Moderna

Caretaker at Facility contacted me to tell me that this morning, patients left arm is red and raised all the way to the elbow and very painful. Patient gets scheduled ibuprofen for arthritis which is helping. She has had no other problems with other vaccinations including flu shot Fall 2020. Denies SOB, swollen tongue or throat, or rash/red areas anywhere else on body. Wondering if getting vaccine 3-1/2 months after getting COVID may be reason she is reacting. Caretaker anticipates she will recover just fine but is concerned about giving 2nd shot of series.

No symptoms at time of vaccine injection. 1 week later pt had hive like rash at injection site after a shower. Solid induration, warm and red, the size of palm of her hand. Pt put some neosporin on it but it?s still present.

Moderna COVID-19 Vaccine EUA Itchy red rash on upper arm below injection site, appearing 7 days after injection. Now day 11, it contunes to spread.

began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead

Injection arm (left) was itchy when we left facility. But other than that, no pain, no feelings of illness. So, didn't think much of it. After about three days, the patient developed (not sure of the technical term), large blood blotches beneath the skin. On both arms and on her back. The itching has subsided. Five days later, the blood blotches are still there but seem to be slowly improving.

Redness, itchy rash erupted on 1/28/21 on the upper left arm where vaccine was administered. Resident reported event today 2/2/21 to nurse at assisted living. Resident stated that this is 2 weeks and 2 days after being vaccinated. Resident does not report any other symptoms. Daughter will be notifying medical provider.

left arm pain and Malaise immediately after, followed by sweling in both feet and purple discoloration in feet that resolved spontaenously over the next 4 days. Erythema and swelling to bilateral upper arms with associated skin tenderness, Malaise / intense fatigue both not yet resolved at time of this writing on 2/3/2021.

7 days after injection developed redness and itching on R deltoid along with a flare of her chronic generalized pruritis primarily involving both breasts. 8X11 cm area of redness on arm; no discernable rash on breasts, some excoriation change on chest and back

11 days post vaccination, warmth, erythema diffusely over R arm 10 x 4 cm, diffuse margins c/w cellulitis, no f/c . presented b/c palpitations

Patient described a "post-card sized" rash about 4 inches below the injection site starting 10d after the immunization. Denies pain, pruritis, bruising.

Redness and swelling noted underneath upper right arm from elbow to armpit. Light pink in color. Denies any pain and occasional itching noted.

Day 12 post-vaccine - both arms red and swollen, swelling in extremities, irritation in vagina. Swelling worse in Right arm. Both legs had rashes, particularly the knees, feet red to the end of the toes. Top of legs were extremely dark. The symptoms are still present as of 2/9/2021

left arm swollen, red, itchy and "feverish. Patient went to the clinic initially provided "bactrim" - helpful with cellulitis. Patient then went to the Emergency Department 2/6/21 - for fever and body aches. Chest xray/labs/UA done with negative results. Recommended to stop bactrim and sent home.

I began to feel very tired and weak the same day slept through the night and all day the next day And all night the second night till 10 o?clock in the morning on the 13th. Within 12 hours my kidneys were working overtime I was running to the bathroom constantly. Couldn?t hold It at all. Made me incontinent for at least 24 hours up three or four times to go to the bathroom. Lack of appetite. Arm is aching at site of injection and a little red.

Received vaccine on 10th. On the 13th noticed arm was itchy and red like sunburn. Spread about 4 inches beyond injection site. Used cold packs for treatment and anti bacterial cream x 1 on Sunday night. Taking Tylenol BID

2 days after vaccination in left deltoid, patient developed erythema, swelling, and firmness circumferentially proximal to elbow and distal to, but sparing, the injection site. She felt mild pruritis and tingling sensation. 4 days after vaccine, she felt nausea without emesis. No throat closing, shortness of breath, chest pain, fevers change in arm's range of motion or strength. Likely represents hematoma (patient is on anticoagulation) vs local injection site reaction.

I noticed it felt itchy the next morning, she does get eczema at times, and thought that's what it was. She tried cortisone cream yesterday for the itching, but it did not help. This morning when she woke up the rash had spread and was all the way up her arm. She was putting cold compresses on it as well. She went to the UC at 1:00 this afternoon, who ordered an antibiotic and told her that there seemed to be an infection at the site of the needle. Told her not to use the cortisone cream, to use the cold packs.

Patient presented with hematochezia and bright red blood per rectum. Platelets were severely down to 1k. This was about 2 weeks after receiving the moderna COVID-19 vaccine first dose. Patient also with extensive ecchymosis on upper extremities and petechial rash on legs. Concern for ITP related to the drug. Patient received IVIg, Platelet transfussion, and steroids. Platelets slowly increasing, patient received NPLATE. The patient remains hospitalized with platelets up trending from 1--- >4--- >6--- >5--- >9--- >11.

Delayed reaction. 5 days after injection - itching, rash at site of injection , shoulder down to elbow. Still treating with Benadryl and hydrocortisone cream.

Patient said she has developed a red spot at the site of the vaccination and she noticed it about 8 days after vaccination. Was advised by staff to take tylenol and benadryl.

Severe redness, burning, pain and rash on arm starting from shoulder to below elbow which was diagnosed as celluitis and was treated with antibiotics.

Itching, inflamed, red patch below injection site upper right arm. Treated with Triamcinolone Steroid Ointment,. Ice, Benedryl. Slowly spread to about a 5 inch square section below the site. Started day 2 after injection. Continued for 14 days. Improved with treatment. Was treated for "infection" after first injection with DoxyCYCLINE Hyclate.. Symptoms were less severe and did not appear for 10 days after the first injection. This was not reported at the time. Due to the delay in the onset of symptoms (10 days) it was not diagnosed as Covid Arm.

Achy, fatigue, dizziness which subsided. Rash appeared at injection site 4 days after injection. Sprayed benadryl.

