Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anti-cyclic citrullinated peptide antibody, Anti-ganglioside antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody
Clinical narrative: Interstitial lung disease; Chronic inflammatory demyelinating polyneuropathy; Right-sided heart failure; Hypoxic vasoconstriction; STEMI; This literature-non-study case was reported in a literature article and describes the occurrence of INTERSTITIAL LUNG DISEASE (Interstitial lung disease), CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (Chronic inflammatory demyelinating polyneuropathy), CARDIAC FAILURE (Right-sided heart failure), VASOCONSTRICTION (Hypoxic vasoconstriction) and ACUTE MYOCARDIAL INFARCTION (STEMI) in a 76-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    The patient's past medical history included Coronary artery disease (Right), Aortic regurgitation and Stent placement. Previously administered products included for Product used for unknown indication: Pfizer (first 5 doses). Past adverse reactions to the above products included No adverse reaction with Pfizer. Concurrent medical conditions included Type 2 diabetes mellitus, Hyperlipidemia and Gastroesophageal reflux disease.    On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death, hospitalization and medically significant), CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (Chronic inflammatory demyelinating polyneuropathy) (seriousness criteria death, hospitalization and medically significant), CARDIAC FAILURE (Right-sided heart failure) (seriousness criteria death, hospitalization and medically significant), VASOCONSTRICTION (Hypoxic vasoconstriction) (seriousness criteria death, hospitalization and medically significant) and ACUTE MYOCARDIAL INFARCTION (STEMI) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous use) at an unspecified dose and frequency; NOREPINEPHRINE BITARTRATE (LEVOPHED) at an unspecified dose and frequency and PHENYLEPHRINE at an unspecified dose and frequency. The patient died on an unknown date. The reported cause of death was Interstitial lung disease, Chronic inflammatory demyelinating polyneuropathy, right-sided heart failure and hypoxic vasoconstriction. It is unknown if an autopsy was performed. At the time of death, ACUTE MYOCARDIAL INFARCTION (STEMI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-cyclic citrullinated peptide antibody: Negative. On an unknown date, Anti-ganglioside antibody: Negative. On an unknown date, Antineutrophil cytoplasmic antibody: (Negative) P-ANCA, C-ANCA. On an unknown date, Antinuclear antibody: Negative, Negative, Negative, Negative, Negative and Negative. On an unknown date, Biopsy muscle: confirmed the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP). On an unknown date, Blood creatine phosphokinase: within normal limits. On an unknown date, Blood immunoglobulin G: Monoclonal protein serum levels were measured which revealed low IgG. On an unknown date, Computerised tomogram thorax: showed ground glass opacities consistent with ongoing and diffuse ILD and burst dose steroids were initiated. On an unknown date, Digital radiogram: were highly suggestive of interstitial lung disease (ILD). On an unknown date, Electrocardiogram: revealed a STEMI. On an unknown date, Electromyogram: showed proximal myopathy concerning for chronic inflammatory demyelinating polyneuropathy (CIDP). On an unknown date, HMG CoA reductase antibody test: Negative. On an unknown date, Immunoglobulins: all other immunoglobins were within normal limits. On an unknown date, Mean arterial pressure: dropping below 65 mmHg. On an unknown date, Myoglobin blood: Negative. On an unknown date, Rheumatoid factor: Negative. On an unknown date, Troponin I: 608 ng/L elevated. On an unknown date, Ultrasound scan: Point of care ultrasound showed a dilated right ventricle with left ventricular collapse.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient not had symptoms of ILD or CIDP prior to the administration of the Moderna COVID-19 booster. Patient presented to the emergency department with Shortness of breath (three-month history of worsening shortness of breath requiring recurrent hospitalizations). Before admission, the patient was started on dexamethasone with the onset of respiratory symptoms and achieved a partial response. On admission, the initial infectious workup was negative. About a week later, the patient developed bilateral leg weakness. In an attempt to elucidate the cause of chronic inflammatory demyelinating polyneuropathy (CIDP), a paraneoplastic panel was ordered, which was negative. The patient was placed on Bilevel positive airway pressure (BIPAP).  Despite a battery of negative laboratory results, the patient started a course of IVIG for interstitial lung disease (ILD) with CIDP and was unresponsive to therapy.  Over the next week, the patient's respiratory effort continued to decline, requiring intubation and subsequent transfer to the intensive care unit (ICU). While admitted to the ICU, hemodynamic instability, requiring maximum dose pressors. The patient passed away one day later due to right-sided heart failure likely secondary to ILD progression versus hypoxic vasoconstriction.  Author concluded that this case would be the first documented case of concurrent development of ILD and CIDP after the administration of the COVID-19 vaccine, which ultimately led to patient mortality.  Company Comment: This is a Literature non-study case concerning a 76-year-old male patient, with relevant medical history of coronary artery disease, diabetes type 2, stent placement and hyperlipidemia, who experienced fatal events of Interstitial lung disease (ILD), Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (AESI), Cardiac failure (AESI) and Vasoconstriction, and the unexpected and serious (due to life-threatening, hospitalization and medically significant) AESI of Acute myocardial infarction, which occurred after SPIKEVAX NOS vaccine, administered as sixth dose within COVID-19 vaccination schedule. Prior five doses were administered with Pfizer vaccine. As reported, the patient presented to the emergency department with a three-month history of worsening shortness of breath requiring recurrent hospitalizations and intermittent BiPAP. The patient's symptoms began two weeks after his 6th dose of SPIKEVAX NOS. Before admission, the patient was started on dexamethasone with the onset of respiratory symptoms and achieved a partial response. On admission, the initial infectious workup was negative, and CT chest showed ground glass opacities consistent with ongoing and diffuse ILD, and burst dose steroids were initiated. About a week later, the patient developed bilateral leg weakness (serum CPK within normal limits), and electromyogram showed proximal myopathy concerning for CIDP, which was consistent with the results of the muscle biopsy. In an attempt to elucidate the cause of CIPD, a paraneoplastic panel was ordered, which was negative. Autoimmune workup including ANA, cyclic citrullinated peptide, P-ANCA, C-ANCA, rheumatoid factor, anti-Ro/La, anti-SM RNP, anti-Scl70, anti-HmG-coA reductase, anti-myoglobin associated glycoprotein, anti-ganglioside G were all negative. Monoclonal protein serum levels were measured which revealed low IgG, but all other immunoglobins were within normal limits. Despite a battery of negative laboratory results, the patient started a 5-day course of IVIG for ILD with CIDP and was unresponsive to therapy. Over the next week, the patient's respiratory effort continued to decline, requiring intubation and subsequent transfer to the intensive care unit (ICU). While admitted to the ICU, hemodynamic instability ensued with mean arterial pressures (MAPs) dropping below 65 mmHg, requiring maximum dose pressors (norepinephrine bitartrate and phenylephrine). EKG revealed a ST-elevation myocardial infarction, with troponin I elevated to 608 ng/L. Point of care ultrasound showed a dilated right ventricle with left ventricular collapse. The patient passed away one day later due to right-sided heart failure likely secondary to ILD progression versus hypoxic vasoconstriction. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2024: Live follow-up received on 25-Sep-2024 which contains significant information: Literature information, medical history, laboratory tests, treatment medications, events seriousness, outcome, cause of death and narrative was update.; Reported Cause(s) of Death: Right-sided heart failure; Interstitial lung disease; Chronic inflammatory demyelinating polyneuropathy; Hypoxic vasoconstriction