Moderna

Blistering burning rash opposite arm of injection site spreading down arm. Time 1 day after injection 24 hours later

Individual reports "woke up with red rash and itching" Took benadryl and applied topical itch ointment Did improve but still with red rash at 1100 on 12/30/2020

Localized swelling, redness and itching 6 cm in diameter at injection site. it developed about 7 days after the injection

9:30 client became lethargic, diaphoretic, pale and taken via w/c to triage area. Oriented x 4 - drowsy. States the symptoms occurred immediately, that he felt too warm, felt clammy and light headed. States he has problems with claustrophobia. Cooled area by opening doors, patient removed layers of shirts. EMT personal at vaccine site in attendance. BP 136/78; HR 79; O2 sat 99% on r/a. 9:32 EMS activated 9:36 EMS cancelled per patient request. 9:50 states he feels much better and wants to leave, ambulated down hall and turned back stating he still felt lightheaded. Sat back in chair. States he last ate last night. provided juice. declined cookies. 10:00 States he feels much better, trial ambulation tolerated will without lightheadedness, gait steady. Left with wife to personal vehicle.

On tenth day, woke up with large red, itchy rash around vaccination site. Applied an ointment with cortisone in it. Not a major problem. Later in the evening, started seriously itching about the neck and face; got worse with time; no sleep that night; continued all next day; doctor prescribed a six day series of steroidal pills; it SEEMS, after 16-18 hours that the itching is easing..

Began having a local reaction. Spread to current size of 6 in by 4 in. Warm to touch, area swollen. Has not progressed in size over past two day. Somewhat sore, very itchy. No other symptoms except for the local reaction.

Fever, fatigue, headache, muscle pain, chills, pain at the injection site. Still have some side effects 6 days later. Sleep for 10 to 13 hours each night. Totally exhausted.

Rash and itch developed at the spot of the inoculation about 10 days after the shot. Treating with benadryl cream. Primary care physician was informed and said it was not serious. He advised taking Claritin if the cream didn't work. So far the itching has abated.

About 8pm I began t experience total body itching. At 11pm the itching was too much to allow for sleep. I took two Gabapintin 300mg. At 4AM I went to sleep. I contactedmy dermatologist. He suggested the vaccine may have started a Grover's response. He asked that I add Zyrtec (over the counter) to my meds. He asked that I continue hydrating my skin with Vanicream cream. I folllowed his advice. The itching stopped on Sunday. I continued with the Zyrtec but stopped the Gabapintin. Today, Tuesday, I am having muscle tightening, especially in my legs.

Swelling, redness,itchy rash. Very hard swelling at the site of the injection. Has been taking oral benedry and applying ice to the site. Today,01,21,2021, the redness is spreading

Low grade temperature of 101.2 dealt with by taking aspirins. Overall body ache dealt with by aspirins. Extreme pain in area of left arm/shoulder where the vaccine was given. Arm severely ached for 48 hours in any position, was very tender/painful to touch, and difficult to use or move. I'm pretty tough where pain is concerned with past injuries (broken leg in 17 pieces, severely sprained ankles, broken ribs, broken tail bone from horse accident. This vaccination arm pain was right up there with the worst.

Eight days after initial injection, I noticed an oval-shaped rash about 1.5 x 3 inches over the injection site. It itches moderately. No fever, headache or soreness to report. Rash continues today.

DELAYED RASH APPEARED AT SITE OF VACCINE ON LEFT ARM AND EXTENDED DOWNWARD . SIZE OF RASH IS 2 INCHES WIDE BY 4 INCHES LONG.

The patient reports that approximately 11 hours after receiving the vaccine he experienced chills and felt weak. Then 2 days after receiving the vaccine, he developed a red, itchy rash to his left side approximately 4 inches dixtal to his axilla. The rash is almost completely gone, and chills and weak feeling resolved when the patient woke the next day.

Moderna COVID-19 Vaccine EUA. Note: I am a retired physician. Minor soreness at injection next day resolved over48 hours. Then, 7 days after receiving vaccine, I developed a pruritic swelling a few inches below injection site. Next day (day 8) noted 4-5" diameter area of slight swelling and erythema below injection site. Pruritis became mild ache. No warmth. Note: when I received vaccine there was a little acute bleeding from injection site, then over next few days I developed a 2" diameter dark ecchymosis at site, still present on day 10, possibly lighter. On day 10 note minimal swelling and erythema extending dow n from injection site in a rough triangle ~ 5-6" high with apex just below injection site, seems to be resolving.

Initially felt mild soreness to injection site, lasting <48 hr. After 2 days, felt increased whole arm soreness with numbness to fingers by day 5 with pain to finger by day 8. He saw a specialist by telehealth on January 21, suggesting neuropathy from inflammation around the ulnar nerve, anticipating recovery in 4 weeks. He was prescribed Meloxicam and Gabapentin and recommended to receive the 2nd COVID dose in opposite arm.

initially, nausea and "weird" feeling for approximately 12 hours.Tthe injection site continued to be uncomfortable , and on 8th day after injection, the injection site began to itch. On 9th day, there was intense itching, and injection site began to swell. by 10th day (today), the swelling and itching is subsiding, but not gone.

Nine days after vaccination, developed a warm erythematous rash on left arm just below the vaccine site which has spread over 3 days to involve the lateral arm down to near the elbow. Now 12 days since the vaccine was given.

Circular red puritic rash surrounding injection site about 8cm diameter, non-indurated, non-tender lasting about 3 days, onset one week after injection. I reported it to public health the day after onset, but they never called back to get the appropriate information. It resolved with no after effects, but I saw an article today that it was an uncommon reaction ("delayed cutaneous hypersensitivity"), but thought I would report it for your data base. I'd be interested if this should cause any concern regarding the second injection, like getting it in the other arm.

Raised red bumps in a rash all over the abdomen, arms & legs. First noticed at 6 pm, majority of rash gone the next morning except. Under arms and upper legs.

Caller had vaccine at 2:30 pm today. Vaccine given in left arm. Now states he has quarter size swelling on his left side of his face starting from his left eye to his mouth with redness and itching. Advised to call his PCP. 24 follow up will be done.

I began having chills, a low-grade fever, sore muscles and soreness at the point of injection at 9 PM on the day of the injection. All of the symptoms except soreness at the point of the injection wore off at about 6 AM the following day. The soreness at the point of injection wore off later the following day.

after 6-7 days of receiving the shot I have a sore arm and a rash from the point of the shot running down my arm about 3 inches, the concern is the reaction occurred 6-7 days after receiving the shot ,Will I be able to take the second shot on 2/17/21 . Have not gone to a doctor , realize this is a normal reaction ,but wonder way it occurred 6-7 days later, concerned about taking the second shot on 2/17/21

11 days after getting the Moderna vaccine I started getting hives on my arms in the morning. Very itchy with small bumps. I have been taking Benadryl once a day when it occurs, and will try to see a dermatologist today.

about 2hrs after shot got really tired, lasted about 2hrs. Next day Sat. in afternoon broke in rash on chest, shoulders, and back. On left arm about 3 inches below injection had a round spot (red) about the size of a tennis ball. Next day Sun. rash got better. Next day Mon. rash got worse. Next day Tues. got better, almost gone by Tues. night. Red spot on arm almost gone. Wed. morning a little rash on chest right below neck.

Almost two weeks after the shot, i noticed itching on my left arm. After showering the next day I noticed a red area about 4 inches wide and 8 inches long with slight swelling and itching. The swelling and itching was not noticed in the days immediately following the shot. I will contact my doctor about the situation and follow up with them if the condition gets worse or does not go away.

"Moderna Covid-19 EUA" The day following the injection and presently there is a rash on my right shoulder in the area of the vaccination. It is approximately 3"X5" it feels warm and itches. I have applied topical Benadryl with some relief of the itching but the symptoms remain. I have notified my Primary care Physician (not contact MD). Awaiting a call back.

Muscle and joint aches, shot site ache, headache, chills, fatigue, no appetite Treating with Tylenol. No abatement yet (9 hours later)

Beginning approximately 72 hours after receiving his first dose of the Moderna, he noted redness around the injection site of the left arm. He said the area felt warm to the touch and was slightly itchy. This lasted for 3-4 days before it resolved on its own without treatment. Today (13 days post vaccination) he noted the rash on the left arm return but it was fainter than when it first came up around 72 hours after vaccination. He states the area today is 3.5 inches by 1.5 inches in size on the left arm only. He denies other symptoms or changes in skin care routine.

At vax day plus six, started skin pricking & itching at ankles. Day +7 whole legs. Gradual spreading. Now, at day +16 whole body for about a week. Low level, tolerable, but annoying & chronic. I wonder about getting my second shot in 10 days. Antihistamine takes some edge off, but does not relieve.

About 4 or 5 hours after the shot I had mild discomfort at the injection site, mild chills followed. On February 6th today I had a runny nose like one would have with a mild cold, slight chills. As I type this report at 9:20 PM Feb 6th, my nose has stopped running, and I don't seem to be having any chills. Definitetly worth having the vaccine

Possibly ?COVID arm?. Large red patch around injection site which showed up 12 days after injection. No pain but some itching. Slightly warm to the touch. The patch has increased in size since first being noticed ( 1 1/2 days ago) Looks very much like those seen on websites describing COVID arm. No other symptoms. There were no reactions at time of injection.

"Covid arm" A red rash six inches high by four inches wide, round at the top and flat at the bottom. There was no itching or pain. It looked very much like the picture in the link above.

pt states he developed itchy during the night in various locations on the body. Next day pt also had mild headache and congestion. Pt has not contacted his PCP at this time.

(2/6/2021) bilateral arm rash developed 11 days after vaccine, seen by dermatologist and was prescribed Zyrtec daily with total resolution of rash. Started taking 5 days ago, will stop today

Patient stated itching and redness did not start until 1 week after vaccine. Large area approximately 4in by 4in

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized, Systemic: Fever, Systemic: Joint Pain

Veteran received vaccine 02/04/2021. He felt very tired/fatigued from Thursday (2/4) until Sunday (2/7). Veteran stated he felt much better on Monday. Then on Friday (2/12) he started having fatigue, diarrhea, headache, and rash from elbow to injection site. He went to a local Urgent Care (2/15), where he received flu and COVID testing (both negative) and steroids. He reported this information to me via phone in the vaccination clinic today (2/16).

Bleeding gums , painless bruises of back, Started about 10 days after vaccine, has now 02/16/21 stopped

Pt is a 76-year old with SIDEROBLASTIC ANEMIA that had been mild and without need for treatment, and IgM MGUS. Presented to ED with newly diagnosed AML, in MDS with WBC counts ~250, 000. He had a normal (EX ANEMIA) CBC on Jan-21. He had COVID vaccine #1 on Jan-25. About 4-days later he developed diffuse dermititis and severe fatigue. He had an ED visit on Feb-8 for these issues and was prescribed Prednisone and Cefalexin (completed Feb-15). CBC was NOT done at that ED visit. He called HEME clininc on Feb-16 (see also the Hematology Note) stating that he was just NOT feeling well in general with increased fatigue and DOE. He noted that the dermatitis was mostly resolved. We rechecked CBC on Feb-17 (results available about 4-PM) that indicated ACUTE LEUKEMIA. Presents to the MC with MDS on FEB18.

bleeding from right ankle / lost a lot of blood; saw a pencil eraser/red looking spot; A spontaneous report was received from a non-healthcare professional (caregiver) concerning a 76 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and hemorrhage and erythema. Medical history included being mentally challenged. Concomitant medication included unspecified cholesterol medication, two unspecified blood pressure medications, baby aspirin, vitamin D, and lorazepam. On 04 Feb 2020, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced bleeding from a pencil eraser red looking spot on the right ankle, had lost a lot of blood. The bleeding had stopped and no treatment was reported. Action taken with the mRNA-1273 in response to the event was not reported. The outcome of the event of hemorrhage was considered resolved. The outcome of the event erythema was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Redness and itching. Redness started small and spread to a circle of 2" diameter after about 10 days from vaccination. The itching started once the redness appeared. My physician prescribed Triamcinolone Acetonide Cream and Benedryl. I have been using the cream for 2 days and the redness is fading away. The itching has stopped. Seems to be improving. Scheduled to get 2nd dose on March 2 at 11:30 AM at the same location.

?COVID arm? The site of the injection began to itch (sometimes awakening me from sleep) and continued for about two days

Injection site sore for two days, joints ached for two days, slightly elevated fever for two days, reduced energy for three days

First 24 hours had cold feet, cold hands sleepy hands and chills ..very fatigued, Within the next 6-hours developed fever---slight fever of 101 that was taken care of with Tylenol. Muscle- aches and slight redness at area of injection. After 48 Hours felt a lot better. No fever--nothing!

Firmness and Redness around injection site on left arm. Itching and Rash which spread to shoulder, chin and chest. Gradually worsened and has subsided.

Several days after receiving my vaccination with the Moderna product I developed a significant rash of both hands on the dorsal side. It is non-blanching and it's only mildly tender and itchy. It was on my neck a little initially, but that has cleared.

2/19: left arm, red spot approximately 2" in diameter at site of shot; itchy 2/20: left arm, redness increased to 3-4" in diameter; itchy; by evening increase to approximately 5" in diameter 2/21: left arm, redness area no change; itchy; swelling increased after physical exertion; tender and warm to touch; 9:30pm took 1 tablet Benedryl; 11:00pm took 2nd tablet Benedryl 2/22: left arm, redness and swelling increased; approximately 5-6" in diameter11:00pm took 1 Benedryl tablet 2/23: left arm, redness and swelling diminish slightly, approximately 5" in diameter; 11:00pm took 1 Benedryl tablet 2/24: left arm, swelling diminished; red area unchanged; 11:00 pm took 1 Benedryl tablet 2/25: left arm, swelling further diminished; red area unchanged - 5" diameter 2/26: left arm; no swelling; red area smaller - color changed lighter, more pinkish, area 2-3" in diameter at shot site 2/27: left arm; pink at injection site; approximately 1-2" in diameter; slightly itchy

Have had muscle pain in left arm since 3 days after shot. Second shot on February 10 in right arm. Have had muscle pain in right arm since three days after shot. Muscle pain in both arms continues. Have had elevated blood pressure coincident with the first shot. Am being evaluated by my doctor for high blood pressure currently, although I suspect it is being caused by Covid vaccination. Keeping BP record.

Initially night of the vaccine 3/2/2021 body felt hot, felt sweaty but temp was 98.0, unable to sleep through the night. just felt uncomfortable. Morning of 3/3/2021 woke up with extreme pain in injection sight, sweaty, but cold, dizzy and weak, no fever., Could not stand up. Was sat down on sofa for maybe 2 mins. all of a sudden shoulders drooped, head fell forward, I asked "dad are you ok" there was not a response, I walked closer to him and his head flew back, his eyes were slit open, and he started gasping for air 3 times then slumped forward and passed out. 911 was called paramedics checked all vitals including blood sugar, oxygen, heart rate etc everything registered as normal.

One week after the second shot I started to get bumps on my neck, that was on a Friday night. By Sunday it was much worse so I went to the emergency care facility and the Dr. told me I had shingles and prescribed Valacyclovir for 7 days. I reached out to people on an App and explained my side effect. There were over 9 people that also had the shingles after the second dose. They didn't necessarily get the shot from the same pharmacy. It is obvious that there is a direct correlation between the two.

ITP, platelet count 1 on 3/5/21 (has petechia, purpura in mouth, and right sided nose bleed). Admitted for steroid therapy.

Itchy red rash on both upper arms, shoulders, upper and lower back, stomach area, both knees. Began after first shot 22 Jan 2021 and got really bad after 18 Feb. 2021 second shot. Saw skin Doctor on 1 March 2021 and got script for rx cream. Rash continues of this date, but to lessor degree.

Just noticed itching upper left arm rash this morning about 2 inches in diameter and adjacent to but not covering injection site. No timeline yet.

Small knot formed at injection site on day 8 and started itching. On day 9 a red rash appeared around the injection site about the size of a baseball. I have not went to seek medical advice

Moderna COVID-19 Vaccine EUA after 2nd shot this one in left arm after 3 days had pain near injection sight and a also a red spot about 1.5 in by 3 in. that was wormer than the rest of my skin and itched real bad . started to get better in about 4 days

Developed bruising around left eye at around 10 PM and n date of injection that continued through today March 8, 2021. Also developed a vertical grey stripe in left eye near pupil of left eye. No pain & no vision loss. Bruising improved overnight but worsened each day as the day went on.

Patient called the morning after her second dose of the Moderna vaccine. She states that she started with a rash (no at the injection site) last night. The rash was down her arms, on her neck and scalp. Rash was red and itchy per patient. She took a Claritin and the rash resolved. Today she is feeling fine but states her skin almost feels "tingly" like the rash may come back. Advised to continue on her normal regimen of 1 Claritin a day (normally taken for treatment of her seasonal allergies) If any of her symptoms come back, worsen or new symptoms are to arise she is to call out office.

Noticed left arm began itching last night. This morning, my arm was hot, red, swollen with a red streak across my upper arm.Put cold compress on arm around 2:00 pm as my wife was concerned. She called her nurse on call line and they told her to watch it and try to have it looked at in 24 hours if not better..

Patient experienced a rash approximately 3-4 hours after receiving vaccine. Rash located in the same arm as vaccination was placed. Rash extended to the elbow. Patient took benadryl 25 mg and rash subsided.

Started 5 days after vaccine with dizzyness, nausea, sever headache, stabbing pain in left thigh, and continued soreness left arm at injection site. Has doctors appointment on 03/15/2021

first day I had chills, tired day three I had a feeling that my herpes was acting up so I took 2 Valacyclovir tablets, and one each day for the next two days, I then noticed on day 4 that my left arm in the area of the shot was very red and very warm, then it has progressed in size down to my elbow and on day 7 it is still red and warm

Moderna COVID-19 Vaccine EUA 3-March to 7-March: sore left arm, then later sore neck, chills, aches all over body and general blahs. Took Tylenol Extra Strength 500 MG as needed 8-March to 15 March : forehead and left side of upper face swollen, red and slightly itch . I Put some Polysporin ointment on and it seemed to help a little. Called my doctors office on 12-March, they these symptoms were due to the Moderna shot and that I should ride it out until they went away.

Second injection at 1:00 PM- around 7:00 PM * 6 hours later ) Fever, chills, nausea, skin is sensitive, loss of appetite, and severe tiredness. As of 24 hours after injection, side effects remain the same or worse. Severe chills throughout the night, only waking to urinate. He did wake up, took a shower only to have alot of coughing and chest discomfort.If he is not better soon, we will take a trip to the ER.

Fever, chills, very tired, extensive redness and swelling at injection site, large fluctuations in blood pressure and heart rate for at least a week, requiring hospitalization

Pt has a rash on the arm/site of injection. it is not itchy or bothersome. Told patient to contact dr and let them know what is going on

Pain at injection site, elevated blood pressure 157/89, 18 hours after injection. Took one Losartan 25 mg as usual in morning after taking BP.

Sharp pains in feet, cramping in feet and lower legs, involuntary spasms of feet and legs all night. Still have some pains in feet this morning, but not as severe as during the night. Injection site quite sore, but that was expected.

Patient reported swelling of left hand and forearm started 2 days after vaccination. Was evaluated by PCP on 3/11/21. Noted swelling left hand, wrist, forearm. few small areas of patchy erythema. u/s negative for DVT. inflammatory markers elevated, uric acid elevated. Given prednisone burst and taper with some improvement in symptoms, but not full resolution. Seen by rheumatology on 3/24/21 with broad differential and plan to monitor/close f/u. recommended against second vaccine dose for now.

Patient and caregiver report redness 7" x 4" around site, hardness, heat to left deltoid with tenderness that developed 3/18 accompanied with low appetite, muscle weakness, and fatigue. Arm symptoms were reported on 3/22 and improving by 3/23. Other symptoms reported on 3/23. They report that on 3/23 symptoms were still present but starting to improve.

Patient's report: About one week after the immunization, I noticed a burning sensation within an ~3 inch diameter region on my back near my right shoulder blade. The pain was a constant 1 to 2 on a 10 point scale--tolerable but concerning. My wife inspected the affected region every night for about a week and saw no sign of inflammation or bruising. She applied lotion once per night for several nights and that might have slightly reduced the pain. I tried Tylenol only once and it seemed to have no effect. The pain has persisted, but seems to be reducing in strength to barely perceptible now.

Some time between the 2nd dose of Moderna and March 18, 2021, developed a severe rash/hives all over body

Had the vaccine, had no reactions, and then a few days later starting on the left arm at the elbow, moving down his forearm had a red rash and itching. He now has the red rash and itching on both forearms. He had this same reaction from taking Bactrim in the past. It normally goes away in 2-3 days, but he can't seem to stop this reaction and it's itching. The Benadryl has slowed it down some but has not stopped it.

10 days after receiving the last of two shots (Moderna) I was diagnosed with shingles, on my left side front and back.

Right leg: Red rash above right ankle Left Leg: red streak halfway up his calf - looked like a streak but was actually an oblong circle

Itching after 30 minutes. Full body hives after 45 minutes. Facial swelling and itching. Racing heartbeat. Took Tylenol at the one hour mark. The hives itching lessened after three hours. The facial swelling and under skin full body itching, extreme tinnitus and racing heart lasted at least 10 days. Two blood pressure readings during the first week confirmed higher blood pressure. Everything was normal after 14 days. My allergist recommended not taking the 2nd Moderna shot. I am now seeking his guidance on getting the J&J shot - hopefully a test on whether I can tolerate its polysorbate.

Red welt appeared on his arm; Itching at the site of injection; A spontaneous report was received from a 76-year-old male patient, who received Moderna's COVID-19 vaccine and experienced itching at the site of injection/vaccination site pruritus and red welt appeared on his arm/vaccination site urticaria. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number 013M20A) via intramuscular route for COVID-19 infection prophylaxis. On an unspecified date, the patient thought the nurse did a poor job administering the vaccine. The patient experienced itching at the site of injection and red welt appeared on his arm. It was not painful . No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, itching at the site of injection was resolved on an unspecified date and outcome of red welt on his arm was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup.

Eight days following second administration, rash appeared at injection site along with itching. This progressed to generalized itching and hives type of rash on the inner surfaces of both arms, head and neck This pattern of hives and puritis continues until this day (approx. 25 days post injection. Itching is relieved by 25-50 mg of benedryl.

COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction). The patient's medical history was not provided. Concomitant medications reported were metoprolol. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

4/2/21- increased fatigue and right arm reddened and itching in right arm 4/3/21- Temp to 101.7, decreased appetite, worsening tremors and weakness. worsening Parkinson's symptoms that lasted 24 hours.

PATIENT WAS TIRED AND SORE AT SIGHT OF SHOT A COUPLE OF DAYS AFTER SHOT HE WAS DEHYDRATED AND HAD LOW BLOOD PRESSURE SO WEAK HE COULDN'T STAND NOT LIKE HIM AT ALL HE USUALLY IS VERY OUTGOING. CALLED 911 RUSHED TO HOSPITAL. ALL TESTS WERE TAKEN EVERYTHING IS NEGATIVE. SENT TO A REHAB FACILITY AT ADMISSIONS HAD TROULE BREATHING CALLED 911 BACK TO HOSPITAL. ADMITTED INTO ICU SAID HE HAS SWELLING ON THE BRAIN RAN EVERY TEST POSSIBLE NEGATIVE FOR EVERYTHING. DOCTOR HAS TREATED HIM FOR ANYTHING HE THINKS COULD BE WRONG. DISCHARGED TO A LONG TERM ACUTE CARE TO SEE IF ANY IMPROVEMENT FOR 25 DAYS. NO DIAGNOSIS OF WHY THIS IS HAPPENING. ONLY THING THAT MAKES SENSE IS THAT EFFECTS OF VACCINE.

exactly11 days after first shot i woke up at 7:30AM with bumps on both arms and very itchy I took2 Benedrill and symptoms went away. The following morning same thing happened. I took a picture of my arm to save. After about a week of less severe bumps I went to a Dermatologist. My arm wasn't that inflamed at the time, but when I showed him the picture, he said it was hives but didn't think it was related to the vaccine. Told me to take Excedrin for 5 days. I was fine then but now every few days my arms get slightly itchy and 1 Excedrin clears it up. (I could text the picture if you want)

Persistent pain in left upper arm over three months after first injection. Worse at night. For the first month, some loss of function in left arm/shoulder but that has resolved now. Dull pain persists.

Roughly 7 days after 2nd vaccine dose patient reports he noticed an itchy red rash on the right upper arm near the injection site.

injection site reaction; sore arm Narrative: Patient is a 75 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination.------------------------------------------------------------------------ SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction Yes Other No If yes describe: sore arm x1 day

swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) in a 76-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 (No medical history reported.). On 08-Apr-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 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms. Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case

Patient received vaccine on 04/17/2021. Reaction started on 04/30/2021. Came to pharmacy and showed left arm was covered sparsely but with red blisters located on left arm, arm pit, left chest, and a little bit on the back arm. Reported soreness and itchiness as well. Has not tried medication but has been putting on a warm washcloth over the area to ease the soreness. Spoke about using otc pain to help ease until seen on Tuesday by doctor as the doctor office is closed today (sunday 05/02/2021).

Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.

Pt had a rash on his arm from the second shot, as well as the first. He also said he had nerve pain in feet and nerve pain in feet that increased during urination.

PATIENT STATES HE GOT THE 1ST DOSE . HE GOT RASH AND SWOLLEN ON BOTH HANDS. IT WENT AWAY AFTER A WEEK OR SO. HE GOT THE SECOND DOSE AND SAME THING HAPPENED. HOWEVER AFTER A FEW WEEKS IT RESOLVED. NOW IT CAME BACK AGAIN. HE ALSO HAD ULCERS IN HIS MOUTH

Hands and feet broke out in blisters, blisters burst and now feet and hands raw.... no fever, chills..

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure

Red rash appeared 4 days after receiving the first shot. Went to doctor, did a biopsy & returned as psoriasiform dermatitis, keeps getting worse, still has it. Itches intensely, using a prescription cortisone cream.

starving for air; rash; my breath is shorter than it used to be; Itching, it has increased all over his body; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (starving for air) and DYSPNOEA (my breath is shorter than it used to be) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included OXYGEN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH ERYTHEMATOUS (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), RASH PUSTULAR (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab) and SCAB (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab). On 24-Apr-2021, the patient experienced PRURITUS (Itching, it has increased all over his body). On 28-Apr-2021, the patient experienced DYSPNOEA (my breath is shorter than it used to be) (seriousness criterion medically significant). On 19-May-2021, the patient experienced DYSPNOEA (starving for air) (seriousness criterion medically significant) and RASH (rash). At the time of the report, DYSPNOEA (starving for air), DYSPNOEA (my breath is shorter than it used to be), RASH ERYTHEMATOUS (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), RASH PUSTULAR (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), SCAB (They're red & little bumps, juice comes off of them when I scratch it, then it makes a scab), PRURITUS (Itching, it has increased all over his body) and RASH (rash) outcome was unknown. The patient reported he presented to Urgent Care on 28-APR-2021 but they did not have any treatment recommendations. On 19-MAY-2021 the patient continued to experience rash and still itching. Treatment included oxygen therapy, antiseptic (Listerine) splashes on the rash without any relief and diphenhydramine once in the morning and twice in the evenings. Action taken with the mRNA-1273 in response to the event is not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-116720 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant follow up received as event details were added and updated; 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. US-MODERNATX, INC.-MOD-2021-116720:

A week after receiving vaccine on May 22nd, patient says rash appeared at injection site for a couple hours and disappeared by noon. On the 23rd of May, the same thing happened, rash appeared in the morning and disappeared by noon. He also says whenever he takes a deep breath or presses on his chest, the place where he had a stent inserted over 20 years ago aches. He is seeing his cardiologist on 6/11/21 and will mention the chest pain also

rom: To: Cc: Subject: Patient Concerns Date: May 29, 2021 6:42 PM Dear Sir/Madam, I would have liked to include her in this message but am not in possession of her official email address. To recap the encounter on April 29, 2021 : I went with my friend to the clinic,where we spent 12 most frustrating hours I expressedly told the staff with my friend present, that I have been an extremely healthy individual, who has never seen a doctor,/ER/hospital in over 40+ years. I am happy to give you my previous employers contact info to verify that I never missed a day`s work. I told the staff I suddenly fell very ill 2 days ago 2-3 weeks after my 2nd CVID 19 vaccination. with sudden massive bilateral leg edema up to the groin and extensive lower leg blood staining and mottling of my skin. The attending dr just called it Pedal Edema. He was not interested in my history (present and past), no examination, had to remove no clothes. My friend and later neighbors in the community where flabbergasted that he did not see the state of my legs. Obvious other symptoms such as abdominopelvic ascites was also present. Further tests were done and inexplicably suddenly pulmonary atelectasis and cirrhosis of the liver become important. Could that really make me so sick in two days? Absolutely incomprehensible. there was an avalanche/cascade of blood destruction with destruction of RBCs, hemolysis, loss of platelets, obvious very high total bilirubin, hypoalbuminemia and ascites. My bed sheets still show numerous blood stains where I bled from many of the skin lesions and scabs Those were all results due to one common denominator:: reaction to COVID vaccination. Forget about pulm atelectasis or liver cirrhosis making me so sick in 2 days i AM INTERESTED TO SEE YOUR EXPLANATION A quick comment for her and her comment about compassion, She is probably unaware, that are quite a few nations in this world, where medical colleagues do not charge their colleagues/family and the pastor/family of their church, I lived/worked for a for a few years in another country. One night I was called to drive into one of the park's camps to attend to a colleagues wife who had an incomplete miscarriage and bleeding, This was quite a drive through the night back to the hospital, doing a D&C and the couple could happily continue their journey that afternoon. No charge by the hospital or me. That is compassion. Dr.

described a painful, silver dollar-sized blister popping up on his left calf approximately one week after his second COVID-19 vaccine. Then a second blister appeared on the right calf within a few days. He went to his primary care provider and they treated it but did not make a connection to the vaccine. It wasn't until a couple weeks later when his (adult) son got his second COVID-19 vaccine and had the exact same large blister appear on one of his calves that they made the connection to the vaccine. Obviously a genetic component here that someone needs to look at.

Loss of appetite; I had fever and chills which lasted three days; headache a couple days; itching started and hasn't stopped - arms, back, body - it comes and goes away - there is one or to places there's a little red but that's from my scratching but otherwise don't see anything; Feeling more fatigued. Loss of appetite - these lasted for at least a month; shortness of breath issues - continued for three or four weeks before it got to be a real struggle. I was going two or three steps and was having real bad shortness of breath. My son said it was called exertion something. ER - CAT scan- multiple blood clots on lungs - 4 of my 5 lobes were not functioning at the time - Bilateral Massive Pulmonary Thrombolism - I got there just in time. They sent me to Catheter lab - two catheters with Antivase and multiple bags of Heparin and other blood thinner with three day stay. Eliquis - prescriptions - 5 mg - twice a day for 6 months minimum and maybe for the rest of my life. They put me on oxygen on three days - 40's and 50's when I got to the hospital but within a day on oxygen it was back up to 90's. Kidney= Creatine levels were high when I got there but close to normal at release. Blood glucose levels were normal. Blood pressure was 120/80 when I left - laying down. When active it was 130 something over. They put me in Surgical ICQ and then they needed the bed and sent me home to rest. Six foot distance between me and the refrigerator - I do have my appetite back now 1200 calories a day in my diet. I am doing some light walking. Minimized stair climbing but I'm in a three story house so have to do it. Doing light construction work for my son so I'm banging nails. Not any running right now. Telephone follow with doctor - I don't have a primary because I hadn't seen a doctor for 35 years.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure Continuing description of events after second Moderna vaccination: my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup. Additional information as of May 24, 2021: I had an examination by Dr., Care Center on April 14, 2021. After discussing the reaction and symptoms that occurred thereafter an EKG indicated a slight heart beat abnormality. Combined with the continuing lightheaded symptoms that periodically recurred he considered the potential that the Timolol that I have used since my late 30s to reduce eye pressure from glaucoma could potentially have reacted with the Moderna shot. As such he later called my opthalmologist, Dr., at Eye Clinic in to discuss this possibility. Dr. also scheduled for me to have an echocardiagram to determine if there has been a resulting heart problem from the Moderna shot. Subsequently after discussing this with Dr. I discontinued taking Timolol for about 3 weeks with a subsequent eye exam to determine the pressure in my right eye to see if a new prescription may be necessary or other alternatives. This was on May 19, 2021. I had been taking my blood pressure daily, sometimes multiple times during the day since the collapse after the Moderna shot. Toward the end of the 3-week period of not using Timilol drops in my right eye the feeling of being lightheaded had become less frequent and blood pressure had become more consistently above 110/65. The feeling of being lightheaded had seemed to often correlate with blood pressure below that, but often my blood pressure was erratic going as low as 100/60 and upward to more normal areas of 120/68-130/75. However, it was not clear to me, or to Dr. if this was a result of having discontinued Timolol or if it was the needed period of time for the Moderna aftereffects to subside. He has me now using only 1-drop of Timolol per day, rather than 2-drops per day in my right eye as my eye pressure is just over borderline of concern for glaucoma in that eye. The cataract surgery on March 8, 2021, 3 days before the 2nd Moderna shot, had eliminated the need for taking Timolol in my left eye. As it stands, I continue to feel relatively normal. I had a second checkup with nurse practitioner at Unity Care Center on May 12, 2021 and she agreed that I should have the echocardiagram as scheduled on May 28, 2021 which is in 4 more days. Additional information as of June 25, 2021: I had an echocardiagram on May 28, 2021 and was provided the evaluation of the results on Jun 9, 2021 by nurse practitioner at Care Center. 1) overall results were good; 2) my ejection factor was 65% and normal; 3) the only abnormality is a mild resistance to ventricle heart relaxing when it is filling up with blood (she further indicated that in positions of some stress is when this was primarily occurring and could result in lower blood outflow and lower blood pressure potentially related to the feeling of being lightheaded and could possible pass out); 4) my heart valves look OK; 5) keep well hydrated to maintain a healthy blood pressure. At the time there was a period of several weeks of having felt relatively normal most of the time with few episodes of feeling lightheaded. However, during a period from June 11 to June 19 there reoccurred daily feeling of being lightheaded and at times the systolic blood pressure dropping to as little as 104 and often no more than 115. However, since that time the blood pressure has returned to the more normal range of 115-130 and feeling more normal. It remains unknown what part the second Moderna shot had to do with this, but there had not been these prior periods of feeling on the verge of passing out combined with lack of energy during these periods. However, the periods of feeling lightheaded seem to be shortening and the periods of feeling normal longer and whatever the causes are gradually subsiding.

'lost feeling of the left side'; still has some shingles; laid on his floor and went to sleep/passed out for 2 hours; got a stroke within 9 hours; got really tired; a small clot in the right side; lost feeling of the left side, couldn't walk, and couldn't do anything; lost control of his bladder/urinated in his pants; left arm went numb; the muscle was sore for about a week; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side) and HEMIPARESIS ('lost feeling of the left side') in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Injury, Back surgery, Gallbladder operation, Heart valve replacement and Heart valve disorders. Concomitant products included METHYLSULFONYLMETHANE (MSM 1000) for Joint disorder, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), CALCIUM, ZINC, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D3), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 10-Jun-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HYPOAESTHESIA (left arm went numb) and MYALGIA (the muscle was sore for about a week). On 11-Jun-2021, the patient experienced THROMBOSIS (a small clot in the right side) (seriousness criterion medically significant), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants) and FATIGUE (got really tired). On 11-Jun-2021 at 2:00 AM, the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours) (seriousness criterion medically significant). On 11-Jun-2021 at 3:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours) (seriousness criterion medically significant). On 22-Jun-2021, the patient experienced HERPES ZOSTER (still has some shingles). On an unknown date, the patient experienced HEMIPARESIS ('lost feeling of the left side') (seriousness criterion medically significant). The patient was treated with GABAPENTIN at a dose of 100 mg three times a day and LORAZEPAM at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side), HEMIPARESIS ('lost feeling of the left side'), HERPES ZOSTER (still has some shingles), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants), HYPOAESTHESIA (left arm went numb), MYALGIA (the muscle was sore for about a week) and FATIGUE (got really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: didn't find anything wrong (Inconclusive) didn't find anything wrong and patient mentioned the small clot in the right side.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 72 hours after receiving the first dose of the Moderna COVID-19 vaccine, the patient got shingles. He still had some shingles, and stated "it is leaving but still numbness in a belt from the stomach center to the back of the left side, front side is well, and back is numb". He was taking Gabapentin 100 mg three times a day for the shingles, which was the only prescription medication he was currently taking then. He was also prescribed pain medicine for the shingles which he no longer took as the pain had left. One of the pain medications is lorazepam. The patient received the second dose, and he stated his left arm went numb. The injection was in the top part of the shoulder, and it did not hurt up there, but the muscle was sore for about a week. In addition, the patient stated he "got a stroke within 9 hours" at 2AM on 11 Jun 2021 and lost feeling of the left side, couldn't walk, and couldn't do anything. He went to the bathroom and lost control of his bladder. He urinated in his pants and got really tired, so he laid on his floor and went to sleep at 3AM. He also described this as "passed out for 2 hours". At 5AM in the morning, he woke up and was fine. He went to the doctor on 18 Jun 2021, who told him that he had a TIS or a small stroke. The MRI didn't find anything wrong, and patient mentioned the small clot in the right side. He was never hospitalized. Prior medical history included spine injury, 2 back surgeries, gallbladder surgery, an artificial valve in his heart, and a clogged aortic valve in the patient's heart. He has taken vitamins and supplements daily for the past 20 years. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-231546 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

72 hours later he got shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (72 hours later he got shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The patient's past medical history included Spinal cord injury, Aortic valve disease (clogged aortic valve in his heart.), Back surgery (2 surgeries.), Cholecystectomy and Heart valve replacement (an artificial valve in his heart). Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]), CALCIUM, ZINC, UBIDECARENONE (COQ10 [UBIDECARENONE]), METHYLSULFONYLMETHANE (MSM [METHYLSULFONYLMETHANE]), COLECALCIFEROL (VITAMIN D3), FISH OIL (OMEGA 3 6 9 [FISH OIL]), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (72 hours later he got shingles) (seriousness criterion medically significant). The patient was treated with LORAZEPAM ongoing since an unknown date for Pain, at an unspecified dose and frequency and GABAPENTIN for Shingles, at a dose of 100 mg. At the time of the report, HERPES ZOSTER (72 hours later he got shingles) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

about 3 weeks ago, the patient experienced a swollen optic nerve that continues as off 7-10-21. loss of vision. Also 3 days ago, he developed a whole body rash

Developed hives; Extremely itchy; It worsened and spread over the entire body; Rash on the shoulder near the injection site; Anaphylactic reaction; Red Bumps; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 76-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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced RASH MACULAR (Red Bumps). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red blotches, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), RASH MACULAR (Red Bumps), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. According to the report it started as a rash on the shoulder near the injection site in the evening of the 1st dose. There were tiny dots which were extremely itchy. Skin like scabs would fall away on scratching them. The next day, it worsened and spread over the entire body. Patient called an ER doctor and he was told that he was having an anaphylactic reaction to the propylene glycol component of the vaccine. He then visited a dermatologist and received a steroid shot and he was put into an oral steroid regimen where the dose tapers every day. These calmed the symptoms down but by the 10th day though they were still visible. It took several months for the events to resolve. He was advised not to take the 2nd dose of any COVID-19 vaccine. No relevant concomitant medication information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received on 14 Jul 2021 as a Telephone Contact Report wherein events anaphylactic reaction, pruritic, injection site rash, urticaria, rash were added. Event outcome updated as recovered. Action taken updated to withdrawn. This case was upgraded to serious as event anaphylactic reaction was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Not having control of their bowels; Completely confused; Constant itching; Very lethargic; Never slept past 9am but after receiving the second dose they could not get up before 11am; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL INCONTINENCE (Not having control of their bowels) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VALSARTAN, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METOPROLOL for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced BOWEL INCONTINENCE (Not having control of their bowels) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Completely confused) (seriousness criterion hospitalization) . On an unknown date, the patient experienced PRURITUS (Constant itching), LETHARGY (Very lethargic) and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am). At the time of the report, BOWEL INCONTINENCE (Not having control of their bowels), CONFUSIONAL STATE (Completely confused), and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am) outcome was unknown, and the events of PRURITUS (Constant itching), LETHARGY (Very lethargic) was not resolved. On 06July2021, the caller could not get a hold of the patient. The caller called 911 to check on the patient. The caller found the patient at home completely confused (not knowing themselves or recognizing any family members), the patient was in their underwear. The patient was admitted to the hospital and stayed for about 10 days. The health care providers have done every test possible according to the caller and tests have come back negative and the HCPs stating "the patient is 100% healthy. No treatment drug details was reported.; 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.

2nd moderna vaccine given 7/12, that night developed some mild low back pain. The next morning the pain was more severe and associated with left leg pain (throbbing). He developed a rash as well (purpura with some bulla) on the buttocks which then traveled down his leg and into the left foot (not painful/pruritic). No fever, chills or other adverse SE.

The first week he started getting sore, affected hand and arm, can't raise right arm completely, soreness and brown spot at injection site

On the day after getting the COVID vaccination, I experienced pain in my left shoulder muscle similar to a flu shot. The pain was so mild that I got the second shot in the same shoulder. I did not mention it earlier because I did not want to dissuade anyone from getting vaccinated or cause undue alarm due to some minor pain. However, after 6 months, the pain persists and appears to be getting worse. Therefore, I feel it should be reported. I took the second shot on 02/09/2021- Moderna 029K20A.

Sweating 20 minutes-took temperatures and they were normal. Continued preparing dinner. Some discomfort at injection site for first 24 hours.

PATIENT A 77 Y.O MALE PATIENT, EXPERIENCED WHAT HE THOUGHT A REACTION TO COVID-19 VACCINE ON 01/12/21. DETAILS BELLOW: HE RECEIVED THE VACCINE AT 3:15PM ON 01/12/21 AND EXPERIENCE RED SPLOTCHES ON FACE WHICH WAS WARM AND WOMEWAHT TENDER TO TOUCH. PATIENT DENIED SWELLING OF THE FACE, MOUTH OR ANY DIFFICULTY BREATHING. HE WENT TO URGENT CARE AND WAS PRESCRIBED BENADRYL AND WAS INSTRUCTED TO TAKE BENADRYL PO EVERY 4-6 HRS AND WAS SENT HOME. AS OF 01/13/21 PATIENT TOLD ME OVER THE PHONE THAT HE IS GETTING BETTER. HE STILL HAS THE RE SPLOTCHES BUT ITS NOT WARM OR TENDER TO TOUCH AS OF TODAY. I WILL CONTINUE TO MONITOR STATUS. PRIOR TO THE EVENT. PATIENT REPORTED THAT ON 12/14/20, HE WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED WITH CLINDAMYCIN ANTIBIOTIC FOR SUPPOSEDLY 2 WEEKS, BUT ON JANUARY 2,2021, HE DEVELOPED THE SAME RED SPLOTCHES ON FACE AND WAS PRESCRIBED PREDNISONE TABLET AND WAS INSTRUCTED TO TAKE IT FOR A WEEK. PATIENT STATED THAT HE TOOK THE PREDNISONE UNTIL JANUARY 8,2021 AND IT RESOLVED THE ISSUE. STATES HE THEN GOT HIS COVID-19 VACCINE ON 01/12/21 AND DEVELOPED THE ABOVE MENTIONED SIGNS AND SYMPTOMS, ALTHOUGH THIS TIME HE WAS NOT PRESCRIBED WITH PREDNISONE, INSTEAD WAS DIRECTED TO TAKE BENADRYL TABLET.

Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.

Around 8pm the injection site started to get sore. I was moderately sore for approximately 48 hours. About one week after receiving the vaccine, around January 6, the injection site started to get itchy. Not continuously itchy but now and then. There were no marks on my arm at all at the injection site at any time.

leg cramps BL, shoulder cramps BL, head felt like it wa puffed up, rash started 1/11 around neck, back and front itchy

leg cramps, BL until 1/13/21, shoulder cramps BL, head felt like it was puffed up, rash started 1/11/21 which was was on the back on the neck, front side had rash but not itchy, rash still on neck, not itchy today 1/14

Patient reports an itchy rash at injection site that has increased in size over the last week since injection. Will be reaching out to his MD this week

Rash all over body. Reported to Primary Care Physician, prescribed a Antihistamine & topical Hydrocortisone Cream. Treatment for 5 days.

Expected: sore arm at injection site. 2 days. Hives on chest area, from waist to neck. Slight itching, red splotchy. Lasted about 3 days.

At site of injection I have developed a red area about 1.5 inched to 2.5 inches . I had my doctor check it in case it was infected or a reaction from the vaccine. He felt it was a reaction to the vaccine. The site doesn't hurt and it's not warm. The site isn't changing from when I first noticed it 2 weeks ago.

Patient reported redness that began to spread down arm towards elbow. Patient consulted w/ PCP and was prescribed oral antibiotics.

Notice minor sensitivity when touch injection site. Some swelling and slight redness around the injection site and site is warm. I am also aware of slight itching feeling. I do not have fever. None of these are severe but rather I am aware of them and wonder if I should still experience them since I received the first dose on 1/7/2021. Do I need to be concerned or contact my primary physician?

Next day (1/18) noticed three small rash spots on inside upper right thigh. Wasn't sure if related. Since then more rash spots have occurred on upper right thigh and across lower back.

Tenderness, redness, mild-swelling and itching at injection site. Symptoms did not appear until slightly more that 2 weeks after injection. Symptoms respond partially to CBD ointment. Symptoms are persistent since onset date (now 2-days). No other symptoms or signs noted.

Chills fever rash on arm right below injection site, also itching on my back. The red rash on my arm is still there today 1/24/2021.

After 10 days soreness reappeared in left arm. Red rash appeared about the size of a saucer. Mild soreness remains. Size of rash has diminished as has color intensity

Rash( raised pink patches and whelps) to back, bilateral arms, buttock, and legs. Characterized by dryness, redness and itchiness. Given Solu-Medrol and Atarax; better by 01/21/2020

Delayed cutaneous hypersensitivity reaction appeared on 1/25/2021. Disappeared 24 hours later. Redness at vaccination site. No swelling or discomfort.

Noticed today that left arm is a bit swollen . Has a pinkish color and slightly warmer than corresponding area on right arm. Slight soreness when area pressed.

4 inch long red area at injection site appeared and gradually faded over three days. No itching or swelling.

Moderna COVID-19 Vaccine EUA First Maderna COVID vaccine No Symptoms at all Second Maderna COVID vaccine on Monday Monday: 12 hours after: Headache Some soreness at injection site Could not sleep at all that night Muscle, joint soreness Chills Tuesday Headache Fever Muscle ache Nausea, little appetite Lethargy Napped in the afternoon for a few hours Could not sleep that night. Took 2 Advil at 10:30pm, then slept Wednesday Felt normal on awaking. No headache A few sweats, so probably some fever. Thursday Normal in every way.

Today I began itching at the exact spot the injection was given. I rubbed it and the more I rubbed the spot the more it ached and itched. Later when I looked at the injection spot, I noticed a 3-4 inch in diameter red spots like hives or shingles. The place is a circle. Rem8indes me of shingles but I've had both shingle shots over a year ago and never had problems.

Rash and severe itching at injection site approximately 7 days after the injection. After about 48 hours the itching is subsiding but rash redness is still there.

I woke up in the middle of the night, with a pain in my left shoulder. This is the injection sight of the vaccine. When I looked at the area around the sight it was extremely red an noticeably swollen. This approximately 10 hours after I received the injection I was unable to left the arm above elbow level without incurring additional pain. I took an Aleve and just rested the remainder of the day. Things returned to normal about 1500 hours on the 28th.

Red itchy rash developed on right shoulder around injection site on morning of 2 Feb 21 - 10 days after being vaccinated. Rash area is approximately 2 inches by 3 inches

Red, Swollen, itchy, warm to touch area developed on arm on 2/1/21, injection was given on 1/21/21. Patient followed up with PCP on 2/3/21, diagnosed with Cellulitis of injection site. Prescribed Doxycycline 100mg , twice a day for 7 days.

pt had rash from thigh up to waist. itching. He took a bath in the evening and had rash after that. He took one dose of Benadryl and got better

delayed reaction by 7 days. Rash over arms and in between fingers. applied cortisone cream 2% however still itchy. outcome promising not effecting airway of breathing in anyway. Advise can use Benadryl if needed. Advised may cause drowsiness.

2-4-21 woke up with a red arm where injection was given but a much larger area. It itched and later that day got puffy. Today redness has gone down a lot but still have some redness and very little itching. Can I still get the second dose?

Received first Covid vaccine on January 29, 2021. One week after receiving injection in left upper arm he noticed redness, itching, pain and swelling (the size of an orange) and aching. No fever or other symptoms. Applied warm compresses and took Benadry. Made an appt. to see our local doctor for evaluation on Monday, Feb. 8. . This was the first injection and don't know what to do about second dose that is scheduled for February 26, 2021.

By 1:30 am on 2/4/2021; patient was shaking uncontrollably. This continued about 1 1/2 hrs. then he could not get out of bed to go to the bathroom; thus wetting himself multiple times during the night; Patient was restless for about 5 hrs. but still could not get up even with me (his spouse) trying to help. He also could not understand how to help move his body to keep from falling out of bed (never fell out but I could not get his entire body on the bed until our daughter arrived around 9:30 am. It took our grandson who is 6'5" tall & 275 lbs. to help get patient up and walked him into our sunroon. throughout the day, patient could not stand without help & continued to urinate on himself. He could, however, feed himself breakfast & lunch. At 7:30 pm grandson and daughter had to walk patient into bedroom. patient could not walk without us telling him how and pushing his feet forward. It took both grandson and daughter to pull him onto the bed as he collapsed when he got to the bed. Patient slept until approximately midnight. at that time our daughter helped him to the bathroom and helped to change his underwear and tshirt which was wet from having a fever. Afterward, patient was able to go to the bathroom by himself but was very tired. He was able to walk outside with the help of a cane on 2/5/21 2 pm. On 2/6/21, patient complained of his back hurting and itching. We discovered he had shingles! Not a full body rash but shingles on his left side around his waist.

patient had dime sized rashes/bumps on arms and back develop about a week after receiving the first dose. His pcp took biopsies of the bumps and shown to be inflammatory growth, not cancerous or due to other causes.