HIVES - ITCHING AND RASH She had Entyvio infusion on 1/12/2021 She had dose # 1 on 1/21/2021 She had dose # 2 on 2/18/2021 Her itching began day after (I believe) of first dose. Dr. contacted and we were prescribed Triamcinolone acetonide cream. That gave little relief. We went to see dermatologist on 2/5/2021 and were prescribed Clobetasol Propionate and itching began to subside. Immediately after second dose on 2/18/2021 the itching began once more. She had a rash that began on her neck and slowly moved to her back, then her arms and now on her buttocks. The itching is continual and rash moving

Warm to the touch; Tender; Swollen; Red spot; A little off from deltoid muscle; A spontaneous report received from a consumer concerning, 90-year-old, female patient who received Moderna's COVID-19 vaccine a little off from the deltoid muscle and experienced redness, swelling, warm to the touch, and tenderness. PT: [Product administered at inappropriate site, injection site erythema, injection site swelling, injection site warmth, and tenderness]. The patient's medical history was not included. Patient's concomitant included calcium, vitamin D, levothyroxine sodium, atorvastatin, citalopram hydrochloride, amitriptyline, triamterene/hydrochlorothiazide, acetylsalicylic acid, and lorazepam. On 02 FEB 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: 007M20A) for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient received the vaccine 'a little off from the deltoid muscle' as described by the patient's daughter (nurse). Approximately 9 days later, the patient developed a red spot on her arm and it was swollen and warm to the touch. At the time of the report, the patient's arm was still swollen. The redness was fading and her arm was tender. Treatment for this event included paracetamol. Action taken with mRNA-1273 in response to the event was not provided/unknown. The event, vaccine administered at inappropriate site, was considered recovered/resolved on 02 Feb 2021 The event, redness was considered recovering/resolving. The events, swelling and tenderness, was considered not recovered/not resolved. The outcome of the event, tenderness, was unknown/ not reported.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273, (lot # 007M20A) with associated injection site erythema, swelling, warmth, and tenderness. Based on the current available information and temporal association between the use of the product and the start date of the injection site events, a causal relationship cannot be excluded.

sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; 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.

The patient reported redness going down her left arm, about a foot in length. It was itchy as well. It has gone down from the initial time, but it is still visible. Patient says it is not bothersome

Per client telephone call: 3 days after injection, pink area developed about 4 inches down from injection site on left arm. Went away after a few days. Now area has returned to left arm and is itchy- returned 3/3/2021. Encouraged to consult with PCP prior to second dose scheduled 3/22/2021

received the Covid-19 vaccine. She reports symptoms of Other: Pt daughter reported her mother had a rash on her cheeks, tip of the nose and chin that wasn't there prior to the vaccine administration. .. I have observed patient sitting comfortably in recliner, no c/o dizziness, sob, itchiness, chest pain, HA , vision or swallowing difficulties. Note redness on checks , tip of nose, chin and noted red rash on forehead. Pt and daughter state pt has history of whitecoat syndrome. After last set of VS taken- bumps on forehead skin were noted. Pt transferred to ED via wheelchair daughter present. Treatment/intervention upon noting redness by daughter, pt monitored VS were: 1452: B/P 193/88, P80, R16, O2Sat 96% 1502: B/P 179/75, P76, R16, O2Sat 97% 1515: B/P 174/71, P73, R16, O2Sat 97% Bumps noted on forehead, patient transferred to ED via wheelchair. Daughter at side

Broke out in rash from lower extremities to thighs, looks like measles rash, slightly raised, red and itchy

Patient has an injection site reaction. Arm is noticeably red and swollen around the site of injection. Patient also reports that the spot is itchy. Patient contacted her PCP shortly after noticing the reaction who told her to use hydrocortisone cream.

Left lower leg and calf: severe nerve pain; skin sensitive to touch; sharp stabbing pain with slightest touch.

Ten days, 03-13-2021)) after receiving vaccine I woke up up at l:00 A.M. with pain, itching, redness and heat at site of vaccination with hard, raised area. I had an hive measuring l7"x5". Applied ice pack 20min on and off. I still have heat and itching at site 33 hours later. Slight pressure at back (right side) of head.

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe

unrelenting pain for 6 days, then in the area on the right side, opposite to the injection site, she broke out in shingles

Patients skin (torso, upper thighs and both arms and hands) began to itch on Friday the 19th. She went into the bathroom to check and found a rash had developed on her skin. She tried putting a lotion on her skin but it did not help. On Sat. she tried Benadryl. She had to take 4or5 doses before she found some relief. The itching and rash has never gone away. She states she used a wet wipe to wash her skin that had light perfume on it. Then wiped her skin with a wipe that had no fragrance.

Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine. The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal. Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific. Action taken with mRNA-1273 in response to the events was not provided. The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments: MOD-2021-047223:Crosslinked case

Bruise to Antecubital of opposite arm, denied having it prior to the vaccine being administered. No Resp. Diff, No urticaria, no Signs or symptoms of an allergic reaction. No localized pain to bruise site.

Patient developed a rash and angioedema at some point later in the day after receiving the vaccine. Patient reported taking Benadryl routinely for several days after the development of symptoms. This was self reported to hospital at time of scheduling the second dose. It is believed patient had some follow up with PCP, possibly per phone or office visit.

Noticed hot, red, swollen area where shot was given in right arm on getting up out of bed. States it was itchy as well. red area was about 2 inches in diameter and had a streak of about 1 inch wide and 2 inches long around the arm towards the inner arm. the area lasted a couple of days this way and then started decreasing in redness and feeling so hot and being swollen. We used an ice pack on it a few times a day. It was finally all gone in a week.

Measles like red itchy rash over all body but especially areas of sun contact such as tops of hands, arms and chest after 7 days of anti histamine pill still itchy and now face swollen and red

On Day 1 of second dose, immediately developed Covid arm. On Day 2, developed a red rash (no papules or discomfort) on ankle tops & shins. Day 3 it spread out on leg tops. Day 4 the spots seemed to get larger and blend together, continued to move up legs into thighs. Day 5 more blending of spots on ankles, legs as there are now large red areas. Rash began to develop on arms. Day 6, rash spread behind legs and under the arms. She only had mild itching at the injection site. Out of concern due to my mother's age I called her physician to report this on Day 3. Dr. advised her to take Zyrtec during day and Benadryl at night for itching as needed but did not see my mother. My mother has not taken these meds. She did not take any Zyrtec or Benadryl because she has no itching, just this awful looking rash that doesn't hurt or itch. Occasionally she gets a prickle of an itch but not much. She takes Tylenol for any aches of arthritis, too. I have pictures of each day of this if it is helpful to you. Today is Day 7 and her leg tops are beginning to look a little better but the backs of the legs and arms are now affected with the large almost melted rash into several big areas of red. She also has minimal spots on her buttocks but nothing like legs and arms. Interesting it is only in her extremities (we are so glad!!) and we are hoping it will resolve completely. She wanted you to know her reaction to help you. Due to her age, I will be taking her calls for her.

On 3/31/2021, it was noticed that she was jaundiced. Labs were drawn which confirmed jaundice (bilirubin of 4.4 - unconjugated) due to a new Hemolytic Anemia (HGB 9.3). The HGB was 11.7 on 2/28/2021.

