Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: acute pulmonary embolism of the left lower lobe/feel pain on the L side of his abdomen one day after receiving vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (acute pulmonary embolism of the left lower lobe/feel pain on the L side of his abdomen one day after receiving vaccination) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031707) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose-0.5 (milliliter), Batch/lot number-026A21A, Route of Administration-Intramuscular) on 09-Mar-2021, Moderna COVID-19 Vaccine (Dose-0.5 (milliliter), Batch/lot number-031B21A, Route of Administration-Intramuscular) on 06-Apr-2021, Moderna COVID-19 Vaccine (Dose-0.25 (milliliter), Batch/lot number-058H21A, Route of Administration-Intramuscular) on 04-Dec-2021, Moderna COVID-19 Vaccine (Dose-0.25 (milliliter), Batch/lot number-037A22B, Route of Administration-Intramuscular) on 01-Jun-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose-0.5 (milliliter), Batch/lot number-053D22A and Route of Administration-Intramuscular) on 13-Oct-2022. Past adverse reactions to the above products included No adverse reaction with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. In March 2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PULMONARY EMBOLISM (acute pulmonary embolism of the left lower lobe/feel pain on the L side of his abdomen one day after receiving vaccination) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (acute pulmonary embolism of the left lower lobe/feel pain on the L side of his abdomen one day after receiving vaccination) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  On 30-Nov-2023 patient received SPIKEVAX 2023-2024 PFS, Dose-0.5 (milliliter), Batch/lot number-3032086, Route of Administration-Intramuscular.  Patient received a COVID booster on 12-Mar-2024. On 15-Mar-2024, patient presented to urgent care with 1 day history of SOB and LUQ abdominal pain. Noted patient felt fatigued the day receiving the vaccine and began to feel pain on the L side of his abdomen one day after receiving vaccination. Ultimately diagnosed with an acute pulmonary embolism of the left lower lobe that was appropriately treated. Patient had been discharged home.   It was unknown if the patient experienced any additional symptoms/events and medication Details and reason for taking the medicine.  Company comment:  This is a spontaneous case concerning a 76-year-old, male patient previously vaccinated with four doses of mRNA-1273 vaccine, and no other reported medical history, who experienced the unexpected serious (medically significant and hospitalization) AESI of Pulmonary embolism. On the same day of the administration of SPIKEVAX 2023-2024 PFS, used a booster dose the patient experienced fatigue and began to feel pain on the left side of his abdomen. Two days later, he had shortness of breath and left upper quadrant abdominal pain. Pulmonary embolism was diagnosed. No further information on clinical course, investigations and treatment received was available in the report. The Benefit-risk relationship of SPIKEVAX 2023-2024 PFS Vaccine is not affected by this report.