Palsy; went to my own doctor following Tuesday; swelling had decreased, on and off; by Saturday (i.e. one week after the shot) I also had a red very itchy rash on my left arm at the vaccination site; swelling still not gone by third week after shot, so went to my ENT (allergist) who said it was not Bell's P., recommended not getting 2nd shot; then (4th week after the shot and still some swelling around the cheek) went to my Cardiologist, did EKG, all OK, but he said both the rash and swelling were allergic reactions and I should not get the second shot - so I will not get the second shot. Now (7 weeks from shot, am still "aware" of lips and cheeks - not exactly swollen, but like an injury that is not completely healed - this occurs when I am "tensed up" about something (l trying to get to an appointment on time :)

1) Most significant reaction began 10 days after receiving vaccination. Itchiness primarily on back & buttocks w/a little on arms, legs, and abdomen. Red raised bumps appeared w/increased itchiness each day & continues to present (Day 4). Took one Benadryl on Day 4 w/slight but temporary relief. 2) Additional reactions prior to outbreak of rash include: a) swollen lymph glands on right side of neck two days post vaccine lasting for two days. and b) Left ear ache/pain on 4/28/21 lasting one day.

Intense Pain in upper back muscles, both upper arm muscles, both thighs and buttocks. This pain is worse at night in morning. It is there randomly during the day and subsides randomly. Physical therapy 2x?s weekly, Acupuncture 1x weekly and Chiropractor initially weekly, now 1x weekly. Waiting to see Rheumatologist June 1.

Developed profound leukocytosis with WBC 173,000 and elevated LDH following first dose. Increased hydrea (already on for CNL). Developed transfusion dependent thrombocytopenia

My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later. She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th with an other doctor and when she asked if she had any other issues, pt. showed her her leg. The eye doctor immediately told her to go to urgent care. When she did she received blood thinners and started injections in her stomach for 5 days. Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room. She was transferred over to another facility in the afternoon and kept overnight. She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks. She also had a check up about her leg, which was still swollen. On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after. By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital. She was monitored and kept over night, but during the early morning she suffered a stroke and a heart attack and passed way the next day.

Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for 2 days,, sleep on and off for 3 days. Just starting to feel a little better. It was hell. 10 days.

Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure

Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.

Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor. 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 19-May-2021: Additional information received captured patient demographics.; 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.

When I got the injection, I took two Tylenols. I noticed after my arm got hot and swelled a little. About 2-3 days later I had a bad rash spread from around the injection site. I went to see my doctor after a week of having that and they told me to take Benadryl. I also was taking cortisone cream. I went back to the doctor because it would not go away. My doctor prescribed me two different pills, the rash and swelling went away a little. I had to back to the doctor and he prescribed a different pill, and the itching and swelling went away.

I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.

I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.

Pt states night of the 2nd vaccinations fever, chills lasted several days. Violent loose stool, vomiting, night sweats . Dr. visit 05/26/2021 - 06/16/2021. Gastro 06/22/2021, still waiting for results. Symptoms still continuing

nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. 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

With a week or 10 days I noticed swelling between legs between ankle and knee and my veins are swollen

About an hour after getting the shot I started not feeling to good. I ended up with a headache, shortness of breath, and swollen glands. I tried to wait it out but it continued to get worse so I went to the emergency room and was admitted.

The arm swollen and redness went from my injection site to past my elbow and around to the back. I contacted my DR about 5-7 days after it began, it was so long ago how am I supposed to remember the dates. The DR gave me a 7 day supply of Cortisone. After that it began to go down, although I did have pain in the arm and around the arm as well, which was constant and is still there for that matter actually. The DR just said it was an allergic reaction to the shot.

Pt reports the day after vaccine feeling chills, slept all day, felt "out of it.". 7/28 she noticed her arm was red and swollen. advised these would all be considered normal side effects. Need to monitor arm. If size increasing please notify dr. If getting smaller should resolve on its own. All other symptoms other than arm have since resolved.

Patient reports that she had facial swelling and some tongue swelling. She took Benadryl and it was helpful.

1/19/21: ER visit for evaluation 1/20/21: Hospital admit due to increased confusion and possible sepsis. Principle Problem listed: Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction; Acute encephalopathy SIRS likely due to COVID-19 vaccine but no current evidence of acute infection. Her acute encephalopathy is likely due to her SIRS response in the elderly and does not require acute intervention other than support.

upon arising on 1/21 c/o redness, soreness and swelling measuring 1.5 in. x 2 in. Denies any symptoms following vaccination until 1/21.

pt stated her right leg has swelling and hardness in between knee and groin area (middle of leg). Pt stated it was itchy when it started to swell but has subsided.

Swollen redness, like hives that appeared 8 days after injection. Area is !4" x 2" and itches. First discovered today, did not notice prior to today. Taking antihistamines, have not been able to see medical professional yet.

Did not have an immediate reaction to injection. 8 days after injection. started to have discomfort, swelling, temperature went up to 100.3 that lasted for a couple of hrs and then went away. slept real good and woke up and not long after waking up my arm started feel very uncomfortable and swelling, turning red and a little itchy. and took a little Acedimidafin and now its back to normal.

Severe pain which continues to get worse after 1 week and radiates into L clavicle, Limited ROM, swelling and redness. She is to F-U with dr in 5 days. Given pain meds.

This is patient (self) report: ?Covid arm? noticed on day 10 post vaccine. Itchy, achy. Classic size as determined by newspaper article/ about 4 inches long/2inches wide. Red, firm swollen area very gradually fading in color. Size, sensations and swelling remain the same. Last two day have had mild yet annoying headache starting mid day. No temp.

right arm pain, swelling, and warmth which has been progressive after receiving her first Moderna Covid vaccine on 1/22/21. No weakness, numbness, or paresthesias of the right upper extremity. Affected area has remained isolated around the injection site without significant spread. No fevers, chills. Patient has noted fatigue, headache, body aches, isolated rhinorrhea/sneezing a few days ago, and intermittent cough. Known issues with postnasal drip.

pain in side and front of left elbow (same arm as I had the vaccine in). and down to the wrist. Difficulty stretching or raising my arm.

Tightness in chest, easily short of breath with lower oxygen levels. Oxygen level when vaccine administered was 97. Following few days concerning so bought pulse/ox monitor Thursday 1/28. Oxygen readings ranging 92-94 from 1/28 onward. Second side effect noted evening of 1/24: bright red as if sunburned throat and center of upper chest and puffy. as of 2/3/21 red color and puffiness diminished.

pt stated that she was fine and then in 2 days seemed to have fatigue. Within in 5 days pt noticed it was sore under the left arm. Within 7 days it became itchy red and swollen. Pt contacted her PCP on 2/3/2021 and she was told to take an antihistamine but she didnt take it since she has dry eyes. She used hydrocortisone to help with the itching.

I received the vaccination on 01-26-21 and on 02-03-21 my arm was itching and the next morning I noticed it was red and a small amount of swelling and a small rash. I called my primary physician and was advised to ice it and watch and report if if got worse. They called to check the next day and I informed them it was about the same - no worse. They advised to ice and call if it got worse. Today is Feb 6 and it is the same. I do not leave sick otherwise.

one week after injection, developed itchy rash which grew into 5" diameter red swelling. Sensitive but not intolerable, still have after one week. Did not take pain relief or use salvlel

On 8th day after Moderna Covid 19 injection, there was a very raised, red area on left arm - felt very warm. By the next day the area had increased in size and some of the swelling had subsided. Today, the third day after the reaction appeared, the redness has spread to a large part of the outside of my upper arm - still feels warm -slight pain. Previous to this side effect, I felt a loss of strength in my left arm during a workout. ( My concern is that this occurred so late after the injection and what it means going forward with second injection.) I have called my doctor but have not talked to him.

Vaccine shot taken on 1/29/21 in the morning. Normal vaccine shot soreness for 2 days. 2/6/21 at 7:00 itching and redness at injection site. White spot at injection. Swelling and itching increased throughout the following day. Treated with cold compress and Cortisone ointment. No change. Spoke with my physician on 2/8/21 at 1:00 P.M. She suggested Benedryl (sp?) ointment for the itching and said to contact her if there were any further symptoms. The rash and itching are still with me today 2/9/21. I am hoping that from what little information is available that the rash and itching should start to abate within the next day or 2.

Maculopapular rash, itching, tender on hands and fingers swollen, scattered rash on arms, legs, knees,top and bottom of feet. Injection site large (2 1/2 x 5 in) red swollen. Skin started peeling 2/12/21. Zyrtec 10 mg twice a day, Clobatesol cream.

My arm became very sore, puffed up, very red, hot to the touch and then very itchy. It has gone down a lot but it is now 10 days after and it is still hot to the touch, a little sore and itchy. Should I take the second shot in the same arm? Can I take Tylenol before getting the second shot?

Moderna COVID-19 Vaccine EUA On Jan. 28th my knees and hips began to hurt. I have osteoarthritis in my left knee and right hip as well as a left hip replacement and right knee replacement I thought perhaps the pain I experienced was weather related as I had not experience pain in these joints like this before. I went to bed that night about 9 p.m. and was experiencing more pain in my legs. The pain kept me awake most of the night and I got up about 4:30 a.m. By then I could barely walk. The pain was not only in my joints but felt like it was in my bones as well. My skin on the lower leg felt tight, almost like my legs were swollen, but they did not appear to be. My right leg hurt the worst. I still have a discolored spot on my arm where I had the shot. It is about a 1/2" diameter. It does not hurt.

Swelling after receiving the Moderna Covid-19 vaccine (EUA) Redness in arm, swollen lymph node in left arm where injections was given

Cold sore at bottom of nose. I am 79 and never before had a cold sore. Started approximately 5 days after being vaccinated. Looks like it is starting to dry up but has not gone away yet.

I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days. I had a headache for a few days. I had "covid arm". It was red, sore, it had some swelling, and intense itching. I am still tired. I have diarrhea as well.

Localized itching since day of vaccine. 3 days ago area became red, slightly swollen. Patient seen by PCP, prescribed doxycycline twice daily for 10 days.

9:05 AM on 2/10/21 - Fever of 101.3F with lethargy; emesis x1 followed by Respiratory distress (O2 sat 90% room air, RR 40); HR 115 regular rhythm; decreased breath sounds with rales upper lobes and no breath sounds at base; tranferred via EMS to local hospital ER where received 2L fluids and admitted to care of hospitalist service with primary diagnosis of "adverse effect of COVID-19 vaccination and possible pneumonia." Presenting hypotension improved with fluid bolus and Zosyn IV was started empirically.

She woke up on the morning of 2/14/21, was not feeling real good, but noticed a tightness in her mouth. Her cheeks were swollen, she felt that maybe her tongue was as well. She got the liquid Benadryl and let it stay there and it helps that feeling. She had taken the Zyrtec and Singulair the night before. She did the inhaler puff in the morning, the feeling did not go away. She then took the Ventolin and it seemed to calm down. The symptoms then went away and didn't come back, and thought that she was ok. She felt bad for about a week and a half like she wanted to sleep all the time, but did what she had to do. She is fine now.

Redness, hard swelling, itching -- swelling lasted about 2 days and the redness diminished over about 5 days.

Swelling, redness, oozing, pain of injection arm, general malaise- returned to vaccine site at CVS and had NP examine, steroid prescribed, also made visit to my mother?s internal medicine dr and he examined as well; my mom was told to discontinue steroids and not to get 2nd dose of vaccine.

Started 5 hours after shot severe arm swelling and redness and confusion. Arm pain and mental fog for 3 days and then started to improve. Still 10 days out and feels like extra effort to concentrate and started had busted blood vessels on vaccine arm and back. swelling and tenderness almost resolved.

Feb. 26 - dizzy spell & weakness in legs lasting less than 2 hours Feb. 28 - hot red rash at site of injection, also swelling of upper arm

Moderna COVID-19 Vaccine EUA Swelling on hands, arms and feet---How likely am I to have swelling with the second shot?? Many, many strong heart palpitations fatigue!! Body aches Low stamina Chills Sore arm Occasional headache

I had very little reaction to the first fax on Feb. 11 other than a slight fever and extreme fatigue through the 3rd day. However, on the 9th day after the vax, I got "COVID Arm" which included upper arm swelling, red, itchy and achey at the vax site and another few days of extreme fatigue. Today (18 days after vax) I am no longer fatigued, felt good when I woke up and I am finally getting some energy back. The redness, swelling and itching is subsiding but is not gone totally and there is only a slight discomfort in my arm. Moderna Vaccination #2 is on March 11 and it will be in my other arm. Only took Aleve twice for pain.

Anaphylaxis Patient "went into cardiac arrest", was taken to ER. Physician stated this was a reaction from the vaccine.

ON FEBRUARY 11, I AWOKE WITH A RUNNY NOSE WITH HEADACHE, EYE ACHE, TEOOTHACHE ON RIGHT SIDE OF MOUTH--UPPER AND LOWER. I ALSO FELT A COLD SORE COMING ON. I TOOK SUDAFED PE AND VALCYCLOVIR, WHICH USUALLY SOLVES THE ISSUE. THESE SYSMPTOMS CONTINUED AND I CONTINUED WITH SUDAFED AND VALCYCLOVIR. I SAW MY DENTIST ON FEBRUARY 11 AND WAS TOLD THERE THERE WERE NO ISSUES AND PERHAPS THE PAIN WAS CAUSED BY SINUS ISSUES. I INCREASED THE VALCYCLOVIR TO THREE TABS A DAY RATHER THAN ONE. THE TEETH ISSUE SPREAD TO THE LEFT SIDE OF MY MOUTH AND TWO MORE COLD SORES APPEARED, ANOTHER ON MY UPPER LIP AND ONE AT THE EDGE OF MY LEFT NOSTRIL. I HAD A ZOOM MEETING WITH MY DOCTOR ON MARCH 1. SHE INCREASED THE VALCYCLOVIR TO 1000M. THREE TIMES A DAY. THE COLD SORES HAVE DISAPPEARED, BUT THE OTHER SYMPTOMS CONTINUE, BUT THE PAIN HAS LESSENED SOMEWHAT. I TAKE TYLENOL WHEN THE DISCOMFORT BEGINS TO INTERFERE WITH MY DAILY LIFE.

Systemic: Lymph Node Swelling-Severe, Additional Details: After administration of the first vaccine, the patient reported to their doctors office with severe lymphedema of the left arm. The patient was vaccinated in their right arm.

CLIENT AWOKE 3/2 WITH SORENESS TO THE INJECTION SITE THAT EXTENDED ACROSS HER BACK AND SHOULDERS ACCOMPANIED BY INTERMITTENT NAUSEA. THIS MORNING (3/5) SHE WOKE UP TO THE LEFT HALF OF HER FACE SWOLLEN.

Bad rash all over body. Itching, swelling, redness. Lasting 3 weeks. Then Dr visit. Prescribed Claritin, Prednisone for 1 week.

Swollen arm( 3 inch circle), red, painful, diarrhea, lethargy. Took Tylenol 1000mg prn for pain, Alternated heat & cold to arm for two days, Nothing for diarrhea

Left arm became very hot, red, swollen, in a large area, for a period of apprx. 2 weeks. Redness continued for another week. Itching began during week two. At one month, still had a small pink area and 2nd vaccination had to be done in right arm, at nurse pract. advice.

2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.

At 1415, patient reported tingling and numbness to her lips. No c/o shortness of breath, tongue swelling or itching. At 1416- assessed by Dr., lungs clear, no stridor, slight rash to bridge of nose. At 1421- 0.3mg epinephrine IM administered. BP 130/84, HR 84, and O2 at 97% on room air. At 1431- 25mg IM of Benadryl given and at 1432, 124 mg of Solu-Medrol administered IM. Patient's vital signs continued to be monitored and remained stable over the next hour. At 1525, patient was reassessed by Dr. and was able to be discharged from clinic. 1540 - Patient's son picked her up and took her home with instructions for a competent adult to remain with her for the rest of the evening. Patient had an Epi-pen at home already and was instructed to use and call 911 if additional symptoms. The following day, patient was contacted by clinic Provider .and reported feeling fine and no new symptoms. On the morning of 3/11/21, patient called clinic with onset of facial swelling and shortness of breath. She was advised to go to the ER.

after first vaccineSymptoms were on left side and I awoke to my neck painful, this pain moved from there to upper arm , elbow, lower arm, wrist, leg , and ended in my foot as it traveled from one are to the next the last area improved. it lasted in total about 10 days with no after effects. after second vaccine right side was affected painful neck and swelling and pain in entire arm was very painful and swollen and very difficult to move. this improved slowly from the neck down took about 7 days to go away. I know I had considerable swelling as it was obvious my wrist and hand.

I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOUND UP IN THE HOSPITAL ON FEB 8 WITH BLOOD CLOTS DOWN MY ENTIRE RIGHT LEG AND IN MY LUNGS. I NEED TO KNOW IF THE MODERNA CAUSED THESE OR MADE THEM WORSE. I HAD NO IDEA I HAD BLOOD CLOTS BUT MY FOOT, LEG WERE SWOLLEN AND I ACHED FROM MY HIP DOWN THAT LEG. I ACTUALLY THOUGHT IT WAS SIADACA.

PATIENT REPORTS ITCHING IMMEDIATELY AFTER VACCINATION 3/12/21. SYMPTOMS PROGRESSED INTO SWELLING OF RIGHT UPPER ARM, TENDERNESS, WARMTH, REDNESS. PATIENT PRESENTS TO CLINIC FOR EVALUATION 3/20/21.

Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/2021. Since then her stomach started hurting and pt. is lethargic. Pt. did not open eyes when asked questions and was quite pale. Son reports increased confusion last day or two. Pt. reports that she started feeling ill immediately after receiving the injection. Complains of generalized weakness and fatigue. Denies dizziness or lightheaded. C/o abd. pain. Denies nausea, vomiting, but admits to diarrhea. Denies fevers, cough congestion. She is alert to place and name, but unsure of date at time seen in ER. When seen in ER she was afebrile, but hypoxic and hypotensive. Initial saturations were in mid 80's, but dropped to low 60's. With a non-rebreather mask she maintained at 90%. BP 60's systolic but with fluids increased to 90's . No rectal bleed or hematemeis. Diagnosis of septic shock, anemia, elevated LFT's, pneumonia, and UTI.

Pt received 1st Covid Shot Saturday 10:30am. Felt some abdominal cramping that evening, and when she woke up on Sunday, had abdominal pain, nausea, vomiting, and a small amount of diarrhea. She continued to vomit all day, and became weak/dizzy. Went to ER, where she was found to have Diverticulitis and Dehydration. She was given IV fluids and anti-nausea medicine and hasn't had any further vomiting over Sunday Night. Patient will continue oral antibiotic treatment for Diverticulitis at home.

swelling of left arm and shoulder from shoulder to below elbow, extreme itching and rash, fatigue, headache, loss of appetite, low-grade fever. This has continued for two weeks.

Swelling from injection site to 2 inches above elbow, very itchy. Swelling/hot skin around entire upper arm. By third day, swelling had migrated past elbow to upper forearm, still itchy.

The patient started to feel swelling, redness on the interior of upper right leg.It was a swollen vein. She went to the physician on 2-15-2021. She was diagnosed with having a blood clot and had to have it removed. She is wearing compression stockings now 24/7.

3/21/2021 Husband , reported that wife attended the Covid clinic 2/13/2021 and received #1 covid vaccine about 11:30 AM Soon after she complained of Discomfort at site on right arm with area from shoulder to elbow swollen extremely tight, red, and had rash by evening. Generalized side effects of nausea and weakness with the inability to ambulate unassisted. She did have Covid #2 3/13/2021 with somewhat similar response but not as severe.

The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went downstairs on my seat (bottom) so I could go down. I then stayed on the couch and called for help. My tongue swelled up and filled my mouth. My neck glands were swelling and my hands itched and they were red (no welts) like crazy. I took Benadryl and it eased up and I went back to bed. The next morning that was gone. I have had another allergic reaction since then and this time I thought I was getting shingles - my throat got very very red, ears itched and my hands itched and I had ropey welts where my bra sat. My whole stomach area was very itchy. I called the doctor (after hours phone call - on the 31st) - and she assured me that I wasn't getting shingles as I already have had them twice. I took Benadryl and then the doctor prescribed a non-drowsy antihistamine - Claritin - and I am taking that every day. I am not someone that has allergic stuff occur. These took it down and I haven't had it again.

pt reports swelling in right leg, went away after 3-5 days; mentioned to physician at next scheduled office visit, and symptoms had resolved

Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.

3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.

Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad

Starting early February about 2 weeks after vaccine administration pt began having intermittent headaches and jaw pain, which progressed to rapid and complete painless vision loss 4/20/21 to right eye. Seen same day in ophthalmology clinic, diagnosed with optic nerve ischemia, likely GCA, Rx'd 80mg PO prednisone, lab evaluation started which revealed elevated CRP. This, in combination new new grey 'veil' over vision of L eye the next day 4/21/21, led to admission and initiation of 1,000mg daily IV methylprednisolone. Unfortunately pt then progressed to complete painless loss of vision of left eye as well on 4/23/21 while inpatient on high dose steroids. Patient is now completely blind in both eyes.

Evening of day of vaccination, arm redness, swelling, warm, itchy No treatment Lasted approximately 10 days

patient felt chest pressure, heart raising, intense heat from toe to head in waves, dizziness (walking on clouds), red and swollen hands

STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO ON HEART. PRESENTLY AM GOING THUR EXPECTED EFFECTS OF BACK TO SLEEP 14/16 HRS DAILY, SWOLLEN LYMPHS UNDER LEFT ARM ONLY, BACK HEAD PAIN WHEN RESTING, PAIN, PALMS HANDS, SAME PAIN, LEFT AREA ABOVE EAR, INTERMITTENT HEADPAIN DIFFERENT AREAS OF SKULL...

Patient called and complained of swallowen arm, redness and hard as a rock. She said swelling is spreading and she feels warm inside her skin.

Stuffed nose, scratchy throat, pressure in head and sinus area. Burning swollen mouth and nose. Teeth feel gritty.

Severe arthritis flare, severe soft tissue pain whole body, unable to get out of bed or chair by myself lasting 3 weeks untill able to get on Prednisone

Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.

ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD

Second dose not given; it was like if periaureal area felt some numbness; there was no visual swelling just the feeling of swelling and numbness; Flushed; Sweaty; possible allergic reaction; Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine; the top of her lip was numb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to vaccine (Allergy to Hepatitis B vaccine.), Psoriasis, Chest pain and Sinus disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (the top of her lip was numb). On 04-Feb-2021, the patient experienced ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness), VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty) and HYPERSENSITIVITY (possible allergic reaction). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not given). On 04-Feb-2021, HYPOAESTHESIA ORAL (it was like if periaureal area felt some numbness) and VACCINATION COMPLICATION (there was no visual swelling just the feeling of swelling and numbness) had resolved. At the time of the report, ANGIOEDEMA (Allergic reaction with angioedema secondary to IM drug and Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Second dose not given) outcome was unknown and FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), HYPERSENSITIVITY (possible allergic reaction) and HYPOAESTHESIA ORAL (the top of her lip was numb) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 198/80 193/80 at 14:38 144/66 at 15:58. On 04-Feb-2021, Body temperature: 97.4 97.4 at 14:48 97.6 at 15:58. On 04-Feb-2021, Heart rate: 77 77 at 14:38 71 at 15:58. On 04-Feb-2021, Mean arterial pressure: 117 117 at 14:38 92 at 15:58. On 04-Feb-2021, Oxygen saturation: 98 percent 98 percent at 14:38 99 percent at 15:58. On 04-Feb-2021, Pain assessment: 4 pain level 4/10. On 04-Feb-2021, Respiratory rate: 18 18 at 14:38 20 at 15:58. 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. Follow up received on 13-May-2021 was significant and included the completed VAERS form. The new events of missed second dose of covid-19 vaccine, angioedema, allergic reaction, flushing, sweaty, numbness top lip were added and medical history was updated. On 04-Feb-2021, it was reported that the patient developed perioral swelling and numbness that came on approximately fifteen minutes after receiving her first covid-19 vaccine. The patient was taken to the emergency department, and was kept under observation for two hours with no worsening of her condition. Treatment medication included 50 milligram of Benadryl (diphenhydramine). The patient was given a prescription for diphenhydramine and asked to follow-up with her primary care physician/ emergency department if symptoms worsened. Company comment This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. 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. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received included the completed VAER form and medical records from the emergency department. Additional information included medical history, patient demographics, age of patient, patient contact details, concomitant medication, new events with outcome of events, missed second dose.; Sender's Comments: This case concerns a 79-year-old female with a serious unexpected event of angioedema and nonserious hypersensitivity, hypoaesthesia oral, flushing, hyperhidrosis, vaccination complication, and product dose omission issue. Latency within 1 day after mRNA-1273 dose. 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.

Left side of her face seemed frozen; Gland and cheeks were swollen; Super tired; Carotid artery was hurting; Sinus was hurting; Could taste the medicine; Little lump on her neck by her ear; Bacterial infection at the injection site; Black scab and a lot of pus at the injection site; Black scab and a lot of pus at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of her face seemed frozen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left shoulder). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, LORATADINE (CLARITIN [LORATADINE]) and COLLAGEN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear) and FATIGUE (Super tired). On 06-Apr-2021, the patient experienced FACIAL PARALYSIS (Left side of her face seemed frozen) (seriousness criterion medically significant) and LYMPHADENOPATHY (Gland and cheeks were swollen). In April 2021, the patient experienced INJECTION SITE INFECTION (Bacterial infection at the injection site), INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site). On 29-Apr-2021, INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site) had resolved. At the time of the report, FACIAL PARALYSIS (Left side of her face seemed frozen), NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear), INJECTION SITE INFECTION (Bacterial infection at the injection site) and FATIGUE (Super tired) outcome was unknown and LYMPHADENOPATHY (Gland and cheeks were swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant medication included: high blood pressure medicine (unspecified), "calfix 10 mg, and "a whole lot of holistic medicine for arthritis." The patient's 2nd dose of the Moderna COVID--19 vaccine was supposed to be on 07-May-2021 but the pharmacy denied her the second dose due to their reaction she had to the first dose given in her left non-dominant arm. The doctor advised that the patient had a bacterial infection at the injection site. The patient was still swollen as of 07-May-2021 and was unsure when all the symptoms began and resolved. The vaccine provider advised the patient that she would be unable to get the second dose unless she went to the hospital. 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 MOD21-091284, US-MODERNATX, INC.-MOD-2021-138847 (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. MOD21-091284:crosslinked US-MODERNATX, INC.-MOD-2021-138847:Daughter's case

Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-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 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. 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, multiple underlying co-morbidities may re; 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, multiple underlying co-morbidities may remain as confounding factors.

5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.

Patient developed malaise and a red swollen face on 3-2-21 after her second vaccination on 2-25-21. She was afebrile, and her doctor instructed her to take OTC Benadryl, which seemed to help. On 3-8-21, her symptoms returned with a persistent headache. Her facial problems came and went over the following month and were accompanied by malaise. On 5-4-21, patient went to the nurse practitioner at her primary care physician's office and was prescribed 40mg of Prednisone for 5 days. Symptoms returned and worsened 4 days later and she was referred to a dermatologist, who prescribed a longer "step-down" course of Prednisone over a 16 day period, which ended a few days ago, patient reports being asymptomatic at this time.

Severe swelling in limbs that severely limits my range of motion even causing me to walk with a walker, developed love handles on my sides

Severe diarrhea and destruction of part of her intestine and subsequent sepsis. ER doctors "could not rule out the vaccine as a contributing factor." It was suggested she have a portion of her intestines removed. She refused and went on a high dose of antibiotics. She was hospitalized in the ICU and eventually released to a nursing home when stabilized. She never regained control of her bowels or had a solid bowel movement. Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis. She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed. She elected to go home on hospice, where she died. Her kidney doctor also relayed to her family that this reaction was a direct result of the vaccine. When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report.

After April 7th shot, the arm was so for a few weeks. Received the second shot on May 5th. The pain lasted a long time - 3 or 4 weeks. Reports starting to lose her appetite and she was losing weight during the middle of June. This continued on. The weekend of July 4th, she reports knowing something was wrong. On July 8th, she reports not being able to sleep and her right arm started to bother her a great deal. On July 9th, July 10th and July 11th, the pain in the right arm was unbearable according to individual. There is also swelling in the arm. On July 12th, she went to the Walk-in center. Doctor felt lymph nodes under the right arm that were swollen. Individual had an ultrasound which showed swollen lymph nodes and fluid in that area. She was given a prescription for Keflex and Naprosyn.

I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the night three days after the vaccine. My lips were swelling up and I had a tickling feeling at the back of my throat. My lips were getting bigger and bigger. I went to the ER and I was given prednisone and Benadryl. My symptoms subsided a little but when the prednisone wore off, I started to have lingering symptoms. The symptoms returned and I had another course of prednisone. I still have permanent swelling in my hands five months later which started about two weeks after the vaccine. My fingers are puffy and swollen in both hands. My index fingers are the worst. I have white knuckles.

septic; did not know who she was or where she was; missed second dose; acting like she had a stroke; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (septic) and DISORIENTATION (did not know who she was or where she was) in a 79-year-old female 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 was provided by the reporter. Concomitant products included LEVOTHYROXINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), PREDNISONE and VITAMINS NOS for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DISORIENTATION (did not know who she was or where she was) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (feeling ill). On 25-Jan-2021, the patient experienced ABNORMAL BEHAVIOUR (acting like she had a stroke). On an unknown date, the patient experienced SEPSIS (septic) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was hospitalized on 25-Jan-2021 due to DISORIENTATION and SEPSIS. At the time of the report, SEPSIS (septic), DISORIENTATION (did not know who she was or where she was), PRODUCT DOSE OMISSION ISSUE (missed second dose), VACCINATION COMPLICATION (feeling ill) and ABNORMAL BEHAVIOUR (acting like she had a stroke) outcome was unknown. 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. 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. 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.

Patient presented to the ED and was subsequently hospitalized for fever and sepsis within 6 weeks of receiving COVID vaccination.

1st day (10:30 am):- left arm sore/painful, overnight : freezing, burning sensation and extreme fatigue. 2nd day(01/15/21):- left arm still sore not painful but fatigue continued 3rd day(1/16/21):- 10:30 am, Temple left vein burst at the fore head from middle to left eye, covered with red dots bleeding from left temple eye until 6:00 pm throbbing pain all day and night. 4th day (01/17/21):- Swollen left side of face, internal bleeding around the left eye, slight throbbing pain, extreme fatigue. 5th day (01/08/21):- Swelling/bruises and internal bleeding visible. Less fatigue, able to go to pharmacy to report. *Report as presented by the Patient.

Patient reported to the emergency room from fever and shortness of breath the day after receiving the COVID-19 vaccine. Patient was found to have a UTI and possible sepsis. Unknown if truly related to COVID vaccine.

Patient complained of swelling and felling hot. ECG done; Afib Benadryl 25 mg po given at 1530. BP 132/80 O2 sat 96% RR 15 HR 84 - 110 irregular Pt released home.

Swelling of lips and face; and rawness inside of mouth after approximately 3 days. lasted approx 3 days with swelling gone completely after 7 days. Rawness and blisters in mouth are still active.

Initially started as itching at the injection site. A couple of days later swelling, redness appeared.

swelling from elbow to chest and upper shoulder. hurts to touch it. skin hurts all over. Sore neck. feels like she is drunk. thursday and friday had staggering. Took conafec for pain in arm. poor appetite, not wanting to cook

No adverse effects day of injection other than mild soreness at injection site for a day or two. Nine days later my arm was swollen, itchy with center being hot, raised and red. I had no fever and no other noticeable symptoms. The next day it had spread over the upper arm and I went to emergency room. ER Dr. said she thought it was cellulitis and prescribed an antibiotic. She advised me to see my primary care provider after the weekend. I went to my primary care provider and the Dr. and the N.P. agreed it was not cellulitis, but an allergic reaction due to it's appearance . In checking CDC site the Dr. found photos of vaccine reactions which looked identical to my arm. I went off antibiotics and took ibuprofhan and it slowly has returned to almost normal within 10 days.

12 days after vaccine, red, hot swollen area on arm where shot administered. Area continues to spread downward towards elbow area. Started out about size of 50 cent piece, now @ 6 inches long and@ 3 inches wide

PER PATIENT, FULL BODY RASH ONSET 8 DAYS AFTER VACCINATION STARTING 1/28/21. INTENSIFIED TO AXILLARY SWELLING/DISCOMFORT ~3 DAYS LATER 1/31/21 AS WELL AS CHILLS AND LOW GRADE FEVER. AS OF 2/4/21, PATIENT INDICATES MAJORITY OF SYMPTOMS HAVE RESOLVED. PATIENT INSTRUCTED BY PCP TO AVOID DOSE 2 OF MODERNA AND SEEK AN ALTERNATIVE, NON MRNA FORMULATION OF VACCINE WHEN MADE AVAILABLE. MANAGED SYMPTOMS WITH METHYLPREDNISOLONE DOSE PACK, BENADRYL Q4H PRN SYMPTOMS, AND TOPICAL HYDROCORTISONE.

began day 7 after injection with itching on back on scapula under bra on one side; day 8 itched on back under bra both sides;day 9 woke at 1:00 am with SEVERE itching and inflammation over both shoulders and upper back and took 2 Benedryl . At 8:50 called GP for help who prescribed 1 Zyrtec twice a day + 2 Benedryl per 4 hours + Cortisone 10 mg cream 3 times/day. At 4:40pm such intense itching and pain doctor prescribed Methylprednisolone pack which I started at 6pm. Rash progressed Jan 31, Feb 1,2,3 to cover whole body. Worst in armpits with swelling. Slept with numerous cold gel packs. Inflammation began subsiding day 6, taking just Zyrtec + cream today day 7.

My arm was sore the next morning, and it still sore as of today. My arm is red, puffy and hot now, I noticed it this morning. The evening after receiving the vaccine I felt really cold all over my body and went to bed.

Received the injection on Wednesday, January 27 and by Friday morning, Jan. 29 the area was itching slightly below the injection site. The itching has continued to get worse . Now there is an area approximately 3 inches in diameter that itches, is red, slightly swollen, hurts and the skin feels slightly bumpy.

Goose-sized egg bump, very red with rash, hot to the touch. Used cold water and hydrocortisone then by the evening time swelling reduced. Next day 2-5-2021 bump was gone but still red and itchy.

Client felt tired on Friday after vaccine, on Saturday (2/6) clients arm was red and swollen, and she had some shortness of breath. Daughter said these symptoms progressively got worse. On 2/8 client went to MD who told her it was an allergic reaction and that she should report it to her local Health department.

Patient received vaccine on 2/13/21 at 2:30pm. went home called after 2 hours around 4:30pm stating that her face turned red& puffy, lips swollen & throat feel funny. Instructed patient to go ER right away. Doctor at the ER diagnosed the patient & mentioned that she had an allergic reaction to the vaccine & put her on prednisone Taper dose. Patient mentioned that she is home & doing fine now, on prednisone taper schedule.

red sore lump initially . Followed by red itchy patch approx 3x4 inches, Took Benydril. Currently, 2 weeks in, red patch has moved forward on the arm and rash has appeared on chest with dappled red spots on arms and thighs. Also my face is swollen .

