Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Tinnitus, Vaccination complication
Clinical narrative: trouble breathing, could not get her breath, struggling to breathe; tired, she was very tired; laid down and all of a sudden she was feeling kind of weird; almost like a dizzy feeling, went upstairs and got more dizzy; tinnitus (from years back) came back, head started ringing really bad; severe reaction; BP was sky high; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (trouble breathing, could not get her breath, struggling to breathe), FATIGUE (tired, she was very tired), FEELING ABNORMAL (laid down and all of a sudden she was feeling kind of weird), DIZZINESS (almost like a dizzy feeling, went upstairs and got more dizzy), TINNITUS (tinnitus (from years back) came back, head started ringing really bad), VACCINATION COMPLICATION (severe reaction) and BLOOD PRESSURE INCREASED (BP was sky high) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     No medical history were reported by the reporter.  Concomitant products included LISINOPRIL, OMEPRAZOLE, CALCITRIOL (CALCITROL [CALCITRIOL]), BUDESONIDE and VITAMINS NOS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DYSPNOEA (trouble breathing, could not get her breath, struggling to breathe) (seriousness criteria hospitalization and life threatening), FATIGUE (tired, she was very tired) (seriousness criteria hospitalization and life threatening), FEELING ABNORMAL (laid down and all of a sudden she was feeling kind of weird) (seriousness criteria hospitalization and life threatening), DIZZINESS (almost like a dizzy feeling, went upstairs and got more dizzy) (seriousness criteria hospitalization and life threatening), TINNITUS (tinnitus (from years back) came back, head started ringing really bad) (seriousness criteria hospitalization and life threatening), VACCINATION COMPLICATION (severe reaction) (seriousness criteria hospitalization and life threatening) and BLOOD PRESSURE INCREASED (BP was sky high) (seriousness criterion hospitalization). The patient was hospitalized on 05-Apr-2021 due to DIZZINESS, DYSPNOEA, FATIGUE, FEELING ABNORMAL, TINNITUS and VACCINATION COMPLICATION. At the time of the report, DYSPNOEA (trouble breathing, could not get her breath, struggling to breathe), FATIGUE (tired, she was very tired), FEELING ABNORMAL (laid down and all of a sudden she was feeling kind of weird), DIZZINESS (almost like a dizzy feeling, went upstairs and got more dizzy), TINNITUS (tinnitus (from years back) came back, head started ringing really bad), VACCINATION COMPLICATION (severe reaction) and BLOOD PRESSURE INCREASED (BP was sky high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Blood pressure measurement: high (High) BP was sky-high, BP systolic was 187-190. On 05-Apr-2021, Blood test: normal (normal) Normal. On 05-Apr-2021, Electrocardiogram: normal (normal) Normal.         Treatment information was not provided  Company Comment: This case concerns a  81-year-old, female patient with concomitant medications Lisinopril, Omeprazole, and Budesonide who experienced the unexpected serious events of Dyspnea, Fatigue, Feeling abnormal, Dizziness, Tinnitus, Vaccination complication and Blood pressure increased. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine which resulted in a life threatening condition and hospitalization. At the time of report the outcome of the events was unknown. The rechallenge is not applicable, since no further dosing is expected. The patient's medical history of concomitant medications Lisinopril, Omeprazole, and Budesonide  remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-403036 (Link).; Sender's Comments: This case concerns a  81-year-old, female patient with concomitant medications Lisinopril, Omeprazole, and Budesonide who experienced the unexpected serious events of Dyspnea, Fatigue, Feeling abnormal, Dizziness, Tinnitus, Vaccination complication and Blood pressure increased. The events occurred approximately 1 day after the second dose of mRNA-1273 Vaccine which resulted in a life threatening condition and hospitalization. At the time of report the outcome of the events was unknown. The rechallenge is not applicable, since no further dosing is expected. The patient's medical history of concomitant medications Lisinopril, Omeprazole, and Budesonide  remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.