Moderna

Cellulitis with moderate pain R arm (injection site area, redness on R upper arm) as diagnosed by attending physician. Bactrim DS x 7 days, currently redness/swelling getting better.

Woke with severe Body Aches , chills and fatigue Two days later shoulder pain, rash at swollen site.

The day following his Moderna vaccination, the pt became profoundly week with difficulty standing on his own and frequent falls. He also experienced sever malaise

Fever, chills, nausea and vomiting, weakness and soreness at injection site. Acute respiratory distress.

Date and time adverse event started: 3/14/21, rash to right hand he has seen nurse for wound care/antibiotic therapy and have recommended hydrocortizone cream and triple antibiotic cream.

Patient reported that after 2 days he broke out in a rash at the injection site. It grew in size over next few days and caused itching. I recommended patient reach out to his doctor for treatment suggestions due to heart condition. I followed up with patient and he said the nurse practitioner told him to take benadryl.

Patient has a lump under the skin at the injection site. This has led to some discomfort and unusual amount of pain that has him attempting to be seen by his primary provider. He has been urged to seek attention from an urgent care facility, but his response was, "I don't want to be a wimp about this, I'll hold out until I can see my primary doctor." This started almost immediately after his second dose. He received the first dose in the other arm 4 weeks prior without any reaction at all.

Patient had started peritoneal dialysis at home with me, his wife, 8 days before the second shot. All was going well. We got his second shot on the morig of March 18. His only reaction seemed to be soreness at injection site. At 11 pm we started dialysis as usual, with the cycler. At 12 pm he was having trouble breathing after just having been filled with 1500 ml of dialysate. This was the first time this happened. I gave hi nitro glycerine and had the cycler take out the 1500 ml of dialysate, and stopped the therapy for the night. He then felt better, and apologized for waking me up. In the morning he was dead. I believe it is possible that the vaccine tipped the balance of patients already taxed system. As I know that people who have serious diseases and are older are encouraged to take the vaccine, this outcome should be known to the CDC.

Soreness of left arm after injection 3/26/21 at injection site. Sore to touch. Sore to use. Sore to bear weight on. Was NOT sore before injection. Has remained sore to this date. 4/23/21. Muscle fatigue and mild pain in right knee 2 weeks (noted by patient and by physical therapist) after injection to this date (4/23/21). No known reason for muscle fatigue but fatigue causing right knee to collapse while upright and weight bearing.

PATIENT'S LEFT ARM CONTAINS ORANGE-SIZE RED, RAISED, AND WARM TO THE TOUCH AREA. NO PAIN REPORTED. AREA IS 'VERY ITCHY.'

Sore armpit region, right shoulder where vaccine was administered. Cannot raise right arm past horizontal.

Received Moderna vaccine on 1/26/2021 in left deltoid. On 1/28/2021 an inflamed area noted to left arm that is warm to touch, tender, and lumpy. 100.0 temp noted and tylenol administered. 1/28/2021 APN and Doctor saw patient here at the facility for concerns of possible cellulitis and new orders received to circle area and notify doctor of increase in redness or any changes in condition, ice to left arm every 4 hours, and one time dose of benadryl allergy liquid. Concerned that patient may not have received the full dose of the Moderna vaccine as it appears that the injection was given too low that muscle may have been missed. Tylenol every 4 hours as needed is also ordered for discomfort . Awaiting to hear back on guidance as to if another dose needs to be given. Continuing to monitor at this time.

Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; 100.0 temp; Possible cellulitis; It appears that the injection was given too low that muscle may have been missed; May not have received the full dose of the Moderna vaccine; A spontaneous report was received from a nurse, concerning a 91-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, it appears that the injection was given too low that muscle may have been missed, and possible cellulitis. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K208) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 26 Jan 2021, at the time of the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient may not have received the full dose of the Moderna vaccine as it appeared that the injection was given too low that muscle may have been missed. On 28 Jan 2021, the patient experienced an inflamed area to the left arm, that was warm to touch, tender, and lumpy. The patient also had fever of 100.0 Fahrenheit (F). He was being evaluated for concerns of possible cellulitis Treatment for the events included paracetamol and diphenhydramine. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of events, inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, and possible cellulitis, were considered unknown. The events, it appears that the injection was given too low that muscle may have been missed and may not have received the full dose of the Moderna vaccine, were considered resolved on 26 Jan 2021.; Reporter's Comments: This case concerns a 91-year-old, White, male, who experienced a Product administration error, Incorrect dose administered, and non-serious unexpected event of injection site cellulitis, injection site warmth, and non-serious expected events of injection site swelling, injection site pain, and pyrexia. There were no reported AEs associated with this case of a Product administration error and incorrect dose administered. The events occurred 2 days after mRNA-1273 (Lot# 039k208). Treatment included Tylenol and Benadryl. 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.

heat on the arm, which is warm to the touch; redness on arm; second dose administered subcutaneously; A spontaneous report was received from a health care professional (HCP) concerning a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the second dose administered subcutaneously, redness on arm, and heat on the arm. The patient's medical history was not provided. Concomitant medications reported included Senna, Zoloft, Risperdal, Aspirin, Aricept, finasteride, Lasix and multivitamins. on 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K208) . On 26 Jan 2021, approximately 28 days after the first dose, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012M20A) subcutaneously for prophylaxis of COVID-19 infection. The HCP stated that the patient's second dose was inadvertently administered subcutaneously. The patient experienced redness and heat on the arm, which was warm to the touch. Treatments of these events included Benadryl and Tylenol. The event, second dose administered subcutaneously was resolved. The events, redness on arm, and head on the arm were not resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 91 year-old, male patient, who experienced the events of redness on arm, and heat on the arm. The events occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Delayed cutaneous hypersensitivity in are which received vaccination, 3 days following vaccination. Had minimal soreness, I At the site of vaccination prior to that. Began with intense itching, followed by erythema, insulation extending down to lower arm. Resolved after 8-9 days

Pruritic rash at both injection sites with scaling, lasted 6-7 weeks. Scaling still present on left arm at injection site.

Caller states that her husband developed itching, red rash on front of upper arm, near injection site, warm to touch and slight swelling. Aprox 2 inch circle, not getting any worse or better. Denies fever or any other symptoms. Has tried topical ointment with no relief. Advised tylenol or ibuprofen, cool compresses and/or topical benadryl Follow up call by Patient feeling much better, swelling and redness to the injection site resolved. Cold compress and benadryl ointment administered to alleviate symptoms.

First shot 1-20-2021 Immediate flushing with hot ears upon injection. Lasted all day. Sore arm at injection site lasted two days. Leg and back pains in three days which disappeared within the day. February 4, 2021 entire body got cold. 15 minutes later cold chills and shivers for an hour. Went to hospital emergency where treated for blood infection with intravenous antibiotics for 6 days. Then home treated with intravenous antibiotics with home health care until February 22, 2921. Experienced many long period cold spells of entire body both in hospital and home. Still get them until this date on occasion. I am very sensitive to cold.

On 1/6/21, 91 yo M amb to ER with c/c of allergic reaction to COVID x 1 day. Pt receive COVID vaccine Moderna Jan 3, 2021. Pt c/o fever, n/v, lower back pain, SOB, dark colored urine. Jaundice noted to bilat sclera and generalized skin. Patient hospitalized and discharged on 1/17/21. Admitting diagnosis was pneumonia, hepatitis, acute repiratory failure with hypoxia and acture renal failure. Patient was treated for sepsis due to acute cholangitis and completed 10 day course of IV zosyn

About 1 and 1/2 month later on 4/4/2021, I got a rash on my head and came down on my right side and chest and back. It was very itchy, red and very painful. I went to the dermatologist right away and was diagnosed with Shingles infection. The doctor gave me an injection (don't remember name) and prescribed Valtrex and Pepcid. The medication did not help resolve the shingles and it got worse. I went to the hospital 4/6/2021 and I was admitted to the hospital for 7 days. I was admitted because I was dehydrated and had an allergic reaction to the shot the dermatologist gave me. I also pneumonia and septic. They ran every test they could run and gave me antibiotics for the pneumonia and infection. I was discharged to follow up PCP.

noticed a rash along his belt line on 01/16/2021. He saw his doctor on 01/19/2021 diagnosed with shingles.

