Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Altered state of consciousness, Constipation, Pancreatic enzymes increased
Clinical narrative: increased pancreatic enzymes; out of it; very constipated; bloated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (out of it) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neuroendocrine carcinoma in 2012, Carcinoid syndrome in 2012 and Tumor excision (tumors removed from liver and pancreas) in 2014. Concomitant products included OCTREOTIDE from 13-Feb-2021 to an unknown date for Prophylaxis, TELOTRISTAT ETIPRATE (XERMELO), OCTREOTIDE ACETATE (SANDOSTATIN), LANREOTIDE, VITAMIN B12 NOS, VITAMIN D NOS, FISH OIL, LEVOTHYROXINE, FOLIC ACID, IRON, VITAMIN B COMPLEX, PANCRELIPASE (ZENPEP), DEXLANSOPRAZOLE (DEXILANT), FAMOTIDINE (PEPCID [FAMOTIDINE]), SUCRALFATE, HYDROXYZINE HCL, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MAGNESIUM CITRATE and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (out of it) (seriousness criterion medically significant), CONSTIPATION (very constipated) and ABDOMINAL DISTENSION (bloated). On an unknown date, the patient experienced PANCREATIC ENZYMES INCREASED (increased pancreatic enzymes). At the time of the report, ALTERED STATE OF CONSCIOUSNESS (out of it), CONSTIPATION (very constipated), ABDOMINAL DISTENSION (bloated) and PANCREATIC ENZYMES INCREASED (increased pancreatic enzymes) outcome was unknown.            Because of reactions to the first vaccine, the patient's oncologist recommended they take a rescue shot of octreotide 1 hour before the second vaccination. The patient had to go her gastroenterologist for the constipation and increased pancreatic enzymes and had to have a X-ray of colon to make sure there was no blockage (results not provided). The patient had to take several rescue injections of octreotide and reduced telotristat ethyl to 250mg per oral daily 1 tablet from 3 tablets per day for the first time in 4 years. Also, her pancrealipase was reduced from 40,000 units to 25,000 units.   No treatment details were provided.  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. However, patient's underlying medical conditions (tumor of liver and pancreas) remains a confounder.   This case was linked to MOD-2021-100644 (E2B Linked Report). This case was linked to MOD-2021-100633 (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. However, patient's underlying medical conditions (tumor of liver and pancreas) remains a confounder. MOD-2021-100644:Reporter's Friend