Second dose given 21 days after 1st dose. Patient reports on 5/21/21 that she feels great and she has had no signs and symptoms to report other than a slight sore arm at the injection site lasting only for a few hours the first night.

Redness and irritation around the injection site, feels warm to the touch, is sore and aches a little bit.

noticed a rash on her back early in the morning. She said it is very itchy especially around the right shoulder. The rash is visible but not extremely noticeable without taking a close look. It looks like there are some hives.

Red skin with a slight rash and a bothersome itch became present at the injection site. it is about one and a half inches in diameter.

Small area of swelling and induration apprx 2.5-3 inches below vaccination site on L upper arm. Denies itching, pain. No discoloration or tenderness to palpation. Area is irregularly shaped d/t gravitational pull of fluid towards her elbow.

injection given 1/20 on 1/28 sister developed redness and warmth at the cite encompassing upper left arm cool to warm compresses tylenol temp bid and monitor

Resident stated that her left arm began to itch three days after receiving the vaccination. Over the last 2 days, her arm became red. Resident has an oval-shaped 7x5 cm red, indurated area on her upper left arm.

Other meds; potassium chloride, VitD3, super B complex, Cal-mag-zinc. Increased neuropathy with increased pain, stiffness, myalgia, arthralgia, prickly skin feeling all over, sensitive. Criteria for reporting: states saw Dr. 1-18-21, prescribed steroids. Took prescribed pain meds and prevented her daily activity; Grade 3 for pain and fatigue, myalgia, arthralgia.

Patient has a large (golf ball sized) welt on back side of left arm that she noticed a few days after vaccine. She had a friend circle the welt and as of today (2/6/21) it has not grown. It is not red, not painful to touch, but firm. I am not sure that it is from the vaccine since it is closer to the back side of the arm and not in the deltoid muscle, though it did occur around the same time. Patient notified her doctor and was advised to ice the lump which provided no help. I advised her to actually be seen by her doctor to have it assessed. She will call to schedule an appointment.

Feb.4th 'shot area' inflamed and itchy. Redness about half around arm and 6 inches vertical. Feb. 9th(2 wk after) redness has faded. Red pimply itch spots appear.

Developed a red Itchy rash on the outside of the arm 10 days after the injection. Rash is on the outside of the left arm from the elbow to the middle of the upper arm. Started on 2/15/21. Still present on 2/18/21.

within 24 hours circular brown spots about the size of a quarter and the color of a dark bruise appeared on both arms and at top of one leg; spots were not painful and did not itch. they are ongoing

pt stated 2/22/2021 she woke up with a red itchy rash on the left arm. On 2/23/2021 pt had rash on both arms and upper chest. It has spread to neck, behind her ears and onto her shoulders. On 2/24/2021 it spread to her left thigh. Pt was putting Sarna cream on the rash. Pt called her Dermatologist. Since they told her they could not see her until 2/26/2021 and told her to go to he ER. Pt ended up going to the hospital. She was treated w/medicine and discharged w/ a prescription for prednisone, Epi pen and also told to take Zyrtec. They told her not to use the Sarna cream any longer. She is going to FU w/ her PCP on 2/26/2021.

After 2-3 days developed redness to arm where the vaccine was given, appears to have a blister at injection site. Saw NP and was given hydrocortisone to apply to area, area still noted to be reddened, no pain noted at this time.

Injection site sore the day of the injection. Soreness went away the next day. Eight days after receiving the vaccine, the patient's arm became sore (2/26/2021) and is still sore today (2/27/2021). Called "Ask A Nurse" was told to apply heat or ice for about 20 minutes.

Started with slight itchy rash on Feb 27 on right side of face. Became more itchy and spread on Feb 28. Face swollen to almost eye shut by Mar 1, very itchy and weepy. Rash also visible on neck and front of torso. Visited doctors office on Mar 1 at 1:00pm. Received prescription for Prednizone 20mg, to be taken over 10 days. Seems to be working, swelling is down and not as severely itching. Still very visable and dry crust forming on face.

several days after 2nd vaccine, pt. had shingles outbreak. Her PCP stated was directly related to vaccine

large area of erythema and mild swelling measuring 26 cm x 28 cm affecting the left upper arm which is where the injection was located (left deltoid is where the injection occurred). Itching noted. No pain, no induration. No systemic symptoms, angioedema, or shortness of breath. I advised use of a non-sedating antihistamine and gave her a prescription for topical triamcinolone.

Patient's daughter called to report that patient had received vaccine Friday morning, by Friday night was in bed with tired, achy and flu like symptoms, stayed in bed all Saturday and woke up feeling better on Sunday. Sunday night arm began to itch at injection site. Has continued to itch and has become red and swollen. Reddened are extends from just below injection site to elbow. She stated it begins at the back of the arm and wraps around the front.

Rash, itching, seeping in large circle around injection site, that cleared up and then it moved outward. Also, liquid under skin moving down through the arm until it was absorbed around and below elbow. Used Benadryl topical on arm and warm compresses.

Rash on arm covering majority of area between shoulder and elbow, treatment with cortisone cream. Recommended Claritin 10mg daily until rash resolved.

One week after receiving the second dose of the Moderna Covid-19 Vaccine, the patient had some swelling and itching at the injection site. The second dose was received on 3/9/2021, and the reaction began on 3/14/2021. The patient reported the event to the pharmacy on 3/18/2021. This reaction is known as "Covid arm". She has tried aloe cream as well as cortisone cream during the day. The patient has taken Tylenol PM (acetaminophen and diphenhydramine) at night.

Severe itch on arm from shoulder to fingertips. I tried ice, but it did not help. After 7 days, I was desperate, so I called Dr. who told me to take a Benedryl and use Hydrocortizone cream. I did that for 8 days and it stopped.

Developed Shingles; This morning had a lot more burning; Itching and Burning; A spontaneous report was received from a consumer concerning a 91 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Shingles, itching and burning, this morning had a lot more burning and it was running down the leg. The patient's medical history was provided not by the reporter. No concomitant medications were reported. On 28 Jan 2021, about seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: probably 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 03 Feb 2021, a week later, the patient developed shingles and an itching and burning. On 05 Feb 2021, this morning had a lot more burning and it was running down the leg. Treatment included anti viral drug for shingles and lidocaine for itch and burning and pain. Lab details were not provided. The seriousness criterion for all the events was reported as other without a rationale. The event is serious meeting Medical Significant criteria due to the necessity of treatment. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, developed shingles, itching and burning, this morning had a lot more burning and it was running down the leg was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Itching and swelling of right hand. Erythema. Began about 30 minutes after injection and lasted through the night, decreasing in intensity but still itching through the next night.

