Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Culture, Culture negative, Diarrhoea, Endocarditis
Clinical narrative: This spontaneous report received from a health care professional via a Regulatory Authority (RA) (VAER reference number: 1872783) concerned a 36-year-old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, chronic kidney disease, depression, endocarditis, hepatitis c, hypertension, substance use disorder, nicotine dependence, and iv (intravenous) drug user, and other pre-existing medical conditions included: No known drug allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 04-JUN-2021 vaccinated on right arm for an unspecified indication. The drug Start Period was 93 days. Dose number series was 1. No concomitant medications were reported. On 05-SEP-2021, Patient who tested positive for covid-19 for further management of acute abdominal low back spinal and neck pain with multiple other complaints was found to have MRSA (methicillin-resistant Staphylococcus aureus) bacteremia secondary to Infective Endocarditis complicated septic pulmonary emboli was admitted to the emergency department (on an unspecified date. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive Patient cultures became negative on 10-SEP-2021 and Viral pneumonia secondary to SARS COVID-19 pneumonia - patient was isolated Constitutional: Positive for appetite change chills fatigue and fever HENT (head, ear, nose and throat examination): Positive for rhinorrhea Negative for congestion sneezing and sore throat Gastrointestinal: Positive for abdominal pain diarrhea nausea and vomiting negative for constipation discharge disposition condition disposition: Home Condition: Stable, potential problems absent or manageable. On 06-SEP-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 10-SEP-2021, the patient experienced culture negative. Due to difficulty clearing cultures, incision and drainage was recommended along with extended course of IV (intravenous) antibiotics from 10-SEP-2021 to 05-NOV-2021. the patient experienced sars-cov-2 test positive. On an unspecified date, the patient experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine was not applicable. The patient recovered from covid-19 pneumonia, septic pulmonary embolism, pneumonia viral, staphylococcal bacteraemia, endocarditis, covid-19, abdominal pain, appetite disorder, back pain, chills, culture negative, diarrhoea, fatigue, nausea, neck pain, pyrexia, rhinorrhoea, sars-cov-2 test positive, spinal pain, and vomiting, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged) This report was associated with a product quality complaint: 90000205227. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed. Additional information received from Regulatory Authority on 11-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2. This follow up version was created to update investigation results. This updated information doesn't alter previous causality assessment made for the events in this case.  20211201836-COVID-19 VACCINE -Covid-19 pneumonia, septic pulmonary embolism, pneumonia viral, staphylococcal bacteraemia, endocarditis, covid-19, abdominal pain, appetite disorder, back pain, chills, culture negative, diarrhoea, fatigue, nausea, neck pain, pyrexia, rhinorrhoea, sars-cov-2 test positive, spinal pain, and vomiting. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211201836-COVID-19 VACCINE Confirmed 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.