Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Laboratory test, Neck mass, Neck pain, Pharyngeal mass
Clinical narrative: The patient was hospitalized for unknown reason; Spider bite; the patient WHELPS ALL OVER BODY/WELTS ON HANDS, WRISTS AND TWO WELTS ON BACK WERE THICK AND RAISED; INFLUENZA; Neck pain; LUMP IN THROAT; LUMP IN NECK; Elevated liver enzymes; POSSIBLE INFLAMMATION/INFLAMMATION ALL OVER BODY FROM 94 TO 152; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (The patient was hospitalized for unknown reason) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    The patient's past medical history included Non-smoker and Abstains from alcohol. Concurrent medical conditions included Drug allergy (LEVAQUIN ALLERGY), Drug allergy (SULFA MEDICATIONS ALLERGY), Ulcerative colitis, Crohn's disease, Indigestion and High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Indigestion.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced INFLAMMATION (POSSIBLE INFLAMMATION/INFLAMMATION ALL OVER BODY FROM 94 TO 152). In September 2021, the patient experienced INFLUENZA (INFLUENZA), NECK PAIN (Neck pain), PHARYNGEAL MASS (LUMP IN THROAT), NECK MASS (LUMP IN NECK) and HEPATIC ENZYME INCREASED (Elevated liver enzymes). On 16-Oct-2021, the patient experienced ARTHROPOD BITE (Spider bite) and URTICARIA (the patient WHELPS ALL OVER BODY/WELTS ON HANDS, WRISTS AND TWO WELTS ON BACK WERE THICK AND RAISED). On an unknown date, the patient experienced HOSPITALISATION (The patient was hospitalized for unknown reason) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In September 2021, INFLUENZA (INFLUENZA), NECK PAIN (Neck pain), PHARYNGEAL MASS (LUMP IN THROAT) and NECK MASS (LUMP IN NECK) had resolved. At the time of the report, HOSPITALISATION (The patient was hospitalized for unknown reason) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) outcome was unknown and ARTHROPOD BITE (Spider bite), INFLAMMATION (POSSIBLE INFLAMMATION/INFLAMMATION ALL OVER BODY FROM 94 TO 152) and URTICARIA (the patient WHELPS ALL OVER BODY/WELTS ON HANDS, WRISTS AND TWO WELTS ON BACK WERE THICK AND RAISED) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test: inflammation from 94 to 152.. In August 2021, Laboratory test: Inflammation was 94. In September 2021, Blood test: Elevated Liver enzymes., Inflammation marker 150. and cholesterol within normal limits. On 20-Oct-2021, Blood test: Unknown.         It was reported that lot number of dose 2 was 048A21A or could also be 048ARIA. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She was not sure if the elevated liver enzymes had decreased because she had not received her results back from blood work that was taken on 20-Oct-2021. The reporter's causality for the event(s) of HOSPITALIZATION, LUMP IN THROAT, LUMP IN NECK, THREE SPIDER BITES ON FACE, ARM SORENESS FROM COVID-19 VACCINATION, WHELPS ALL OVER BODY/WELTS ON HANDS, WRISTS AND TWO WELTS ON  BACK WERE THICK AND RAISED, WELTS ON FACE AROUND MOUTH AREA/WELTS ON FACE INCREASED TO EIGHT TO NINE AND WERE THICK AND RAISED, INFLUENZA, ELEVATED LIVER ENZYMES and NECK PAIN was not provided. The reporter's causality for the event(s) of POSSIBLE INFLAMMATION/INFLAMMATION ALL OVER BODY AND INCREASED FROM 94 TO 152 CAUSE BY THE HUMIRA with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. There was no reasonable possibility that the events of HOSPITALIZATION, THREE SPIDER BITES ON FACE and ARM SORENESS FROM COVID-19 VACCINATION are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). The events of LUMP IN THROAT, LUMP IN NECK, POSSIBLE INFLAMMATION/INFLAMMATION ALL OVER BODY AND INCREASED FROM 94 TO 152 CAUSE BY THE HUMIRA, WHELPS ALL OVER BODY/WELTS ON HANDS, WRISTS AND TWO WELTS ON BACK WERE THICK AND RAISED, WELTS ON FACE AROUND MOUTH AREA/WELTS ON FACE INCREASED TO EIGHT TO NINE AND WERE THICK AND RAISED, ELEVATED LIVER ENZYMES and NECK PAIN are not assessable. There was a reasonable possibility that the event of INFLUENZA is related to HUMIRA 40MG/0.4ML(ADALIMUMAB). She was taking an unknown cream for treatment of welts. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  This spontaneous case concerns a 65  year  old female patient, in treatment with co  suspect product Adalimumab due to ulcerative colitis and Crohn´s disease, and medic   This case was linked to MOD-2021-622546 (Patient Link).  Company comment: This spontaneous case concerns a 65  year  old female patient, in treatment with co  suspect product Adalimumab due to ulcerative colitis and Crohn´s disease, and medical history of drug allergy, who received two doses of mRNA-1273 vaccine and experienced the serious unexpected event of hospitalization. Onset date of was not reported; hence latency and temporal association cannot be properly assessed. The patient was hospitalized for unknown reason. No further information regarding the event was provided for medical reviewing. Patient´s mentioned medical history remains as confounders for hospitalization. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65  year  old female patient, in treatment with co  suspect product Adalimumab due to ulcerative colitis and Crohn´s disease, and medical history of drug allergy, who received two doses of mRNA-1273 vaccine and experienced the serious unexpected event of hospitalization. Onset date of was not reported; hence latency and temporal association cannot be properly assessed. The patient was hospitalized for unknown reason. No further information regarding the event was provided for medical reviewing. Patient´s mentioned medical history remains as confounders for hospitalization. The benefit risk relationship of mRNA-1273 is not affected by this report.