Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes
Clinical narrative: Stomach issues as a child/Vaccine triggered some of her childhood health challenges; Feels like she is going to die/Does not feel good; Does not have the same mental statues; she feels tired; Wakes up from deep sleep due to pain from her hips to her ankles; she has no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues as a child/Vaccine triggered some of her childhood health challenges), FEELING ABNORMAL (Feels like she is going to die/Does not feel good), MENTAL STATUS CHANGES (Does not have the same mental statues), FATIGUE (she feels tired), ARTHRALGIA (Wakes up from deep sleep due to pain from her hips to her ankles) and ASTHENIA (she has no energy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 050E21A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Abdominal discomfort (stomach issues as a child and in early 2019, her mother treated her with vitamins), Hay fever, Penicillin allergy, Drug allergy (Morphine allergy) and Drug allergy (Percocet allergy). Concomitant products included VITAMINS NOS from October 2019 to October 2021 for Stomach discomfort.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues as a child/Vaccine triggered some of her childhood health challenges) (seriousness criterion hospitalization), FEELING ABNORMAL (Feels like she is going to die/Does not feel good) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Does not have the same mental statues) (seriousness criterion hospitalization), FATIGUE (she feels tired) (seriousness criterion hospitalization), ARTHRALGIA (Wakes up from deep sleep due to pain from her hips to her ankles) (seriousness criterion hospitalization) and ASTHENIA (she has no energy) (seriousness criterion hospitalization). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues as a child/Vaccine triggered some of her childhood health challenges), FEELING ABNORMAL (Feels like she is going to die/Does not feel good), MENTAL STATUS CHANGES (Does not have the same mental statues), FATIGUE (she feels tired), ARTHRALGIA (Wakes up from deep sleep due to pain from her hips to her ankles) and ASTHENIA (she has no energy) had not resolved.            Patient did not have positive COVID test in past. Patient did not receive other vaccines given within 1 month prior to Moderna Covid-19 vaccine. Patient stated that the Moderna COVID 19 vaccine triggered some of her childhood health challenges. She had stomach issues as a child, her mother treated her with vitamins. In early 2019, she started having the issues again, she used Vitamins from Oct-2019 to Oct-2021 and was fine. After receiving the vaccine, she started having the stomach issues again. In addition, since receiving the vaccine, she feels like she is going to die, she just does not feel good, she feels tired, she does not have the same mental statues. She was hoping to retire at 70 but now she is ready to retire because she has no energy. She wakes up from deep sleep due to pain from her hips to her ankles. No treatment details reported.  Company comment: This spontaneous case concerns a 61 year old female patient with relevant medical history of abdominal discomfort, who experienced the unexpected serious (hospitalization) events of Abdominal discomfort, Feeling abnormal, Mental state changes, Fatigue, Arthralgia and Asthenia, unspecified days after receiving a dose of mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The outcome of the events was not resolved'. Medical history of Abdominal discomfort could be confounding for the event Abdominal discomfort. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year old female patient with relevant medical history of abdominal discomfort, who experienced the unexpected serious (hospitalization) events of Abdominal discomfort, Feeling abnormal, Mental state changes, Fatigue, Arthralgia and Asthenia, unspecified days after receiving a dose of mRNA-1273 vaccine. No further information on clinical course and management of the events was available in the report. The outcome of the events was not resolved'. Medical history of Abdominal discomfort could be confounding for the event Abdominal discomfort. The benefit-risk relationship of mRNA-1273 is not affected by this report.