Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | 013M20A | IM / RA |
she does have an autoimmune disease.; skin feels like it's going to peel off/it was sun damage; She got itchy spots on her skin, basically on her face and neck; It also itches around her eyes; Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis; At the injection site, her arm was sore and swollen; Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid; Pt had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm; it also felt hot; She also got cold sores in the corners of her mouth; mild case of the flu; aches/feeling feverish, with chills and body aches; stomach upset; Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching,burning,hurting,flaking, face blotchy/eczema in right ear/bad sunburn; could taste the medicine, it went right up to tongue; didn't eat anything; hands were like ice, was clutching "Hot hands"; PT had "Covid arm" (right arm was red, swollen, sore, and itchy); Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm); feeling feverish, with chills and body aches; At the injection site, her arm was sore and swollen; chills; but nausea started by dinner time/kinda yucky; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (she does have an autoimmune disease.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 012A21A, 066F21A and 057M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dermatitis, Back pain, Weight loss and Shoulder operation (Left Shoulder surgery, Both shoulders and both wrists were operated) in 2019. Concurrent medical conditions included Hearing aid user. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (aches/feeling feverish, with chills and body aches), ABDOMINAL DISCOMFORT (stomach upset), ECZEMA (Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching, burning, hurting, flaking, face blotchy/eczema in right ear/bad sunburn), TASTE DISORDER (could taste the medicine, it went right up to tongue), FEEDING DISORDER (didn't eat anything), PERIPHERAL COLDNESS (hands were like ice, was clutching "Hot hands"), PAIN IN EXTREMITY (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)), VACCINATION SITE REACTION (Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm)), PYREXIA (feeling feverish, with chills and body aches), INJECTION SITE PAIN (At the injection site, her arm was sore and swollen), CHILLS (chills) and NAUSEA (but nausea started by dinner time/kinda yucky). On 09-Mar-2021, the patient experienced FEELING HOT (it also felt hot) and PERIPHERAL SWELLING (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm). In March 2021, the patient experienced ORAL HERPES (She also got cold sores in the corners of her mouth) and INFLUENZA (mild case of the flu). In 2023, the patient experienced EAR INFECTION (Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (she does have an autoimmune disease.) (seriousness criterion medically significant), SKIN EXFOLIATION (skin feels like it's going to peel off/it was sun damage), PRURITUS (She got itchy spots on her skin, basically on her face and neck), EYE PRURITUS (It also itches around her eyes), ANGULAR CHEILITIS (Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis) and INJECTION SITE SWELLING (At the injection site, her arm was sore and swollen). The patient was treated with Cortisone in 2021 at an unspecified dose and frequency; Ruxolitinib phosphate (Opzelura) at an unspecified dose and frequency; Avena sativa fluid extract (Aveeno) at an unspecified dose and frequency; Paracetamol (Tylenol) on 10-Feb-2021 at an unspecified dose and frequency; Bismuth subsalicylate (Pepto bismol) in February 2021 at an unspecified dose and frequency; Tacrolimus at a dose of twice a day; Mineral oil light, Paraffin nos, Petrolatum, Wool alcohols (Aquaphor) at an unspecified dose and frequency and Zinc oxide (Desitin) at an unspecified dose and frequency. In February 2021, NAUSEA (but nausea started by dinner time/kinda yucky) had resolved. At the time of the report, AUTOIMMUNE DISORDER (she does have an autoimmune disease.), PAIN (aches/feeling feverish, with chills and body aches), ABDOMINAL DISCOMFORT (stomach upset), ORAL HERPES (She also got cold sores in the corners of her mouth), SKIN EXFOLIATION (skin feels like it's going to peel off/it was sun damage), PRURITUS (She got itchy spots on her skin, basically on her face and neck), FEELING HOT (it also felt hot), EYE PRURITUS (It also itches around her eyes), ECZEMA (Chronic eczema/Face red/hot, mouth rash(flaky, hurt, spread to face),dark red/maroon spots, stabbing/heat itches, red/itchy/painful/flaking splotches to face/neck, constant itching, burning, hurting, flaking, face blotchy/eczema in right ear/bad sunburn), TASTE DISORDER (could taste the medicine, it went right up to tongue), FEEDING DISORDER (didn't eat anything), PERIPHERAL COLDNESS (hands were like ice, was clutching "Hot hands"), INFLUENZA (mild case of the flu), ANGULAR CHEILITIS (Both corners of the mouth split, and it hurt/the left side of mouth started developing a rash that "Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face/angular cheilitis), EAR INFECTION (Right ear started to "Hurt real bad"/it was an ear infection due to the hearing aid), VACCINATION SITE REACTION (Covid arm (right arm was red, swollen, sore, and itchy)/upper arm (swollen from top of arm)), PYREXIA (feeling feverish, with chills and body aches), INJECTION SITE SWELLING (At the injection site, her arm was sore and swollen), INJECTION SITE PAIN (At the injection site, her arm was sore and swollen) and CHILLS (chills) had not resolved and PERIPHERAL SWELLING (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)/This time including the upper arm (swollen from top of arm) and PAIN IN EXTREMITY (PT had "Covid arm" (right arm was red, swollen, sore, and itchy)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, Antinuclear antibody: The result showed that she doesn't have Lupus autoimmune disease. No concomitant medications provided by the reporter. It was reported that that before covid-19 vaccination patient had a good skin condition. Patient had never pimples and acne. It was reported that after first vaccination patient experienced symptom of chills, aches, stomach upset