Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum culture, White blood cell count
Clinical narrative: COVID-19; Retroperitoneal hemorrhage; This literature-non-study case was reported in a literature article and describes the occurrence of RETROPERITONEAL HAEMORRHAGE (Retroperitoneal hemorrhage) and COVID-19 (COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Loop colostomy (diverting descending loop colostomy was placed due to a non-healing perineal wound for over a year that had progressed to the point of causing complete loss on the left side of her sphincter complex) in January 2021 and Allogeneic peripheral hematopoietic stem cell transplant in July 2020. Previously administered products included for Vaccination: TDAP in November 2014; for Sinusitis: levofloxacin (500 mg orally once daily for 7 days approximately one month earlier.). Past adverse reactions to the above products included Cough with levofloxacin; and No adverse event with TDAP. Concurrent medical conditions included Hodgkin's disease since August 2017, Hypothyroidism, Anxiety depression and Gastroesophageal reflux disease. Concomitant products included NIVOLUMAB for Hodgkin's disease refractory.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced RETROPERITONEAL HEMORRHAGE (Retroperitoneal hemorrhage) (seriousness criteria death and medically significant). The patient was hospitalized for 12 days due to COVID-19. The patient was treated with OXYGEN (nasal) at a dose of 6 liter; TOCILIZUMAB (intravenous) at a dose of 800 milligram; REMDESIVIR (intravenous) at a dose of 200 milligram; REMDESIVIR (intravenous) at a dose of 100 milligram once a day; DEXAMETHASONE (intravenous) at a dose of 4 to 10 mg qd; CEFEPIME (intravenous) at a dose of 2 gram every eight hours; VANCOMYCIN (intravenous) at a dose of 2 gram; VANCOMYCIN (intravenous) at a dose of 1 gram every twelve hours and LEVOFLOXACIN (intravenous) at a dose of 750 milligram once a day. The patient died on an unknown date. The reported cause of death was Retroperitoneal hemorrhage. It is unknown if an autopsy was performed. At the time of death, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antimicrobial susceptibility test: Aztreonam more than or equal to 64 (resistant), Ceftazidime 16 (intermediate), Ciprofloxacin 1 (susceptible), Imipenem 1 (susceptible), Minocycline 0.5 (susceptible), Piperacillin/Tazobactam less than or equal to 1 / 4 (susceptible), Ticarcillin/Clavulanate 8 / 2 (susceptible), Trimethoprim/Sulfamethoxazole 4 / 76 (resistant), results were not available until the day the patient expired). On an unknown date, Blood culture: (Negative) Negative Cultures were collected from multiple sites on day 11. On an unknown date, Blood pressure measurement: 114/80 mm/Hg. On an unknown date, Body mass index: 39.94 kilogram per square metre. On an unknown date, Body temperature: 36.7 degree Celsius and 38.1 degree Celsius from days 10-11 Fever. On an unknown date, Bordetella test: positive for 2+ B. bronchiseptica identified by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry and on day 8 was positive for 1+ B. bronchiseptica. On an unknown date, C-reactive protein: 18.1 mg/dl Elevated. On an unknown date, Chest X-ray: A chest X-ray obtained in the ED demonstrated extensive bilateral, widespread, mixed ground-glass opacities, on day 4, a repeat chest X-ray demonstrated slightly increased bilateral opacities raising the concern for a potential superimposed bacterial co-infection and on day 11, a chest X-ray demonstrated improvement in the right lower lobe opacity and no change in the lower left lobe opacity. On an unknown date, Computerized tomogram: computed tomography scan revealed a massive right retroperitoneal hematoma with smaller hematomas in the right psoas muscle. On an unknown date, Culture urine: (Negative) Negative Cultures were collected from multiple sites on day 11. On an unknown date, Fibrin D dimer: 256 ng/mL. On an unknown date, Hemoglobin: 18.7 g/dL on day10 and 5.2 g/dL on day 11 (Decreased) causing concern for an internal bleed. On an unknown date, Heart rate: 109 beats per minute. On an unknown date, Oxygen saturation: 68 % on room air. On an unknown date, Red blood cell sedimentation rate: 61 mm/hr. On an unknown date, Respiratory rate: 32 breaths per minute. On an unknown date, SARS-CoV-2 test: (Positive) positive for COVID-19.. On an unknown date, Serum ferritin: 727.3 ng/mL. On an unknown date, Sputum culture: positive for normal respiratory flora only Cultures were collected from multiple sites on day 11. On an unknown date, White blood cell count: 7 10 thousand cells per microlitre Baseline laboratory values within normal limits and did not demonstrate lymphopenia (25.6%), 12.5 10 thousand cells per microlitre on day 10 and 36.4 10 thousand cells per microlitre leukocytosis on day 11.