Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: MULTIPLE BILATERAL PULMONARY EMBOLI; BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a  patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use (very rarely), and non smoker. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041a21a, and expiry: UNKNOWN) dose was not reported,1 total administered on 03-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the patient had headache, chills, and experienced body aches. On Monday, 05-MAR-2021, the patient woke up with chest tightness and pain to left shoulder and side. The patient visited emergency room for treatment of the events. The patient was admitted to hospital (date unspecified) with multiple bilateral pulmonary emboli. Laboratory data included: computerized tomography (CT) scan (NR: not provided) showed bilateral pulmonary emboli, and Fibrin D dimer (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and headache on and unknown date, was recovering from body aches, and the outcome of multiple bilateral pulmonary emboli was recovering. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: The case concerns a patient of unspecified age and sex who developed pulmonary embolism 2 days after, and body aches, chills and headache the same day Janssen COVID-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The patient's concurrent conditions included penicillin allergy, alcoholic, and non -smoker. The patient had no history of drug abuse or illicit drug usage. No concomitant medications were reported.  Two days post vaccination the patient woke up with chest tightness and pain to left shoulder and side and was admitted to hospital. A chest computerized tomography (CT) scan showed multiple bilateral pulmonary emboli, and elevated D- dimer. The patient recovered from chills and headache and is recovering from body aches and pulmonary embolus.  Given limited information regarding the subject's risk factors and  short time to onset it is unlikely that the vaccine caused or contributed to multiple pulmonary emboli and is considered to have an indeterminate causal association to immunization, per the WHO causality classification for adverse events following immunization.  The company causality for events of body aches, chills, headache is considered related and for pulmonary emboli is considered not related to Janssen COVID-19 vaccine (Level 4 -Insufficient information available to confirm a possible, probable or a definitive case of venous thrombosis, per the Brighton Collaboration case definition). Additional information has been requested for further assessment (subject's age, gender, medical / family history, concomitant medications).