Moderna

SIRVA due to injection being delivered too high and delivered to shoulder capsule instead of deltoid muscle.vaccine was delivered One centimeter form the Acromion.

Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative: employee was told to follow up with his physician and get tested for covid

Headache, Myalgia, Arthralgia, Fever, injection site pain/redness/swelling, chills, fatigue, night sweats Narrative: Employee reports experiencing fever, chills, night sweats, headaches, joint and muscle aches, fatigue, and injection site pain/swelling/redness. Reports all symptoms have resolved.

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

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

Moderate pain (4 on 1-10 scale) upper R. deltoid, persisted for approx. 36 hours. Not tender to touch. Pain was sensitive to movement and somewhat restricted movement of R. shoulder for a while. Not considered serious by patient. Pain was fully gone 48 hours post injection.

After monitoring patient for 15 mins he then returned to his office. Called around 30 mins or so later and stated he was experiencing itching all over body and extreme nausea. Employee health went to office to check on patient. Face did appear flushed, but no rash seen. Stayed with patient until he stated he felt better and no further issues.

Began to feel ill ( stomach pain / Headache ) .. my skin became flushed ( face was very red ) blood pressure was elevated ( 180/90) I normally have low BP.

1. Incontrollable Shaking of body and limbs-- for 2 days, 2. Migraine, Body aches, Stomach Cramps, Cough, Shortness of breath, Chills, Heavy chest, Hives, Soreness at injection site --all for 9 days

5 hours post vaccination broke out with a hive on my face, felt lightheaded and heavy in the chest but not short of breath. went to bed around 10 that evening and slept well. felt fine the next morning, hive stayed for about 2 days.

Large red rash (baseball size) around injection site that appeared two weeks following injection. No rash until that time. Rash still appears two days following notice.

Seven days after receiving shot, left triceps became very itchy and swollen. I had experienced mild pain in left triceps for approximately three days after shot, pain left and have had no adverse condition until today (01-19-2021).

Patient describes right shoulder soreness/ pain beginning a couple hours after the injection. Shoulder pain increased and made his "shoulder feel like it might pop out of the shoulder joint." He states that his shoulder feels "loose."

The patient was scheduled to receive the second dose of the series on 1/25/21 and received it on 1/19/21. The patient reported injection site soreness lasting 24 hours.

Mild fatigue, general aches & pains, very sore shoulder at injection site, chills, difficulty sleeping due to muscle aches.

Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise. Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained. Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours. Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms. I often work through illnesses like the flu. Couldn?t work through this.

Moderna COVID?19 Vaccine EUA. On the day after my shot, injection site muscle pain, nausea, flu-like symptoms throughout the day.

migrating rash from injection site to elbow now within 2 to 3 days, itchy. started 5 days post vaccine

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

Rash and swelling in the shoulder area from injection site downward. approximately 4 inches wide and 6 inches long.

Early the next morning I had a red rash on my chest and the back of my shoulders. It really itched and I went to the Doctor. They gave me anti-itch stuff from the injection. Then my Lymph nodes swelled up in my throat. I went home and took my medicine and the itching stopped in about two days.

Oval bright red, lesion immediately adjacent to injection site over left deltoid with mild to moderate swelling. Started app. 3"x1", over 3.5 days grew to app. 7"x2.5". Extremely severely itchy, not relieved by Benadryl cream or hydrocortisone ointment. Very temporarily relieved by applying ice. On day 4 lesion has mostly faded, swelling is reduced and itching is now mild and intermittent.

Rash on left upper arm around injection site and up to shoulder. Rash is itchy and warm to touch. Raised area under skin adjacent to injection site.

10 days after first Moderna Covid 19 vaccination, the patient developed a generalized pruritic morbilliform eruption involving the trunk, bilateral axillae, bilateral inguinal folds. Patient initially seen by his PCP and then the emergency room. He presented to our office 2/1/21 with above findings on a prednisone taper from emergency room.

body flushing, fatigue, and itchiness of his right arm accompanied by intense over his entire left arm. Patient felt his body getting overheated

Rash over whole body, greatest on bilateral legs. Rash is raised and itchy, had some that appeared blistery yesterday. Medical provider gave Hydroxyzine 25 mg, every 6 hours

Red lump and soreness at injection site. Warm and sore to the touch. Itchy skin in a 2-3 inch circle around the injection sits. Lump is injection point

Extreme untreatable Headaches, burning sensation left side of body, backache left side, Eye Pain and sudden onset of shingles.

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

Reports soreness and tingling at site of vaccine administration, denies any additional complaints; no swelling or redness noted. Medical monitoring x 30 min; reports symptoms subsided post rest. BP 136/89 HR 72 Released home from facility to self, encouraged PMD prn

Caller stated that he had his shot in the right arm and hour later he developed hives to the left side of his face. He took 50mg of Benadryl and the symptoms went away. He denies any other concerns at this time. Member informed to report the symptoms to website and follow up with his PCP or call back if he develops new symptoms.

Headache, fever, body aches, nausea, fatigue, lethargy, injection site pain over first 12-18 hours. Fluids only for treatment

Right upper arm became very swollen, hard, and painful to the point that I could not raise my arm or touch the spot. I also had a fever and headache.

Since 12 Feb to present I have had aching bones and joints alone constant fatigue and general weakness in my left arm.

On 2/6/21, I noticed that my right arm had a large patch of erythema 10cm by 8cm that was hot to touch and tender. The patch was slow to resolve but is mostly resolved today 2/18/2021.

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

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

RPh administered the vaccine, and the patient passed out 10 minutes afterwards and hit his head. Patient felt very faint even after sat up with feet up. Patient was given orange juice and he drank it all. Paramedics arrived and checked him out. 45 minutes after him passing out, patient felt fine and went back to work. He had gashed his head open on the fall.

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

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

Right elbow redness soreness burning , right kneecap burning Pimples on left shoulder and neck area very itchy right and left wrist area pimples and itchy FYI Elbow and wrist pimples had 2 small holes on each sore that almost looked like I was bitten by something but I wasnt. Dermatologist stated to apply Mometasone Furoate Ointment USP,0.1% which helped with the burning and itching.

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

Shot received 2/21/21 and started to feel itchy on my legs about 5 days later and on 3/3/21 i developed a rash on my arm and hands which is itchy and i still have itch on my legs

-Severe soreness in injection area lasting 3-days -101 fever starting 18-hours after vaccination and lasting 10-hours -Fatigue of whole body lasting 3-days -Loss of appetite lasting 2-days -Acute soreness in both shoulders that have existing tendonitis and in right ankle that has existing arthritis lasting 2-days -Internal lower abdominal pain starting 2-days after shot and lasting 24-hours

About 10 days after !st shot started getting a rash on back and stomach areas, treated with Hydrocortisone 2.5% , Hydoxyzine HCL 55mg/Predisone. After 2nd shot still treating as before and after a few days rash has got a lot worst and is all over body about 90%. as of today no change in rash and medication has ran out and doctor contacted

Approximately 12-18 hours after receiving the 1st dose, I developed a minor skin rash on arms and legs. within 24 hours the rash became itchy with no relief. 72 hour began taking Antihstamine 25 mg every 4-6 hours and using Diphenhydramin hyroclhoride !% cream. No breathing or swallowing problems have been noticed.

Initial pain at the injection site - which resolved within 24 hours. After 3 weeks, mild rash on the stomach area. Very Itchy. The rash is there for 2 days. Taking Benadryl. Not much reduction.

First two days, typical injection site soreness; third day my left shoulder joint had a tendonitis feel to it and it has progressively worsened such that range of motion is limited and certain movements very painful

I read today of "covid arm," as described in an article about a symptom that may arise for those who got the Moderna vaccine. I simply wish to share my reaction for the sake of the statistics. The evening after I took the first shot of the vaccine I had a hard red bump on my arm near the injection site. My arm ached that night, and was notably better already in the morning, without aches the following day. The blister was gone the next day. I'm relatively healthy, trail run and get strenuous exercise usually twice a week.

Vomiting, diarrhea, shaking, difficulty breathing, OSat down to 90, whole body sensitive to touch, pain in left arm

Patient received a rash on arm just below site of injection within 24 hours of injection. It was warm to the touch and slightly itchy. No medications or treatments were pursued, just observation. The rash resolved spontaneously within 4 days.

Moderna COVID- 19 Vaccine EUA: Three days after vaccination patient reported rash on chest, back, and legs. No itching reported. Patient advised to use antihistamines if itches and to return to clinic as needed. Two days later patient reports rash has not improved and has developed runny nose, sneezing, nasal congestion, mild cough, and cold symptoms: denies itching, fever, sore throat, shortness of breath, changes in taste or smell, and pain. Patient diagnosed with mild COVID-19 and being managed at home.

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

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

Within 24 hours I have experienced a severe red rash along my mid drift / hip area and up my sides reaching towards armpits. Knees and calves also rashed. itching at times, not constantly.

Injection was given very high up near shoulder. Experiencing pain in left shoulder and unable to fully extend my arm. Was not able to sleep first 2 nights with pain. Still not able to lift arm without pain in shoulder.

Pain, redness, swelling at injection site since day of vaccination. Also fatigue; sleeping 10-12 hours per night since vaccination date.

Hard knot under skin at injection site, skin red about 3 inches diameter around injection site, some itching, turning into a slightly lumpy red rash after a few days with a few very small pimple-like pustules, now a week later, most of this has subsided.

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

Up and down persistant fever with very bad chills for 2 days straight on Sunday and Monday 3/14- 3/15/2021. Also accompanied by very bad body aches and pain in my left arm. Left arm pain radiated to left axilla. Strong headache for three days 3/14-3/16/2021. Left arm still hurts on 3/17/2021

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

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

Fever up to 102.8 that is not lowered with Tylenol, significant bilateral knee pain, and redness at vaccine site. Was seen in the ER and advised to "Take ibuprofen ( 3 Advil tablets) 600 mg every 6 hours. In between you can also take acetaminophen (2 Tylenol extra strength) 1000 mg every 4 hours . For example Ibuprofen 600 mg at 8pm. 2am, 8am 2pm regularly Then can take tylenol in between those doses if needed. Drink fluids well." Follow up call to patient on 3/19/21 "States he is feeling better today. Has been taking Ibuprofen which is controlling his fevers. Does not think he has a fever at this time. States I sweat it all out last night. No questions or concerns."

One week after receiving first Moderna Covid-19 shot left arm, at injection site, was slightly swollen and red. There was also tenderness in the arm.

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

Morning after injection. Severe flu like symptoms including nausea chills fever muscle/joint pain pain at injection site sore throat and runny nose. Took ibuprofen for fever and body pain. Next morning body aches runny nose sore throat and a full body rash that did not itch.

After the 2nd inj of Moderna, I?ve been experiencing a chronic pain on the injection site, now it?s forming a lump exactly where the needle was placed, the pain is increasing and sensitive to touch the area of the injection, I?m unable to sleep on the left side of my body.. What should I do?

Itchy injection site area 4? diameter irregularly shaped red skin at injection site area Slight pain at injection site area when pressed ?Hard? skin at injection site area

I developed an itchy, red rash approx. 3' x 5" on right arm around the injection site 2 days after the injection. There were no other discernable effects and the rash lasted about 1 week.

A few days after my first dosage, I started getting incredible itching all over my back, as well as some on my arms and chest. I tried to ignor it but I found myself scratching and scratching. I tried all sorts of creams and washes. I hadn?t changed any soap or clothes. I put in for a dermatologist consult with my PCP. I couldn?t imagine this was from the vaccination so I hadn?t even brought it up. I finally got a derm appt for 01/25/2021. My first Moderna vaccine was 01/27/2021 and my second Moderna vaccine was 01/24/2021. When I went to my first appt, I was told it appeared to be allergic. I did not even tell her that I had the second Moderna vaccine the day before because I didn?t think there could be a connection. I had a derm f/u on 03/25/2021. The allergic rash was no longer diffuse but in patches, mostly on back and some on chest. She thought is could be eczema, something I never had on my body. A biopsy was taken.

For 2 days after the injection, the area around the injection was tender, but there was no swelling or other side effects. On Sunday 3/28/21 around 4:00 pm, a 2" x 1-1/2" area around the injection site turned light red, became sore, slightly swollen, and warm to the touch. Temperature is 97.2 degrees. Applied over-the-counter Hydrocortizone cream last night and again this morning. Did not make it better or worse. Will apply Benadryl next.

Patient reports he developed a lump under his skin about 5cm x 5cm immediately after the injection. Over the next few days the lump got smaller then about 3 days after the injection started getting worse again. Today, 10 days post-injection, he presented to our clinic with a large area of induration measuring 7cm x 10 cm with a dark red center measuring 2 cm x 3 cm.

Patient reports he developed a lump under his skin about 5cm x 5cm immediately after the injection. The lump initially improved but 3 days later it started getting worse. Today, 10 days post-injection, he presents to our clinic with a large area of induration measuring 7cm x 10cm with a dark red center measuring 2cm x 3cm.

Patient is complaining of profound fatigue for the past five (5) days since his vaccination, He states that he has been unable to leave his bed since he got is shot. Also reports , left arm pain (vaccination site). stiffness. Today he is ambulating with a walker (typically uses a cane).

Patient got an allergic reaction (rash on cheeks and forehead) the day after the first dose of the Moderna vaccine. Patient came to pharmacy to let us know today. We recommended benadryl to help with his allergies.

3/30/21 - Vaccination administered 0645, minor soreness at injection site. 3/31/21 - Upon awakening at 0600, minor soreness at injection site with additional minor pain in right trapezius muscle. Later, 400 p.m. feeling of minor weakness, 900 p.m. more noticeable pain (muscle soreness) in right trapezius. 4/1//2 - Awaken at 3:00 a.m. by more severe pain in right trapezius. Upon getting out of bed at 6:00 a.m. found pain expanded to full right trapezius, partial extension to middle of right pectoral, fully up right side of neck, and partially in right armpit. Right side of face experiencing numbness along right cheek bone and right side of right eye. Experiencing increased pain when raise right arm elbow above shoulder. Typing this is difficult.

fever of 101.8, aches from tips of right fingers to tips of left fingers and down my back to my buttocks, headache, blurry vision,extreme fatigue. all lasted about 28hours. now just pain at the injection site.

The evening of the shot, around 10pm, I noticed that I was getting chills. A hour or two later the fever started. Sleep was difficult in bed because of pain in right arm. Fever and chills continued Saturday, with a high temperature of 101.5F, along with body aches and pain. Symptoms started to lessen on Sunday, chills first then fever, and finally disappeared on Sunday night. Pain at injection site lasted for a few more days.

1st vaccination on March, 4, 2021 - Right arm, soreness at injection site for 2-3 days. No swelling. After that I was fine. 2nd vaccination on April 1, 2021 - Right arm, Slight bodily flushing within 15 minutes of injection. About 4:00 PM started to develop mild aches and chills.. As the day progressed, aches and chills became substantial with a 2:00 AM temperature of around 102 degrees F headache and mild nausea. now 5:00 PM the following day ,i.e., now, with a temperature of 100.5. F. Injection site slightly diminished in pain. No swelling. Monitoring my condition.

General covid symptoms. Very tired, loss of appetite, muscular aches especially hip area, inflammation at injection site, mild nausea

I had my second Moderna Covid-19 vaccine at noon on Thursday, April 1. I felt lethargic evening of injection, and injection site was sore to touch for next few days with a mild case of diarrhea. Sunday, April 3 I noticed that there was a large red circle with a slight rash surrounding the injection site that hadn't been there the day before. It was gone by the next day. The only reaction I had to the first injection was a sore arm for two days.

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

9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was wheeled to the stretcher were he was advised to lay down. BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57 Client still complaining of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild reactions and to call 911 if he began experiencing chest pains ,difficulty breathing or any other severe reactions. Client released with his wife and 2 other family members.

Aching muscles over entire body. Particular soreness at injection site. Head ache, chills. lasted 36 hours.

Large red area where shot was given, had heat in the area for 2 - 3 days, went away in about 5-6 days.

3 days after 2nd dose developed itchy rash on left side of upper back and very painful, saw Dermotologist and she diagnosed it as Shingles

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

loss of sight in his eyes; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (loss of sight in his eyes) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 31-Mar-2021, the patient experienced BLINDNESS (loss of sight in his eyes) (seriousness criterion medically significant). At the time of the report, BLINDNESS (loss of sight in his eyes) and VACCINATION SITE PAIN (Soreness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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 event of vaccination site pain, a causal relationship cannot be excluded. However,very limited information regarding the event of Blindness has been provided at this time. Further information has been requested.

Overview of symptoms in order of occurrence: Pain in the arm; Dry eyes; Fatigue; Nausea; Headache; Chills; Joint pain; Muscle aches; Dizziness; Measured Fever; and Arm rash. Symptoms of greatest concern: Nausea, Headache, Chills for 1-2 days; and the ongoing Fatigue is now in its 4th day. Details of symptoms with time of onset, duration and severity are provided below (Note: Injection with 2nd dose of Moderna vaccine took place at 9:24AM on 07APR21): 07APR21, 10:30AM ? Arm Pain: Onset of mild pain in arm that was noticed when not touching the arm; Level of pain was a ?1? out of 10). An annoying level of pain where the pain ramped up to 3 or 4 on a scale of 10 when the arm was moved about began at 7:00PM on 07APR21 and lasted 12 hours until 7:00AM on 08APR21. The pain diminished to a mild ache for another 33 hours until it became insignificant by 4:00PM on 09APR21. 07APR21, 1:00PM ? Dry Eyes: Onset of an intermittent feeling of very dry eyes that lasted approximately 1-2 hours at a time and continued over a period of 9 hours until 10PM on 07APR21. 07APR21, 3:30PM - Fatigue: Onset of mild fatigue that steadily increased until bedtime at 10:00PM on 07APR21; and was significantly more pronounced at 1:00AM on 08APR21 (was difficult to stand and walk 20? to closet to obtain a thermometer; could not walk straight and bumped into hallway on left 4-5 times). Fatigue was rather frightening and severe from 3:00AM to 3:30AM on 08APR21 when I crawled to the bathroom, but could not get off my knees and collapsed on the floor until I could return to bed by crawling on the floor. Was able to stand again at 7:00AM on 08APR21 and walked (slowly) 30? to a sofa. Slept from 10PM on 07APR21 to 1:00AM on 08APR21; 4:00-7:30AM on 08APR21; 8:30-10:30AM on 08APR21; 11:00AM to 3:00PM on 08APR21; 7:00PM on 08APR21 to 3:00AM on 09APR21; 3:30AM to 7:30AM on 09APR21; 9:30PM on 09APR21 to 9:15AM on 10APR21; 6:40PM on 10APR21 to 7:00AM on 11APR21. Ongoing weariness continues as I write this at 11:00AM on 11APR21. 07APR21, 7:10PM - Nausea: Onset of continuous nausea that lasted 13 hours and 20 minutes until 08APR21, 8:30AM. Nausea was particularly bad with intermittent dry heaves for the 7.5 hours lasting from 1:00AM to 8:30AM on 08APR21; Nausea then came in waves for 23 more hours until 09Apr21, 7:30AM when it was finally gone. 07APR21, 7:10PM - Headache: Onset of headache that has lasted 4 days (as of 11APR21, 10:30AM). Finally gave in and took one extended release tablet of 650mg Acetaminophen tablet about 25 hours after the vaccination (i.e., took painkiller at 10:30AM on 08APR21). Took two Ibuprofen at 9:00AM on 11APR21. 07APR21, 7:15PM ? Chills: Onset of chills that increased to intermittent shivering by bedtime at 10PM on 07APR21. Awoke at 1:00AM on 08APR21 and could not get warm. Two hours later, at 3:00AM, I felt completely opposite and could not feel cool. These symptoms gradually subsided and were gone by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Joint Pain and Muscle Aches: Onset of joint pain and muscle aches that occasionally became annoying with twinges of pain. These symptoms subsided by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Dizziness: Onset of mild dizziness that lasted 12 hours until 7:15AM on 08APR21. 08APR21, 1:00AM ? Measured Fever: Decided to measure temperature due to significant chills and shivering and found temperature was 101.0 at 1:00AM on 08APR21. At 3:00PM on 08APR21, my temperature was 100.2 (this was 4.5 hours after taking one extended release tablet of 650mg acetaminophen). At 3:00AM on 09APR21, my temperature measured 98.6 degrees and has remained near there ever since. 09APR21, 4:00PM ? Arm Rash: First noticed presence of a rash measuring about 2? x 3? on upper arm near the area that received the injection. Mild itchiness was present about an hour later and a topical 2% diphenhydramine gel was applied. The rash had dissipated by 5PM on 10APR21.

Fever up to 104.6F. Extreme fatigue. Random occasional shooting pain in various parts of the body. General aches and pains. Pain and swelling at the injection site. Continued excessive sweating (night and day sweats). Tenderness on scalp.