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An immunocompromised female patient, with mulitple comorbidities and on nivolumab, got her 1st and 2nd COVID-19 vaccinations approximately 3 and 6 weeks prior to presentation to the ED, respectively. She received a 7-day course levofloxacin for her sinusitis complicated by cough with green and yellow sputum production approximately 1 month prior to ED consultation. 10 days earlier, she was at the ED for abdominal pain and increasing stool output in her colostomy. She presented with a new onset of worsening dyspnea over the previous 24 H with chronic cough at the ED in spring 2021. Exam showed high heart rate, fast respiratory rate, and oxygen desaturation prompting oxygen support. Baseline diagnostics were remarkable except for her white blood cells. A positive COVID-19 PCR test was reported.   She was transferred to the ICU for mechanical ventilation. Tocilizumab, remdesivir, and dexamethasone were started. Chest X-ray findings indicated superimposed bacterial infection on day 4. On day 5, endotracheal sputum culture was collected and cefipime plus vancomycin were started. On day 7, sputum culture came back positive for Bordetella bronchiseptica prompting discontinuation of vancomycin but retaining cefipime and initiation of levofloxacin. A 2nd endotracheal sputum culture came out positive for B. bronchiseptica on day 8, which prompted susceptibility testing. On days 10 to 11, condition worsened as she presented with fever, leukocytosis, and decreased hemoglobin. On day 11, CT scan revealed retroperitoneal hemorrhage with small hematomas in the right psoas muscle. On day 12, patient expired presumably due to retroperitoneal hemorrhage.   Susceptibility test results were not available until her death and cefipime was not included to rule out B. bronchiseptica resistance. The authors suspected COVID-19 infection before development of full immunity after her 2nd dose. Multiple risk factors for B. bronchiseptica were noted.  Company comment: This literature non-study case concerns a known immunocompromised 50-year-old, female patient with a body mass index (BMI) of 39.9, who experienced an unexpected, medically significant event of COVID-19 that led to hospitalization and an unexpected, medically significant, fatal event of Retroperitoneal hemorrhage after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the symptoms relative to vaccination cannot be established with the available information (reported as "received her 1st and 2nd COVID-19 vaccinations approximately 3 and 6 weeks prior to presentation to the ED, respectively"). Medical history included owning a cat, diverting descending loop colostomy placement due to non-healing perineal wound in January 2021, allogenic hematopoietic stem cell transplantation in July 2020, Hodgkin's lymphoma since 2017, hypothyroidism, depression with anxiety, gastroesophageal reflux disease, Tdap vaccination, and nivolumab given every 14 days for refractory Hodgkin's lymphoma. She received a 7-day course levofloxacin for her sinusitis complicated by cough with green and yellow sputum production approximately 1 month prior to ED consultation. She was also seen at the ED 10 days earlier for abdominal pain and increasing stool output in her colostomy, but with no respiratory symptoms and fever. She presented with a new onset of worsening dyspnea over the previous 24 H with chronic cough at the ED in spring 2021. On admission, her temperature was 36.7 C, blood pressure was 114/80 mm/Hg, heart rate was 109 beats per minute, respiratory rate was 32 breaths