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Life Threatening? No
Write-up: SAFENA VEIN DAMAGED; CONSTANT PAIN; VERY LITTLE SLEEP FOR FEW DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient''s height, and weight were not reported. The patient was healthy and had no previous conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021 immediately after vaccination, the patient felt pain in the left leg and her veins began to feel inflamed, the inflammation began to show in the foot and developed upwards. On an unspecified date in JUL-2021, the patient experienced constant pain and very little sleep for few days until then the patient visited the physician''s office and was told that the patient had her safena vein damaged for which she had to undergo unspecified treatment and potentially surgery. The patient reported that her leg was just fine prior to the vaccine and that the treatment would last for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very little sleep for few days, safena vein damaged and constant pain was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210722944-JANSSEN COVID-19 VACCINE Ad26.COV2.S- venous injury-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).
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