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

mild fever cold sweats severe headaches nausea bad shaking dizziness severe fatigue achy joints severe pain at injection site loss of energy loss of appetite diarrheafelt just like covid 19 symptons lasted approx. 2.5 days

pt had flu like symptoms, fever chills etc right off. Today he started with a rash over his face and neck and hot also. pt is calling dr just to make sure rash doesn't need any medication besides benadryl. Pt also was taking bactrim and stopped 4/12/21

I had a mild rash after my 1st shot... really didn't remember till the dayn after my 2sd shot... i woke up with red itchy arms and legs. I had small welts around my waist and inner thighs. I showed my wife , she said use some anti itch cream in the bathroom.I did and it got better... went back to sleep. the next night i woke anain to really red and pissed off knees with welts all over my legs.. Treated again with cream. the next night...4-12-2021 it only started on both feet..kinda itchy with mild pain..no cream.. all good sofar..

day after receiving 2nd moderna vaccine, patient start breaking out in welts on arms and back. Told patient's wife he needs to contact his doctor. He can try antihistamine (Benadryl otc) but needs to contact his doctor.

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

Left arm (where vaccination shot been done) redness (spot approximate 4 in. diameter) and filling higher temperature than other parts of the body, little stiiness at that area, started 5-6 days after vaccinaton and does not dissapear after couple days,.

date recorded on report states 4/15 after 1st dose given 9am. Reaction began at 10 pm. The reported date of the vaccine is 3/25/21. Client not found in Immunization Registry. Note on report that month and day for DOB is fictitious. Pt stated they are close to turning 60. Adverse events experienced and are they still occurring now: 1st dose rcvd 4/15/2021 at 9am, ADE occurred at approx 10pm in the evening - pt experienced warmth on the left arm, the skin was rise with welts that was 3-inch in diameter, with dull pain; these symptoms lasted for 2-3 days. About 8 days later, the welts reoccurred but without any pain just rise skin and itchiness for another 2-3 days. ADEs not occuring now. What happened as a result of the adverse event? Pt reported they applied ice to the left arm area, helped with the itchiness both times the hives/welts occurred. ***NOTE*** After consulted with Dr. and CDC info site, advised pt that the ADEs he experienced is not a contraindications to getting his second dose since the welts was localized at the injection site area and it was not widespread to other part of his body. Recommend pt to consult his MD if he is still concern about getting his second. Also recommend after rcvding second dose to wait and be observed for 30 minutes instead of the standard 15 minutes, and of course to the discretion of the pharmacist administering the 2nd dose base on observation time.

Purpuric rash; Accelerated hypertension; Systolic congestive heart failure exacerbation; nausea; Generalized non-itchy, non-painful rash a day after receiving the vaccine; Thrombocytopenia; few loose stools; Fever; Chills; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) and NAUSEA (nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Purpuric Rash and Thrombocytopenia After the mRNA-1273 (Moderna) COVID-19 Vaccine. Cureus. 2021;13:4 Previously administered products included for Viral hepatitis C: Interferon. Concurrent medical conditions included Viral hepatitis C, Chronic kidney disease (Stage 4, with a baseline creatinine of 3 mg/dl.), Uncontrolled hypertension, Systolic heart failure (Ejection fraction of 35%.) and Liver cirrhosis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine) (seriousness criterion hospitalization), THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization prolonged and medically significant), PURPURA (Purpuric rash) (seriousness criterion hospitalization), ACCELERATED HYPERTENSION (Accelerated hypertension) (seriousness criterion hospitalization), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized for 3 days due to ACCELERATED HYPERTENSION, ACUTE LEFT VENTRICULAR FAILURE, NAUSEA, PURPURA, RASH and THROMBOCYTOPENIA. At the time of the report, RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. In March 2021, Alanine aminotransferase: 90 (abnormal) 90 U/L. In March 2021, Aspartate aminotransferase: 196 (abnormal) 196 U/L. In March 2021, Bilirubin conjugated: 5 (abnormal) 05 mg/dl. In March 2021, Blood albumin: 1.9 (abnormal) 1.9 gm/dl. In March 2021, Blood alkaline phosphatase: 216 (abnormal) 216 U/L. In March 2021, Blood creatinine: 3.2 (Inconclusive) 3.2 mg/dl. In March 2021, Blood lactate dehydrogenase (122-222): 381 (High) high. In March 2021, Chest X-ray: abnormal (abnormal) Findings consistent with pulmonary edema.. In March 2021, Glomerular filtration rate: 19 (Low) eGFR - 19. In March 2021, International normalised ratio: 1.13 (Inconclusive) INR - 1.13. In March 2021, Platelet count: 84000 (Low) 84000/uL. In March 2021, Serum ferritin (24-336): 2400 (High) 2400 mg/ml. In March 2021, Ultrasound liver: abnormal (abnormal) Ultrasound of the liver confirmed liver cirrhosis.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered THROMBOCYTOPENIA (Thrombocytopenia) and PURPURA (Purpuric rash) to be possibly related. No further causality assessments were provided for RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). Concomitant medications were not provided. Hepatitis panel showed a heavy viral load of more than 11 (no reference range was provided). Per reporter, on presentation to the emergency room the patient was afebrile, had a blood pressure 183/106 mmHg, pulse rate of 82 per minute and oxygen saturation of 96% on room air. Treatment included anti-hypertensives and intravenous diuretics. On day 3 of hospitalization, patient left the hospital against medical advice. Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.; Sender's Comments: Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.

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

The day after the shot, I had upset stomach, stiff neck and shoulders, and chills in afternoon. 2nd day after the 1st shot, I came down with a severe case of a rash (similar to shingles) across my entire back, and left side mostly. After 2nd shot, the same symptoms as the first shot and 2 new areas of rash broke out again. Dr. put me on steroids. ( Methylprednisolone 4 mg)

First symptom was sore injection site. This occurred about 10 hours after the injection. Body and joint soreness started at 14 hours after injection. Also experienced chills but did not record a fever. Also developed a persistent headache beginning at 14 hours post injection and lasting for about 48 hours depending on treatment. Experienced fatigue for about 48 hours after injection. Took Tylenol first to treat at 14 hours post injection. Took Advil at 18 hours after injection to augment Tylenol performance. Maintained this treatment at appropriate dosage (2 pills/dose) and intervals for about 48 hours after injection. Most symptoms subsided after 48 hours but injection site is still a bit sore even now which is almost 72 hours post injection.

Noticed rash of red bumps spreading on left side, waist level, the itched but more burned. Was not sure if possible Poison Ivy, which was highly unlikely, or perhaps shingles, which I had had 2x earlier many years ago. Called Dr.'s office and was told to come in so Dr could look at rash. She was unsure at first but thought most likely shingles. She said there was a yellowish liquid seen in pustules and prescribed both a hydrocortisone cream and Valcyclovir. Dr. said that if next day it is more painful than itching it is most likely Shingles. Area much more painful and Valcyclovir started. A week later red marks drying up, but pain is still significant across left side.

Right eye developed a green line like a fat magic marker from inside of eye up towards middle of outside of eye. Changes color to Orange and red. Never had this before. Had symptoms for one hour on the night of injection then went away, returned mid day the next day. As I am writing this.

Within 12 hours or so the following effects were noted. This was the first injection. 1. Injection site soreness/tenderness for up to 3 days. 2. General sore joints throughout my body. 3. Intense and long headache that lasted for up to 36 hours until Acetaminophen was final taken. The headache continued for another day or so at a lower intensity. 4. Fever up to 101 F and chills for up to 1.5 days. 5. General feeling of lack of concentration and being "hazy" in general condition. As of 4/20/2021 most effects have subsided. General treatment for discomfort was Acetaminophen after 36 hours from the injection date and time. The injection site is still sore but no mark or rash exists.

He had a fever and felt bad the day after the vaccine and then had a rash come up and was diagnosed with Shingles.

On 4/3/21 about 2 weeks after my 1st dose of Moderna I noticed a raised rash/hives on my left middle back consistent with shingles I?ve had before. Very itchy but painful to the touch. While rash stayed localized the itchy sensation grew larger and wrapped around my left side to my left lower stomach. Itchy, painful to touch and actually also numb. Situation persists now almost 3 weeks later. Situation is livable but uncomfortable. Virtual doctor consultation to monitor situation.

Delayed rash on upper arm below vaccination point. Itchy and hot to the touch. Lasted for 10 days before going away.

Onset of mild headache 8-hours post-injection. Extreme fatigue, generalized muscle soreness, increased soreness at injection site. Rest, stayed home, no physical activity, no NSAIDs or prescription pain-relievers. Constellation of symptoms increased in intensity and was most intense 24-36 hours post-injection with low-grade fever and chills. Forty-hours post-injection all symptoms resolved. No further symptoms noted. Resumed normal AODL.

Passed Out; Suspecting Seizures pending EEG Results; Sore Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (medication history was not reported) and Pacemaker insertion (cardiac) since an unknown date. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed Out) (seriousness criteria hospitalization and medically significant) and SEIZURE (Suspecting Seizures pending EEG Results) (seriousness criterion hospitalization). On 10-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed Out) and SEIZURE (Suspecting Seizures pending EEG Results) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported. diagnosis yet to be determent Suspecting Seizures pending EEG results Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information is available at this time. Further information is 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.However, Very limited information is available at this time. Further information is requested.

Moderna COVID-19 Vaccine EUA Fever, shivering, sweating, nausea, headache, extreme fatigue, loss of appetite, and general malaise beginning approximately 12 hours after injection, and persisting for the next 24 hours. Swelling , soreness, and redness near injection site are still present at 40+ hours after injection. OTC cold medicine (Alka-Seltzer Plus Day and Night), and PLENTY of rest (I must have slept 24 out of the last 48 hours) were the only treatments used. Note: Adverse reactions to the first dose, on 3/25/2021, were limited to the symptoms at the injection site, as noted above.

Extreme fatigue within 14 hrs of shot Body aches (all over) within 14 hrs of shot Sore arm at injection within 4 hrs of shot Light headedness, occasional within 14 hrs of shot

Had severe headaches and joint aches the first 8 to 12 hours which was on April 14th on a Wednesday. On Thursday April 15th I had a fever of 103.5 which took several hours to ever break below 103. On Friday April 16th early a.m. in the morning I my temp had drop to low grade around 99 F. Saturday April 17th I noticed a 3 to 4" diameter big red lump on the injection site which itched and hurt. Note! I used to give myself allergy injection in my twenties, the reaction was very similar to those reactions but bigger. It's been a week later I still not 100 percent and feel very tired all the time. But I know it was better than getting Covid.

A week after injection, I developed a large area of itchy rash, ranging more than half way down my right upper arm from the injection site. It is extremely itchy, similar to the cases of large hive welts I experienced as a teenager in the 1970s.

Red rash and blisters on right leg and foot started on 04/17/2021 a couple days after the Moderna vaccine and continued to worsen over the next 5 days. On 04/22/2021 dermatologist confirmed the condition was shingles. He prescribed Valacyclovir (Valtrex) for one week. The condition is starting to clear up now on 04/26/2021.

Patient developed shingles 4 hours after the shot. The patient had never had a case of shingles before. Still dealing with these symptoms three days later. His primary care doctor put him on Valtrex for treatment.

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

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

Sore shoulder at injection site after 12 hours, aching joints. Aching joints lasted until I took a couple of Advil and went away within 30 minutes. Soreness and symptoms showed no evidence in the first 12 hours. Sore shoulder lasted 3 days, was not debilitating.

Sore injection site, 102 fever, chills, diarrhea, vomiting. Most symptoms ended by 4/23. Lingering diarrhea.

About two months after my second injection I started developing impingement in pain in my left shoulder joint. This has become progressively worse necessitating an evaluation by orthopedic surgeon.

On day 8 after injection red rash on injection site; hot, severe itch, swollen. Approx 3 inches x 2 inches oblong shape/size.

Patient obtained 2nd dose at 4/30/21. Recalls he went to store after leaving the clinic. Had itching on arm that was vaccinated. Then he developed rash on lower legs, neck, and back. Rash is slightly itching.

Redness occurred and has yet to go away. There is no health issues that I am aware. I feel fine. That is yet.

patient received second moderna covid-19 vaccine on 5/8/21, lot number 037B21A. patient reported to the ED with blistering at the injection site (right arm) one day later. patient did not have this reaction after the first vaccine in the left arm but reports still being sore from the injection 4 weeks ago. patient was discharged with clindamycin for possible secondary infection.

presents with redness and blisters at the mid during a vaccine injection site on his right forearm. The patient states he received his second injection about 2 days ago, instantly developed redness at the injection site. However, he awoke this morning and he had large blisters. Patient states the arm does not itch and he does not have pain, he does describe it as burning sensation in his upper arm. The patient denies fever, shortness of breath, cough, facial swelling, numbness and tingling down the arm, pain in his arm. There is a large area of erythema surrounding the injection sites with 2 large bullous appearing blisters.

Pt started bleeding after the shot, he reported that it did not stop bleeding , changed the dressing 4-5times until he went to the ER

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

Rash broke out on left arm about 38 hours after shot. Today rash has spread to under both arms, around neck and in groin area. Taking Claritin & Tylenol. Contacted doctors office and following their prescribed treatment.

1. Sore upper left arm for a few days 2. Mild numbness in left arm from elbow down to fingers similar to tendonitis (experienced from day 1 to current day 10) 3. Significant upper body itchy rash on abdomen, back, arms, hands, chest, neck and face starting 8 days after injection and continuing.

Within 12 hours or so the following effects were noted. This was the second injection. Both injections had similar effects. 1. Injection site soreness/tenderness for up to 3 days. Note : Different arm this time. 2. General soreness throughout my body. 3. Intense and long headache that lasted for up to 36 hours. Acetominophen and ibuprophen taken in series after approximately 20 hours. 4. Fever up to 100.5 F & chills for up to 2 days. 5. Some nausea for 2 days. 6. General feeling of lack of concentration and being "hazy" in general condition.

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

chills in extremities, dizziness, headache, rash/swollen skin about 3 inches surrounding injection site

Started with a little rash on arm then blisters appeared at site of injection and spread down arm and patient states rash and blisters appeared on other arm also, has been applying hydrocortisone cream to affected area

He came in for his 2nd vaccine and had a case of shingles on his left flank. It had started on 5/15/21.

patient developed blisters on his left shoulder upper arm and spread to left breast area 8 days after vaccine given. Blisters got bigger and fluid filled. Blisters burn and are painful. Patient advised to see a doctor for diagnosis ASAP.

Flu-like symptoms lasting a day. Aches; pains; chills; possible fever; soreness at shot site. Fine the next day.

Persistent Skin discoloration/rash on various parts of body, unable to focus, struggle to remember simple things, persistent fatigue.

I received the Moderna Shot in My R arm on Wednesday 4/28/21. My R arm stayed sore ( not at the injection site ) but up in the shoulder joint. It was stiff and sore with abduction or any rotational movements. On may 10th I noticed that the injection sit was showing signs of irritation. Ove the next 2-3 day lesions formed at the posterior aspect of the shoulder joint and in the crook of the R elbow. By the end of the week lesions began to form on the anterior forearm 2 inches below the elbow joint and 1/2 way down the anterior forearm. A small Lesion also formed 3 inches above the wrist on radial aspect of the forearm and another small lesion on the bas of the R hand just below the wrist. I started on proteolytic enzymes, L lysine and an anti viral 3x a day and acupuncture. Now on 5/27 the lesions are mostly gone and the pain in the shoulder is almost gone also

Patient said had covid19 last august. He said that he was hospitalized. He said he was followed up for cardiac issues, now they are follow up with his lungs, because he said he is winded. He said after the vaccine he had a rash on his arm that had cleared up. He said he was fatigued and winded. He said that the symptoms are still off and on.

Headache, pain at injection site, headache, fever around 100, and I was very tired. I mostly recovered after a couple of days, but still have some headache. Then yesterday, 6 days after injection, I started experiencing vertigo. It is like my vision is shifting quickly and I lose my balance. It happened yesterday morning when I first woke up, and cleared up in a minute. Then it happened again in the afternoon when we were on a long hike, and I fell into some bushes. Last night it happened 3 more times as I awoke from sleep.

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

Rash under vaccine site on upper arm developed a few days following vaccine and lasted for about 10 days. I also had the same reaction after the first vaccine, although the rash was delayed after a week following the first vaccine.

The main symptom I had a head to toe rash. The rash was profusely on my stomach, I though I was going to have scars from the rash. It was extremely itchy. I also got tingly fingers, which I still have as of today. I made 3 trips to the walk-in clinic and got cortisone shots and cortisone pills 3 different times. I also gained 15 pounds over that time period. I also went to a allergist and he advised I was probably allergic to something in the shot. He advised not to take the second shot. All the other healthcare providers advised me not to take the second shot as well. I have not had the second shot due to the symptoms I had. With the "tingly" fingers there was also joint pain in the wrist and hands.

Severe dental pain (9/10) beginning several days after vaccination, affecting upper left and lower right molars. Molar on lower right turned out to have an abcess, and required a root canal and crown. Mild tooth ache on upper left continues at low level. Immediate post vaccine course after 1st injection complicated by swollen and painful (injection) arm; after second vaccination - course complicated by pain in injection arm, fever to 104, myalgia and fatigue.

pain left upper arm since injection, can't sleep on that side because of pain. Throbbing. No position helps. Tingles in fingers if picks things up. Can't put hand in hip pocket because it hurts to move arm back that far. Patient states he feels like there's a knot under left shoulder blade. Felt dehydrated when had lab draw 2 weeks ago (1 week after shot). Grip strength right 94.6lb, left 24.6lb, "makes it throb" when grasping.

PATIENT SAYS HE DEVELOPED A RASH ON HIS HANDS 3 DAYS AFTER VACCINE -WAS BROKEN OUT WITH RAISED LIGHT COLORED BUMPS ON HANDS THAT ITCHED.

It was a very busy day at the pharmacy. I was working as a floater pharmacist, and the pharmacist of record told me they had some extra COVID shots and asked if I wanted one. I told him I did. He came back to me about 20 minutes later, after the paperwork had been completed, billed and my questionnaire filled out. He delivered the shot when I was standing and he was standing. I happened to glance over at him just as he injected me, and I thought he'd injected me too high. I emailed my scheduler and told her to get in contact with him and get him to review his technique for administering vaccines. Two weeks later, I started having pain in my left shoulder. Stretching exercises helped me maintain a certain controllable level of pain until about a month ago. My condition has since gotten quite a bit worse to the point I had to leave work early two weeks ago. I went to urgent care and saw the PA listed earlier in this report. I missed the next week at work, and have since seen an orthopedic specialist who administered a cortisone shot. I have been advised to keep a log of my progress and report back in 2-3 weeks.

Like he was going to pass out; Weakness; Cold sweat; The vaccinator pulled out the needle, blood came out and ran down his arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Like he was going to pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Passed out (Patient has history of passing out when blood drawn from right arm as it usually hits a nerve). On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Like he was going to pass out) (seriousness criterion medically significant), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm). At the time of the report, LOSS OF CONSCIOUSNESS (Like he was going to pass out), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm) outcome was unknown. Patient has drank water & ate M&M to relieve the symptoms. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.; 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. Of note, the patient's history of 'passing out when he gets blood drawn on his right arm because they usually hit a nerve' is a confounding factor that may play a possible contributory role.

Approximately 20 hours after the injection I was sick with much fatigue and body aches. At about 30 hours had fever, 102 temp with face and injection sites hot to touch. Fatigue and aches lasted the next 24 hours. I also developed about 4 cankers sores in my mouth within about 30 to 48 hours and they continue today 6/27 at 1400 hours. Also have fatigue and aches but less severe than the 24-48 hours following the vaccine.

1st dose vaccine, I had very typical reactions- redness and soreness at the injection site, muscle aches and low grade fever. It went away a couple of days and I am fully recovered. The 2nd dose vaccine (IM RA)-I had the same reactions as the 1st dose. About 8-10 days after, I started having SOB, coughing and chest congestion. I went to urgent care and got a covid test (negative) and got a Chest x-ray which came back positive for viral pneumonia. I was prescribe amoxicillin, albuterol inhaler, Codeine base cough medicine, and prednisone. I am fully recovered from my viral pneumonia.

Approximately 04/27/21, I started getting a sharp pain above my right ear, eye, forehead and right temple. I went to Urgent Care and was diagnosed with Shingles. The sores began to irritate my right eye, so I saw my Eye Dr who also diagnosed me with Shingles. ( My R eye and vision all checked out ok ). Except for Shingles. I then saw my Primary Care Dr. who also diagnosed me with shingles. All three doctors diagnosed Shingles due to the possibility of a low immune system caused by the vaccine. To this date, I am still suffering from the nerve pain above my right eye and forehead area. I broke out twice within this period which is unusual.

Patient complained of pain at injection site of the left arm. He mentioned that he can't move his arm normally and had to do physical therapy. It has been an ongoing pain and affect his normal life.

Peri-oral edema, hives, esophageal spasm/pain. Avoiding NSAIDs and taking fexofenadine have been preventive.

