Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Inappropriate schedule of product administration, Influenza virus test, Myalgia
Clinical narrative: Bacterial pneumonia; COPD exacerbation; Unintentional weight loss; Sepsis; Nausea; Body ache; Temperature upto 102; Vomiting; Runny nose; Sore throat; Congestion; Diarrhea; bilateral conjunctivitis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of SEPSIS (Sepsis), PNEUMONIA BACTERIAL (Bacterial pneumonia), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) and ABNORMAL LOSS OF WEIGHT (Unintentional weight loss) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid nodule (Benign, BX done on 6jun2014), Cholelithiasis, Cranial nerve paralysis, Diverticulosis (Diverticulosis of intestine without bleeding, unspecified intestinal tract location), Hepatic lesion, Smoker, Inguinal hernia repair, Colon operation in 2016 and Thermal ablation. Concurrent medical conditions included COPD (Exacerbation) since 06-Jun-2014, Hypokalemia (Started potassium for 3 days, rechecking K+ today), Anemia (Started daily iron, after hospital visit), Malnutrition, Idiopathic osteoporosis, Thyroid disorder, Unspecified disorder of adrenal glands, Lung nodule and Weight loss. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) from 01-May-2021 to an unknown date and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 24-Apr-2017 to an unknown date for COPD, GENTAMICIN (GENTAMYCIN EYE/EAR DROPS) from 09-Jun-2021 to an unknown date for Conjunctivitis.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced CONJUNCTIVITIS (bilateral conjunctivitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA BACTERIAL (Bacterial pneumonia) (seriousness criteria hospitalization and medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Unintentional weight loss) (seriousness criterion hospitalization), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), NAUSEA (Nausea), MYALGIA (Body ache), PYREXIA (Temperature upto 102) and VOMITING (Vomiting). The patient was hospitalized from 26-Jun-2021 to 28-Jun-2021 due to SEPSIS. The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) (oral) on 11-Jun-2021 for Cough, at a dose of 4 mg; CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) at a dose of UNK dosage form; LEVOFLOXACIN (LEVAQUIN) at a dose of UNK dosage form; FLUCONAZOLE at a dose of UNK dosage form; GUAIFENESIN (MUCINEX) at a dose of UNK dosage form; PANTOPRAZOLE at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. At the time of the report, SEPSIS (Sepsis), PNEUMONIA BACTERIAL (Bacterial pneumonia), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD exacerbation), ABNORMAL LOSS OF WEIGHT (Unintentional weight loss), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), CONJUNCTIVITIS (bilateral conjunctivitis), NAUSEA (Nausea), MYALGIA (Body ache), PYREXIA (Temperature upto 102) and VOMITING (Vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Blood pressure measurement: 130/72 (Inconclusive) BP : 130/72 Manual(Sitting, left arm, standard). On 09-Jun-2021, Body temperature: 97.9 (Inconclusive) temp:97.9 degree F. On 09-Jun-2021, Heart rate: 76 (normal) Regular. On 09-Jun-2021, Oxygen saturation: 98 percent (Inconclusive) P.OX : 98%. On 11-Jun-2021, Influenza virus test: negative (Negative) negative. On 11-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Previous lab data of the patient include fall risk screening on 8sep2020  low risk, depression screening on 8sep2020, Mammogram screening on 6dec2019  normal, Bone density study on 10may2018, declined screening  PAP; SHINGLE VACCINE, Screening AAA on 28jun2017  Normal ; MRI, Colonoscopy screening on 19may2017  abnormal repeats 3years, Pneumovax on 1may2018 - normal.  It was reported that the patient went out of state and could not receive her second dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Patient´s history of COPD is a co suspect for some of the events.   This case was linked to MOD-2021-201168 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Patient´s history of COPD is a co suspect for some of the events.