The injection on the first dose was totally painless. Thus, it was a shock when the injection stung so much at the time it was administered. The pain in my arm continued throughout the 12th and 13th necessitating being on pain relievers. By the evening of the 13th , a 3" red swollen area became apparent . The pain continued which was annoying but did not limit my activities . I remain puzzled as to why I responded as I did when I hadn't before; it almost appears I have a cystitis issue now.

Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but nothing like the initial one. Started to get dizzy and felt weird on the ride home from the vaccine. The headache lasted a fairly long time and got tired by the evening and the next morning. The headache has still continued a little off and on until now, 2/17/21. The dizziness has gone away, the feeling "out of it" feeling has gone away, does not feel well about the concentration. The tiredness and fatigue started the day after the vaccine and has gotten worse, has to drag herself through the day and by 1:00 PM is done through the day due to the fatigue. Some days can go to 4:00 but most days only lasts until 1:00. She gets up at 7:30 and today at 10:37 has the feeling of tiredness. The gland under her arm a couple of weeks ago was swollen, which is still sensitive but not as bad as it was. The fatigue is the main thing that continues to bother her. She has not taken anything for these reactions. She has seen her doctor, and is supposed to get some blood tests today, 2/17/21.

PATIENT'S ARM BECAME RED AND SWOLLEN AND HARD TO TOUCH 4 INCHES TOP TO BOTTOM. Patient took motrin to alleviate swelling and redness.

BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FOR 5 DAYS

Redness, swelling and itching that came on 9 days after she was given the shot. We read on her information sheet that we needed to contact someone if this happened after 24 hours so she is concerned.

Angioedema, onset began 8 hrs after vaccination. Did not have adequate response to steroids & antihistamines; required nasotracheal intubation, now with our team in the ICU. Unclear if secondary to vaccine or other cause.

had shot 2/11, on 2/18, left arm was red, swollen,extreme sting, also, chills,no fever, felt tired. took tylenol. 2/19, was better, less tired no chills. arm was still same, took benadryl.arm did not settle down until 2/21. on 2/24 stinging rash appeared across upper chest, small areas on both arms, took benadryl, symptoms went away. 2/25, small area had rash, more benadryl.

Pt reports painful left arm right after her vaccine was administered. Nine days later, patient noticed arm was swollen and red and remained very painful. Called clinic 3 days later as there was no improvement. Pt was prescribed doxycycline 100 mg twice daily for 10 days

I woke up next morning with a Herpes outbreak. I usually have a warning in advance. The site (on my lower backside) tingles and warns me of what is coming. This was different. No warning. Two bumps (or lumps) were there where they always appear. I haven't had an outbreak for at least 6 months. My feeling is that is came on from the vaccine, though I have no proof other than it came after the shot. It may have come on earlier than 7 a.m., but I wasn't aware of it until I woke up. I usually take valacyclovir 500 mg when it starts but I am going to wait a few days as I don't want it to interfere with the vaccine. However I will check with my doctor to get his advice.

First dose was in the right arm and it it became inflamed about a week after the shot. Itchy, hot, inflamed, and pink. I visited the doctor advised warm compresses and the problem subsided in a few days. After the second dose I woke up in the middle of the night with the chills and chattering teeth. It was uncontrollable shaking. My temperature of 102 degrees in the morning. I had shooting pains in my arms and legs. Felt terrible all day. Took Tylenol no effect. Advil worked better. The lymph nodes were sore under my arm. On the third day I felt a little better but on the fourth day I felt a little better.

02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night, same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care

The vaccine was given in lymphedema arm, they decided to give the shot in that arm because of the swelling, redness and pain still there in the opposite arm from 1st dose. Because the 2nd dose was given in my left lymphedema arm, it caused a flare up of lymphedema and I'm still working with it to bring it back down to where it was before the shot was given. I feel that those giving the injection should be made aware of pre existing conditions like lymphedema arms, there should be an alternative to give the vaccine in other arms.

Pt developed a rash on both arms and torso 9 days after the shot, she noted that her arm pain from the injection just recently went away (lasted about 2 weeks if she "pushed on the site of injection") she also noted that she had leg swelling before the injection but noticed it was worse after the injection when the rash started she is unsure if they are related. The patient self treated with benadryl and is currently doing well.

One week after receiving the vaccine, started itching at the vaccination site and developed a red rash. Still has swollen rash two days later, with soreness when presses on the rash, and the rash area is hot to the touch.

the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell, 2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today

By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morning to go to the restroom and my dog needed to go out. I felt light headed as soon as she was back in the house. I felt things going dark and I passed out in the hallway. I don't know how long I was out but when I came to, I felt like I couldn't move. I laid there for a while and finally crawled back to my bed. I was able to get back in bed. By then it was 3:00am. The next night I woke in the night and had an irregular heartbeat. I could not get back to sleep until it finally went away. For several days after the vaccination, I had very little energy.

Following vaccine slight discomfort but nothing more than regular flu shot. Ten days after, I woke up to swelling redness and hives covering my upper left arm to the elbow. Waited 24 hours to see if it would disappear and when it didn't, I then went to the doctors office. I was seen by the nurse/practitioner who gave me a steroid shot and advised me not to continue with the vaccine program. Everything healed up in a couple of days and I continued with the vaccine program , receiving my second dose on January 28th. with no reaction.

Severe grade 3 Headache, high fever, chills, grade 3lymphadenopathy, pain and swelling, high fever (grade 3) persisting several days, fatigue, lethargy, myalgia, arthralgia, grade 3 chills.

Heavy legs, numbness in arms, reported swelling of face, tingling of tongue. Hypertensive. Hx of anxiety, HTN on Zanax. Only took 1/2 dose this morning. Patient taken to emergency room.

Client states her eyes swelled shut, her hands became swollen and she had noisy breathing(maybe wheezing) all started 2 days after vaccine and the symptoms didn't resolve until 8 days after they started. She did not obtain medical care. She doesn't speak English and didn't know she should've gone to the ER. Plans to now schedule to see her doctor to find out if she should get a different covid vaccine as she had a reaction to Moderna.

Swelling of lips and face. Started where I had rubbed Aquaphor Healing Ointment on the nose the night of the Vaccine shot. Some of the ointment got on the right lip and face during the night. Next morning swelling of right upper lip and right ride of face. During the day left side of face swelled up. Trip to ER for IV of Benadryl, Pepcid, and Steroid.

Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep by chest pain. (3/13/2021) pericarditis, atrial fibrillation, and CHF

PT WAS VACCINATED WITH SECOND MODERNA DOSE ON 02/16/2021 . DR CALLED ME TO INFORM OF PT ADVERSE EVENT. PT PRESENTED TO DR WITH SWELLING IN LEFT LOWER LEG. DR ORDERED VENUS DOPLAR SHOWING A LARGE BLOOD CLOT FROM PT'S GROIN TO HER CALF MUSCLE. DUE TO NO PREVIOUS HX OF CLOTTING OR BLOOD DISORDERS NOR FAMILY HX AND PROXIMITY TO VACCINATION, DR BELIEVES VACCINE CAUSED THE CLOT. DR PLACED PATIENT ON ELIQUIS. DR WISHES TO BE CONTACTED IF FURTHER DETAIL IS NEEDED.

03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea on exertion. The patient was admitted for a congestive heart failure exacerbation for IV diuretics. Patient currently still admitted and now having lower GI bleeding on a heparin infusion.

Patient experience severe arm, hand pain/ swelling 2 days after the vaccine in the same side as injection. Redness/Swelling/pain continues 3 weeks after the vaccine.

She completed 2nd COVID vaccine and reported left arm swelling and redness, occurred one day after administration and lasted one week.

PATIENT HAD ANAPHYLAXIS. IT PRESENTED AS A LIGHT COUGH THAT GOT WORSE AND BEGAN PROGRESSING TO SHORTNESS OF BREATH . THIS HAPPENED APPROXIMATELY 15 MINUTES AFTER SHE RECEIVED THE VACCINE. I ADMINISTERED AN EPIPEN THAT IMPROVED SYMPTOMS FOR ABOUT 5 MINUTES. THE EMT'S ARRIVED AT THAT TIME AND TOOK OVER CARE.

pt states that 1 day after vaccine, she couldn't move her legs and couldn't get out of bed. swelling in legs, mostly right side. doctor gave her diuretics, and natural medicines. she is taking advil. she got some sort of electric shock? treatment. she is walking and talking to me today

2.2.21 - 2nd COVID inj. 2:50pm 2.3.21 - Fever - 101.0 deg Fever 5:00pm - arm swelling, some redness 2.4.21 - Fever - 102.2 deg Fever 8:30am 2.5.21 - Fever - 99.9 deg. off and on all day - arm swelling, more redness 2.6.21 - Fever - 99.2 deg - redness around inj site growing - itching 2.7.21 - temp - 97.9 deg - ER visit - prescribed Benadryl & steriod cream 2.12.21 - visited,- prescribed XCyzal & cream (redness now 7-1/2" dia.) 2.19.21 - itching mostly gone. 3.16.21 - Breast cancer oncologist visit - found enlarged lymph nodes, revisit 4.16.21 for added testing due to recent Covid shot.

allergic reaction on left arm increasing in size daily. Red, itchy, swollen, feverish, slightly painful. The redness is beginning to cover the entire arm. Benadryl and Ibuprofen are not relieving the symptoms. Symptoms occured on day 2 and are continuing adversely.to day 6 with no relief

I develop a red erythema rash, hot to the touch that developed in to large blister on my arm. The use of arm was compromised and the blister grew bigger and bigger. When to Urgent Care and the Emergency Room and blister was drained. The pain and swelling last for several days. Give IV Motrin in ER. Blisters continued to form for 4 more days and required medical attention. After a week, the skin was dead and black. The skin fell off and the derma and subcutaneous tissue was exposed. (Area looked like a burn).

She got her vaccine, and started with her arm hurting that evening. The next morning it was itching, and then blotchy. She then started scratching her arms, shoulders, back, chest, and there were little clusters of measles like areas. She scratched on her wrist that had fluid in it. She had them in both of her eyes, and has been horrid, and they jump all over and now she has clusters of scabs that are itching as well. She went to the doctor and they gave her steroids which did not help much, but was given Benadryl also which has helped some. She also saw her cardiologist who told her she could take up to 4 Benadryl a day. She was fine last night, and this morning she had the itching and scratching again in the same areas as before. No fevers and no other reactions other than the itching rash. She also had swelling of the palms of her hands and itching, which is the reaction she gets when she gets anaphylaxis. She said that they are all over her back, all over her chest. She said that yesterday it seemed to be calming down. She was told not to get her vaccine on the 20th, but to wait until things settled down a bit.

She got the vaccine on the left arm, it was okay, and acted like the 1st vaccine, and about 7-8 days later she noticed a lump on her neck near her collar bone. It feels like a round ball, not real big around the size of a dine, it is still there on 4/16/21, but not as big as it was. She did not have any other symptoms. On Monday she had a knot on her right leg which is still present. She does notice that her left wrist swells up which has been present since the knot appeared on her neck. She did call her doctor and she went to see him and he ordered X-rays and was sent to a throat doctor who said he did not see anything wrong, but no other treatment. She has not run any fever, and has not taken anything for the symptoms.

my breathing started to get heavy, felt it hard to breathe; I started to develop large hives just above the collar bone; pain in the lymph nodes under her left arm; started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and; little pain at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) and ANGIOEDEMA (I started to develop large hives just above the collar bone) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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). Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE (FLOVENT HFA). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (little pain at the injection site). On 05-Apr-2021, the patient experienced DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe) (seriousness criterion medically significant), ANGIOEDEMA (I started to develop large hives just above the collar bone) (seriousness criterion medically significant), VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and). On 05-Apr-2021, VACCINATION SITE PAIN (little pain at the injection site) had resolved. At the time of the report, DYSPNOEA AT REST (my breathing started to get heavy, felt it hard to breathe), ANGIOEDEMA (I started to develop large hives just above the collar bone) and VACCINATION SITE LYMPHADENOPATHY (pain in the lymph nodes under her left arm) outcome was unknown and RASH PRURITIC (started to develop a red, itchy rash on left shoulder which spread 3/4 way down her left arm and) had not resolved. 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. No treatment information was provided. Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

PATIENT REPORTED HAVING A "SWOLLEN" FOOT THAT LASTED FROM 9 TO 13 DAYS, AFTER RECEIVING THE FIRST COVID MODERNA SHOT. SHE HAD A DOCTOR VISIT BUT THERE WERE NO INTERVENTIONS INITIATED BY HER DOCTOR. THE SWELLING RESOLVED ON ITS OWN.

PATIENT REPORTED RIGHT FOOT SWOLLEN FOR ABOUT 4 TO 5 DAYS. LEFT FOOT HAD "MINOR" SWELLING. THIS WAS AFTER THE SECOND COVID MODERNA SHOT. SHE ALSO HAD SWOLLEN LEG AFTER THE FIRST SHOT WHICH RESOLVED ON ITS OWN BUT PERSISTED FOR ALMOST 13 DAYS.

Tightness in neck muscles. Then lips swelled. Then inside of nostrils swelled. All fairly slightly. Was all over by 3:15pm same day

Pt noticed 3 days later that there was a giant swollen welt spanning the entire upper arm area almost down to the elbow. It was blue and purple in color and lasted more than 10 days. It was very painful and pain was constant the entire >10 day period. She did not take any pain medication for it. Did not start getting better until after at least 10 days, and even then it took a long time to go away. She mentioned a similar thing happens with her pneumonia vaccine, only that was a much bigger much more painful welt. However flu vaccine does not do that so it is not exclusively an injection site reaction. So it is unique just to pneumonia shot and covid shot. Pt stayed 30 minutes after 2nd dose. Arms looked fine when she left.

3-4 hr onset fatigue. for 3 days confined to bed from fatigue. Has slowly remitted. - Now - 8 weeks after second shot still daily fatigue, pedal edema with activity. Nap required daily. Occasional episodes of sleep disruption. 2-4 days severe arthritis flare with rheumatoid joints swelling as well as mild swelling in OA joints: fingers, wrists, elbows, neck, back, hips, knees and ankles. deformity of dips, not previously present. Now, 8 weeks later, swelling resolved but arthritis still worse than prior to 2nd immunization. Severe bruising in R upper arm. 8 weeks later still have brown discoloration over6 inch area - INR increased to 5.4 3-4 hour mild headache lasted 2 days reoccurred 2 or 3 times over the week

80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021

March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.

One week after receiving the 2nd Moderna Covid-19 vaccine she had swelling and numbness on the right side of her face - mouth, lips & cheek. She had pain in her right cheekbone. The right side of her face drooped down. She went to her doctor. They told her to go to the dentist to be evaluated. The dentist didn't find anything abnormal and by then the symptoms had subsided. The swelling and pain subsided after a couple days.

atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face was flushed; led to intense red marks; Scratching would make blood vessels burst underneath; swollen armpits; Chills; big rash all over body; low grade fever of 99.1F; Itching on left scapula; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Drug allergy (Augmentin and Demerol). Concurrent medical conditions included Allergy (banana and plantain). Concomitant products included AMLODIPINE, EZETIMIBE (ZETIA), ATORVASTATIN CALCIUM (LIPITOR), NEBIVOLOL HYDROCHLORIDE (BISTOLIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN 2000), CENTRUM SILVER +50 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching on left scapula). On 31-Jan-2021, the patient experienced PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F). On 13-Feb-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized on 13-Feb-2021 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), PRURITUS (Itching on left scapula), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Diphenhydramine, Cetirizine, OTC Cortisone cream, Methylprednisolone. Company Comment - 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. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.; 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.

admitted to hospital 3/20 for weakness and increased WBC to 70K, started on hydrea due to concern for progression of CMML

pt became very sleepy immediately after taking the vax. She got home and was so fatigued and in so much pain she went to bed and slept for almost 2 days. She says she has severe body aches and pains and is having major problems with both hands going numb, tingling, and hurting. On 4/20/21 she went to her PCP, Dr. and she was told to take Ibuprofen for her pain. On 5/6/21 she went to Dr. He did blood work. No Arthritis or other problems were found. CRP was elevated at 14. She has been to her Chiropractor on 2 different occasions to help with pain. She has had this pain going on 2 months and will see her PCP again at the end of the May.

Headache, nose bleed, body aches, swollen feet, anxiety, palpitations, very very tired, feeling of desperation , crying episodes, sob

Patient was referred to emergency department by primary care physician for concerns of sepsis. Patient UA outpatient that showed a urinary tract infection and was experiencing hypotension. During screening for admission, was found to be COVID-19 positive. Patient was asymptomatic for COVID-19 infection at presentation and was only recieving supportive care. She does not require antiviral, steroid, or supplemental oxygen at time of writing. Patient is currently admitted at time of writing.

Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24) noted to feel lethargic, dizzy, and had elevated temperature. She sought medical attention and in the ER was found to have temperature of 104°F, tachycardia, and elevated lactic acid. The patient has had no headache, change in vision, photophobia, neck stiffness, abdominal pain, cough. There is no report of sick contacts the patient resides with daughter-in-law and son. She received Rocephin empirically in the emergency room along with 30 mL/kg IV fluid bolus.

A few hours after vaccine, right arm started to get red and swell. Patient had chills, fever, headache. Feeling unwell. Two to three days later she felt like she had Covid-19 again. Right Arm continued to swell from shoulder to elbow for 3 weeks. The arm was hot to the touch. Fever, headache, chills, diarrhea for 3 days. Had Covid-19 feeling all over again. Poor taste and sense of dread. Did not seek medical treatment for swelling in arm or symptoms.

Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis

Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.

Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, now. Swelling on right side= arm, legs, breast pain still continues, also.. no treatment other than aspirin and or Tylenol initially.. swollen right side has still persisted as well as painful breast nipple area.

supraclavicular lymphadenopathy; Swelling on thyroid gland; Nodules on right side of thyroid; benigh lesions on the left side of the thyroid.; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (supraclavicular lymphadenopathy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid hormones increased. Concomitant products included ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (MULTIVITAMIN[ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), CALCIUM CARBONATE, COLECALCIFEROL, PHYTOMENADIONE (CALCIUM PLUS VITAMIN D & K) and VITAMIN D NOS for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced LYMPHADENOPATHY (supraclavicular lymphadenopathy) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.). The patient was hospitalized on 03-Mar-2021 due to LYMPHADENOPATHY. On 03-Mar-2021, LYMPHADENOPATHY (supraclavicular lymphadenopathy) had resolved. At the time of the report, GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LYMPHADENOPATHY (supraclavicular lymphadenopathy) to be possibly related. No further causality assessments were provided for GOITRE (Swelling on thyroid gland), THYROID MASS (Nodules on right side of thyroid) and BENIGN NEOPLASM OF THYROID GLAND (benigh lesions on the left side of the thyroid.). Treatment information was not reported Patient was told to wait 6-8 weeks to repeat the thyroid tests and six months to have the sonogram repeated to look for changes. 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 14-Jul-2021: Significant Follow-up information received on 14-JUL-2021: Updated event outcome for lymphadenopathy, Pregnancy info as no .; 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 following second vaccination I woke in night with hands swollen and painful trying to use them even to pull up sheets in bed. Pain not changed by Tylenol. Ordered Paraffin and used baths on hands with only temporary relief. Symptoms seemed to constantly change over following days and weeks. Individual joints in hands would be inflamed and tender to touch. This varied from day to day as to which joint was inflamed. Shooting pains in lower arms and hands in April and May,. Sometimes extended to all joints. Pain when interlacing fingers. Pains shooting through fingers when just sitting. Sensations of pin pricks or bugs crawling on my skin when nothing touching me.

Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm. Nausea but it passed; feels weak and slept 6 extra hours today. Joint pain in shoulders and legs. No fever.

Approx. 1/10/21 --R arm, red little knot itching few days after then resolved. 1/19/21 R arm, large red very itchy area, deeper red area in injection site, very warm touch.

Red oblong circled area at base of deltoid muscle area. area is red, warm and slightly swollen. non tender. slightly larger today than yesterday. area size is 9cm x 6.5 cm Treated with ICE pack TID and elevation of left arm. Will continue to monitor

Left base of deltoid oblong circle 9cmX 6.5cm area of redness, sl swelling, warm. no tenderness at this time. Onset 1/21/2021. Today 1/22/21 slightly larger than yesterday - still denies pain. Treated with ice pack TID and elevation of left arm. Will continue to monitor

WINDBURN TYPE OF RASH ON FACE THAT WAS MOVING DOWN TO UPPER NECK, FACE SWELLING WITH SKIN FEELING REAL TIGHT THAT STARTED ON 01/22/2021. ITCHING THAT STARTED ON.NEXT DAY WITH REDNESS INCREASING ON 01/23/2021. WENT TO URGENT CARE ON 01/24/2021 THINKING i HAD POISEN OAK/IVY/SUMAC UNTIL I READ SIDE EFFECTS ON INFO PROVIDED AFTER COVID-19 SHOT ON 01/21/2021. PA PROVIDED PERSCRIPTIONS METHYLPREDNISOLONE 4MG DOSEPK AND TRIAMCINOLONE 0.5% OINTMENT. OINTMENT DID NOT HELP ITCHING SO CHANGED TO CORTISONE 1% 2X A DAY. 01/25/2012 STATUS - RASH AND ITCHING GETTING BETTER BUT NOT GONE. SWELLING SEEMS TO BE GONE.

Pt came into be evaluated for a possible reaction to covid vaccine that she received at senior center. Pt was experiencing left subzygomatic cheek swelling (quarter sized area), Pt denies difficulty breathing, denies ever having facial dermal fillers. Pt on low dose of prednisone that has been previously prescribed by HCP. Pt took Claritin D. Pt was told to take OTC Benadryl at Dr. Visit with other HCP.

Pt came into be evaluated because she received first covid vaccine at senior center. Pt was experiencing left subzygomatic cheek swelling (quarter sized area), denied difficulty breathing, and denies ever having facial dermal fillers. Pt on low dose of prednisone, and took took Claritin D. Told to take OTC Benadryl

SWEELING OF LIPS AND FACE. She started Benadryl 2 days after but after 2 doses the swelling increased. Saw the doctor who gaver her an injection (forget the name) and the predsolone med pack. The swelling started to go down 2 days after taking this medication. A week after taking the Moderna vaccine and taking this medication her swelling was gone. Medication was started on Wed Jan 21,2012 and completed on Tue Jan 26, 2021. The swelling didn't get life threatening but when we noticed that inflamation was worsening and Benadryl didnt work we worried and she went to see the doctor for the treatment described above.

redness swollen hard to touch bruised sight began to widen symptom began on the day of the injection which was 01/14/2021 and now just began to look better 01/29/2021

No reaction day1. Day 2 swelling and redness size of dime. Day 3-6 no reaction. Day 7 pm red, swollen , itchy red spot size a little larger than golf ball and slight headache . This lasted 5 days with red area 31/2? wide and feeling tired and slight headache. Days 12and 13 all symptoms vanish. This morning, 2/05/2021 my arm is again 3? area red, itchy, slight headache and fatigue. I hear that this called Covid arm and seems to affect about .06 % of those who have had the Moderna vaccine. I thought I should report this because my husband who had the same injection had no symptoms at all...not even redness at the site.

81 year old female presents to the urgent care with a raised red rash to her left arm. States she received her COVID-19 vaccination on 1/23, denied having any symptoms except for a subjective fever about 36 hours following her vaccine. Patient stated on 1/31 she noted a coin sized red spot to her left arm, then placed vitamin A ointment to arm, then throughout the week it has continued to grow and feels that it has started to "swell". Patient denies fever, difficulty breathing, pain, itching, or fluid from red area on arm.

Itching, swelling, redness at injection site. Patient noted symptoms within a day or two. Staff noted redness and swelling on 1/23/21 (10 days after injection). Evaluated in clinic on 1/28/21. Felt to be either allergic response to vaccine or possibly resolving hematoma. Treatment: Benadryl cream.

COVID ARM Inflammation, itching of vaccine site beginning on the 8th day after vaccine was administered. Used Anti-itch cream Still in progress

Started at 5 am throwing up, sore, weak, headache, freezing On Sunday 2 days after shot felt better, still weak and started canker sores in mouth and swelling. Still have symptoms as of today 2/18/21. Doctor calling in steroid.

(Sorry, couldn't read 2 numbers of the lot number) I did experience the shot hurting just a little on first and second day, not unlike any other injection I have had in the past. On or around 2/14/21, I started experiencing itching/redness and a lump and warming of the skin which got a little worse in the next few days. The lump went away first. I still have a small amount of warmth and redness/itching today 2/20/21. Yesterday on the 19th, I did have a slight headache (not usual for me) and was a little more tired than normal. Today, so far, I feel fine other than the small amount of itching and redness.

Macular papillary rash on thighs, buttocks, and trunk. She took a dose of benadryl, and I advised she take Claritin and zyrtec.

pt stated after she received the vax she got a strange taste in her mouth. At 1 AM pt woke up with a heavy feeling in her left arm. Her left arm, hand and fingers started to swell. At 3 AM her head felt warm and the entire left side of her face was swollen, including lips, gums, nose and eyelids. Her teeth felt strange. At 5AM she could feel a sensation going down the left inside of her body moving from her neck to her toe. Then the right side of her face started to swell from the neck to the top of her head. Pt woke up at 7 AM next day and the swelling was starting to go down on the right side. On 2/26/2021 she is noticing the swelling is going down out of her left side. She never really had any pain or discomfort just swelling. Pt. has not contacted her PCP at this time.

Received vaccine on 2/23. On 2/24 arm became swollen and red and spread beyond injection site to approx 4 inches in diameter. There was slight itching, and pain. On 2/28 became nauseated in shower and felt extreme weakness requiring assistance to get to bed to lie down. Thought she would pass out. Lasted 3 hours and then was recovered.

Aggravated my Neuropothy for approximately 3 weeks. Also affected muscles in Right Foot. Every night Right Foot would get "BURNING HOT" & would have to soak foot in cold water. For last 10 days of problems, Right Foot, Middle of Leg, and Total Knee TOTALLY SWELLED UP AND STAYED THAT WAY FOR THAT LAST 10 DAYS! Burning foot is no longer and swelling is almost gone.

Left arm swollen and large red area and itchy. Treat,emt Trying ice and tylonal. still using this treatment as of 3/2/2021

Covid arm. Red, swelling, large bump., hot, sore. Called clinic told it was probably nothing. CDC website said go to dr or ER. Dr there glanced at my arm and said it was an infection and gave me antibiotic, Cephalexin 500mg, 10 days. Feel really bad but maybe better today and that is after tramadol and tylenol. Headaches. Tylenol helps.. now afraid to take 2nd shot.

The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective

Swelling in arm starting the following day, continued for approx a week then on the 4th week after the dose the arm began swelling and pink again just like after the injection

arm redness, pain and swelling had subsided after injection by 2/10 but then on 2/12 it flared up again and was much worse than before, did not go away for a week. Very swollen, and extremely itchy. I can still see a slight circular mark on the left arm. I had the second dose in my right arm on 3/5 which is still itchy and sensitive.

Weakness in both arms started around 2:40 Thursday afternoon. The weakness in right arm subsided but continued in left arm until Monday evening. There has been swelling and redness in the upper left arm since Sunday still persists until now. There is also itching and redness around the upper left arm, injection sight.

Patient received her 2nd dose on 3/4/21. Today, she woke up with the right side of her face swollen and patchy. Her right arm is also red and itchy all the way down to her fingers. Her daughter called the pharmacy and feared that she might have Bell's Palsy. She took her mom to a walk-in clinic. The doctor's office blamed the COVID vaccine for her symptoms and said that she is to never receive another COVID vaccination in the future. I am unaware of the treatments that the patient received

Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of chest. Symptoms continued to get worse. After 45 minutes went to ER Vital signs taken + EKG, observation. After approximately 3 hours breathing, dizziness, swelling of face improved. Some rash remains.

Modern a COVID-19 Vaccine . On 3/4/2021 my right arm became red and itchy. red are was about the size of a baseball. I used antihistamines and topical steroid cream. Also topical Benadryl cream for the itching. The redness and itching cleared 3/14/2021. I did not consult a physician regarding this

Patient complains of facial swelling and numb feeling in the face the evening after receiving the vaccine. The patient did not have any difficulty breathing and took over the counter allergy medication. Patient was instructed to switch to Benadryl and if it continues to worsen or affects breathing to seek immediate medical attention.

Patient reported arm to be swollen and warm. She contacted the pharmacy and her primary care doctor. She was advised to use a cold compress and analgesic. A follow up call was made to the patient a few days later, she reported that her arm was fine.

Swollen right neck Lymph node- CT Scan shows neck mass and thyroid obliterated. biopsied 6 days after dose #2 and diagnosed with Thyroid cancer! This is the 3rd case of thyroid cancer I've heard of that starts b/w doses 1 and 2 of moderna!!!

Fever x 3 days with left upper arm circumferential cellulitis and swelling and streaking down left lateral chest wall and breast.

Described by patient over phone - evaled in ER. Delayed arm redness/swelling. Resolving 1-2 weeks later.

4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease

Warm redden area and swollen upper arm down to elbow with swollen lymph node at the inner part of the elbow. Diagnosed by physician as a cellulitis, antibiotic infection and instructed to take benadryl , 25 mg, with as needed, apply ice pack to affected area.

Several hours after receiving her second Moderna vaccine, she developed a burning sensation in her face. The next day she went to the urgent care with edema and erythema of her face (sparing lips and tongue) and was diagnosed w/ urticara, and received IM Solumedrol and IM Benadryl and was advised to take oral diphenhydramine, Motrin and Tylenol upon discharge. 2 days later she went to the ER w/ persistent symptoms and was diagnosed w/ erysipelas, vaccine reaction and ARB allergy (though she continued to take her ARB) and was treated w/ Benadryl and Clindamycin. Symptoms resolved. She never had lip or tongue swelling or respiratory distress.

We noticed my mother's foot was swollen, after alerting her nurse practicioner they ordered a scan to be done on my mother. It confirmed that she had a blood clot between her groin and below her knee. They prescribed eloquis.

Patient started experiencing itching two days after her vaccine. With time, she started experiencing redness, swelling, a hot sensation, and a rash started to form. To this day, all of these symptoms are still present. Advised the patient to go see her primary care physician or a walk in clinic as soon as possible.

Intermittent swelling and pain at injection site (no longer). Doctor appointment made for 05/20. She stated she has elevated feet and taking Lasix (helps very little).

Per nursing notes: patient received Moderna vaccine #1 on 2/1/21. There is no mention of skin issues or rashes in notes until 2/25/21. Then there is an alert note indicating she has red spots all over skin. Skin intact on 2/28/21. Lotion was applied. No itching. On 3/8/21, she received Moderna #2. Hydrocortisone cream started on 3/8 for itchy skin. Eucerin and hydrocortisone used daily. On 3/27, Nystatin topical was added. On 3/30, per primary request, patient went to see Dermatologist. Triamcinolone cream started. On 4/2, reddish raised rash on neck and shoulders noted. On 4/15, she had a fall, hit head and transported to ER. Suffered a brain bleed and vertebra fracture. Upon readmission, itching rashes remained upper/lower extremities, back/front of body, with skin intact. Mention neurodermatitis in notes. On 4/26 ration noted all over hand and body with left hand swelling. Triamcinolone cream applied. On 4/27 rash on body worsening and clear fluid filled blisters noted on left hand, therefore Change in condition noted. 4/28 visit dermatologist. 4/28 blisters with clear fluid open and drained. Bacitracin applied. Red raised rash on her body slightly improved. 5/2 rashes on upper and lower body more raised, itching started. Several small blisters on leg, neck, right hand. Dermatologist appointment on 5/5 noted. 5/4 multiple blisters with clear fluid on upper and lower body, different sized. 5/6 prednisone oral taper started. Triamcinolone and mupirocin topical started. New diagnosis of bullies pemphigoid noted. Treatment in process.

4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN

Herpes on lip, all joints aching, temperature, hot and cold shivering, headache, moaning in pain. Took Excedrin. 24 hours

Has bilateral LE edema, reddened areas w/ rashes and exudate or drainage from areas. Looks like a cellulitis

Systemic: Dizziness / Lightheadness-Mild, Systemic: Unilateral pitting edema/swelling of calf+ankle & bruising-Medium, Additional Details: Referred to closest urgent care

On the second day I was shivering and freezing. Despite testing my temperature, it never registered as a fever. I went to the doctor and was given a prescription for doxycycline. It did not make any difference. I went back a second time because I was concerned that the redness and swelling was not going away. I was not experiencing any pain. Somewhere along the line I had developed hives on my head and face. I as put on doxycycline again and a strep test was done. The strep tests was negative. After a few days I went to an allergist. The allergist said she did not see anything indicating I needed a food allergy test. They also tested me for a penicillin allergy which came back negative. The allergist sent me to an ENT. No one was able to determine a cause. I went back to my PCP. He put me on singular and Allegra. He also drew blood to be tested for food allergies so I am awaiting the results of that.

This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed (she was actually a DNR and was not supposed to be intubated). On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management

Redness, extreme itching, swelling, hardness from shoulder to elbow and under armpit. Used hydro-cortisone and benadryl in beginning. Then used anti-itch spray.

Resident reports that her arm is swollen a lot from vaccine. Pain also present. No treatment at this time.

Initial sore arm, then vomiting and diarrhea, then pain intestional tract like diverticulitis from past. Saw doctor on 1-25-21; prescribed ciprofloxacin HCI with blood work done, Blood work showed infection

Arm: itching, redness, slight swelling, noticed the site mark (not seen at time of injection) Weakness, internal shakiness, tiredness, overall lack of energy

the day she received the vaccine: that night she had fatigue the entire day and major sweating. 7 days later She developed a rash on her left arm, and has enlarged lymph nodes under her left arm and is still sweating. Since the vaccine she has experienced achy body, chills, and fatigue like the flu symptoms.

Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.

A red rash has been gradually going down her arm since the night of the vaccine. The right arm is also swollen.

Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, and "intense chest tightening". She took a children's tylenol tab and put heat on her back and then rested and fell asleep for a period of time. SHe woke up to "pins and needles" feeling in her head and face that felt "intense" to her maybe 4-5 hours after vaccination. She continued to feel "discomfort, tightness in chest/back" for 2-3 days. SHe then stated around day 10 she had abdominal tightening, overwhelming nausea, and pressure in her stomach, but no diarrhea for about 6-7 days. She also states she had "bad reflux". Around Feb 14th-16th she started feeling a rash on both arms/neck/chest and then hives that were red/blotchy a few were raised and hard on thighs/hip/arms. She went to physician and was given Benadryl and Steroid cream. She then reports that on Feb 20th she had swollen lymph nodes under arm.

RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS; CONTINUED FOR 5 WEEKS AND STILL CONTINUES ALTHOUGH SUBSIDING. STOMACH MUSCLES HURT BUT NO NAUSEA. EXPECTED FATIGUE, DIZZINESS AND WEAKNESS BUT NOT CONCERNED ABOUT THAT. RAISED BLOOD PRESSURE AND PULSE RATE ON 2/3/2021. STILL EXPERIENCING VARIATIONS IN HEAT/COLD FEELINGS..MAY OR MAY NOT BE RELATED.

patient called pharmacy on 2/26/2021 to report that on 2/21/2021 arm became "really sore, red, swollen, itchy and warm to the touch" and she had a fever and chills; patient states she took Tylenol for the fever and applied Benadryl gel for the itching; patient states color is back to normal today (redness lasted until 2/25/2021), slight itch (1 on scale of 1 to 10) remains today

Chills, fever, headache, body aches, A couple of nosebleeds, and my arm hurt from the injection site down to the end of my fingers. Headache continued for four days and fever would come and go but usually at night. I did not receive treatment but I did let my cardiologist office know what was going on. When I continued with the headache, I contacted the internist?s office and I only had a TelMed visit with them. My nostrils had something like cold sores but then I started sneezing and realize there was infection also. Had a second TelMed visit with the PA who started me on an anabiotic Amoxicillian. The infection is clearing up in my sinuses but I am coughing a lot. Overall continue to feel very tired and weary

2/19- woke to swollen, redness and itchy arm. It spreads to the lower arms the next day. By 2/23/21 found swollen lymph nodes on both arms and still there as of today. Pt will contact Md tomorrow for treatment options.