Client was vaccinated in the triceps area of the arm instead of the deltoid. The vaccinator stated that the client was very frail and he did not feel there was enough muscle mass in the deltoid to administer the vaccine there. He opted to give the vaccine in the triceps instead. Vaccinator has been counseled on this and explained that a better muscle to use would have been the anterolateral thigh. Per information from CDC, this dose does not need to be repeated. District Nurse Manager followed up on client today (3/26/2021), and client only complains of soreness in arm at site of injection.

24 hours after-headache- sinus type 48-hours -after- headache and body aches particularly left buttock 72- hours after- all of above plus 100.2 fever, extreme body aches, chills and could barely walk 96 hours after- symptoms going away, 120 hours after- only headache remained and red spot on left arm developed One week later all symptoms gone

Felt weak; Neuropathy; hot skin all over; skin burning; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak) and NEUROPATHY PERIPHERAL (Neuropathy) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt weak) (seriousness criterion hospitalization), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Felt weak), NEUROPATHY PERIPHERAL (Neuropathy), FEELING HOT (hot skin all over), SKIN BURNING SENSATION (skin burning) and PRURITUS (itchiness) had not resolved. Treatment Medication was cortisone cream, cerave, and Citalopram. This case concerns a 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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 91-year-old female hospitalized with serious unexpected events of peripheral neuropathy and asthenia, along with nonserious unexpected skin burning sensation, feeling hot and expected pruritus. Event onset Day 2 after second dose mRNA-1273. Events ongoing. 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.

cellulitis was developed belowher injection site which is 3-5 inches in size; Fever 99.7 F; mild headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) (seriousness criterion medically significant). In April 2021, the patient experienced PYREXIA (Fever 99.7 F) and HEADACHE (mild headache). At the time of the report, CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) was resolving and PYREXIA (Fever 99.7 F) and HEADACHE (mild headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 99.7. The patient was taking unspecified concomitant medication. The patient visited her Doctor's office and started treatment which her MD prescribed sulfamethoxazole oral antibiotic, and mupirocin 2% Ointment. Action taken with mRNA-1273 in response to events was not applicable. Treatment included Sulfamethoxaz and topical ointment. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter details, event (fever 99.7) and treatment medications were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Son states that on February 7th his mother developed shingles. On February 12th developed Bell's Palsy. On May 15th at 9:00 PM his mother had a heart attack. Is recovering at healthcare facility.

Patient called today, June 3, stating last night she experienced itching on the arm in which she received the vaccination. She also states the area is red. I informed her she could apply ice to the area to help with itching and told her the redness should resolve in about a week.

Exactly two weeks following the vaccine, the patient broke out in both upper arms which she described as similar to hives. She has been diagnosed with agranular accura. She had little red marks on her skin that she described as very itchy.

passed away; received second vaccine 44 days after receiving the first dose; Pain the injection site from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain the injection site from the first dose). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose). On 05-Apr-2021, VACCINATION SITE PAIN (Pain the injection site from the first dose) had resolved. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose) had resolved. The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-132760 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Case upgraded to Serious due to death.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-132760:Son; Reported Cause(s) of Death: Unknown cause of death

April 1, 2021 a rash occurred on both legs from above her knees down to her toes. Legs began swelling, experiencing nerve pain. Received one shot of prednisone in the shoulder. June 28, 2021 legs are still swollen.

2 weeks after after her second moderna vaccination which was on 3/30/21 patient states that her hair fell out making her almost bald.she showed me on 7/6/21

The patient described a red rash that started about a week after the vaccination and resolved over a couple of days.

blood pressure became very low; experienced cellulitis in her legs; Diagnosed with COVID a week later; she couldn't even remember anybody; acute Alzheimers; had mild dementia but towards the end it seemed to have exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), HYPOTENSION (blood pressure became very low) and CELLULITIS (experienced cellulitis in her legs) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dementia. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers) (seriousness criteria death and medically significant), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated) (seriousness criterion medically significant), HYPOTENSION (blood pressure became very low) (seriousness criterion hospitalization), CELLULITIS (experienced cellulitis in her legs) (seriousness criterion medically significant), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody). The patient died on an unknown date. The reported cause of death was death was acute alzheimers. It is unknown if an autopsy was performed. At the time of death, DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), CELLULITIS (experienced cellulitis in her legs), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody) outcome was unknown and HYPOTENSION (blood pressure became very low) had resolved. Treatment included unspecified pressors. No concomitant medications were reported. Patient received the 1st dose of the Moderna COVID-19 vaccine in FEB-2021. Caller did not know the exact dates of administration of the two doses. Patient was then diagnosed with COVID a week later. Patient did not have much of a reaction to the 1st dose or any symptoms from COVID. She then received her 2nd dose of the Moderna COVID-19 vaccine in middle of FEB-2021, per the caller. In the end of APR-2021 or beginning of MAY-2021, patient experienced cellulitis in her legs. Her blood pressure became very low and she was hospitalized for treatment. She was put on pressors. She recovered from it and was sent back to her assisted living facility. However, on 25-MAY-2021, she passed away at the assisted living due to acute Alzheimers. Patient had mild dementia but towards the end it seemed to have exacerbated, where she couldn't even remember anybody. Her diagnosis at the time of death was acute Alzheimers. This case was linked to MOD-2021-034532 (Patient Link).; Sender's Comments: This is a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch unknown) who experienced exacerbation of her DEMENTIA, ALZHEIMER'S DEMENTIA, HYPOTENSION and CELLULITIS after her second dose of vaccine, leading to her death from ACUTE ALZHEIMERS. Advanced senior age also could be attributed to the development of the events. It is unlikely, that the events are related to the vaccine based on long standing illness of DEMENTIA. . Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: death was acute Alzheimers

12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics

1/8/2021- 1/12/2021- complaints of intermittent L thigh pain 1/8/2021- Moderna Vaccine given 1/12/2021- continued c/o pain to Left hip/thigh, Rash noted to L inner thigh/groin. 1/13/2021- VS: 97.1-69-18-110/70-SpO2 97% on RA. Notified PCP regarding rashes/lesions with vesicles to left inner thigh and left posterior leg and left lower back. With orders to start on contact/droplet precautions. Famciclyclovir 500 mg tab PO QD x 7 days. Dx. Shingles. 1/13/2021- Medical director advised reporting to VAERS.

She developed erythema, swelling and a rash to Left deltoid area. She also developed increase swelling to BLE with rash and itching.