After shot blisters stop popping up on upper and lower arm which spread to his thighs and back filled with clear fluid, start popping up again on hands and arms

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

PATIENT HAD EXCESSIVE BLEEDING DUE TO TAKING A BLOOD THINNER. PLACED SOME GAUZE PRESSED FIRMLY TO STOP THE BLEEDING. BANDAGE THE INJECTION SITE . PATIENT FELT DIZZINESS DUE TO LOSS OF BLOOD. HAD PATIENT PUT HEAD BETWEEN LEGS. PATIENT TRIED TO STAND AND LOST HIS BALANCE AND FELL. HELPED PATIENT UP AND SAT BACK ON CHAIR. PLACED A COLD CLOTH ON FORHEAD. LATER PATIENT FELT FINE TO LEAVE

PER NURSES NOTES AT APPROX 10:15 PM, THE NURSING ASSISTANT WAS MAKING ROUNDS AND NOTICED THE RESIDENT DID NOT LOOK "LIKE HIMSELF". RESIDENT WAS SWEATING/VERY WARM. SPO2 64-70% ON ROOM AIR. BLOOD SUGAR READING "HI". TUBE FEEDING TURNED OFF, PLACED RESIDENT ON 5L O2, SPO2 INCREASED TO 71%. RESIDENT TAKEN TO THE HOSPITAL. VITAL SIGNS AT TRANSFER: BP 98/59, PULSE 132, RESP 36, TEMP 101.9, SPO2 66% (STATED ON ROOM AIR). HCP AT FACILITY STATES HE IS NOW IN THE INTENSIVE CARE UNIT.

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

Left antecubital rash and pruritic lasting last 5 days, self treated with hydrocortisone 2.5% cream two times partially relieving the pruritic and redness, but still present at time of report.

Approximately 18 hrs after vaccination, pt woke up with injection site soreness, Tmax 104, dizziness, myalgias, athralgias.

headache ringing in ears and light sensitivity and one week later redness swelling and itching at injection site.

patch on your arm shaped like a square of 2x2x2x2 that red in the middle and the outside edge is yellow and blue like a tattoo, it was hard the first then, a little tender but mostly reddish, square and yellowish blue brushing.

I was fine the day of the vaccine. When I woke up the next day I felt like I had a severe case of the Flu. I had severe body aches, headache, muscle weakness, worse cough, injection site pain and swelling, chills, weakness/tiredness, I felt like I had been hit by a car. I just tried to sleep and drink Gator Aid. The second day out from vaccination I felt much better. Just slight headache, body aches, weakness. My injection site started to hurt later in the second day. It still hurts today-seven days out from administration.

No problems on vaccination day. I woke up the next day with severe flu-like symptoms. I had a severe headache, severe body aches, cough, injection site pain, weakness, extreme tiredness, The flu like symptoms lasted one day and were gone by the evening of the second day out from vaccination. One week later I still have muscle pain at the injection site.

Sudden onset of rash on my back Sunday evening, spreading to most of body by Monday. Applied hydrocortisone 2.5%, took benadryl (2) every 6 hours, prednisone 10mg on Monday, prednisone 20mg on Tuesday. At this time rash is still active, meeting with dermatologist on 1/13/21

feverish, chills, shaking, 99.9 fever, extremely nauseous, Zofran did not work, nausea went away that night, fatigue, red square size of a stamp at injection site, size has increased in size, Dr rx Bactrim antibiotic

10 days after receiving vaccine I experience spread hives and throat itchiness. Went to ED. Took Prednisone for the next 7 days with hydroxixyne which totally alleviated all symptoms. Also I went to my Primary Care MD for f/u. After treatment hives started again, then I started to take benadryl orally which kept my symptoms in check but today it came back worse again despite medication.

Patient received the vaccine, and waited 30 minutes, due to history of allergies. After the vaccine, he walked to his car, and he felt flushed and facial tightness. He was driven home, took Benadryl, and then a 1.5 hour nap. When he woke up all symptoms had resolved and he has not had any symptoms since.

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

Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. Fever 102.9. Severe headache. Vomiting next morning. Bedridden 36 hours total.

shingles outbreak right hip. Last shingles outbreak 10 plus years ago. Have received the shingles vaccine

numbness at and near injection site noted within 12 hours, numbness extended to elbow and shoulder by 48 hours. Treated at 48 hours with heat and Ibuprofen 600mg PO q6hours x24 hours with reduction in Sx to shoulder and injection site only. Employee work and PCP contacted.

5 days following vaccine patient developed itchy rash over L arm and back. Presented to his primary care physician on 1/27/21.

2nd shot stung a bit unlike 1st one. around 10:30am head felt woozy/slightly dizzy, left work at 1:30pm dizzyness getting a little worst body started aching. fell asleep for about 30 minutes once home, bed at 9:30pm and started to shake violently like I was freezing but not cold, didn't feel like I had a fever, put on sweatpants and tshirt, turned on elec. blanket, I stopped shaking after about 45 minutes, took acetaminophen and 1 dose of zquil and fell asleep. up at 3:30am in pain, especially my left arm I couldn't lift with pain. called out of work all muscles and joints hurt, less pain with no movement, more acetaminphen every 6 hrs, started feeling better around 4Am Saturday

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

Patient reported experiencing pain, redness and swelling at injection site, mild fever, headache, fatigue. Symptoms onset about 6 hours after second dose of Moderna COVID-19 vaccine. Symptoms resolved within 24 hours of onset.

initially he said welts occurred on first day of vaccination. on questioning, learned hives started on abdomen0700 to 0800 the day after the first dose of the Moderna vaccination for COVID-19 prevention. 2 days later hive on lip. then subsequent days progressively worse urticaria with back, neck, arm, leg, feet, ankles affected. Rashes, welts he says covered 50 to 60 % body.

PATIENT WOKE UP WITH PAIN IN HIS ARM FROM HIS SHOULDER SOCKET TO THE MID BICEP ON THE INJECTED ARM (LEFT). THERE WAS NO DISCOLORATION ANYWHERE OR BRUSING. THERE WAS NO HEAT. IT WAS DEFINATELY MUSCULAR PAIN. THE PAIN PERSISTED FOR 3 WEEKS TREATING WITH IBUPROFEN OVER THE COUNTER. THE ARM HURT SO MUCH HE COULD BARELY LIFT IT TO EVEN SHOWER OR WASH HIS HAIR.

Pain right arm- site of injection- not able to move for almost 3 days, followed by chills, body ache, and headache. Symptoms lasted for 3 days.

injection site pain and tenderness. fatigue , headache, muscle pain , joint pain , chills, fast heartbeat.

Moderna COVID-19 Vaccine EUA - 2nd shot - Pain in L Arm at injection siterna COVID-19 Vaccine EUA - General weakness, flu-like symptoms

Occurring in late evening of 2/8/21 and all day 2/9/21: Muscular aches/soreness/stiffness (no intense pain)...primarily lower back, lower sides (kidney area), upper back, neck. Left upper arm "pain" at injection site. Slight fatigue. Very slight headache (not serious). Fingers of both hands ache (not sure if arthritis flareup). NO fever.

February 2, I developed 30 red, raised, itchy welts all over my body, including arms, legs, back stomach. Welts were dime sized. No breathing difficulty, Began benadryl 50 mg q 6 hours around the clock for one week. Benadryl did not cause the welts to subside. Welts worsened into larger 2x2 areas of redness and itching. Contacted my physician, who prescribed a medrol dose pak. Took from 2/1 to 2/5. Welts improved but did not go away. 2/10/2021 - welts are still developing, Have 6 new welts today 2/10/21... taking benadryl but not improving . Will call my doc back this date

Moderna COVID-19 Vaccine EUA Body aches, tiredness, headache, muscle pain, chills, coughing, injection site pain, exhaustion.

fever 101; max, lasted for about 24 hours; fatigue 24 hours; headache 36 hours; sensitivity at injection site 36 hours

Injected 2/8 began getting headache afternoon of the 10th, developed sever night chills by 1130p the night of the 10th, along with fever of 102 degrees, body aches and pain. Low O2 saturation at 92%. Though possibly unrelated I developed cellulitis at incision on left knee which is now being treated with antibiotics. Was directed to and seen by Urgent Care facility.

Large (2 by 3 inch) swelling at injection site, warm to the touch with considerable itching. There was no swelling or itching at the time of the injection (2/5/21) or the next 7 days. It appeared on the morning of the 8th day following the injection (2/13/21) and has persisted all day. I did not receive an automated ?health check-in? text today so I was unable to report it. The size of the swelling has not changed but there is a constant itch.

large red bright red bumps on forehead and top of skull that is painful/irritation to touch, off and on nausea , intermittent headache

I was fine that day and no real reaction. My arm was getting redder each day and around day 10, I went to the doctor. I was diagnosed with a skin infection, Cellulitis. I was given Keflex. I cleared up after a week.

The fist 48 hours had a sore shoulder. On the 7 1/2th day I felt a pinching sensation, slightly sore at injection point. This morning I noticed the injection site red and slightly more sore than usual.

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

1) Muscle Pain at Injection site with large red area of swelling at injection site 2) Severe headache for several days 3) Chills & Fever 4) Fatigue

My right arm where the shot was given was sore for about 2 days, there we no other reactions to this 1st dose.

On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sleep, headache, profuse sweating lasting until 2/3/21. Still experiencing lingering arm pain at injection site.

approx 5 days after vaccination, pt states he developed itching and swelling around left ear, that then spread left side of arm over the last few days. Lesions were without vesicles or drainage, primarily raised red lesions related to hives. He visited dermatologist who rx'ed antihistamines, benadryl and OTC hydrocortisone. Denies anaphylactic reaction with no SOB, respiratory distress, swelling of tongue, mouth, eyes or lips. As of now, he is no longer itchy but with rash still present. He will have f/u on 3/8 with dermatologist for final opinion about whether he can receive his next vaccine as scheduled on 3/11/21.

Ok I got my 2nd shot on Tuesday (03/02/2021) about 2:30 p.m. and was feeling great all evening. I woke up at 2:30 a.m. and thought I'd been hit by a truck, my whole body was aching like nothing I've ever experienced. I also got chills and was shaking I thought I was on one of those machines that shake paint cans. I also had (and still do) a headache. The body aches subsided about 10:00 p.m. (03/03/2021). It is now about 5:00 p.m. on Thursday 03/04/2021 and I still have a slight headache and I am fatigued but starting to get some energy. On my left arm where I got my shot it is very warm, red, and about the size of a goose egg in the area I got the shot.

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

red rash, about 2 inches circular at injection site started about 10 days after injection. almost gone after 5 days.

Rt. arm lateral to vaccine injection site had a cavitous necrotic area near laterally to and at the injection site itself. spouse said 1hr after injection large blisters occurred and showed us pictures, did not seek out care. All of this was revealed at 2nd dose which was held due to discovery of the skin site.

COVID arm. Reddness, swelling, pain around injection site beginning on the 9th day after first injection. Treated with ice.

Headache, grogginess, jittery, shivering, soreness at point of shot, tiredness, feel like a truck ran over me, extremely lethargic. now it's the second day. Feeling cold stopped, a little better.

Pain, tenderness, and swelling at injection site for two days. Plus joint pain, chills, fever fatigue for three days.

Patient had severe swelling at injection site at a few hours after vaccine for 48 hours. Swelling was 1inch by about 4-5 inches. Patient compared to size of a goose egg or rubber ball. Treated with soaking, ice, topical diclofenac.

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

Chills, body aches, fever 36 hours. Rash started two days after vaccine and lasted approximately 12 hours

My injection site was sore. I had chills the night after I received the vaccine and bodyaches the next day.

Pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection; Sugar was very high; Blood pressure was very high; Face look flushed; A spontaneous report was received from a consumer concerning a 61-years-old male patient who experienced pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection (cellulitis), sugar was very high (blood glucose increased), blood pressure was very high (blood pressure increased), and face looked flushed (flushing). The patient's medical history included diabetes mellitus, heart disease (unspecified), kidney failure, and chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the event, included insulin and oral medications for diabetes (unspecified), rosuvastatin calcium, acetylsalicylic acid, umeclidinium bromide and vilanterol trifenatate, diuretics unspecified (water pills), omeprazole magnesium, and cortisone. On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient got cortisone injection. On 18 Feb 2021, the patient experienced high sugar level, high blood pressure and face looked flushed. On 20 Feb 2021, the patient started having pain in the ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection. Treatment for the events included Keflex. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events of pain in ankle where they administered cortisone shot and it progressed to bacterial cellulitis infection, sugar was very high, blood pressure was very high, and face looked flushed, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Severe welts like burns on whole body with uncontrollable itch ive had for 5 days just got prednisone none

After first shot in series, I developed slight headache, minor weakness, minor shoulder pain. After second shot in series, 8 hours post-injection, I developed headache, moderate to severe joint pain throughout, fever around 100, extreme fatigue and weakness, slight difficulty breathing. Went to bed for 19 hours and began to feel better with recovery in two days. 14 days post-injection, I developed a systemic rash throughout my body. Consulted with my PC physician. Was prescribed Medrol Dose Pack. This had very minor effect on rash. Returned to physician for consult upon completion of steroid series. I then received a steroid shot intramuscular in right hip and one week oral steroid protocol. This achieved a more positive result, almost clearing up the rash. I had a consult with a dermatologist on 03/02/2021 who confirmed the opinion that the rash was probably a side effect of the Moderna vaccine. The rash has returned fully as of 3/14/2021.

Wife states patient started experiencing a red rash on arm that fades to pink 1 week after shot administered. Wife states that rash burns and is itchy to patient. Wife states she went online and found what she believes is called "Covid arm." Wife states they have been doing benadyrl and cold rag on arm to help with symptoms.

March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch. March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.

Red raised bumps or hives on skin of legs , arms and buttocks Symptoms subsided after a few hours. I took Loratadine (antihistamine) to treat Symptoms did not recur.

23 HOURS AFTER VACCINE DEVELOPED LIP SWELLING , BODY PRURITIS, AND BILATERAL BLOTCHY HANDS. ABDOMINAL PERIUMBILICAL PAIN. SYMPTOMS LASTED 12 HOURS. STARTED ON OZEMPIC 7 WEEKS AGO AND HAD SAME ABDOMINAL PAIN 3 WEEKS AGO BUT NONE OF THE OTHER SYMPTOMS. THIS ABDOMINAL PAIN MAY NOT BE RELATED. IMPRESSION: PROBABLE ALLERGY TO MODERNA. PCP WAS NOTIFIED BY VACCINE CLINC. PATIENT ADVISED TO SEE ALLERGIST IF HE CHOOSES TO PROCEED WITH SECOND DOSE OF MODERNA.

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

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.

Developed bad, itchy hive-like rash all over trunk of body front and back within 6-7 hours of injection. Treated with 25mg Benadryl for very little relief. By four days post vaccine it has spread to groin and head. Mild nausea and fatigue

Severe headache, 97.1 temp with extremely hot skin, rapid heartbeat (120 bpm). Next day felt fine with elevated heart rate. Monday, 3/22, all normal, including normal 60 bpm heart rate

Injection to L/arm and was very sore an hour later. Now 4 days later the pain is worse, the area is red, and I now have limited mobility in this arm. Significant muscle pain in this arm and can not lift it over my head.

Redness and extreme itching. Have rubbed raw. Been taking benadryl and anti itching cream with no relief

Shingles; Abdomen started to bloat and becamne incredibly swollen; Sore arm; A spontaneous report was received from a consumer concerning a 61-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed shingles/ Herpes zoster, abdominal started to bloat and became incredibly swollen/abdominal distension and sore arm/injection site pain. The patient's medical history included hepatic cancer and unspecified liver procedure. Concomitant products known to have been used within two weeks prior to the vaccination included pembrolizumab. On 19 Feb 2021, the patient received her first dose of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 19FEB2021 the patient had a sore arm. On 24 Feb 2021, the patient developed shingles which broke out all over his face affecting his lips, ears, gums and inside of his mouth. His abdomen started to bloat and became incredibly swollen. It was unknown if he received any treatment in response to the events. Action taken with mRNA-1273 and pembrolizumab in the response to the events shingles, abdomen started to bloat and became incredibly swollen and sore arm was not known. The outcome of the events, herpes zoster, abdominal distention and injection site pain were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Acute urticaria to left outer upper arm 3 inches away from injection site and left cheek. Treated with 50 mg of liquid benedryl po. Near complete resolution in 1 hour

Severe brain fog for days. Dizziness and off balance. Forgets what he's talking about mid sentence. Pain at injection site. Feels funky still after 4 days.

Moderna COVID-19 Vaccine Eight days after my first dose, I developed an itchy red rash circling the injection sight. The rash is faint, pinkish, and about two inches in diameter. It's not painful nor lumpy. Following the phone advise of my physician, I took an antihistamine.

1. Muscle soreness at injection site/arm 2. High Uric Acid Levels as determined through blood teats 3. Gout-type joint pain in the knees and back. The pain limits movement and and causes stiffness of the joints when sitting or after sleep. I still experience the pain. I have altered my diet (Gout symptoms recommended foods) to try and reduce the uric acid levels.

Severe soreness at injection site. Fatigue Stomach cramps Joint and muscle aches Bad headache Diarrhea High fever chills severe sweating Dizziness

Per patient (reaction occurred after leaving the clinic): Hives 30 minutes after vaccination; resolved with Benadryl

Extreme pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my shoulder. I did not have the rash or redness at the injection site. I could not move my arm without felling pain and could not sleep well because of it.

Patient said two weeks and one day after his first dose, he experienced a red, round, itchy ring about 4-5 inches in diameter around injection site. He said it appeared and disappeared w/in about two minutes.

Monday 3/29/2021 at 9:00 am received the second Moderna vaccine. After 5:00pm, pain started at the injection location followed by body chills. Tuesday & Wednesday 3/30-31/2021: Arm pain, body chills, and joint pains. Thursday 4/1/2021: light arm pain, on and off body chills, joint pains, and fatigue. The second shot?s symptoms were less severe than the first shot.

On April 1, 2 weeks after Dose 1, began experiencing upper R arm aching radiating from shoulder to elbow, similar to strain. However, no injury or muscle strain occurred. In addition, began feeling tired in the afternoons, yawning continuously for a few hours. Pain relieved with Aleve. Reoccurs daily. Symptoms have continued. Knowing my daily activity, these are not usual symptoms for me. Of course there is nothing to link this to the vaccine, however, I feel it prudent to report. When I initially received the shot, I had some aching at the shot site, but that went away after a few days.

I was very sore in the back and shoulders the following day. Also, my blood sugar dropped severely into the low 60's and I was shivering cold. Two days later I started to develop a rash that worsened over the next several days. I tried treating it with Benadryl spray and tablets but there was no relief. A doctor prescribed Prednisone which also provided little to no relief.

Moderna COVID-19 Vaccine EUA - Developed Cutaneous Hypersensitivity approximately 8 days after injection which last about 3 days. Raised firm feeling area around injection site measuring about 4" in diameter and about 1/4 inch thick

the patient stated that he noticed that the left side of his face and his left arm up to the point of injection became numb at about 8:00 pm the evening that he received his second dose of the moderna covid vaccine. He stated that the condition has been improving some as he moves his arm around. I urged the patient to call their primary care doctor to rule out any other possible causes of this issue.

5 hours post #2 Moderna Covid 19 vaccine, developed fever, 102.9, headache and full body urticaria. Patient refused steroids or benadryl. Taking Advil to control fever with good effect. Seen in clinic 4 days later with intermittent fever, headache and continued rash. Did a Covid 19 PCR NP swab, awaiting results. Patient only PE finding is hard palate erythema and petechiae.

6 days after the injection, area of shot began to itch during overnight hours. next morning the area was tender and slightly red and felt swollen. on day 8, approximately 30 hours after the initial itching- the site is a little more red, rather sore and a bit swollen.

two after shot, patient had joint stiffness and pain all over body and rash all over the body. Patient mentioned top layer of the rash (patient said it was like dead skin) would peel off. It is still going on and patient mention its hard to walk. Patient saw PCP on 4/9/21 and got a shot of steroid and also oral steroid to take. Patient was informed to come back next Friday for follow up and blood work.

Significant fatigue - 36+ hours Deep muscular contraction, soreness at injection site Slightly elevated body temperature (97.5F to 99.0F)

I woke up with cold chills. Throughout the day I had fatigue in all extremities, irritability and sensitivities to the skin on my arms. I felt discomfort while urinating throughout the day. I had a low grade fever later in the day.

I woke at 4:30 AM and spent the next SEVEN HOURS explosively vomiting and diarrheic. Muscle pain and tightness spread from my left shoulder, across my back, to my right shoulder. Lying flat gave me dry heaves. Standing up made me dizzy. I?m coughing like there is fluid at the bottom of my lungs. The base of my skull felt like it was in a C-clamp. My temples felt like they were in a vise. I have a rash on my shoulder and arm. I smelled like rotting flesh. (To head off any concerns over lifestyle or hygiene, I have a BA, BFA, MBA, MSL, and completing my PhD.) After two days of exhaustion, vomiting, diarrhea, pain, etc. I took a shower at 11:58 PM Saturday. When I swiped my soapy face towel over my left should, I wiped away a layer of skin, like a burn victim. Be grateful I don?t have power. I would stop the Moderna injections until someone finds out what it is about my genetic makeup that might signal those with similar genetics to stay clear of Moderna.

Numbness and tingling on right arm, originating at general site of shot in upper arm and travelling down inside of arm to thumb. Happens several times a week, from mild to very noticible. Lasts for a minute or two, with moving of my arm. Tingling slowly goes away.

