Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Periorbital haemorrhage, Peripheral swelling, Platelet count decreased, Platelet factor 4
Clinical narrative: SAGITTAL VEIN THROMBOSIS; RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS; THROMBOCYTOPENIA; FEELING BAD; JAW PAIN; NASAL PAIN; PAIN BEHIND EYES; HEADACHE; BILATERAL LEG SWELLING; SYNCOPE; BRUISING; PERIORBITAL PETECHIAE; viral syndrome; FEVER; RIGORS; MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a health care professional concerned a 28 year old female. The patient's height, and weight were not reported. The patient did not have any chronic or long-standing health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805031) on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included oral contraceptive nos. On 25-MAR-2021, the patient experienced viral syndrome and was hospitalized presenting with fever, rigors, muscle pain, and shortness of breath. She received azithromycin as corrective treatment. Her fever persisted for one day after her Emergency Room (ER) visit but continued "feeling bad". The following day she experienced severe jaw pain (right side greater than left), headache with standing, pain in the cartilage on the tip of her nose and shortness of breath. Headache and jaw pain persisted, as did pain behind her eyes.  On 30-MAR-2021 the patient noticed increasing bruising and periorbital petechiae. She sought help from her primary care physician on an unspecified date and she was noted to have bilateral leg swelling (much greater on right than left). She had a syncopal spell on an unspecified date and was brought to the ER where she was diagnosed with sagittal vein thrombosis, right lower extremity deep vein thrombosis and thrombocytopenia.  Laboratory data (dates unspecified) included: Blood smear test (NR: not provided) No clumping, no shistocytes, Computerized tomogram (NR: not provided) showed a dural sinus thrombosis, Duplex ultrasound (NR: not provided) showed right lower extremity thrombosis, Magnetic resonance imaging (NR: not provided) dural sinus thrombosis. Platelet count (NR: not provided) was noted to be 34,000 and 125,000 (dates not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 26-MAR-2021, and shortness of breath on 31-MAR-2021, and had not recovered from viral syndrome, rigors, muscle pain, jaw pain, nasal pain, pain behind eyes, headache, bruising, periorbital petechiae, bilateral leg swelling, syncope, sagittal vein thrombosis, right lower extremity deep vein thrombosis, thrombocytopenia, and feeling bad. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This case involves a 28-year-old female who was diagnosed with sagittal vein thrombosis, right lower extremity deep vein thrombosis, and thrombocytopenia 11 days after vaccination with JNJ vaccine intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. On an unspecified date after vaccination, the patient presented to the emergency department (ED) with a "viral syndrome" including fevers, rigors, muscle pain and shortness of breath for which she was treated with azithromycin. The fever persisted for 1 day after her ED visit, but she continued to "feel badly." The following day, she awakened with severe Right>Left jaw pain, posterior headache with standing, pain in the cartilage of her nose, and shortness of breath. The shortness of breath was noted to have resolved by 12 days after vaccination but the headaches, jaw pain, and pain behind the eyes persisted.  She also noticed increasing bruising and periorbital petechiae 11 days after vaccination and was found to have bilateral leg swelling (R>L) by her primary care physician. She had a syncopal spell and was again taken to the ED where she was diagnosed with a sagittal vein thrombosis, right lower extremity deep vein thrombosis, and thrombocytopenia. CT and MRI of the head showed a dural thrombus thrombosis. Her platelet count was reported as 125,000 and also 34,000. The blood smear showed no clumping and no schistocytes. A hypercoagulation panel as well as ANA, Anti PF4/HIT is pending.  She was noted to be stabilized but has not yet recovered. This rare event is assessed as indeterminate with a causal association to immunization, per the WHO causality classification for adverse events following immunization based on a lack of a definitive plausible biological mechanism, however, considering temporal relationship, the low platelet counts, and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.