On 1/20/2021 the resident experienced hypotension while at dialysis and was not able to complete treatment prior to being transferred to the hospital. He also had congestion in lungs. The hospital notes indicate upon admission to the hospital he was being treated for # Shock - distributive - cover for sepsis, check u/s RLE, possible SIRS response after second COVID vaccine. MAP >55 and # ESRD. While in the hospital resident was treated for hypotension, right lower leg cellulitis and the rate of pacemaker was increased.

Injection to left arm next day elbow pain with soft, nontender swelling to LEFT elbow, brucites noted on xray also normal injection reactions that are expected, tender to site of administration otherwise no fever or other problems. Symptoms improving wihtout complications

Bruising started at injection site and has expanded down the right arm up to the forearm through the time period of 3 days. and is associated with severe pain

Narrative: Developed "penny sized" erythematous rash around injection area that he noticed on the same day of the initial vaccination, which persisted for about a week before resolving. Associated with pruritus and fatigue, but no warmth to touch, induration, swelling or sloughing. He denied any other adverse effects. No therapies tried or applied.

The morning after the vaccine, my arm from the shoulder past the elbow was pink, red and purple both on the outside and inside. Since I am a retired Physician, I decided to give it time to hopefully heal.

92 y/o M, hx of HTN, otherwise healthy and well here for second dose with no reported adverse rxn from first dose. VR was driving from the vaccination area and got app 250 meters away when he became lightheaded. He got out of the vehicle and had a syncopal episode, had an unwitnessed fall backwards and struck his head on the roadway causing a full thickness 5cm stellate laceration. Vitals: BP 215/98, HR 50 and regular, O2 93% on outdoor air. Reports taking BP meds this am. Pt was amnestic to the event but denies LOC. Had one episode of N without V. No midline C spine tenderness. Reports no blood thinners. EMS was summoned and transported him to a nearby hospital for further evaluation and treatment.

Swelled immediately at injection site, about 1.5inx1.5in, about 1 inch rise. No other signs. Denied any symptoms.

Patient developed a maculopapular , itchy rash on 3/10/21. This was 8 days after receiving the 2nd Moderna COVID-19 vaccine. He had no fever or chills. No body aches. Diagnosed as delayed hypersensitivity eruption due to the vaccine. Topical Triamcinolone was given for symptomatic relief. His rash spread and he returned on 3/18/21 at which time the diagnosis of Erythema Multiforms was made based on the target lesions and areas of dusky erythema that had developed. His itching had improved however. He did not have oral lesions. He was treated with IM Kenalog 60 mg and noted improvement of the rash within 3-4 days

ice cold body; shivering-chills; leg pain; back pain; head pain; injection site soreness; shoulder pain; flushing; cramping neck pain; red hot ears; A spontaneous report was received from a 92-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing with red hot ears (ear discomfort), mild soreness at the injection site (vaccination site pain), right-sided cramping neck pain (muscle spasms) accompanied by shoulder pain (arthralgia )radiating to the head (headache), leg pain (pain in extremity), back pain, body became ice cold, chills and shivering (chills). The patient's medical history, as provided by the reporter, included pulmonary fibrosis, sleep apnea, acid reflux and prostatitis. Concomitant medications reported included aciphex and ativan. On 20 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced immediate flushing with red hot ears which persisted throughout the day and mild soreness at the injection site lasting approximately 24 to 48 hours. He experienced two instances of right-sided cramping neck pain accompanied by shoulder pain radiating to the head, lasting 5 to 10 minutes per episode between 20 Jan 2021 and 04 Feb2 021. These episodes were brief and have not returned and awaking to both legs and his back "filled with pains" on 23 Jan 2021. The leg pains subsided upon standing; back pain lasted all day 23 Jan2 021. The patient felt normal from 24 Jan 2021 until 04 Feb 2021. On 04 Feb 2021, the patient's whole body became ice cold at approximately 3PM. By 3:15PM he was experiencing chills and shivering that lasted approximately one hour. Patient called his physician, and was directed to the Emergency Room (ER) immediately. There he received blood tests and prophylactic broad spectrum antimicrobial therapy immediately upon admission. Patient reports that Infectious Disease confirmed there were two strains of bacteria present in his bloodstream. From the patient additional samples were collected for culture to tailor antimicrobial therapy accordingly. He also said he was hospitalized for six days and discharged on 10 Feb 2021 with at home Iintravenous (IV) infusion device to administer continuous (24 hour) antibiotic therapy for a full 14 days. He was released from the hospital to his daughter's care. He had no history of significant adverse events or allergic reactions post vaccine administration. He is concerned about the origin of the infection, as no source could be confirmed per Infectious Disease. The patient is concerned the infection could have stemmed from the vaccine or it's administration. He attests that his physician wants him to proceed with his second dose of Moderna. Action taken with mRNA-1273 in response to the events is unknown. The events, flushing with red hot ears, mild soreness at the injection site, right-sided cramping neck pain accompanied by shoulder pain radiating to the head, leg pain, back pain, body became ice cold, chills and shivering were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

