PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; ANTICOAGULANT THERAPY; BLOOD CULTURE; BLOOD ELECTROLYTES; BLOOD TEST; BORRELIA TEST; COMPUTERISED TOMOGRAM THORAX ABNORMAL; ERYTHEMA; FULL BLOOD COUNT; GROIN PAIN; PERIPHERAL SWELLING; ULTRASOUND DOPPLER ABNORMAL; ULTRASOUND SCAN; PAIN IN EXTREMITY; This spontaneous report received from a health care professional by a Regulatory Authority (reference number 1958624) on 31-DEC-2021 concerned a 22 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to Right Arm on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAY-2021, the patient experienced anticoagulant therapy, blood culture, blood electrolytes, blood test, borrelia test, computerised tomogram thorax abnormal, deep vein thrombosis, erythema, full blood count, groin pain, pain in extremity, peripheral swelling, pulmonary embolism, ultrasound doppler abnormal, ultrasound scan. Starting at the end of May had groin pain extending down right leg This progressed to red streaking on both lower extremities with extreme pain and swelling Seen in ED (emergency department) and Ultrasound Ct (computerized tomography) scan, Blood work completed Diagnosed with pulmonary embolism and Deep Vein Thrombosis. The patient hospitalized for 4 days and discharged to home on blood thinners Tried going off blood thinners in October and started with leg and groin pain-seen in ED three times Re-started on blood thinners end of November after all blood work-up was normal. Laboratory data included: Blood culture (NR: not provided) Unknown, Blood electrolytes (NR: not provided) Unknown, Blood test (NR: not provided) Unknown, Borrelia test (NR: not provided) Unknown, Computerised tomogram thorax (NR: not provided) abnormal, Full blood count (NR: not provided) Unknown, Ultrasound Doppler (NR: not provided) Abnormal, and Ultrasound scan (NR: not provided) Unknown. On 04-JUN-2021, Laboratory data included: Blood culture (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. On 05-JUN-2021, Laboratory data included: Culture (NR: not provided) Not reported. On 06-JUN-2021, Laboratory data included: Acid base balance (NR: not provided) Not reported. On 07-JUN-2021, Laboratory data included: CBC (NR: not provided) Not reported. On 13-OCT-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Not reported. On 21-OCT-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Not reported. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anticoagulant therapy, blood culture, blood electrolytes, blood test, borrelia test, computerised tomogram thorax abnormal, deep vein thrombosis, erythema, full blood count, groin pain, pain in extremity, peripheral swelling, pulmonary embolism, ultrasound doppler abnormal, and ultrasound scan. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  Version created to amend previously reported information on 31/Dec/2021. Upon review following information was amended  labeling of the events deep vein thrombosis, pulmonary embolism, groin pain, peripheral swelling, erythema and pain in extremity as unlabeled.; Sender's Comments: V1: This version is created to amend the following information: labelling corrected for events deep vein thrombosis, pulmonary embolism, groin pain, peripheral swelling, erythema and pain in extremity, MAC amended.  20220100201-Covid-19 vaccine ad26.cov2.s -Deep vein thrombosis, pulmonary embolism, pain in extremity, anticoagulant therapy, blood culture, blood electrolytes, blood test, borrelia test, computerised tomogram thorax abnormal, erythema, full blood count, groin pain,  peripheral swelling, ultrasound doppler abnormal, and ultrasound scan. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).