After 12 hours of being vaccinated was bed ridden, high fever, unable to walk for 12 hours. , skin color turned grayish and very pale for 24hours. Broke out in hives, particularly on back and chest area. Several bumps per sq/in., unbelievably itchy. 5 days later hives seriously affect sleeping habits and can barely sleep at night. Have had mild eczema for years, 95% out breaks occur on hands and forearms, never back. Vaccine cleared up eczema on fingertips and one small spot on forearm. Now 30% of body covered in hives (ie, small itchy bumps). 5 days later still have slight headache, thinking still a little cloudy.

DEVELOPED HIVE LIKE APPEARANCE ON 04/05-SAW THE DR ON 04/07, RECEIVED STEROID, BY 04/10 IT WAS MUCH WORSE WITH PIERCING PAIN AND BURNING ALONG WITH HEADACHES, AND ON 04/12 SAW THE DR AGAIN, DIAGNOSED WITH SHINGLES

Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040. Pt reported no allergies to medications, no severe allergic reaction in the past. Pt states doing fine with the 1st dose of the Moderna vaccine. Pt was waiting his observation time of 15 min and began itching face, arms, and legs. Nurse questioned pt if he was feeling ok? If he is itching? Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water. Pt declined. Pt started clearing throat and coughing. Nurse questioned pt if he was still feeling ok and again offered pt some water. Pt declined. Pt reports that he is feeling ok. Pt's timer alarmed and pt got up ready to leave. When asked if he is doing ok, pt reports that he is. Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out. Pt was escorted by nurse. Nurse questioned pt again if he is feeling ok. Pt states that he is. Nurse notifies pt that if he not feeling ok then he should come back. Pt states understanding and exits building. Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building. Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified. Pt grabs the wall while ambulating. Nurse provided stand by assist. Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately. Crash cart arrives. Epi 0.3mg autoinjector administered IM to LT at approx 1100. IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered. Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered. Pt O2 sat 97% on RA, HR 102. Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called. Approx 1113 pt O2 sat 90% on RA. Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider. Pt's wife contacted via pt's cell phone. Approx 1116 Epi 0.3mg administered IM to LT as ordered. Pt O2 sat 97% on 2L O2, HR 87. Pt reports itching getting worse. Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119. Approx 1125 EMS arrived. Approx 1127 BP 183/75. Pt taken by ambulance with EMS to ER at approx 1135. Report called to ER by provider. ER transfer form faxed to ER.

pain in abdominal area right front next morning, skin extremely sensitive, pain also right back , rash started 4 days later, 5th day noticed blisters on rash, Doctor's appointment on 6th day confirmed Singles which I had as a teenager, Given a prescription for Valacyclovir Hcl 1 GM 3 times a day.

About 8 days after vaccination noticed rash on underside of right forearm and rash on left side of body. Rash does not cross midline of stomach. Also smaller rash above right eye. Rash also under left eye near midpoint of nose. Applied Cali nine and hydrocortisone ointments. Took over the counter Benadryl but rash has not healed. Concerned as I may be scheduled for 2nd shot between Wed. April 21 and April 29th according to vaccine appointment card.

No adverse event after first shot on 17 March 2021. Second shot on 14 April 2021 with following symptoms: redness and pain at the injection site; general symptoms were headache, joint pain, body aches, fatigue, fever, and chills.

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

Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, injection site considerably more painful/tender than with first dose, inability to sleep all night, a bit light headed, weak and balance problems while walking, dry mouth After roughly 6 hours, most symptoms gone or greatly improved. Still had some headache and body aches, felt mildly feverish, injection site still painful, fatigue due to lack of sleept

Per dermatologist, erythematous eczematous patches started right arm, then appeared on left arm and both legs and feet over the course of 3-4 days. The patches were itchy. Primary care physician prescribed Doxycycline 100 mg. 2 times daily for 10 days and prednisone 50 mg. daily for 5 days; however, a nose bleed developed after the 1st dose of prednisone and it was tapered off. Coincidentally, an appointment was made with a dermatologist for an irritated seborrheic keratosis, and Betamethasone augmented 0.05% topical cream was prescribed. As of this date (4/24/2021), there are no new patches, the original patch on the arm is still present but much improved and the patches on the legs and feet are also improving.

Headache, chills, fever,( pain ,tenderness , edema, redness & hot to the touch of injection site), fatigue, dizziness, muscle & joint pain, restlessness. Increased fluid intake & took Tylenol ES every 6 hours, rested as much as possible.

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

complained he is hot then he was passed out---he was sweating a lot . We called 911 . was back when ambulance came----they checked on him and saidis fine--and they left. is fine after that then he left 30 min later.

Vaccine was administered on 3/26/21. On 3/28/21, started experiencing symptoms which included hives, joint pain, and difficulty walking.

Patient presented to the Emergency department on 4/25/21 with complaints about a rash on the forehead which started out as small blisters and is now become open blisters and some scabbing. Started on 4/23/21 per patient report to the ED provider. On 4/25/21 he is having swelling of his left eye and was concerned about ophthalmologic involvement, denies any foreign body sensation or pain, just can't keep his eyelids open. Patient stated had received the Covid vaccine several days before this started (second shot on 4/21/21)

Injection site redness...more than 5 days. Arm soreness has decreased daily. Initial noticed effect besides slight soreness in arm... Chills 10 to 11 hours after injection. These increased for next 12 hours. Weakness, moderate to severe nausea( vomiting).. lasted 2 days. Not able to keep food down. Headaches...slight to moderate migraine headache..3 days..in duration...decreasing in severity daily. On second night and third night.....profuse sweating on Second night....restless and little sleep. Third night slight sweats in early morning. After 4 days....eating and getting energy back from a really bad experience.

Tinnitus (ringing in the ears), not sure if it comes and goes or just when occupied I do not hear it. Only other symptom was sore arm after each injection. Was only tired after the second shot.

Per patient and gf, started to develop "mosquito bite" type rash on both arms roughly 3 hours post second Moderna COVID 19 injection. Called to inquire if benadryl was appropriate to take. RPh confirmed the rash stops at the shoulder and elbow bilaterally with no itching or swelling on/in the throat, mouth, or tongue. Patient and girlfriend notified to seek medical attention should symptoms worsen or threaten breathing. Both parties verbalized understanding and stated they would take one 25 mg capsule with one additional if needed.

7 days after vaccine - rash on underside of right fore arm and on right side of body.- rash did not cross midline of body. Itchy- looked like Shingles. Rash cleared up after 2 weeks. Treated with cortisone cream and calamine lotion and Benadryl. But Health Dept. Denied 2nd shot because of rash.

They are suspecting Dress Syndrome; erythema all over his body; broke out into a rash, started as a bulls eye rash in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Parkinson's disease, Drug allergy (penicillin) and Drug allergy (ampicillin). Concomitant products included CEFALEXIN, CARBIDOPA, SILDENAFIL (VIAGRA [SILDENAFIL]) and DILTIAZEM for an unknown indication. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome) (seriousness criterion medically significant), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (They are suspecting Dress Syndrome), ERYTHEMA (erythema all over his body) and RASH (broke out into a rash, started as a bulls eye rash in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter mentioned patient is a mostly healthy, active farmer. 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.

Took 2nd Moderna shot on Wednesday April 28. Rash began next day after shot. Shoulder muscle was sore, lasted two days after shot. Rash was around the area of shot, all pink, about 3 inches long vertically and 2 inches wide. Itchy and hurt when touch. Today is Monday, 5 days after shot, rash is slowing going away and improving. No other rash in other parts of my body. Other symptoms: some fatigue and headache and muscle soreness which lasted for two days after shot. Took tylenol and symptoms went away. I did not get rash on 1st Moderna shot on March 31 but did get sore shoulder muscle for 4 or 5 days. No symptoms.

Headache, fatigue, chills with some shaking, slight nausea, soreness at injection site. Started in the afternoon and increased until about midnight. Took a normal ibuprofen dose. Slept and mostly resolved by morning. Mild symptoms today (May 4). Note: I had minimal symptoms with the first dose; less soreness at the injection site, which came on more gradually. Reporting this more for data purposes, not as a health problem.

Nerve pain across front and back of torso, blisters along nerve trunks. Diagnosed as shingles. Toradol injection, oral prednisone, and Franchville prescribed.

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

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

This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma) and DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heavy smoker in 2020. On 01-May-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 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 03-May-2021, the patient experienced PRURITUS (Feeling scratchy). On 04-May-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) (seriousness criterion medically significant) and WHEEZING (Wheezing sounds). On 02-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 03-May-2021, PRURITUS (Feeling scratchy) had resolved. On 06-May-2021, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) and WHEEZING (Wheezing sounds) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Oxygen saturation: 91 Low. On 03-May-2021, the patient was feeling scratchy and mentioned it could be due to pollen. On 04-May-2021, he was experiencing difficulty breathing, which began in the morning and exacerbated by the evening. He had wheezing sound and by 6 PM he could barely catch his breath. He got breathing treatment using nebulizer and his oxygen level was 91. By 8 PM he went to the ER and underwent tests. He was diagnosed to have Asthma and COPD. Treatment: Inhaler, nebulizer and steroid. 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.

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

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

A few hours after receiving the shot, my left arm got a little sore. The next day, and for about 2 weeks after getting the shot, my arm remained sore at and around the injection site. Then 3 days later my arms and legs and around my waistline broke out in small, hard bumps and rashes. The rashes worsened to the point of oozing a clear liquid and became very painful. It felt like I had broken glass circulating in my bloodstream. It got so bad I drove myself down to the Montage Health urgent care facility.

Rash on forearms started 05/06/2021, lasted 3 days, then went away, R eye got red & sore x3 days, then resolved; L eye, neck & face are now affected, pt attributes sx to 2nd COVID vaccine, has been using Sarna topical & oral Benadryl with good results

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

Following night after shot a rash started on upper right shoulder going down to middle of back; also on upper left hip and midway down left leg. Itching stopped 5/17/21, but rash is still visible. Did not see a doctor.

Erythematous hives starting 10/26/2021 which were located on the face covering the entire body to the top of both knees. No changes with diet, household cleaners, or detergents.

Patient developed erythematous hives starting around his face extending down to the top of both knees. Was resolved slightly with Benadryl but returned the following day. He was seen in the clinic and started on Medrol Dose pack. He denies having any changes with household detergents or cleaners, no new foods or medications. He was previously on Cipro and Flagyl which was stopped 3 days prior to rash developing.

Within 3 minutes of vaccination, pt began to feel lightheaded and was assisted to lie down on a cot. He c/o a "scratchy throat" and a little trouble breathing; he developed a rash on his neck. VSS were stable throughout episode with SpO2 95-99%. Pt was administered Benadryl 50mg po x once w/good effect. The reaction resolved and patient left for home after an hour.

had redness around and below the injection site. area was slighly raised and felt warm to the touch.

1) within 1 week of having received 2nd dose of Moderna vaccine I developed a low grade fever and was quite lethargic soon after awakening; (May/15 - May/21); 2) I started feeling less lethargic but something was not right; 3) on Sunday 5/23 - I awoke to a fever and night sweats; this would continue every night I tried to sleep from Sunday 5/23 - Friday June/04. 4) I reported this to my primary care physician and a blood draw appt was made for May/27 and face-face annual check-up on June/1st. 5) Several of my blood marker results were concerning and I was asked to repeat blood test and include Urine test. I am being told that I have markers for potential Multiple Myeloma.

Day 1 through 12-None. Day 12 fatigue and developed skin pain on left side of face and ear. Pain progressed to scalp and left side of face. Day 14 went to urgent care and Dx shingles. Doctors notes-"Shingles v trigeminal neuralgia?" . Rx VALTREX. No relief and moderate to severe pain extended to other side of face and scalp. Day 16 went back to urgent care. Rash on forehead and no blisters. Rash is maculopapular. Not shingles and discontinue VALTREX. Rx Prednisone and Cetirizine (oral). Resolved after 5 days. Following up with allergist on 6/7/21 for advice on second dose.

Cellulitis; Pain; oxygen saturation decreased; Headache; Chills; Pyrexia; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bypass surgery in July 2020. Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol and Hypertension. Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), LOSARTAN, METOPROLOL, VITAMIN D NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). 10-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen saturation decreased). At the time of the report, CELLULITIS (Cellulitis), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and OXYGEN SATURATION DECREASED (oxygen saturation decreased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: clear (Inconclusive) Clear. On 10-Feb-2021, Oxygen saturation: 92% (Low) 92%. On 10-Feb-2021, Pyrexia: 102 degrees (High) 102 degrees. On 10-Feb-2021, SARS-CoV-2 test: no results (Inconclusive) no results and inconclusive (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was injected on 08-Feb-2021. He began getting headache the afternoon of the 10-Feb-2021 and developed sever night chills by 11.30 pm the night of the 10-Feb-2021, along with fever of 102 degrees, body aches and pain. He experienced low O2 saturation at 92%. Though possibly unrelated the patient developed cellulitis at incision on left knee which was being treated with unspecified antibiotics. The patient was directed to and seen by urgent care facility. Treatment information was not 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Sweating concurrent with extreme chills 7 hours duration. Headache. Fully body aching. Nausea no vomiting. Loss of appetite. Injection site rash/reaction 3 day duration. Muscle pain below the injection in left arm 4 day duration.

Shortness of breath, injection site soreness, fever, weakness, night sweats first night following injection and progressively worsened.

3 days after vaccine, patient started getting petechial rash to legs and then multiple bruises to thighs. Took him some time to seek care but was found to have thrombocytopenia. with Platelets as low as 20. Required admission to the hospital, platelet transfusions/IVIG/ and long term steroid course. Still undergoing treatment but is recovering.

I developed hives, hands, legs feet and arms. The next day it got worsen, It went into my head, neck, ears and back. So I called my doctor and he stated that I go to the ER. They gave me injection of histamine and steroids. They gave me a script of histamine to take for 10 days. I then got some over the counter histamine and took that. The hives started going away and then they will come back and then go away again. It eventually started to get better.

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

Rash over shoulders and chest area. Strange red rash on instep of right foot about 3-4 inches in diameter. Showed up 36 hours after vaccine. Not too bothersome. appears to be more rash today 3 days later.

pt experienced delayed body rash on back/arms/legs- beginning 7/5/21- advised pt to try Benadryl and consult with physician regarding 2nd dose of Moderna

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

Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site) and my wife had to call 9-1-1 and EMT's took me to hospital and I was hospitalized for four days. Hospital. I am recovering from the medications still but I have recovered from the health event from the vaccine.

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: red line going down arm-Medium, Additional Details: Pt reports dark red line going injection site down to bicep; no fever

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: muscle cramps in leg-Mild

Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp; Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis; Red rash; Blister; Scalp felt tightening like someone was pulling on his head; Itching; worry; Entire body swipe out; skin bleeding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039821A and 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Parapsoriasis (in the past and has been with dermatologist for 10 years.). On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced SKIN EXFOLIATION (Entire body swipe out) and SKIN HAEMORRHAGE (skin bleeding). On 06-Jun-2021, the patient experienced PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp) (seriousness criterion medically significant), SEBORRHOEIC DERMATITIS (Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis), RASH ERYTHEMATOUS (Red rash), BLISTER (Blister), PAIN OF SKIN (Scalp felt tightening like someone was pulling on his head), PRURITUS (Itching) and ANXIETY (worry). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Adverse event, at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE ongoing since an unknown date for Adverse event, at a dose of 0.1 %, topical oil; TRIAMCINOLONE ACETONIDE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) ongoing since an unknown date for Adverse event, at a dose of 2.5 %. At the time of the report, PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp), SEBORRHOEIC DERMATITIS (Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis), RASH ERYTHEMATOUS (Red rash), BLISTER (Blister), PAIN OF SKIN (Scalp felt tightening like someone was pulling on his head), PRURITUS (Itching), SKIN EXFOLIATION (Entire body swipe out), SKIN HAEMORRHAGE (skin bleeding) and ANXIETY (worry) outcome was unknown. No concomitant drugs were 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. Due to the severity, duration and lack of response to treatment the event psoriasis aggravated is considered serious due to medically significant criteria. This case was linked to MOD-2021-207698 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Additional information received on 03-Jun-2021 contains significant Follow-up included updated the reporter's information, relevant medical history, treatment medications and newly added events. On 07-Jun-2021: Additional information received on 07-JUN-201 contains no new information. On 09-Jul-2021: Follow-up received included no new information. On 09-Jul-2021: Additional information received included additional event.; 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. Due to the severity, duration and lack of response to treatment the event psoriasis aggravated is considered serious due to medically significant criteria.

Pt developed dry cough, low grade temperature 100.2 on 7/18/21. He has had a runny nose and mild skin achiness

1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness 4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches 7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus Note, items 2, 8 and 9 remain

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

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

Headache, Myalgia, reports redness running down arm the afternoon of and today is feeling flush, and mild shortness of breath Narrative:

Moderna COVID-19 Vaccine EUA - I have experienced the following : The injection site is very tender to the touch. The soles of my feet have become numb. Slight exhaustion through the first 24 hours after the vaccine.

4 days after injection, redness and severe itching at site. Treating with warm compress and Benadryl cream.

On January 11th, 2021 patient called to report that he will probably not get the second dose of Moderna due to side effects he had after he received the first dose of Moderna. He reports that for a week after he had brain fog, ie. couldnt remember common things, he reported that he got a 1/2 dollar size black and blue mark to skin where the injection was given, and reports it is still there two weeks after receiving the injection. He also stated that his arm was very painful after the injection.

Significant pain at injection site, worsening overnight. 24+ hours later I am still having difficulty raising my L arm to shoulder level. Significant point tenderness as well. Pain about a 6/10.

Localized allergic reaction. Uticaria on the left side and rash on his abdomen. Benadryl 50mg IM. IV TKO.

1/18/21 6 PM left arm soreness, took tylenol. Patient states that he started having chills, muscle aches, Patient states that he started having fever of 101 degrees Fahrenheit, dizziness, and tachycardia 1/19/21 at 8 am. Pt. states he took tylenol at 8 am and heart rate and tachycardia improved and dizziness improved as well. Pt. states that he feels good now, but feels like his covid symptoms are light with a cough. Pt. states that arm is still sore.

Patient with intellectual disability received his vaccine on 1-7-2021 in his right deltoid. On 1-11-2021 it was noted that he was developing a rash on his right ear/cheek area and a raised red rash near the sight of his vaccine by the attending nurse on 1-12-2021. is unable to verbalize his symptoms, an anatomical diagram was completed by his nurse on 1-12-2021, noting continued redness on the right side of his face and his right upper arm. Photos were also taken to archive this. His PCP was notified and an order was received to give a dose of diphenhydramine at approximately 1:30 PM on 1-12-2021. By 1-15-2021, the arm and facial redness had resolved per patients nursing notes.

About eight hours after the injection, I noticed some hearing impairment in my left ear. Sounds are muffled, almost as if I have water trapped in the ear canal. I noticed this right before I went to bed, and the hearing loss is still present and similar in magnitude this morning. There is no pain, and the hearing in my right ear seems to be normal, although I can't rule out some slight loss on that side. Aside from a slightly sore arm at the injection site, I've had no other side effects (e.g., no fever) from the vaccination.

Patient received Moderna COVID Vaccine on 1/12/2021. On 1/20/21 patient noticed redness, swelling, rash appearance looking and area was warm to touch around the injection site. Ice pack applied on patient before bedtime. On 1/21/21 symptoms were improved around 12 noon.

Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatigue, dizziness. Disturbed sleep. Joint pain overnight. Took advil during the night and helped immensely. Following day mild dizziness and fatigue, just feeling slightly unwell. Slept 9 hours that night where normally sleep 6-7. Thursday morning back to 85% and by end of day back to normal.

Half hour after shot experienced minor itching on neck, head, face and torso. Took 2 benadryl over the counter and itching is slowly subsiding.

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

COVID-19 Vaccine EUA. Severe pain at injection site approx 6 hours after injection. Weakness, joint pain, slight headache started around 7:00pm 1/23/21 and continue at the time of this reporting 8:00am 1/24/21 If symptoms persist beyond today I will schedule a visit with my primary care physician.

Dec. 29, 2020 - first Moderna Vaccine dose. On same day I had mild localized injection site soreness/pain & felt minimally tired. The next day the injection site was a little more sore/panful & I had moderate headache the whole day. The next day I was fine, Jan. 26, 2021- second Moderna Vaccine dose. Six hrs. later the injection site was mildly sore/painful. 12 hrs. after receiving the dose I began to feel body aches, some chills, decreased energy level & did not fall asleep the whole night. The next day I had moderate headache, continued to have some infrequent chills, body aches, decreased energy level & injection site soreness/pain was still mild but had increased from day before.

on week latter a red spot 1&1/2 inch tall and 2inchs wide developed around the injection site and is warm to the touch -slight swelling (?) maybe.

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

Moderna COVID-19 Vaccine EUA. Received 2nd dose on 1/28/21 approx. 10:30 a.m. Approx. 13:30 p.m. ears began feeling warm, left shoulder more painful to touch than first injection, and body slightly sluggish. Left work approx. 17:00, upon arrival home wife noticed my ears were red and I felt very warm. Digital temperature of forehead was 102.7, and ears were 106.4. Took digital B/P and it was 185 / 85. Took two Aleve tabs and sat down to rest. One hour later took temps again and forehead was 100.4 and ears were 102.4. Still felt drained. Removed some clothing, took shower and to sleep. 02:00 a.m. awoke, temps within normal range. Next morning B/P normal as well 135 / 56.