upon arrival at home the same day and patient did not eat. Because patient experienced symptom of nausea and which was started by dinner time. Also, it was reported that patient arm was sore and swollen at the injection site (right arm was red, swollen, sore, and itchy) and the moment the nurse gave her the shot, she had a medicine taste in her mouth. She had to stay for 15 minutes at the pharmacy. The next day she felt hurt all over and she felt like she was in a car accident. She was unable to get out of bed or down the stairs. Patient felt that her hands were like ice and hot hands. Patient took treatment medication Tylenol, and she took a nap. Patient symptom continued for couple of days and patient symptom of nausea was resolved. But patient symptom of covid-arm was continued almost until the second dose was due. After 3 weeks patient was received her second shot. And after 2nd Moderna Covid-19 vaccine; patient experienced symptom that her face got red like a bad sunburn, and it also felt hot and that was lasted a couple of hours. She also got cold sores in the corners of her mouth. She never had that before. Patient started getting something weird after the first shot, had other symptoms, had more symptoms and now, the first part of this year, it really blew up. Patient never had pimple and acne and never really had anything and all of a sudden this stuff, stuff blew up in a month and My face and that were a mess. After second vaccination patient also experienced symptom of Covid arm and which was started the day after the shot, but the symptom was worse than the first time. Patient experienced symptom in the upper arm (swollen from top of arm) and symptom was lasted a couple of weeks. It was reported that patient called to dermatologist and dermatologist was prescribed treatment medication cortisone ointment for two weeks to patient. It was reported that patient symptom initially did not go away, but latter patient had no symptom. Patient had a little reaction but no worse than a mild case of the flu with no nausea. And about a week later both corners of the mouth split, and it hurt. That Spring of 2021 patient was experienced symptom of face was red, but that was not felt that hot. When patient went home, face now felt hot and looked very red. Patient experienced symptom of face got red like a bad sunburn on 09-Mar-2021. Post 1st booster dose patient left side of mouth started developing a rash and it Went up half the lip. It was flaky, hurt, and it started to spread up to the actual face. Patient went to a new dermatologist who diagnosed it was as angular cheilitis. For patient treatment medication of tacrolimus ointment twice a day was prescribed, and patient symptom was improved. Post second booster vaccination patient experienced right ear started to hurt bad in Feb or Mar of 2023. Patient thought that it was an ear infection due to the hearing aid. Patient went to urgent care and doctor prescribed an unspecified treatment medication which did not help to patient. And patient symptom went worse. Then patient visited to an ENT and who said there was eczema in the right ear. Patient received treatment medicine which helped but her. Also, she used treatment medication of Aveeno and an unspecified treatment medication product for her hearing aid-related itching. In Jul-2024 patient noted that she had a dark red, maroonish spots to the left face. Patient took a second opinion with another dermatologist who diagnosed it as sun damage. The maroonish spots did not hurt or peel or anything to patient. After 2-3 weeks patient developed little stabbing itches, like heat itches, heat rashes, but patient did not have a rash. Then the right face she had red splotches, and which were itchy and painful and started flaking. This was worse than on the left side and this was spread to the neck for patient. Patient went back to original dermatologist who scanned for cancer and removed one spot from the face and prescribed a treatment cream which patient stopped to use. Patient ended up use of treatment medication Aquaphor to the face and Desitin to the corners of the mouth. It was reported that in 2025 patient got itchy spots on her skin, basically on her face and neck. It was also reported that when patient put on makeup, that time patient had big red swatches on her face on the left side of her face. She went to her dermatologist who told her it was sun damage. One week later, she got red swatches on the right side of her face suddenly and patient noticed that itchy spots on her neck and in her mouth. It got worse when she used facial water on her face. It was reported that patient does not have heart problems, but patient had an autoimmune disease. She received samples treatment medication of cream Opzelura to use, and it was the only cream that helped for her skin problem as it calmed her skin down and felt normal again. Now she ran out of the samples. At present patient used treatment medication of Likeerra V and Aveeno and it helped a little bit to patient, but her skin felt like it was going to peel off. It was reported that it also itched around her eyes. This case was linked to US-MODERNATX, INC.-MOD-2025-787026 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2025: Live significant follow-up received in which Patient demographic was updated (DOB), new event was added, treatment medication was added, and new reference number was added. On 29-May-2025: Live-non-significant follow-Up received in which case narrative was updated and new reference number was added.; Reporter's Comments: The medical history of Dermatitis is a confounder for skin exfoliation, pruritus, eye pruritus, eczema, and angular cheilitis events. Due to lack of biological plausibility, the causality of the events Oral herpes , Influenza, ear infection was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787026:Invalid case for multiple people
Hearing aid user
Medical History/Concurrent Conditions: Back pain; Dermatitis; Shoulder operation (Left Shoulder surgery, Both shoulders and both wrists were operated); Weight loss
Test Date: 2025; Test Name: Lupus test; Result Unstructured Data: The result showed that she doesn't have Lupus autoimmune disease