Age: 58.0
Sex: M
Vaccine: COVID19, FLUA4, COVID19, FLUC3
Symptoms: Dyspnoea, Hyponatraemia, Hypoxia, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Recent COVID infection/COVID pneumonia; This spontaneous case was retrieved on 15-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2048405-1), reported by other healthcare professional and concerned a 58-year-old, male patient.  The patient's concurrent conditions included respiratory: COPD, moderate (chronic obstructive pulmonary disease), circulatory: internal hemorrhoids, benign hypertension, infectious/inflammatory: tinea pedis, hematologic: iron deficiency, anemia, nervous: tobacco abuse in remission, alcohol abuse, tension-type headache, intractable, diabetic polyneuropathy, endocrine/metabolic: type two diabetes mellitus and other: environmental allergies and anxiety. The patient's historical condition included malignant melanoma of right neck. The patient's concomitant medications included albuterol HFA inhaler (brand names used: Proventil HFA, Ventolin HFA, Proair HFA), Lipitor (atorvastatin), Decadron (dexamethasone) and lisinopril-hydrochlorothiazide (brand names used: Prinzide, Zestoretic), all used for unreported indications.  On 10-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one'; route of administration: injection (reported as 'SYR'); anatomical location and indication: not reported). The batch number reported was 308451.  On the same date, the patient was vaccinated with a booster dose of non-company co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as '3'; route of administration: injection (reported as 'SYR'), anatomical location and indication: not reported). The batch number reported was FE3590.  On unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient experienced COVID-19 infection, reported as 'recent COVID infection' and was placed on prednisone in the outpatient setting.   On 07-Jan-2022, two months and 28 days after receiving Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient presented to the emergency department with worsening symptoms of shortness of breath, cough and congestion. In the emergency department, the patient was hemodynamically stable, with desaturations noted 87% with ambulation and was placed on 2 L nasal cannula. On the same date chest X-ray was performed due to acute cough/dyspnoea and hypoxia, frontal and lateral. The heart size and pulmonary vascularity appeared normal. There appeared to be mild left basilar atelectasis or scar. There was focal eventration of the right hemidiaphragm. The remainder of the thorax was without significant change.  On the same date, a nasopharyngeal swab specimen was collected for the PCR (polymerase chain reaction) detection of COVID-19, Influenza A and B, and RSV (Respiratory syncytial virus). All test results came back negative. Labs were with mild hyponatremia, otherwise unremarkable. The patient was admitted to the hospital for COVID pneumonia, with steroids increased, dexamethasone at a dose of 6 mg. The patient did well and remained stable on 2 L nasal cannula.  On 09-Jan-2022, after two days, the patient was discharged home on home oxygen. At time of discharge, the patient had vital signs within normal limits, and was comfortable with discharge plan home.   The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The events of 'COVID-19 pneumonia' was considered to be serious due to seriousness criteria of hospitalization and was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 58-year-old, male patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccines. An unknown amount of time following vaccination, the patient experienced COVID-19 infection. In addition, two months and 28 days after vaccination, the patient presented to the emergency department with worsening symptoms of shortness of breath, cough and congestion. In the emergency department, the patient was hemodynamically stable, with desaturations noted 87% with ambulation and was placed on 2 L nasal cannula. A nasopharyngeal swab specimen was collected for the PCR (polymerase chain reaction) detection of COVID-19, Influenza A and B, and RSV (Respiratory syncytial virus). All test results came back negative. The patient was admitted to the hospital for COVID pneumonia. Causal role of the suspect vaccine is assessed as not related due to biological implausibility.; Sender's Comments: Company comment: A 58-year-old, male patient was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccines. An unknown amount of time following vaccination, the patient experienced COVID-19 infection. In addition, two months and 28 days after vaccination, the patient presented to the emergency department with worsening symptoms of shortness of breath, cough and congestion. In the emergency department, the patient was hemodynamically stable, with desaturations noted 87% with ambulation and was placed on 2 L nasal cannula. A nasopharyngeal swab specimen was collected for the PCR (polymerase chain reaction) detection of COVID-19, Influenza A and B, and RSV (Respiratory syncytial virus). All test results came back negative. The patient was admitted to the hospital for COVID pneumonia. Causal role of the suspect vaccine is assessed as not related due to biological implausibility.