Late injection reaction. Awoke to find a large rash (about 3 inches long, 1 inch wide) around the site of the injection. I had not noticed it before that time. It resolved by itself over the next few days.

Patient did feel itchy all over and ached some after first shot, but didn't say anything about that. Morning after 2nd shot became nauseated; ran fever and ached all over. He felt this was for 2 -3 days, and also very tired. Still very tired on 4th day after shot, but no fever or aching. Patient did take Tylenol, didn't help so also 1 dose of Ibuprofen. Take Prasugrel, so Ibuprofen wasn't really an option for him.

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

Pain in upper left arm, approx 2 hrs after injection. Nausea, headache, light-headedness: approx 21.5 hours after injection

pain and soreness at injection site, chills, fever, muscle and joint pain, nausea, headache, fatigue "symptoms almost identical in type and order felt when I first experienced having COVID-19 in late November 2020, except of course; for the duration of each stage".

Fatigued. Retired to sleep at 2/2/2021 @ 1800 hrs. Woke at 2330 hours experiencing pain in right arm, chills and RINGING IN EARS. The ringing in ears lasted 2 days. Bilateral ear ringing. Increased dramatically. Note: In 12/2017 he experienced ringing of ears. 2020 decreased substantially to mild level.

Fever of 100.0 lasting approximately 12 hours. Slight body aches, lack of energy lasting through 2/13/2021. Largely resolved, by 2/14/2021 a.m.. Pain at the left arm injection site continuing through 2/14/2021. Treated with acetaminophen, 200mg three times daily. Discontinued 2/14/2021 a.m.

Intense Injection site pain. Much worse than first does (in left arm). Fever and feelings of overheating. Chills to the point of not being able to get warm. Sleeplessness and fatigue. Headache and fogginess. All symptoms occurred overnight while in bed. Arm pain remains as well as headache and fogginess after attempting to sleep for 7 hours.

On Feb 16, day 26 after dose 1, at around 7:30pm I started having continuous Chills suddenly and felt my body temperature rising. I confirmed with Thermometer every 15 minutes, going from 99.1F to 101 F in the span of 2 hours. I took 2 Tylenols (500mg each) at around 9:30pm and started drinking over 1 liter of water, fortified with Electrolytes... My temperature gradually started to go down by 10:30pm and back to normal 98.7 F by midnight... I was worried that I have COVID (my Dose 2 was scheduled on 2/18). I went and did a COVID PCR test which thankfully came out "Negative" in the evening of 2/17. I re-established my Dose 2 appointment for today 2/18 same facility as Dose 1. It is worth mentioning that on 1/29, 8 days after my first dose, I developed sudden itching and redness at the site of the vaccine injection (right arm) and my skin was hardened around the site. Also, this reaction lasted 24 hours and as if nothing happened in next day.

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

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

Right arm pain with movement starting next day after injection 12/24/2020 and then about one week later the injection site is painful to touch, redness present, swelling, and itching.

Patient received Moderna vaccine and developed a rash all over body. Very itchy. Recovered, Refused second dose.

Noted red blotchy areas 2 days post vaccination on bilateral inner thighs. Patient states he has yellow drainage if he expresses the areas. Has a photo of the rash. They are circular individual areas about 1 cm circumference. Each individual area is bright red with a open pinpoint area in the center. Some have a crusty area. He denies itching, burning. Denies rash in any additional areas post vaccination. Referred to see physician.

Red rash, VERY itchy area around injection site. Did I mention VERY itchy. No medications, ointments, or creams used on itchy area. No oral medications taken for itch or rash. Currently on day three of itchy and it seems a little better. Waiting for a few days for condition to clear.

Hives. First started with extremely itchy palms (both hands), spreading to forearms, then hives developed on trunk and backs of thighs. Symptoms improved after taking benadryl, but returned about 5 hours later.

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

Fever and terrible chills about 12 hours after receiving the shot. Lasted about an hour. Woke up the next morning with mild fever, headache, aches, injection site very painful. Started taking Tylenol.

After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.

Swollen lips, slight rash on my face 50 mg Benadryl upon noticing the swelling around 8:30 pm 50 mg Benadryl at 4:30 M the next morning 9:45 am lips are still swollen

Approximately 12 hours after injection, had horrible chills off and on for several hours with fever. The following night, the fever spiked to 103.6 and stayed above 103 for several hours. Fever finally broke 3 days post injection. Injection site was very painful and is still somewhat painful after 4 days. Experienced body and muscle aches, nausea and headache. Still experiencing nausea and dizziness 4 days after the injection. Have been taking Tylenol on a regular basis and pushing fluids.

Initial site soreness and two days of flu like symptoms, mild headache, muscle soreness/body achs, fatigue, after second dose. Fatigue has persisted to this date

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

Moderate itchy feeling on skin extending from lower left ear area to middle of throat on face/neck. Nothing obvious visually but itching is very similar to mild poison ivy. Local ointments (benadryl, hydrocortisone, etc) have zero effect.

Woke up at 2:00 am extreme headache I took ibuprofen 200 ml. 7:00 am very weak headache not as bad. Day 2: dull headache, very fatigued, muscle ache between shoulders into upper neck. Day 3: same as Day 2. Day 4 same as Day 2 but now small rash on hip. Day 5 dull headache and rash, not fatigued and no muscle aches. I hope this info is helpful.

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

Delayed (8 day delay) allergic reaction. Swollen, inflamed ears -- both upper portions of external ear (helix, anti-helix, triangular fossa). Isolated clustering of small bumps and blistering on hands and feet and systemic bumps and blisters on torso, arms, and legs. Receiving hydroxyzine HCL, topical cream for itching. Day 8 after vaccine itching at vaccine site, hands and feet and inflamed ears. Each day after the itching symptoms are easing, although the blistering began day 10 after vaccine.

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

Pain at injection site - began day after injection and lasted about 3 days Fever - began two days after injection and lasted about 2 days Headache - began day after injection and lasted about 3 days Fatigue - began day after injection and lasted about 3 days Sensation of dermal scratchiness over torso and legs (no visible rash) - began day after injection and lasted about 7 days

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

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

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

Hard red patch at injection site, noticed 10 days after shot. Continues to grow larger 5 days later, forming ring.

03.24.2021 New onset of injection site tenderness 03.25.2021 Red, slightly itchy rash developed around injection site

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

Red, itchy, rash developed on left arm just below injection site. Also lumps formed under skin. Happened 8 days after injection.

Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,

No longer has symptoms, but 2 days after vaccination experienced swollen, and redness at injection site What happened as a result of the adverse event? patient saw provider and was recommended to take benadryl and ibuprofen which has helped resolve symptoms

Extreme itchiness in feet and hands the next day. Rash onset initially bilaterally in armpit region on day 2. Rash spread and severity has increased since then until day 4 (today). The rash is quite red, sensitive to touch, raised and flat-topped. It's spread downward from armpit to 6-8 inches below armpit on torso and upwards to the underside of the biceps region. By day 3, it also appeared on the inner thighs in the groin area, but not as intensely as the first appearance in the armpit area. Very slight rash on the palm of left hand. Itchiness in hands is still present, although not in feet.

patient experienced shallow breathing, hives, sweating and low systolic blood pressure 85 within 5-10 minutes of receiving first moderna covid vaccine. Had pt lie down on his back and administered epinephrine 0.3mg on thigh within 5-10 minutes of monitoring pt. Patient became more alert and sbp came up to 110. EMT came and took him to er

Following 1st dose of vaccine, patient developed skin rash on 2nd day, mild maculopapular rash on anterior chest - persisted. Following 2nd dose of vaccine, developed skin rash involving anterior chest and lower back ~ 7 days after the vaccine. Rash is pruritic, painful, raised. No fevers/chills/sweats. No oral/ophtho lesions. Still getting worse. Unable to sleep last night due to itching/pain.

contact dermatitis; significant rash which is very itchy; bruise; Afibrillation; A Spontaneous report was received from Consumer concerning 49-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and afibrillation, noticed a significant rash which was very itchy on his hips where he got a bruise, stated his wife thought it was contact dermatitis. The patient's medical history was not reported. The concomitant medication included Zoloft, Aspirin, Fish oil and Vitamins. On 11 Mar 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 038A21A, Expiration date: not provided) via intramuscular route in the right arm for prophylaxis of COVID-19 infection. On same day, patient experienced afibrillation which was resolved on 13 Mar 2021. On 15 Mar 2021 he noticed a significant rash which was very itchy on his hips where he got a bruise and he stated his wife thought it was contact dermatitis. Action taken was unknown with respect to events. The outcome of other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

I had the usual symptoms, but one symptom I don't see anywhere. Usual: Sore vaccine site, body aches and pains, headache, tiredness. I was unable to sleep due to the symptoms the first night. I convalesced the entire next day and tired easily for the next two days after that. Here's the unusual side affect: I had uncontrollable and very painful leg cramps, that I could not relax. I had to take a muscle relaxer. That was the night of the second vaccine. The cramps were abated thereafter. I am reporting them because I saw them as a side effect no where online.

Awoke between 2am and 3am with chills and fever of 99.9f. The chills lasted about 15 minutes. I awoke two more times during the night with chills also. The fever persisted until about 5pm that evening. However, there were no more chills. I also had injection site soreness for about 36 hours.

patient had a fever for 24 hours, increased heartrate for 24 hours and a tingling that started around the injection site and traveled to his elbow and down to his fingers. He also had a tingling on his left leg. This tingling started about 24 hours after the shot and is still continuing to occur. The tingling is only on his left side which is the side of his body that received the shot.

Fever, chills, nausea, headache, injection site pain on the first day after shot on March 26th. On day two after injection all the other symptoms subsided, but headache continued. On April 1st the fever, chills,and nausea returned and temperature had reached 100.8 degrees and headache intensified. On April 2nd I woke up feeling better but still had the headache, as the day progressed the chills and fever returned with temperatures up to 100°. On April 3rd I woke up with no temperature but the headache continued. On April 4th The headache finally went away. My treatment was plenty of water aspirin, ibuprofen, acetaminophen and bed rest.

Small rash on the arm, just below the injection site, appeared about 10 days after the vaccine. Faded slowly over several days.

After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination . I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand. At that point, 7:00am 03/23/21, my wife drove me to the ER. I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.

A day after the vaccine subject started experiencing blisters all over head and eyes and then spread to arms and legs. Subject went to urgent care on March 21 and was prescribed a medication for itching. On March 22nd subject had no relief so he went to ER because he wasn't getting any relief. Doctor stated he wanted to keep the subject for observation but subject did not want to stay. Subject states the progression stopped about day 7 but still has scabs and wounds that are healing.

Significant skin outbreak of Hives primarily on extremities, legs and arms. Started a week after second shot. Treatment Benadryl.

He had a red rash on his right arm starting below the injection site extending past his elbow halfway down his forearm. Just on the one side covering about 25% of the skin. It is not itchy or hot. If it gets worse or doesn't go away he will call his dr.

Patient said that a few days after his immunization, he developed a strange rash on his hands. He said he it looked like red/pink streaks. He thought he had accidentally written on himself with a highlighter or something, but then realized it wasn't something that he could wash off. He said it was not painful or itchy. It resolved after a few days.

Severe itching @ 10:00 following day, hives, arm pits, soles of feet palms of hands Treated with Benadryl. Symptoms gone by evening of second day following injection. No other symptoms since. Concerned about second dose??????

Temperature of 99.4; Headache; Chills; Body aches, soreness and redness with slight swelling at injection site. All lasted for about 24 hours, except headache and redness at injection site which lasted for almost 48 hours.

Slight Nausea 20 mins about 10:15 - 10:20 AM after injection vomiting about 5:00pm Nausea for about 2 hrs after vomiting. sore arm for a day after injection Small itchy Bumps/Rash, over entire back for two or three days after inection

Rash on both legs just above the ankles. No treatment. Subsiding now. I have no changes in lifestyle or habits that would oterwise explain the rashes.

My right leg has been very tight with a small bump between knee cap & ankle. Shortly after the second dose. ON 3/26/2021.

On 01/20/2021 I got the vaccine. About 36 hrs later, I developed hives from left shoulder down to hand left. I had to remove my wedding ring. I also developed hives on my shin from knee to down to my ankle. I still have numbness in both thumbs and forefingers like they are asleep.

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

Several days prior to the shot, I had been experiencing sore, muscle-related pain in my neck, especially the left side and shoulder area, making it difficult to turn my head to the left. I was still experiencing this pain at the time of the shot. The evening of receiving the shot, I awoke at about 11:30 p.m. with extreme pain in my left shoulder (would describe as 8 on scale of 1 to 10)...not sure I could even get out of bed. Was able to "walk it off" and went back to bed, but had the same pain and difficulty getting out of bed twice more that night. Once prone, the pain would eventually subside. Went to work that morning (the day after receiving the shot) but returned home after an hour as I had a mild fever (100.1) and chills. I took 2 Ibuprofen and slept for about 2 hours. I awoke with temperature down to 99.7 and less pain in the left shoulder/arm area. Throughout the day, my temperature continued to go down and the chills lessened. Two days later, I have no fever and mild pain at injection site.

Aching neck and upper back shoulders, lack of energy (~6PM). Chills and low grade fever sore injection site (~1AM). Sore injection site and lack of energy (following morning).

While getting ready for work, I noticed a large red splotch on my arm where I received the injection. I had not noticed this prior to the morning of 04/19/2021. No itching, or soreness. Just a large (approx. 2 inches) red blotch.

Severe case of shingles (Herpes Zoster) started 3/26/2021 just cleared up but severe pain from neuropathy. (I know of another case where I work of someone in their 20's).

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

Client has had a very achy arm since his second injection on April 8th. It was bruised but is healing. Client had a flare up yesterday 04/22/21 of not being able to move left arm well. Client states the injection site is 3 to 3.5 inches below shoulder. Client advised to place heat on arm for 20 mins and complete range of motion exercises.

Red itchy "rash" on underside of right arm. 3 days after 2nd covid19 Moderna injection. Slightly elevated heart rate over normal?

Patient states" In the morning about 30 hours after his vaccine" patient broke out in rash (redish pink circles) mostly on his stomach, one circle in the middle of his back and some on his leg. Slightly itchy and started out smaller circles then bigger. Once it got bigger it actually stopped itching but he also states that he used cortisone cream for itch. He says he may be a little bit dizzy but he sometimes gets dizzy even before the vaccine. He states "no other symptoms" and rash is getting better. He is concerned whether or not he should have the second dose of Moderna Vaccine.

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

Tenderness at injection site after a few hours that went away after a few days / Achy muscles and joints after a couple days (ongoing) / After nearly 2 weeks, a red patch about 2 inches in diameter appeared at the injection site causing concern but no real discomfort (ongoing).

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

Bleeding Gums, Rash, fatigued, shortness of breath, random joint pain, fever, chills, brain fog, electric shock in arms, left arm weakness. 2 emergency rooms, 1 walk in medical center, 1 doctor visit, cardiologist, rheumatologist. Extensive blood work at both ER's and Doctors, x-rays, EXG, cat scan. Yesterday received cortisone shot left arm. Presently on prednisone 2o mg 2x, hydroxyzine 25mg 2x bed, gabapentin 100 mgg 3x.

Severe headache for 20 hrs. starting at 2am. Very weak and no apatite. Severe lower back pain for 30+ hrs. Slight fever for short period of time. (100.1) Sore arm at shot location.

About three days post 2nd vaccine, my left upper arm/shoulder area started to experience only when I'd extend my arm or try working with my left arm overhead. No redness or swelling. It is now 8 days post injection and I am still experiencing the same pain only when my left arm is extended or raised overhead. Feels more like a muscle tear than stiffness.

By 14:00 on 4/30/2021 my body started aching all over. by 20:00 the pain was severe, even the arches of my feet hurt. I had taken acetaminophen by 18:00 and again at 24:00. Much to no avail. At 06:00 the pain was pretty severe yet and acetaminophen was not cutting it. I had some hydrocodone from a previous injury still in my medicine cabinet, so I took one of them. It made a big difference. By 08:00 most of the symptoms had diminished. I didn't take anything else until 17:00. By then my left arm was really hurting. By 21:00 the pain was all the way down my arm and up into my neck and jaw. I took another hydrocodone. The pain was still pretty severe at 22:30 so I took 2 Ibuprofen. my pain had diminished enough to get to sleep by 23:30. When I work up this morning my pain was localized to just around the injection site .

Patient developed severe bruising on left inner side of the arm. This developed around one week after the second dose of the Moderna vaccine. He also informed us that the night before he had wrapped a CPAP cord around the arm. The arm had a ball that was painful at touch. Patient came in today (05/04/21). The bruise was still there but formed a yellow color indicating the bruise is dissolving. There was no heat or nodule in the middle. Informed patient to call his PCP as soon as he can. He is due to have surgery next week for his DVT issue on the left leg.

Redness, swelling, and itching covering the entire upper arm area where the injection was given. Symptoms began 2 days after the second dose.

Extreme muscle and joint pain. For 2 days. First day after shot I couldn?t get out of bed. Same feeling as the COVID toes I had with COVID-19 Shot site soreness for 1 week following the vaccine.

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

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

Delayed skin response. Blisters on and between fingers and toes and on hands and feet. Isolated areas of red bumps all over body that itched like poison ivy. Extreme itching at night making it difficult to sleep and be comfortable. I went to medical facility after an evening phone conversation. They prescribed an antihistamine and topical lotion. The first days were the worst with the blistering and very itchy small red bumps. After the first few days, improvement occurred each day until about the 10th day when the skin reaction had resolved.

Shingles break out. Had previously had within the past year and a half the two dose shingrix vaccine.

POSSIBLE DELAYED REACTION-FEW DAYS AFTER VACCINE IN THE EVENING (4/29) EXPIERIENCED HIVES ON TORSO (NOT AT INJECTION SITE)LASTING FEW DAYS 5/2 PURCHASED BENADRYL AND HYDROCORTISONE CREAM. . HE SPOKE TO A NURSE ,DONT BELIEVE ACTUAL OFFICE VISIT., WHO BELIEVED REACTION WAS DUE TO SOMETHING HE ATE. HE DID HAVE EGGS AND UNWASHED STRAWBERRIES THAT DAY BUT ISNT ALLERGIC. AS OF 5/11 FOLLOW UP CONVERSATION HAS FULLY RESOLVED. MODERNA CASE NUMBER MOD21-085398 VI PHONE CALL.

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

After my first shot on March 10, I had minor soreness around the injection site and fatigue the day following the injection. After my second shot on April 6, I had minor soreness around the injection site, fatigue which lasted two days and low grade fever which I treated with one 400mg dose of ibuprofen. I also developed a persistent high pitch "ringing" in my head/ears. I believe it's what is know as tinnitus. The volume on a range of 1(low) to 10(high) is 2/3 to 5/6. For the first four weeks after my second shot, the ringing was constant and daily. I noticed beginning week 5 that there would be days where it would completely stop or be barely noticeable. The quiet periods ranged from a couple of hours to almost an entire day. The quiet periods are generally begin in the mornings when I first get up. Otherwise they don't appear to follow a pattern. I also noticed, if I consume alcohol it lessens or eliminates the ringing.

1) Soreness in injection site and arm where the shot was administered 2) Tiredeness and very light fever 3) Teeth sensitivity to cold

10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy. ADDENDUM: TEMP WAS 97.1 THIS MORNING (MY NORMAL TEMP) 97.1 WHICH IS MY NORMAL TEMP AND JUST NOW WENT UP TO 100.2 AT 6PM ET

10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy.

Persistent itchy skin bubling on arms, mainly near left forearm near elbow. Persistent peeling skin on hands and fingers - mainly right hand. Never had this before.

A Hive like rash appeared on my left arm approximately 2 weeks after my 2nd shot, and now appears over various parts of my body such as, both arms, my torso, my legs, and my back, however, it comes and goes throughout the course of the day with minimal itching.

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

Approximately 20 hours after administration of the second dose, the following symptoms arose and subsided (except for pain at injection site) over approximately 48 hours, seemingly completely: pain at injection site; fatigue; heavy chills; and serious diarrhea.

Within less than 24 hours after the first injection, patient went into tachycardia with heart rate 117 -120 for 2 weeks. After the second dose which patient was encouraged to get from their clinic, his heart rate went in excess of 139 for 1.5 weeks and he ended up in hospital for one week. Per patient's report, despite all treatments, they were only able to get his heart rate back to around 117. He was discharged home in tachycardia. Then, without change, 6 weeks after his second dose and being perpetually in SVT, patient's heart rate dropped into the 50s and has remained bradycardic. These have been the first changes in patient's last 5 years of daily heart rate logs since being diagnosed with paroxysmal a-fib in 2016. This has been unlike patient's history and a frank change in his heart rate and lots. Patient also reports having multiple whelps all over his lower abdomen since the injections.