Redness, warmth, pain, RUE measuring 9.5cm x 15.0 cm noted on 1-17-2021 continues with redness (fading) on 1-21-2021 warmth. Denies pain unless bumped. Resident afebrile. Size remains unchanged

the following day 1/14/21 was extremely fatigued and had the big red mark and itch in the area of the injection. It went away and 8 days later 1/21/21, 2" diameter big red area that was itchy came out. No pain in the arm unless touched, hard to touch. Still has red hard area, warm to touch.

Modern a COVID-19 Vaccine EUA Pink circle at shot location, seems to be itchy , is not warm to caregivers touch, person does not have a fever Warm cloth, cream on arm lesson the itchy feelings in other parts of her arm due to normal dry skin Calling her primary care doctor 01/25/2021

PROBABLE CELLULITIS OF ARM AT INJECTION SITE (BLISTERED) WITH WARM ERYTHEMA FROM SHOULDER TO ELBOW. WENT TO ER AND HAD WEEK COURSE OF ANTIBIOTICS.

Moderna COVID-19 Slight swelling at site of shot Rash and slight itching along upper arm eight days after shot. Now four days later - no worse and no hindrance

Resident was noted with generalized rash throughout her lower and upper extremities, trunk, back area. left harm at injection site was grayish red.

Symptoms hit suddenly around 2pm on 2/112021( approx. 25 hours after vaccination) Soreness in right arm, Stomach cramping, Severe Chills, Low grade temp 99.8, Nausea. Pt was given Tylenol at 530pm and again at 2 a.m. on 2/12/2021. Symptoms subsided by the morning of 2/12/2021 but patient remained fatigued and "drained." She did not seek medical attention for this

Right arm redness started on 2/5/2021. Treated with ice to site TID. Mostly resolved at this time.

SWELLING AND PAIN IN HAND AND WRIST IN RIGHT ARM (WHICH IS THE ARM THAT WAS VACCINATED). PAIN AND HEAT AT SITE OF VACCINATION. INTENSE ITCHING, SORENESS AND REDNESS WHICH BEGAN 2 TO 3 DAYS AFTER VACCINATION OVER INJECTION SITE. THE PINK/RED, ITCHY, RASHY AREA HAS NOW DESCENDED TO HER ELBOW, IS SLIGHTLY SWOLLEN, 3 INCHES BY 5 INCHES (NO LONGER OVER INJECTION SITE)

Red spot about 2" diameter, itchy and itchiness in wide area around injection site., slight ache in right arm

Already reported "covid arm". Additionally, rash appeared on left foot, as well as both arms itching. Itching has subsided and rash is disappearing.

Hives on trunk, cellulitis at injection site Treated with prednisone, claritin, hydrocortisone cream and antibiotic for cellulitis

"Moderna COVID-19 Vaccine EUA"; experienced itchiness at the injection site about 2 hours after the injection. After about 48 hours developed a circular rash at the injection site and it continued to itch. Applied a topical OTC hydrocortisone 1% ointment on the affected area at about 9:00 PM on the second day after the vaccine. The itchiness has thus far subsided as of this report.

Received the vaccine had no reaction, no temp, no headache. She felt a little funny, and possibly a week later she started getting reaction in her body, burning sensation in her chest, possibly thought related to acid reflux. She then had sensation down her leg nerve pains. Sometimes she also gets some hot flashes but they go away. She woke up early in the morning yesterday and had a pressure like sensation in her head, she still has that today. She still has burning sensation in her chest, and her legs and ankles are hurting still. She has taken some Tylenol for the aches and pains. Also has itchiness of her arm from the vaccine, as well as soreness.

Rash developed on upper chest, underarms, forearms, under breasts, stomach, and pelvic area over a period of three days, progressing in area coverage and intensity of itchiness. Physician diagnosed it as "old age skin" problem, recommended using Eucerin lotion to hydrate skin. Did not prescribe any medications and said it was not related to the Covid vaccine, since the rash took a week to appear after the second dose.

pt developed golf ball size swelling on left arm immediately following covid vaccine dose 1 administration. pt had minor bleeding after needle removed from pt, then blood pooled in the surrounding area to a golf ball sized lump. applied pressure to stop the bleeding, monitored swelling and provided pt with ice pack to reduce swelling. swelling decreased significantly during 30 minutes post administration. followed up with pt via telephone 2 hours post administration - pt said that swelling continues to reduce. no pain.

Patient c/o feeling flushed, color pale pink, warm, dry. Radial pulse strong, steady. Breathing unlabored.Patient given bottle of cold water to drink, no swelling to face or lips. Patient stated she did eat breakfast that morning. Patient states water helping, then has some coughing after a drink. Patient states she often coughs after drinking things, denies difficulty breathing or swallowing. Patient c/o head throbbing after drinking. C/o nausea and has dry heaves x 1 but no emesis. Patient states has some chronic breathing problems and heart problems. Family member at side. BP 146/90 left arm sitting automated cuff, pulse 84. Respirations even and unlabored, O2 sat 88% on RA, Patient remains alert and talking, nausea subsides. Patient assisted to stand and ambulate with walker to be dismissed at 1053, but is dizzy so sat back down and dizziness subsides. Patient remains sitting and alert, talking to volunteer medical staff member. BP decreases to 132/86 and pounding in head decreases. Patient reports feeling okay to leave and at 1107 ambulates out with her walker and stand by assist from volunteer member and patient's family member.

EMT who administered the vaccine alerted me to swelling posterior to the injection site. Vaccine appears to have been aimed at the posterior edge of left deltoid. Skin laxity probably led to tracking subcutaneously. Unclear how much of the vaccine was IM vs SQ.

She got the vaccine, the first day it was very very mild until later. Then it started hurting in the back, but the arm did not hurt at all the first day. Four days later it started itching bad, and the 5th day it itched terribly bad. She stated it lasted a long time and stayed hard for several days. She states that she is still having some of the feelings. The 5th day was the worst by the 5th day,. It took a long time for the symptoms to go away.

Swelling in mouth, bottom lip, and tongue, sore throat Itching on entire body and head Rash on entire body --looks like sunburn PCP prescribed-- Prednisone 10mg tab--12 day course on 04/5/21 Betamethasone valerate 0.1% ointment on 03/25/21 Patient claims to be recovering

After few minutes she complained about itching, asked her to stay more than 30 mins and she said still itching. After an hour gave a Benadryl and she said she can fell that the itching is going down. Monitored for 1.5 hours and let her go with instructions to follow if needed.

