Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Feeling abnormal, Myalgia, Nausea
Clinical narrative: sick to her stomach; Feels crappy; Threw up/tends to wake up in the mornings and starts throwing up.; Nausea; Had Covid arm, went all the way to elbow, turned pink. Still has some blotchy pink spots on arm; Bright pink patch 4x6 inches in their arm; Patch is swollen; Whole arm got really really sore down to their elbow; Place where the actual injections was is slightly raised, like a little pimple; Patch is hot to the touch; Low grade fever of 99.; Whole body was hurting so much they could not believe it, they could not move/she was hurting from head to toe, every square inch of her; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Had Covid arm, went all the way to elbow, turned pink. Still has some blotchy pink spots on arm), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN IN EXTREMITY (Whole arm got really really sore down to their elbow), VACCINATION SITE MASS (Place where the actual injections was is slightly raised, like a little pimple) and VACCINATION SITE WARMTH (Patch is hot to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Previously administered products included for an unreported indication: RITUXIMAB. Concurrent medical conditions included Vasculitis, Diverticulitis, Colitis, Immune disorder (NOS), Relapsing polychondritis (Relapsing polychondritis with vasculitis.), Wegener's granulomatosis (Wegener's granulomatosis with polyangiitis), Sjogren's syndrome, Lupus syndrome and Tuberculosis. Concomitant products included METOPROLOL, CLONIDINE, DOXAZOSIN, LISINOPRIL, METHYLPREDNISOLONE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OMEPRAZOLE, PROMETHAZINE, BACLOFEN, VITAMIN D NOS, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), PYRIDOXINE HYDROCHLORIDE (B6) and ONDANSETRON (ZOFRAN [ONDANSETRON]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Whole body was hurting so much they could not believe it, they could not move/she was hurting from head to toe, every square inch of her) and PYREXIA (Low grade fever of 99.). On 12-Mar-2021, the patient experienced VACCINATION SITE REACTION (Had Covid arm, went all the way to elbow, turned pink. Still has some blotchy pink spots on arm). 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Whole arm got really really sore down to their elbow), VACCINATION SITE MASS (Place where the actual injections was is slightly raised, like a little pimple), VACCINATION SITE WARMTH (Patch is hot to the touch), RASH (Bright pink patch 4x6 inches in their arm) and VACCINATION SITE SWELLING (Patch is swollen). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feels crappy), VOMITING (Threw up/tends to wake up in the mornings and starts throwing up.) and NAUSEA (Nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PROMETHAZINE at an unspecified dose and frequency. On 11-Mar-2021, MYALGIA (Whole body was hurting so much they could not believe it, they could not move/she was hurting from head to toe, every square inch of her) had resolved. At the time of the report, VACCINATION SITE REACTION (Had Covid arm, went all the way to elbow, turned pink. Still has some blotchy pink spots on arm), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN IN EXTREMITY (Whole arm got really really sore down to their elbow), VACCINATION SITE MASS (Place where the actual injections was is slightly raised, like a little pimple), VACCINATION SITE WARMTH (Patch is hot to the touch), FEELING ABNORMAL (Feels crappy), RASH (Bright pink patch 4x6 inches in their arm), VACCINATION SITE SWELLING (Patch is swollen), PYREXIA (Low grade fever of 99.), VOMITING (Threw up/tends to wake up in the mornings and starts throwing up.) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment provided include aspirin and promethazine for nausea. Patient was on a medication called Rituximab, she then developed tuberculosis and has been off the medication for 6 months The patient is almost done with TB treatment and is going back to chemotherapy. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-May-2021 included: Current conditions were updated, concomitant medications and treatment drugs were added, new events were added.