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

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

06/03/2021 1800 - Headache duration 24 hours. 06/03/2021 1900 - Elevated blood pressure, mild hypertension continues. 06/03/2021 1900 - Pain at injection site rated 6/10, 24 hours duration. 06/04/2021 1500 - Severe flu like symptoms, 24 hours duration. 06/04/2021 2000 - Fever 101.00, 8 hours duration. 06/04/2021 2000 - Nausea 24 hours duration.

05/07/2021 1000 - Headache, slight numbness of left side of face, body aches continuous. 05/08/2021 0800 - Lower extremity aches 48 hours duration. 05/09/2021 0600 - Red non itching red rash noted on chest, 6 hours duration. 05/25/2021 1500 - Elevated blood pressure. Diagnosed with mild hypertension with no previous history of mild hypertension.

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

Fatigue, 102 temp, headache, swelling at the injection site, pain behind my eyes, skin painful to the touch. sore body aches, cold and hot chills, appetite suppressed, lower abdominal pain and cramps, diarrhea, All events lasted 24 hours except: Headaches, skin pain, and body aches, and appetite suppression, which lasted another 24 hours. After 48 hours just appetite suppression.

Day after vaccination started having bumps on head, arms, legs, feet and face. Progressing into blisters, then blisters on top of blisters, lasting 7 to 8 days. Emergency room recommended admission, declined. Went back to the Emergency room the next day: recommended burn center. The next day the blisters started to resolve. Currently has two lesions one on hand one on foot that still has not healed.

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

After vaccine I started having a very bad rash all over my body I went to my primary care doctor and he prescribed me a cream and I used it for a few weeks but it didn't help so I went to a dermatologist and the dermatologist gave me a stronger cream and biopsy that came back negative. I still have the rashes.

About a month after getting the second moderna dose, I began having hives, which was new to my health. Hives were never an issue previously. They are almost 24/7 now. Break outs have occurred almost everywhere on body.

PATIENT INDICATED SIGNS OF UNSUAL BLEEDING (PURPURA) ON BOTH OF HIS ARMS AFTER I HAD GIVEN HIM HIS SECOND DOSE OF THE MODERNA COVID 19 VACCINE. SINCE HE HAD NO PREVIOUS HISTORY OF ANY CHRONIC ILLNESS OR ON ANY MEDICATION, ALSO HE HAD NOT BUMPED INTO ANY OBJECT BY ACCIDENT.

(02/08/2021)(102)Fever, Bone rattling chills, aches, nausea, 3-5in of major swelling at the injection site, Tylenol for fever, light clothing, bed rest and fluids. took about 4-5 days to come to normal

Suffered an unwitnessed fall this evening ~ 0130. Prior to this he had been ambulating in the dayroom around midnight without difficulty at his baseline and interacting with staff. He then went to his room. During rounds ~0130, the staff found him in the bathroom face down. He stated he lost his balance but was not able to provide more information. He was assisted up and he had difficulty walking . RN noted three abrasions on his forehead and one on his chin. His vitals were 146/86, 20, 74, 97.2. He had a change in his baseline mentation and ambulatory status at that time. Patient transferred to local ED, where he was seen by two providers. At that time, patient was noted to be using his right arm and left.

On March 31st, 2021 I received my first shot of the Moderna Vaccine, after testing negative following a 5 week session with Covid-19. The results of the first shot was a violent reaction within 10 minutes of the vaccination. Symptomes included; tingling in my face, followed by the 2 extreme symptomes (numbing left ear and left neck spasming) that I experienced during my spell with the Covid-19 on January 5th 2021, I was diagnosed with Viral Pneumonia. After vaccination, I was sent to the emergency room for treatment. While waiting for the ER personnel to address my symptomes, I went numb from top of my head to my toes. I told the nurse what happened and the medical staff came in and started treatment of (Benytrel, steroids by I.V. delivery. I broke into a red rash from head-to-stomach. The doctor administered Adrenaline to speed the medication effect. I left the hospital 2.5 hours later, pink skin color instead of red. The rash would come and go for 30 days. Because of the reaction I experienced. I did not move forward with the 2nd shot in fear of another violent reaction. So, I had a strong case of the Covid-19 without any breathing problems and had my first shot of Moderna vaccine. What are my options to be fully protected against the New Delta variant? My current age is 62. Please advise! Thanks

Deltoid muscle pain at injection site began D1; involvement extended to all upper arm musculature and elbow on around D3 and to distal arm around D5. Presently (D10) muscle involvement and severity is unchanged. Muscle pain is dull ache whereas injection site pain is sharp. No swelling or redness is noted. No fever, chills or other signs of infection, just myalgia and questionable arthralgia of joints.

Hives on arms, legs, trunk 3 days after (started 1/2/21) vaccination. Itching controlled with Benadryl.

Patient reports having a 1 cm x 1.5 cm " blister- like " lesion at his injection site since 01/03/2021 at 7:00 pm.

Immediately following injection, area surrounding injection site began swelling. Site was bright pink and was approximately 4-5cm in size. Swelling considered moderately severe. Swollen area was not centered directly around infection site but slightly above. Area was iced and patient was given 50mg Benadryl po and monitored for additional 30 minutes for any additional adverse affects. Patient was given instructions on to call 911 for any additional severe reactions and to call clinic to report any other non life-threatening reaction. Note: Patient is a physician and is familiar with reactions and side effects to report.

One week after the vaccination, sudden onset of severe itching at the site, with a raised red bump at site of needle puncture. The itching is severe, bad enough to prevent sleep, and there is redness around the injection site followed by burning pain. It has been a day since the itching started, and it has not let up.

Injection site soreness that was worse over night Headache this morning that would not go away. Has been taking Ibuprofen and Tylenol and just now Tramadol in repeated doses for relief. Fatigue

RASH STARTED IN THE ANTERIOR WAIST , AND BIALTERAL LOWER LEGS ABOUT 30 HOURS AFTER VACCINATION. THE RASH EXTENDED TO THE ANTRIOR PELVIS, THIGH , UPPER ABDOMEN, ANTERIOR NECK AND FOREARM, AND EXTEND TO THE UPPER ARM IN 48 HOURS. THEN ABDOMINAL RASH DESAPPERED. NO-MINIMAL ITCHING, NO FIEVER , NAUSEA OR DIARRHEA. MINIMAL HEADACH AND ABDOMINAL PAIN. NO TREATMENT.

Headache, Myalgia, Arthralgia, Flu-like symptoms, woke up slightly restless on eve of 23rd, increased nasal congestion, profound fatigue following 48hrs difficult moving/getting out of bed, severe low back pain, left deltoid sore x 3 days, chills no documented fever, alternating Acetam Narrative:

Symptoms were first noticed the following day of the vaccination at at 6 AM. They were chills, hands and feet being extremely and unusually cold, fatigue, body aches and soreness at point of vaccination. Body temperature increased but not to above 98.6.

"Moderna COVID-19 Vaccine EUA" Soreness/pain at injection site. Noticed 8 hours after injection. Lasted about 48 hours

Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, Fatigue Narrative: Lost time of work

Extreme soreness in left shoulder at site of injection. Pain would possibly be in the 8 category. Very uncomfortable and cannot lift left arm anywhere near shoulder height.

On day 2, left shoulder turned red near injection site. On day 4, redness turned into a small patch of hives on left shoulder (injection site). Today is day 6 and hives are still present.

Rash on arm of injection and neck problems Date of Onset: approximately 10 days ago: 01/10/2021 -reported due to late onset rash

Acute severe vertigo associated with nausea. Approximately 10 events each lasting 1-2 minutes. Treated with OTC meclizine and seems to have resolved. No associated headache. Only other symptoms was moderate pain at the injection site

7 days after injection patient admit upper (L) arm started itching and 8 day after injection arm swollen at injection site and arm upper became red and increased warmth. Initial visit today 1/29/2021

1/22/21 0800 AM noticed rash to left arm injection site, back, bilateral posterior legs along with itching to bilateral arms, legs, back, chest, and stomach. Pt. denies taking anything for it. Pt. states that the itching has become worse over the course of one week and is worse today.

Approximately 5 days after receiving 1st dose of vaccine, patient woke up from nighttime sleep feeling 'itchy' all over body. Found approximately 10 red, raised spots or 'welts' on skin that he had never seen before. They were sporadic, NOT clustered. He described as not quite hives. He checked bed for 'bugs' but didn't find anything. He had taken metaxolone for only the second time in his life before bed. Prior use did not elicit any type of 'rash' as described. He applied no topical nor ingested any oral medication at this time. He mentioned he has IBS and also had 1 instance of diarrhea. He then took 1 imodium. He was able to eventually fall back asleep. When he awoke the next morning, all but 1 spot were gone and no indication this had ever happened. He has experienced a mild headache off and off since injection, but nothing significant that keeps him from his normal business.

Covid arm. Red blotch at injection site, itch at injection site, warmth at injection site. Not planning on any treatment as it is not bothersome. Event in progress.

2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on the signs of Stroke "FAST" Patient Issues: Physical shaking like Parkinsons , Heart Palpitations and rapid BPM, Chest Pressure, shallow breathing, stuttered speech, Slurred Speech, Headaches, Confusion and lack of short term recall, red flush face, difficulty in comprehending conversations, reading

on the second Shot, the area has about a 1 and a half inch , very dark bruise after a few days. Also, arm seems weak a week later. First shot had no issues.

2/9/21 - pain/soreness injection sight afternoon, from 9 pm on flatulence 2/10/21 - in bed around 12am chills on and off, woke up with headache, body aches and general malaise, cramps and diarrhea around 4pm, 6 pm severe chills, could not stop and started hyperventilating, used paper bag and after about 15 minutes got breathing under control and got in bed fully clothed with 2 blankets and with heat turned up finally stopped shaking. 2/11/21 - fatigue, cough 2/12/21 - fatigue, cough 2/13/21 - better, normal bowel movement

Fever 100.1. Nausea. Joint pain. Fatigue. Chills. Pain redness rash swelling at injection site. Rash still on 2/14/2021.

I just had pain and swelling at the injection site that lasted over three days. On the 7th Thursday night, I developed a fever 101.5 and took Friday the 8th off of work. I also got a Covid test that came back negative and saw my PCP also tested for Flu A and B, tested negative. I felt lousy, has chills, aches, sinus head aches, I was miserable. My fever went away the afternoon of the 8th and I did not have a fever after that. On the 11th I saw my PCP and he referred me to an ENT and I saw the ENT on the 13th. I also called off work 14th-29th. I was admitted at the Hospital on the 14th with a code and had two surgeries and Gallbladder removed. I was in the Hospital for 5 days. I had my 2nd shot on the 5th with approve from Medical Dr.s with a little swelling but no other symptoms.

Severe arm ache at injection site. Headache. Slight Fever Tired Could not sleep General poor feeling All took place early morning right after shot

Injection 1 - Slight headache. Appeared a couple hours after shot, went away about 4 hours after that. Injection 2 - Sore at injection sight. About 12 hours after injection, woke up with moderate chills and joint & muscle ache, diarrhea. Developed headache a few hours after this. All of these symptoms went away after 5 - 6 hours except for joint/muscle ache. Those took about a day to dissapear. On the 5th day after 2nd injection I developed a cough in the chest trying to expel phlem. Still have a little bit of chest cough (10th day) but very minor.

Difficulty breathing upon going to bed/ shortness of breath had to sleep flat on my stomach constantly blowing for 3-5 hours until I fell asleep from exhaustion of standing in line for five hours to get vaccinated. Awoke with rash on both forearms. I awoke this morning and breathing was "normal". I drank lots of water this morning to combat rash and it seems to be going away.

Severe muscle spasms in both shoulders extending down the arm where the vaccine was injected. Nausea, fever and servers soreness at site of injection

1st dose was given on Feb 14,2012, and on Feb 24,2012, the injection site was red, itchy, and swollen. The swelling did go down a bit on 2/23/21.

Developed pruritic rash that began approximately 48 hrs after vaccination and lasted 1 week then resolved. He had bloodwork done 48 hrs after vaccination prior to giving blood. He was told that he was "positive for HIV and leukemia" based on that bloodwork. He was then seen by PCP and had repeat labs which were normal. He denies any further symptoms. The PCP attributed the false positive lab results to having the COVID vaccine 48 hrs prior to initial labwork.

approx. 95% of body covered in severe rash, some turning into whelps. Rash is like a prickly heat rash or shingles and extremely itchy and stings. The rash has continued after 4 weeks and is still affecting patient. Physician has given triamcinolone acetonide, decadron injection, and oral prednisone but none have helped. The only thing that seems to relieve the itching temporarily is OTC antibacterial hand sanitizer with isopropyl alcohol.

rash all over chest, stomach, arm pit, shoulder arms etc. Itchy sensation for the past more than 24 hours (2/24/2021 11am to now 2/25/2021 4pm)

Day #1-3-- >Sore arm, edema to the site (resolved after day #3) Day #5-- >Symptoms include fatigue and increased stomach upset. Routine labwork drawn on 2/19/21 (see results below). Will be having labs redrawn on 3/5/21 and will see the hematology oncologist on 3/16/21.

initially patient had no symptoms with Moderna vaccination, no pain worked out at gym in week after shot, initially felt well then started having throbbing severe pain in right deltoid area of arm where vaccine was placed reports no falls, no accidents to this body region noted as well a rash over the area, itchy, 1 week duration, with red vesicles that are now older pain is worsened with palpation of deltoid muscle, acromioclavicular joint and passive abduction and flexion at shoulder and range of motion was limited incidentally patient also had new-onset hypertensive urgency at that time, possibly secondary to pain

Extreme raised rash on torso, under arms and part of neck. Took Benadryl first day but with minimum relief. Went to urgent care and received prescription for prednisone.

Headache started ~ 1-2 hours after injection and lasted ~ 4 hours (treatment was nap and no activity). ~ 8 hours after injection arm pain near and around injection site. Still present with slight rise in pain level after 1st night.

On day 8 after vaccination upper right arm was Itchy, soreness, skin was red , slight swelling, warm to the touch, around the injection site. Cleared up in 3 days and was fine.

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

Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure. The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported. On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection. On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had received his first dose. On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.

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

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

First Moderna shot- about 2 hours after shot developed symptoms. Body aches, headaches, and chills for the first 24 hours. After the symptoms eased up, I came down with a rash over more than half of my body

Severe arm pain at and around the injection site 6 hours after the injection. Nausea and slight headache during the night at about 3:00 AM that went away in a couple of hours. Arm pain persisted the next day. The following day the pain also involved the armpit, possibly lymph glands. Lesser pain at the injection site and arm pit areas the following day and was very slight the third day after the injection. Can?t wait for my second dose and despite the side affects will happily stand in line for my next dose.

Several hours after the vaccination, my back started itching. The itching lasted that evening and into the next morning and then subsided - no treatment done. No rash. Also had fatigue the entire day after the vaccination. My right arm was sore.

OVAL RASH ON THE UPPER ARM ON SATURDAY MORNING THEN A OVAL RASH ON LOWER LEFT ARM LATER IN THE DAY BOTH ON THE LEFT ARM NOT AT THE INJECTION SITE. MONDAY THE RASHES WERE OOZING A CLEAR TO YELLOW LIQUID. IT GOT WORSE SO I WENT TO PRIMACARE ON WEDNESDAYMARCH 10, 2021 i WAS GIVEN METHYPREDNISOLONE ACETATE 80 MG DOSE 80 MG INTRAMUSCULAR DOSE (200)INJ CETRIAXONE SODIUM PER 250 MG DOSE 500MG INTRAMUSCULAR (200) INF CEFTRIAZONE SODIUM PER 250 DOSE 500 MG INTRAMUSCULAR

The day of the shot in the evening I developed a rash on my upper arm. It itched. I visited the doctor the following day for the rash. That night the rash grew to my forearm on the inside which lasted 48 hours. Second shot no side effects.

The day after I started to have fairly serious muscle pain in my shoulder. It now nearly four days later and it is reoccurring multiple times each day, with red inflammation visible near the injection site. I'm treating with ibuprofen.

Moderna COVID?19 Vaccine: Left arm rash slightly below injection site, 9 days after 1st Dose. Raised circular rash, itching and warm. I am using Cortizone 10 Maximum Strength cream to relieve itching

The next morning I had a low grade fever with some fatigue that subsided by the evening. Next morning I was completely fine. But approximately one week later I developed rashes on the back on my neck and both wrists. They aren't conspicuous, but they do itch. I've had them for about two - three days. The rashes are slowly subsiding.

Pt had stated he had a tetanus shot last week; the nurse triaging thought she heard him say last month until she noticed after the fact that it was 1 week prior. I called and spoke with the client today, he verified the Td had been given 1 week prior. He voices mild pain to the inj site, LD, other than that voices no difficulties.

Day 1 Arm soreness; Day 2 - alternating times of trembling/chill with fever conditions throughout the day. After 5PM mainly 101 fever, tired, muscle aches, headcahes, chills, hair follicles hurting ( had this when I had COVID-19 mid-March 2020); My symptoms from the 1st shot brought back memories of how the COVID-19 virus felt, except I did not have the congestion and sinus issues. Fever broke at 3AM morning of March 13, woke up soaking wet, entire body and hair drenched as if I stepped out of the shower, did not dry off and got into bed. Felt fatigued Day 3 but feeling a lot better, able to be more active. Today is March 19, 8 days since shot #1 and my arm at the Vaccine site is still a bit sore, redness has subsided however. Worried post shot 2 may be worse.

48 hours after vaccination, I experienced majority of side effects, fever, chills fatigue, headache, sniffles, sore arm where shot administered,etc. side effects only lasted 48 hours except for arm, it was sore 3 days.

some pain at the injection site tiredness headache body aches joint aches I felt bad for around 18 to 24 hours the folling day i didn't feel great, but not bad either

illness onset 1 day post vaccine (headache, fever, chills, aches) Severe body rash and Prurtus appearing over multiply locations on the torso, back, head, legs and arms approximately 2 weeks after second (2nd) Moderna vaccination shot. Other symptoms include headache, fatigue, dizziness, asthenia, Current course of treatment prescribed for rash is Prednisone 20mg. Symptoms as yet NOT resolved.

Moderate Tinnitus 2 days after injection. Migraine 6 days after. Tinnitus is continuing and has not stopped after 12 days. Tinnitus is high pitched and constant Also had sore arm around injection site for 3 days

Shoulder pain at injection site that resolved over 48 hrs; mild chills and fatigue that resolved within 24 hrs.

Client received 1st dose of Moderna vaccine on 3/17/21. Client began experiencing itchy hives on his stomach and right side near his belt line on Friday 3/19/21. On 3/22/21 client is still experiencing these hives. Client reports the hives have remained the same. He has not had any worsening or spread of the hives. Client denies any shortness of breath or difficulty breathing. Client also reports experiencing an increase in his arthritis symptoms, but reports he missed his Celebrex dose on 3/20/21 which may also contribute to these symptoms.

On 2/19/21 veteran had Moderna Covid-19 vaccine #1, then 2 days later developed a rash on the trunk, which spread to extremities. He also had seafood recently and so cause of rash unclear at the time. He subsequently had vaccine dose #2 in 3/2021 and developed pruritic maculopapular rash again (no recent seafood or other changes) that manifested over the same time course, symptoms appearance and pattern of spread - trunk -> extremities .

ARM was hurting for 3 weeks, blisters on the upper arm vaccine area, rash on the entire right arm, full torso and and both legs, short of breath, shivers, fever and body ache for 2 weeks. This lasted from March 10th through March 20th

Patient reported "covid" rash that he had from previous infection last year that got worse after vaccine, patient reported chest tightness feeling like his sore arm made his chest hurt.

After the first day I developed soreness at the injection site. After about 2 days, the soreness moved to my left shoulder joint. Currently, 8 days after the injection, my left shoulder joint remains sore and any motion to left my left arm laterally from my side is painful; like my joint is inflamed. There is no redness or other visible external signs or discoloration. I can not say for certain it is linked to the Modern vaccine as I've had left shoulder issues infrequently in the past. But timing wise, my current discomfort started shortly after receiving the vaccine.

After about 10-12 hours, injection site was sore to the touch. In the morning (next day), it was still sore to the touch.

No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fatigue. No fever. Loss of appetite. Soreness at injection site which spread from shoulder to elbow of left arm. Chills. Poor night's sleep with most symptoms continuing in morning.

Moderna Covid-19 Vaccine EUA, first shot. Multiple raised red rash spots on the injected arm. Looks similar to chicken pox, surrounded by angry red circles.

102 F temperature this morning. Taken with two different oral thermometers. Temp has now subsided to 99.5 F. Chills. headache, nausea, painful site injection arm, lethargy.

slight rash around injection site, with reddish raised skin extending outward from injection site approx 5 cm, more visible/raised when exposed to hot water, persisted for approx 6-7 days before receding simply reporting for database

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

No issues first 48 hours, however on day 3 Fever, fatigue, headache and Rash on chest/back and face developed. Felt run down with alternating chill and sweating for next 3 days then subsided but chills and fatigue remained for addiotnal 2 days. On Day 8 felt mostly back to normal. I almost never get sick. I get Flu shots every year. I am very active and in excellent condition for my age. My wife says I have a very strong immune system and was worried this would happen. I suspect I may have been exposed to Covid earlier this year and that is why the delayed strong reaction. My wife does not want me to get the second shot.

fever (38.1oC), shivers - starting some 10hrs after injection, and then lasting for approx. 20hrs "vaccine arm" 6" dia. around injection site starting on 4/2/21

Had first COVID vaccine dose in right deltoid 3/30/21. On 4/2/21 started having soreness in his back and right breast. Was seen in urgent care 4/3/21 after noticing some bumps, and was diagnosed with shingles (noted to be located in right shoulderblade area).

