Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Urinary tract infection; Rash; Cellulitis of arm; Fever; Chills; Lymphadenopathy axillary; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis of arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Thyroid cancer. Concomitant products included CEFAZOLIN SODIUM (ANCEF [CEFAZOLIN SODIUM]) and INFLUENZA VACCINE for an unknown indication.   On 10-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy axillary), PYREXIA (Fever) and CHILLS (Chills). In September 2021, the patient experienced CELLULITIS (Cellulitis of arm) (seriousness criterion medically significant). On 17-Sep-2021, the patient experienced RASH (Rash). In November 2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). In 2021, CELLULITIS (Cellulitis of arm), URINARY TRACT INFECTION (Urinary tract infection), LYMPHADENOPATHY (Lymphadenopathy axillary), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) had resolved.            The patient has other concomitant therapy of Cholesterol, Thyroid medication, blood pressure medication. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment information was provided by the reporter. 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.  Company comment.  This spontaneous case concerns a 70  year  old, female patient, with relevant current condition of chronic lymphocytic leukaemia in treatment with Ibrutinib, who received the third dose of mRNA  1273 vaccine and experienced the serious (medically significant) unexpected event cellulitis. The event (described as "cellulitis of the arm") was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. The event was recovered. No further clinical information was available for medical reviewing. Patient´s mentioned medical history (as it could lead to infections) and co  suspect product Ibrutinib (which could produce neutropenia), remains as confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up received include Concomitant (Influenza Vaccine ) added, Event (Pyrexia, Rash, Chills).; Sender's Comments: This spontaneous case concerns a 70  year  old, female patient, with relevant current condition of chronic lymphocytic leukaemia in treatment with Ibrutinib, who received the third dose of mRNA  1273 vaccine and experienced the serious (medically significant) unexpected event cellulitis. The event (described as "cellulitis of the arm") was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. The event was recovered. No further clinical information was available for medical reviewing. Patient´s mentioned medical history (as it could lead to infections) and co  suspect product Ibrutinib (which could produce neutropenia), remains as confounders for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.