Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Tinnitus, Vertigo
Clinical narrative: Leukemia/Ldiagnosed  Leukemia; Covid-19 Symptoms; Cramps; Diarrhea; Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth; Pain on right side of her head and feels like a chronic headache; Dry eye; Tinnitus was louder than normal; Vertigo; Light headed; Nauseas/ She still felt queasy; Stiffness in her neck, going up back of her head; Joint pain as an increase in the arthritis pain; This spontaneous case was reported by a patient and describes the occurrence of LEUKAEMIA (Leukemia/Ldiagnosed  Leukemia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Venous ulcer NOS. Concurrent medical conditions included Arthritis and Tinnitus.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRITIS (Joint pain as an increase in the arthritis pain). On 09-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in her neck, going up back of her head). On 10-Apr-2021, the patient experienced VERTIGO (Vertigo), DIZZINESS (Light headed) and NAUSEA (Nauseas/ She still felt queasy). On 11-Apr-2021, the patient experienced TINNITUS (Tinnitus was louder than normal) and DRY EYE (Dry eye). On 17-Apr-2021, the patient experienced STOMATITIS (Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth) and HEADACHE (Pain on right side of her head and feels like a chronic headache). On 19-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramps). On an unknown date, the patient experienced LEUKAEMIA (Leukemia/Ldiagnosed  Leukemia) (seriousness criteria death and medically significant) and SUSPECTED COVID-19 (Covid-19 Symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Apr-2021, VERTIGO (Vertigo), DIZZINESS (Light headed) and NAUSEA (Nauseas/ She still felt queasy) had resolved. The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, MUSCULOSKELETAL STIFFNESS (Stiffness in her neck, going up back of her head), DIARRHOEA (Diarrhea), SUSPECTED COVID-19 (Covid-19 Symptoms), TINNITUS (Tinnitus was louder than normal), MUSCLE SPASMS (Cramps), DRY EYE (Dry eye), STOMATITIS (Mouth sores,canker sore-like on the roof of her mouth and on backside of the gum behind her back tooth), ARTHRITIS (Joint pain as an increase in the arthritis pain) and HEADACHE (Pain on right side of her head and feels like a chronic headache) outcome was unknown.            Concomitant medications were not provided. Additional treatment information also included the use of unspecified eye drops. Patient was on chemotherapy for 4 weeks.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Leukemia which the Company believes is unlikely related due to the natural course of the disease.   This case was linked to US-MODERNATX, INC.-MOD-2021-080458 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant followup contains new event Leukamia with outcome fatal. On 03-Aug-2021: Follow up received included no new significant information. On 03-Aug-2021: Non Significant follow up appended included no new significant information (AE contact info updated); Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Leukemia which the Company believes is unlikely related due to the natural course of the disease. US-MODERNATX, INC.-MOD-2021-080458:Husband case