Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast; really uncomfortable; rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes; having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something; MAC lung disease progression; shaking; feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out; thinking would throw up; "thinking she would throw up; MAC lung disease progressing; felt ice cold / being cold; rash on shoulder and back/rash on shoulders looked different from the rash on back/; rash was red; that was red; swollen arm; Hot swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISEASE PROGRESSION (MAC lung disease progressing), ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something) and MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in 2001, Chickenpox in 2001, Mycobacterium avium complex infection since an unknown date and Hives. Concurrent medical conditions included Hyperlipaemia, Sleep disorder and Contrast media allergy. Concomitant products included ROSUVASTATIN for Hyperlipidemia, ESZOPICLONE (LUNESTA) for Sleep disorder NOS.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot swollen arm), VACCINATION SITE ERYTHEMA (that was red) and VACCINATION SITE SWELLING (swollen arm). In March 2021, the patient experienced ERYTHEMA (rash was red) and RASH PAPULAR (rash on shoulder and back/rash on shoulders looked different from the rash on back/). On 27-Apr-2021, the patient experienced FEELING COLD (felt ice cold / being cold). On 28-Apr-2021, the patient experienced DISEASE PROGRESSION (MAC lung disease progressing) (seriousness criterion medically significant), MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression) (seriousness criterion medically significant), TREMOR (shaking), VACCINATION COMPLICATION (feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out), THINKING ABNORMAL (thinking would throw up) and NAUSEA ("thinking she would throw up). On 08-May-2021, the patient experienced ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast), DISCOMFORT (really uncomfortable) and RASH PRURITIC (rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form; AMOXICILLIN for Pneumonia, at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-May-2021 at a dose of 1 dosage form and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE WARMTH (Hot swollen arm) had resolved. At the time of the report, DISEASE PROGRESSION (MAC lung disease progressing), ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something), MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression), URTICARIA (huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast), TREMOR (shaking), FEELING COLD (felt ice cold / being cold), DISCOMFORT (really uncomfortable), ERYTHEMA (rash was red), VACCINATION COMPLICATION (feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out), THINKING ABNORMAL (thinking would throw up), NAUSEA ("thinking she would throw up) and VACCINATION SITE ERYTHEMA (that was red) outcome was unknown, RASH PAPULAR (rash on shoulder and back/rash on shoulders looked different from the rash on back/) and RASH PRURITIC (rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes) had not resolved and VACCINATION SITE SWELLING (swollen arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Biopsy: not provided (Inconclusive) 2 biopsies done Results-not provided. On 28-Apr-2021, Body temperature: 91.1 (Inconclusive) 91.1 and 95.2 (Inconclusive) 95.2. On 28-Apr-2021, Chest X-ray: no results provided (Inconclusive) no results provided. On 28-Apr-2021, Computerised tomogram: mass in lung (Inconclusive) Mass in lung. On 28-Apr-2021, Electrocardiogram: normal (normal) normal. On 08-May-2021, Body temperature: 95.3 (Inconclusive) 95.3. On an unknown date, Biopsy: possible drug allergy (Inconclusive) Possible drug allergy. On an unknown date, Blood test: inconclusive (Inconclusive) Sepsis was ruled out. On an unknown date, Body temperature: 95.8 (Inconclusive) 95.8 and 95.5 (Inconclusive) 96.5.         Treatment medication included Cortisone cream for itching, Allegra (took twice), Zyntec and Valtrex for symptoms, Amoxicillin for Pneumonia and Benadryl on 11May2021.  Concomitant medications included Cholesterol and sleeping pills.  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.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-020008 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up added on 25-May-2021 included significant data: New events added. Treatment medications and conmeds added. Lab added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.