Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: BLOOD CLOTS IN THE LUNG; PNEUMONIA; CONFIRMED CLINICAL  VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; TERRIBLE MEMORY; LOST MUSCLE TONE AND STRENGTH; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 212 pounds, and height was 63 inches. The patient's concurrent conditions included: thyroid, epileptic, electrical palpitation in the heart, smoker, non alcohol user, and penicillin allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included steroids, metoprolol for electrical palpitation in the heart, topiramate for epilepsy, phenobarbital for epileptic, and levothyroxine sodium for thyroid.  Patient stated that after the vaccination she had no reaction, no soreness. On October 18th, she woke up at night because she could not stop coughing, it was a dry cough. she thought it was allergy. Next day she had little fever and she could not remember the reading and did not feel good. On 20-Oct-2021, the patient went for both the rapid test and another test. She did not remember the name of the test but described it as the test that takes 2-3 days to get the result and another was done via nasal swab. On same day, the patient experienced confirmed covid-19 infection, and had confirmed clinical vaccination failure. Laboratory data included: COVID-19 (NR: not provided) Positive. On 24-OCT-2021, Laboratory data included: Blood pressure (NR: not provided) Not reported, and Body temperature (NR: not provided) 103.5. On same day, the patient called for an ambulance just to check her because she found that the oximeter reading was 88. The paramedics measured her blood pressure and oxygen levels. The paramedics told her that there was nothing more than hospital can do for her. The patient had temperature 103.5. She could not breath and could barely walk from living room to bathroom. On 26-Oct-2021, the patient visited her PCP (primary care provider) as she knew something was wrong. The patient was diagnosed with Pneumonia and prescribed antibiotic, and she could not remember the name and cough drops which the patient described as pearl and looked like small vitamin E. Patient stated that despite taking the antibiotics, she kept getting worse. She could not walk very far and had to sit down to breath from the nose and out from her mouth. On 01-NOV-2021, the patient visited to hospital and was admitted, and on same day she diagnosed blood clots in the lung. Laboratory data included: CT scan (NR: not provided) pulmonary embolism. and Laboratory test (NR: not provided) not reported. The blood work done three times during hospitalization. The patient stated that she was on oxygen. Treatment medications (dates unspecified) included: rivaroxaban (Xarelto) for 6 months. The patient was hospitalized for 4 days. On 04-NOV-2021 she was discharged. On 04-NOV-2021, the patient experienced lost muscle tone and strength, and had terrible memory. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia on NOV-2021, was recovering from blood clots in the lung, and confirmed covid-19 infection, had not recovered from terrible memory, and lost muscle tone and strength, 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:90000203000.; Sender's Comments: V0: V0; 20211141849-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  20211141849-COVID-19 VACCINE AD26.COV2.S- pneumonia, blood clots in the lungs, confirmed Covid 19 infection. 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).