5/18/21 9:20pm - c/o general aches & soreness right arm 5/19/21 6:10pm - c/o general aches, sleepiness, soreness to right arm temp 99.8 5/20/21 11:21pm - redness adminstration site, redness & puffiness to eyes & face, arm very sore 5/21/21 11:02am - c/o pain at injection site, red, warm, swollen, afebrile 5/21/21 10:03p - arm red, warm, swollen at injection site, afebrile, states feels better today 5/25/21 4:27am - lethargic, tremoring, nausea, diarrhea, temp 103.4 pulse 128, SPO2 82%, sent to hospital

Erythrodermic rash of the torso and extremities. Not responsive to prednisone and hydroxyzine after a week of high dose burst.

Rash and itching developed over arms, legs, neck, trunk, stomach, crotch, scalp. Persisted for weeks and would not abate with several prednisone treatments. Blisters arose at each point of irritation along with red splotches. Begins with burning, then itching, followed by visual eruption. Inflamed sites are hot and swollen. About 15-25% of body affected at any given time, mostly upper body and arms. Rashes moved over time to various locations. Patient began to feel badly around June 15 2021, with symptoms including: extreme weariness, novel tinnitus, severe itching an burning at night, novel severe brain fog and confusion, inability to drive or accomplish household tasks, novel ocular migraines/loss of vision, headache, loss of appetite.

within 24 hours- Large "golf ball size" lump. Hard, hot to touch, red from injection site down to elbow. after 36 hours swelling had gone down, redness had moved all the way from the injection site to wrist. No pain noted, skin temperature was back to normal.

pt stated within 10 minutes after receiving vax she became flushed, had chills, cold sweats and palpitations. Pt stated her vitals were taken and her BP was 215/104. After about and hour it came down to 160/?. Pt stated that 2 weeks after the vax she developed a 6" red, warm, swollen, itchy area around injection site. Pt stated her symptoms have subsided but she has contacted her PCP about getting second dose and was advised not to take it.

Rash, redness and swelling, also itching around injection site. Saw primary physician who prescribed Keflex, but I learned that symptoms would be short lived so I talked with MD and cancelled the RX. Symptoms are gradually disappearing.

Pt received Moderna COVID vaccine at 0850. RN responded when pt c/o dizziness at 0905 while sitting in observation area. Pt pink, warm and dry. RR easy and regular. Radial pulse 100, BP 174/108. Pt stated she took her morning meds including antihypertensives this am at 0800 on an empty stomach and then did not eat breakfast. Pt given water to hydrate and crackers. At 0910 pt denied dizziness. At 0910 BP 200/76 and pt stated I feel better. Both nurses remained with pt at all times. At 0918 BP 208/88. Pt encouraged to go to ER or her PCP for further evaluation. Pt's niece was in attendance and made an appt with pt to go to her PCP at 1215 today. At 0930 pt stood and ambulated and stated she felt fine to go to her doctor. Pt escorted by wheelchair to her car per volunteer staff. Pt discharged with her niece in attendance.

Rash first starting to present mildly on 1/8/21 after receiving the first vaccination on 1/6/21. However after the vaccination on 2/3/21, the rash spread and became more severe. On 2/10 the nurse manager stated the following: The rash is located on bilateral arms, back, chest, upper bilateral thighs, and groin area. The areas present as little bumps that are raised and have been scratched open. Resident is saying they are extremely itchy and causing her much distress. Resident went to the ER on 2/10/21 and received a steroid, antihistamine, and diflucan and they also prescribed Doxycycline and Triamcinolone cream.

In the morning following the shot, she could not get out of the bed without assistance. She was very weak and could not stand by herself. She did not want to eat very much. Then by lunchtime, she was running a fever of 102.5 fever for many hours. We put her to bed. On Sunday morning she was much better with a better appetite and no fever. She also had normal amount of energy. She had a rash on her arm that received the shot and it ran from her spot of injection to her elbow. It was hot with the rash for about 5 days.

Day after vaccination patient reported arm was red and warm to the touch at injection site. Advised the patient to see her PCP. Called her to follow up and patient reported that she cancelled the PCP appointment because the reaction went away on its on a couple of days later.

Sharply demarcated pruritic 2.5 x 1.5 inch oval shaped red area of inflammation / erythema at site of injection. Symptoms started 2/21/21, 13 days after the first dose Moderna COVID-19 vaccine series. Treated with diphenhydramine for 2 days. No longer pruritic. Red area completely resolved by 2/26/21

SOA, hives, anxiety started immediately after getting vaccine. Treated with Benadryl, methylprednisolone, Pepcid. Pt was in ER for one hour and discharged home.

pt has CTCL and has developed more intense itching than usual. Pt has dementia but has had more severe episodes of aggression, confusion and delirium. Her upper left arm is red and has developed more defined lesions around the injections site and on her lower back. Her arm pain and back pain seemed to be heightened more than usual and she also has some fatigue. Pt saw her cancer Dr. on 3/24/21. Dr. made notation in her chart about her symptoms and was instructed to continue the using the cream that she was currently using. Pts PCP is aware of the increased episodes of confusion and being argumentative since taking the vax. Pts daughter is her full time care giver and is dealing w/ her increased intensity of the patients symptoms.

Moderna COVID-19 Vaccine - Pt reported dizziness, nausea, chills and red and swollen arm after receiving her first dose of the moderna covid-19 vaccine. Pt stated that she rested and stayed hydrated and symptoms went away after a couple of days. She decided to forgo her second dose until she has talked to her doctor.

4/16 515am Itchy at vaccine area, nausea, used Sarna itching lotion, tylenol 230pm more itching lotion 315pm redness the size of baseball, hot to the touch, went to urgent care, icing 4/17 physical aches throughout, continued icing and tylenol 4/21 4am nausea and aching all throughout the limbs, couldn't walk due to pain in thighs, short of breath, tried to rest. the pain continued for over an hour till fell asleep.

Noticed some itching and redness around injection site on 4/28. Redness expanded in band around upper arm by 4/30. Today there is some itching and most of the redness a gone away.

Pacemaker Surgery; patient did end up missing the date of her second vaccination and has not received it; feel itchy; feeling very funny and real strange; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange). On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it). At the time of the report, CARDIAC PACEMAKER INSERTION (Pacemaker Surgery), PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Electrocardiogram: normal (normal) heart was operating properly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taking unspecified blood pressure medication concomitantly. Following the administration while the patient was in the clinic, she began to feel itchy, very funny and real strange. At this time the EMS on site were concerned and preformed an electrocardiogram (EKG) on the patient to make sure that the heart was operating properly. It was deemed that it was and the patient was then sent home. After that time no other side effects were present but the patient did eventually have to go into the hospital for a Pacemaker Surgery that was believed to be unrelated. The date of this surgery could not be remembered at the time of the call. No treatment 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.; 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.