5:00am 2/21/21 thru 5:00am 02/22/21 (24 hrs) chills, fever (99.7), headache, nausea, muscle/joint pain; For reainder of 2/22/21 thru 2/2/24/21 experienced Fatigue, lack of energy and did have swelling, soreness, redness/heat Upper Right Arm where had injection.

Skin rash on left arm, "Covid Arm." Patient says that she noticed it the morning of 3/8/21, about 2 weeks after the vaccination was administered. The rash is a few inches below the site where COVID-19 vaccine was administered.

I notice a different feeling in my arm-it seems to be a itching burning sensation. After a few minutes I pulled up my sleeve and noticed small red spots forming, It was splotchy over a little over an inch wide and long. I watched this and it continued but was more annoying than anything. Later in afternoon it was spreading to a wider area and was showing a brighter redness. By 11 p.m. the coloring had spread and my upper arm felt warm to the touch and had swollen some. I slept fairly well, woke up and it had increased in size . Wednesday morning the redness was bright red and much of the upper arm was affected. I called Dr. office and saw Dr. not my usual doctor..

Daughter provided the information for her elderly mother who, at this time, was being evaluated in the ED at Medical Center . 3/5/21 - approximately 16.5 hrs after her mother's second dose of Covid 19 vaccination, she woke up very weak and felt very tired. 3/6/21 Patient noticed rash (not raised) but reddened in the left upper arm where the injection was given. She stated it was oval in appearance and covered most of the upper arm. She noted a lump in her underarm of the left axilla also. Denied any fever or other symptoms and otherwise felt fine. On 3/9/21 she noticed a lump in the groin area and noticed that walking was a little more difficult than usual since both of her knees bothered her. 3/12/21Pt went to orthopedic surgeon and had a "cortisone injection" in the right knee. This afternoon, the patient's daughter suggested that she go a local Urgent Care because the patient stated that the lump (previously in groin area) "was moving." She waited in there for over one hour and then a nurse came out and told her to go to the ED for evaluation of her left upper arm for the redness and swelling. She went directly to the ED and is being evaluation and having bloodwork done. Daughter said if the lab results are normal, her mother will be discharged with an oral antibiotic and benadryl

Swelling developed, area got hot, got purplish, and felt acute pain. The area where injection was given was lower than usual about 5 " from shoulder joint.. Saw MD for regular check up and he commented then " thats where they gave you your injection.?" Have been applying heat compresses and cold packs alternating. Today still has some discomfort on touch but not painful like it was and swelling has decreased but still slightly purple. Md stated she was doing what would help and to take Ibuprofen or tylenol. This was the 2nd injection for the Covid 19.

Angioedema of the upper lip started about 50 minutes after receiving her second dose of the vaccine. She was seen in the ED and discharged home. Also on lisinopril for many years with no adverse events to it. Unclear which of these agents caused her swelling. No prior history of dermal fillers or any aesthetic procedures to her face.

Several days after receiving the 2nd Moderna vaccine for COVID 19, I began have pain in all the joints in my hands, shoulder. Unable to use my hands due to excruciating pain. The pain began 3-4 days after the 2nd shot, starting in 2 of my fingers and progressively moved to all the joints in all of my fingers, wrists and my shoulders. In addition there is swelling. I have very little use of my hands, requiring assistance to care for myself. I have never had joint pain in my hands before. The pain has continued for 2 weeks non-stop. At the doctors recommendation I have been taking Tylenol for Arthritis, however this does not alleviate the pain, only reduces some of the discomfort.

Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy." When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.

Took the vaccine on the 24. Next morning I has pain in my arm and was swollen and itchi, hot and red. Placed an Icepack but the swelling,redness and itchiness is not gone. Went toda to a pharmacy and the pharmacist recommended to take Benedril and to let you know I have my arm swollen, red and itchi.

Pain and swelling commenced on day 6 as reported to V-Safe- itchiness rash and frequent urination....unable to sleep throughout night on day 7 and an ER visit confirmed shingles.

Fatigue the day after increased and progressed to weakness and confusion for the week following the vaccine, culminating in Emergency Department visit with hypercalcemia and acute kidney failure and subsequent 9 day hospitalization.

10 days later pt called to say arm still hurts, swollen and hard to the touch, has worsened since receiving vaccine

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

Patient presented to the outside hospital on 4/27/21 with lower extremity weakness which progressed to paralysis and back pain (which had been intermittent since Dec. 2020), but had started to become persistent and rapidly worsen starting around 4/24/21. Patient subsequently transferred to HCF on 4/28/21 for concerns of Guillain-Barré syndrome with recent COVID-19 vaccination (Moderna: first dose on 4/14/21) with lower extremity paraplegia lack of deep tendon reflexes. Unable to perform MRI due to type of pacemaker that patient has. Lumbar puncture done 5/1/21 was consistent with Guillain-Barré with elevated protein. However, patient had minimal improvement in symptoms despite full 5-day course of IVIG. During her hospitalization, concern emerged for central compression and after further imaging patient was subsequently found to have a T8 compression fracture, spinal mass, and severe spinal canal stenosis at the level of the compression fracture. Spinal biopsy completed suggestive of DLBCL. Hematology/Oncology were consulted, and chemotherapy initiated. Bone marrow biopsy done on 5/7/21 with results pending as of 5/11/21.

Guillain Barre syndrome. Presented with rapid onset L >R leg weakness, numbness and radicular pain. Symptoms came on overnight. 3 days later developing hand symptoms.

blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is swollen; Area of the left leg below the knee is red; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot was discovered in the left leg) in an 82-year-old female 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 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (blood clot was discovered in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red). At the time of the report, THROMBOSIS (blood clot was discovered in the left leg), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red) had not resolved. The patient's concomitant medication was not reported. The information regarding the patient's treatment medication 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 these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-116642 (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 these events, a causal relationship cannot be excluded.

Pt was found by daughter 3/14/2021 weak, unable to stand and with swollen legs. Pt was taken to ER where she was found to have left leg DVT despite being on Eliquis 5 mg bid which she confirmed she was taken as prescribed

1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.

not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female 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. The patient's past medical history included COVID-19 in January 2021. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved. Concomitant medications were not reported. Company Comment ; Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR) upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Massive heart attack

Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelling; Hand pain; CARPAL TUNNEL OF BOTH HANDS; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. The patient's past medical history included Hip discomfort in 2019 and Alcohol use in 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HAEMORRHOIDS (Hemorrhoids), ABDOMINAL PAIN UPPER (Stomach cramps), OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS), ABDOMINAL PAIN UPPER (Stomach cramps), SWELLING (Swelling), PAIN IN EXTREMITY (Hand pain) and FATIGUE (Tiredness) had not resolved, DIARRHOEA (Diarrhea) and HAEMORRHOIDS (Hemorrhoids) was resolving and OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) 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 event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.; 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, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.

patient went on hospice 7/16/21 and expired 7/17/21 developed sudden neuro degenerative disease unspecified with paralysis of lower extremities first then arms, neck and complained of shortness of breath, swelling left and then progressive swelling

Few hrs after getting shot at mid day, lower back started aching. By 10:00 p.m. my lower back, sides were in pain and abdominal muscles and stomach were like frozen in place. Couldn't move anything and the area seemed to be swollen. Had lost appetite in late afternoon so had not eaten dinner, only liquids since figured I needed something. Couldn't sleep, aspirin didn't help. Next day around noon my abdominal area was better and pain decreasing on sides. Still no desire to eat. Trouble sleeping, 2nd day after shot, still lower back pain, feel bloated, no desire to eat. Very little side pain. Had slight headache This third night after shot I could finally sleep. This fourth day I felt back to normal. During all this time, the arm that had the shot never really bothered me

swelling, itching and redness of left arm 24 hrs after injection. treated with ice pack and Doxycycline 100 mg bid for 7 days

Two different reports: First indicated the patient developed redness, swelling, warmth and blotchiness the day of vaccine. Second indicated the patient developed redness and warmth a week after vaccine. Pt was taken to urgent care, diagnosed with cellulitis and given one round of antibiotics.

Arm swelled next morning and arm was immobilized for 1 day. Swelling just started to go down on 9th day. Puncture mark not closed and site very itchy on and off since 1/16/21. Going to Dr. on 1/25/21

Resident was hospitalized on 1/17 after having multiple falls and change in condition. Resident returned to facility on 1/20- continued to be unable to ambulate as previous baseline. Son brought resident back to Hospital on 1/21 for further testing. Resident now being treated for Guillan Barre after having lumbar puncture and MRI. She has received IV IG treatments. Resident remains hospitalized.

redness, soreness, itchy, swollen glands in armpit and top of my arm, continues to be red hives on my arm and has not cleared up. Took a Claritin to stop itching . Also had a very bad headache on sat.

2:30pm Received 1st dose of Moderna. Hx of SOB/swelling with allergy shots. 2:45pm c/o itching around lips. VS BP 166/19 P 90 o2 sat 97% RA, alert, ambulatory. 2:50pm Benadryl 50 mg IM stat LGM. 2:55pm BP 171/71 P 90 O2 sat 98% RA, reports itching resolved. 3:00pm BP 147/88 P 87 O2 sat 97% RA. 3:15pm ambulatory, but became unsteady, sat in chair. 3:19pm BP 153/75 P 77 3:24pm BP 148/78 P 80 3:25pm ambulatory to truck. 3:28pm husband returned to clinic to report wife's rash. Instructed to go to ER. Report called to ER. 01/21/21. F/U call. Pt reports observed in ER, no treatment. Instructed to take Benadryl 50 mg po bid x 2 days. No further problems.

Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1), dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate. It is now the 3rd day and except for tiredness I'm feeling more normal

pt first developed a swelling without redness, purple, that receded quickly with cold compress Pt within 5 minuted developed resp distress, sob, chest pain and crushing chest feeling along with lip tongue mouth tingling, difficulty swallowing, increasing anxiety and diaphoresis.

A week later I noticed my arm is itching and when I looked at it, it was swollen and red. It was itching like crazy. I went to the doctor. I went to my doctor's office and she prescribed a cream for the itching and told me to put ice on it.

Bad headache, very stuffy nose, I couldn't breathe and almost went to the hospital. Ears were ringing, my eyes were ready to pop out of my head. Temples hurt, lymph glands were swollen, sore throat. Mostly in upper part of anatomy above collar bone. It made me very weak, I had trouble getting out of rocking chair to answer phone. So I took another Tylenol. I usually only take 1-2 Tylenol a day and that was my second one by the middle of the day. I had to lay down and I live alone so I was nervous and had phone beside me and debated calling 911 which I have never done. I dozed and when I woke up about a couple of hours later it was much better. Still had headache and a little stuffiness but anybody can handle that. Also, I was very nauseated and couldn't eat but I did drink water.

Chilling, Body Aches, High Fever, Light Headed, Very Tired, Arm swollen and very red. Had fever and stayed in bed all day. Still had fever the next day. Arm on third day still very red and swollen.

swollen . sore arm, elevated temp, 2 degrees above normal, weak, ache all over, feet burnt and itched (not normal) today, 13th, temp is down, arm is better, still sore , weak, but not the ache all over as bad, feet not burning, now today diarrhea, but at 11;30 getting better, eyes have been more sensitive and blurry than normal and still are.

Upper arm pain from elbow to shoulder and throbbing. Some swelling in lower arm near wrist. Considering Urgent Care Visit

Vaccine was administered on 2/08/21. Pain at injection site that day. On 2/16/21, I started to develop hives on my upper stomach region. By the next morning (2/17/21), the hives turned into large, red, swollen welts and spread to other areas on my torso, under arms, and back of my neck. I went to an Urgent Care and was prescribed two antihistamines. By the next day (2/18/21), the welts spread even more.. I went to the Emergency Room. Both my heart rate and blood pressure were elevated. I was given an IV with a steroid. Upon discharge, I was prescribed a steroid to be taken for 6 days, continue with the nighttime antihistamine for 10 days and Allegra for 30 days.

pt states the next day after receiving the vax her right shoulder swollen and it started itching badly. She called her pharmacist and he told her to use hydrocortisone and she used Benadryl as well. On the fourth day the itching moved from her right arm to her left arm which lasted for 2 days then moved to her right upper chest which lasted a couple of days before subsiding. Pt has not contacted her PCP at this time.

About 24 hours after receiving the vaccine she was running 100.8 temperature, aching to the point of soles of her feet hurt, wanting to sleep. Went to bed at 4:00 PM and stayed asleep until 11:00 AM the next morning. Her arm swelled very high, there was a bruise at the site of the injection and itching all around it with a rash. Arm is still swollen and tender to touch, but the rash is not bothering her to the point of scratching. She did take Tylenol for the fever several times.

Patient came to office on 02/26/21 stating that her arm was having redness and swelling that was spreading. Note area of right arm to have redness, swelling and bruising with measurement of 8 x 10 cm. Pt denies pain or drainage. Pt was seen by provider, advised to elevate arm and place cool compresses over the weekend, provider gave pt personal cell # to call with any concerns and office would contact her on Monday 03/01/21. Pt contacted today and came to office and again was seen by provider. Area not as reddened and has fading yellow/ brown bruising area. Pt continues to deny pain, states it itches at times.

On the third morning after vaccination, the patient observed swelling on her face, primarily around the left cheek. She went to the local emergency room and was examined. No fevers, chills or eruptions inside the mouth or anywhere on her body.

Woke up on Monday March 1 with a hard swollen shoulder (size of a tennis ball) red mark (size of a golf ball) shoulder, took a motrin, Saw my doctor on March 2, who diagnosed this as a reaction to Covid -19 vaccination and advised use heat This is 10 days after the vaccination.. Site is tender .Still resolving. It is now 18 hours after the first signs

THINK THE VACCINATION TRIGGERED MY PSEUDO GOUT. AS SYMPTOMS STARTED FOLLOWING DAY. 9 DAYS LATER I WENT TO MY DOCTOR AND SHE SAID THEY JUST DID NOT KNOW FOR SURE IF THE VACCINATION WAS THE TRIGGER FOR THE PSEUDO GOUT. SHE TREATED ME WITH 3 PILLS OF PREDNISONE 20 MG 1 PILL A DAY. IF CONDITION DID NOT IMPROVE SHE WOULD ADVISE MORE MEDICATION. AM ON SECOND DAY OF MEDICATION. SOME OF THE SWELLING HAS GONE DOWN BUT STILL PAINFUL. CAN USE MY RIGHT HAND A LITTLE AS YESTERDAY I COULD NOT LIFT A FORK.

3/5/21 emergency roomHPI 83 y.o. female who presents with Complaints of nose bleed reports that she had a nose bleed this ongoing now for the past hour she could not stop at home and came for help she reports her symptoms are mild-to-moderate better with putting pressure on her nose worse without pressure denies any injury FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Hypertensive urgency I16.0 401.9 2. Epistaxis R04.0 784.7 2/22/21 Emergency room HPI 83 y.o. female who presents with SHORTNESS OF BREATH ONSET BEFORE ARRIVAL. EMS GAVE PT A DUONEB AND NOW SHE STATES SHE FEELS FINE. DAUGHTER STATES THAT PT HAD A YELLOW STOOL YESTERDAY. PT STATES THE SHORTNESS OF BREATH IS WORSE WITH LAYING FLAT. NO OTHER EXACERBATING FACTORS. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Acute urinary tract infection N39.0 599.0 2. Shortness of breath R06.02 786.05

Second Moderna vaccine. Itching, Swelling and redness on arm from just below injection to elbow and covering that part of my upper arm. Appeared on next day and getting worse today. Tried ice pack. This happened with first vaccine injection also and eventually went away. This might not be adverse to you but it is to me.

patient let us know today that she had a reaction to the vaccine, Her arm was red and swollen and itchy. She went to the Emergency room and the md gave her benadryl and advised her this was a side effect of the vaccine and that the effect could last for 6 to 8 weeks

daughter stated the pts left arm is very red, itchy, and swollen about 4 days after getting the vax. Pt has also has headaches that come and go. Pt went to CVS and the nurse told her to take Benadryl and cortisone cream. Pt is only using the cortisone cream and no Benadryl. Pt still has some itchiness and headaches but is getting better.

Reaction occurred approximately 60 minutes after vaccination. Flushed and swollen face. Rapid heart rate. Some dizziness. Treated with Benadryl and bed rest. Symptoms began to subside within 30 minutes after first dose of Benadryl.

My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th.

Fever, right deltoid swelling, hot to touch and redness. High fevers of 102.0-103.0F Patient reports having high fevers, headache and nausea. Presented to ED with the mentioned symptoms. Swelling approx. size of softball.

Develop a blood clot on their left knee; Left leg kept swelling up; A spontaneous report was received from a physician concerning a 83-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a blood clot on her left knee and left leg kept swelling up. The patient's medical history included cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included vitamin D and medications for cholesterol. On 26 Feb 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date after the vaccination patient developed blood clot on left leg, leg also kept swelling. Relevant treatment for the event included blood thinners and aspirin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, blood clot on their left knee and left leg kept swelling 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 the events, a causal relationship cannot be excluded.