per minute, and oxygen saturation was 68% on room air prompting Oxygen supplementation. Baseline diagnostics included a chest radiograph showing an extensive bilateral, widespread mixed ground-glass opacities, elevated C-reactive protein of 18.1 mg/dL, erythrocyte sedimentation rate of 61 mm/h, ferritin of 727.2 ng/mL, normal white blood cell count of 7.0 x 1000/microliter with no lymphopenia (25.6%), D-dimer of 256 ng/mL, and a positive COVID-19 nasopharyngeal polymerase chain reaction swab. Respiratory failure ensued following admission that led to intensive care unit (ICU) transfer for mechanical ventilation. From day 0 in the ICU, tocilizumab was started once, remdesivir was given until day 9 day, and dexamethasone was given until day 10. Repeat chest radiograph showed slightly increased bilateral opacities indicating potential superimposed bacterial co-infection on day 4. On day 5, endotracheal sputum culture was collected and cefipime plus vacomycin were started. On day 7, endotracheal sputum culture was positive for 2+ Bordetella bronchiseptica. Vancomycin was subsequently discontinued, cefipime remained, and levofloxacin was started. A 2nd endotracheal sputum culture collected on day 8 was also positive for 1+ B. bronchiseptica, which prompted susceptibility testing at a reference laboratory. She became febrile (38.1 C) with leukocytosis of 12.5 x 1000/microliter on day 10 that increased to 36.4 x 1000/microliter on day 11, and with decreased hemoglobin from 8.7 g/dL on 10 to 5.2 g/dL on day 11 - implicating internal bleeding. On day 11, chest radiograph showed improvement in the right lower lobe opacity with no changes in the lower left lobe opacity, endotracheal sputum culture showed positive for normal respiratory flora, blood and urine cultures were negative, and a computed tomographic scan revealed massive right peritoneal hematoma with smaller hematomas in the right psoas muscle. On day 12, comfort measures were initiated but the patient continuedly deteriorated and expired later that day presumably due to retroperitoneal hemorrhage. Autopsy was not reported. Susceptibility test results were not available until her death and cefipime was not included to rule out B. bronchiseptica resistance. The authors suspected COVID-19 infection before the patient had developed full immunity after her 2nd dose based on the self-reported dyspnea that occurred 19 days post 2nd vaccination. Per the authors, the risk factors for B. bronchiseptica infection included history of chronic cough in immunocompromised patients, exposure to pets such as cats, and immunosuppressants. The authors acknowledged current guidelines that vaccination response rate could be less in immunocompromised patients. Strong confounders associated with the patient's demise were her immunocompromised status, presence of multiple comorbidities including high BMI, administration of immunosuppressants (nivolumab, tocilizumab, and dexamethasone), history of chronic cough, exposure to her pet cat (source of B. bronchiseptica), superimposed bacterial co-infection that led to severe respiratory pneumonia, and delayed susceptibility testing excluding cefepime for B. bronchiseptica resistance. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2022: Follow up received by safety on 6-Oct-2022 has Email and contains significant information: Reporter information, literature information, patient details, suspect details, concomitant, treatment details and event information updated. Sender's Comments: This literature non-study case concerns a known immunocompromised 50-year-old, female patient with a body mass index (BMI) of 39.9, who experienced an unexpected, medically significant event of COVID-19 that led to hospitalization and an unexpected, medically significant, fatal event of Retroperitoneal hemorrhage after receiving a 2-dose primary series of mRNA-1273 vaccine. Exact onset latency of the symptoms relative to vaccination cannot be established with the available information (reported as "received her 1st and 2nd COVID-19 vaccinations approximately 3 and 6 weeks prior to presentation to the ED, respectively"). Medical history included owning a cat, diverting descending loop colostomy