Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: He believes he has a blood clot in the arm; Interchange of vaccine products; Revaccination with different COVID-19; Redness It is developing, it is bigger/The injection site is still red were he received the shot.; sore arm; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (He believes he has a blood clot in the arm) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011M22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive last year) in 2022. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) on 15-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose) on 05-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (3rd dose) on 27-Sep-2021 and PFIZER BIONTECH COVID-19 VACCINE (4th dose) on 07-Jun-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Shellfish allergy, HIV infection (Concomitant disease), Hepatitis B (Concomitant disease) and Cancer (Concomitant disease).    On 02-Jan-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PAIN IN EXTREMITY (sore arm). On 04-Jan-2023, the patient experienced VACCINATION SITE ERYTHEMA (Redness It is developing, it is bigger/The injection site is still red were he received the shot.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced THROMBOSIS (He believes he has a blood clot in the arm) (seriousness criterion medically significant) and COVID-19 IMMUNISATION (Revaccination with different COVID-19). At the time of the report, THROMBOSIS (He believes he has a blood clot in the arm), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness It is developing, it is bigger/The injection site is still red were he received the shot.) and PAIN IN EXTREMITY (sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) last year.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient past first 4 doses were from Pfizer and patient didn't want to provide the lot numbers. Patient received Moderna Bivalent Booster dose 2 days ago. One day after patient had Sore arm and Two days after (today) patient had redness It was developing, it is bigger. The injection site was still red were the shot was received. Patient believes patient had a blood clot in the arm, patient will call his HCP or go to the ER. No treatment information was reported.  Company comment: This spontaneous case concerns a 59-year-old male patient, with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis (Thrombosis arm) that occurred after receiving the fifth dose of mRNA-1273 Bivalent BA.4/BA.5  vaccine in covid-19 vaccination series. Latency could not be assessed as the exact date of onset of the event is not available. Patient had received four doses of PFIZER BIONTECH COVID-19 VACCINE previously (Interchange of vaccine products). One day after vaccination patient experienced sore arm, next day he experienced injection site redness and he believes he has a blood clot in the arm. No further information regarding risk factors, relevant medical history, concomitant medication, investigations and treatment received were provided. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59-year-old male patient, with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis (Thrombosis arm) that occurred after receiving the fifth dose of mRNA-1273 Bivalent BA.4/BA.5  vaccine in covid-19 vaccination series. Latency could not be assessed as the exact date of onset of the event is not available. Patient had received four doses of PFIZER BIONTECH COVID-19 VACCINE previously (Interchange of vaccine products). One day after vaccination patient experienced sore arm, next day he experienced injection site redness and he believes he has a blood clot in the arm. No further information regarding risk factors, relevant medical history, concomitant medication, investigations and treatment received were provided. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 vaccine is not affected by this report.