His First shot on 3/8/21 only had a slight sore arm in injection area. On 4/13/21, (9days later) he woke up in the morning to find a rash/hives over his upper torso. It itched and in the following days spread over his complete torso, arms, back and lower torso. ,We now see a few on his legs and face, also and his body looks like I have painted his body and it covers all areas. We have checked with His Dermatologist, his Internist and nurse who have noted this response to the second dose and suggested Zyrtec and Calimine lotion for the itching. At this time he still has the rash over all of his body. I can send a picture if you like. I would say this is a severe reaction for a 2nd shot.

Hives/Rash 9daysafter injection. got worse and lasted until 4/21. covered complete body. no temp but needed zrytec to aleviate itching along with Calimine Lotion as his body was orange in color as if painted on. His coloring is now becoming lighter but has a few pimples on wrists Would appreciate hearing from you for your opinion on this matter

Date and time adverse event started: Patient stated he started to experience symptoms about 1.5 weeks after the 1st vaccine. he started to notice red blisters on his legs that proceeded to arms and fingers and on his head. He felt itchy (still itchy but not as much). He stated he went to his PCP and they referred him to a dermatologist (seen about 3 weeks ago). He was prescribed Triamcinolone Ointment by the dermatologist and stated it's helping and blisters are subsiding. The PCP didn't prescribe anything. About 2 weeks ago he stated he started to feel neck pain (about 4 weeks after the 2nd shot). Patient has no c/o headache,fever or chills. pt received dose 2 on 3/1/2021. I advised the neck pain wasn't related to the vaccine but recommended to continue with the Triamcinolone ointment and he can also apply cortisone-10 cream/ointment to the help with itchiness or benadryl. He stated that the blisters have been getting better but he feels the problem is internally and he feels he needs to see the dermatologist again on 4/20/21. 4/21-onset 2 weeks after vaccine dose 1 --moderna on 1/28/21; 8.5 weeks of symptoms; feeling better but symptoms still present. Dermatologist said not vaccine related; using topical steroids. Saw PMD - to check blood work; told internal allergy. Will call next week for follow up.

Stung by 200 bees; Slight swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD STING (Stung by 200 bees) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced ARTHROPOD STING (Stung by 200 bees) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Slight swelling at injection site). The patient was hospitalized on 20-Feb-2021 due to ARTHROPOD STING. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) at an unspecified dose and frequency. At the time of the report, ARTHROPOD STING (Stung by 200 bees) and VACCINATION SITE SWELLING (Slight swelling at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Additional treatment for the event included IV steroids. Company Comment : Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.; Sender's Comments: Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.

