Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exposure to SARS-CoV-2, Fatigue, Fibrin D dimer, Foot deformity
Clinical narrative: This spontaneous report received from a health care professional via Regulatory Authority ( ID: 1937008) was received on 17-DEC-2021 concerned a 61-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: mixed stress and urge urinary incontinence, and microscopic hematuria, and concurrent conditions included: COPD (chronic obstructive pulmonary disease), hypoxia/nocturnal hypoxia, tobacco abuse CODP, chronic pain syndrome, recurrent major depression, acute hypoxemic respiratory failure due to covid-19, osteoarthritis of lumbar spine, DDD (degenerative disc disease), lumbar rotator cuff tear, lumbar radiculopathy, cervical spinal stenosis, cervical radiculopathy, insomnia, chronic prescription opiate, osteoarthritis of right knee, mixed hyperlipidemia, allergy to iodine, and allergy to demerol ivp dye. The patient received covid-19 vaccine (Janssen series 1, suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAY-2021 for a prophylactic vaccination. Concomitant medications included acetylsalicylic acid, duloxetine hydrochloride, hydrocodone bitartrate/paracetamol, salbutamol, and salbutamol sulfate. On 02-DEC-2021, the patient experienced shortness of breath (dyspnoea), cough, nausea, chills, fevers, and chest pain. The patient had more shortness of breath than normal. Patient had been using her home inhalers without much relief. The patient required more oxygen than her baseline which was 2 litre. On 06-DEC-2021, the patient had detected covid-19 by COVID-19 PCR (polymerase chain reaction) test and admitted to medicine-severe COVID pneumonia, acute on chronic hypoxemic respiratory failure. The patient underwent chest x-ray examination which showed cardiomegaly and mild prominence of the pulmonary vascularity (pulmonary edema). Patient was tachycardic and tachypnoeic. During exam, patient was diaphoretic and tired. Patient was wheezy but not using increased respiratory effort. The patient started treatment with remdesivir and daily renal and liver function monitoring for kidney and liver toxicity due to remdesivir. The patient was wheezing, therefore received 125 mg Solu-Medrol (methylprednisolone sodium succinate) in the emergency department and will continue Solu-Medrol 40 mg for every 6 hours. The patient was on albuterol inhaler and on daily trends laboratory tests which included C-reactive protein (CRP) (NR: not provided) not reported, Complete blood count (NR: not provided) not reported, comprehensive metabolic panel (NR: not provided) not reported, Fibrin D dimer (NR: not provided) not reported, Liver function test (NR: not provided) not reported, Pulse oximetry (NR: not provided) not reported, Renal function test (NR: not provided) not reported, and Spirometry (NR: not provided) not reported and Foot overpronation (NR: not provided) not reported. The patient stated that under no circumstances want to live with the respirator. Number of days of hospitalization was 3. The patient visited emergency room. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from acute respiratory failure, c-reactive protein, covid-19, covid-19 pneumonia, cardiomegaly, chest x-ray abnormal, chest pain, chills, cough, dyspnoea, exposure to sars-cov-2, fatigue, fibrin d dimer, full blood count, hyperhidrosis, liver function test, metabolic function test, nausea, pulmonary oedema, pulmonary vasculitis, pyrexia, renal function test, respiratory failure, sars-cov-2 test positive, tachycardia, tachypnoea, and wheezing, 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 90000207907. 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 Regulatory Authority on 22-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result and product indication.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: Product quality complaint investigation result and product indication. This added information does not alter the causality of previous reported events. 20211240789-COVID-19 VACCINE Acute respiratory failure, COVID-19 pneumonia, Pulmonary vasculitis, Pulmonary oedema, Respiratory failure, Cardiomegaly, COVID-19, Chest pain, Exposure to SARS-CoV-2, Tachycardia, Tachypnoea, Hyperhidrosis, Cough, Dyspnoea, C-reactive protein, Chest X-ray abnormal, Liver function test, Metabolic function test, Fibrin D dimer, Full blood count, Renal function test, SARS-CoV-2 test positive, Wheezing, Chills, Fatigue, Pyrexia, Nausea. 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. 20211240789-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.