Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Vaccination site lymphadenopathy
Clinical narrative: Liver cancer after second dose 90 cist; Diabetes diagnosis/diabetic from a time that coincides whit the first shoot; High blood pressure (200); Lump Under Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jun-2021 and was forwarded to Moderna on 26-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC CYST (Liver cancer after second dose 90 cist) and DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, SALBUTAMOL (ALBUTEROL HFA) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN & MINERAL for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HEPATIC CYST (Liver cancer after second dose 90 cist) (seriousness criterion disability), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) (seriousness criterion medically significant), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm). At the time of the report, HEPATIC CYST (Liver cancer after second dose 90 cist), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal (abnormal) Blood sugar was not under control.. On an unknown date, Blood pressure measurement: high- 200 (High) Blood pressure high. On an unknown date, Glycosylated haemoglobin: high (High) Diabetic.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include CPAP machine used for Apnea. The treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.  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. Further information has been requested.   This case was linked to MOD-2021-237510, MOD-2020-001691 (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. Further information has been requested