Delayed hypersensitivity eruption; Erythema multiforms; Rash on back and neck that itches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforms) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Coronary artery disease, GERD and Prostate cancer (Historyan of Prostate cancer). Concomitant products included GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) and POTASSIUM for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Rash on back and neck that itches). On 18-Mar-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforms) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE REACTION (Delayed hypersensitivity eruption). The patient was treated with TRIAMCINOLONE (topical) for Hypersensitivity reaction (NOS), at a dose of UNK dosage form and GRAMICIDIN, NEOMYCIN SULFATE, TRIAMCINOLONE ACETONIDE (KENALOG-S OPH.) (intramuscular) for Rash, at a dose of 60 milligram. At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforms) and INJECTION SITE REACTION (Delayed hypersensitivity eruption) outcome was unknown and RASH PRURITIC (Rash on back and neck that itches) had resolved. The action taken with mRNA-1273 in response to the event was not applicable. It was reported that, the patient developed a maculopapular itchy rash on 10-Mar-2021 after 8 days after receiving second dose. He had no fever and chills. He was diagnosed with a delayed hypersensitivity eruption due to vaccine. Topical Triamcinolone was given for symptomatic relief, Later, he developed dusky erythema but itching improved. He was then treated with IM Kenalog 60 mg and improvement in rash was noted in 3-4 days. 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 28-Jun-2021: The case was upgrade to serious as new event erythema multiforms added along with delayed hypersensitivity eruption, patient demographics updated along with HCP details.; 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.

rash on chest primarily, some on thigh and arm mentioned by patient on a routine visit, relates rash started about a week after the 2nd vaccine, has been applying over the counter cortisone with improvement but not complete resolution so is asking for a prescription steroid cream

Patient describes area as slightly red below injection site and that it is about 2 inches in diameter. He reports slight numbness and that the area is slightly warm and raised.

Pruritus began in both legs (ankles to knees)and spread to beltline. Applied Cetaphil skin lotion. Resolved 4 hours later. No visible cutaneous changes other than excoriations from scratching. Patient reports similar pruritus frequently after bathing.

Patient's left arm swelled 10 days after the Moderna injection. There was a delayed skin reaction, which included a large red painful lesion around the injection site and some itching,

Red, itchy rash started a few days after receiving vaccine. First started on right leg, then left leg, then both arms, back and chest. Still ongoing. Taking Famotidine 20 mg every 12 hours and Fexofenadine HCL 180 mg once daily.

Severe thrombocytopenia (Platelet 12, 000) with associated bruising. April/29/2021 He has normal platelet from March/23/2021 in 200,000

Days 1-3 - fatigue, lightheadedness, shoulder pain. Day 7: redness, mild swelling, mild tenderness at injection site (no infection)

Has developed rash around injection site about 5 inches in diameter and it is red at the injections site. Patient reports not feeling well in general. Sent picture to his provider and left message with provider.

Arm stiffness for 1 day after vaccination Other relevant Hx: injection site reaction, arm stiffness x1 day

Diagnosed with Cutaneous Mucor Mycosis at injection site by biopsy Narrative: Pt. had to have a port-a-cath placed to receive at least 2 weeks of anti-fungal medication treatment. He has not yet been hospitalized but there is potential for that to occur.

Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.

Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia. The patients medical history was not provided.No relevant Concomitant medications were reported. On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection. On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

He developed DRESS syndrome confirmed by labwork (elevated WBCs, elev eos, AKI, ) and biopsy (superficial and perivascular interstitial dermatitis with eosinophils) and clinically (diffuse rash, swollen face, multi morphologies - vasculitic, targetoid, erythema)

2 days after vaccination patient experienced a severe generalized pruritic rash from the shoulders to the feet. He also felt terrible for the next 10 days with severe general malaise. He continues to have a residual rash over his back and abdomen with persistent itching. The patient felt so terrible that he is reluctant to get the second dose.

Red rash all over back, upper left arm and across stomach area. Gets more red with application of rash cream.

Patient is a retired physician and my grandfather. I gave him the shot on 1/6/21. Sometime on 1/7/21, Patient started to experience severe arthralgia that started in his left arm and was radiating down from his shoulder area to his wrist continuously throughout the day. Sometime late 1/7/21 or early 1/8/21, he was experiencing severe arthralgia radiating from the right shoulder down to his wrist. Sometime on 1/10/21, the arthralgia was consistently happening in his hip and back region. Patient has a doctor appointment scheduled for 1/12/21 which was the first appointment available.

