Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure increased, Blood pressure measurement, Cardiomegaly, Fluid retention
Clinical narrative: Fluid retention/fluid does not have the chance to drain; Heart seen to be enlarged; Edema in her left arm which is like elephantiasis; Neuroma on the left foot measuring 3.5 cm in diameter,which is painful - like being stabbed in the foot; Lymphatic system is no longer there; Throbbing pain in her back; Blurred vision; Blood pressure has increased; Headache; Edema was exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Fluid retention/fluid does not have the chance to drain), CARDIOMEGALY (Heart seen to be enlarged) and OEDEMA PERIPHERAL (Edema in her left arm which is like elephantiasis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 023M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer from 1994 to 1996, Flu, Breathing difficult, Lymph node dissection (Removal of lymph nodes on the left side) and Abdominal operation (Had abdominal surgery where they took out a portion of small intestines). Concurrent medical conditions included Drug allergy (Betadine), Allergy to sting (Bee stings) and Iodine allergy. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced OEDEMA (Edema was exacerbated). On an unknown date, the patient experienced FLUID RETENTION (Fluid retention/fluid does not have the chance to drain) (seriousness criterion medically significant), CARDIOMEGALY (Heart seen to be enlarged) (seriousness criterion medically significant), OEDEMA PERIPHERAL (Edema in her left arm which is like elephantiasis) (seriousness criterion medically significant), NEUROMA (Neuroma on the left foot measuring 3.5 cm in diameter,which is painful - like being stabbed in the foot), LYMPHATIC DISORDER (Lymphatic system is no longer there), PAIN (Throbbing pain in her back), VISION BLURRED (Blurred vision), BLOOD PRESSURE INCREASED (Blood pressure has increased) and HEADACHE (Headache). At the time of the report, FLUID RETENTION (Fluid retention/fluid does not have the chance to drain), CARDIOMEGALY (Heart seen to be enlarged), OEDEMA PERIPHERAL (Edema in her left arm which is like elephantiasis), OEDEMA (Edema was exacerbated), NEUROMA (Neuroma on the left foot measuring 3.5 cm in diameter,which is painful - like being stabbed in the foot), LYMPHATIC DISORDER (Lymphatic system is no longer there), PAIN (Throbbing pain in her back), VISION BLURRED (Blurred vision), BLOOD PRESSURE INCREASED (Blood pressure has increased) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: no antibodies for covid (Negative) no antibodies for Covid. On an unknown date, Blood pressure measurement: increased (High) increased.         Past history included patient had an abdominal surgery where they took out a portion of her small intestines thought that the breast cancer had spread but results were came out negative.  No history of documented Covid-19 infection although in Feb2020.  It was reported that patient might need surgery for the neuroma and draining of the fluid on left arm.  This is a spontaneous case concerning a 74-year-old female patient with medical history of breast cancer, lymphadenectomy, abdominal operation and multiple allergies, who experienced the serious unexpected events of fluid retention, cardiomegaly, oedema peripheral and other non-serious events. The events occurred within unknown period prior or after the third dose of mRNA-1273 vaccination. The events were conservatively assessed as related to the product administration. The medical history of breast cancer, lymphadenectomy, abdominal operation and multiple allergies considered as major contributory factors to the occurrence of the reported events. The rechallenge was not applicable since the events occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-441056 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with medical history of breast cancer, lymphadenectomy, abdominal operation and multiple allergies, who experienced the serious unexpected events of fluid retention, cardiomegaly, oedema peripheral and other non-serious events. The events occurred within unknown period prior or after the third dose of mRNA-1273 vaccination. The events were conservatively assessed as related to the product administration. The medical history of breast cancer, lymphadenectomy, abdominal operation and multiple allergies considered as major contributory factors to the occurrence of the reported events. The rechallenge was not applicable since the events occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.