Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hepatic enzyme increased, Hypersomnia, Hypotension
Clinical narrative: Liver enzymes increased; Iron level increased; Constipation; Could not move my left arm for 4 days; Blood pressure was very low; arm Pain at the injection site; Exhaustion; Massive headaches; Felt a sensation going up the left side of my neck and face; Tingling in my feet and hands; felt dizzy; Slept for several hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (Liver enzymes increased), BLOOD IRON INCREASED (Iron level increased) and CONSTIPATION (Constipation) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Carcinoid syndrome in 2012, Neuroendocrine carcinoma in 2012 and Tumor excision (Tumors removed from liver and pancreas) in 2014. Concomitant products included TELOTRISTAT ETIPRATE (XERMELO), OCTREOTIDE ACETATE (SANDOSTATIN), LANREOTIDE, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D [VITAMIN D NOS], FISH OIL, LEVOTHYROXINE, FOLIC ACID, IRON, VITAMIN B COMPLEX, PANCRELIPASE (ZENPEP), DEXLANSOPRAZOLE (DEXILANT), FAMOTIDINE (PEPCID [FAMOTIDINE]), SUCRALFATE, HYDROXYZINE HYDROCHLORIDE (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 16-Jan-2021, the patient experienced SENSORY DISTURBANCE (Felt a sensation going up the left side of my neck and face), PARAESTHESIA (Tingling in my feet and hands), DIZZINESS (felt dizzy) and HYPERSOMNIA (Slept for several hours). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Liver enzymes increased) (seriousness criterion medically significant), BLOOD IRON INCREASED (Iron level increased) (seriousness criterion medically significant), CONSTIPATION (Constipation) (seriousness criterion medically significant), INJECTED LIMB MOBILITY DECREASED (Could not move my left arm for 4 days), HYPOTENSION (Blood pressure was very low), VACCINATION SITE PAIN (arm Pain at the injection site), FATIGUE (Exhaustion) and HEADACHE (Massive headaches). At the time of the report, HEPATIC ENZYME INCREASED (Liver enzymes increased) had not resolved, BLOOD IRON INCREASED (Iron level increased), SENSORY DISTURBANCE (Felt a sensation going up the left side of my neck and face), PARAESTHESIA (Tingling in my feet and hands), DIZZINESS (felt dizzy), HYPERSOMNIA (Slept for several hours), INJECTED LIMB MOBILITY DECREASED (Could not move my left arm for 4 days), HYPOTENSION (Blood pressure was very low), VACCINATION SITE PAIN (arm Pain at the injection site), FATIGUE (Exhaustion) and HEADACHE (Massive headaches) outcome was unknown and CONSTIPATION (Constipation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: increased (High) increased. On an unknown date, Blood pressure measurement: very low (Low) Very Low. On an unknown date, Liver function test: increased (High) increased.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Because of reactions to the first vaccine the patient's oncologist recommended to take a rescue shot of Octreotide 1 hour before the second vaccination.   No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  There is not enough information to assess the causal association between the event of hepatic enzyme increased and blood iron increased and the administration of mRNA-1273 as the onset of the event was not provided,  Events are confounded by the medical history and concomitant medication. Based on temporality, the causal relationship between the other events and the product use cannot be excluded. Vaccination site pain, fatigue and headache are consistent with the product safety profile.   This case was linked to MOD-2021-100644 (E2B Linked Report). This case was linked to MOD-2021-104568 (Patient Link).; Sender's Comments: There is not enough information to assess the causal association between the event of hepatic enzyme increased and blood iron increased and the administration of mRNA-1273 as the onset of the event was not provided,  Events are confounded by the medical history and concomitant medication. Based on temporality, the causal relationship between the other events and the product use cannot be excluded. Vaccination site pain, fatigue and headache are consistent with the product safety profile. MOD-2021-100644:Reporter's friend