Shoulder joint pain, Swelling at various places near injection site, upper arm, and shoulder Neck pain and tightness

I had my (Moderna) first dose yesterday. Within ~6 hour the soreness level of the shoulder joint (but not especially the site of the jab) zoomed up to intense. So much so, that simply lifting my arm slow-motion to the level of my eyes caused intense pain spasms. Last night and this morning were equally severe. Within the last hour or so, the pain level has diminished a bit. NOTE: I know how people rate pain is super subjective. In my case working as a geologist in a quarry a number of years ago, I was struck and pinned by a large boulder. The ER crew would not give me a pain killer, so that they could monitor how the Jaw of Life was working (it broke, the boulder was too heavy), so I not surprisingly passed out several times from the pain level before being extricated. Needless to say, this compound fracture of the tibia and fibula accident was a 10 of 10 pain level. Yesterday's CV-19 jab pain level was an 8-9 of 10. Nothing I read before yesterday's jab, Fauci et al, prepared me for this pain level. So, is this normal??? My POV is, I think, atypical in this matter of pain. Should I be concerned about a return to normalcy right now (today / tomorrow) as well as for the second dose?? I HOPE THAT A MEDICAL PERSON WILL RESPOND TO THIS EMAIL - NOT SOME BOILER PLATE WORDS. If you want more details, feel free to phone me

Moderna COVID- 19 Vaccine EUA: soon after vaccination patient reported feeling warm and naseated. Symptoms resolved within one day. Six days after vaccination patient developed an itchy rash on the face that is warm to the touch, stomach cramping, dizziness, and chest discomfort. Physical exam remarkable only for rash: patient presented alert and oriented, well-appearing. Patient prescribed hydrocortisone cream.

became light headed, then had to go to bathroom Hand, arms and legs began to itch I could barely get him up to walk to bathroom had to lay him on floor - he was staring off into space and not really reacting to me. Called 911 due to his extreme reaction. by time ambulance got there, had gotten him up and to toilet, and back into a chair. he went on to hospital and was released several hours later

mild case of the shingles on right side of stomach area approx. 6 inches by 4 inches tender to the touch t-shirt hurts the area

Erythematous patch over deltoid oval measuring about 10 by 6 cm; lasted two days, followed by mild itching in area for another two days. Painful red spots on multiple toes lasting about 5-7 days.

Rashes started with only 2 itchy rashes on 2/9. On 2/10, rashes spread to right neck, right and left side of the body including armpits, left upper arm and some on the abdomen and chest. The actual injection site which is the left arm became red and warm to touch. On 2/11, rashes spread to bilateral lower arms. Rashes are red, raised, itchy and in different sizes and shapes.

Rash x 3-4 days began 3 days after receiving first dose Covid-19 vaccine. Presented to walk-in clinic after trying benadryl and coconut oil. Also with chills and headache. Patient prescribed Medrol Dosepak. Also advised to try OTC benadryl/claritin as needed, OTC hydrocortisone cream as needed. Patient instructed to follow up with his PCP in 1 week and to go to the ER for shortness of breath, swallowing troubles, worsening rash, or worse symptoms.

Event: "Delayed Cutaneous Hypersensitivity" or Lay Term "COVID arm". Symptoms at Injection Site: Itching, 3-inch high by 2-inch wide rash, slightly elevated surface temperature. Elevated Surface Temperature: Determined by Exergen temporal thermometer on 2/5/2021 with surface temperature readings of 99° on temple, 97.9° on upper right arm and 99.2° on upper left arm injection site. Treatment: No treatment of symptoms undertaken. Outcome: Symptoms subsided without treatment. Start of Symptoms: 2/3/2021 or 6-days after Dose 1 injection. End of Symptoms: Itching subsided on 2/6/2021 or 3-days after Start; Rash had (see Continuation Page...)Additional information for Item 18: 99% subsided on 2/12/2021 or 9-days after Start.

Vaccine received on02/12/2021 Next morning at 8 am pain noted at injection site. 02/13/2021. By 7 pm site is swollen, painful and red.

It was itching. The outside of my upper arm was itchy and I rubbed it and scratched it a little and the itchiness seemed to be centered at the injection site. The itchiness lasted for about 3 days. I have not been itchy today which is the 4th day so it seems to have gone away. It was not irritating me all of the time, I could concentrate on other things and be oblivious to it. But sometimes when I rubbed it I could feel a little bit of swelling again at the injection site. When I looked at it there was some redness that could have been caused by my rubbing or scratching, some redness on the skin. I tried to located swelling when it first appeared but couldn't find any and I didn't notice any that was worrying.

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

After nine days, I then had a reaction with a redness, itch and slight soreness in injection area. I did not have a reaction at the time of injections and still have the redness but the itch has lessened

Patient reports at least two falls following COVID vaccine. Requiring assistance to stand up. Legs reported as "giving out" resulting in falls. Reports being shaking within 24 hours following vaccination. Reports extreme weakness and needing to be lowered to the floor at least twice. This is new for him. Did not report feeling dizzy; blood sugar was reported as normal during the time. No confusion or feeling out of it reported at the time. Ended up with abrasions. Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday. Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030. Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved. Assessment 1. Fall from standing, initial encounter 2. Multiple abrasions 3. Adverse effect of vaccine, initial encounter 4. Generalized weakness PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility PT EVAL AND TREAT I suspect his falls and weakness are due to Covid-19 vaccine reaction. I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain. Feeling better overall today. Recommended getting up every 2 hours to walk around, use walker for now. Call if more falls or continued extreme weakness.

2/15/21- client started with itching rash on cheek which then spread to neck, top of head, temple, and eyelid. Still present 2/19/2021

Pt presented on 2/22/21 reporting right sharp and stinging arm and shoulder pain for 3-4 days. Pain was worse with touch/pressure. On 2/21/21 he developed a lesion on his shoulder. Provider found 2 vesicular lesions concerning for shingles. She started pt on gabapentin an valcyclovir and will follow up as needed.

Significant soreness at the injection site that persists now 2 months after the vaccination and does not seem to be going away.

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

sore injection site next day. 2 days later started feeling sick, headache, chills and upset stomach, patient has been feeling worse with fever and wanting to vomit and aching all over. Each day goes by he feels worse, Called Doctors office let the nurse know he is not feeling well, no response back yet.

Patient said his neck felt itchy about 20 minutes after getting the vaccine. He said it was topical and localized. No problem breathing/swelling/shortness of breath. Said the itching was not internal, just externally. Gave him 25mg benadryl liquid. It did not change the itching but it also did not get any worse. Patient waited 30 minutes with no increase in symptoms and said he felt fine to go home.

felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more. The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction." The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.

Vaccine received 2/15. Slight soreness the next day then no further symptoms until 2/25. 2/25 Watery diarreha during night. Light rash/itch mainly on torso and right arm. Itch comes and goes 2/26 Light rash/itch mainly on torso and right arm. Itch comes and goes. No diarreha. No bowell movement. 2/27 Watery diarreha during night and this morning. Took 2 Imodium tabs this morning. Light rash/itch mainly on torso and right arm. Itch comes and goes.

Had 1st shat on the evening of February 12th at around 5:30 PM - next day, had some slight soreness in the injection area - subsided after several days - 2 weeks later (2/26), my left arm in the site injection area started to itch - then I got swelling, redness about4-5 inches in circumference surrounding the injection site - area was also warm - not hot. Have not had a fever. 2nd dose is scheduled for Friday evening, March 12th @ pharmacy.

Flu like symptoms, fever, chills, then a rash broke out all over his body. It didn't itch, it hurt when something was dragged over it, like a finger or clothing. It was deep, deep red and some parts of his body there was no regular skin showing. Took him to ER, where tests were run, showing his liver counts were way off. Biopsy was taken of the rash. It was determined that the rash was similar to Stevens-Johnson and he was admitted for 2.5 days. They put him on large doses of steroids, which helped the rash. All labs were headed in the right direction except his liver panel. He was sent home and returned to doctor in 3 days to run panels again. All were headed in right direction, even the liver. He will see his cardiologist to be put back on his heart medicines.

Pt received his 2nd dose of the Moderna COVID19 vaccine, while sitting in observation he reported feeling itching in his right leg. Pt reported to RN in observation that after his 1st dose when he got home he developed an itchy rash and a sensation of "fullness" in his lips. Pt did not seek medical care or speak with his PCP. Pt also did not mention this to his vaccinator. BP 126/91 HR 95 O2Sat 95%. EMS on site and evaluated the pt. Pt stayed in clinic for over 30 minutes with no progression of symptoms. Pt signed a refusal for transport to the hospital with EMS. ED precautions were given to pt and pt was advised to call his PCP. Pt verbalized understanding.

rash started on thighs and spread all over body, rash has decreased each day and now he has a small amount on thighs.

I developed serious hives all over my body, my throat closed up and my tongue swelled up. We called in 911 and the paramedics gave me benadryl and prednisone.

After receiving the Moderna COVID-19 Vaccine EUA, my left arm from shoulder to wrist became very sore the next evening. It was very sore for about one week. The soreness gradually dissipated over the next week, but then began to get worse over several days. Beginning the third week after this dose, the soreness is mainly in my shoulder.

Moderna COVID-19 Vaccine EUA Soreness at the injection site. Fever (101). Stiffness and pain in every joint in my body. Duration 24 hours.

<10 degrees movement in flexion and abduction with left arm. Pain and aching at injection site. Site was not warm or red but firm. Possible flare of RA.

On 3/6/2021 I started itching and noticed at the injection site a baseball size area was swollen and very red it was itching and hot to the touch. The initial all over lasted only about 1 hr then just at the injection, this has continued and is still slightly swollen and pink and still itchy. PCP notified

Symptoms reported by patient when he came today, ie 3/10/2021 for his 2nd dose of Covid Vaccine. 2nd dose not given due to an allergic reaction to the 1st dose. Explained to him about the same. Pt was given the 1st dose, made to wait for 15 minutes , no reaction so was sent home. He apparently did not feel good the night of vaccination and subsequently developed rashes all over his torso, the next day. He had a lot of itching as well. He did not go to any facility for care. He said that he did some home remedies. Per pt, the rash lasted for 8 days. He is ok now.

On 03/10/2021 Pt presented to clinic for follow up of recent hospitalization. During visit Provider noted a rash above his left eye. Pt reports that he noticed it a "few" hours after his 2nd Covid-19 vaccine, which was given on 03/08/2021. Pt describes it as "achy". Pt denies pruritus. No adverse reaction reported on 1st vaccine done on 01/25/2021. Rash not present anywhere besides above left eye. No evidence or report of systemic symptoms. Provider dx as shingles. Pt prescribed valACYclovir 1g 1 tab q 8 hours x 7 days. Pt referred to ophthalmologist as precaution. Pt was not seen until today, no report yet.

Neurological, including trigeminal neuralgia and one Bell's Palsy symptoms. Tried to complete online at library on 2/24/2021 but timed out at 20 minutes. Item #18: CDC asked to report any Bell's Palsy symptoms (also trigeminal neuralgia is related to BP). 48 hrs post vax, mid-afternoon Sat, Feb 6th: Suddenly unable to comprehend book I was reading; and there was a physical sensation of irritation just inside my skull, wrapping around my brain (meninges?) - it did not intrude into brain. Felt lack of 'presence' in room. Slightly unstable on my feet. Believed these were related to vaccine, would soon abate, but, also, that this would be no way to go through life! These lasted 2-3 hours. (I neither drink alcohol or take recreational drugs.) About that time, a 'twinging' precursor to trigeminal neuralgia began – uncertain whether it was TN? Recurred every 3 hrs. But then awakened at 6:30 a.m. by two painful TN jabs, repeated more strongly at 9:40 a,m. At about 12:30 pm, return of light 'twinging' sensation, then nothing – no recurrence. 3rd TN episode in 3 years, the briefest, the only one not requiring oxcarbazepine. Checked for Bell's Palsy symptoms (which I've never had): The left side of my mouth wasn't producing any saliva at all – none. This improved very slowly, continuing for 5 or 6 days; by far the longest lasting symptom. About Monday, the 8th, experienced an expanded time warp driving to library – took forever to reach two roundabouts. Lucid, alert, vision & reactions normal. Speed was a mile or two above limit. No euphoria or nystagmus. At library, conversation and work seemed normal. Around the same time I had about an 18 hour complete memory loss with regard to medications. Two dose periods in succession. On Monday, Feb 8th, I called our 4 day a week neurologist. He said the symptoms were an immune response to the vaccine but that he's never seen them together before. It was scary. I'm not going to take the second dose at this time. And will depend upon PCP. Filling out this form because you've asked about any adverse reaction related to Bell's Palsy (which TN is closely related to). I wonder how many others have experienced trigeminal neuralgia symptoms following vaccination? It's a cumulative disease and devastating in advanced forms. :-(

tenderness...then turned pink the next day about 3 1/2 inches x 2 inch oval Was gone by Sunday 3/7/2021. and the pink area starting with itchiness appeared on 3/12/2021..Itchiness stopped after applying topical Benadryl but the area is still pink.

After nearly 2.5 months I still have pain in my upper left arm near the injection site and in the right arm from the second dose. This makes it difficult to put on jackets, shirts, etc without significant pain and also interrupts my sleep. This pain is constant but aggravated by movement. I would rate it 7 on a 10 scale. I am wonder if this might be SIRVA or something similar. I have never had issues with vaccinations previously.

Continued significant pain at the vaccine site. Significant pain with any activation of the deltoid muscle. Left arm is worse than the right arm - left arm was the vaccine done earlier December 30, 2020.

Immediately after the injection I felt dizzy for approx. one hour. Experienced severe itching and mild pain at injection site one week after injection. I had a red area about the size of an apple. Telephone conversation on 3/16/2021 with family physicians' office resulted in treatment to use TRIAMCINOLONE ACETONIDE CREAM, .1% twice a day. Cream reduced itching for approximately 4 to 5 hours after each application.

blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased). The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride. On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient felt kind of sleepy. On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site. On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90. He said his normal blood pressure was 20/70. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event of blood pressure was high at 160/90 was not resolved at the time of this report. The outcome of left eye blood covered inside, kind of sleepy, itching around injection site, and injection site reddish and oval shaped was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Mild soreness and swelling at injection site plus slight itching. No rash or discoloration. Dissipated by the third day. Had no noticeable reaction to the first dose.

adverse events: multiple joint swelling, redness and pain, plus bilat led edema Treatment: steroids oral and injected, Outcome: improvement at first but wrist pain and swelling came back requiring injections

Day after the vaccination I had chills and was very lethargic. Persisted till next morning. On Thurs 18th my left arm was red from my left elbow almost to the top of the arm. Problem Still persists. Using cold compresses.

patient started experiencing swelling in the face and arm, arm is red, hot to the touch just below the injection site

Patient reporting tenderness when moving arm. Patient reports 0/10 at rest. 5/10 if raised above head. Patient states he feels weaker in that arm since the injection. Patient assessed in office and refused any imagining or treatment. Provider believes a nerve is affected/irritated after injection. there is no redness, no mass, no other symptoms besides pain and weakness, only in the affected arm. Patient contacted us to let us know.

Cellulitis in left arm with his first dose; Tremendous painful itch; Bad rash all over body; Swelling at injection site; Sore; A spontaneous report was received from a consumer concerning himself, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis in left arm after the first dose (cellulitis), bad rash all over body (rash), tremendous painful itch (pruritus), swelling at injection site (vaccination site swelling) and sore (vaccination site pain). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dutasteride, chlormadinone acetate and trazodone. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced cellulitis in left arm with his first dose. The patient had bad rash all over the body and tremendous painful itch. The patient reports swelling at injection site and sore. Treatment information included cefalexin, methylprednisolone sodium succinate, hydroxyzine and trimeolon. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, cellulitis in left arm after the first dose, bad rash all over body, tremendous painful itch, swelling at injection site and sore, was not recovered.; Reporter's Comments: This case concerns a 77 Y/O M who had serious unexpected cellulitis with NS unexpected painful pruritus and rash and expected vaccination site pain and vaccination site swelling. Event onset with unknown latency after the first dose of mRNA-1273. Treated with cefalexin, methylprednisolone, hydroxyzine, trimeolon. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

On the evening after the vaccine was given, the patient stated that his right leg started to itch excessively, this was alleviated with cortisone cream. On Wednesday morning, both of his hands began to itch and that's when he called his doctor to report the issue. On Tuesday, March 30, the patient reported swelling on his lower right lip.

started with just injection spot swelling and red bumps, after 2wks its full upper body. Including arms, elbows, back, groin area, buttocks, belt line/waist, down the tops of the legs.

sore arm for 3 days. I have a psoriasis flare up in areas I dont normally have flare ups in. I also have an arthritis flare up

Patient developed painful, non-itchy rash on R arm accompanied by clear fluid-filled blisters 3 days after receiving 2nd COVID vaccine. Arm became increasingly painful and blisters spread down entirety of arm over next 2 days. Patient diagnosed with shingles in Emergency Department.

Patient complained of intense abdominal burning sensation across abdomen followed by intense flushing redness of face and lightheadedness. Symptoms resolved within 5 minutes, cool wash cloth to face. Patient on home oxygen canula. BP 142/84. HR 64 and regular. Resp 20-22. Patient observed for 45 minutes after vaccination without further complaints or symptoms

A blotchy, erythematous, scaling rash spread across shoulders, upper chest and arms over a period of about 1 week. Since then, the rash has remained stable. Mild pruritis is noted. No fever or systemic symptoms. No laoratory results available at this time

1 week after 2nd dose of Moderna COVID vaccine patient had shingles outbreak. Never had shingles before. Had shingles vaccine years ago.

SHINGLES WITH TERRIBLE RASH AND NERVE INFLAMATION, TREATED WITH PRESCRIPTION VALTREX, (ON ORIGINAL PLUS 1 REFILL}

Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided Concomitant medication included unspecified statin for high cholesterol. The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins. Treatment medication included Seroto to treat the blood clots. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:

About 2 weeks after 2nd dose patient broke out in a red rash to left arm, stomach, chest, neck, and left ear. Rash started as a red dot that became a sore with a head then became scabbed over. Patient states it liked like shingles. There is no itching, pain or fever with rash. Rash is still ongoing. Patient has seen a dermatologist.

Had the first shot on 02-02-2021 Arm was slightly red and itchy Diarrhea started 4 days later on 02-04-2021 Diarrhea has continued unabated through 04-09-2021 at which time it started to let up. I still have diarrhea but to a milder extent, only going twice a day with somewhat formed stool.

77 y.o., male come to ED on 12/24/20, with complaint of SOB and neck swelling. Per ED notes, PE: Large left side neck mass (Erythematous, warm and tender). Possible abscess vs gland infx vs lymphadenitis , which started 4 hours PTA. Pt stated he woke up with the symptoms after having his COVID vaccination yesterday (12/23/20). Patient was given clindamycin in ED, had an anaphylactic reaction (neck, tongue and epiglottis swelling), developed progressive respiratory distress requiring intubation. Noted to develop complete heart block, had 2 cardiac arrests with preceding bradycardia, had transvenous pacer and and tolerated procedure well. He was discharged back to SNF on 1/02/21. Patient noted to have a subclavian DVT on DC, and will start Eliquis.

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Patient came into the clinic today to report the following: He states he received his first Moderna injection on 1-26-2021 and the second on 2-23-2021. One week after the second shot he began to have severe joint pain in his hands, knees and shoulder. 2 nd week after the last shot he had the shingles. The 3 rd week after the shot he was diagnosed with blood clots in both lungs and was hospitalized for 3 days. They gave him blood thinner in the hospital and sent him home with more to take. States as of today (6-4-2021) he is still having problems with fatigue and swelling/ pain in his hands, knees and shoulders.

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

Moderna COVID-19 Vaccine First injection: 01/22/2021 ( left Deltoid ) ; Second injection: 02/19/2021 ( right Deltoid ) Pain remaining in both injection sites continuously after injections beginning three days after innoculation. More pronounced in right arm and extends to antecubital fossa area. Pressing on injection sites causes increased pain. No improvement since innoculations.

condition aggravated; attempt to rise from bed difficult and painful; attempts to walk were difficult; severe pain in body joints / in constant knee pain; Malaise; sleepiness; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (attempts to walk were difficult) and CONDITION AGGRAVATED (condition aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal stenosis (His Spinal Stenosis is worse.) since 1999, Osteoarthritis (He is scheduled for a right knee replacement on 04 Jun 2021. Both knees will have to be replaced.) since 1999 and Pollen allergy. Concomitant products included METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication. On 10-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Feb-2021, the patient experienced MALAISE (Malaise). 10-Feb-2021, the patient experienced SOMNOLENCE (sleepiness). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (attempts to walk were difficult) (seriousness criterion disability), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated) (seriousness criterion disability). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (attempts to walk were difficult), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain) had not resolved and CONDITION AGGRAVATED (condition aggravated), MALAISE (Malaise), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

Received vaccine left deltoid has soft tender area 8 inches from injection site pain with palpation 4/10. No brusing or rash noted . Ice pack applied. Moderna information number given to client.

As soon as the shots were giving later that night began itching, called the hospital they said to report to the ER, went and the give a little pill to helping with the itching it did not help. Called a dermatologist they gave another round of medicine it has not helped either and has a rash all over the body.

I took my first shot 01/13/2021, second shot 02/11/2021 Moderna 029L20A Moderna 024M20A I had the standard sore arm about 4-5 inches below the site. This went on to be pain down my left arm extending to my left ring finger and middle finger. I have had cramps muscle pain over my chest left rib area. Pain down my left side ribs. pain down my back over my ribs. Neck pain muscle tightness left side. Pain on my left shoulder turned into a muscle pain/cramp shoulder down my back lasting 12 hours. The muscle was standing up over 1 inch. I called my doctor he wasn't available, went to the ER the next day. I saw Dr. 07/01/2021 he said he couldn't do anything for me. He said he could treat the symptom. He gave me

Sore injection site, fever, chills,extreme muscle fatigue 24 hours after injection. Full ?recovery ? by 1/8(Friday)

C/O itching "all over". No rash or respiratory symptoms reported or observed. Pepcid 20mg po and Benedryl 50mg IM X 1 dose. Symptoms resolved within 15 minutes. Pt. discharged home with driver.

9 hours after the injection, I developed chills, the inability to regulate my body temperature, shaking, cold, red in the face and a server head ache. Recovered the next day.

After 2+ days of pain, soreness, swelling at injection site this abated. Today, 4 days after dose I have cold-like symptoms ... runny nose, watery eyes and slight sore throat. Been outside twice and maintain social distancing, wear mask.

Rash at injection site, on lower back, left hip, chest, arms, inner thighs, armpits, Swelling, itching, burning on both hands and fingers. Itching and burning on lower back. These symptoms began a day following injection and grew much worse on the second day after injection. Prescribed a prednisone steroid, zertec, over the counter Benadryl, and an epipen

short of breath Narrative: patient complained of shortness of breath prior to getting covid vaccine, patient and wife stating it was his norm. After vaccine he complained of increasing shortness of breath, and hypoxic with bluish nail beds, lips, and greyish in color. Applied O2 via mask, and nail beds, lips, and facial color returned, sent patient to local ER for treatment and evaluation.

day after injection noticed approx 1/2 inch diameter hard lump at site oozing clear liquid. Has since almost disappeared but leaving small longitudinal scab.

Large lump on left arm at injection site. Redness and skin feels rough. Slight itch. Unsure if related, but have itcy skin under jaw in neck area for about a week.

Moderna COVID-19 Vaccine EUA; moderate fatigue, very mild fever, moderate sore arm centered on injection site, beginning about 18 hours post vaccination. Resolved spontaneously within a day and a half after onset of symptoms.

Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection

Fever and sore arm at shot site. Ibuprofen took care of the fever that day. No fever the next day. Sore arm with some swelling persisted for 2 days thereafter and subsided.

Pt developed a burning red rash on multiple parts of his body, feet, legs, back, arm, which was it extremely itchy and painful.

Upper left arm area where received vaccine broke out in a red itchy rash after a little over a week, lasted 3-4 days, red area about 2-3 inches in diameter.

Pruritis starting approx. 2 days ago (1/26/21). After showering this morning, spouse noted redness surrounding injection site. Spouse called RN, and RN observed red, warm, indurated area measuring 8 x 6.5 cm in a square shape surrounding vaccination site on L deltoid.

Large red circular area at injection site. Slight pain and feels slightly warm. Noticed on 1/27/2021 and was vaccinated on 1/13/2021 and no reaction at time. No temperature.

The patient's right arm is all bruise- It is purple in color. He cannot raise his arm beyond his shoulder.

