Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Heparin-induced thrombocytopenia, Nasal congestion, Pain in extremity, Platelet count
Clinical narrative: PLATELET COUNT NORMAL; ULTRASOUND SCAN ABNORMAL; DEEP VEIN THROMBOSIS; FIBRIN D DIMER INCREASED; NASAL CONGESTION; SARS-CoV-2 TEST POSITIVE; PAIN IN EXTREMITY; ANTIBODY TEST NEGATIVE; COVID-19; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1595967) concerned a 49 year old male of unspecified race and ethnicity.   The patient's height, and weight were not reported. The patient had no current illness, no history, and no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, one total administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-AUG-2021, the patient antibody test was negative (suspected immunological vaccine failure) and experienced Covid-19, and pain in left calf. On 08-AUG-2021, the patient's Covid-19 rapid test was positive, experienced nasal congestion and family members with Covid-19 DVT (deep vein thrombosis). On 10-AUG-2021, the patient experienced fibrin D dimer increased to more than 4000. On 11-AUG-2021, the patient experienced deep vein thrombosis, ultrasound scan was abnormal (confirmed deep vein thrombosis). Laboratory data included: Heparin-induced thrombocytopenia was negative. On 12-AUG-2021, the patient platelet count was normal. On an unspecified date the patient visited physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep vein thrombosis, nasal congestion, antibody test negative, covid-19, fibrin d dimer increased, platelet count normal, sars-cov-2 test positive, ultrasound scan abnormal, and pain in extremity, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage). This report was associated with product quality complaint: 90000192643. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 15-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The follow up information received updates: Product quality complaint investigation result. This updated information does not alter the causality assessment of previously reported events.  20210908191-covid-19 vaccine ad26.cov2.s-deep vein thrombosis, nasal congestion, antibody test negative, covid-19, fibrin d dimer increased, platelet count normal, sars-cov-2 test positive, ultrasound scan abnormal and pain in extremity,. 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).  20210908191-covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS