Age: 46.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Abscess which was the Bartholin's glands near vagina became soft and full of fluid/Abscess on vulva drained; Perianal abscess; Infection to the drainage; Chills; Fever; Body aches; Bad headache; Achy arm; This spontaneous case was reported by a consumer and describes the occurrence of BARTHOLIN'S ABSCESS (Abscess which was the Bartholin's glands near vagina became soft and full of fluid/Abscess on vulva drained), ANAL ABSCESS (Perianal abscess) and INFECTION (Infection to the drainage) in a 46-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 products included non-company products ADALIMUMAB (HUMIRA) for Ulcerative colitis and AMOXICILLIN for Infection.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen and AMOXICILLIN (unknown route) at an unspecified dose. On an unknown date, the patient experienced BARTHOLIN'S ABSCESS (Abscess which was the Bartholin's glands near vagina became soft and full of fluid/Abscess on vulva drained) (seriousness criterion medically significant), ANAL ABSCESS (Perianal abscess) (seriousness criterion medically significant), INFECTION (Infection to the drainage) (seriousness criterion medically significant), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Bad headache) and PAIN IN EXTREMITY (Achy arm). At the time of the report, BARTHOLIN'S ABSCESS (Abscess which was the Bartholin's glands near vagina became soft and full of fluid/Abscess on vulva drained) and ANAL ABSCESS (Perianal abscess) was resolving, INFECTION (Infection to the drainage), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Bad headache) outcome was unknown and PAIN IN EXTREMITY (Achy arm) had resolved.            Concomitant product use was not provided by the reporter.  On 10-Apr-2022, the patient underwent emergency surgery due to abscess which was the Bartholin's glands near vagina became soft and full of fluid.  The patient developed a fever and this happened the day of Humira injection, which did not help with healing of antibiotics. Patient was really stressed due to work projects and was not able to get Humira on time. After Covid-19 vaccine, patient had bad headache, fever, chills and body aches was out of work for a day one and half days, also had mild fever after third shot. Patient had abscess on vulva drained. Patient wound up back at emergency room for a slight infection to the drainage due to the antibiotics of Amoxicillin. Patient had to switch to another which did work. Patient injecting Humira because the last time it made the abscess surgery site react.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information included warm compress.  Company Comment: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Bartholin's Abscess, Anal Abscess, Infection, and other non-serious events which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine and the co-suspect drug Adalimumab. No further information on risk factors, co morbidities were provided. As reported, the patient underwent emergency surgery due to abscess which was the Bartholin's glands near vagina became soft and full of fluid. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-587548 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Additional follow-up document received included suspect drug information and narrative was updated. On 15-Apr-2022: Additional follow-up received included seriousness, added event of abscess which was the Bartholin's glands near vagina became soft and full of fluid, suspect drug details (Moderna) and narrative was updated. On 10-Jun-2022: Additional follow up received included additional events, of abscess on vulva drained, perianal abscess, abscess surgery site react, infection to the drainage and achy arm. added suspect drug Amoxicillin, treatment information and narrative was updated.; Sender's Comments: This is a spontaneous case concerning a 46-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Bartholin's Abscess, Anal Abscess, Infection, and other non-serious events which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine and the co-suspect drug Adalimumab. No further information on risk factors, co morbidities were provided. As reported, the patient underwent emergency surgery due to abscess which was the Bartholin's glands near vagina became soft and full of fluid. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.