Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site discharge, Vaccination site discolouration, Vaccination site erythema, Vaccination site induration
Clinical narrative: Aches, pains; Feeling miserable; Arm was hot/ The whole area was hot,  it covered half of her upper arm/  went all the way around her entire circumference of the arm to the elbow; Looks like a stain in the skin where she was injected; There were 3-4 small hard lumps/clumps; Syrup seeping out to the surrounding tissues and that the vaccine spilled out in the surrounding tissues; There were 3-4 small hard lumps/clumps; Itchy around the clumped areas; The red area underneath arm was more like contact dermatitis-rash type of thing compared to the outside red dark lumpy stuff; Arm was red, it was round, circular disc shape around the injection site; Arm continued to swell and swelling got bigger; It was very painful; Headaches/ Headache would come and go; Fever 103F for one day/ second and third day she had fever of 100F; Asthma was not significantly worse but she used her inhaler a little more; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (Asthma was not significantly worse but she used her inhaler a little more), PAIN (Aches, pains), FEELING ABNORMAL (Feeling miserable), VACCINATION SITE WARMTH (Arm was hot/ The whole area was hot,  it covered half of her upper arm/  went all the way around her entire circumference of the arm to the elbow) and VACCINATION SITE DISCOLOURATION (Looks like a stain in the skin where she was injected) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L012F21A, 0474B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine (Flu vaccine  a few years ago gave her worse reactions ). Past adverse reactions to the above products included Vaccination adverse reaction with Flu vaccine. Concurrent medical conditions included Asthma. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Fever, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DICLOFENAC (VOLTAREN [DICLOFENAC]) and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PAIN (Aches, pains), FEELING ABNORMAL (Feeling miserable), VACCINATION SITE WARMTH (Arm was hot/ The whole area was hot,  it covered half of her upper arm/  went all the way around her entire circumference of the arm to the elbow), VACCINATION SITE DISCOLOURATION (Looks like a stain in the skin where she was injected), VACCINATION SITE MASS (There were 3-4 small hard lumps/clumps), VACCINATION SITE DISCHARGE (Syrup seeping out to the surrounding tissues and that the vaccine spilled out in the surrounding tissues), VACCINATION SITE INDURATION (There were 3-4 small hard lumps/clumps), VACCINATION SITE PRURITUS (Itchy around the clumped areas), VACCINATION SITE RASH (The red area underneath arm was more like contact dermatitis-rash type of thing compared to the outside red dark lumpy stuff), VACCINATION SITE ERYTHEMA (Arm was red, it was round, circular disc shape around the injection site), VACCINATION SITE SWELLING ( Arm continued to swell and swelling got bigger), VACCINATION SITE PAIN (It was very painful), HEADACHE (Headaches/ Headache would come and go) and PYREXIA (Fever 103F for one day/ second and third day she had fever of 100F). In November 2021, the patient experienced ASTHMA (Asthma was not significantly worse but she used her inhaler a little more). At the time of the report, ASTHMA (Asthma was not significantly worse but she used her inhaler a little more) outcome was unknown and PAIN (Aches, pains), FEELING ABNORMAL (Feeling miserable), VACCINATION SITE WARMTH (Arm was hot/ The whole area was hot,  it covered half of her upper arm/  went all the way around her entire circumference of the arm to the elbow), VACCINATION SITE DISCOLOURATION (Looks like a stain in the skin where she was injected), VACCINATION SITE MASS (There were 3-4 small hard lumps/clumps), VACCINATION SITE DISCHARGE (Syrup seeping out to the surrounding tissues and that the vaccine spilled out in the surrounding tissues), VACCINATION SITE INDURATION (There were 3-4 small hard lumps/clumps), VACCINATION SITE PRURITUS (Itchy around the clumped areas), VACCINATION SITE RASH (The red area underneath arm was more like contact dermatitis-rash type of thing compared to the outside red dark lumpy stuff), VACCINATION SITE ERYTHEMA (Arm was red, it was round, circular disc shape around the injection site), VACCINATION SITE SWELLING ( Arm continued to swell and swelling got bigger), VACCINATION SITE PAIN (It was very painful), HEADACHE (Headaches/ Headache would come and go) and PYREXIA (Fever 103F for one day/ second and third day she had fever of 100F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 103 (High) 103F, 100 (High) 100F and 99 (High) 99F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included unspecified inhaler for asthma.    This case was linked to MOD-2021-403381, MOD-2021-403378 (Patient Link).