History and exam as noted below, differential of acute, tender lymphadenopathy reviewed, although no obvious source of infection, this could be a reaction to the second COVID 19 shot even 2.5 weeks later, reviewed with patient the results of her blood tests including inflammatory markers that were normal, US results discussed as well as the radiologist's impression, in the absence of an other associated systemic changes or red flags we will monitor for now and follow up ion 8 weeks or so, sooner if sx are not improving or she develops any of the new changes we talked about

Within two hours the arm became itchy, swollen and red hot. It continued to get worse over three days. In additional I had exhaustion. The symptoms continued for the next four days and began to subside on the sixth day. At this writing I am at the seventh day and till have residual symptoms which are gradually diminishing. The degree of itchiness could be described as like bad shingles. The degree of redness could be described as a bad sunburn. The degree of swelling was like a hard muscle cramp in my deltoid, triceps, and biceps widespread across most of the upper arm and shoulder.

leg was hurting and had a hard time to get out of the chair; Tried to sit in the kitchen chair which is hard, and also had hard time walking; can hardly bend the leg and that didn't hurt when was laying in bed; goes from the groin area to the toes; A spontaneous report was received from a 83-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg was hurting and had a hard time to get out of the chair, tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed. The consumer's medical history was not provided. The consumer's current condition included congestive heart failure (CHF). No relevant concomitant medications were reported. On 23-FEB-2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. On 03-MAR-2021, after the second dose the consumer experienced events leg was hurting and had a hard time to get out of the chair, tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed. No treatment information for the events was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events was unknown. The assessment was not provided for the events.; Reporter's Comments: This case concerns an 83-year-old female with PMH of CHF who had serious unexpected events of pain in extremity and gait disturbance along with nonserious unexpected limb discomfort and peripheral swelling. Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. 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.

tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled to receive the second dose after 58 days; Runny nose; hard area at injection site; tender to touch the injection site; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 reported medical history). Concomitant products included CITALOPRAM, RIVASTIGMINE (EXELON [RIVASTIGMINE]), FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], ZOLPIDEM TARTRATE (AMBIEN), XANTOFYL (LUTEIN OPT), KRILL OIL, CALCIUM, VITAMIN B3, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and EVOLOCUMAB (REPATHA) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling). On 15-Feb-2021, the patient experienced FAECES DISCOLOURED (tarry black diarrhea) (seriousness criterion hospitalization), PERIPHERAL SWELLING (swollen foot) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOUT (possible gout attack) (seriousness criterion hospitalization), CELLULITIS (possible cellulitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days). The patient was hospitalized for 8 days due to CELLULITIS, FAECES DISCOLOURED, GOUT, PERIPHERAL SWELLING and VOMITING. On 03-Feb-2021, RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling) had resolved. At the time of the report, GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was started on antibiotics and prednisone treatment for possible gout attack or cellulitis. No treatment information regarding other events was available.; Sender's Comments: This case of an 83-year-old female patient who experienced inappropriate schedule of vaccine administered after first dose of mRNA-1273 (58 days). Based on temporal association between mRNA-1273 use and onset of the events of runny nose, vaccination site induration, pain and swelling, a causal relationship cannot be excluded. There is not enough information to assess the other events due to lack of critical details in patient's medical history. Additional information is being requested.

Moderna vaccine #1 administered on 1/18/21 Adverse event observed 1/24/21 @ 1am: soft tissue swelling eyelids, cheeks, lips. No swelling of gums, tongue or throat. Severity: Moderate. No airway obstruction. Severe itching of eyelids, face. Interference with speech due to swelling. treated with OTC diphenhydramine 25 mg oral every 6 hours. Adverse event lasted 72 hours. Moderna vaccine #2 administered 2/22/21 Adverse event observed 3/2/21 @ 1am: severe edema peri-orbital tissue, intense redness peri-orbital tissue; intense itching of eyelids. Skin changes over few days to "lizard skin". Chronic redness, itching, swelling, texture changes; Scheduled for dermatologist tomorrow, 4/7/21. Approximate length of time adverse reaction has existed > 30 days.

A lump has formed under her right arm and breast. Her physician has scheduled her for a scan and says the lump needs to be removed.

Carbon dioxide narcosis; legs swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERCAPNIA (Carbon dioxide narcosis) and PERIPHERAL SWELLING (legs swelling) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERCAPNIA (Carbon dioxide narcosis) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelling) (seriousness criterion medically significant). On 26-Mar-2021, HYPERCAPNIA (Carbon dioxide narcosis) had resolved. At the time of the report, PERIPHERAL SWELLING (legs swelling) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment of the events were not reported. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

About 8 days after the vaccine pt developed slight swelling of her upper left arm and then developed redness around the site. After a few days the redness extended from the top of your left arm down to the elbow. The redness and swelling slowly subsided and then cleared after about another 4 to 5 days.

Swollen, red band around upper arm , below injection site on day 4 after second dose. Puffy, not, very pink with a clear, distinct line. Area was about three inches in height and circumferenced the arm with swelling and arecwas hot compared to nearby skin

Herpes breakout on gums and lips with swelling and swelling of joints with severe pain (left ankle and right wrist)

Severe L. arm pain and swelling, L. neck, L. face and head severe pain w/headache; chest pain w/malaise and felt sick. Incapacitated for 5-6 days . Symptoms lasted for over a week

drained fluid off her liver; they thought she was dehydrated; Throwing up; Small headache; Not eating; Not drinking; Not peeing; Sore feet; Sepsis; Death; Screwed up kidneys; Fluid overload; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (shoulders and knees), Hypertension, Acid reflux (esophageal), Penicillin allergy, Drug allergy (Lyrica), Drug allergy (cymbalta) and Drug allergy (ibuprofen). Concomitant products included AMLODIPINE for Blood pressure management, AMITRIPTYLINE for Sleep disorder, HYDROCODONE, POTASSIUM and PARACETAMOL (TYLENOL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Not eating) (seriousness criterion hospitalization), FLUID INTAKE REDUCED (Not drinking) (seriousness criterion hospitalization), ANURIA (Not peeing) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization) and HEADACHE (Small headache) (seriousness criterion hospitalization). In April 2021, the patient experienced RENAL DISORDER (Screwed up kidneys) (seriousness criterion hospitalization prolonged), FLUID OVERLOAD (Fluid overload) (seriousness criterion hospitalization prolonged) and PAIN IN EXTREMITY (Sore feet) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization prolonged), LIVER DISORDER (drained fluid off her liver) (seriousness criterion hospitalization) and DEHYDRATION (they thought she was dehydrated) (seriousness criterion hospitalization). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) in May 2021 at a dose of UNK dosage form. The patient died on 21-May-2021. It is unknown if an autopsy was performed. At the time of death, SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood potassium: abnormal (abnormal) abnormal. Additional concomitant products used included a non-specific acid reflux pill. Treatment information includes fluids, medications NOS, diuretic NOS, dialysis, a catheter, duloxetine (Cymbalta) and antibiotics NOS. Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received 25-MAY-2021 included no new information.; Sender's Comments: Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected.

Chills Jun5,Jun6 and Jun7. Fatigue, sleepy with no energy Jun5 and Jun6.Heavy stiffness and joint pain in lower back waistline,thighs and legs. Swelling increased in leg foot but lower on Jun7. Arm sore but better Jun7.

A week after the injection hardly able to move arm. large red spot and appeared swollen. Dr. advised to give it time, then after several weeks of no improvement Dr. referred her to physical therapy. On 5-20-2021 before she could respond she suffered a stroke that has paralyzed her left side, can't walk, can't talk or eat on her own. Has a feeding tube and is currently in Rehab facility.

Mom woke me up with her pulse at 134, 140, her BP about 160/90, she was out of breath, complained of chest pain, refused going to the ER. I increased her Toprol b/c it had controlled her pulse when she developed A-fib in 2011. I was afraid to do it, so I increased it very little after I confirmed clinical protocol online, plus I know her condition well, but still I am not a physician. Very early in the morning with her cardiologist from home called me and told me to increase by half the Toprol dosage. He is her cardiologist when mom lives . It took almost a week to bring her pulse down to the 70's which is the ideal goal Dr. set. Her feet remained swollen for a few weeks. I am taking her to the clinic to see her cardiologists there as well on July 7th. PCP ordered two ekg's locally and her usual blood work-up for tikosyn (every 90 days). We go once a year because it was Doctor who stabilized her back in 2011 with tikosyn. I drove her from out of state then to the clinic. She had had an awful adverse response to multaq . It almost killed her. My brother was traveling abroad an took her to my home. I had her hospitalized to have her pulse stabilized and then arranged the clinic visit. Since then she has the yearly visits and her home cardiologist supervised her care. She is very lucky to have such amazing physicians. This year was a bit different because of online health care, but now that we are vaccinated we are driving in.

sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. 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 29-Jun-2021: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; 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.

admitted for severe sepsis and septic shock after developing leg cellulitis one month after the second dose of covid shot. required ICU care.

SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.

(L) shoulder pain at injection site, no improvement x 3 days (+) mild redness (+) swelling (+) reduced shoulder motion (1) start ibuprofen (2) Recommend active range of motion (3) warm compresses 12-23-2020 Positive Covid Case

8th of January got shot. achy right arm and swollen for week. 24th took shower whole shot area was red with rash. could see mark where needle went in. felt tired and arm ached.

Light headedness & slight headache followed by rash on hands and feet and thighs, then hands and feet turned beet red and swelled, uncontrolled shaking and chills. Went to emergency clinic and was given a steroid injection. Within an hour symptoms began dissipating.

Approximately 10 days after vaccine, she started to have itching around area. It became red, raised and extremely itchy. The area grew and grew over the next several days. Pictures were take to show the progression. We treated it with cortisone cream and oral Benadryl. By Monday (Feb 1), 5 days after it started, it was approximately 10"x 5" very red, raised welt, itching and burning. Was able to get appointment with dermatologist the next day (Tuesday Feb 2) He did a punch biopsy in office. By Wednesday Feb 3 it was starting to get better. Now everyday is getting much better

1/27/21 developed dime sized redness and soreness in arm. the next day was 2 inches the next day was 4 inches across and swollen and warm. Pt also having difficulty breathing, Went to Doctor and ER due to breathing distress. Was monitored but not admitted. Still continues to experience headaches, chills, and an increase in salivary secretions.

It became red, swollen w/a big lump, achy. Then it went away. On 2/17 it came back again only covered a bigger area & was very itchy. I was concerned that I got a 2d reaction a week after the first reaction. As of 12:50 a.m. 2/19 it is still reacting.

Redness at site; 7cm circular of erythema, palpable axillary lymph node Doubt infection Instructed to monitor, hot compresses

Mild soreness started on February 25th, slight rash and slight swelling, itching started on about February 28th. Still some soreness when touched. The itchiness has stopped. This seemed to be a pretty mild reaction.

02/20/2021 at 6:30am when getting up, dizziness, nausea, vomiting, fainted, fell and hurt back. 9:00am when getting up a second time, again - dizziness, nausea, fainting , falling and hitting head in bathroom. During day , hematoma over left eye, swelling, no Headache, no blurred vision, back pain increased. Treated with heat.

84 yo woman here to follow up from recent episode of vasculitis. She started getting a rash - started 7 days after 2nd dose of vaccine At last visit, we did testing for vasculitis after the rash looked more vasculitic to me; ANCA testing was positive, as was ANA. - 17 days after 2nd vaccine She was given prednisone 20 mg taper over the last 8 days. She is feeling much better in terms of her rash and swelling. She is having surgery on the 29th for her BCC on the left eyelid. She is noticing blurred vision in both eyes since this all started and she is mentioning this to the eye doctor when she sees them. She says her head was fuzzy when this started and this is better but is still "fuzzy sometimes" Her renal function was normal. Her CBC was mildly elevated WBC but otherwise normal. She denies any breathing problems, blood in stools or blood in urine, or neurologic symptoms other than the fuzzy head.

Pt is an 84-year-old female who was hospitalized for sepsis/ pyelonephritis secondary to obstructive uropathy status post stent from 2/9-2/11 discharged home on 10 days of Ceftin twice daily only to return on 2/26 with complaints of diarrhea resulting in C. difficile positive status treated with Flagyl and PO vancomycin with her diarrhea completely resolving on 3/4 when she was discharged to for rehab and reported no recurrence of diarrhea and normal stools up until 3/20 when she began to have copious amounts of diarrhea again 2 days after receiving her 1st Moderna covid 19 vaccination- resulting in readmission for c diff colitis on 3/22. She remains hospitalized with severe c difficile colitis and is possibly progressing to megacolon or need for fecal transplant.

small amount of tireness at 2nd day. Tiredness increassing and then decreasing on 3rd day.Itching and swelling on 3rd day. Redness at site and beyond, gradually migrating down upper arm. Still migrating downward but not outward on 7th day. Treated with benydryl, tylenol, added antibiotic 2x day on 7th day.

Right lower extremity swelling/pain 4/13/21 Improved swelling of right lower extremity 4/14/21 Heparin 1,000 unit/ml 5,592 units IV (80 units/kg x 69.9 kg) daily 4/12/21 Eliquis 10 mg po BID 4./14/21 to 4/20/21 Eliquis 5 mg po BID 4/21/21

Patient said her arm swelled, it was hard and hot. She said she followed up with her physician, and he said to put ice on it. She said it cleared up.

Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) vomiting, tachycardic, and febrile with increased home oxygen use. Denies chest pain. Found to have positive blood cultures and diagnosed with NSTEMI, underwent heart catheterization and found to have severe ostial RCA stenosis, and admitted for medical management of CAD and antimicrobials. Patient discharged medically stable to home.

Felt dizzy the night of, pressure on chest, shaking, blood pressure elevated more than usual, blood glucose levels elevated more than normal, increased SOB, flushing of face. When walking very short distance about 5 feet would feel dizzy, winded (SOB), face would turn red and hot, and blood pressure would elevate. Treatments: 2/24/2021: EKG, Rapid & PCR COVID test, both negative. BW ordered for CBC w/autodiff, CMP, TSH 2/26/2021: Gabapentin D/C 3/04/2021: RX for Hydralazine 25mg, was too strong and D/Cd on 3/19 3/19/2021: UC visit for decreased urinary output, dizziness and elevated blood pressure. on 3/24/2021: follow up OV, patient is now feeling back to normal, but experiencing SOB with exertion 4/20/2021: follow up OV, patient is feeling normal, but experiencing SOB with exertion.

Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown. Treatment for the event included paracetamol. 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 these 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 these events, a causal relationship cannot be excluded.

Arm very red and very swollen, very itchy. Minute clinic doctor thought it might be infected. Sent to ER. Didn't feel it was infected. Ordered to take Benadryl. Check with PC if symptoms persist.

pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-year-old female 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 Cardiac disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. 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. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: added the event (missed dose) and treatment medication; 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.

Upper left thigh bruised and swollen (April 20) Ultrasound (4/21) results showed DVT. Prescribed treatment Xarelto starter pack 15/20 mg. Maintenance dose 20 mg once per day

Patient called today and said her arm really hurts and kept her up at night. It is also swollen , red and hot to touch.

Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21. Vaccines not administered, but found via immunization query. Presented to ED with leg pain and chest pain. CXR showed worsening heart failure. Because of tachycardia, tachypnea, keukocytotis, and lactic acidosis received 5 days of vancomycin and zosyn for possible sepsis. CPR prior to discharge positive for COVID. Currently not on any supplemental oxygen.

Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine. She has red and itchy bumps. She saw a primary care doctor who diagnosed scabies. She was treated medically and it did not work. She saw a dermatologist who twice biopsied. A skin inflammation was diagnosed and Sarna was advised. Her primary care doctor prescribed prednisone: it made her puffy but did not help much. Her primary care doctor gave her a sulfa antibiotic and she completed it without benefit. She has an ointment to mix with Sarna and it helps. She cannot sleep. She has used Zyrtec: it does help her to sleep but nothing else. Allegra did not help. Individual lesions can last a week at a time. She has a history of ?swellings? of her bones. She has had problems of her knees and heels. She has had injections of her knees, shoulders and heels. Her fingers sometimes hurt, and they have been injected. She denies any other swellings. She started Edarbyclor and Bystolic last year. She started Diltiazem in March or May. Baby aspirin was started in the early 2000s. Simvastatin in about 2003. She recently completed a week of sulfamethoxazole-trimethoprim.

Thursday morning at 5:00 started having chills, started running a fever 101 to 102 all day, arm was swollen and real red, shoulder and neck pain, started sneezing, and eyes were watering, had weakness in legs, Friday the fever remained in the 90s. As of today, 01/25/2021 no fever, just arm pain and swelling and red. have taken some Ibuprofen every four hours

This patient developed the onset of forearm swelling and redness 1 week (onset 1/28/2021) after receiving COVID-19 vaccine. There was no redness induration or other findings at the immunization site, all findings were distal to the elbow, and they included a very mild erythematous streak from the antecubital fossa to the wrist as well as mild to moderate edema on the volar aspect of the forearm. The symptoms were improving with Tylenol and application of topical Aspercreme at the patient had started prior to my evaluation on 2/1/2021.I could not explain the relationship to her vaccination, but felt it necessary due to the timing and fact it was in the same extremity as the immunization was given that I should report this

Itchiness, rash, redness and swollen in upper arm which started Wednesday morning. Visited Doctor Thursday, 2/11 and believes the rash is caused by detergent.

Left arm developed itchiness at site of injection on 4th day after vaccine with swelling and rash. 2/13 - bilateral leg rash, had some swelling to BLE. Pt states used compression stockings, and that it helps with swelling, pt states has bilateral leg swelling at baseline. Pt reports rash is improving, but still present, not spreading. Denies any fevers, red streaks, spreading redness/swelling, CP, SOB, dizziness/weakness, drainage, open areas, or any other associated symptoms. Pt states has been using cool compresses

Injection site reaction after several hours : pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling, (hardness) and redness

Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.

