Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test, Surgery
Clinical narrative: Neck or hip might hurt; Had back problems also; Has to be completely straight in order to go to sleep; Middle fingers pain on both hands; dense breast tissue / possible breast cancer & she had to go to biopsy to see if it was cancerous; Neck or hip might hurt; had a surgery procedure; Had COVID 19; Felt weakness; Sweating so bad; Fever; Dense breast tissue; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISORDER FEMALE (Dense breast tissue), BREAST CANCER FEMALE (dense breast tissue / possible breast cancer & she had to go to biopsy to see if it was cancerous) and SURGERY (had a surgery procedure) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Breast cancer (About 6 years diagnosed.), COVID-19 (Felt feverish and weak. Was okay in 2021.) in December 2020 and Radiation therapy (related to breast cancer.). Concurrent medical conditions included Insomnia and Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced BREAST DISORDER FEMALE (Dense breast tissue) (seriousness criterion medically significant). In September 2021, the patient experienced ASTHENIA (Felt weakness), HYPERHIDROSIS (Sweating so bad) and PYREXIA (Fever). In December 2021, the patient experienced SURGERY (had a surgery procedure) (seriousness criterion medically significant) and COVID-19 (Had COVID 19). On an unknown date, the patient experienced BREAST CANCER FEMALE (dense breast tissue / possible breast cancer & she had to go to biopsy to see if it was cancerous) (seriousness criterion medically significant), NECK PAIN (Neck or hip might hurt), BACK DISORDER (Had back problems also), INSOMNIA (Has to be completely straight in order to go to sleep), PAIN IN EXTREMITY (Middle fingers pain on both hands) and ARTHRALGIA (Neck or hip might hurt). In September 2021, ASTHENIA (Felt weakness), HYPERHIDROSIS (Sweating so bad) and PYREXIA (Fever) had resolved. On 14-Dec-2021, COVID-19 (Had COVID 19) had resolved. At the time of the report, BREAST DISORDER FEMALE (Dense breast tissue), BREAST CANCER FEMALE (dense breast tissue / possible breast cancer & she had to go to biopsy to see if it was cancerous), SURGERY (had a surgery procedure), NECK PAIN (Neck or hip might hurt), BACK DISORDER (Had back problems also), INSOMNIA (Has to be completely straight in order to go to sleep) and ARTHRALGIA (Neck or hip might hurt) outcome was unknown and PAIN IN EXTREMITY (Middle fingers pain on both hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: Dense breast tissue. On 14-Dec-2021, SARS-CoV-2 test: (Negative) Negative.   No concomitant medication provided. Treatment information mentioned muscle relaxants NOS.  Lab test included blood work ordered by physician with no results provided.  Patient was diagnosed with breast cancer 6 years ago, got treatment for the same and it was all okay. Patient had COVID in DEC2020, but got better. Later in 2021, at the mammogram, found dense breast tissue. Not sure if cancerous or not. Patient went back for second diagnostic test and still could not tell. Patient took vaccinations and had sweating, fever and weakness with the booster. Lasted about 24 hours.  Patient has had trouble sleeping for years, started to take muscle relaxants as neck or hip might hurt and had back problems too.  In 2021, middle fingers would pain, for both hands. Would jerk open mostly on left hand. Had a surgery procedure NOS in DEC2021 and also had COVID for second time then. Nose was still running and coughing. Tested on 14DEC2021 as negative.     Reporters causality for events with co-suspect of RINVOQ is that there is no reasonable possibility and they are not related.  Company comment: This spontaneous case concerns a 70  year  old female patient, with relevant medical history of breast cancer (with radiotherapy treatment), who received 3 doses of mRNA-1273 and experienced the non  serious unexpected AESI of COVID-19, approximately 3 months after receiving the third dose of mRNA-1273. Also, three months after vaccination, the patient had an unspecified surgery procedure, for which no indication was disclosed. It was also reported that in the same year of vaccination with mRNA  1273, patient had a biopsy  due to a dense breast tissue found in a mammogram possibly related to breast cancer (medically significant unexpected event of breast disorder female). No further clinical information was available for medical reviewing. Co-suspect product included Upadacitinib. Patient´s age and mentioned medical history remains as risk factor for breast cancer . The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Significant follow up. New event updated. On 21-Dec-2021: Significant follow up received: In patients medical history Insomnia and rheumatoid arthritis added as current condition. Newlab data, co-suspect information and event updated and new event surgery, breast cancer female added. For event Breast disorder female, in non - drug treatments notes: Biopsy in 2021 was added.; Sender's Comments: This spontaneous case concerns a 70  year  old female patient, with relevant medical history of breast cancer (with radiotherapy treatment), who received 3 doses of mRNA-1273 and experienced the non  serious unexpected AESI of COVID-19, approximately 3 months after receiving the third dose of mRNA-1273. Also, three months after vaccination, the patient had an unspecified surgery procedure, for which no indication was disclosed. It was also reported that in the same year of vaccination with mRNA  1273, patient had a biopsy  due to a dense breast tissue found in a mammogram possibly related to breast cancer (medically significant unexpected event of breast disorder female). No further clinical information was available for medical reviewing. Co-suspect product included Upadacitinib. Patient´s age and mentioned medical history remains as risk factor for breast cancer . The benefit-risk relationship of mRNA-1273 is not affected by this report.