Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Electrocardiogram, Fibrin D dimer, Intensive care
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc.  On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. 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 was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events.  20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. 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).  V0: 20210705031-COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS  20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . 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).