Started at 8:30 pm on 1/28/21. Pain at the site of the shot. started mild grew to medium until about 03:30am on January 30, Woke up to a feeling of an entire body flush with the left arm hurting. I was afraid that this was the life ending adverse effect that I was hearing about. Took my temperature it was 98.5 degF. was able to get back to sleep. When I arose at 7:30am the pain in my left arm had diminished substantially.. Now I can only feel it if I push on the injection site.

Only mild tenderness at injection site first two days after first dose Moderna vaccination on Jan 20, 2021. No other side effects noticed and felt fine. 8 days later on Jan 28, developed a large elongated 4" by 2" itchy red rash at the injection site (upper left arm). As of today Jan 31, 3 days later, I still have the rash and so far not diminishing. Feel fine otherwise, no fever or pain, just annoying and unsightly rash.

Other than slight soreness at the injection site, I had no noticeable effects from the vaccine for the first 10 days. Yesterday (January 31st), I noticed for the first time a redness on my left arm surrounding the injection site. I had just bathed and the hot water may have made the redness more apparent. Today when I bathed I again noticed the red patch and took a photo of it, which I will share if requested. I am reporting this so that you can include this instance in your tracking of "Covid Arm", about which there has been some reporting in USA Today and other newspapers. Please notify me if you have any recommendations.

Shingles:I received my first Moderna vaccination shot at the on January 14th. I had no immediate bad reactions. However, a week ago I developed a rash on my right foot & lower leg. It got worse and so I visited with my dermatologist. He immediately diagnosed it as SHINGLES. The only reason I can think of that brought the attack on seems to be the vaccine?? I?m scheduled for the second booster shot on Feb 11th and quite frankly, I?m worried. Have other vaccinated folks complained about getting Shingles? Do you have information about getting the second shot and how that affects getting Shingles? Thanks for your assistance.

Moderna 025L20A Ten days after received the 1st Moderna vaccine this patient had a paretic rash on arms and legs. Around that same time the patient sprayed his home with pest control. Patient called his PCP and reported that they could not tell if the rash was from the bug spray or the Moderna vaccine. The patient's PCP advised him it would be fine for him to receive his second vaccine, but to take Zytec 10mg x1 the day of his second vaccine and to observed for 30 minutes after that vaccine was given. Patient did not have any problems immediately after the second moderna vaccine on 2/1/2021.

1/31/21 - Light Headed all day. Nausea at 7:00 pm. Slight temperature rise at 8:00 pm. Arm sore at vaccination site. 2/1/21 - Light headed all day til now. Arm sore at vaccination site.

Pain at shot site, chills, low blood pressure, rapid pulse. felling better now. went to doctor was diagnosed with atrial flutter. still gets out of breath and blood pressure jumps around.

Slight rash and itching at site of injection. This occurred exactly one week after inoculation and is now in second day.

7 days after injection, onset of maculopapular rash at vaccine site. At day 14, has continued to spread and upper arm w/ generalized erythema. No itching or pain.

Moderna COVID-19 Vaccine EUA Mildly itching rash on stomach, lower back, neck, a couple toes. Using cortisone cream on affected areas. Rash still exists 36 hours after first being noticed. Does not seem to be getting any worse.

Pt called office and an apt was made to see Dermatologist. Pt. c/o scattered , red plaques on his trunk , upper and lower extremities 3 mornings after his shot. Pt denied any itching

Within one minute of my injection l felt numbness surround my mouth. Three minutes later I felt flushed. I asked my wife if my face was red and she said, ?yes?. I felt somewhat weak and paramedic called the Dr over. We talked and he determined that I had not eaten. Walked me around car, put me in the passenger seat. My wife then drove. I was a little disoriented late but didn?t complain. Since then I have felt like I did in July 2019 when I had coronial virus. Felt bad, 93oxygen, 77 heart beat which is high for me. Friday I did not get out of bed nor went outside. Sat more of the SamE. Woke up at midnight sat and felt better. I?m better but weak.

About 4 hours after his vaccine, the injection site starting hurting, but not bad. He could not sleep on it at night as he felt like he was sleeping on a red hot pocker. On Saturday he was extremely tired in the afternoon. Had to come in from yard work as he could not function. He also had pain in his neck and shoulders. On Sunday he the feelings were going away, but his muscles started aching. On Monday he felt really strange, felt like he was in a fog, and his muscles ached. He could not get relaxed, did his normal Monday chores, laundry and house cleaning. He then tried to relax but his muscles and nerves were very tense. He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg. It was worse on the left side than the right arm. This went on every 10-15 minutes for about 3-4 hours. Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today. He hasn't had any more of the seizure type feelings in his arms or legs. He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.

weakness, clammy, low blood kpressure, treated with rest and hydration sudden wide spread red rash with severe itching on day 3 treated with steroid injection, Benadryl and steoid cream

muscle ache at injection site and fatigued and tired at the end of the 1st day and throughout the 2nd day. 3rd day i was fine

Sore and inflamed left arm and red rash. headache medium, fever 100.4 thru 100.8 for about 42 hours starting early Saturday morning after a Friday inoculation, and ending Sunday evening. Woke up Monday feeling well and no after-effects. Took some tylenol during the event.

Red itchy rash on both arms and both legs- used anti itch creams- rash erupted two days ago 11 days after second vaccination shot

On Thursday following shot. Legs of both legs became itchy. Felt like they were on fire. skin was still clear. . After applying a some steroid cream it settled dawn and I went to sleep. Next morning I awoke with spots on my legs, and over the last few days, there were deliniated spots everywhere on my body - front and back - with the exception of my face. I thought it was measle, though my temperature was nomal (no fever) . I've not been able to contact my doctor. The spots have becom less definite and delineated, have grown into one another.. In general they're not teribly itchy, but they're everywhere. I'll see my Doctor tomorrow. I have spent the days in bed, not feeling my usual self. I feel a little better today but the spts (rash are everywhere.

pt stated around midnight after getting the vax he had some GI issues, fever of 101, body aches, fatigue, felt like he had the flu. Said it hurt to touch the hair on his body. The left arm was sore around the injection site. After about 30 hours after his vax his symptoms subsided.

2nd shot 10th @ 1115 , 1st shot 1/13/2021 lymphedema, red, itchy, fatigue lump under arm that has moved to breast.

Yesterday, 2/17, I noticed a large (approx 5" circle) rash around my injection site. It is itchy, a bit firm, and a little swollen. I'm not certain as to when it started, just noticed it after a shower. No other symptoms.

Red, mildly swollen area, egg-sized and shaped, quite itchy, quite warm, on left arm at vaccination site.

redness at an angle 2 inches wide and 6 inches long and has increased in size since first noticed but about the same today. Maybe somewhat redder today

14 days after receiving the dose, pt had 3 boils on his face. Additionally at the location of his vaccination on his arm became red/pink. An area of 2" circle

Severe headache lasted three hours; pain in left arm where shot was given; body tiredness 12-hours. 36-hours later: chills, shaking, temperature 101-degrees - lasted 2.5 hours.

Nausea, vomiting, dizziness, distorted vision, sore arm, fever, injection site swelling, ambulatory deficiency. Admitted to Hospital

Extreme pain at the injection site and unable to lift my arm. Believe shot was not administered properly - into bursa sac and not the muscle

He got the vaccine, 2 days later patient stated that he had a full body red, itching rash. He went to the ER where they prescribed Famotadine, hydroxyzine and Prednisone for next 5 days. When the allergy clinic saw the patient on 2/16/21, the rash was already gone. He has subsequently recovered completely. He informed the allergy clinic that he tried to see his PCP but they referred him to the ER.

Head to toe hive like rash which started seven days after received first dose of the Moderna COVID-19 vaccination.The rash spread over entire body within twenty four hours

arm became really itchy around injection site; thought it be cellulitis; whole arm around injection site was swollen up like a balloon; whole arm around injection site was red; doses given 14 days apart; very nervous; became nauseas; ended up throwing up; very low fever 100F; just tired; This spontaneous report was received 10FEB2021 from a consumer which refers to a 78-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced nausea, vomiting, tired, itchy around injection site, arm swelling at injection site, arm red around injection site, first and second dose were given 14 days apart. The patient's medical history included current cancer, dermatomyositis (autoimmune disease), Concomitant medications included chemotherapy (Keytruda infusion). On 15JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: 039K20A). On 29JAN2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (Lot number: 028L20A). Doses were given 14 days apart, out of window 15 days early. The event(s) were, " injection site soreness, fever he became nauseas, "I never get nauseas", ended up throwing up, very low fever 100F, tired, the arm became really itchy around injection site, whole arm around injection site was swollen "up like a balloon" whole arm around injection site was red, first and second dose were given 14 days apart". The action taken for Moderna COVID-19 Vaccine was reported as taking Tylenol after the first vaccine injection for fever and Amoxicilin after second shot, 1x1000mg. The outcome of the events was reported as Resolved.; Reporter's Comments: This report refers to a 78 Y/O male with Inappropriate schedule of vaccine administered (second dose at 2 week interval) for mRNA-1273 (lot # unknown) with serious unexpected cellulitis 5 days after second dose and NS Vaccination site pruritus, vaccination site erythema, vaccination site swelling, fatigue, fever, nausea, vomiting. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Arm red, warm, and swollen from shoulder down to hand. Right side lymph nodes also enlarged. Some tightness, pain, and itching. Arm warm to touch. Today is 15 days after injection. Arm swelling has reduced every day, but still persists.

Itching rash initially around waist that spread to lower back and the entire body trunk. Cannot be completely sure that initial symptom did not exist before vaccination.

RASH DEVELOPED ABOUT 2 DAYS AFTER INJECTION, AND STARTED GROWING IN SIZE. THERE WAS NO PAIN OR ITCH, BUT SKIN WAS WARM TO THE TOUCH. WENT TO HOSPITAL AND WAS GIVEN CEPHALEXIN. AFTER 2 DOSES IT SEEMS THE RASH IS LESSENING AND FADING IN COLOR.

chills @ 24 hrs to 36 hrs; muscle pain @ 36 hrs to 72 hrs; redness of skin over muscle area @ 72 to present

Pt developed rash in several spots on his body started at his back , his arms then his legs, rash started 2 days after getting the moderna vaccine.

Moderna COVID-19 Vaccine EUA. Day 1 after injection: fever (100.4), constant headache, very sore at injection site, general fatigue and muscle soreness. Day 2: woke at 3:00 am, all symptoms gone except sore arm. Day 3: mild tenderness at injection site.

2/27 Saturday - vomit and severe body tremors, upper and lower body 2/28 Sunday - body tremors and unaware of situations around him for less than 1 minute 3/6 & 3/7 &3/8- welts and itchy rash over both arms and entire both legs Fatigue and no appetite

Vaccine administered in the dorsogluteal. 24 hours following administration developed red rash of the upper body. No pain or itching, no raised, blistered or textured areas. On day 5 following vaccination patient reports rash is unchanged.

LITTLE, ITCHY PIMPLE TYPE BUMPS ON ARMS AND LEGS. RECEIVED A CORTISOL SHOT THE NEXT DAY. TOOK ANOTHER 10 DAYS OR SO AFTER THAT FOR IT TO CLEAR UP.

day 1- Mild soreness Day 2 -more soreness-boneache Day 4-11- intestinal distress and high volume Day 10-14-Renewed soreness in shot area

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/9/2021 9:00 AM Expand AllCollapse All COVID VACCINE CLINIC 3/8/2021 Patient: Date: 3/8/2021 MRN: 9750775 Subjective Patient is a 78 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 30 minute waiting period after the injection, the patient began to experience itching. He denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and skin changes. PMH: idiopathic anaphylaxis in 1995. Hx of copd, a-fib (on eliquis) and hypothyroidism. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, dizziness and headaches Previous Reactions: none to vaccines. Unknown cause of his anaphylaxis in 1995. At that time he developed rash/hives and it progresses quickly. He's had itching off/on chronically. He doesn't think the itching today changed from baseline. His wife would like him to be checked out. Objective Vitals Vitals: 03/08/21 0338 03/08/21 1555 BP: (!) 133/93 Pulse: 93 73 SpO2: 99% 99% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash (visual exam of abdomen, chest, back and groin and upper extremities w/o evidence of rash/hives.). Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines benadryl Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Itching. Chronic vs new itching. He reports immediately upon getting back to the bay that he doesn't think it's anything but his chronic itching that he gets. He declines feeling like this is an allergic response like he's had in the past. Benadryl given as requested by pt's wife for comfort measures. This request was reasonable. Pt's wife will be driving. They both are aware of what to monitor for and when to call 911. Pt's exam is unremarkable. VS stable. Follow up with pcp otherwise. APRN Electronically Signed 3/8/2021 3:48 PM

Blistering rash to Left forearm 2 weeks after first vaccine-?Shingles. Redness and warm around vaccination site from second vaccine.

Difficulty breathing. Inhaling and exhaling. Two visits to the ER. Swelling arm, ankles, swollen arm , very red. Breathing treatment, inhaler, antibiotics. I have a Dr appointment Monday to see my primary. Still struggling to breathe

Dizziness blood pressure increased, shot injection area swelled and was red the size of an orange. Light headed, stomach cramps, overall fatigue, not able to sleep.

Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying. Really bad. The arm is swollen up like a balloon, black and blue from the injection. Took aspirin, and still having the chills and he can hardly move his arm.

I developed 2 large bruises on my left arm in the vicinity of the injection sites. They developed all of a sudden exactly 4 weeks after my second shot of the Moderna vaccine. I had no treatment and the bruises are beginning to dissipate.

Rash with blisters, spreading on right butt cheek, down the top part of the right leg, right groin. Painful, itchy. Prescribed Valtrex for 7 days

After vaccination that evening I started vomiting, the fatigue started the next day and it was mild. Day 6 or 7 in the middle of the night I had an itchy arm that woke me up,went back to sleep, woke up the next moring my arm was blown up like a balloon and I was worried about cellulitis, but this lasted about 4-5 days and I was back to normal.

Got the vaccine, went home and didn't have any problems. He woke up this morning to use the bathroom and his legs were aching. His wife came in and said that he was warm with a fever, and also has a headache, no energy. He has not taken anything for the symptoms. He has not notified his doctor. The arm where the vaccine was given is a little sore, but not too bad, just the achiness and fatigue.

38 days after second shot, rash appeared on right arm between wrist and elbow, also appeared on left hand and right hand. Rash was slightly bumpy bright red in center surrounded by lighter red, very itchy. Have never had adverse reaction to any medications no allergies. Never had hives

Moderna COVID-19 Vaccine EUA. DAY 0 (03/01/2021): REDNESS & TENDERNESS AT INJECTION SITE. INCREASING ACHE DISCOMFORT UPPER ARM. DAY 1: CONSTANT ACHE-TYPE PAIN, ENHANCED TENDERNESS UPPER LEFT ARM. UNABLE TO RAISE ELBOW ABOVE HORIZONTAL WITHOUT EXPERIENCING INTENSE ACHE/SORENESS-TYPE PAIN. UPPER ARM FELT AS IF PATIENT HAD RECEIVED A SERIOUS NUCKLE-PUNCH ADJACENT TO BICEPS. REDNESS AT INJECTION SITE. NO SLEEP-TIME INTERRUPTION. UNABLE TO LAY ON LEFT SIDE WITHOUT SERIOUS ARM DISCOMFORT. DAY 2: DIMINISHED CONSTANT ACHE-TYPE PAIN & TENDERNESS AT INJECTION SITE. ABLE TO RAISE LEFT ARM ABOVE HORIZONTAL WITH MILD DISCOMFORT. ABLE TO LAY ON LEFT SIDE WITH MILD CONSTANT ACHE IN ARM. SEE CONTINUATION PAGE.

3 days after receiving the injection, patient woke up with severe bruising on both arms, particularly behind his elbows. VERY LARGE bruised areas when injury or trauma had not occured as if his blood vessels are leaking.

Very little after Dose #1. The day after Dose#2: achiness (back, chest, head and of course the injected arm). These are NOT severe enough to seek help immediately. However, patients ought to be aware of the potential.

Eight days after the vaccine I got a rash and swelling and redness and itching in my arm around the vaccine site. I t was my whole upper arm from shoulder to elbow and it looked like cellulitis. There was no pain, so my doctor prescribed Benadryl and it went down after 48 hours. On the second dose I had a low-grade fever for 24 hours.

Fax no. is unknown by me. Vaccinated Ap 1, 2021, noon. The following morning, 6am, I awoke to find pigment changes on the tops of both hands and less on the fingers. Blotchy, light coffee brown in appearance. (I'm a male, old skin, some blemishes, nothing like this). Also, on the right, lower areas of my left forearm. Some of the darkness of the coloring has dissipated overt he past 3 days, but not much. If I didn't know better, I would think a painter, using a cheap sprayer had painted me with brown stai I ave no other things . feel fine.

Large rash developed a couple of days after injection. It was below the injection site and itched considerably. I thought it might be related to my eczema so I treated it with Triamcinolone Acetonide. Rash and itching went away after 2-3 days.

"On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-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 Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved. Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.

INITIALLY ITCHING RASH ON BACK AND SCALP. SUBSEQUENTLY ALSO APPEARED ON TORSO, STOMACH, ARMS, THIGHS..

Rash with red lumps. First appeared on arms! Then included back , the a few days later, upper chest. Lumps were very itchy. Put anti itch ointment on rash areas. Condition did not improve. Sought medical help. Dr. Prescribed Prednesone and Claritin generic pills. Itching de teased significantly. Rash and bumps are still visible, but appears to be healing. Course of medication is continuing. Itching has mostly subsided.

Within 24 hours of vaccination, he had chills, HA, malaise and increased dyspnea a feeling of dyspnea that began soon after the vaccination. All symptoms resolved within a few days except the dyspnea. It is improving now 6 weeks post vaccine, but not yet back to his baseline. The red rash was a fairly classical "Covid arm". It is resolving, but the left arm is still overall a littler redder than the right.

First Night, High Fever had to take PJs off to get cool, Next day, Cold,very Cold.Arm ached, had red colot going from injection towards elbow on outside for 6 inches. about 1-12 inch wide. Tired and slept except to get up for bathroom, eat a little, go to bathroom. Kidneys hurt, could feel pulse in Kidneys. Was weak. Back and legs ached. Legs felt almost numb. Hard time walking from back pain and had to sit ina chair for about 30 minutes to get relief from kidney pain. This continued until the 9th @ noon. Arm stopped aching then. Kidneys still hurt. Back strain started getting better. Bak and kidneys still hurt hen I first get out of bed. Have to sit in chair till it goe away. If the Kidney pain continues, I will se

23 hours after receiving dose, Hives developed and by Noon I was experiencing heavy chills. Began taking Benadryl 4x/day and HydroCortison 1/2% cream. Stayed warm

pt says a couple of weeks after taking the vax he has a significant amount of hair loss. he said he would be covered with his hair. he finds the hair in his hairbrush. he asked his PCP and Oncologist about this since he thought steroids could be the cause of this but he was told no. Pt says he thinks this is because of the vax. He thinks it is getting better now since he no longer is getting the big clumps of hair coming out. Pt got his second dose on 2/25/2021 in the left arm.

It was just a few small red blotches; A rash started on my front torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH MACULAR (It was just a few small red blotches) (seriousness criterion medically significant) and RASH (A rash started on my front torso) (seriousness criterion medically significant). At the time of the report, RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) outcome was unknown. Patient received treatment cortisone cream. No concomitant medication was reported. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-068590 (E2B Linked Report).; Sender's Comments: MOD-2021-068590:2nd dose of vaccine

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROSTOMY (nephrostomy bleeding) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urostomy, Nephrostomy and Colostomy. Concurrent medical conditions included Lymphoma (stage 4 lymphoma cancer), Renal failure (stage 4 renal failure) and Neuropathy NOS (chemo related neuropathy). On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), FATIGUE (fatigue) and CHILLS (he had chills). On 27-Apr-2021, the patient experienced NEPHROSTOMY (nephrostomy bleeding) (seriousness criterion hospitalization prolonged) and DEHYDRATION (he was dehydrated). On an unknown date, the patient experienced MYALGIA (hurting all over). The patient was hospitalized on 28-Apr-2021 due to NEPHROSTOMY. At the time of the report, NEPHROSTOMY (nephrostomy bleeding), DEHYDRATION (he was dehydrated), PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), MYALGIA (hurting all over), FATIGUE (fatigue) and CHILLS (he had chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. After the patient got the vaccine, he was very fatigue for a few days. He had a lot of arm pain. The doctors noticed that he got rash on both of his forearms. He complained of headaches and it was hurting all over. He was very weak and had chills. He had labored breathing. His nephrostomy was bleeding a lot in the tubes so they had to hospitalize him. He went to hospital on 27-Apr-2021 and was currently in the hospital. He had blood transfusions and he was very dehydrated. He was put on IV saline. He took Eliquis but doctors wanted to stop it because his kidneys were not in good shape. Company comment: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.

Redness, bruising, rash and skin dryness and burning sensation on both full arms and lesser so on legs and lower back recurring since vaccination

shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Heart disease, unspecified since 1994. Concomitant products included RIVAROXABAN (XARELTO), VALSARTAN, SOTALOL and ROSUVASTATIN for an unknown indication. On 26-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion hospitalization). The patient was hospitalized from 03-Feb-2021 to 04-Feb-2021 due to HERPES ZOSTER. On 01-Apr-2021, HERPES ZOSTER (shingles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment also included Acyclovir. The patient described the adverse event as "a rash with blisters, very itchy and painful". The patient received their second dose of mRNA-1273 (Moderna COVID-19 Vaccine; batch no. unknown) (Intramuscular) 1 dosage form on 04-Mar-2021 at 1:00 PM, and no adverse events were reported at the time of the report. Company Comment : This case concerns a 78-year-old male with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Case upgraded via VAERs form received which listed hospitalization for event; Patient race, history, Suspect drug dosage details, concomitant drugs details; Sender's Comments: This case concerns a 78-year-old male hospitalized with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient's entire upper right arm became bruised 1 week after receiving the vaccine. Patient did not have any pain or itchiness.

Within minutes of receiving vaccine, there was an emergent swelling black and blue spot on his right hand, followed by black and blue marks on both his hands and arms.. As he was waiting the 15 minutes after receiving the vaccine, he saw this swelling .The black and blue areas lasted for over 2 weeks. No pain, just the discoloration.

Sudden onset of severe pain in the left mid-thigh, medial area. Felt like knife wounds. Each episode, lasted several minutes and was partially relieved by deep massage of the area. No abnormalities were palpated in this area. This repeated, several times, over the next month, in the exact same area and then disappeared. One month later, this exact same thing, happened on the medial part of my right mid-thigh. It responded to the same treatment and lasted for the same duration. This right side pain returned several times over the course of the month, then disappeared. So far, those have been the only episodes. More recently, (05/10/21), a small, firm bump appeared on my left forearm - that was very sensitive to lightest touch and was itchy but not painful. Thankfully, this has not grown and is less sensitive.

Patient developed a rash that progressed. Patient was seen by his doctor 1 day and 4 days post vaccination and it was determined that the reaction was significant enough that he should not receive a second dose of the vaccine.

Patient came in for 2nd dose and mentioned a rash showed up on arm approximately 7 days after immunization and resolved on its own. Rash was about 1 inch from the injection site.

rash and constant itch. After three visits to Dermatologist, two biopsy's amd various cream ointments, and oral medicine, I still have the constant itch.

Patient has a red sore arm and loss of appetite still on 7/14/21 since the date of vaccinations. Patient was vomiting on 7/10/21 but has stopped

Reports he had muscle tenderness, swelling and redness after shot was given. Reports he still has muscle soreness and some limitation of movement if he moves his arm a certain way

After patient received Covid-19 Vaccine (EUA) patient was fine. Patient called pharmacy on morning of 7/23/2021 stating that a whole body rash had developed during the day of 7/22. After inquiry patient stated that no other things had changed and only cause could be the vaccine. Patient was advised to seek medical device if symptoms did not subside in next 24 to 36 hours or if they got worse.

Four months after the second injection I was awakened after midnight by a painful red rash from my neck to my feet that burned and itched for about 2 hours. I put a wet towel on my chest and neck, but it did not stop the pain and the redness. I began rubbing my body from my neck down to my waist. After about 20 minutes the pain and redness began to disappear very slowly. I then began to rub my chest and legs for another 20 to 45 minutes and the pain and redness begin to be releaved. Last night (7/23/2021) I awoke at 1:30 AM with a painful red rash on both legs that itched like mosquito bites. The rash was primarily on the inside of both legs and down to my feet. I started using Cortizone 10 (it did not help), then I switched to Triamcincolone Acetonide Cream USP, 0.1% (that did not help) and then Halonate .005% (that did not help). It took almost an hour of rubbing my legs before the itching and burning subsided.

Soreness at injection site for first 4 days, then the soreness returns on 7th day with intense itching and pink hard slightly raised area expands in circumference over next few days from 1 1/4 inch to 2 1/4 inch and continues. No fever.

7 days after the first shot the injection site became very itchy and has continued .no treatment was given and the site did not appear to be red or swollen.

