Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast conserving surgery, Breast mass, Chemotherapy, Computerised tomogram, Condition aggravated
Clinical narrative: hepatis C reactivated/lack of appetite/ their feelings. Caller can't stand the taste of meat anymore/ makes her want to gag; skipping beats; their blood splirted on the floor during administration; their right hand, thumb, pointer finger and middle finger can't bend the last 3 joints; she was injured; heart was pounding out of their chest; looked like there was a lymph node; Inappropriate schedule of vaccination; breast cancer/lump developed on the side of her chest/has no energy/brain fog; muscle pain; muscle wasting; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (breast cancer/lump developed on the side of her chest/has no energy/brain fog) and HEPATITIS C (hepatis C reactivated/lack of appetite/ their feelings. Caller can't stand the taste of meat anymore/ makes her want to gag) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008CZ1A and 034C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip discomfort (right hip issue) and Hepatitis C (got Hep C when they were 14 year old but was always stable.).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced BREAST CANCER (breast cancer/lump developed on the side of her chest/has no energy/brain fog) (seriousness criterion medically significant), MUSCLE ATROPHY (muscle wasting) and MYALGIA (muscle pain). On an unknown date, the patient experienced HEPATITIS C (hepatis C reactivated/lack of appetite/ their feelings. Caller can't stand the taste of meat anymore/ makes her want to gag) (seriousness criterion medically significant), EXTRASYSTOLES (skipping beats), VACCINATION SITE HEMORRHAGE (their blood splirted on the floor during administration), MUSCULOSKELETAL DISCOMFORT (their right hand, thumb, pointer finger and middle finger can't bend the last 3 joints), INJURY (she was injured), CARDIAC DISCOMFORT (heart was pounding out of their chest), LYMPHADENOPATHY (looked like there was a lymph node) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency; CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) at an unspecified dose and frequency and GLECAPREVIR, PIBRENTASVIR (MAVYRET) for Hepatitis C, at an unspecified dose and frequency. At the time of the report, BREAST CANCER (breast cancer/lump developed on the side of her chest/has no energy/brain fog), MUSCLE ATROPHY (muscle wasting) and MYALGIA (muscle pain) was resolving, HEPATITIS C (hepatis C reactivated/lack of appetite/ their feelings. Caller can't stand the taste of meat anymore/ makes her want to gag) and CARDIAC DISCOMFORT (heart was pounding out of their chest) had resolved and EXTRASYSTOLES (skipping beats), VACCINATION SITE HEMORRHAGE (their blood splirted on the floor during administration), MUSCULOSKELETAL DISCOMFORT (their right hand, thumb, pointer finger and middle finger can't bend the last 3 joints), INJURY (she was injured), LYMPHADENOPATHY (looked like there was a lymph node) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: A walnut size lump developed on the side of her chest that was biopsied to be stage 3 non hormonal breast cancer. On an unknown date, Computerised tomogram: their thigh and lung in their recent CT scan something that may be cancerous. On an unknown date, Hepatitis C virus test: Hep C went up to 47 millsion. On an unknown date, Weight: they were always 120 and now weight 103, has lost 20 pounds, Weight decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BREAST CANCER (breast cancer/lump developed on the side of her chest/has no energy/brain fog), HEPATITIS C (hepatis C reactivated/lack of appetite/ their feelings. Caller can't stand the taste of meat anymore/ makes her want to gag), EXTRASYSTOLES (skipping beats), VACCINATION SITE HEMORRHAGE (their blood splirted on the floor during administration), MUSCULOSKELETAL DISCOMFORT (their right hand, thumb, pointer finger and middle finger can't bend the last 3 joints), INJURY (she was injured), MUSCLE ATROPHY (muscle wasting), CARDIAC DISCOMFORT (heart was pounding out of their chest), LYMPHADENOPATHY (looked like there was a lymph node) and MYALGIA (muscle pain) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccination).    Historical Drug name was reported. She thinks the reaction was to the second dose but may have been an accumulation from the first dose. Patient had lost 20 pounds, heart was pounding out of their chest and skipping beats, hepatis C reactivated after being dormmate for 50 years. A walnut size lump developed on the side of her chest that was biopsied to be stage 3 non hormonal breast cancer, muscle wasting, muscle pain, and right hand, thumb, pointer finger and middle finger can't bend the last 3 joints. Patient stated that cancer was the hardest and they went through chemo. Her thigh and lung recent reports of CT scan showed something that may be cancerous. She can't stand the taste of meat anymore and makes her want to gag. Patient think the vaccine went into their bone instead of their muscle.  No concomitant medications were reported. The symptoms of breast cancer included has no energy and brain fog. The symptoms of hepatitis c reactivated included lack of appetite/ their feelings, caller can't stand the taste of meat anymore/ makes her want to gag.  Company comment: This spontaneous case concerns a female patient aged 64 years with relevant medical history of Hepatitis C (at the age of 14 years, but was stable) reported, who experienced the unexpected, serious (medically significant) events of Breast cancer and Hepatitis C (reported as hepatis C reactivated) along with non-serious event of Extrasystoles. The event Breast cancer occurred about 3 months after and Hepatitis C, Extrasystoles occurred on an unknown date after second dose of mRNA-1273 vaccination in COVID-19 vaccination series. Inappropriate schedule of product administration was noted as the interval between 1st and 2nd dose of same vaccine was 22 days. It was reported that 3 months after vaccination, patient had lost 20 pounds, heart was pounding out of her chest and she had skipped beats, hepatis C was reactivated after being dormant for 50 years. A walnut size lump developed on the side of her chest that was biopsied to be stage 3 non hormonal breast cancer. She also had muscle wasting, muscle pain, and was unable to bend the last 3 joints of her right hand fingers. She is on medication Norco and Flexeril daily since she was injured. She underwent chemotherapy, details not reported. Recent CT scan shows some lesions in thigh and lung that may be cancerous. Patient has lack of appetite, taste disorder and retching. Hep C was treated with Mavyret and has resolved. Heart is much better and normal. Outcome of Breast cancer was reported as resolving. Relevant medical history could be confounder to the event Reactivation of Hepatitis C. Age could be the risk factor for the event Breast cancer. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient aged 64 years with relevant medical history of Hepatitis C (at the age of 14 years, but was stable) reported, who experienced the unexpected, serious (medically significant) events of Breast cancer and Hepatitis C (reported as hepatis C reactivated) along with non-serious event of Extrasystoles. The event Breast cancer occurred about 3 months after and Hepatitis C, Extrasystoles occurred on an unknown date after second dose of mRNA-1273 vaccination in COVID-19 vaccination series. Inappropriate schedule of product administration was noted as the interval between 1st and 2nd dose of same vaccine was 22 days. It was reported that 3 months after vaccination, patient had lost 20 pounds, heart was pounding out of her chest and she had skipped beats, hepatis C was reactivated after being dormant for 50 years. A walnut size lump developed on the side of her chest that was biopsied to be stage 3 non hormonal breast cancer. She also had muscle wasting, muscle pain, and was unable to bend the last 3 joints of her right hand fingers. She is on medication Norco and Flexeril daily since she was injured. She underwent chemotherapy, details not reported. Recent CT scan shows some lesions in thigh and lung that may be cancerous. Patient has lack of appetite, taste disorder and retching. Hep C was treated with Mavyret and has resolved. Heart is much better and normal. Outcome of Breast cancer was reported as resolving. Relevant medical history could be confounder to the event Reactivation of Hepatitis C. Age could be the risk factor for the event Breast cancer. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.