Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug hypersensitivity, Hypersensitivity, Inappropriate schedule of product administration, Pruritus
Clinical narrative: acute allergic reaction; itching in the arm; caller mentioned that each shot was 6 months apart; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (acute allergic reaction) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (acute allergic reaction) (seriousness criterion hospitalization), PRURITUS (itching in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller mentioned that each shot was 6 months apart). The patient was hospitalized from 06-Nov-2022 to sometime in December 2022 due to HYPERSENSITIVITY. At the time of the report, HYPERSENSITIVITY (acute allergic reaction), PRURITUS (itching in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller mentioned that each shot was 6 months apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated she already received 6 Moderna COVID-19 Vaccines so far, but she did not have the dates. Last dose of the Bivalent vaccine she got it on JUN/JUL2023. Patient did not experienced symptoms after 1st dose but with next doses she had itching in the arm during a few days, and it seemed to be a cumulative thing because after each next dose it spread more from the arm to the shoulder and it went progressively worse until the last dose when she experienced itching all over her trunk, arms and back during approximately 10 days to 2 weeks, it was just itching without rash. Patient did not take any treatment for this symptom.  Patient experienced acute allergic reaction to Plaquenil. After this experience on JAN2023 she thought it might be when she got her 5th Moderna shot and she started noticing itchiness, she did not know if the allergic reaction to Plaquenil was related to these symptoms. Patient mentioned this reaction could be related to thimerosal which was a preservative.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 69-year-old female patient, with relevant medical history, who experienced the unexpected and serious (due to hospitalization) event of Hypersensitivity, which occurred on a date after an unspecified dose of mRNA-1273 vaccine. As reported, patient experienced acute allergic reaction to Hydroxychloroquine sulfate (for psoriatic arthritis), which remains as a co-suspect product. Patient remained hospitalized for approximately 1 months. No information disclosed about diagnostic tests performed or treatments received. Causality for the event was assessed as not related, due to relatedness with hydroxychloroquine sulfate. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-743885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743885:Bivalent Case