Rash on his chest, back, arms, and the bends of his legs, and his head. It is itching and painful, it has not gotten worse but it is about the same.

rash on abdomen, back, arms, back of legs and in his head. Says it has not gotten worse that it is about the same and itches and is painful

3 inch diameter rash. It never showed up until 2 full weeks after the shot. Located where the shot was given

Bad rash over entire torso, some on the arms and legs. Itchy and painful. Very red. Day 3 and still major.

Rash around vaccination site & larger rash about 3 inches from vaccination site. Very red & hot to the touch.

Reports redness on the left cheek few minutes after the vaccine. Denies chest pain, SOB, itching, blurred vision. BP: 121/75 HR: 81 Sp02: 100% T: 97.3 seen and cleared by EMS

Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.

After monitoring time was complete, client stood from sitting position and fell forward and sustained ecchymosis to forehead and nose. He became less alert with delayed response to verbal commands. VS measured; BP 78/50, Pulse 65, O2 Sat 96% Room Air, R 16. He became clammy with repeat of BP 161/60, Pulse 63, O2 Sat 91% Room Air. EMT summoned and client transferred to ER for further assessment and treatment. Call to local hospital confirmed ER visit and release same day.

Exactly two (2) weeks after injection, injection site became painful and a mild rash, approximately 3X4 inches, developed directly under the injection mark. Persisted2-3 days

Injection was ginve aroound 1:00 Pm on 1/23/21. Injection site redness was iInitally a small circle with strong soreness for about 3 days. There was firmness under the skin at the injection site also. On or about 1/31 in the am, I noticed the redness was getting larger and has expanced to a oblong area about 6-7 inches in length. The area is not real sore but is somewhat hot. Spke with my primary care today and she has prescribed me to take Benedryal and use cold compress on the area for now. If now better in 2 to 3 days.to go back and see her. I am scheduled for my 2nd shot on 2/20/21.

Patient was given Covid-19 (Moderna) at 2300. We are the reporting facility. Pt did not receive vaccine by us or at our office. Patient was seen by our office after receiving the vaccine for Physical Exam. Pt was given the vaccine on 01/18/2021. He was seen in our office on 02/02/2021 and still had evidence of severe reaction. At this time he had 3 quarter size ulcerations, no drainage and minimal tenderness. Pt's first sign of reaction was on 01/23/2021. He had fluid filled blister about the size of an adult hand on his right upper arm at the site of injection. He was seen at the Urgent Care on 01/24/2021 when he first noticed vaccine reaction. Pt was treated with Bactroban 2% ointment and Triamcinolone 0.5% ointment.

Patient called the office and stated that where the vaccine was given his arm is starting to turn red, swelling, itchy, and the redness is moving down his arm. Patient came to the office and was seen BY Dr. and she is treating the Cellulitis with Ibuprofen/Tylenol, ice, Benadryl and hydrocortisone cream.

Patients wife, noticed a red and slightly swollen, slightly warm spot on Patients right arm this morning around 9am. located in the spot where he received his shot. He did not complain of discomfort. He did not not complain of being tired. We do not know when it first appeared. It was not there the first few days, then we quit checking. As of now, 5pm, it seems less red than earlier today.

Moderna COVID-19 Vaccine EUA. 02/04/2021: Patient called to report adverse side effects following receipt of Moderna COVID-19 vaccine on February 3, 2021, 9:05 AM. 02/03/2021, 1 hour after vaccine, patient stated left arm pain at site of injection. 02/04/2021: patient had worsening Left arm pain, vaccination site redness, inflammation, and skin warm to touch at vaccination site. Patient notified health department approximately 3 PM. Nurse provided assessment questions via phone. In addition to previous stated symptoms: client stated slight numbness and tingling at site of injection (denied radiation down arm and to fingers), and rated pain ?4 or 5? (according to 1-10 pain scale). He was advised to: use cool compress 10-15 minutes per hour (vaccination site on the arm), contact his PCP to determine for evaluation, and determine if able to take ibuprofen or acetaminophen. 02/05/2021: Patient notified by health department nurse (9:00 AM) for cont. evaluation: identical evaluation as provided on 02/04/2021. Client stated he had contacted PCP office this AM and spoke with receptionist/nurse. He stated he was waiting for return call. 02/05/2021 (2 PM). Client again contacted byRN. Client had message to NP and had not received return call. RN explained, from evaluation, arm soreness was localized. RN stated that RN would notify client on 02/06/2021 to review symptoms. It was explained to client that if there was an increase in pain severity, swelling, redness, or transmission of tingling or numbness extending to fingers that he should go to the nearest Emergency Dept. for evaluation. Client verbalized his understanding.

I received my first vaccination yesterday in my car, a 1999 Miata. If you would allow folks to exit very low cars, it would let us avoid a virtually straight down shot angle. My injection was in the very top of the bicep muscle and it is still quite swollen.

I had Moderna COVID-19 Vaccine on Wednesday February 3 at 11:30 AM . After the vaccine I went home and had virtually no pain. Around 10PM that night I felt some pain in the toes on my left foot. When I looked, I noticed that my toes were red and appeared slightly swollen. My big toe was the worst. It was sensitive to the touch and very red. I also felt a short intermittent sharp pain that would last a second or two. It would happen every 3-4 minutes. The next day the redness was gone on all but my big toe. As I write this today Saturday February 6 at at 11 AM. My big toe is still sore, but does appear a bit better. I have had gout once in the past. So, gout or Covid ? The people at were great.

Developed a minor red itchy rash within inches of the injection site. After 2 days applied 1% hydrocortisone to the affected area 3 times a day. Today, 02/08 2021, the itching and redness have substantially declined to the point that I have discontinued the hydrocortisone treatment.

pt states after getting vax on 2/6/2021 he got and itchy feeling around injection site. On 2/7/2021 the pt noticed a 3x3 red, swollen area around injection site and hot to the touch. Pt also had a tender spot under his right eye. Pt states he does not have a temp. Pt has not contacted his PCP yet but will if his symptoms do not subside.

When I got the shot, It was painful but everything was fine. I was fatigued that evening and then when I went to bed I slept excessively. On a scale of 1-10 I was experiencing a 4 in pain. I took Extra Strength Tylenol and am still having pain. I feel tired.

3 days after I got the first COVID-19 Vaccine shot, I started to have itching in the area plus area is a little swollen.

Intense itching of hands and randomly on other parts of body. Red rashes. Occurred only at night and disappeared in the morning.

Large red rash on upper left arm appearing two weeks after vaccine administered No itching but painful.

Large area of rash on arm where COVID vaccination was given. Also some rash on both arms between elbows a d wrists

maculopapular rash started after January 14th vaccine progressed became widespread after February 11th vaccine. Itchy uncomfortable but no dyspnea Fever or mucosal lesions. Predominantly trunk proximal arms and legs. No genitalia or mucosal surfaces involved. office visit February 16th. Oral antihistamines topical steroid cream prescribed.

day after vaccine was administered to this Long Term Care resident, his arm was noted to have a rash over 22cm X 16cm area at the injection site. It became red, warm and painful. The redness and rash lasted approximately 4 days. Provider was consulted for evaluation.

swelling;redness; rash; infection: Treated by Family Doctor. antibiotic Doxycycline, Allegra,Prednisone. Condition cleared the following day after meds.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe

Client has developed a whole body rash/ hives (ankles to face) starting 2-18-202He still has the hives (2-22-2021)

HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. . COULD NOT RAISE EITHER ARMS AND STATED THAT THE "BALL JOINTS" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS. BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21

Extreme itching and red areas on torso. Stopped in 48 hours. Then 8 days after shot, flashes of nerve pain in left upper arm (like electric shock). Then 10 days after shot, this flash of "electric" pain has occurred across the top of left foot.

Client reported reaction to 1st Covid vaccine during 2nd dose of vaccine. Client reported he woke up at 2:20 am 2 days after receiving first Covid 19 vaccine with itching on head, Rt lateral side of torso and lateral Rt leg. Reports of rash and itching on head lasted 1 week and rash and itching on Rt lateral torso and Rt lateral leg lasted 2 weeks. Client stated he saw the doctor the week of 1/23/21. took oral Benadryl and topical anti itch cream for rash and itching. Client reports he was told it was ok to have 2nd vaccine.

started Saturday on his calf and up his knees to his thighs in the morning and by the afternoon it got redder and skin started to get hot but the night it went to his arms and wrist and shoulder and back and up to the neck. then on Sunday he was getting blotches on his legs on the front and the back. his skin was getting puffed up around the blotches and then it started to spread to his feet. Monday saw the doctor was told its a Induced eruption rash- full body. was given steroids- methylprednisolone 4 mg DOSPK prescription is a 6 tablet 1st day and decrease tablet each day for 6 days. The itch currently is at a low level and Dr. Did advise not to get the 2nd dose.

PT PRESENTED TO EMERGENCY ROOM WITH NOTED RASH THAT CAN BE DESCRIBED AS MACULAR, PAPULAR, URTICCARIAL LOCATED ON THE BODY DIFFUSELY. THERE IS ALSO SWELLING, THAT IS MILD, OF THE RIGHT EYE AND LEFT EYE, MINIMAL SWELLING TO BOTH LIPS. PT STATES THE SYMPTOMS BEGAN 2 DAYS AGO AND HE RECENTLY RECEIVED HIS FIRST COVID-19 VACCINE 6 DAYS AGO. PATIENT DISCHARGED WITH THE FOLLOWING PRESCRIPTIONS: PEPCID 20 MG, 1 TABLET ORAL EVERY 12 HOURS FOR 5 DAYS. PREDNISONE 20 MG ORAL TABLET, 2 TABLETS ONCE DAILY FOR 5 DAYS. VISTARIL 50 MG ORAL CAPSULE, TAKE 2 CAPSULES 4 TIMES PER DAY AS NEEDED FOR ITCHING. PT ADVISED TO FOLLOW-UP WITH HIS PCP IN 3-4 DAYS FOR RECHECK OF TODAY'S COMPLAINTS, DO NOT DRIVE WHILE TAKING MEDICATIONS THAT MAY IMPAIR HIM, AND TO RETURN TO THE EMERGENCY ROOM IF SYMPTOMS WORSEN OR PERSIST OR IF THERE ARE ANY QUESTIONS OR CONCERNS THAT ARISE AT HOME.

Nine days after injection a round red flat slightly itchy lesion about 3 in in diameter developed below the site of the injection called "Covid Arm"

The day after my second injection I developed a non itchy rash on my chest and arms. I also had fever and chills the first two days and fatigue.

Patient experienced generalized weakness and inability to ambulate. He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2. He presented with a rash at site of vaccination on left arm over deltoid muscle. He had a red petechial rash on anterior chest and upper abdominal wall.

1st dose recd 1/6 and broke out on foot it looked like small cuts but the capillaries and it spread to the let then to the opposite foot and leg. 3 days later a big rash broke out on shoulders and back of hands. 2nd dose, the same thing happened but it had a mark where it stopped then jumped to the arms and to the back which felt like my nerves in my body was being attacked by fire ants. They did a biopsy on the area on right leg and I feel like ants are crawling all over me and biting. on my back there's no redness but it feels like ants biting and itching. the doctor's stated there's no bacterial or fungal infection. This attack is from the knee down both arms and back only and the doctor had no other treatment for it other than cortisone cream and nothing seems to stop it.

Moderna Dose #1: The only adverse event was a mild ache in my arm at the injection site. Moderna Dose #2: About 7 hours post-injection I experienced a temperature (101 F peak) and mild chills, a short-term mild headache, mild muscle /joint aches, and an ache at the injection site. These effects lasted for about 36 hours and then were gone. I would compare them to a mild 2-day case of the flu.

Red spots with what looks almost like scab in center Started about a week after 2nd injection, itched for several days...Now just there, but no itching

Sore left arm Red raised rash about 2" by 4" inches appeared on the 11th day at site of injection for about 30 hours

profuse sweating less than 2 hours after receiving the shot. swelling and tenderness at shot site 12 hours or so later continuing to 3/2/2021

"COVID Arm": 2/19/2021 had swelling & itching at injection site. 2/21/2021 injection site became red. Given hydrocortisone cream for itching. APRN advised it was ok for patient to receive second dose.

Rash occured 2 days after injection from the injection site to the elbow. Site was red and itched. Patient went to the ER and was given Benadryl and an antibiotic. Patient states rash cleared within 8 days.

79 year old male here for evaluation of possible allergic reaction to Moderna COVID-19 vaccine. 1.Allergic reaction, Urticaria Pt received hist first dose of the Moderna vaccine on Tuesday, March 9th at 11am in his left arm. On Wednesday he began experiencing chills, felt cold and developed a fever of 101.9. Today his symptoms from yesterday resolved however he developed a pruritic urticarial rash on his upper thighs bilaterally, upper arms bilaterally, lower back and abdomen. He took one tablet of Benadryl this morning which did not improve his symptoms. He is not experiencing any shortness of breath, cough, sore throat, difficulty swallowing or wheezing. He has not tried applying any topical creams or ointments. No new medications, laundry detergents, body wash, perfumes or bedding. No history of allergies to food, environment or medications. He has a history of COVID-19 and was hospitalized 2nd to COVID-19 pneumonia for 25 days in 12/2020. - Take OTC Claritin during the day and OTC Benadryl at night for one week - Take 20 mg Pepcid once daily - Start medrol pack - Increase fluid intake - Apply moderate strength triamcinolone ointment to rash - Labs drawn today will call with results - Will report allergic reaction to public health department - VAERS - Reviewed previous labs, HGB low - ER/red flag precautions given. Followed up with patient today 3/12/2020 over the phone: Called pt to follow up. He reports the rash worsening this morning and spreading behind his knees, behind his thighs and behind his calves mostly on his left leg. He applied the steroid cream this morning and he reports the rash greatly improved afterward reducing to about 10-15% remaining. States his rash is almost gone. Patient has been taking all of his medications as prescribed: Medrol dose pack, steroid cream, Claritin, Benadryl, Pepcid. Advised pt to continue to finish full course of medications as prescribed. PT denies any wheezing, cough, SOB. Advised pt that if symptoms worsen or do not improve over the weekend to go to urgent care or ER if life threatening. Red flag signs and symptoms provided. Pt verbalized understanding.

Itching at injection site started about nine days afer second dose. No noticeable itching after first dose (012M20A) administered at local facility, site on Feb 3, 2021. Slight redness of about 1 sq. in at injection site and also similar redness about 2 inches away.

Patient reports continued pain at L shoulder joint after receiving first Moderna vaccine. This was reported when coming to receive his second dose from writer today. pain started resolving 1-2 days ago in the L shoulder and pt believes it is slowly getting better.

Itching, redness at injection site starting to appear 10 days after vaccination. 1 day later still itching, redness, and some swelling, hard to touch. 2 days later (2 days after initiation of symptoms), significant swelling around injection site, hard to touch, redness, still itching.

2.5 weeks after shot and first time experiencing tenderness at site of injection. No reaction to first shot or until now from second shot. Seems odd?

First day itchy rash appeared on medial side of right bicep Second day itchy rash appeared on top of right bicep Third day itchy rash appeared on lateral side of right bicep

Swelling and erythema of the right forearm after second COVID-19 vaccine along with shoulder pain. Symptoms started on 3/14/21.Pt was admitted to the OBS Unit and subsequently diagnosed with Right Upper Extremity Cellulitis.Tx in hospital was Rocephin IV for failed po Keflex tx. and subsequently discharged home on Doxycycline 100mg po BID x10 days .Pt. was also in the ED on 3/17/21 for same c/o and discharged on po Keflex.

Slightly feverish & tired. Second day left foot turned bright red, very warm & itchy. Gone by next morning. No other issues.

rash from the elbows to the wrists in both arms; Moderna arm; a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021. This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH (rash from the elbows to the wrists in both arms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported. ). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash from the elbows to the wrists in both arms) (seriousness criterion medically significant), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching). At the time of the report, RASH (rash from the elbows to the wrists in both arms), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling. Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

He received the 2nd dose of the Moderna shot on 3/10/21. Within the following week he developed an itchy, painful maculopapular rash of both forearms. Patient continued to have the symptoms on 4/2/21--despite trying aveeno lotion and benadryl--at which time at his clinic visit he was prescribed triamcinolone cream for his arms.

About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.

Severe Pain in left arm fro injection site down the forearm. Severe Pain radiating through the left chest and the left shoulder blade. Inability to sleep unable to find a comfortable position for my arm due to tingling, numbness and lack of ability to use my arm in greater than 70 % movement.

Patient has bruised area on inside of left arm opposite of the injection site. Patient also has rash at the injection site.

High fever for 2 days followed by chills and profuse sweating. Severe case of Shingles developed after 9 days.

The first Moderna was given to me in the left arm and not affect. The second was given to me on 03/27/2021 and after it my arm ached in the area of the immunization for only the first day.

I have a sore left arm in area of where the shot was taken. Arm accidentally bumped which made the soreness apparent on 5/4. On 5/5 still very sore. I cannot raise my arm past shoulder height.

Patient got first dose Moderna on 04/29/2021. On 05/21/21, he came to pharmacy to pick up refills. He mentioned to pharmacist that he still got rash and blood on the injection site since the day of injection. The size of the rash was like a penny with redness and a small dark spot in the middle probably a small scab there, He said there was blood there before. No fever no pain. Pharmacist told him to consult his primary care doctor and put ice over the area in the meantime.

Classical pityriasis rose onsite with about 3 herald patches, slowly evolving rash on dorsal & ventral torso

Pt came in with wife to the pharmacy to pick up some prescriptions and wanted to show his arm that is still swollen from the vaccine that given back on 05/12/21. When I saw it, the injections site was elevated, red, and looked infected. I told the pt it is possible it got infected and he should get checked out by the dr. His wife said she will take care of getting him checked out by his dr.

11X6 cm mildly erythematous, slightly raised, warm ovoid lesion. Became apparent 6 days after vaccination, has been unchanged for past 2 days.

VS: 113/62-57-97.9-99%RA. Resident called clinic reporting rash to arm and body. No s/sx of distress noted. Remains alert and oriented to person, place, time, and situation. Speech clear and coherent, able to follow instructions appropriately. Resident denies SOB or difficulty breathing. Breathing even and non-labored. SpO2: 99%RA. Noted rash to left upper arm and bilateral sides of upper body from the waist to chest. No rash noted to anterior chest. No swelling or elevation of rash noted. Denies pain to LUA. Able to perform full ROM. Resident stated he has allergies to bee stings, statins, and contrast dyes. Denies hx of anaphylactic shock. He reported he received his vaccine at 1330. Denied any ASE within 15 min after receiving vaccine.

Rash on both arms, chest, sides, stomach and back. Also just a bit on both legs. Rash began 3 days after vaccine and has not abated.

3? round red hive at injection site ,hard X 2days. Itching on lower arm day after then stopped by end of day

considerable itching, formation of one hive (2" x 1" x 1/4 ") located 4" below injection site. Hive went away after 2 days. Itching continued for 3 days. Injection site very hot for 3 days. Blood glucose elevated two days. No treatment, just observation., Epinephrine on hand in case of greater reaction.

redness, swelling and itching beginning at shoulder and extending downward past elbow first noticed on 1/19/2021 and worsening on 1/20/21. no reaction noted at injection site.

As a 1a health provider I received my vaccination a weekend half ago resulting in dizziness, difficult mentation eg, administering my clinic, headache, a firey, red, rash over 90% of my upper body and 30% of my lower body, joint pain and muscle ache, worsening So far all the medical help I have received advices cortisone for the itch but I am really trying to understand what I need for my immune system and should I, or should I not get the 2nd dose

Received letter from client stating that when he received his vaccine the vaccinator stated as he pulled the needle out...something to the effect: I may have inserted the needle too deep. States it felt to me at the time that it was a deep penetration. We waited 15 minutes and was dismissed, arm was not hurting. 1/9/2021noticed upper right arm had a mixed red, yellow and black discoloration from bicep to elbow. There was a large elevated knot on top of biceps. 1/10 discoloration lessened but the large discolored now on bicep remained. 1/11/21 more discoloration lessened but large elevated knot still remains on bicep - swelling, discoloration and hardness. Made appointment with Dr. and his

Received the vaccine 1/19/21. On 1/20/21, states hurt all over - generalized aches and pains, nausea, diarrhea. Did not get out of bed all day. Denies any chills. Subsided over the next 2 days and was gone by Friday. All s/s gone by Saturday. Also c/o arm soreness at injection site for the same time frame.

Racing heart rate >100 woke him up out of a sound sleep around 10pm on day of vaccine. (Vaccine was given approx 1:40pm) lasted about 30 minutes then it calmed down to more normal heart rate. Next morning bad headache 5-10am. Took Tylenol for it. Also, pain at injection site, across shoulder and lower neck for approx 24 hours after shot.

Patient never tested for covid-19 prior to vaccination. Symptoms of stuffed and running nose and small rash may be related to covid-19, cold or flu, or the vaccine. What affect the vaccination will have, if any, on the patient's condition is unknown.

Right after the injection had warmth around injection site. Around 12:00 on 1/27/21, he looked wilted. Wife checked his temp and it was 103.8. Was given Tylenol and temp went up to 104. She called the doctor at 2:00 PM, told her to see the doctor. Lethargy and weakness. Tested him for COVID and flu and still had fever. Was negative for both, told to alternate Tylenol and Ibuprofen, went down to 102. At 6:30 PM went up to 103.8, at that point she called the doctor, could not speak to him until 6:45 PM instructed to bath down with warm rag, and was told it was probably a reaction to the vaccine. Was called in a steroid pack. He went to bed running about 103.6 at 8:30 PM. Was able to get up, was given more Tylenol/Ibuprofen and his fever finally broke around 101 about 4:00 AM. Got up this morning and does feel better. Running around 100-101 temp. The vaccine is the only thing that has been different in his normal routine. Still has warmth to the injection site, red.

Very itchy rash at injection site. Showed up 6 days after vaccine was administered. Somewhat improved three days later.

Slight redness and itching. Could be from the bandaid. Reacted to a bandaid last year after a reg flu shot.

Approximately 30-45 minutes after receiving vaccination, hands started to itch. The itchiness built to a level of extreme itchiness then eventually went away. The total reaction lasted approximately 20 minutes.

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

Oval reddened area approximately 8 inches around injection site on upper outer arm. Redness was first noticed 10 days after vaccine. No pain. No itching.

Approximately 11 days after the vaccination, I began to break out with a skin problem, which became quite pronounced. After visiting a dermatology office, I learned that I had psoriais. I had previously phoned the County COVID hot line number to ask if the vaccination could cause a skin problem as it takes hold several days after the injection. They were unaware of any history of this type. Likewise the dermatologist was unaware of any such history, but said that it was a possibility. In fact, it could simply be a coincidence in timing. However, I wanted to bring it to someone's attention. (Note: I currently intend to proceed with the 2nd shot in a couple weeks unless advised otherwise.) I do so simply because I read on the web this morning that high activation of the immune system can cause psoriasis.

Arm a little sore at site but nothing out of the ordinary, then about 3 days later increased soreness and redness. As of this date, pain somewhat improved but redness is about 5-6 inches. Looks like an "ink spill". Denies accompanying fever, swelling, or chills. Denies ever having any adverse reaction following a vaccination other than mildly sore arm. Reporter recommended consultation with his PCP to assess arm as well as advise on whether to receive 2nd COVID vaccine.

extremely dizzy when first got out of bed. Difficult to walk. Mostly abated in a few minutes. Very sore at location of shot

Pt presented to ED 1/25/2021 with 1 week history of bilateral shoulder pain, started on right, left involved later, wore with movement. NKI. He was given IM ketorolac 30 mg and seen in Clinic by chiropractor with some relief 1 day. PT consult placed and is still pending. Known hx osteoarthritis right shoulder by x-ray 12/10/20 Pt returned to urgent care/walk-in clinic 2/8 with worsening bilateral shoulder pain. ROM of both shoulders quite limited. NKI. Treated for PMR.

Two weeks after the vaccine he got up and had a nickel sized blister on his arm between the shoulder and elbow, below the injection site. He pressed on it and it burst open and water came out of it. The skin then dried up and came off, and left a dime sized sore place under that blister and is still there on Monday 2/8/21 and has not gone away. It has not scabbed up. He did not take anything for it.

Swelling and redness at site, nightmares several nights, fatigues, had labs done today and has appointment with MD 2/11.

Narrative: Veteran reports fatigue + injection site pain. Both resolved after 2 days Other relevant Hx: Symptoms: & fatigue at injection site pain Treatment:

ABOUT FEBRUARY 6 A RATHER LARGE, OBLONG PINK AREA APPEARED ON MY LEFT ARM AROUND THE VACCINATION SITE. THE AREA APPEARS TO SLOWLY GROW, SINCE I NOTICED IT ON FEBRUARY 6. THERE HAS BEEN SOME ITCHING AND SLIGHT DISCOMFORT.

Patient with symptoms of burning and tingling initially lasting 1-2 minutes 2-3 times per day about 4-5 days after first vaccination. On 2/11, concern for increase in symptoms - episode of 5 minutes of itching - spreading down arms and into stomach.

Some swelling of my arm near the injection site and a bright rash on my skin of about 40 mm x 50 mm with slight itch was first noticed February 4th. Over the course of the next week the spot got bigger, about 65 mm x 100 mm, but began to fade away. By February 12 it seems everything was back to normal. I did not seek treatment because of the many articles I saw about "Covid Arm".

