Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, COVID-19, Dry gangrene, Intermittent claudication
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; Arthralgia; Myalgia; Pyrexia; Peripheral artery occlusion; Pulmonary embolism; Pulmonary infarction; Dry gangrene; Angiogram pulmonary abnormal; Anticoagulant therapy; Arterial occlusive disease; Asthma; SARS-COV-2 TEST POSITIVE; Intermittent claudication; Pain; Peripheral arterial occlusive disease; Respiratory symptom; COVID-19; Ultrasound Doppler abnormal; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1963520) concerned a 50 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar disorder, hypertension and tobacco dependence. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAY-2021 for an unspecified indication. No concomitant medications were reported.  On 17-DEC-2021, the patient experienced L great toe dry gangrene and also found to have an acute pulmonary embolism and covid 19. Dry gangrene L great toe suspect underlying peripheral artery disease. The patient had chronic claudication with tobacco dependence possibly with exacerbation thrombosis embolus due to covid 19 as her respiratory symptoms preceded her L toe symptoms continue pain control. She still reports significant pain and had continue intravenous vancomycin started in the emergency department and will reassess need duration at 48 hours. No imminent surgical procedure anticipated. She had arterial duplex left lower extremity mild occlusive disease of the anterior and posterior tibial vessels and mid peroneal artery. Unable to obtain complete bilateral study due to covid status per vascular department. The patient was on heparin gamma-glutamyl transferase for pulmonary embolism as continue statin holding as a plavix pending further workup. She had chest obtained in the emergency department this hospitalization and heparin gamma-glutamyl transferase for 48 hours given increased risk for pulm hemorrhage with pulmonary infarct but still no hemoptysis. The patient reported URI symptoms for about 7-10 days preceding her other complaints including her progressive L great toe gangrene. As per her symptoms have improved reports only residual myalgias arthralgias and subjective fevers. The patient also checked for covid 19 at hospital and was reportedly negative. She had isolated for now asthma Mild Intermittent and was stable. Pulse oximetry Q shift Oxygen 2 L nasal cannula as required. She had Albuterol Shortness of breath with wheezing Hold. On same day, the patient experienced ultrasound doppler abnormal, angiogram pulmonary abnormal, anticoagulant therapy, On an unspecified date, the patient experienced confirmed clinical vaccination failure. The patient was hospitalized for 3 days. Treatment medications (dates unspecified) included: vancomycin, heparin and salbutamol. Laboratory data (dates unspecified) included: Angiogram pulmonary (NR: not provided) abnormal, CT angiography (NR: not provided) unknown, SARS-CoV-2 test (NR: not provided) positive and Ultrasound Doppler (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19, was recovering from asthma and dry gangrene, had not recovered from angiogram pulmonary abnormal, anticoagulant therapy, arterial occlusive disease, arthralgia, sars-cov-2 test positive, intermittent claudication, myalgia, pain, peripheral arterial occlusive disease, peripheral artery occlusion, pulmonary embolism, pulmonary infarction, pyrexia, respiratory symptom, and ultrasound doppler abnormal, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000210095. 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 the Regulatory Authority on 12-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: Additional information in this version is regarding: Product quality complaint investigation result. This does not alter the company causality of previously reported events 20220100335-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination 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 20220100335-Covid-19 vaccine ad26.cov2.s-Covid-19, asthma, dry gangrene, angiogram pulmonary abnormal, anticoagulant therapy, arterial occlusive disease, sars-cov-2 test positive, intermittent claudication, pain, peripheral arterial occlusive disease, peripheral artery occlusion, pulmonary embolism, pulmonary infarction, respiratory symptom, ultrasound doppler abnormal. 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). 20220100335-Covid-19 vaccine ad26.cov2.s-Arthralgia, pyrexia, myalgia. This event(s) is labeled per RSI and is therefore considered potentially related