The entire outer forearm, starting about an inch below the vaccination site, all the way down to the elbow, turned red and would itch. This began the next day after the vaccination and has persisted for the past six days. I have applied Hydrocortisone creme 1% two or three times every day and that helps relieve the itch, but the swelling and redness continues.

Patient reports red dime sized circle near injection site. She noticed it on 7-10-21 but is not 100% sure when it began. It is not itchy or painful. Patient advised to follow up with PCP.

PT CALLED 1/11/21 STATING THAT SHE RECEIVED HER 1ST SHOT HERE ON 12/30/20. PT STATES THAT HER RIGHT ARM WAS BRIGHT RED FROM THE SHOULDER TO HER ELBOW. SHE SAID IT WAS HARD WHERE HER SHOT WAS GIVEN, BUT NOT HOT TO THE TOUCH. SHE STATED THAT SHE DID NOT HAVE A SMART PHONE OR COMPUTER SO SHE WAS UNABLE TO CONTACT ANYONE. I TOLD HER I WOULD DO THIS REPORT AND ATTEMPTED ON 1/11/21 BUT IT DIDN'T GO THROUGH. I ADVISED HER TO SEE HER PCP. SHE CALLED TO MAKE AN APPOINTMENT AND THEY TOLD HER TO CONTACT THE HEALTH DEPT.

Client noticed on 1/27/21 that arm was itching, then noticed on 1/28/21 that arm was red and warm to touch. redness progressed to lower arm by 1/31/21. Saw MD on 2/1/21. Advised she was ok and client was ok to get 2nd dose. Client started using Benadryl and cool compress on 1/29/21 or 1/30/21.

Large Rash 4"x 2.5" developed under the left breast. Red/purpleish in color. No pain or itching reported by patient. Patient never had a rash under breasts in past 7 years of care after TBI . Treatment with OTC Gold Bond Medicated Extra Strength Body Powder and tissue to prevent skin from breast touching skin on the rib cage. Rash has not gotten any worse or better since first found a little over 24 hours prior to reporting this

On 2/11/21 bruising possibly related to anticoagulant use. D'C's med. 2/21/21 recieved vaccine, dose #2. on 2/14/21 resident expereinced a temp of 100.4°F. C/O "pain all over". MD visited resident in the facility on 2/14. Spoke with family, comfort measures only. Due to history of ESBL treating empirically with ABT. As of 2/19 no improvement in condition. On comfort care.

Left upper arm, at site of injection, has become red, hot, and swollen but with minimal pain reported.

Red, itchy rash on arm 2 days after injection Very sore arm 1 day after injection and slightly swollen arm at injection site A feeling of heaviness in the arm Some Nausea 3 days after injection

Patient was awakened by itchiness on left arm from elbow to wrist. Increased in severity to feeling as though on fire and being bitten by a thousand mosquitoes. Spread to other arm, both becoming bright red and blotchy. Some areas became raised. The itchy red began to creep up to injection site. Next day, February 21, legs began to ache, swell, and itch. Developed bright red, splotchy hives similar to arms spreading from knees to ankles before creeping up thighs. Large, hard, itchy area behind both ankles, and navel also became inflamed and itchy. Today (March 1) arms and legs are still red, though it has faded in some areas, and the itchiness is persistent but has subsided.

Rash across her cheeks, nose, and forehead. patient went to er 02/26/2021 and was prescribed Cetirizine

Swelling, redness and resultant pain of both ankles, and lower legs worse at the end of the day, improved in the morning. Awakening with swelling of hands (moderate) and face (mild) resolving as the day goes on.

Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization

Blood clot in blood vessel in the left hand at the base of the middle finger causing darkening in the lower part of the finger and numbness in the whole finger.

client had Right side severe joint and muscle pain. barely able to move. large bruise on leg; lasted 7-10 days; saw her provider who thought she should not take the 2nd dose of the vaccine

Moderna COVID-19 Vaccine EUA sore injection site, itchy injection site, left side and lower back itchy with small bumps (hives)? - have to put topical to relive itchiness. As o today, Mar 28, still somewhat itchy. Injection on left arm. Injection site soreness and itchiness. Itchiness and small hives on the left side and lower back.

Mechanical fall; Cut her wrist pretty bad and had to get stitches; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mechanical fall/ fall and very bad cut on the wrist /skin lacerations. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 20 Mar 2021, the patient experienced a life threatening and medically significant event of mechanical fall and cut on her wrist which was pretty bad and had to get stitches. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, mechanical fall and cut her wrist pretty bad and had to get stitches was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested

Rash/whelts and much itching, first on left arm where injection was given and then on the right arm. She used anti-itch ointment and within about 1 hour the rash went away and the itching stopped.

Shingles. Treatment to-date: Valacyclovir, Lidocaine topical 3%. Condition ongoing, pain, discomfort.

Large unusual swelling with non puss pinnacle and black subdermal discoloration. Very dark yellow urine. Itchy non painful swelling on top of left shoulder. Never had anything like this before.

patient called today (July 1, 2021) stating her vaccine site was red, swollen since Saturday. She states no fever, no pain. She didn't even know it was red,swollen until she noticed it while looking in the mirror. She states it is much better this morning than previous mornings but still noticeable.

PATIENT REPORTED HIVES AND LIP SWELLING ON 7/23/21. PATIENT IS FOLLOWING UP WITH PRIMARY CARE PROVIDER FOR TREATMENT.

Patient skin around the injection site began to itch about 48 hours after her vaccination. She says it is a mild itch, but seems to have increased over time. The skin appears a bit red in that area, but seems to be relatively smooth.

First dose of vaccine given in left arm now eight/nine days later there is an itchy rash on this arm below where the vaccine was given. My concern is does she still get the second dose, do we tell who is giving it that there was a reaction to the first dose and if so does she get it in the same arm?

nausea, vomiting, insomnia, runny nose--started 1:00 AM 21. /Left arm sore at injection site. Still have runny nose

The day of vaccine she had no problems. The following wee her arm was red, swollen and hot at the top. That reaction slowly went down and it's just above her elbow, she's 95 and it is kind of filled up with a hard mass in that area. Her arm looks like a sunburn with two different shades of skin, on the back side of her arm where it is red. She still has it on her arms today, 2/11/21. She has not taken anything for it or put anything on it. Her doctor told her to call us to see what we said she should do. There is no pain, but it just looks bad and she is concerned.