Received 2nd dose of Moderna in left arm on 1/26/21 and on 1/29/21 redness, swelling, and warm to touch noted to all of the left arm including around the elbow. Unsure if the injection site was muscle or subcutaneous. Benadryl one time only dose ordered by NP and cold compress also ordered on 1/29 and area circled with marker.

On 2/2/21, the patient started to show redness and swelling at the injection site and most of the upper arm. The redness occurred from the deltoid muscle to the elbow. The nursing staff at the LTCF applied ice and monitored the patients condition. By 2/4/21 , the reaction was improving and resolved by 2/8/21. No additional medical attention was necessary.

Warm to touch to left arm including around the elbow; Redness to left arm including around the elbow; Swelling to left arm including around the elbow; Unsure if the injection site was muscle or subcutaneous; A spontaneous report was received from a healthcare professional concerning a 95-year-old, male consumer who developed redness, swelling, warm to touch after receiving a second dose of Moderna's COVID-19 vaccine administered at inappropriate site. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Lot number:039k20a) intramuscularly in the right arm on 30 Dec 2020. On 26 Jan 2021, approximately 3 days prior to the onset of the symptoms, patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection. The patient was administered mRNA-1273 vaccine incorrectly, on 26 JAN 2021. On 29 Jan 2021 redness, swelling, and warm to touch noted to all the left arm including around the elbow. Treatment for the event include Benadryl(diphenhydramine) onetime only dose and cold compress. Area circled with marker. The patient received both scheduled dose of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, vaccine administered at inappropriate site, was considered resolved. The outcome for the events redness, swelling and warm to touch, was 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.

rash throughout torso, red pin point and welt, very itchy no blisters rash on arm date of 2nd vaccine below shot site oral benedryl , topical aspercreme with lidacane

Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Patient had presented these reactions a month after their second dose of the vaccine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

New right knee pain, ongoing 10 days after vaccination. Patient also reports redness + swelling x3 days after vaccination Other Relevant Hx: & knee pain + injection site reaction

Onset of fever, myalgias, headache, fatigue 1-2 days after 2nd dose of COVID vaccine then with onset of erythematous rash on bilateral legs 3 days after vaccine. Of note patient also taking Keflex which he started on the same day as the vaccine. Symptoms resolved by 4 days post vaccine.

Cellulitis on chest; Swollen; Tender; Red; Chills; Fever; A spontaneous report was received from a consumer concerning a 96 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, fever, chills and injection site swelling, tenderness, and redness. The patient's medical history included serving as an employee, episodes of days with fever, feeding tube, Pulmonary issues and cellulitis on arm.. Concomitant medication included triamcinolone acetonide cream 0.1%, Tessalon and Robitussin. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in his left arm for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced injection site swelling, tenderness, and redness. On 24 Feb 2021, the patient experienced chills. Vital signs included a temperature of 103.9 degrees Fahrenheit. Also, his sputum had some blood in it. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events cannot be excluded. Fever, chills injection site swelling, tenderness and redness are consistent with the known safety profile of the mRNA-1273 vaccine.

Severe left upper extremity edema and erythema (extended from the shoulder to arm and hand) with small bullae and weeping on forearm. Progressive acute onset over the course of a week. Started on oral clindamycin, however superimposed cellulitis was NOT suspected but oral antibiotics are low risk. Limited to left arm, showed no signs of systemic illness (afebrile). Had no signs of neurovascular compromise, was able to move hand, sensation intact and notable pulse.

pts daughter stated ear lobes were red, he had low grade fever and left arm was warm to touch about 3" below injection site the day after the vaccine. Next day after the arm was increasingly turning more red. On 1/12/2021 the pt went to the ER clinic and was diagnosed w/ cellulitis on left arm. Pt is now recovered from this after being treated w/ antibiotics.

EXTREME weakness, pain in left arm with reddened welt size of orange. Unable to collect thoughts. States does not feel good all over. Denies headache, dizziness. Previously able to transfer with minimal assist to wheelchair but unable to even help with transfer after reaction. Continues to have reddened itchy welt on arm 3 days later but now able to transfer again and converse normally.