Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Catheterisation cardiac, Chills, Computerised tomogram, Illness, Inappropriate schedule of product administration
Clinical narrative: Blood infection; Sick; Didn't feel good; chilling; Patient received both the doses on smae month; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEPSIS (Blood infection), ILLNESS (Sick), MALAISE (Didn't feel good) and CHILLS (chilling) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20 and 035J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Aortic valve calcification in 2011, Alcohol use (6 bottles beer/week) from 1964 to 2000, Ex-smoker from 1964 to 2015, Eyes red (while on Humira) in 2020, Back surgery in 1996, Open heart surgery in 2003, Carotid endarterectomy in 2006 and Cataract in 2013. Concurrent medical conditions included Diabetes (DIABETES TYPE 2), Blood pressure high, Acid reflux (esophageal), Cholesterol, Plaque psoriasis and Bladder cancer (bladder cancer cells) since 25-Nov-2020. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ACETYLSALICYLIC ACID (ASPIRINA) for Anticoagulant therapy, METOPROLOL and LISINOPRIL for Blood pressure high, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for Digestion impaired, HYDROCHLOROTHIAZIDE for Diuretic therapy, NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Pain.   On 17-Dec-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML(40 Milligram, Solution for injection in pre-filled. In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both the doses on smae month). On 12-Apr-2021, the patient experienced SEPSIS (Blood infection) (seriousness criteria hospitalization prolonged and medically significant), ILLNESS (Sick) (seriousness criterion hospitalization), MALAISE (Didn't feel good) (seriousness criterion hospitalization) and CHILLS (chilling) (seriousness criterion hospitalization). On 17-Apr-2021, ILLNESS (Sick), MALAISE (Didn't feel good) and CHILLS (chilling) had resolved. At the time of the report, SEPSIS (Blood infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both the doses on smae month) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Catheterisation cardiac: aortic valve calcified (abnormal) Aortic valve calcified. In April 2021, Computerised tomogram: aortic valve calcified (abnormal) Aortic valve calcified.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ertapenem for the blood infection.  Company comment: This report refers to a case of inappropriate schedule of product administration for mRNA1273, lot# (035J202A and 030L20) with no associated adverse events, however the patient experienced some reaction approximately. three months later. Based on available information, there is no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patient's advanced age and co-morbidities are strong confounders.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA1273, lot# (035J202A and 030L20) with no associated adverse events, however the patient experienced some reaction approximately. three months later. Based on available information, there is no clear temporal association between the use of the product and start date of events, a casual relationship was assessed as unlikely related. the patient's advanced age and co-morbidities are strong confounders.