Swelling in shot area. Turned pink under Band-Aid, Hurt to the touch. Swelling continued for 5 days and now is fine. Area of show still a light pink. I did not need any help. Took no meds.

2 days after his shot he got a severe itchy slightly raised red rash on his chest, back and arms, he found over the next 24 hrs it spread to include his buttocks and thighs. Her tried benadryl without any change; hydroxizine and claritin combo together things improved slightly but then started a prednisone burst

Basically I came after the shot, I drank about 6 beers and got something to eat. About 6 hours after receiving vaccine, I started to develop a chest cold, and started coughing a lot, I was coughing up phlegm and it had blood in it. Yesterday I had chills, my fingertips were kind of a white in color. My temperature was 99.7. I had like a rumbling feeling in my chest and it caused an urge to cough. It went through all the next the day and including all last night. This morning I feel fine.

18 HOURS AFTER INJECTION: SLIGHT SWELLING AT BICEP , APPROXIMATELY TWO INCHES BELOW INJECTION SITE. ITCHING. 28 HOURS AFTER INJECTION: FEVER OF 102. BROKE AFTER 8 HOURS. 36 HOURS AFTER INJECTION: REDNESS PATCH ON BICEP APPROXIMATELY 3" X 3", CONTINUED ITCHING AND SENSITIVITY. 106 HOURS AFTER INJECTION FEELING WELL, SENSITIVITY, ITCHING AND SLIGHT REDNESS CONTINUES.

i HAD RADIATION ON MY SKIN IT WAS HEALING AND AFTER I TOOK THE SHOT IT BECAME INFLAMED. tHE DOCTOR TOLD ME TO TURN IT IN

Over the weekend 2/27/21, 15 days after vaccination, Patient Just experienced symptoms similar to those he initially experienced after receiving the immunization. Patient reported diarrhea, fever, body aches and pain and swelling at the injection site. The symptoms lasted about 48 hours.

headach, runny nose, orange/reddish coloring in 3" circle at injection site, 14 days after injection, lasted 6 hours.

Client doctor sent a note to our facility reporting patient was seen in his office 2/23/21 and client had a severe, diffuse, rash reaction and recommended he does not receive 2nd dose

Chills and violent shaking at 7:30pm temp 99.0. Gave 2 Tylenol. At 10:00 temp 101.6 then went to 101.7 and gave Ibuprofen 400mg. At 11:00 pm temp down to 99.7 and fell asleep. 9:00 a temp 97.5. Had no appetite all day 2/26 injection site red, swollen and bad pain. When fever went high had no mobility and could not sit up to take meds. Next day tired and listless.

Received 2nd covid vaccine on 2/9/21 and 1st shingrix on 3/3/21. Reported the following "I had the same reaction to the 1st shingles shot as I had to the 2nd Covid shot. I believe I have correctly diagnosed this reaction. It has a photograph of one cluster of bleeding capillaries (petechiae) and discussions regarding immune thrombocytopenia (ITP) with respect to vaccines. "

Soreness at injection site, Muscular & joint soreness, extreme fatigue. Tylenol taken for 2 days. Slept 2 nights and next morning slight lingering of affects. All gone after 3rd day. NOTE: No adverse affects after injection 1.

Rash/ hives on entire body from the neck down. Concentrating especially on the back and stomach completely encompassed in splotches and running down both legs. Swollen hands and sanative to the touch.

2 DAYS AFTER SHOT , AT INJECTION SITE GOT SWELLING AND RED SPOT THAT ITCHED. I MESSAGED AREA THAT CAUSED AREA TO EXPAND. SIZE OF AREA NOW IS 6 INCHES DOWN ARE AND 4 INCHES WIDE. tHIS IS TWICE THE SIZE AS AREA FIRST 3 DAYS.

Approximately 15 minutes after injection, patient developed a severe headache, dizziness and swelling of the face with red rash across cheeks and nose. Profound fatigue - needed to lay down rather than sit up. Was admitted to the Emergency Room for observation and benadryl IV was administered. Patient experienced the profound fatigue for seven days after the vaccine.

Muscular pain in the upper and mostly lower arm muscles of the left arm which is the arm that received the vaccine shot. Symptoms have continued to date, waxing and waning over this period. Do not recall straining or otherwise injuring left arm muscles.

Adverse event occurred after 2nd dose. Rash developed under lower lip across middle of the face and a lump developed inside the left nostril. 5 days later, rash and lump in nose still present, mild pain in back right side of the head (behind the ear) developed. Pain behind the right ear grew more intense each day and on Thursday, March 11 was seen at Urgent Care with intense pain. Was diagnosed with Shingles and prescribed Valacyclovir and Prednisone, Acetaminophen-Codeine for pain. Saw Dr. on Monday, March 15. Pain is gradually reducing, but still present today, March 22, 2021.

On the 5th day after the 2nd Moderna COVID19 vaccination my left arm, at the injection site, broke out into a rash the size of a softball that extended toward my elbow. It began to itch and sting while I was cutting my sister's grass. It is feverish and can be felt when rubbed across with my hand. No other symptoms noticed.

Patient called the office stating that his arm is red and hot and his arm is swollen all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0. Patient was also having arm pain. Patient was advised to go into UC.

about a week or so after I got a sever burning on my left rib gage that was very itchy, thought it might be Shingles but I've had the shot. I disappeared after a few days. Then I got s similar reaction after my second shot that was on my belly and it also went away in a few days.

PATIENT STARTED HAVING ITCHING AND RASHESS THAT STARTED LATER DURING THE DAY AND THE RASHES IS STILL PRESENT AFTER 2 WEEKS HOWEVER IT IS SUBSIDING. PATIENT STARTED TAKING BENADRYL TO RELIEVE THE SYMPTOMS.

Severe chills, fever (99.6+ F), lasted about 60 min., treated with 500ml APAP.. Accelerated heart rate (~105), ache at injection site persisted overnight. Difficulty sleeping. Mild cough from onset of symptoms until present.

Vasculitis; Urticaria both hands; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VASCULITIS (Vasculitis) in an 80-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 (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VASCULITIS (Vasculitis) (seriousness criterion hospitalization) and URTICARIA (Urticaria both hands). The patient was hospitalized on 05-Apr-2021 due to VASCULITIS. At the time of the report, VASCULITIS (Vasculitis) and URTICARIA (Urticaria both hands) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact

Hives began on day 9 post Monderna vaccination. Resemble chigger bites and has several with cause itching & discomfort. Also had fatigue and a low grade fever which resolved within 2 days but the hives/rash has persisted for 2 weeks.

Had the COVID shot and two days later he can't use the arm. Right shoulder hurts very badly. Also the shoulder joint hurts. Top of shoulder can't use the arm. Painful, very sore.

Severe bruising to bilateral hands (thumb and forefinger area). Pt notes no injury. Bruising began to develop the day after vaccination and steadily worsened over the next several days. Bruising is still apparent 6 weeks later.

Regularly get chills every day. Muscle soreness. Discomfort at injection site. Difficulty lifting right arm.

Mild rash with occasional itching on the forearms. No change since the shots (nearly three months ago). [This is not a serious problem. I am reporting it only because somebody said that you want to keep track of all side-effects, no matter how small.]

Reports soreness to injection site since 5/24/21 however developed increased swelling and warmth at the injection site on 5/26/2021. On 5/27/2021 the swelling and redness began to spread down his arm and he started to not feel well with chills and nausea. The patient was then seen by primary care this a.m. on 5/28/2021 who obtained blood work and an ultrasound. The patient was then instructed to present to the emergency department for IV antibiotics. He reports the arm is painful however declines need for pain medication. The patient does have a scabbed over area to the right hand which he reports is from his daughter's puppy that happened approximately 3 weeks ago. He has been applying bacitracin to this at home.

I noticed on April 3rd at 5pm that I had a rash on my both legs I went to the hospital and they just treated with a topical lotion and I was also having SOB. and was given albuterol and that helped.

Patient describes full-body itch that developed after the vaccine within a day. Slightly better at the present time than when it began.

4/29/21 hpi admission to inpatient: 80 y.o. male with a past medical history notable for Diabetes, history of CVA, arthritis, reflux, BPH, hyperlipidemia, hypertension. The patient presents for evaluation of Worsening issues of weakness and hyperglycemia in addition to being worsening itchiness. Patient states he has had some issues with worsening reflux. Patient has not any emesis. Patient's wife thinks he may be slightly jaundiced. Upon further evaluation patient was found to have pancreatitis. Patient was placed in-patient will hold patient NPO and provide IV fluids. Patient has had pancreatitis previously. Patient's itchiness is probably due to elevated transaminases. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Transferred to hospital 5/1 HPI: 80 y.o. man with a history of type II DM, hypertension, and remote h/o CVA who presented to hospital following transfer from another hospital for acute pancreatitis. Patient was initially admitted to their facility on 4/29, treated for pancreatitis with IVF, pain medication, and antiemetics. He LFTs failed to improve. RUQ US with no evidence of gallstones. Transferred here for MRCP/ERCP. He currently denies any abdominal pain. No chest pain. Breathing stable. No fever or chills. He states he has been having some belching and acid reflux for the last 1-2 weeks, worsening after a trip 1 week ago. 5/17/21 radiology: Malignant neoplasm of pancreas Admitted 5/20 - 5/24: Open biopsy of liver/Pancreas, ECRP 6/14 Office Vist : oncology, pancreatic carcinoma metastatic to liver

Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.). On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; 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.

VACCINE ADMINISTERED AROUND 11 AM. NURSE DISCOVERED A LARGE HOT RED 2 INCH PATCH ON HIS LEFT CHEEK (98.2 DEGREES). THERE WAS A OVER A DEGREE DIFFERENCE IN TEMPERATURE FROM RIGHT CHEEK TO LEFT CHEEK (97. - ISH DEGREES) THERE WAS ALSO A SMALL AREA ON THE LEFT SIDE OF FOREHEAD THAT WAS 100.2 DEGREES. THE REMAINDER OF THE FACE WAS UNCHANGED AND 97 ISH DEGREES. UPON INSPECTION THERE WAS NO RASH ON TORSO. WE DID NOT CHECK HIS LEGS.

FACIAL SWELLING, RASH, ITICHING OF EYES & FACE. STARTED 3 DAYS AFTER INJECTION. METHYLPREDNISOLONE 4MG TABLETS GIVEN.

Patient with unwitnessed fall after vaccine administration. Found down with small forehead laceration in front of post-vaccine observation area. Sent to ED. On review of hospital admission note, patient left vaccine observation area prior to 15 min observation period to assist his wife. Went to bathroom unassisted, had BM without issue. Upon leaving bathroom syncopized with head strike.

About one hour after injection, patient experienced overwhelming fatigue such that he had to lie down in bed. He slept two hours. Upon awaking, he noticed soreness at the injection site, which has persisted the following day.

Patient stated that his arm is warm, itches, and is hard at the area where the vaccine was given. Started approximately 2-3 days after the vaccine was administered. Instructed patient to take Benadryl to help with the itching. Also told patient to contact his primary care provider.

Client called to report that the night that he received the vaccine he noticed a small red rash around mouth and nose. Reported that he took Benadryl at that time. On 2/21/2021 he reported elevated B/P and rash has continued but now the redness is on face and jaw line.

swelling, hardness in shoulder around vaccine site, pain when site is pushed or arm raised, very little otherwise

01/12/2021 (8:00 A.M.) Felt dizzy. (8:15 A.M.) Severe fatigue. Went to sleep in recliner. Slept for 13 hrs. (only waking up to go to the bathroom or to eat lunch and dinner). Went to bed at 9:00 P.M. Slept for an additional 8 hrs. Woke up at 5 A.M. and felt fine. 01/19/2021 Began itching at the injection site. Spots all over body appeared shortly thereafter (with exception of neck, face, head and feet). Resembled chicken pox. Severe itching for 4 days. Itching subsided slowly. Got better each day until no itching ~ 01/24/2021. Spots mostly gone by ~ 01/29/2021.

Redness at shot location Swelling Hot to the touch Rx ( antibiotic was prescribed by doctor It happened a week after the shot.

Pt came to office stating that 8 days after receiving first dose of covid vaccine he has "an infection". Pt had area of erythema, 11.5cm X 7.5cm, oval shaped on his right arm, At the top of the oval, there was a more hard and reddened area, 4cm circular, and the area around it was more diffuse, lightening to the edge. Pt denies "any real itching" but did c/o tenderness when pressed on. Pt states that the first 7 days after his vaccine there was no reaction, visibly, at all. He had a "bit" of soreness after shot, like he expected, then nothing until day 8. He did use ice on the area from the 1/20/21 through 1/28/21, when he came to our office. Nurse initially viewed area, had PA also look. PA felt after her examination that the area was urticarial, and prescribed prednisone and Benadryl orally, and advised pt to use hydrocortisone 1% cream up to 4 times daily. Pt returned the next day, area was much less red, smaller in size, and less swollen and hard. He was advised to use Benadryl orally and hydrocortisone 1% topically, prophylactically, after his second injection.

patient left hand non-palmar surface, red, + itchy, per patient he wasn't sure if it was itchy prior to receiving vaccine, no labored breathing, no further rashes nor hives noted, not scratching hand post vaccine

Next morning after injection, woke up not feeling well. Temperature, shakes, internal quivering, chills, tired, aching joints. This went on for 2 more days. Temperature ranged from 100.2 to 101.6. Friday morning (2/5) woke with fever of 101 but soon dropped down to 99. As the day went on temperature became normal and has stayed that way. Lost 3 pounds and still feeling very tired. Arm at injection site was swollen and very hard.

Patient reports that received COVID-19 (Moderna) Vaccine 1st dose on 01/28/2021 in left deltoid. Had no pain; swelling; bruising or other complaints following immunization. Reports that 6 days later (02/03/2021) when getting ready for bed; he noticed bruising to the area. Discussed changes in medications/illness prior to vaccination. Reports that 2 weeks prior to receiving COVID-19 Vaccination (approx. 1/14/2021) on his own he had increased Chewable ASA; 81 mg daily to Chewable ASA 81 mg twice a day. Did recently consult primary provider regarding bruising noted 6 days post vaccination. Has had no pain; swelling; warmth or other concerns other than healing; resolving; persistent bruising to left deltoid.

Moderna COVID-19Vaccine Injection site became hard, red, swollen and itchy 9 days after vaccination. Same symptoms, though milder, persisted through 2/11 i.e. 10 days after vaccination. I am completing this form on behalf of my husband, who has vision problems. We got our vaccination at the same time and place. I had exactly the same symptoms at the same time, i.e. 9 and 10 days after vaccination. (I don't plan to fill out a second report for myself - sorry!)

Covid-19 arm - raised rash type swelling, itching, light redness. Currently treating with generic Benadryl, which seems to be resolving issue.

Eight days after the shot I woke with an itchy rash that circular and about 3 inches in diameter. Based on what I read, it was "Covid Arm." It is now 7 days since the rash started and it is mostly gone. There is just a little redness at the bottom of the area where the rash was. It largely stopped being itchy after 3 days.

5 days after vaccination started getting small red splotches on arm below the injection site. In 3 days the pinkish/red area was 3 1/4" and 2 1/4" wide. Surface itched and sore in the muscle. Doctor's nurse advised to just watch it and if gets worse to call back. After another 7 days it went away other than a very faint outline.

Got the vaccine and did not notice anything until he looked in the mirror on 2/17/21, became pink, patch round 2-3" in diameter, warm to touch. Still has the area, it has not grown and a few degrees warmer than the rest of the skin in the area.

Light red rash at injection site noticed about one week after shot. Still there two weeks after shot. About two and on half inches in diameter.

Severe hives accompanied by shivering, significant itching, three fainting episodes close together about 8 hours after the onset of the hives and very low blood pressure following the fainting episode. At home treatment taken on phone advise from Doctorr with Benadryl and Fomantadine with no effect. Prednisone now prescribed. Doctor had suggested a visit to ER but this was taken as the patient was more stable at this time. Potential life threatening event due to the fainiting and low blood pressure/heart rate. These symptoms have occured on previous occassions as a result of virus and other infections.

After 2 weeks of first dose of COVID vaccine, on Friday Feb 26th around 5 pm, he had allergic reaction on his left arm where the shot was given. A large red flame area around the arm of the shot area and itchy too. His lower leg have the same large red area of itchiness. He took benedryl and applied hydrocortisone to ease the itch.

On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.

Raised Bump on face similar to a small lentil bean. Then got bigger then more on face then on neck and scalp then on back now chest also. They vary in size and redness. Some are near the eyes. He took Benadryl then after urgent care started doxycycline by late 100 mg. March 1st they are getting worse. They would not run blood work though he asked for some.

Shot taken 9:30AM 2/25/21 DaQuil taken around 3:30PM Chills, violent shakes. Around 6:00PM 911 called , EMT arrived I did not know birthdate, where I lived, date, or where I was. Transported to ER do not remember any part of the trip or arriving at the ER. Bright red circle around shot with fever still have 3/4/21 plus sore.

arm could hardly be raised in evening and had large lump at injection site, woke up around midnight with bad chills, felt feverish and dizzy. Stayed in bed and slept pretty much until 2:30 when was woken up by wife. around 11:00am on 03/05/2021 face looked swollen and still feverish and dizzy. Wife called the hospital and spoke to a nurse who wanted him to be woken up to check facial swelling and advised going to a walk in clinic or emergency room. face looked better so did not go, he went back to bed around 7:00 p.m and the next morning on 03/06 still felt light headed and not normal. Today 03/10/2021 still doesn't feel right still some light headedness, just not normal at all.

02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it. In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell. He felt like he was going to vomit too. He was so weak that he could not get up off the floor by himself. My son lifted him up. He also noticed Friday night that there was a bubble where the vaccine was given in his arm. 02/27/2021, the bubble had burst and liquid was coming out. It was an open wound which was sore and really red. He also had a headache and continued weakness. 02/28/2021, he still had a headache and the arm was sore. 03/01/2021, felt pretty good.

mild rash on chest and both upper arms. rash was itchy and consisted of raised red spots about 1 cm in diameter. rash persisted for one week and then disappeared

Began having severe itching and breaking out with red rash on upper torso including chest, back, arms, neck, face and scalp. Some areas resembled sun burn with pockets of puss.

Site of injection became very red and raised up - about three inches in diameter. Not itchy. This happened in about 24 hours after injection.

Rash at injection site. Cleared up in approximately 1 week. Body rash appeared yesterday (1 month after 2nd vaccine) Headache and diarrhea also.

Difficulty breathing; Legs have also itched; Hives painful to touch; Hives; Little nausea; A spontaneous report was received from a consumer, who was a 81-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch. The patient's medical history included afib (atrial fibrillation). Products known to have been used by the patient, within two weeks prior to the event, included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that he felt a little nausea for the first few days after vaccine administration. On 25 Jan 2021, the patient woke up at 1:00 AM with hives on his right arm from the elbow to the shoulder. He stated the hives were painful to touch. The patient took diphenhydramine and the hives disappeared that morning. Later that day, the patient developed difficulty breathing and the hives appeared on his left arm from the elbow to shoulder. The patient went to the emergency room and was hospitalized overnight due to breathing issues. He was given diphenhydramine and steroids and was released from the hospital on 26 Jan 2021. On 27 Jan 2021, the hives reappeared from the patient's hands, spreading to the arms, shoulders, head, neck, and face. He described some of the hives as being nearly a quarter-inch high and he stated they looked like water blisters. On 28 Jan 2021, the patient went to the emergency room again because he was having a lot of trouble breathing. On an unknown date, the patient's legs had also itched but there were no spots. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch, was unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, with medical history of atrial fibrillation, who experienced serious unexpected event of dyspnoea, and non-serious unexpected events of urticaria, pruritus, pain, and non-serious expected event of nausea. The event of nausea occurred on day 1 after mRNA-1273 (Lot# Unknown). The event of dyspnoea, urticaria, and pain occurred 14 days after mRNA-1273 and the event of pruritus occurred on an unspecified date after mRNA-1273. Treatment included diphenhydramine and steroids. Concomitant medications included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Red rash on left arm. It was itchy, About 3 inches round. Appeared 2 weeks after 2nd shot . By 3 weeks had spread to right arm and behind both ears. Treated by cortisone ointment. When I had a regular office visit, the doctor prescribed 5 cortisone tablets and I took those with none since. Still have rash and wonder if it will ever go away.

Broke out in a rash on the left side of the chest and a bit on the left arm. The rash started the following day after vaccination and continued increasing for 2 days. It has now stabilized but is still there (March 23rd).

On 2/5/2021 Patient had an upper body rash on his back with itching. There was some improvement. About a week after he got the second does of Moderna on 2/21/2021 his rash was much worse,. very very red, some blotching redness, some more like pimples with intense itching. The itching continues 24/7. At this point the rash is getting worse, under arm pit, about nipples, over chest and one arms and legs. He itches everywhere not just where the rash is.

Injection site is sore and tingles. Muscle in arm aches. Difficulty using arm to hold objects at angle.

About 20 hours after the (2nd) shot I got up from my chair after watching the 6:30 PM News and walked about 4 steps and had a breathing "seizer." I could not get any oxygen and in a near panic tried to hyperventilate. After 45 sec I was able to walk another 4-10 steps but the seizer occurred again. Took me 5 minutes to get from the living room to the kitchen and then another 5 to get to the bedroom. In the morning I was reasonably "fine." but then had flu like systems for 1.5 days and then was totally over it all.

Red area with small bumps that continuously itch around injection site. Using Benadryl in attempt to relieve itching. No other treatment sought at this time. I have never had an allergic reaction to any previous injection or medical treatment

Mild patchy red rash about 5 days after first dose of Moderna COVID vaccine, which cleared. After second dose (3/11/21) rash returned much worse and more painful and was seen on top of head, abdomen, both arms and both legs.

Patient states that two to three days after receiving his second dose, he developed swelling and bruising in the arm where the vaccine was administered. This reaction happened only on the arm where the vaccine was administered and no other part of his body. He states that after applying ice, the swelling went down but the bruising persisted weeks after the shot, until date. Upon review today, the patient still had the bruising but the swelling had gone down completely.

Bleeding left arm; Scabs left arm; Itching left arm; A spontaneous report was received from a consumer concerning an 81-year-old, male patient who developed blooding arm and scabs/haemorrhage, itching/pruritus, and a scab.. The patient's medical history included heart disease, COPD and diabetes. Products known to have been used by the patient, within two weeks prior to the event, included hydrocortisone stick. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 2 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) on 19 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection. The patient symptoms included itching (left arm), bleeding arm, and scabs. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events, hemorrhage, pruritus and scab were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded. Further information has been requested.

Slight fever 1 point elevated. Muscle, body aches, fatigue, tiredness, slight headache, joint pain, sore Rt. arm, sore injection site. Side effects have subsided after approximately five (5) days. None of the side effects were considered severe!

broke into hives; cannot walk; muscles were stiff; diarrhea; throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (cannot walk) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine normal (Inconclusive) CT Scan was fine.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. An ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criterion hospitalization), GAIT DISTURBANCE (cannot walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine (Inconclusive) fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. Treatment information included an ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. 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.

Diagnosis - Left forehead shingles with left eye involvement Allodynia of left face and left front scalp about 4/7/21 Left eye soreness and slight redness 4/8/21 Raised red blemishes on left forehead 4/9/21

APRIL 9 EVENING LUMP IN RIGHT LEG, PAIN TENDERNESS AND REDNESS, SITE IS HOT AS WELL. SWELLED OUT, RUNS 2 INCHES, RIGHT ON INNER PART OF LEG, BELOW KNEE LEVEL, HAS HAD 2 NEW KNEE IMPLANTS ON RIGHT LEG.

Red, swollen ,hard, itching , sore area from deltoid to elbow at site of injection. Swollen and tender lymph nodes under left arm

rash around site of injection; patient complains of itching outside and inside the arm; large area of rash on arm

The patient's wife called today to ask about the second shot and reported an itchy rash all over stomach and some on arms and legs. The patient's wife also states he has a rash on his back, but that and practitioner said it looks more fungal and not related to the rash on his stomach, arms and legs.

Rash and pustules beginning on left hand and spreading to hands, arms, trunk, thighs, and legs, persisting to current date, but improving.

Very itchy right ear lobe, few days later also right cheek was itching, a week later also right jaw was itching, two weeks later also right collar bone was itching. I didn't report this at the time because I didn't think it came from the Vaccine. I still have the same symptoms and began to wonder if others have the same condition. Condition is worse in the morning. Affected areas also tingle at times. Condition is much better after about 10am. I have not talked to a doctor yet because it is not a servere experience. During my annual physical exam in July I will talk to my doctor about it.

Wife stated that one month after receiving his 2nd dose of moderna vaccine, patient started to develop a bruise that's red and the size of a dime on right arm. The same bruise travels from right arm to left arm

Pain and skin sensitivity began in right arm on Feb. 1, 2021. On the evening of Feb. 8, a rash broke out on the arm. The next morning I set up a telemedicine visit with my doctor for that afternoon (Feb. 9). In that visit I described my symptoms and showed him the rash. He diagnosed shingles. That evening I started a course of the anti-viral drug Valacyclovir. It took approximately two weeks for the pain and rash to disappear. I got my second Moderna shot on Feb. 26.