7 days after the vaccine the site became itchy and a welt about 3 inches in diameter an medium pink in color appear at the injection site. . I have a photo of this on her arm.

fever 100.4 (2 days duration), diarrhea ( on day 4), extreme fatigue ( durated 2 days commenced on day 4), erythema and swelling of right arm where injection administer( commenced day 1 , fading but not gone on day 8).

Pt has continued to experience injection site reaction 2+ weeks post vaccination. Area of arm is red and feverish and itching. The itching has lessened at this point however. Patient has been self-treating with diphenhydramine and ibuprofen per recommendation from home pharmacy.

Pt call hospital call center 5/14/2021. Pt c/o difficulty breathing, swelling throat, palpitation, itching whole body, tiredness, body aches whole body since pt got 2nd covid vaccine 5/12/2021. Pt recommended pt to call 911 or go to nearest ED d/t emergency covid vaccine side effects shown. Pt refused to call 911. The writer offered to call 911 on behalf of pt. Pt agreed the writer to call 911 on behalf of pt. Called 911 and connected with pt in conference phone connection.

Developed a rash similar to Herpes Zoster. No spreading, painful or blistering, no treatment to date, monitoring

Rash presented several hours post vaccination- ranged from injection site to top half of torso & trunk. Rash was flat & large red spots, no itchiness. Rash gone by the next morning.

Rash at injection site and above the site on her arm; across clavicle and chest to sternum; half way up neck. No other side effects. Rash was gone in the morning. Do not know when the rash appeared. Noted it when I changed her for bed at 10 PM. (Rec'd vaccine at 1:20 PM) She had moved her arm throughout afternoon as instructed.

Resident began experiencing pain in her left upper arm on 2/16/2021. Arm has been red, warm, and swollen from approximately 3 inches above elbow to 1 inch below shoulder. Some bruising to area as well.

According to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.

-Swelling and small lump at -some bleeding at site that stopped w/ light pressure injection site immediately after vaccine administration at left deltoid. -No redness, and cool to touch at site patient denies discomfort at site

Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia

Cellulitis left upper arm at vaccine site. Erythema measures 17.0 cm x 12.0 cm, area is warm to touch and painful

Arm turned bright rosy pink/red in a 2? area, then extreme pain, throbbing, heat, fever, and then area extended down and around arm. At this time it was lighter: spreading out. Began to itch. Still hurting somewhat at varied times but not nearly as bad.

Patient's home healthcare worker tested positive for COVID19 and Filomena had some mild symptoms, so was tested 2/4/21. She had dry cough and tiredness. She received antibody treatment 2/5/21 outpatient. After infusion she had rash/ hives.

Started with pain at injection site 2 days later felt itching all over then found redness and swelling and redness the size of a surgical gauze radiating from her shoulder to the crook of her arm. It was warm to touch.

Patient called about 10 days after the shot and said she had a red circular rash on her arm where the shot was given to her. She said it was a little itchy and warm. She had it looked at to confirm nothing else was going on. I followed up with her today and she said that it has gone away.

Complained of itchy ankles and wrist. Didn?t notice anything . Noticed rash on waist backside moved to inside of legs, plentiful inside knees. Slowly progressed. Moving to different locations. Went to doctor on day 5 do to it not slowing down with Benedryl they gave her prescription antibiotic cream and told to take over the counter 24 hr allergy pill. Helped with itching. Took her back to doctor in day 7 because it kept advancing. Gave her predisone and by day 9 we saw improvement. Another 8 days and no sign of it.

developed pain, redness and heat in her left wrist on 1/11/21. I saw her on 1/12 and evaluated it. It could be gout or pseudogout and just a coincidence but we need to fill out a VAERS report on it, just in case.

Swollen arm, lymph nodes, neck, sinuses, and chest on left side; redness and pain in arm; difficulty breathing and heaviness in left side of chest; chills; loss of appetite; fever (her normal is 96.5 and she had 101 degrees); lethargy; aching all over

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. 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 dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

Starting the afternoon of 1/14/21 patient stated the injection site started to feel itchy. When she looked in the mirror, there was an area of bright pink surrounding injection site. She reports the site felt swollen and she could not tell if it was warmer than her other shoulder. Early on the morning of 1/15/21, patient reports the area around injection site was bright pink and remained swollen. At this time it is less itchy, but remains lightly itchy intermittently. At 9am on 1/15/21, RN visited patient and was informed of her reaction. RN observed her L upper arm and she has an oval-shaped light pink area with injection site at the center. Oval measures 8.8 cm x 6.1 cm. The site is warm, slightly swollen, and feels indurated from the swelling. Patient is afebrile at 97.4 orally. Patient reports the light pink coloring at this time is less bright than it was earlier in the morning. Report is being made at 10 am 1/15 so outcome of reaction unknown at this time.

Raised erythema itching area 4.5" by 4.5" on upper right arm, slight itching noted on back, but no rash noted on back.

Swelling of tongue and throat, red itchy area on Left collar bone. Dr prescribed Benadryl and Prednisone 60mg 1xday for 5 days. Symptoms started around 9pm in the evening of same day as vaccine was given.

10 minutes post vaccination, pt developed severe swelling at the injection site. Patient's deltoid muscle swelled up to the size of a golf ball. No other adverse symptoms reported or observed.

Redness and warmth at injection site, spreading approximately 3 inches below injection site. Area soft to touch with with slight itching. No open areas. No pain or loss of function of arm. Temperature 98.6

These side effects lasted about 24 hours: fever-101, chills, pain ,swelling and redness at injection site, swelling/ knot the size of orange, throwing up, very tired. The pain and swelling of injection site/ arm lasted about a week. My mom tested positive for covid=19 on 1/15/2021. She had a negative covid test on 1/22/2021. She received the 1st Moderna vaccine on 2/24/2021 in which she had the above side effects. the 2nd vaccine is supposed to be given on 3/24/2021.

17 days after shot resident presented with Cellulitis to right arm. Red, swollen, warm to touch. No pain reported or assessed. Arm is completely cleared.

Resident L)arm red, warm and swollen. Treated with Abx. Left arm is being assessed by staff, no pain noted. Resident had 1st vaccine on January 9th in the R ) Arm, on January 26th patient was assessed to have a red, warm and swollen R) arm, approximately from the shoulder to the elbow. Due to time frame (17 days) was not sure if it was an actual reaction to the vaccine. Resident had 2nd vaccine on February 6 in the L)arm and by the 8th was having the same reaction in L) arm. as the right. Both times patient has been treated with antibiotics. The R)arm at this time has completely cleared, L) arm continues to be warm, red and swollen.