placement due to non-healing perineal wound in January 2021, allogenic hematopoietic stem cell transplantation in July 2020, Hodgkin's lymphoma since 2017, hypothyroidism, depression with anxiety, gastroesophageal reflux disease, Tdap vaccination, and nivolumab given every 14 days for refractory Hodgkin's lymphoma. She received a 7-day course levofloxacin for her sinusitis complicated by cough with green and yellow sputum production approximately 1 month prior to ED consultation. She was also seen at the ED 10 days earlier for abdominal pain and increasing stool output in her colostomy, but with no respiratory symptoms and fever. She presented with a new onset of worsening dyspnea over the previous 24 H with chronic cough at the ED in spring 2021. On admission, her temperature was 36.7 C, blood pressure was 114/80 mm/Hg, heart rate was 109 beats per minute, respiratory rate was 32 breaths per minute, and oxygen saturation was 68% on room air prompting Oxygen supplementation. Baseline diagnostics included a chest radiograph showing an extensive bilateral, widespread mixed ground-glass opacities, elevated C-reactive protein of 18.1 mg/dL, erythrocyte sedimentation rate of 61 mm/h, ferritin of 727.2 ng/mL, normal white blood cell count of 7.0 x 1000/microliter with no lymphopenia (25.6%), D-dimer of 256 ng/mL, and a positive COVID-19 nasopharyngeal polymerase chain reaction swab. Respiratory failure ensued following admission that led to intensive care unit (ICU) transfer for mechanical ventilation. From day 0 in the ICU, tocilizumab was started once, remdesivir was given until day 9 day, and dexamethasone was given until day 10. Repeat chest radiograph showed slightly increased bilateral opacities indicating potential superimposed bacterial co-infection on day 4. On day 5, endotracheal sputum culture was collected and cefipime plus vacomycin were started. On day 7, endotracheal sputum culture was positive for 2+ Bordetella bronchiseptica. Vancomycin was subsequently discontinued, cefipime remained, and levofloxacin was started. A 2nd endotracheal sputum culture collected on day 8 was also positive for 1+ B. bronchiseptica, which prompted susceptibility testing at a reference laboratory. She became febrile (38.1 C) with leukocytosis of 12.5 x 1000/microliter on day 10 that increased to 36.4 x 1000/microliter on day 11, and with decreased hemoglobin from 8.7 g/dL on 10 to 5.2 g/dL on day 11 - implicating internal bleeding. On day 11, chest radiograph showed improvement in the right lower lobe opacity with no changes in the lower left lobe opacity, endotracheal sputum culture showed positive for normal respiratory flora, blood and urine cultures were negative, and a computed tomographic scan revealed massive right peritoneal hematoma with smaller hematomas in the right psoas muscle. On day 12, comfort measures were initiated but the patient continuedly deteriorated and expired later that day presumably due to retroperitoneal hemorrhage. Autopsy was not reported. Susceptibility test results were not available until her death and cefipime was not included to rule out B. bronchiseptica resistance. The authors suspected COVID-19 infection before the patient had developed full immunity after her 2nd dose based on the self-reported dyspnea that occurred 19 days post 2nd vaccination. Per the authors, the risk factors for B. bronchiseptica infection included history of chronic cough in immunocompromised patients, exposure to pets such as cats, and immunosuppressants. The authors acknowledged current guidelines that vaccination response rate could be less in immunocompromised patients. Strong confounders associated with the patient's demise were her immunocompromised status, presence of multiple comorbidities including high BMI, administration of immunosuppressants (nivolumab, tocilizumab, and dexamethasone), history of chronic cough, exposure to her pet cat (source of B. bronchiseptica), superimposed bacterial co-infection that led to severe respiratory pneumonia, and delayed susceptibility testing excluding cefepime for B. bronchiseptica resistance. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement. Reported Cause(s) of Death: Retroperitoneal hemorrhage.