The injection site began to hurt the evening of the day of the injection. I did not sleep well that night and was generally achy and fatigued the next day. Additionally I had a very dry mouth . By that evening I began to feel better although I was still a little tired but by the next day began to feel normal. The injection site is still tender (day 3) but getting better.

Narrative : Symptoms: SkinRash& SWOLLEM GLANDS UNDER JAW-SORE. BLISTERS DEVELOPED WHERE THE RASH WAS ON PTS KNEE Treatment:

On 1/20/21 developed a rash with whelps at the injection site, measured 4 1/2 inches long and 2 1/2 inches wide. Hot to the touch. Itching. As of 1/22/2021, still has itching but is improving with cold packs and topical Benadryl as recommended (phone call) by his health care provider's office. He was instructed to notify the health department.

Pt uses a walker, upon moving to observation area, patient fell trying to sit down. Pt states he simply missed the chair. He has very thin skin and suffered several skin tears. We applied pressure and bandaged wounds and observed pt for 30 minutes. He did not hit his head. Followed up with pt's wife next day and she reported that his arm was sore, but no other complaints. I recommended they see a Dr. for his skin tears.

Patient into clinic on 1/26/2021 reporting fever, redness, swelling, soreness to injection site. Patient states temperature on Sunday was 104.0. He self-administered Acetaminophen and no fever since. Left arm appears swollen around injection site with redness extending about 1 inch above the bend of the elbow.

Dizziness the morning after vaccination (lasted 1 hour), chills the morning after vaccination ( lasted 3 hours), sore shoulder around vaccination injection (lasted 2-3 days)

minor muscle soreness during late afternoon - no treatment light Injection-site pain since late afternoon for 2...3 days - no treatment

Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.

Covid Arm reaction 5 days after the second Moderna dose -- an angry dark red blotch 6 in by 4 inches that persisted for 4 days before fading in color. It was warm to the touch and itched.

This started about a week or so ago, which was 2 weeks after the vaccine. He had a band of scaly skin that itches like crazy. When you scratch it it flakes off. He has been putting on lotion to moisturize it and antiitch medicine hydrocortisone on it, and it stops the itching for a while but then it comes back. Still having the same symptoms and has an appointment with his dermatologist on 2/11/21. He said that it feels like dead skin that you can take your fingernails and just peel it off.

Dark bruise. About 1 1/4 inch in diameter with smaller dark spots in the circular site. I reported this before and tried to send a photo but it evidently did not go . The bruise is finally going away but has lasted almost three weeks. There were no other symptoms that I noticed except some soreness at the injection site. When I received the injection it seemed to be lower down on my arm than. I had thought it would be and there was some bleeding, along with unusual pain during the injection.

Lite rash developed 2 weeks after the 1st shot(1/9/21) Day after the 2nd shot the rash became red and in the net couple days has spread over the arm and on my left chest and become bumpy.

I received my Moderna shot on Saturday 1/23/21 around 4PM. On Tuesday -- 1-26/21 -- AM I woke up with a slight pain on the side of my left foot. In the middle of the pain there was a small black dot . I am an unusually healthy 83 y.o. physical active, ex Marine, with a high tolerance to pain. So at first I paid no attention to this and went and played pickleball that very day. But the next day I awoke to find that the foot was not only bright red and swollen, but painful. I immediately called my doctor and the next morning I had a telephone conference with him. We discussed the possibility of what could have caused this problem. Although I am pre-diabetic (111) he ruled out diabetes. He also ruled out gout. This only left the possibility of an infection. But since I had not stepped on any nails, etc. the only possibility was a bug bite. So he prescribed an antibiotic, which I started taking that very day. After several days the foot got progressively worse and turned into a ulgy, oozing sore and redness grew to the whole left side of my foot. So I made an appointment with my doctor for a physical visit, however this was delayed until 2/5/21. By then the swelling and redness had subsided considerably and the wound was healing. He ordered lab tests to rule out the possibility of diabetes and gout. He also gave me a prescription for stronger antibiotic and antibiotic ointment. Unfortunately the lab was by appointment only and I did not get the tests done until 2/12/21.I would not even be writing this except for the fact that on 1/27/21 I also developed a rash all over on my back that was very itchy. This is when my attention turned back to my vaccine shot, and the reports that Maderna had a track record of rashes from their shots. So I thought I had better write to see if it would be safe for me to get my 2nd Maderna shot which is scheduled in just 6 days (2/20/21).I do have a history of occasional painful rashes since childhood and I am wondering if the Moderna shot could have possibly triggered one, or both, of these problems? If it will help I did have photos taken of my foot during this episode and will be happy to send them to you if you feel it necessary?Thank you for your immediate consideration and response.

rash appeared on torso day 5, diffuse blanching, slightly itchy, progressed, covering entire back by day 5 post vaccination.

Pt broke out in a rash over his entire the day after receiving the vax. Pt had office visit w/ PCP on 1/20/2021 which was then referred to a Dermatologist. Doctor took biopsy that showed he was allergic to something and was told that it could be the vax but it could also be from something else as well. Pt was told to change soaps and detergents. He was prescribed Aquaphor healing ointment, Claritin, Fluocinolone. Pt still has the rash on his entire body.

vaccine rec'd 2/11, and 5 days ago there was a swollen area, warm to touch and red, if I tough it, it itches.

slight pain at injection site, extreme fatigue, muscle and joint pain in areas where arthritis had caused discomfort, abdominal pain, one incident of vomiting, and most concerning, I felt "foggy" till March 1.

Presented 2/25/21 with right arm swelling, redness, warmth to palpation, most apparent around right elbow. Normal range of motion of right arm without pain. No pain to palpation of right arm. Also had pacemaker surgery 2/11/21. Patient was referred to healthcare facility for further evaluation.

pt states the next day after he got the covid vax he had pain in his left arm and had this pain every day since then.

Severe muscle ache and trismus radiating from the Deltoid (site of injection) throughout the entire shoulder, including the Trapezius and Sterno-Cleido-Mastoid muscles. These conditions lasted for one week, until my Orthopedist (whom I saw for follow-up knee replacement) prescribed a Medrol Doz-pak, which finally gave me relief.

left deltoid injection site pain with swelling. Tylenol was given, resident refused ice pack/warm pack

Large red bump, very itchy. Applied OTC anti itch cream and took a dose of Benadryl. Itch went away within 24 hours. Redness stayed for several days

Quarter size raised welt immediately after injection applied instant ice pak while still at pharmacy after 15 minutes welt reduced in size. Spoke to patient 3 hours later to follow up and he said no pain or welt in injection area

right big toe red on bottom and left side have used hydocortizone with some relief. Will contact Dr in the morning

On 1/27/21 noticed severe itching in upper back, scratched places formed scabs. Went to dermatologist on 1/29/21 and was told it was shingles. They performed a biopsy to confirm the diagnosis. Positive for shingles. Took the second Moderna vaccine on 2/22/21 and developed a raised, red rash on left upper arm. It subsided after about a week.

High fever 104, Balance hard to stand. deep red rash on lower legs and blotchy condition on rest on body. Went to Torrance Memorial Emergency 03/07/2021 for day and half -- every test they could run with Xray, EKG, and covid test

"Moderna Arm", muscle swelling, pink itchy rash occurring 12 days after first injection, has not gone away after four days. Am using anti itch cream externally.

The left arm has a softball sized rash that is itchy and has raised bumps. There is a ring on the outer part of the inflamed area.

I noticed a long raised red bump on my left arm (3/21/2021) from the vaccine 1st dose received on 3/5/2021. Feel okay other than the red bump.

Had confusion; They said it is due to the reaction from covid vaccine / it is just getting worse; It was hot as a fire cracker; Rash on arm of injection; It was hot as a fire cracker and was so red; 101 F Fever; A spontaneous report was received from a consumer concerning her husband, a 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced confusion/confusional state hallucinating/hallucination, wasn't even able to sleep/insomnia,, he didn't even know where he was/daydreaming, very restless/restlessness, he couldn't walk or anything/gait inability, they said it is due to the reaction from covid vaccine/it is just getting worse/vaccination site reaction with seriousness criteria as intervention/medically important, rash on arm of injection/vaccination site rash, it was hot as a fire cracker/vaccination site warmth and was so red/vaccination site erythema, 101 F fever/pyrexia. The patient's medical history was not provided by the reporter. Concomitant medications reported included carbidopa, levodopa(25/100mg), tamsulosin, acetylsalicylic acid, pravastatin, rivastigmine, irbesartan, levothyroxine sodium. On 10 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 040A21A) through unknown route of administration for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced my husband is hallucinating, wasn't even able to sleep, had confusion, he didn't even know where he was, very restless, he couldn't walk or anything. They took him to ER on Thursday and they did all the tests, but everything was good. Then it just got worse they said it is due to the reaction from covid vaccine/it is just getting worse, rash on arm of injection, it was hot as a fire cracker and was so red, 101 fever. On an unspecified date, lab details included flu test, covid test, strep throat, EKG, lung, and all the other blood work, body temperature (101 F) but everything is normal. Treatment for the events were not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, my husband is hallucinating, wasn't even able to sleep, had confusion, he didn't even know where he was, very restless, he couldn't walk or anything, they said it is due to the reaction from covid vaccine/it is just getting worse, rash on arm of injection, it was hot as a fire cracker and was so red, 101 fever were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Approximately four hours after administration of Moderna vaccine the patient had a sudden syncopal event without warning. He suffered a scalp contusion. His equilibrium, hearing and vision were diminished for 7-10 days thereafter, gradually returning to normal.

Inflamation at site and progressively down the arm over three days with simptons of swelling and itching as well as some pain and stiffness. Took some pain killer - one ibuprofen per night. And when itching severe enough used Sarna lotion sometimes twice over the night

Lump and itchiness at vaccination site on day 1, took 10 mg Cetirizine Hydrochloride tablet Flu symptom like muscle and joint aches, tiredness, headache, no appetite. on day 2, took 500 mg acetaminophen (2) caplets Severe vertigo, nausea, tiredness, and no appetite on day 3, took 12.5 mg of Meclizine caplet

c/o Progressive Redness warmth of injection site (about the size of palm) with mild pain still 10 days post injection. Loose stools x 2 days

Client reports feeling fatigues day after vaccine. however, on 3/28 he reports his face bilateral near the nose is firm swollen and red. he reports no relief with gels or antihistamine. He sought dermatology assistance and is seeking allergy evaluation and is contacting his primary MD.

soreness at the site for about 2 days gout at the right toe, swelling, redness, burning, tenderness, pain. took (1) motrin every 4 hours four times. pain subsided by 75% in 2days.

I have developed a rash since my second dose and it have spreaded over areas of my body especially my stomach and shoulders and areas of my back

Patient had increased respirations, SpO2 declined, 15 seconds of apnea, mottling to BLE, minimally responsive

Developing flushing of face within 15 minutes of vaccination, upon getting home, noted full body rash - itchy bumps. Headache and lightheaded with a slight little cough and able to taste something in mouth immediate. then one week later, 1/18/21 developed stabbing chest pain, medivac'ed 1/19/ 21 to tertiary facility hospital. had 2 stents placed on 1/20/21. Received second dose of Moderna on 2/09/21, again having flushing, headache, taste, smell of medicine, rash, less severe than first dose. Took a nap following. Hurt all over all night 2/10/21. 2/11/21 felt somewhat better. one week later, again experienced shooting chest pain on 2/16/21 (pain 'down my breast bone'). Has not followed up with medical care. Has been 'living with it' due to expense of Medivac. Finally does have a follow up appointment with Dr. on June 7th.

7 or 8 days after the second dose of the injection a rash covered my entire body and was very itchy . Went to doctor on April 27 and he prescribed prednisone 10 mg for 20 days. Also Fluocinonide cream for itch 0.05 % 60 grams I have one more day of prescription and still have rash and itch.

after 2nd DOSE patient said they developed pain at the injection site, a slight rash and redness appeared as well. was feverish and had chills as well. took tylenol to help with the fever and pain.

Early morning day following 2nd shot. EXTREME/VIOLENT shaking/chills for 2 hours....very concerning---upset stomach =slight temperature. General sickness. Extremely sore arm/shoulder at injection location. 2nd day was bet ter. 3rd day most symptoms gone gone with exception of shoulder pain. In the last few weeks pror to this date the pain in the shoulder has increased SUBSTANTIALLY and migrated in the the lower area of the shoulder. It is now difficult to LIFT my arm and have use of it do the the pain and decreased ability to use it. Having had major joint surgeries in the past I know what pain and lack of function can be. This is something different and becoming worse quickly.

Patient complained of feeling unwell and having headaches after his second dose of Moderna vaccine on 2/2/2021. He became increasingly confused, paranoid and started occasionally refusing medications. On early March 2021, he started refusing all medications. Around 3/17/21, his increasing confusion and paranoia prompted suspicion for UTI which was confirmed with a urinalsis. Unfortunately, he refused antibiotic treatment. On 3/20/2021, nursing staff noted that patients right lower extremity was purple from toes to mid-calf, cold to touch and pedal pulse were not present. He complained of right leg pain. He was evaluated and diagnosed with probable thromboembolic event, since patient refused his oral anticoagulant for weeks prior to these event. Patient was sent to the local Emergency Department (ED) and diagnosed with acute critical right limb ischemia. At the local ED, he had a CTA which showed as per radiology: "Occlusion of the right superficial femoral artery beginning just beyond the origin. Occluded right popliteal, anterior tibial, tibioperoneal, peroneal, and posterior tibial arteries without reconstitution on arterial and delayed phases. Patent right deep femoral artery with minimal luminal stenosis in the proximal segment. Patent mid and distal right external iliac artery with up to mild luminal stenosis." Per discharge summary, "vascular surgery evaluated patient in the ED and did not feel operative revascularization with fasciotomy would provide any benefit; recommended continued anticoagulation with amputation/palliative management." He was admitted to the general medicine service which consulted orthopedic, infectious diseases and palliative care. Medicine Service also contacted patient's daughter who is his next of kin who opted for comfort care. He was discharged to facility on 3/25/2021 and started in the Comfort Care Program. He was pronounced dead on March 27, 2021 at 0807 hours. His autopsy showed that he also had thrombi on: 1. Pulmonary embolism, Left pulmonary artery 2. Left renal infarct

04/03/21 Redness and swelling in upper left arm. On or about 04/09/21 very bad cough and great difficulty in breathing. On advice of Dr. went to Emergency Room. After chest X-ray, EKG, and blood panels was diagnosed with congestive heart failure and furosemide was prescribed. On 04/27/21, 05/05/21 and 05/12/21 had previously scheduled with Dr. Echocardiogram, Stress Test, and Carotid Svan, respectively. As a result, it was found that there was abnormal perfusion scan with severe evidence of infarct in the apex apical inferior, mid inferior apical anterior and mid anterior segment(s). Abnormal left ventricular size with abnormal systolic thickening and systolic function..

rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel

When I had my first inj. 3 days later I developed a significant rash. Now it appears to have returned on my left arm but significantly smaller

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product information was 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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; 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, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included exercise nerve tests with electricity. The patient has been to his hospital and has not seen any success in his treatments. 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.

Redness, bumps, minor burning pain limited to forehead and chin. Pt washed hair and applied lotion to mitigate the minor burning sensation. Pt advised he noticed onset at about 6 hours post injection on same day, Saturday, January 2, 2021. As of this date, burning and bumps have dissipated and redness is only minor. Photos from Sunday evening, Jan 3, 2021 and Tuesday evening, Jan 5, 2021 showing progression of symptoms, are available upon request.

Moderna COVID- 19 Vaccine EUA No reaction reported until day 3 post vaccination. Patient reports a red rash that erupted over his upper body. He also reports itching and swelling at injection site. Patient was treated by his primary care physician with steroids. Rash still reported today, but he states it is improving.

Reaction occurred 9 days after injection: injection site pink and swollen; no fever, pain, other symptoms. No previous complaints Doctor visit on 1/7

12/30/2020 nursing staff noted fine sl. rash on trunk and lower abdomen. He c/o itching and physician notified. Orders were received to monitor. 12/31/2020 red rash persist, pt. denied much itching. Did report he has a hx. of rashes and "uncertain as to cause". Denied any diff. with breathing.

Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported none but mild soreness at injection site. On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00 pm. Patient reportedly complained of "pain" unspecific and collapsed at home. Hospital reportedly told family that it appeared to be a "heart attack".

A feeling of significant lassitude, pain at injection site and also the site opposite in the right shoulder. I could not sleep after 3 am, awake until 7:30 am. January 13: in the morning, body aches, requiring bed rest. After 12 pm, relief came with normal feeling.

Injection was in right arm. Rash on right temple. Itching on right arm, right trunk, right thigh. Bleeding on right thigh and in right groin. Red spots on right arm. Smeared sites of itching with Mometasone Furoate cream, which stopped with itching. Some bleeding in the groin still occurs

pt stated having pain in the are of the injection site, chills, and headache. pt wanted to notate that he had been tested in November 2020 for covid anti bodies and was found to still have them in his system.

Ras covering entire body, including arms, legs, thighs, stomach, and chest. Treated at urgent care with prednisone and loratadine. On 1/22/2021 rash has been resolved. Urgent Care ran a battery of blood tests at time of visi. Photographic depiction of body rash was forwarded to MD. Discussions are on-going as to

Reddening of cheeks, mildly light headed 1.5 hours following injection. Took 2 benadryl - sxs remediated in 3 hours time

redness, itching and swelling at vaccine site starting 1 week after injection. starting resolving 2 days later without further treatment needed.

48 hours after vaccination the patient had a severe erythematous rash over his entire body sparing only his face and mucous membranes. It blanched but not raised. It was extremely itchy but without sob, fever, joint pain, facial swelling, trouble talking or swallowing

Rash over much of body -- legs, back, stomach, chest, arms. Skin has spotty red areas. Much itching. Symptoms began about 24 hrs after vaccination. Because of itch, difficult to sleep on nights 3,4,5,6 after vaccination. Applied Desoximetasone Ointment (0.25%) to red spots morning and evening. Itching and redness are beginning to decrease.

reports blood sugars have been higher than normal. Usually morning blood sugar is 120 and it has been 160 since the day of vaccination. Rash on head has flared up and is more painful and hot than normal. Pain at injection site. No fever no rash on arm or near site of vaccination.

First noted itchiness over L upper arm and when he looked at the area noticed it was red and "blotchy." Area is light red in color, warm to touch with induration, and measures 8 x 3.5 cm. He has tried using hydrocortisone cream over the area but states it has not reduced the itch.

shoulder discomfort vaccination site, mild covid symptoms, fatigue, chills, lack of appetite, mild temp

Developed itchy rash on upper arm just below vaccination site. Treated with cortisone cream. I have photo

PATIENT SOUGHT EVALUATION WITH PCP ON 2/5/21. PCP STATES THAT PATIENT REPORTS MINOR RASH BEGAN ON 1/31/21 THAT HAS CONTINUED TO WORSEN DAILY. PCP REPORTS THAT PATIENT HAS A RED RAISED BLISTERING RASH OVER MULTIPLE BODY SURFACE AREA THAT RESEMBLES SHINGLES. NO OTHER SYMPTOMS. PCP REPORTS THAT HE PLANS TO TREAT PATIENT WITH STEROIDS.

On 11/25/20 had a physical and they took him off of Atenolol, and put him on Metoprolol, one a day at bedtime. He took those for almost 2 months without any problem until he got his shot. He took his pill at 10:00 when he went to bed, woke him up around 12:30 AM and had severe itching all over his back, and his mouth, tooth area felt like they fell asleep. Got some water and rinsed his mouth and felt that it was something he ate. Again for the next 2 nights after taking his blood pressure medicine he was woken up with the same feeling (like it was asleep). It did not affect his swallowing. He then called his doctor and he put him back on his other medicine, and not having any trouble since switching back to Atenolol. He is scheduled for the 2nd vaccine on 2/25/21. Has an APT with his PCP 2/16/21.

Developed increasing mild soreness at site, also slight redness from injection site extending to elbow. Now slight itchness. continues to date.

Patient had shingles a year ago, two days later, and exacerbation occurred and he started to have shingles symptoms again.

Approximately 9-10 days following receipt of the first Moderna vaccine, my father stated he observed a large rash appear at the injection site the covered a large area of his arm. The tissue was warm to the touch and he described feeling an occasional itchy / pulsating feeling in the surrounding tissue.

Day of injection patient noticed increased redness at injection site, over the next few days the redness spread, became hot to touch. Patient was seen in the clinic and given keflex.

I noticed the reaction about 2 days ago, my husband has memory lost but says it was there longer and it has been itching. He has a rash on his back, it is little pin point red spots. I gave him Benadryl Wednesday evening, and I put hydrocortisone 1% cream on his back. Yesterday I gave him one Loratadine 10 MG. It is still there today, it looks like it spread more

One week post vaccination, the patient developed bilateral lower leg rash - described as small pinpoint dots around the ankles feet and anterior and posterior calves in a stocking like distribution He awakened one morning with this development . No injury reported no tight clothing noted

swollen, tender left shoulder, nausea, vomiting, syncope referred to primary provider if symptoms worsen

Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope. Patient sustained head trauma with scalp laceration and staple were placed. Patient has longstanding history of atrial fibrillation and has been taking Eliquis. He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started. Patient had a Covid vaccination on 2/8/2011. Patient denies any respiratory symptoms. No cough no chills no fever. Complain of exertional shortness of breath. He was seen in the emergency room at and tested positive for COVID-19.

Do not have access to records from the VA. Diffuse erythema surrounding injection site and extending to the mid forearm no pain or swelling

Moderna COVID-19 Vaccine EUA: 4 hours after the injection, started the benign pain around the injection hole. It gradually disappeared over the following 3 days. In the 1st night after the injection, the immune system started fighting the vaccine, culminating in 39°C fever the following morning. Dozing in bed in polar dress under a triple blanket the entire day got the fever down to below 38°C. It was gone the next morning below 37°C.

One day after receiving the second dose of Moderna vaccine (specifically, 32 hours after receiving it), my left upper arm started to feel uncomfortable. I found a rash of approximately 2 1/2" x 4 1/2" had developed on the arm. The area is slightly warm and extremely itchy.

Patient had flu-like symptoms that included low grade fever, fatigue, aches and pains. Developed rash with itchiness near vaccine administration site on 03/06/2021. Patient began to take Benadryl to alleviate itchiness. Advised to contact PCP for further follow-up and to seek urgent care if shortness of breath, facial or throat swelling, high fever over 101, or rash spreads to rest of the body.

Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains

About 5 days later I noticed a swollen lump at injection site and a light pink rash -- several days later it's still there. I have no pain - feel fine-- just have the warm lump with the rash --- I have not been to the doctor'- just thought you would want to know about lump and rash.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

Went to the ed on saturday about pain at the injection site. They did an ultra sound and it was neg, some swelling was noted. Was given meloxicam 15 mg, after calling md thursday.

Went on line and found out people were getting the same symptoms I had and it said to take Benedril.(Antihistamine). I have Zyrtec on hand so started taking that and it stopped the itching. As of today I still have a couple of bumps on my wrist that still itch but have quit the Zyrtec after 3 days

tightening in his throat muscle; unable to move much; unstable blood pressure; unstable oxygen; bled due to blood thinner; weak in terms of walking; coughing; every joint and muscle from neck to toe in pain; every joint and muscle from neck to toe in pain; cold; entire body in excruciating pain; A bit off; Bruising in arm; A spontaneous report was received from a consumer concerning a 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following events: bruising in arm (contusion), a bit off (feeling abnormal), entire body in excruciating pain (pain), every joint and muscle from neck to toe in pain (arthralgia/myalgia), tightening in his throat muscle (throat tightness), unable to move much (hypokinesia), unstable blood pressure (blood pressure abnormal), unstable oxygen (oxygen saturation abnormal), bled due to blood thinner (haemorrhage), cold (feeling cold), weak in terms of walking (muscular weakness), and coughing (cough), The patient's medical history included small cancer treated last year with 38 radiation treatments. No concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031620A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced little bruising in the arm. On 12 Feb 2021, the patient was a bit off. On Sunday, 28 Feb 2021, in the evening, the patient got cold, and within minutes his entire whole body was in excruciating pain, every joint and muscle from neck to toe were in pain. It felt like it was invaded with COVID. He went to hospital and got tested for COVID, Strep throat and Flu, and all three test results were negative. On an unknown date, the patient experienced tightening in his throat muscle and he went to the hospital where he was admitted. While there, they did every possible test, chest MRI, Neck MRI, all possible viral tests, and rapid and full COVID test. The rapid and full COVID tests came back negative. Results for chest MRI, neck MRI and viral tests were not provided. The hospital also performed a blood culture for bacteria. Results were not provided. The patient was unable to move much, his blood pressure and oxygen were a little unstable. On 06 Mar 2021, the hospital did a major blood test which came back negative and the patient was released from a hospital. He stated that he was still weak in terms of walking and coughing. He stated that he recently bled due to taking blood thinner. Treatment included major antibiotic treatments and steroids for pain during the hospital stay. The patient was still taking prednisone at a tapering dose. Action taken with mRNA-1273 in response to the events was unknown. The events of weak in terms of walking, coughing were unresolved, while the outcome of the events of tightening in his throat muscle, unable to move much, unstable blood pressure, unstable oxygen, bled due to blood thinner, Bruising in arm, cold, entire body in excruciating pain, every joint and muscle from neck to toe in pain, every joint and muscle from neck to toe in pain was unknown.; Reporter's Comments: Based on a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Myalgia and arthralgia are consistent with the known safety profile of the vaccine

arm was sore for the first few days. 2-3 days later I broke out in a itchy rash on my upper arm near the injection site and then the itch went away and I had tiny scabby red bloody bumps on my arm. it is gradually going away.

about 7 hours after injection of sedond Moderna Covid-19 vaccine, the left arm became very sore and by the next morning was noticeable red and slightly swollen; very tender to the touch (skin hurt); this symptom lasted for about 4 days. A low fever 99F was observed in midafternoon for 3 or 4 days but subsided by suppertime. Chills seemed to occur in midevening and into bedtime, requiring hot drinks to comfort him, and extra blankets on top while watching TV or retiring for bed. Tired easily; would drift off to sleep sitting in chair about 10 or 11 AM; trouble focusing on reading or doing computer games. Took 3 and 4 hours naps in the afternoon but still felt like going to bed earlier than normal. Day 7 or 8 felt significantly nauseous and queeezy on and off for three days, and didnt eat very much. Sudden headache in upper forehead area lasted about 3 hours on two consecutive days. Constipated days 8-14 so took a stool softener days 12 and 13 and ate more fruit. Joints hurt, especially the right hip, to the point of not being able to dress himself days 6-13; could not do normal activities (stopped his daily exercise and walks, avoided getting up off couch or chair and asked me to bring things to him, used a cane when walking inside the house due to balance issues that got worse. Tylenol and Tylenol PM were taken to manage pain and for sleep. Took additional vitamin C and ate mandarin oranges for healing.

Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death

CLIENT DEVELOPED RED RAISED RASH WITH ULCERATION WAS SEEN BY PRIMARY CARE MD X2 VISITS. RECEIVED PRESCRIPTIONS FOR CEPHLAHEXIN 500MG AT FIRST VISIT AND BACTRIM DS AT FOLLOW UP

Hives with generalized itching. Clinioc nurse administered Solu-Medrol inj 125mg and benadryl injection 50mg. After 10 minutes Itching had stopped but hives remained. patient left facility

Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.

approximately one day following the event. noticed that his left upper arm (vaccine injection site) deltoid area and elbow are purple in color, the area is swollen and raised and tender to the touch, especially around the elbow. there are also pale raised bumps in the area.

No loss of function. 7 days after 2nd dose, noticed rash on left wrist, spreading to right wrist, then to right inner thigh, then to left inner thigh, over next 4 days. Right thigh is solid red, skin is thickening, with some cracking, white powdery apprearence. Wellness check w/PCP in two days (04/20/2021 9:40am).

RESIDENT STATES THAT HIS RIGHT ARM ITCHES FROM VACCINE SITE TO FOREARM AREA. AREA HAS RED DISCOLORATION. DENIES ANY PAIN AT THIS TIME.

Need to be able to attach photos of patient's arms and hands. Left arm became inflamed, colored, pustules, swollen, blackened fingers, swollen knuckles, five days after vaccine. Three weeks later, right arm did same thing. Patient continues to live with this condition, without pain, some minor itching, but much discomfort and embarrassment for people to see arms. He has seen multiple doctors, including primary care, dermatologist, urologist, cardiac specialist, oncology doctor, been in a rehab facility for two weeks after fall and L-1 fracture, and no one knows what it is, or what caused it. Very frustrating. Suspicious of Covid vaccination. Pt stopped taking amiodarone a couple of months ago, with no change.

Pt reports onset of macular type rash 3 days after receiving dose 1 and dose 2 of Moderna COVID vaccines

Patient had lymph node swelling within a couple of days after first shot (1/28/21) and rash or hives on his body and head. He has continued to have this rash even after the second shot (2/26/21). It looks real bad on one day then not as bad the next. It is random where he breaks out from his legs, arms, back, abdomen, etc...not staying in any one particular area. Could not get him to go and see a doctor yet. Pictures available if required. BIRTH DATE IS (disclosed) BUT PROGRAM KEEPS CHANGING IT TO THE 9TH INSTEAD OF THE 10TH.

Syncope; Injection site pain; Injection site swelling; Nausea; Vomiting; This case was received (Reference number: 1063219) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperlipidemia, Diabetes mellitus, GERD and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), METFORMIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 27-Feb-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 27-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient stated he developed a rash on both forearms approximately 3 weeks after receiving his second dose

but his liver had inflammation; jaundiced; dark urine; He did not receive second injection of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (but his liver had inflammation) in an 83-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. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine). On 30-Mar-2021, the patient experienced CHROMATURIA (dark urine). On 01-Apr-2021, the patient experienced JAUNDICE (jaundiced). On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATITIS (but his liver had inflammation) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Liver inflammation, at an unspecified dose and frequency. On 27-Mar-2021, PRODUCT DOSE OMISSION ISSUE (He did not receive second injection of the moderna vaccine) had resolved. At the time of the report, HEPATITIS (but his liver had inflammation), CHROMATURIA (dark urine) and JAUNDICE (jaundiced) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Biopsy liver: (abnormal) cancer free but liver had inflammation.. On 06-Apr-2021, Blood bilirubin: 36 (High) 36. On an unknown date, Blood bilirubin: 26 (Inconclusive) 26. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. On 30-Mar-2021, patient stated that his urine was getting dark and two days later, he started looking jaundiced. Patient saw the doctor on 06-Apr-2021. He was started on 20mg per day of prednisone. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. This is also a case of a 83 year old male who missed dose as a result of experienced illness.

blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-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. Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication. On 18-Feb-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) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved. Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners. Company 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, 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. However, Further information has been requested.

Moderna COVID-19. Vaccine EUA Exactly 12 hours after my injection, 1:30 am, I awoke with a severe coughing attack. In addition, my chest was wheezing and felt as if "bubbles" were in my chest. My arm felt very hot and tender at the injection site. This attack lasted for half an hour. I went back to sleep and awoke the following morning feeling very weak and confused. Feeling extremely fatigued, all I wanted to do was sleep. I also lost my appetite. The next day, I had occasional coughing which subsided with my over the counter cough medicine.

Oval shaped rash developed on or about 6 days after the injection. Lasted for several days. Slight itching experienced early on.

Pt. woke up the next morning after vaccination and "didn't feel well", described by wife as fatigue, no energy. At approximately 2 PM, he vomited. His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair. EMS squad was called but when they arrived he was asystole and mottling present. Did not start CPR since he was already gone too long. Pronounced by coroner on scene.

On January 20th, after 8 days site of injection was swelled the size of an orange, red and itching. This lasted about 4 days. I used Cortizone cream and took Benedryl. Five days later my wife had a reaction in her arm, but it did not swell , only got pink the size of an lemon. I only wanted to know if this was just a delayed reaction when I called your number, but was informed I needed to fill this form out & call my doctor. I never felt bad at any time.

Redness, rash, and swelling around injection site migrating to adjacent areas of the upper arm associated with severe itching. This began 9 days after injection and has continued for 6 days and is on-going at this time. Doctor has prescribed cold compresses and Ultravate topical lotion.

Non- cardiac chest pain intermittent 3 days. Soreness at vaccine site about 5 days. Lack of energy 4 days.

No immediate reaction to Moderna COVID-19 Vacination 01/15/2021. Swelling, tenderness, at vaccination site started on 01/21/2021. Increasing discomfort over few days included swelling, tenderness,and increasing bruising / hematoma on upper arm extending past elbow. Ultrasound of neck to wrist ordered by on Monday, 01/25/2021, revealed no venous blood clots. Swelling, tenderness, discomfort, range of motion limitation, though somewhat less intense, continuing through today (01/31/2021).

Rash on upper arm that has spread to both arms, legs, back of the neck and cheeks. Itchiness, redness, swelling. Joints swollen - particularly left elbow. No other symptoms (no difficulty breathing or other issues).

01/19/2020 Has shingles and it starts from his left ear in the back then down his neck in the back and half way down his back and up his left arm at the top. then it circles around to his chest and up to his nipple and half his breast area. went to and gave him something for the shingles.

Initially, red rash with severe itching at injection site on left arm, spreading down arm with increasing swelling, itching, and discomfort. Treated with Benadryl cream locally, Benadryl and Tylenol orally for 4 days with improvement. MD visit on 5th day of reaction for evaluation and prescribed Keflex for possible cellulitis. Swelling remains after 7 days but itching and redness decreased.

LEFT ARM STARTED TO BECOME VERY ITCHY AND RED STARTING ON FEBRUARY 3, 2021, 9 DAYS AFTER THE INJECTION. IT CONTINUES TO BE ITCHY AND RED AS OF TODAY, FEBRUARY 5, 2021.

Redness, soreness and severe itching started February 3, 2021. Progressed to include swelling of site. As of February 6, area of redness and swelling is now 8 by 10 centimeters. Has not responded to anti-histamines and steroid cream and local heat or cold.

Arm was sore after initial injection-but soreness increased and our first sighting of swollen redness was this morning-2-8-2021. NO fevers-just sore and swelling-about 3" by 3" and reddish in color-currently no itching or signs of rash.

ITCHING, RASH, SWELLING, PAIN ALONG DELTOID TO INSIDE OF ELBOW. STARTED ~2 DAYS AFTER ADMINISTRATION. AS OF 2/10/21- STILL RED "LIKE SUBNURN TURNING TO SUNTAN" NO LONGER SWOLLEN, OCCASIONAL MUSCLE PAIN "IF [HE] BENDS IT THE WRONG WAY"

Heavy itching at site of injection and down the arm for approximately 2 weeks Used itch cream and Claritin tablet every few days

Shaking chills, cold extremities, livedo reticularis on the thighs, lasted about 2 hours on the night of vaccination. Treated with tylenol. The next afternoon, he had documented ventricular tachycardia and his defibrillator fired 4 times in 1 hour, requiring EMS activation and hospitalization. His last ICD firing prior to that (only once) was in August 2020 and prior to that more than 2 years of no ICD firing.

SWELLING, REDNISS, MILD PAIN, ITCHING. TREATMENT: TOPICAL STEROIDS. Symptoms started 1 day after injection' Had similar episode after first vaccination, but onset was in 2-3 days, discomfort was less; first event lasted between 2 and 3 weeks duration.

Very sore arm with hard area at injection site, hematoma at injection site (day1), Headache, muscle pain, joint pain, fatigue (day 2), rash on left arm upper and lower (day 3 and 4 - current day).

Swelling of upper left arm to the elbow patient said it is red, doesn't really hurt but is very itchy. The redness started after the injection on 2/10/2021. Instructed patient to use ice pack on the upper arm arm and to take benadryl and use a topical anti itch cream.

pink swelling, warm, itchy circle at the injection site about the size of a silver dollar appeared 1 week after injection, and 24 hours later had grown in size by 4x.

soreness at injection site; 5 days later extremely sore left shoulder/neck, 2 days later extremely sore right shoulder neck

Patient reported mild rash that started at injection sight and spread across body on 2/11/2021. Patient was seen in clinic by one our doctors and given steroids. Patient's rash did improve and was able to present for second injection.

A FEW DAYS AFTER GOT 2nD COVID VACCINE STARTED TO HAVE RASH ON OPPOSITE ARM/SHOULDER THAT HE GOT VACCINE IN. SINCE THEN IT HAS SPREAD TO BOTH SHOULDERS AND TO NECK. SEEN PCP AND WAS PRESCRIBED SOME OINTMENT AND HAS BEEN TAKING BENEDRYL

February 11, 2021 – Arm pain – He starts taking Tylenol as prescribed on day of Vaccination. February 13, 2021 – Stabbing pain on the left side of the head (above his ear) – Poor sleep the next 2 days February 14, 2021 – Spoke to Dr – He ordered a CT Scan and recommended for him to take Tylenol Extra Strength. The headache continues to escalate. February 15, 2021 – He is taken to ER (Hospital) February 16, 2021 – He is released with pain/insomnia medication February 20, 2021 – He is confused, disoriented, repeats things, forgets things, has difficulty functioning normally and sleeping February 21, 2021 – He has difficulty standing, he falls, he has difficulty swallowing. He is taken to ER (Hospital) February 21-26 - He is still at the Hospital. Was diagnosed with Viral Meningitis/Shingles

3 days later redness and beginning swelling. Redness increased to about 5", some fluid developed, a lot of itching. Took about a week to go away.....no mobility issues. Vac site is fine now. Did not need to seek medical intervention.

loss of hearing/hearing completely gone in right ear; Ringing in left ear; probably vertigo; Extreme dizziness; blood pressure was 214/113; vomitng; Weakness; nasal drip; dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee; diminished hearing in left ear/sounds like listening through a drum; pressure in temples like a hammer on each side of head; headache in back of head; A spontaneous report was received from a consumer who was also an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme dizziness, nausea ,vomiting, nasal drip, weakness, loss of hearing/hearing completely gone in right ear (deafness unilateral), diminished hearing in left ear/sounds like listening through a drum (hypoacusis), blood pressure was 214/113 (blood pressure increased), pressure in temples like a hammer on each side of head (head pressure), headache in back of head, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 020L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported he felt fine for about one week after the vaccination. Then, in the early morning of 05 Feb 2021, right after midnight, he experienced extreme dizziness, vomiting, weakness, nasal drip, and loss of hearing including ringing in his left ear and no sound in his right ear. He also started to notice a dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient was taken by ambulance to the hospital. In the ambulance, he vomited and his blood pressure was 214/113. He was placed the COVID-19 wing of the emergency room (ER) and given tests including a COVID-19 test, sonogram, "echogram", MRI, and EKG (results not provided). The patient reported he was admitted to the hospital. He was told he probably had vertigo. After his ER visit, the patient had appointments with his general practitioner, an ear nose and throat specialist, and a hearing specialist. He was told his hearing was completely gone in his right ear and diminished in his left ear. The patient could still somewhat hear out of his left ear but it sounds like listening through a drum. He states he has to have his television up very loud to be able to hear it. At the time of this report, the patient continued to feel extremely weak, dizzy, and he had pressure in temples like a hammer on each side of his head, a headache in back of his head, and the hearing changes. Treatment for the events included unspecified medications in the ER. Action taken with mRNA-1273 in response to the events was not reported. The events of dizziness, weakness, loss of hearing/hearing completely gone in right ear, vertigo, weakness, diminished hearing in left ear/sounds like listening through a drum, pressure in temples like a hammer on each side of head, and headache in back of head were not resolved at the time of this report. The outcome of the events of blood pressure was 214/113, nausea, nasal drip, vomiting, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee was unknown.; Reporter's Comments: This case concerns an 84 year old, male patient, who experienced a serious unexpected event of Deafness (unilateral) among others, 9 days after receiving 1st dose of mRNA- 1273 (Lot# 020L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

Injection site area was hard; Injection site area was swollen (left arm); Vaccine not given in the deltoid muscle correctly; A spontaneous report was received from a consumer (patient), an 84 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced injection site area was hard (vaccination site induration), injection site area was swollen (left arm) (vaccination site swelling), and vaccine not given in the deltoid muscle correctly (incorrect route of product administration). The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 031L20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. The patient was concerned that they did not give him the vaccine correctly in the deltoid muscle on 09 Feb 2021. On 10 FEB 2021, the patient experienced that the injection site area was hard like a rock and swollen, approximately five inches below the actual injection location. No further information was provided. Treatment information was unknown. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome for the events, injection site area was hard, injection site area was swollen was considered as unknown, that of event they did not give him the vaccine in the deltoid muscle correctly was considered recovered on 09 Feb 2021.; 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.

02/21/2021 Patient was found on the floor of his room at 0800am hitting the right temple resulting in a laceration of the area. Patient complaining of Right arm pain within the location of vaccination site. 02/21/2021 1215 pm Patient fell forward out of his wheelchair hitting his right temple resulting in bruising and hematoma arm. 02/23/2021 1300 patient with increased agitation, combativeness, and change in mental status. Patient sent to emergency room for evaluation to rule out intercranial bleeding. Patient has fallen 3 times since the vaccine striking his head twice and now with changes in mentation.

raised, red, itchy scaly rash on arm after first dose worsening rash on both forearms, arm, back, legs after second dose, progressively getting worse over the past week

Patient received 2nd dose of Moderna vaccine on 3/5/21 to his left deltoid. On 3/14/21, he began to develop tender, swollen, and erythematous area of lymphadenopathy to his left axillary region. He presented to clinic on 3/16/21 with concerns for infection and was noted to have area of induration with surrounding erythema and swelling. Was treated for possible underlying cellulitis.

Swelling and redness at injection site and down arm. MD requested pt. be sent to ED. Was treated like a topical allergic reaction in ED with orders to continue and monitor. No further complications. Status improved.

9 days after vaccination area of injection started itching and became red. A little bit warm also. There seems to be a small bump. Before that there were no symptoms whatsoever. I do not feel any other reactions. Because of the original reaction to the vaccine which was none whatsoever, I was surprised by the redness and itching some 9 nine days later and decided to report it just in case it has some meaning.

2/22/21 - achy/weak, nausea/vomiting with clear vomit taste like blood, no fever 2/23/21 to 2/25/21 - continues with weakness and developed joint pain and red rash on arm that had injection - rash lasted 4 days 3/12/21 - developed pain behind left knee and down to left foot 3/15/21 - knee/leg pain contiues and goes to urgent care - diagnosed with DVT 3/22/21 - developed chest pain, goes to ER, diagnosed with kidney stones

After feeling OK for six weeks I felt like I was getting a normal reaction to the flu ? headache, achey legs, sensitive skin ? which cleared up after I took oscillococcinum; but then Saturday 3/27 my chest felt constricted and by Sunday I couldn't get my full breath. After being extremely low-energy all this time it occurred to me to take a reading on our oximeter and it momentarily registered 83, then 86, and came to rest at 91-92. I took a reading a little later and it was 95. I felt fine Tuesday morning but ran out of gas about noon. Then yesterday (Wednesday) morning everything seemed normal and has remained so. Now my reading is 97-98.

Rash, red and raise , intense itch on arms and legs and the body. Pt was prescribed zyrtec and used steroid cream. It has been continuous since the first dose on 2/27.

Severe pain on right side of body, rash. Took Tylenol to help relieve pain, went to see primary provider today and was diagnosed with shingles, MD prescribed Valtrex by mouth to help alleviate symptoms.

One week after the vaccine, my dad noticed that his urine was darker than usual. Then over the weekend, he started having jaundice. He was seen by his PCP who ordered labs and then referred us to a GI specialist. He has had multiple labs and a liver biopsy.

Large blisters all on the back and back of legs. Extremely itchy. Resolved in 1 week. Pt reported same side effects from a bubonic plague vaccine received decades ago.

No appetite, dizzy, rash around chest and very tired for 4 weeks. No treatment, Advised to consult with his primary care provider.

Singles virus broke out within one week of receiving the 2nd COVID-19 vaccination shot. The patient reported to Dr who was then given 400 mg of anti-virals medication. Patient did not improve and was taken to Hospital on 5/17/2021. The Patient was transferred to Hospital on 5/26/2021 and then died on 6/4/2021.

PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.

Upon awakening at 07:00 began an uncomfortable feeding in chest. Over the next few hours, the feeling became painful. The pain was radiating from the center of my middle chest outward. It became more painful to breath deeply. At about Noon I began feeling worse all over my body. Joint aches, sensitive skin and just feeling not well. It is now 1:48 and I feel no better, but no worse. A nurse from the facility, is going to give me and my wife a Covid-19 test momentarily.

Last night 01/24/2021 broke out in red bump that itch on my knee and legs and on my arms, on my hips and butt all the way down back of my legs. Called EMS and was given Benadryl and thats it.

day 10 after injection , light red swollen patch at vaccine location , approximate size 2" diameter, irregular shape, slightly itchy, Plan to visit family physician.

Area was red, lump and itchy for a few days after injection and was fine. On 1/29/2021, the area became red the size of a dime and on the next day, became about a two diameter and became itchy and hot.

So around 1/30/2021 I started itching all over my body and little red color bumps starting to come to up. I still got some bumps but it seems like they are getting better. I have tried to taking Benadryl.

Approximately 7 days after receiving first COVID 19 Vaccine dose, patient presents to clinic with rash on Trunk

9 days post vaccination pt developed a hard lump at injection site along with redness. States redness was itchy and warm like a "sunburn" approximately 3" x 2". As of date of report pt states symptoms are increasing.

Severe diarrhea starting at 0700 on Feb 11, 14 hours after receiving shot. Lethargic, weakness, no energy. Moderate soreness at vaccination site.

A few days after getting the vaccine, we had bad wind storm come in and I was without power for about a week. I was unable to shower and could not see my arm good. Around the 22nd I went over to my granddaughter's home to shower and noticed that my bicep was black, over the next week it spread to the left breast, collarbone to the elbow. The where the shot there is about a mark on the muscle where I got the shot. On 28th of January, I went to see my doctor, my shoulder was swollen and I could not raise my arm to about my shoulder level. When I try to move I could feel a pain up there. Doctor put ice on it and told me to take Aleve. Since the swelling has went down I am no longer putting ice on it, I am not using heat. I tried to put my arm in a sling but it is painful. The other pain I feel no pain in my arm is I sit on the couch and put my arm straight out and do not move. The black area on the bicep is almost gone, the darkened area up by my collarbone went away, most of the darkened area is on my left breast. If I rotate my arm counter clockwise or clockwise there is pain there and it feels like it is stretching the muscle. I have also seen Doctor on the 2nd or 4th of this month. I am thinking of going to see him again this week. My doctor thinks that the person who gave me the vaccine, hit a blood vessel and that is what caused the blackness on my arm. The pain is mainly in the collarbone area and in the bicep. Before this started, about the first of January I came home and went to put my keys up and went to reach up and had some pain in my arm, but the pain and mobility issues both went away before receiving the vaccine.

Squeezing headaches started Sunday afternoon and ended late Tuesday or Wednesday morning. On Wednesday, I had what I thought was a bug bite on my forehead but my wife said it looked like a broken blister. Thursday morning I had more blisters on the right side of my head (Forehead to the back of the my hairline). and went to a doctor. We all thought it ws a burn from a barbecue blow back on Sunday but the ophthalmologist a week later diagnosed it as Shingles. A week later the wound care specialist also said it was shingles.. I am starting the 6th week of Shingles.

patient received vaccine at Hospital and presented to our office w/ reaction 1.5 in x 2 in desquamation of skin with bleeding present to left upper arm, no purulent drainage, Cleansed area with sterile saline and covered with non adherent pad and Tegaderm, PLAN OF CARE: Obtained culture. Will start prophylactic antibiotic. Discussed skin care. F/u 2 days with prescribed clindamycin 300mg oral TID

Papular erythematous rash on left forearm with clear discharge. Rash is itchy. Started applying bacitracin, reports decreasing itchiness after 4 days of treatment, started on 02.22.21. Started on clindamycin, mupirocin ointment today for secondary bacterial infection on 02/26/21.

Mysterious rash appeared under both arms, down sides and on lower back and somewhat on lower abdomen Being treated with Mometasone Furoate Cream 01%

RED, ITCHY, BLISTERED RASH BEGINNING AT 4" SQUARE IMMEDIATELY BELOW INJECTION SITE NEAR TOP OF LEFT SHOULDER, AND GRADUALLY EXTENDING TO MID-FOREARM, RECEDING UP TO ELBOW AS OF 12 DAYS POST-INJECTION, TREATED WITH TOPICAL CORTISONE CREAM, RASH STILL EXTANT

presents to the emergency department status post mechanical fall this afternoon with a scalp abrasion. Patient states he had surgery performed 6 weeks ago to correct spinal stenosis for L3-L5, and had a recent fall with no LOC. Patient found to have a subdural hematoma. Currently admitted.

Started on 2/14, was full blown by 2/17. Rash covered Full body. (knees, torso, arms) Saw PCP who gave methopredisone. Steroids have helped relieve itching, started those on 3/3/21. Received second dose of moderna on 3/4/21, rash did not worsen after dose, remained the same. Rash is still visible but not as itchy.

Inflammed after the first shot and after second 5 days later very itchy rash left arm and all over body and back, not on legs.

Around mid-day the day after vaccination the patient started to experience chills, muscle aches, and flu-like symptoms. Throughout the day, he developed edema in his legs and feet. The following day, he noticed a rash on his feet, which resolved after about 24 hours. He had severe pain through the right side of his body, and some tenderness at the vaccination site.

Rash on left/right arm and to lower ribs. Continues to spread to right wrist. Consulted MD and was prescribed mometasone furoate0.1%. Has helped some but hasn't cleared completely.

4 days after 2 nd dose on 3/18/2021 my father/patient has growing rash, unusually large swelling of injection site arm, left arm. increasing sensitivity to shot, soreness.

Pt reported "chills and aches all over the body for a couple of days", he also had a red and swollen arm from shoulder to elbow. The arm is still red, but the swelling went down.