Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Haemorrhagic ovarian cyst, Headache, Joint swelling
Clinical narrative: The patient reports developing a complex right ovarian hemorrhagic cyst/swelling around the lymph nodes in my groin; swelling around the lymph nodes in my knees; body aches most persistent for 48 hours but lasted for 5 days.; The patient had a sudden weight gain of 20 pounds recently; lower extremety swelling around my lymph nodes,swelling was pronounced at the lymph nodes around my groin and my knees; total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees; low grade fever most persistent for 48 hours but lasted for 5 days.; headache most persistent for 48 hours but lasted for 5 days.; chills most persistent for 48 hours but lasted for 5 days.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Sep-2022 and was forwarded to Moderna on 26-Sep-2022.    This spontaneous case was reported by a nurse and describes the occurrence of HAEMORRHAGIC OVARIAN CYST (The patient reports developing a complex right ovarian hemorrhagic cyst) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 013M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC OVARIAN CYST (The patient reports developing a complex right ovarian hemorrhagic cyst) (seriousness criterion medically significant), PAIN (body aches most persistent for 48 hours but lasted for 5 days.) and WEIGHT INCREASED (The patient had a sudden weight gain of 20 pounds recently). an unknown date, the patient experienced SWELLING (swelling around the lymph nodes in my groin), JOINT SWELLING (swelling around the lymph nodes in my knees), LYMPHADENOPATHY (lower extremety swelling around my lymph nodes,swelling was pronounced at the lymph nodes around my groin and my knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees), PYREXIA (low grade fever most persistent for 48 hours but lasted for 5 days.), HEADACHE (headache most persistent for 48 hours but lasted for 5 days.) and CHILLS (chills most persistent for 48 hours but lasted for 5 days.). At the time of the report, HAEMORRHAGIC OVARIAN CYST (The patient reports developing a complex right ovarian hemorrhagic cyst) had not resolved, SWELLING (swelling around the lymph nodes in my groin), JOINT SWELLING (swelling around the lymph nodes in my knees), WEIGHT INCREASED (The patient had a sudden weight gain of 20 pounds recently), LYMPHADENOPATHY (lower extremety swelling around my lymph nodes,swelling was pronounced at the lymph nodes around my groin and my knees) and ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees) outcome was unknown and PAIN (body aches most persistent for 48 hours but lasted for 5 days.), PYREXIA (low grade fever most persistent for 48 hours but lasted for 5 days.), HEADACHE (headache most persistent for 48 hours but lasted for 5 days.) and CHILLS (chills most persistent for 48 hours but lasted for 5 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HAEMORRHAGIC OVARIAN CYST (The patient reports developing a complex right ovarian hemorrhagic cyst), SWELLING (swelling around the lymph nodes in my groin), JOINT SWELLING (swelling around the lymph nodes in my knees), PAIN (body aches most persistent for 48 hours but lasted for 5 days.), WEIGHT INCREASED (The patient had a sudden weight gain of 20 pounds recently), LYMPHADENOPATHY (lower extremety swelling around my lymph nodes,swelling was pronounced at the lymph nodes around my groin and my knees), ARTHRALGIA (total body arthritic pain,arthritic pain was most  pronounced around my pelvis and knees), PYREXIA (low grade fever most persistent for 48 hours but lasted for 5 days.), HEADACHE (headache most persistent for 48 hours but lasted for 5 days.) and CHILLS (chills most persistent for 48 hours but lasted for 5 days.) to be related.    No concomitant medications were reported.The patient had no medical issues before receiving the Moderna Covid-19 vaccine.  The patient was being evaluated for damage to her ovaries, uterus and to her pelvic girdle, hips, and sacral iliac joints. The patient reported that developing a complex right ovarian hemorrhagic cyst which was undergoing work up for Ovarian Cancer. The patient was undergoing a work up for uterine cancer. The patient stated that she will not receive her bivalent booster vaccine because of these adverse reactions.No treatment drugs were reported.  Company comment: This is a spontaneous case concerning a 48-year-old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Hemorrhagic ovarian cyst, which occurred unspecified days after third dose (reported as booster) of mRNA-1273 vaccine. Additionally non serious events weight increased, lymphadenopathy, arthralgia is also reported. After vaccination patient experienced lower extremity swelling around lymph nodes at the groin and knee, Significantly the swelling was pronounced at the lymph nodes around my groin and my knees. Patient had arthritic pain most pronounced around pelvis and knees, patient also had low grade fever, headache, body aches, chills, which lasted for 5 days. Patient gained sudden weight 20 pounds recently. patient is being evaluated for damage to her ovaries, uterus and to her pelvic girdle, hips, and sacral iliac joints. The patient reports developing a complex right ovarian hemorrhagic cyst which is undergoing work up for Ovarian Cancer.  The patient is undergoing a work up for uterine cancer. At the time of reporting event is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 48-year-old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Hemorrhagic ovarian cyst, which occurred unspecified days after third dose (reported as booster) of mRNA-1273 vaccine. Additionally non serious events weight increased, lymphadenopathy, arthralgia is also reported. After vaccination patient experienced lower extremity swelling around lymph nodes at the groin and knee, Significantly the swelling was pronounced at the lymph nodes around my groin and my knees. Patient had arthritic pain most pronounced around pelvis and knees, patient also had low grade fever, headache, body aches, chills, which lasted for 5 days. Patient gained sudden weight 20 pounds recently. patient is being evaluated for damage to her ovaries, uterus and to her pelvic girdle, hips, and sacral iliac joints. The patient reports developing a complex right ovarian hemorrhagic cyst which is undergoing work up for Ovarian Cancer.  The patient is undergoing a work up for uterine cancer. At the time of reporting event is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.