I have a psoriasis rash, and maybe another rash mixed in. My joints have been sore. I can't sleep because of the itching. I'm taking Orencia and was taking that at the time of the outbreak (I forgot to put that in the medicines that I take) that's given to me by my rheumatologist. He also prescribed lorazepam to deal with the excessive itching. Then I saw a dermatologist he gave me some shots in my skin, but there was so many of them it couldn't continue I would be a pin cushion. He also gave me some cream that really isn't working. Seems like it's getting worse instead of better.

Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection location soreness and pain. Cannot sleep at night. I thought to call 911.

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

Started with itchiness in hands and arms; the next day the itchiness spread to back and legs, and I discovered a hard, raised area at the injection site. Furthermore, the injection site was surrounded by a red patch, approximately 3.5" X 2" in size, and the entire area was itchy,. These symptoms are on-going as I report this.

Soreness at injection site - prolonged. Extreme fatigue - chronic and ongoing. Loss of appetite Chills, fever elevated.

rash, bumps and itching on neck and chest on right side of body. muscle sore in area of administration. warm to touch. Advised patient representative to inform PCP of reaction prior to receiving 2nd dose. Tried to contact patient, left voice messages, no response to obtain further information for reporting and to check on current condition.

Injection site red and hot, hard oblong swollen place; also, tingling in thumb; weakness & trembling in that arm.

Headache for 2-3 days, some minor body aches, arm so sore at injection site that it was hard to lift my arm for 24-36 hours. Tylenol helped with the headache and it was better after 3 days.

Delayed hypersensitivity left arm at vaccine site, rash, itching continued. Note...lethargy, generalized pain started 16 hours after vaccine and lasted 48 hours

Next day fever mild headache severe redness and aching left arm/during the week left arm itching under armpits and wrist, went to physician on Friday 4/9/2021

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

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

I have red sore spots on my toes on both legs. They are red and tender and painful to touch and walk. They seem to vary a bit from day to day. I did not visit a doctor. I never had something like this before and nothing changed in my behavior or shoes. Just concerned about what they are and how to treat them.

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

Covid vaccine placed 3/4/21. Several days later developed "clot" like lesion on lateral aspect of arm below injection. No erythema or hardness. No warmth or fever/chills. fROM. no inflammation.

Between 36 and 40 hours after shot (early Saturday AM), my RIGHT arm began to itch in the unhairy area to a degree that disturbed my sleep. I applied cortisone cream. About two hours later, BOTH arms were itching in the hairy areas. I applied cortisone cream to affected areas. A seeping sore eventually developed on each arm, and I started applying Clobestasol Propionate (leftover from prior eczema treatment) to those spots twice daily in addition to cortisone on other arm areas. After contacting my doctor's office via email, I was advised to continue with my self-administered treatments (but not use Clobestasol for more than two weeks and schedule doctor visit if rash/sores do not subside), and suggested I take antihistamine such as Zyrtec shortly after second vaccine shot to possibly prevent recurrence of reaction. Not yet recovered from rashes/sores, but treatments greatly alleviate symptoms.

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

Fatigue, headache, lethargic, severe chills, body aches, pain at injection site, itching at injection site, fever between 100 degrees F to 102 degrees F. Treatment was Tylenol every 4 hours

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

Red/pink non-raised blotchy rash noted left upper extremity about 4x3 inches and warm to touch noticed today 1st Day after vaccination I experienced fever 100.6 F, body aches, headache and chills lasting for 24 hours, began 4/15/21 and ending 4/16/21. Rash noted today 4/17/21

Next day (Friday) Very sore arm at injections site, body aches, muscle aches, join ache, temperature 100.5 day after. Felt like I got hit by a bus. Better on Saturday

Headache which started on 5th day after 2-shot vaccination. Typical side effects - fatigue, fever of 99-100, pain at injection site from 7 to 38 hrs post injection.

He started getting hives and itching about 2 days after receiving the Maderna vaccine. Pt states most of the itching is in his trunk and back.

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

Today is day 10 since vaccination. Past 2 days unusual post nasal drip and restless sleep. This morning red rash appeared at injection site on right arm, and right are is getting sore at injection site.

Patient came into pharmacy for second dose and explained that he had a rash a day after his first dose on his left arm. Rash went away in about 3 days.

(all dates are 2021)He had his first COVID vaccine on Feb 2nd - then he went to Punta Cana on Feb 3rd. He got a lot of sun while there, and when he returned had extensive light spots on his skin. He has a photo on his phone dated Feb 6th that showing no hypopigmentation the central chest or abdomen and only faint hypopigmentation at the flanks. He was evaluated in clinic on Feb 18th and noted to have hypopigmented annular patches extensive on the trunk and upper thighs. He was treated with ketoconazole shampoo and cream and ciclopirox cream. His 2nd COVID vaccine was March 2nd. From his Feb 18th visit to the April 15th visit, the hypopigmented areas on the trunk became depigmented and hypopigmentation spread to arms and legs. His skin lesions did not respond to treatment prescribed on Feb 19th. Biopsy done on April 15, 2021 was consistent with inflammatory vitiligo. Unknown if coincidental that vitiligo developed at that time, but temporal correlation and fast progression is suspicious for vaccine relation.

Extreme pain in arm at injection site beginning 6 hours after injection and lasting 4 days. Fever, chills, shaking, body aches beginning 6 hours after injection and lasting 2 days.

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

Sore arm below injection site, redness, swelling. Sore shoulders and lower back. 100.7 fever for 12-24 hrs after shot. Slight feeling of nausea. Fatigue for 48 hrs.

4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole body rash with severe itching, swelling in mouth and throat, extreme weakness, close to fainting within minutes. Emergency room visit, EPI pen injection, steroid injection, EKG, chest x-ray, blood work. 4 hours of observation in hospital. Still weak today, voice weak, and can't seem to take in enough oxygen to go on a walk or do simple yoga stretches.

A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast

I recently received the second Moderna vaccine, April 20. The next day I experienced severe body aches and extreme tenderness to the skin of the arms and upper torso, followed by 1-2 days of malaise. Then, on 29-30 April, I began having extreme pain in the lower back, migrating up the thoracic spine and around the left to the mid-chest area. I took one 500mg Naproxen 3x/day which helped mitigate the pain temporarily. I then discovered a red blister on my side 1 May. Since then my symptoms have been painful back/chest and stabbing pain at the site of the blisters which followed the path of the pain described above. I was diagnosed with Shingles yesterday, 3 May. I have been prescribed 1000mg of Valacyclovir

Patient reported soreness after 1st day of vaccination which went away within 24 hours. However, several after weeks after vaccination patient developed soreness at the injection site with a raised bump and redness surrounding the area on 4/28. There was no associated weakness in the arm except due to pain which prevented him from lifting his arm. The patient experienced diarrhea for about a week prior. He did not see a doctor for this and attributed this to a viral illness. The soreness and swelling resolved after 4 days. The patient reported the reaction on 4/28. He was given a prescription for PT, but as it resolved by the time of his appointment, he did not see PT. The patient reports that the injection was high on his shoulder, about 2.5 fingerwidths below the joint. He denies experiencing joint pain.

Muscle and Joint aches, upset stomach, mild loss of balance, temperature 102.4, Pain at injection site. Lasted for 48hrs

Intestinal gurgling, heavy sweating, palor, general malaise occurred within 10 minutes of receiving vaccine. Symptoms persisted for 5 hours until bedtime. Next morning had fatigue, headache and feeling of scalp tingling but other symptoms had lessened or subsided.

Severe Rash around waist and hip area and along the inside leg area of the knee the rash is still present and has not cleared as of today

Left shoulder where both doses were administered has become numb. It has remained numb since the second day after the second shot was given. When I move the arm during normal daily activities, I get a "tearing" sensation. This tearing sensation is the followed by waves of pain throughout the arm. I contacted my primary physician and was told to use warm soaks. This has not helped. I will be contacted my physician on Monday 5/10/21 for further instructions.

Hello, Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM. The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home. Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects. Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days. Then I also started with a slight fever, which of the times checked, reached about 101. Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch. I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again. That went on all day. When laying down that night the cramping would subside enough to sleep a little on and off during the night. The calf muscle cramping started to gradually subside, but took about 17 days to go completely away. The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended. Best regards,

1 week after 2nd vaccine, a rash developed on lower rt leg. Thinking it was topical ( Poison Oak etc...) I watched. over 2 weeks it worsened. I took a photo and sent to Dr on April 29. April 30 dr said eczema - use Triamcinoline as prescribed. I filled and began applying 5/6. By 5/7 rash was on all limbs and torso.

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

Patient received injection in left arm 3/18/21. When expected soreness in arm resolved several days later patient still experienced mild to moderate joint and muscle pain in left shoulder. Patient has no preexisting condition and engaged in no activity that would explain symptoms. Patient canceled second dose of vaccine because of symptoms, which continue to date. Patient is managing symptoms with OTC medication and has received no medical treatment at this time

DAY AFTER IMMUNIZATION PATIENT'S INJECTION SITE SWELLED UP MORE THAN AN INCH HIGH AROUND ENTIRE DELTOID AND THE ENTIRE DELTOID AREA TURNED BRIGHT RED ACCOMPANIED BY SEVERE PAIN AT INJECTION SITE, REDIATING DOWN THE ARM AND AROUND THE BACK UP THROUGH THE NECK. HE SUFFERED A HEADACHE. AT 6 DAYS POST VACCINE HIS ARM STILL ACHES AT NIGHT AND HAS BRUISE ACROSS ENTIRE DELTOID.

A knot the size of a quarter rose up immediately after the shot was given. After chectking with the patient, he did not have any apparent allergy or difficulty breathing. Localized reaction only

I woke up on March 30th covered in Hives. This was 20 days after my first vaccine. I contacted my primary care physician and he suggest I begin taking either Allegra or Zyrtec. I then got my second vaccine shot on April 7th. I have been to both an allergist and a dermatologist and they both agree that this is a reaction to the vaccine. They too have prescribed over the counter Allegra or Zyrtec. This is now the 49th straight day that I have had this issue. At time they are more severe than others, but they have been present in one form or another since March 30th.

Small raised rashes appeared about 1 week after the vaccine. Size about 3mm in diameter, red edges, top of rash skin tone color. Rashes did not itch, and resolved in about 2 weeks. There were about 5 rashes in total, on arms.

This report concerns the aftermath of the second of the two Moderna vaccinations that I received: Mild point of injection pain. Fever after 48 hours 100.4 F, lasted one day. Heavy night sweat on third night after shot. After about 10 days, a light but persistent rash developed on my upper right shoulder. Approximately a week later, I experienced :"tingling" through out my right shoulder. This right shoulder has had prior rotator cuff damage (in the early 1990s). The sensations of tingling in the shoulder are identical to those from the past,. There is also an itching sensation that is best described as "inside the skin", not on the surface. In the last two weeks, the rash has expanded to my right chest. There is little to no surface lesions or irritation, just itching and tingling as mentioned, with very slight raised bumps. None of these symptoms were present before the vaccination. The tingling is heightened depending on arm position and when I am prone. There is no associated pain. The itching, tingling, and rash have not gone away. Today is May 27th. I went to my family doctor today for other reasons, and mentioned the rash and post-vaccine reraction to him.

After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information has been provided at this time. 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Skin rednesses/inflamation/flushing that started in hands and since initial and second covid vaccination has spread to arms, legs, torso and face resulting in FATIGUE and MUSCLE WEAKNESS. Eye and nasal irritation along with rash arounf lips. Tingling and numbess in feet and ankles. Weight loss

A rash from my shoulders to my knees, very itchy. On June 2, 2021 I received an injection of steroids. This shot had very little affect on curing my rash. On June 7, 2021 I began a six day prescription of MethylPREDNISolone 4 mg. Day one started with 6 tablets, reducing by one tablet each day until conclusion on day six.

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

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

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

I had a persistent rash on the top of both arms, it had spread to the underside of both arms and was showing up on both ankles. Dr took two biopsies. They came up with the diagnosis of interface dermatitis. No treatment provided, was told to let it run its course.

Patient's wife called to inquire if lip swelling was side effected of covid vaccine. Information obtained from conversation with wife: had 2nd dose of Moderna COVID-19 on Friday 7/2/2021 * 7/3/2021 notice lower lip swollen throughout the day. * 7/4/2021- lower lip resolved. Then upper lip began to swell. Still swollen as of approx 4:15 pm 7/4/2021. Also noticed small white bumps on lower arm. * Swelling localized to lip, no report of systemic reactions, did not report any symptoms except normal expected side effects ie tired * Stated has never received any dermal fillers * Had surgery on 6/30/2021, IV antibiotics administered, stated did not receive any steroids during surgery

Hives on back, arms, and stomach. Teledoc prescribed Mometasone 0.1% cream, some relif, outbrakes continued and I went to my PCM on the following Wednesday and received a steroid shot, hives continued and continued for about 5 months.

about 4 days after vaccine administration patient developed rash behind right ear and periauricular area, persistent headache, scalp tender to the touch as if he had sunburn, seen 3/21/21 diagnosed with shingles prescribed valtrex rash resolved in about 3 days. 4/1/21 patient seen again continued headache, diminished hearing on right side, rash resolved. Audiologist referral placed meclizine prescription given. 4/12 seen again, dizziness, ringing in right ear, hearing loss, dizziness is not positional but emanating from the right side. Lightheaded, woozy feeling, numbness/tingling, and sunburn-like feeling around right ear down neck. Chiropractor performed epley maneuver no improvement, meclizine ineffective. Now also describing "feels like water in ear". 4/15/21 Audiogram demonstrated sloping sensorineural hearing loss right ear with STS score of 76% and type A tympanogram, symptoms persisting urgent ENT referral sent. 4/28/21 seen by ENT Right ear with hearing loss and disequilibrium prednisone 60mg once daily in the morning prescribed, repeat audiogram 1 week, MRI with contrast ordered. 5/7/21 ENT completed course of prednisone hearing has significantly improved on right side still describing equilibrium, NOT acute episodic vertigo. Audiogram SDS improved from 76% to 92% and SRT improved 30-10DB. Physical therapy offered. 5/18//21 MRI performed impression: 1-no acute findings, no acute neuroma, no abnormal enhancement temporal bones eitherside. 2-several nonenhancing white matter T2 Flair hyprintensisties bilaterally 3-giant cisterna magna 4- generalized cortical atrophy 6/7/21 follow up with ENT still experiencing disequilibrium MRI does not show any significant pathology to account for hearing loss or disequilibrium. 7/7/21 follow up with PCP patient reports he is not feeling any better, symptoms of loss of balance and tinnitus continue although hearing in right ear largely improved.

About a week after getting the first dose, blood blisters started to form on my hands, arms, legs. Bruising has been noted.

I had severe pain at injection site when initially given but it went away after a few days. I had emergency Gall Bladder surgery on Jun 9, 2021 and a afterwards, my arm where the initial COVID shot was given, had the same pain develop at the injection site along with a slight amount of swelling

About 2 weeks after 2nd injection - Substantial facial acne vulgaris. Symptoms still persist up to date of this report. Some history of minor acne but not to this extent and for such a prolonged period. No other changes in lifestyle, eating habits, medication, etc. Have tried increasing cleansing, use of skin cleaner, aloe vera gel and plant rubs, epsom salt solution. No effect.

Itchy changing to painful rash worsening to appearance of burn. Scabs formed. Mainly inside fold of left elbow. Some scabs on upper left and upper right arm.

Immediately after injecting the 0.5 ml vaccine dose, the patient started bleeding and then a lump slightly smaller than a grape formed. The lump was not warm to the touch and the patient said it didn't hurt or make him feel any different. The lump was still there 5 minutes later and the patient confirmed no swelling of face/throat, itching, or tingling and refused to stay any longer for observation.

Pt states that he experienced local reaction at site of Moderna injection which was red and hot- approximately 4"x6", severe body aches, extreme fatigue. He states that he was only able to get out of bed to use the restroom. He was unable to leave his home for 4-5 days following the immunization.

Chills, fever, headache, started about 9hrs after injection Fever peaked @ 100.8? injection site very sore. And continues to be sore. Fever broke the following day. Weakness, fatigue, headache persisted until afternoon of 1/1 2021

Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.

2 hours after injection:- Sore arm. 12 hours-99 degree temp, elevated pulse, shivers. 14 hours-100 degree temp, elevated pulse (120 bpm), chills, persistent moderate headache, achy muscles, sore back. 24 hours-98 degree temp, head ache gone, just a worn out feeling, 36 hours-back to normal other than a very sore arm at injection site and a worn out feeling.

Patient began having headache and fatigue 12/29. Early morning of 12/30 patient reported severe chills. Felt better during the day of 12/30 with only a headache. Night of 12/30 patient reported severe chills again and wanted to call the doctor in the morning, but the felt better on 12/31. The night of 12/31 patient again had chills, but less severe (rated 3/10 on scale). Night of 1/1 patient reported slight hive like rash that went away with warm Epsom salt bath. 1/3 0100 patient woke up with severe hives down back of legs and lower back. Got into a hot tub to soak and once the patient got out he was standing at the sink and passed out. His wife got him back to bed. Around 0700 on 1/3 patient woke up to urinate and he passed out again. He states both times he passed out felt the same stating "I felt like I was going to vomit and then all of a sudden I couldn?t breath, almost like I was choked out."

Moderate to severe muscle pain at injection site lasting 4-5 days. Overall body aches lasting 2 days. High Fever (over 101) with intermittent periods of chills and then sweating for 48 hours which turned into an nocturnal fever (100.1) the second 48 hours.

Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain

MODERNA INJECTION GIVEN TO PATIENT IN DRIVERS SIDE OF PATIENT CAR. INITIALLY BLED AND THEN BECAME SWOLLEN WITH A KNOT THE SIZE OF A DIME. AFTER 5 MINUTES SWELLING HAD INCREASED TO A SIZE SLIGHTLY LARGER THAN A HALF DOLLAR. AT 15 MINUTES SWELLING HAD NOT INCREASED AND PATIENT DENIED ANY OTHER SYMPTOMS. ICE OFFERED AND PT STATED HE WOULD PUT ICE ON IT WHEN HE WENT BACK TO THE OFFICE. INSTRUCTED PT TO GO TO ER IF THINGS WORSENED. PT RELEASED.

WITHIN 11 HOURS AFTER INJECTION - BEGAN EXPERIENCING SLIGHT RASH OVER MOST OF BODY- SORENESS AND INFLAMMATION AT INJECTION SIGHT (LEFT ARM), CHILLS, SHIVERING, ABDOMINAL PAIN, RISING TEMPERATURE (MAX 100.8) MUSCLE/JOINT PAIN, AND VERY SEVERE HEADACHES, LASTING NOW FOR THREE DAYS.

Day 1 headache progressing to migraine and nausea, injection site pain Day 2 - 3 continued migraine with aura, nausea worsening, runny nose Day 4 abdominal cramping , migraine subsided to dull headache Day 5 abdominal cramping worsening and muscle soreness (abdomen and lower back) hurt to urinate. Day 6 - 7 abdominal cramping subsided general soreness lessened Day 8 recovered

Muscle soreness in left arm for the first two days then marked fatigue on days 3-4, major urticaria developed on day 8 after vaccination with large patches of red, raised, very itchy rash on both sides of the anterior abdomen, with smaller patches on both of the lower legs and some on the posterior upper arms. The itching made sleep very difficult for the next two nights. The itching was decreased somewhat by the use of 1% hydrocortisone cream and moreso by 10 mg of Loratidine. The severity of the urticaria has decreased somewhat over the last 3 days since onset but is definitely still present.

Hives on back, neck, and chest. Took two Benadryl and applied cortizone cream to skin. Almost gone by morning

11 days after the vaccine a red dot appeared at the injection site. It itches and burns severely. That was yesterday. Today, the red is bigger and there is a lump forming under the skin. Itch and burn is worse.

Moderna COVID-19 Vaccine EUA Reddish Blotch @ 2-3" in Diameter at Site of Vaccine-appeared 2 days after vaccine Swelling at the same area -continues as this is day 11- area not warm to touch or causing any pain just swollen

Soreness at injection site (mild) and Fever 99.7 started about 6 hours after injection. Still feverish at bedtime, No fever next morning

8 days after SECOND dose of moderna vaccine for covid, my husband broke out in a rash. He does have eczema in the cold winter months which we treat with over the counter lotions. At first, he thought the rash was due to the lotion we used because it started shortly after application of the lotion. (However, he has never had a reaction to lotions before over many years of using different brands and formulas). His skin was burning and itching throughout the day. By the time he returned from work, he had raised bumps over his back, upper arms, legs, buttocks, chest and forehead. He found some relief after a shower and use of an anti-flammatory cream (although his skin was still covered in the rash). By the time he woke next morning, it was gone.