Client complains of normal vaccine side effects on 2/18 and 2/19 (chills, muscle aches, nausea, vomiting). Client reports extreme arm pain, redness, and swelling of arm. Redness and swelling has now extended down past elbow of right arm. Advised client to seek medical treatment by primary care physician.

About 12 hours after the receiving the vaccine, I started running a fever. I had mild body aches. That lasted about 36 hours. I had a lost of appetite. The next day (2/18/2021) my arm became swollen and itchy. As of today it slightly swollen, slightly red in color and itching occasionally around the injection site.

Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise). The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter. On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided). On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill. On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell. Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication. Action taken with mRNA-1273 in response to the events was unknown. The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction 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 the events, a causal relationship cannot be excluded.

Edema of left upper arm. redness, pain of area , it looked a giant sized hive. It is beginning to resolve. Tomorrow will be 1 week since I had the vaccine and it was my second

Golf ball sized swelling. Arm bruised/turn black all the way down to elbow and was warm. Was seen by a doctor and has improved. Treatment was icing and elevating.

Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental status. Sent to ER. Had elevated cardiac enzymes. Admitted to hospital and treated for sepsis and altered mental status.

First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the same time. Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours. Normal O2 sat. Pt was evaluated and seen in memory care where she currently lives. Treatment: ASA discontinued, Eliquis and Levaquin started. Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.

Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told to increase Lasix to 40 mg daily for 4 days. Swelling became worse over next 2 days and patient became short of breath and on 03/02/2021 she went to Hospital and had a CT scan of chest which showed a pulmonary embolus and a bilateral lower extremity ultrasound which showed a right femoral DVT and popliteal occlusive thrombus and a posterior tibial and peroneal vein occlusive thrombus. She was started on Lovenox and admitted to the hospital . she was discharged on 03/05/2021 and had a right femoral thrombectomy as an outpatient on 03/ 08 2021 with complete resolution . She was discharged home on Lovenox and later switched to Eliqus. She is home and doing well at time ofreport.

Swelling of both hands within 10 days of vaccination ' Various arthritic treatments. Still swollen after three months.

On March 18-slept all day. On March 19 woke up with red, swollen, hot arm (injection side). Contacted doctor and sent picture which did not make it to vaccine coordinator completing this form. Pt states improved. 2 weeks later, April 2 pt was traveling and woke with right wrist swelling. Went to MD while traveling and diagnosed covid arm. Pt also put on course of cephalexin orally. Pt also instructed to go to ER in 2 days if not improved-pt reports arm significantly improved and did not follow up, but did finish antibiotics. Pt was doing well until 5/1 and woke with right foot swelling and pain. Went to PCP and they took xrays which were negative. Pt prescribed prednisone and another course of cephalexin. Advised to contact vaccine clinic over concern these reactions to right side of body were from Moderna. Pt had not problems with first vaccine on 2/17/21. Symptoms only started after second dose.

About 4 or 5 days after the vaccine, patient came down with a recurrence of her lupus. She had been in remission for over 10 years but was still taking hydroxychoroquine to maintain. It took several days to get into the clinic and do the lab work to confirm that this was in fact lupus. She finally had a Dr visit at Clinic and February 2 and they did a complete work up: lupus is subtle. After several blood test lupus was confirmed and the results were also confirmed by her Rhumatologist by telemedicine. Once diagnosed, the treatment was a dose of prednisone which she is still taking in a taper of dosage.

initially warm to touch and slightly swollen later that day, then a week later area very red, hard to touch, hot and bumps in the area almost like hives, very itchy.

Red rash, itching day 2 and 3 (1/15 and 1/16) Red rash, itching, and swelling 1/20, 1/21, 1,22 continuing. Swelling is getting hard and worse

At approx 5:13pm on 1/21/2021, change in status with being unresponsive to conversation, Face flushed, taken no food for fluids for the day. T-101.5-102.3 pulse 88-100 02 sat 86%. Unable to take anything orally. Dr updated with request to be evaled in ER. Admitted to rule out UTI, Covid test was negative, continued high temp, WBC count high.

Red bumpy rash with extreme itching and slight swelling for 2 days until I dosed with Benedryl. After dosing every 4 hours for 2 days, it subsided. Will call my doctor today!

After approximately 5 days began developing rash and swelling at injection site, so-called "Covid Arm". Swelling, some pain, and significant itching in a patch some 4 to 5 inches in extent. Gave her some over-the-counter antihistamine (Claritin) and this helped to resolve the symptoms somewhat. Redness had abated somewhat by the end of the day. I am reluctant to give her too much of the antihistamine due to dizziness and increased lack of mental clarity (she suffers from Alzheimer's). Being a military wife, she has had many vaccinations, but has never had a reaction like this before.

10days after shot, my arm got hot the spot got swollen. it was about 5 inches in diameter and it was hot red and swollen. Physically i had all the chronic fatigue attack where my mind is not sharp, I was depressed, and tired, and i was hurting. My hips were hurting, i have paraphasia in my right foot but it went from my toe to my knee and it was painful. lasted for 10days. I woke up Saturday and everything was fine and i was back happy. I am still stressed

my mother developed a rash on chest, back, face with facial swelling, lip swelling and tongue swelling 10 days after second vaccination. Placed on steroids and prescription antihistamines. not sure if related to vaccine but no other change or administration of anything else.

Started happening the day after, swelling, heat, pain, and redness. Swelling has went down(still slightly swollen) but the rest of the symptoms are still present.

Pain. Swelling (hard area, size of lemon), redness, fatigue, headache, muscle pain joint pain , 4 hours of chills on and off,) nausea. loss of appetite, fever of low grade, duration, some lasted 1 week small vesicles on R face above R lip and R shoulder sutured area. Took tylenol and Benadryl which decreased pain and curbed itching.

Date and time of vaccination: (list both if they received both shots): 1st: 1/13/2021 @ 1030, 2nd: 2/11/2021 @1030 1st: Moderna #012L20A, 2nd #: 012M20A Stomach pain, cramps and diarrhea, nausea began aprox 2 hrs after 2nd vaccine, resolved after about 3hrs. On 2/13, began having a raised welts on left side of neck/back with itching. Called physician on 2/13, applied cream as ordered. On 2/15, saw PCP, who put her on cortisone cream and who recommended oral benadryl as needed. On 2/16, noticed that rash has moved around her neck to front of chest/neck area. In addition, left buttocks began having same rash as well as right arm at injection site. Intermittent low-grade fever throughout. Follow-up call with PCP scheduled for today. Advised to continue using cream/benadryl/tylenol as needed as prescribed by PCP.

It started to itch about Tuesday the 23rd. My daughter said Mom look at your arm. It is red, warm and itching. It is the size of a baseball. The side of necks also seems a little puffy. I have took Benadryl and put ice on it. Today the redness and warmness is still these but it is not itching.

Red, warm itchy rash with some swelling on 2nd day after injection. Still here on 4th day. No treatment as yet.

Worst headache ever had, fever, sever coughing, red swollen face, felt like a semi truck ran over ,tired

Extreme long standing arm pain with inability to raise arm, progressed to other arm. Diagnosed with Subacromial bursitis, shoulder capsulitis, SIRVA

Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg. The patient's medical history included cellulitis in left leg. No concomitant medications were reported. On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not. Patient did not take anything to treat symptoms but contacted her doctor and pharmacist. The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine. Seriousness criteria for the event of swelling and edema was medically important. Action taken with mRNA-1273 was unknown. The outcome for all the events was considered as recovered/resolved. No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.

Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many years and has had many blood draws. Patient had blood taken at her appointment and was waiting when the nurse came back out and said her blood had clotted so they needed to redraw her blood. She states this has never happened before and wondered if her blood clotting would have been due to her covid vaccine the week prior. She states the first girl who drew her blood was slower than the second time around when a different nurse drew her blood.

GRAND DAUGHTER CALLED NEXT MORNING REPORTING THAT THE ENTIRE RIGHT SIDE OF THE PATIENT'S BODY WAS SWOLLEN. SHE SAID THE FACILITY SENT HER A PICTURE WHERE THE RIGHT SIDE OF FACE, RIGHT ARM AND RIGHT LEG WERE SWOLLEN.

January 19th I had extreme pain in my stomach and chest, I went to the hospital and they diagnosed me same day with pancreatitis, I was put on medication for it omeprazole

Extreme fatigue and weakness, swelling of injection site (left arm), elevated temperature, mental confusion, complete loss of appetite ,cold sore

Day after the injection the area around the site became reddened, gradually worsening daily until the redness was 3.5" long x 4" wide, L arm was swollen from the shoulder to fingertips, and the arm was painful with limited ROM. Redness began to fade after 3 weeks; L arm remains swollen and painful. Pt was evaluated by the MD on 5/18/21 and was advised to hold off on 2nd vaccine (scheduled for 5/25/21) MD will decide if/when 2nd vaccine will be administered.

Covid-19 vaccine administrations (Moderna) 3/23/21 lot# 013A21A 4/20/21 lot# 013A21A Admission to Hospital (5/2/21 ? 5/10/21) for hypertension and acute on chronic back pain requiring ICU admission, hyponatremia thought to be due to SIADH. CT of abdomen done at hospital noting no significant lumbar abnormalities and a plain film of her lumbar spine with no obvious compression fracture. Outside hospital notes do not further outline why she could no longer ambulate. Brain MRI done and negative during that admission. Discharged to a rehab facility for ongoing weakness. On 5/13/21, patient?s son requested admission to hospital for further evaluation. She states that she feels confused and her legs are very heavy and she can barely move them. Notably she lives alone in her own home, used to drive, did not use any assistive device to walk, and paid her own bills until 2 weeks ago. The symptoms did occur approximately a week after receiving her last Covid vaccine. Pt also notes around April 1, 2021 having taken an engorged deer tick off her head. 5/14/21 Lyme serology IgM & IgG = negative. Neurology was consulted. She had an MRI of her thoracic and lumbar spine, as well as an LP. She had had an MRI brain at a hospital. Her MRIs did not reveal a source of her weakness and pain. Her CSF revealed albuminocytologic dissociation. Given this finding and the constellation of symptoms and LP findings, it was thought she had Guillain Barre Syndrome, presumably due to her COVID vaccine. She was given IVIG for 5 days. She improved with this. As above, she had a recent admission for hyponatremia and hypertensive urgency. Here, her blood pressure was somewhat labile, but at times was low. She was started back on amlodipine and carvedilol, but at much lower doses with plan for ongoing monitoring. In terms of her hyponatremia, her salt tabs were stopped, and eventually her fluid restriction was able to be lifted. Her sodium was 136 at discharge.

Client complained of swelling and redness to site of injection and radiating down arm. She also complained of facial and legs swelling. Client received vaccine at 10:30am and symptoms started around 11pm that night. Symptoms resolved per client on Monday 5/31/2021. Patient did not seek medical care, symptoms resolved on its own.

numbness in bilateral legs, SOB- states her GBS symptoms have slowly been progressively getting worse since Feb. after receiving the 1st dose of the COVID vaccine.

Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitted 6/8. Increasing lower extremity edema. Is obese. Coughing up phlegm. No fever/chills/chest pain/abdominal pain. COVID negative. Found to have a saddle pulmonary embolism and DVTs in the lower extremities . Appears unprovoked. Started on Eliquis. Still currently admitted 6/11

On March 18, 21. pts. left fingers were blue. she was diagnosed with blood clots. Ends of fingers died, lack of blood flow. They have been amputated. She is also swollen.

Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell and become hot and started to itch. She had a fever as well. She stated this continued until 1/5/2021.

No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.

?Moderna COVID-19 Vaccine EUA? patient has the following reactions: -Redness -Warm to the touch -Lump at injection site -Itchy -Swelling in the armpit area but no pain

At first didn't feel anything, her arm was puffed up a little bit which did not bother her. Then started to feel fatigued to the point of falling down. Light headed, dizziness with vertigo which is not getting any better. Has been taking Meclizine which did not help. Still having the same symptoms, lethargic, cannot get any energy. Took some Tylenol and Ibuprofen about once a day but still having symptoms.

Left upper arm has a large red raised area. Area measures 4.5 inches X 3 inches . Area is not painful and patient is not running a temperature. Patient is 12 days out from receiving her vaccine.

Per PCP patient saw her on 2/4/21 w/ c/o Swollen, pink, warm area of vaccine. Per patient she had mild GI symptoms about 48 hrs post vaccine which resolved with antacid. Arm was sore but not red or swollen. and by day 3 was completely well. On 2/3/21 stated had single wave of heat that lasted a few seconds then resolved. Awhile later her left deltoid started to itch. On 2/4/21 patient stated that arm was same as day before and felt fine otherwise.

On Saturday while getting your night medicines from the shelf, and started feeling dizzy, tried to reach the shelf and said to herself that "i can't do it, I just can't do it". She staggered back and sat down on a towel hamper and apparently fell off of that onto the floor, lost kidney function. Tried to get up and managed to get her phone out and called her husband (he's hard of hearing - was downstairs). She said when he got there her head was towards the bathroom door and felt that he could not get in and could not get her up so she tried to get up. She did not have any strength. Finally she got up to get on her elbow and crawled into the vanity area and raised up and pulled herself up. She did not enough strength to walk to the bed. She got to the bed and then started with chills, turned on her electric blanket. She felt better Sunday, 1/7/21, and is real shaky today. She feels a little stronger but is not back to where she wants to be. Yesterday evening she felt her arm itching a little bit, and looked at it and it was swollen and red, and had an area about the size of her hand. Her husband felt of it and said that he felt she had fever in it. The arm was sore to touch. It is itching a little bit this morning. She had a headache for a couple of days as well, took a Tylenol one night and her head felt real weird. It was not real severe, and it hurt more times than it did others. It would come and go. Has not taken anything else for these symptoms. Her husband checked her BP, Friday was 108/62, and last night 106/67.

Prt had facial redness due to a hair dye treatment PRIOR to vaccine. After vaccine, left side of face and left ear was observed by staff to be swollen and increasingly red. Vital signs stable; prt was not in any distress and prt had no complaints. Prt was evaluated by medical provider and given dose of benadryl and observed in clinic after for 2.5 hours with some improvement.

Redness, itching, rash, swelling, and sore to the touch on 02/09/2021 Improved but still present on 02/11/2021

On 2/16/21 area on arm became red, hot and swollen. Area approximately 4 inches across and 6 inches in length . Not itchy Ice applied

Lips tingling and swelling - same day as vaccine. Also developed a sore underneath the lip Also, slight swelling om side of head (above ear - along hairline) and a small bump, and cheeks slightly swollen. No pain, no nausea. Felt fine otherwise On Monday, red blotch under 1 eye. Lip swelling is reduced. On Tuesday. Redness under 2nd eye slight rash Feeling fine otherwise.

From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal, temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle. No head trauma or fall. Deceased 1/26/2021

Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.

Received call from patient on 3/3/2021. She reports that approximately 1.5hrs after receiving her COVID vaccine, she began having pain in the top of her head, neck, between her shoulder blades, down both arms to her fingertips, and down her spine. Reports also began having swelling in her feet. Reports having nausea and pain in her chest with walking. She reports she already had trouble with ambulation prior to vaccine, but it has been worse since receiving the vaccine. She reports as of 3/3/21, the pain is still occurring and not getting better. She has not seen her primary doctor since being vaccinated. I encouraged her to speak with her doctor or schedule a visit with them as her pain is not improving.

Approx onset 24 hrs after vaccination w/ weakness in legs and generalized malaise/myalgia, fell and diminished ability to ambulate -- > approx. 48 hrs after vacc was brought by EMS to ED for evaluation (2/19). Admitted to hospitalist service w/generalized weakness/ambulatory arrest, developed new onset urinary retention night of admission requiring straight cath intermittent. Increased weakness of leg, progressed to right arm/leg weakness > left leg weakness, so TELENEURO Consult initiated, hMRI w/o gado (2/21) checked, no CVA; recommendation for possible LP and EMG. Progressed to apparent areflexia ; seen by NEURO consult onsite (2/23) -- > felt to toxic encephalopathy due to COVID vaccination, motor predominant and detrusor involvement. Bladder atony resolved completely over approx. 3-4 days. Leg strength recovered somewhat over 4-5 days, and patient was referred for SNF rehab discharge. Developed low grade fever and pyuria on 2/24, urine cx grew ecoli ; initially treated with empiric ceftriaxone. Then patient developed left elbow and left knee pain/erythema/edema/tenderness (2/25) and was seen by ID in consultation. Got vancomycin empiric, and had aspiration of left knee joint effusion, revealing no crystals, 500cells monocyte predominant consistent with pseudogout. Vanco d/c'd; NSAIDs contraindicated for frail elder so patient was treated with prednisone short course. Ceftriaxone iv transitioned to po Keflex for ecoli uti to complete 7d course. Patient was discharged to SNF for rehab

Patient had an undiagnosed/unknown UTI at the time of her second vaccine on 3/2/21. She was admitted to Hospital on 3/3/21 with organ failure; she passed away on 3/5/21. Her cause of death is listed as Sepsis, and UTI. The vaccine was not listed as a cause of death, but might have been a "tipping point" in her inability to recover with antibiotic treatment.

I had soreness and redness at injection site, around the first of March I started having left foot pain, the doctors think it's gout or maybe something else they're looking for, but I've never had anything like this before. I had horrible pain in my left foot that didn't have before. Still in pain, wearing a boot and the leg is swollen from the knee down the whole foot.

started with swollen legs about an hour after the shot, about 3 hours after the injection developed swelling in face, slurred speach, chest pain.

Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died.

Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021.

felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot; couldn't swallow; antibodies absent; Fatigue/tiredness; Severe sore throat/not just a severe throat; Neck swelling; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt great weight and pressure on my chest) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Drug allergy (allergic to medications), Allergy to animals and Perfume sensitivity. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLIMEPIRIDE for Type 2 diabetes mellitus. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat), SWELLING (Neck swelling), SWELLING FACE (Facial swelling) and FATIGUE (Fatigue/tiredness). On 15-Apr-2021, the patient experienced DRUG SPECIFIC ANTIBODY (antibodies absent). On an unknown date, the patient experienced CHEST PAIN (felt great weight and pressure on my chest) (seriousness criterion hospitalization), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot) and DYSPHAGIA (couldn't swallow). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (felt great weight and pressure on my chest) and OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat) had resolved and SWELLING (Neck swelling), SWELLING FACE (Facial swelling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot), DYSPHAGIA (couldn't swallow), DRUG SPECIFIC ANTIBODY (antibodies absent) and FATIGUE (Fatigue/tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) states that patient does not have any antibodies. 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. The patient's HCP advised to wait for two more weeks to receive the second dose of vaccine. Med Info Agent: *Crosslink with MOD21-058959, MOD21-062129, MOD21-076250, MOD21-085519* Call received from consumer who stated she had reported a previous event, but is frustrated because on the form it says if you have a problem, call us, but there is no number to call. Caller provided her address and confirmed contact information, contact information updated. The consumer stated she does not leave her house, and she does not have a fax machine, so it makes it difficult for her to send it back. The caller would like the company to know about this, but did not have any further requests. Consumer stated she will eventually have someone send it out for her. Caller stated it wasn't just a severe throat as the form mentions, she couldn't swallow, but did not elaborate. Consumer stated she is not going to get the second shot per providers direction, and stated she had no antibodies from the first dose. No further information provided. 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 report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs. This case was linked to MOD-2021-058039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: significant: event added On 03-May-2021: Missed dose On 20-May-2021: Significant follow-up received On 21-May-2021: VAER from uploaded; 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. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.

Had Covid Vaccine AM of 1.8.2021. Woke up with Nausea, Vomiting X 4, Chills the following AM. Presented to ED. Found to be hypotensive during ER. Nausea Vomiting resolved. Tx with fluid replacement and dismissed home instructed to monitor BP. B/P dropped again at home returned and admitted to hospital.

localized cheek and tongue swelling, with some itching at same location, which began approx 10-12 after IM injectgion

patient presented to clinic today with two day history of pain, swelling, redness and warmth at injection site. no fever chills, malaise or other new symptoms. area of erythema covered entire deltoid area lateral humerus approx 10 cm dia . swollen entire arm. tender. warm.

Patient developed edema and redness to about 70% of her upper left arm the next day, 01/18/2021, in the morning is when she noticed and it worsened for several days. By the seventh day, the swelling and redness started to improve. She did experience intense itching especially around the injection site. She did take Benadryl around day seven or eight for the itching. She did have muscle soreness for about 1 - 2 days that resolved. She did not have any further pain despite the redness and swelling. She had no fever, chills, body aches. She did not have any wheezing or SOB. Overall, she reports that besides the itching she felt good.

1-16: Cant take deep breath, 1-17-18: R hand swollen, painful - Advil, 1-21-23: Extreme pain in L wrist, Swollen. Advil pm, Advil, immobilized with stretchy bandage

- redness, swelling, itching since vaccine was administered. Pt treated at home with Benadryl. - Pt sought treatment at our facility - given oral Keflex 500mg one QID x 5d and Prednisone 5mg one QD x 7d.

Spoke to daughter on 1/26/2021. On 1/23/2021, client began itching on the back of her neck then 1/24/2021 redness on upper right arm - almost her whole upper arm swollen. Not hurting at all. Right side of face is red. Denies lips swelling, SOB, or feeling bad. Daughter is concerned that the redness and swelling worsening. Daughter asked if she needed to take her to the doctor. Instructed that if she feels that it is worsening that I would recommend that she take her to her PCP. States will take to doctor or urgent care today.

Patient called and stated day after receiving her second dose of Moderna she began to have generalized edema BLE, BUE, and swelling around joints, she states her vision doesn't seem the same, slightly blurry, but she can see, states hard to describe. States she had a fever 101. on day after and took Tylenol - fever resolved. Other symptoms continue.

Deep vein thrombosis (DVT) of left lower extremity She reported swelling of her left leg and was seen at Family Medicine Urgent Care on 2/19/2021 and was diagnoses with a thrombosis of the left popliteal vein. She was treated with Xarelto for anticoagulation and compression stockings. Her treatment course was uncomplicated when I saw the patient at follow up and was made aware of her condition at her appointment with me on 3/1/2021.

02/25/2021 by 12:30 feeling very tired , did not sleep well as right arm was painful and hot to touch. 02/26/2021 weak, lethargic, pain right arm , redness, swelling and warmth 1" x2", Temp 101.7, Tylenol at 12 noon and temp 100.7 @ 6PM Tylenol given, did not get out of bed till 8PM, only drank water during day, finally Jello around 8 PM. 02/27/2021 still lethargic, resting in bed, right arm red 3"x 3" and warm, itchy, took Claritin and did cool compresses and hydrocortisone cream as had been directed by Dr. after first vaccine . On 2/28/2021redness 3"x4" with two painful bright red itchy spots near inside of right arm continued with treatment. On 02/29/2021 area 4x4 but less redness, still sore and itchy. By 03/01/2021 redness , itching, swelling, pain gone.

Activated a BAKERS SYSTS; she could not get up, she could not go to bathroom; Left leg was very sore; Left leg very swollen; Chills; Had fever; Inconsistencies to remember; Not feel well; Delirious; A spontaneous report was received from a consumer concerning 88-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad reaction, began to not feel well, had fever, was delirious, inconsistencies with speech, problems with the left leg, left leg was very sore, very swollen, could not get up, had chills, couldn't sit in the bathroom, overreaction and activated a Baker's cyst The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, approximately three hours prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced to not feel well, had fever, was delirious(considered medically significant event), inconsistencies to remember, problems with the left leg. On Wednesday 17 Feb 2021, the patient experienced left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills. On Thursday 18 Feb 2021, the patient experienced could not sit in the bathroom. On Friday 19 Feb 2021, the patient was still very swollen. On an unknown date, the patient experienced activated a BAKERS SYSTS Laboratory details included, on Saturday 20 Feb 2021, the patient went to the hospital and got an ECO DOPPLER. Treatment for the event included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, bad reaction, began to not feel well, she had a fever, she was delirious, said inconsistencies, problems with the left leg, left leg was very sore, very swollen, could not get up, could not go to the bathroom, had a fever and chills, couldn't sit in the bathroom, overreaction and activated a BAKERS SYSTS was considered recovering(getting better every day).; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship cannot be excluded.

3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed

pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes. She had trouble swallowing, no appetite, and had severe chills w/ no fever. She had trouble sleeping and eating. She could only drink water. She said she could only get a couple of hours of sleep a night. Pt developed thrush. She went to her PCP on 3/18/21. She was prescribed meds to take. Pt went to Dr. on 4/2/21 since she was not feeling any better. She was prescribed more medicine. She went to PCP on 4/19/2021 he gave her valium so she could some sleep. He ordered a sleep study. Pt says she is just starting to get her appetite back but is still having trouble sleeping.

Pain in eyes; Lips was swollen; Itchy; Burning; all around her cheeks and near the nose was in pain; Like a rash; Mouth went to one side of her face; Left side of her face get swollen; 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful; Big and red spot in the upper part of her face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL ASYMMETRY (Mouth went to one side of her face) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high (Takes medications for high blood pressure.). Concomitant products included INSULIN for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FACIAL ASYMMETRY (Mouth went to one side of her face) (seriousness criterion medically significant), SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash). 02-Apr-2021, the patient experienced ERYTHEMA (Big and red spot in the upper part of her face). On 06-Apr-2021, the patient experienced EYE PAIN (Pain in eyes). At the time of the report, FACIAL ASYMMETRY (Mouth went to one side of her face) and ERYTHEMA (Big and red spot in the upper part of her face) was resolving and SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), EYE PAIN (Pain in eyes), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash) outcome was unknown. Treatment: Hydrocortisone and Antihistamine Concomitant: A couple of High blood pressure medication Additional information:Immediately after receiving the vaccine (she thinks) the L side of her face get swollen. Her lips was swollen, all around her cheeks and near the nose was in pain. And developed 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful. She also developed a big and red spot in the upper part of her face. Still there but is getting better (seem is going away). Her mouth went to one side of her face, to the R side. It still there but is getting better (tomorrow is going to be a week). Also, 4 days after the 2nd dose her eyes started to hurting and couldn't put drops. She never had fever, cough, chills or nausea. 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.

She got her vaccine, was tired, no energy. No rash or fever, perhaps a reddened area around the vaccine site but it went away. About a week later she found a lump by accident under her arm in the armpit but down a little further towards her breast. The lump is painful when she puts pressure on it when she's trying to sleep. She knows it's there. She went to her PCP yesterday, 5/24/21 and he told her that they will watch it and it should dissipate. He did not give her any treatment for it. She did also have a stiff neck on the side of her vaccine and a headache, which have disappeared. She just wishes it would go away as it's a nuisance. Her doctor said that it was swelling of the lymph node. If she wears something tight it hurts her, but otherwise it doesn't, especially if she wears a bra. She just does not have the energy that she had before. She did get a Prolia shot on 2/4/21 but had no reactions from that, and was told that it would not interfere with the vaccine.

Patient report to have developed red blotches all over both lower extremities a few weeks after receiving first covid vaccine. Leg began to swell with bleeding and open sores. Required hospitalization 4/22/21.

Pr received her Moderna covid 19 vaccines on 2/26 and 3/26/21 and per the daughter she went downhill since with progressive fatigue and not acting herself and failure to thrive with poor appetits. she was hospitalized from 6/9-6/19/21 with recurrent urinary tract infection despite appropriate treatment as an out pt, severe sepsis, diffuse pneumonia, acute metabolic encephalopathy, severe, persistent hypokalemia due to poor po intake and a pancreatic mass- possibly malignant with negative ca 19-9 incidentally found on imaging. She was sent home on comfort/hospice care on 6/19/21 as family opted for no further aggressive treatment for the pancreatic mass. she was treated with antibiotics for the sepsis, pneumonia and urinary tract infection during her hospital course.

Fully vaccinated patient admitted to hospital with detected COVID PCR test. Patient with positive COVID swab in ED on 05/31/21. Came to ED with leg swelling, weakness. Discharged home on 1 L/NC of O2 due to lower O2 sats 92-94%. Patient seen again in ED on 06/06/21 this time for increasing shortness of breath, increasing oxygen demand, and icnreased work breathing. O2 needs since last ED visit increased to 2-3 L. Admitted to hospital for COVID infection and CHF exacerbation. Treated with aggressive diuretics, remdesivir, and dexamethasone. Blood cultures tested positive and was started on IV ATB's. Patient discharged back to AFC with Hospice services.

upper arm red swollen hot itchy, resident states has felt terrible since receiving the vaccine will not get the 2nd dose, has had chills, body aches, headache, backache, was in bed for days states she would rather die than have the second vaccine still not feeling "right" to this day

Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination. Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual. Presented to the ED the next day c/o SOB and weakness for the last week. Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID). Patient did admit she lied about her symptoms on the day of vaccination to get the shot.

Patient received the first Moderna vaccine IM left deltoid on January 23, 2021 and the next week developed redness, discomfort and swelling in the left arm. She had seen her dermatologist that week for another issue and the dermatologist was so concerned that she described Keflex. The patient was afraid to take the Reflex as she has a PCN allergy so she presented to Urgent care. She has a cellulitis in the arm. She has antihistamine a home and took one last night. I advised her to take it nighty until resolves and to start Clindamycin po TID x 10 days to treat cellulitis and also may take Famotidine prescribed by her physician which she had not started yet and may use OTC cortisone cream on area.

Patient experienced labored breathing, rails bilaterally, and a temp of 99.2. Labwork showed a critical sodium level of 163. She was started on D5/NS 2 liters and then sent to the hospital when her fever spiked to 101.3. She was also very lethargic. She was diagnosed with pneumonia / sepsis

1/21/2021 started feeling achy joints and restless at HS, reported feeling chilled 1/22/2021 Reports fatigue, states "slept all day" 1/23/2021- 1/26/2021 reports face "puffy", continues with muscle aches Reports used Tylenol to treat symptoms. Not able to recall date/time of initial dose.

Paralysis swelling. Seizure, lost eye sight, partial speech ! And is bed riding and loss of balance

patient says at insertion of syringe into arm she experienced what she says is an electrical current in her arm. The injection hurt immediately and thereafter. that afternoon and night 48 hrs patient could not lift her arm above her waist and was in significant pain in her shoulder. Patient has had previous bursitis in both shoulders. Patient claims that injection site location may have caused her bursitis to flare up. patient used cold compresses for 48 hrs and then switched to warm. as of 48 hrs patient still in pain and cannot lift arm above waist. Arm was also sore at injection site. Patient did not feel it was neceassary to go to dr but would monitor symptoms over next couple days.

Patient was admitted for lower extremity pain, swelling, and development of a blood blister. Hematoma was drained and pt was found stable for discharge

Redness, swelling, itchy, peeling skin, hot to the touch beginning 2/26 and site was really itchy and hot on 2/28. No other side effects. Feels a little better today 3/2/21.

Felt feverish, fever blisters in and outside of nose and mouth, headache, swollen and sore right arm to elbow, severe word finding deficit. Word finding problems subsided in 90 minutes. Arm swollen for 2 weeks. Headache lasted one day. Fever blisters lasted 2 weeks.

Patient seen and evaluated by PA-C. with myself. We agreed on the clinical findings and implemented our plan together. Please see PA's note for details. All relevant procedures supervised. Patient arrived to the emergency department due to respiratory symptoms, hypoxic, reported that Wednesday he received his 2nd dose of COVID vaccine. His initial workup was concern for NSTEMI with elevated troponin and peaked T-waves, his chest x-ray concerning for COVID/pneumonia. Patient initially tolerated oxygen by nasal cannula and sepsis protocol was started including IV fluid resuscitation that was done cautiously due to the concern of COVID with respiratory failure. The biotics were given. PA-C readdressed code status with patient who confirmed that his DNR DNI, she so contacted his daughter. Patient had multiorgan failure including acute kidney injury, and pneumonia with respiratory failure +/- respiratory failure. Due to the concern of NSTEMI patient was initially going to be transfer to was hospital and transfer was started. Patient respiratory status started deteriorating and his blood pressure dropped slightly but improved after 500 cubic centimeters of IV fluid and he was also placed on a NIPPV. Around 6:00 p.m. patient has significantly desaturation and he discontinued himself NIPPV. Due to inability to intubate patient, he was ventilated with BVM, patient is slowly improved saturation levels and was opening his eyes, he was placed on a non-rebreather. At this point there is high concern of ARDS and due to inability to intubate or give for the respiratory support His daughter was at bedside and updated of current medical status and poor prognosis. Patient continued deteriorating and at this point he had agonal breathing. His daughter was at bedside and she was made aware of the futile prognosis of patient due to his respiratory failure. Patient rapidly became bradycardic and went into cardiac arrest. No CPR was done due to the DNI DNR status of the patient. Critical Care Procedure Note Authorized and Performed by: MD Total critical care time: Approximately 30 minutes Due to a high probability of clinically significant, life threatening deterioration, the patient required my highest level of preparedness to intervene emergently and I personally spent this critical care time directly and personally managing the patient. This critical care time included obtaining a history; examining the patient; pulse oximetry; ordering and review of studies; arranging urgent treatment with development of a management plan; evaluation of patient's response to treatment; frequent reassessment; and, discussions with other providers. This critical care time was performed to assess and manage the high probability of imminent, life-threatening deterioration that could result in multi-organ failure. It was exclusive of separately billable procedures and treating other patients and teaching time. Please see MDM section and the rest of the note for further information on patient assessment and treatment. PE: VITAL SIGNS: BP: 126/75 Pulse: (!) 122 Resp: (!) 40 SpO2: (!) 82 % Temp: 98.1 °F (36.7 °C) Height: 5' 8" (172.7 cm) Weight: 152 lb (68.9 kg) General: Alert, nontoxic, in no acute distress. Lungs: Clear to auscultation bilaterally. CLINICAL IMPRESSION: 1. Sepsis with acute hypoxic respiratory failure and septic shock, due to unspecified organism (HCC) 2. Suspected COVID-19 virus infection 3. NSTEMI (non-ST elevated myocardial infarction) (HCC) 4. Multifocal pneumonia 5. ARDS (adult respiratory distress syndrome) (HCC) 6. Acute kidney injury (HCC) Further care and disposition otherwise as outlined by PA. ED on 2/14/2021 Revision & Routing History Detailed Report Note filed date Mon Feb 15, 2021 8:46 AM

Patient had a COVID vaccine on 3/12/21, this was her Second dose of Mederna vaccine. She states she had a scrap on her right elbow 4 hours after she states it turned red and swelled up. She then scrapped her left pointer finger and that swelled and turned red and going up just past her wrist. She states these are really improving but the swelling and itching around her left eye is getting worse. She feels her nose feels swollen. She states her eye is matted shut in the AM. She feels fatigued.

Pt received her 1st Moderna covid 19 vaccination on 3/12/21. She developed sudden Left lower extremity swelling on 3/17 which progressed to her hospitalization for a left lower extremity DVT on 4/6/21. she was placed on eliquiss and eventually discharged home.

Pancreatitis; When she got back home she wasn't feeling well so went back to the hospital two weeks after; She got sick and got into the hospital for 3 weeks; She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.; second dose was cancelled due to lack of product; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (She got sick and got into the hospital for 3 weeks) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) (seriousness criterion hospitalization prolonged), PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product). At the time of the report, PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) outcome was unknown and PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provide by the reporter. Treatment information was not provided by the reporter. Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time. Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not applicable.; Sender's Comments: Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time. Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not aplicable.