Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, White blood cell count
Clinical narrative: Left Arm was sore; Left Arm was Red; Fever; Chills; 80% blockage of her heart/received a Cardiac Stent in August or September of 2022; This spontaneous case was reported by a patient and describes the occurrence of ATRIOVENTRICULAR BLOCK (80% blockage of her heart/received a Cardiac Stent in August or September of 2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 039F21A, 028A21A and 025A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emphysema (had a medical history significant for Emphysema), COPD (had a medical history significant for COPD) and White blood cell count high (Chronic). Concomitant products included CLOPIDOGREL, BUDESONIDE, IPRATROPIUM, LEVALBUTEROL [LEVOSALBUTAMOL] and AZITHROMYCIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced VACCINATION SITE PAIN (Left Arm was sore), VACCINATION SITE ERYTHEMA (Left Arm was Red), PYREXIA (Fever) and CHILLS (Chills). In 2022, the patient experienced ATRIOVENTRICULAR BLOCK (80% blockage of her heart/received a Cardiac Stent in August or September of 2022) (seriousness criterion medically significant). The patient was treated with Surgery (Cardiac stent) for Atrioventricular block. In May 2022, VACCINATION SITE PAIN (Left Arm was sore), VACCINATION SITE ERYTHEMA (Left Arm was Red), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ATRIOVENTRICULAR BLOCK (80% blockage of her heart/received a Cardiac Stent in August or September of 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: High.         The patient received Moderna COVID-19 vaccine first booster dose on 30-Oct-2021 and second booster dose on 19-May-2022. Patient received a Cardiac Stent in August or September of 2022. Patient did not remember the month that she received the stent in. It was reported that Left Arm sore, red, fever, and chills lasted for 2 to 3 days.  Company comment: This spontaneous case concerns a 70-year-old female patient, with relevant medical history of chronic obstructive pulmonary disease, emphysema, chronic high white blood cell count, who experienced the unexpected serious (medically significant) AESI of Atrioventricular block in the context of receiving the 4th dose of mRNA-1273 vaccine (2nd booster). Onset latency could not be determined as onset date of event was not provided. As stated in report, patient received first four Moderna COVID-19 vaccine and had 80% heart blockage. Patient underwent cardiac stenting approximately three or four months after the administration of 4th dose of mRNA-1273 vaccine. Clinical course was not reported. The outcome of event was unknown. Patient received 2-dose primary series of mRNA-1273 vaccine 28 days apart. Seven months later, the 3rd dose of mRNA-1273 vaccine was administered. And the 4th dose, which is the current mRNA-1273 vaccine was given approximately 7 months after the 3rd dose. It was reported that patient also experienced left arm sore, fever, and chills from previous doses. The medical history of chronic obstructive pulmonary disease could be considered as a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.   This case was linked to MOD-2022-657251, MOD-2022-657182 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with relevant medical history of chronic obstructive pulmonary disease, emphysema, chronic high white blood cell count, who experienced the unexpected serious (medically significant) AESI of Atrioventricular block in the context of receiving the 4th dose of mRNA-1273 vaccine (2nd booster). Onset latency could not be determined as onset date of event was not provided. As stated in report, patient received first four Moderna COVID-19 vaccine and had 80% heart blockage. Patient underwent cardiac stenting approximately three or four months after the administration of 4th dose of mRNA-1273 vaccine. Clinical course was not reported. The outcome of event was unknown. Patient received 2-dose primary series of mRNA-1273 vaccine 28 days apart. Seven months later, the 3rd dose of mRNA-1273 vaccine was administered. And the 4th dose, which is the current mRNA-1273 vaccine was given approximately 7 months after the 3rd dose. It was reported that patient also experienced left arm sore, fever, and chills from previous doses. The medical history of chronic obstructive pulmonary disease could be considered as a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.