36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection site, and severe diarrhea. The diarrhea lasted about 12 hours. I also felt general discomfort over entire body as if I had flu. This discomfort lasted for approximately 2 to 3 days. I was unable to perform normal activities during this time.

Not sure if this was related to vaccine. 2 days after getting 2nd dose I developed eye pain and irritation. I was seen and diagnosed with ocular shingles. Currently being treated with Valacyclovir.

Red patch about 4 inches by 4 inches on upper left shoulder near injection site, and two or three red dots in skin

10 days after the first shot I got ?Covid arm? at injection site. By Day 16 the redness had doubled in size, approximately 11 mm by 15 mm. The area is hot to touch versus the non impacted skin.

He reports that he got an all over body rash after the 2nd dose. He has a chronic condition that give him a rash, and tried using the soap he uses when he has a flair, but it did not work, so he saw his dermatologist. He was told that it wasn't due to his condition, but was vascular in nature. On 2/10 he was prescribed a steroid cream, and told to take Zyrtec. He will follow up to let me know if this helps.

Initially had some mild redness at vaccination site noted on 2/4/2021, this continued to worsen despite use of cold compress, Benadryl and Tylenol; was sent to Urgent Care on 2/7/2021 and diagnosed with Cellulitis; treated with a course of oral antibiotics

Onset 12-16 hours after injection: extremely sore arm at site of injection, chills and body aches & pains. No fever. Treatment- 800mg Ibprofen/rest/fluids. Symptoms lasted about 12-14 after onset.

The day following vaccination, I started having lethargy, chills, lack of appetite, dull pain at injection site and sore neck and shoulders. by end of day, symptoms were as severe as when I had COVID last Nov. The next day, I felt fine, except for continuing site pain.

Swelling, redness, very firm and painful, from left shoulder to just above elbow. On day 4 still having these symptom.

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

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

Approximately 23 hours after vaccination, erythematous rash on face, trunk/back & arms, not noted on lower extremities. Mild tingling. No other symptoms at all. Rash subsided spontaneously in 2-3 hours. The question is: Should 2nd vaccine dose be given and if so should it be given in a facility better equipped? PCP has not responded to this question.

Pt reports that starting about 3 days after vaccination, he began developing pruritic rash, first in axillae, then groin, and after receiving second COVID-19 vaccine on 2/14/21 (lot # O13M2OA ), rash increased. Pt was seen in clinic on 2/18/20 with cluster of ~4 1cm, raised, erythematous nodular lesions lateral aspect of axilla bilat; few similar lesions upper arms, left scapula, inguinal-medial thighs bilat, right suprapubic area, lower legs, as well as few <1mm vesicular lesions on legs and groin, excoriations noted on flanks, no intertrigenous lesions or linear tracking; no open lesion or crusting

About 24 hours after I received the first dose of the Moderna vaccine, I broke out in itchy hives all over my body. I too two Benadryl and the hives went away.

Injection site had a little blood at the site that I noticed the day after when I took off the bandage. After showering it was all gone and has not returned. The evening after the vaccine, I started to experience a little pain in the left arm, especially the shoulder joint area. It did not prevent me from sleeping but did wake me when I rolled onto my left side. The pain was more severe the next morning but started to decrease after lunch. At 8 pm the day after it is just a dull ache now.

Sore arm at injection site (day of shot and next 2 days) Severe Gout flare up (10 pm day following shot and next few days) recovered - lingering Tiredness

Itching,hives,redness from right waist to right ankle.Started 2/27/2021 ongoing.Cannot take antihistamines due to Sjogrens.Cortisone cream not helping

Rash and itching first at the injection site and then over most of body- still itching after 2nd dose on 2/23/21

Next day about 11 am, began fatigue, chills, low grade fever. 99.8 to 100.3 slept most of the day. Vaccine sight was sore but no more than expected. All side effects have subside by this morning as I got up. Still tired but had a poor nights sleep with an episode of heavy sweating. Feeling fine now..

Moderna COVID-19 Vaccine EUA, mild headache, achiness in neck, injection site soreness. All for 36-42 hours from injection. Took 2 Tylenol before bed 2nd night.

The evening after my vaccine, I had fever, chills and backpain for about 12 hours. the next evening my Scutum itched and then swelled up triple it's regular size for about 12 hours.

I'm sick, like the second dose has made a lot of people. I began to feel soreness at the vaccine site about 08:00 pm. I began to feel like I was getting sick about 10:00 pm. I went to bed then, and woke up at 02:00 am, feeling like I had the flu -- body aches & feverish. Not horrible, but enough that I didn't feel like moving. I got up to go to the bathroom, and was uncovered, and then I got chilled. I went back to bed, and now at 07:30 am, I don't feel much better. My temperature is 100.6. It'a normally 96 to 97.

A volunteer (vaccinator) who was being trained by a nurse injected the vaccine very high in the shoulder - approximately 1 inch below the acromion process. Pain in the area of the injection site and shoulder began 3 hours after the injection. Pain was exacerbated by active motion of the arm, especially abduction. The pain resolved over 48- 60 hours. There were no other symptoms from the vaccination- there was no fever, fatigue, nausea, chills, adenopathy, etc. The concern is that the injection was clearly not in the proper location and I have questions about the efficacy of the 2nd dose that was administered and the efficacy of the overall vaccination series because of this. I contacted the Health Department and reported this. They instructed me to also submit it to Vaers.

I left the vaccination feeling nothing at all. I awoke the next morning with a moderate pain/discomfort in my left upper arm at the vaccination site. I went to work because I felt okay. I have five years of recovery. As a result every 8-12 moths I undergo an episode of about three days where my brain forgets how to sleep properly. So the morning after my injection, I was on my second day of irregular sleep. Around 10 am, the side effects started kicking in. I had a slight to moderate pain above my ear on the right side of my head. I probably had a slight fever as I felt warm and sweaty for about four hours. I felt slight to moderate chills during the height of my discomfort for about four hours. I could hardly walk the five blocks to my girlfriend's home because I was very conscious of my breathing. (I have been a heavy cigarette smoker for 4o years and an developing a heightened awareness of my breathing and pulse as I feel that I am overdue for a stroke or heart attack after 40 years of heavy smoking.) Therefore his side effect was largely hypochondriacal. I took off work yesterday even though the side effects had subsided. Today, I feel great. I feel so great that I laughed at the entry below - "Patient Died".

Patient reported hives 7 minutes after injection under direct observation to bilateral upper extremities. Patient denied itching, shortness of breath, hoarseness, throat tightness, altered tongue sensations, fatigue, dizziness, lightheadedness, or any other associated symptoms at that time. Patient given 4mg of dexamethasone immediately following reaction and observed for an additional 30 minutes. Patient reported no acute distress and hives were localized with some shrinking in size. Patient released at 310 in no acute distress with medication sent to pharmacy. Medications that were sent are medrol dose pack and hydroxyzine 25mg to take TID. Patient also given information regarding reaction and Moderna fact sheet. Patient ambulated to car without assistance to return home with instructions to report to nearest ER should any symptoms worsen or new symptoms present.

arm was sore for 3 days. then a week later I had intense itching in my arm. It went away and then for a few weeks now I have had sudden onset of diarrhea. I have taken Imodium and it isn't working. I even tried eating a bunch of cheese.

Sore at vaccination injection site on left shoulder and redness (Red splotch).. Redness looks to be expanding on shoulder at site of injection.

I experienced body aches and major fatigue right after receiving the vaccine on 03-04-21. It was worse on the second day. On the third day my right hip area and right leg was very sore and tender to the touch and noticed a rash on my hip area. The rash spread all over my right leg and foot and the pain got worse. My toes and foot became numb. I took Tylenol and Aleve to relieve the pain for a few days however I did not improve for a week. I visited an emergency care on 03-13-21 and was diagnosed with Shingles and I was prescribed Famiclovir. I started taking the meds as of yesterday and I am still experiencing pain all over my leg and numb foot.

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

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

Painful injection site, sick stomach, fever, earache, headache, After 24 hours from injection I developed a bloody taste in mouth, severe bloody nose.

Minor headaches started about 10:15 AM and Left arm started hurting at the injection site at 12:40 PM. I Felt tightness around the front of the face upper cheek bones nasal area and from face of head. That night I woke up about 3 AM with a sinus headache and sore left arm, Sunday evening around 9 o?clock my temperature climb to 99.0 I took a nap and when I woke up it had returned back to normal. Today 3/15/21 my left arm is now just tender

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

MILD ITCHING: OVERALL BODY ITCHING MANIFESTED APPRX. 4 HOURS AFTER INJECTION ESPECIALLY AT FEET, EYES, HANDS AND ARMS. NO RASH. PATIENT TOOK DIPHENHYDRAMINE FOR ITCHING. ITCHING LASTED APPRX. 24 HOURS. AUDITORY SENSITIVITY: MINOR SOUNDS SEEMED AMPLIFIED. TO THE POINT OF IRRITATION TINNITUS: SEVERE TINNITUS 4 TO 10 HOURS AFTER VACCINATION. HAD SOMEWHAT DISAPPEARED BY 8 AM FOLLOWING DAY. PATIENT STILL HAS MINOR TINNITUS. MUSCLE AND JOINT STIFFNESS: MUSCLE AND JOINT STIFFNESS MANIFESTED APPRX. 2 DAYS AFTER INJECTION AND LASTED FOR APPRX. 5 DAYS TOTAL. PATIENT HAD NO INJECTION SITE REDNESS OR SWELLING. PATIENT DID NOT SEEK MEDICAL TREATMENT FOR SYMPTOMS.

Woke up the morning of 3/14/21 and noticed a large reddened circular area on the left arm about 2 inches below where the vaccine was given in the Deltoid muscle. Area was warm to the touch but no itching. Area was quite large in circumference (approximately 3 inches long by 3 inches wide). Have heard this reported in the media as "Covid arm". Area is less red as of 3/17/21 but is still noticeable.

4" x 6" swelling and redness around shot area generating temperature of 101 degrees two and three days after being administered, headache lasting 2 days, joint pain lasting one day

Left arm was sore for 2-3 days, then fine until I had carpal tunnel surgery on left hand 9 days after shot. Then on the same evening as surgery my covid vaccine injection site began to get red and hard and grew to approximately 3? in diameter. It was hot and red. This persisted for about 2-4 days then back to normal again?

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

Fever, chills, fatigue, nausea, diarrhea, itching all over (itching has resolved). All but chills and fatigue have resolved.

Itching, redness, swelling, soreness on vaccination site (upper right arm) starting today. Much like if I had an insect bite. Using Benadryl Cream.

Upon waking on the third day after receiving the second dose of the Moderna vaccine, I've experienced vertigo/disorientation. This side effect has continued a second day causing me to notify my primary care provider and preparing this event report. Other side effects experienced after the second vaccination were soreness at the injection sight, mild fatigue, and slight fever which were all anticipated. These side effects have passed.

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

2 INCH RED PATCH, SWELLING, AND ITCHING AT INJECTION SITE ABOUT A WEEK AFTER SHOT. ONLY SYMPTOMS RIGHT AFTER INJECTION WAS MILD SORENESS IN ARM FOR A FEW DAYS

Patient described yellowing of skin and eyes. This was not observed by provider. Lab work including bilirubin and LFTs were all normal. Patient then reported on 3-25-21 that since the day after 2nd vaccine, he has had intermittent paresthesia's in left cheek, left arm and left leg. No weakness.

Veteran developed small bump behind left ear on 3/23/21, then on right ear morning of 3/24, two hours later to right upper leg, then spread to groin, then entire abdomen /chest area.

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

Moderna COVID-19Vaccine Pain in left arm at injection site. Stiff neck, headache, chills. Most symptoms resolved in 24 hours. Arm pain lasted 48 hours

Rash appeared at injection site about a week after injection. Rash has now gone away but did not hurt or itch.

Urticaria on both left and right sides of trunk (under arms) and along inner upper thighs. Began along right side and progressively spread to left side, then to thighs. Treated with 25 mg oral diphenhydramine.

Patient reports itchy rash all over upper torso that started about 6 hours after receiving vaccine. Patient denies swelling, difficulty breathing, or signs/symptoms of anaphylaxis. Patient took an antihistamine (does not remember which one, but not Benadryl), and the condition began to improve, yet not fully resolved as of 4 days after vaccination. Patient was instructed to inform primary care physician of reaction and to sign up for the V-Safe program to report the reaction to the CDC as well.

8 days after receiving Moderna shot # 1(received on 03/22/2021), a 1 1/2+/- inch round raised red bump itchy rash developed at the injection site. It remains the same as of 9:00PM EST this evening, although the itch has subsided. It remains warm to touch with little bumps in the raised area. No fever. The day before this reaction, I had my annual physical with no issues at the time. Prior to this reaction, 30 minutes after receiving the injection on 03/22/2021, I experienced a sudden red flush to my cheeks that lasted for only 15 minutes. No swelling of face, neck, throat. No elevation in heart rate noted. The evening following the day of injection, I had a 99.4 degree fever for about an hour, then fine. No fever since. No other reactions.

erythematous mildly pruritic rash 2 x 4 cm at site injection occurring two days after Moderna vaccine dose 2

Continued, persistent (after first injection on 02/16/2021), and spreading rash onto right Arm and Hand, Chest, top-of and middle back (along spine). Also front and back of legs. Observed the "spreading" (to right-side), about 5-days, following second (Moderna) injection into right arm. It is itchy/and looks like Dermatitis-? Continue to self-treat with daily doses of Hydrocortisone 1% cream on rash areas+50mg of: Diphenhydrammine. It remains "persistent".

Rash, Mild Lip swelling Patient called Allergist she told him to take Benadryl and predasone also NOT to get the second dose in 4 weeks. she did tell him to get J and J vaccine in 4 weeks

A rash appeared, starting on my left forearm and hand about 7 days following first vaccination. Immune response? Red splotches at first, then swelling and quite itchy. No other symptoms or difficulty breathing. Received 2nd vaccination on 02/15/2021 in Right arm. The "rash" has spread to upper chest, back and a bit on both legs, front and back. My self-treatment has been: Hydrocortisone (anti-itch)-topical cream on itch areas. Also taking 50mg/day of: Diphenhydramine. It remains quite persistent, but seems to be slowly dissapating? It's now 17 days since second injection.

Moderna COVID-19 Vaccine EUA Mild headache/eye aches, vertigo, no elevated body temp. Eight days after injection got a large, splotchy rash around injection site. At nine days the rash turned into a 2"x4" hive with various hive around it on my shoulder and neck.

2.5 WEEKS AFTER THE FIRST SHOT, I HAVE A SORE ARM NEAR THE INJECTION SITE. **I HAVE HAD PERIODIC BUT CONSIDERABLE MUSCLE STIFFNESS/SORENESS. LIKE I HAD JUST STARTED LIFTING WEIGHTS AGAIN AND OVER-DID IT ON THE FIRST DAY. STARTED ABOUT A WEEK AGO. MUSCLE SORENESS, WAS/IS HEAD TO TOE. THEN TODAY IS WHEN THE INJECTION SITE MUSCLE BECAME SORE.

Swelling at vaccine site , general aches mild chills for about 12 hours. Swelling lasted 24 hours. Self medicated with Tylenol.

After exactly one week, at the injection site - redness and soreness, itching, swelling, and hot to the touch. This lasted for 2 or 3 days then cleared up.

Patient displayed about a 4 inch red area on the arm he received his shot. It is itchy. He first noticed it on 4/1/2021 and still has it today 4/3/2021. Patient received the shot 3/18/2021.

First, my right arm was sore for four days. That was okay. Second, I have been experiencing constant discomfort on my right arm where the vaccine was injected. Third, I have been experiencing numbness all over my right side when I lay on it. I need guidance before taking the second dose. Please help!

Patient presented to the pharmacy on4/6/2021 showing older rash/hives on forearms and stated they began to appear the day after his first Covid Vaccine on his arms, trunk, inner thighs and the worst is on his back. He stated the inner thigh hives were starting to become irritated from rubbing. He administered Cortisone -10 over the counter and it had provided no relief. He had contacted Urgent Care and was told it was normal, but the pharmacist after seeing the patient urged him to go into the Urgent Care and present as he said it is not getting better but becoming worse. He stated he has had no trouble breathing.

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

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

No immediate adverse reaction when first got the shot. It was sore for a couple of days, then it felt fine. After 8 days a swollen, red rash, appeared around the vaccination site about the size of a baseball or so. It is/was slightly sore. I believe it to be "Covid arm." After 4 days the rash was almost gone, but now on day 5 (today), it is back just like it was initially. I was wondering if others had "Covid arm" appear, then mostly go away, then have it return.

"COVID RASH" on upper left arm near injection site developed 7 days later on 4/5 . Size about 2" x 3" oval. Warm and itches. Discomfort stops with Benadryl Allergy Liqui-Gel 25mg antihistamine. One week later now 4/8 rash is 95% gone.

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

My arm started hurting and is now itchy and there is a hard spot about 3 inches in diameter where the injection was.

Headache, joint and muscle aches, sore injection site. Mild the day of, increased to moderate the next day.

Roughly 3 inch bruise like discoloration on the inside of the right forearm mainly yellow to brown with areas of reddish purple tinge and 1 - 1.5 inch bruise - like discoloration of left upper inner bicep (mainly yellow/brown tinge small area of purple), fever of 101 degrees Fahrenheit, and generalized body aches.

(NB: He doesn't remember if the 2nd dose was in the right or left arm -- the first dose was definitely the right arm.) Sunday, April 4 awoke with severe facial pain. The next day, Monday April 5, a small rash on the left side of the neck, above the collar-line was visible. It was obvious it wasn't a bug bite, nor a burn. It looked like possibly contact dermatitis, though there was no known cause. Pt had a trip planned and left for out of town that morning (April 5); the place where he was staying in out of town provided Hydrocortisone cream + Zyrtec. Over the next several days the pain continued & the rash spread down his neck and up his neck, to his left cheek & ear. Pt went to urgent care on Thursday, April 8 and was diagnosed with herpes zoster. He was Rx: Valacyclovir He is still taking Valacyclovir -- the herpes vesicles are crusted over / healing

reaction following day pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever

Covid arm. Started itching several days after injection (3-4, I think) followed by a rash a day or two after that.

itchy rash appearing to be allergic in nature, resembling eczema/hives with welts and scaling lasting for at time of reporting 4 weeks and requiring medical attention, course of steroids prescribed patient also describes overwhelming fatigue, muscle fatigue and significantly diminished ability to perform daily activities/work, partially resolved but still present/recurring

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

Extremely sore at injection site. Fever, chills, all body joints extremely sore, heavy breathing with flu-like symptoms.

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

First dose received 3/17/2021. First two days I had muscle aches. Third day, lack of coordination and fatigue. Fourth day also had chills, sneezing and runny nose. Brain fog, fatigue and lack of coordination improved over the following days. The second dose receive 4/13. First day fatigure, chills, lack of coordination and muscle aches along with a lot of soreness at the site of the injection. Second day also had dizziness, mild abdominal cramps and mild headache. Could not eat until midday. The third day dizziness, brain fog and lack of coordination continue. Close to a point of seeking medical care but probably worth filing a report.

Day 1 after the shot: Bump around the area of shot. Light itching in the shot area. Warmer to the touch in the shot area. These symptoms lasted approx. 3 days. Day 8 after the shot: Return of the bump around the shot area. Light itching in the area of the shot. Since the original symptoms had gone away, my concern is the out-of-the-blues return.

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

MODERATE ITCHING FOLLOWING FIRST AND SECOND VACCINATIONS. ITCHING LASTED 24 HOURS AFTER FIRST SHOT. TREATED WITH BENADRYL. ITCHING LASTED ABOUT 4 HOURS FOLLOWING SECOND SHOT. TREATED WITH BENADRYL. TINNITUS AND AUDITORY SENSITIVITY BEGAN WITHIN 6 HOURS OF THE FIRST INJECTION. SUBSIDED BUT STILL PERSISTENT UP TO AND AFTER THE SECOND INJECTION. TINNITUS HAS BECOME WORSE 10 DAYS AFTER SECOND INJECTION. IT IS LOUDER AND MOSTLY IN LEFT EAR. AUDITORY SENSITIVITY HAS BECOME WORSE ALSO.

Patient reported full body itching. No hives/rash, no dsypnea. Patient reported at appointment for 2nd dose.

Sore arm at injection site within an hour or so. 4 days later fever 99.7, chills, body aches, abdominal pain

3/13/2021 Lt shoulder rash and lt eye swollen; 4/14/21 had acupuncture for neck pain; 4/15/21 herpes rash started LUE advanced to both UE, neck, lt ear, and lt hip; lt eye swollen Increased Valtrex from 500 mg daily to 1 gm three times daily. Advil for pain. Benadryl for itching. Initial rash abating; new rash developing; eye swelling diminishing.

Woke Saturday morning around 12:00am with patient and bed sweated wet and patient had chills. Extremely tired to point could barely move. Sunday morning still extremely tired, red rash around injection area about three inches around, large knot under armpit of injection site the size of a softball. Monday morning still tired but not as extreme. Still had rash at injection site and entire upper arm swollen. Still had knot below armpit.