Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cyst, Lymphadenopathy, Procedural pain
Clinical narrative: surgery for cyst under right arm/underarm was sore; Low back pain; Pain in hip; surgery for cyst under right arm/underarm was sore; enlarged lymph node under arm; This spontaneous case was reported by a consumer and describes the occurrence of CYST (surgery for cyst under right arm/underarm was sore), BACK PAIN (Low back pain) and ARTHRALGIA (Pain in hip) in an adult 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 ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CYST (surgery for cyst under right arm/underarm was sore) (seriousness criterion medically significant), BACK PAIN (Low back pain) (seriousness criterion medically significant), ARTHRALGIA (Pain in hip) (seriousness criterion medically significant), PROCEDURAL PAIN (surgery for cyst under right arm/underarm was sore) and LYMPHADENOPATHY (enlarged lymph node under arm). The patient was treated with Surgery (SURGERY FOR CYST UNDER RIGHT ARM) for Cyst. At the time of the report, CYST (surgery for cyst under right arm/underarm was sore), PROCEDURAL PAIN (surgery for cyst under right arm/underarm was sore) and LYMPHADENOPATHY (enlarged lymph node under arm) outcome was unknown and BACK PAIN (Low back pain) and ARTHRALGIA (Pain in hip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient had not seen any changes in psoriatic arthritis since had been on Humira.  Patient dose was increased to weekly for eight weeks and then patient was back to bi-weekly, and patient had to stop Humira for about three weeks.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter causality for the events of surgery for cyst under right arm and underarm was sore unknown onset and surgery for cyst under right arm/underarm was sore unknown onset was not provided. The reporter's causality for the events of enlarged lymph node under arm with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the events of pain in hip, lower back pain and not seen any changes in psoriatic arthritis since had been on Humira with Humira(adalimumab) was a reasonable possibility.  No treatment medications were reported. 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.  Company Comment:  This spontaneous case concerns an adult female patient with relevant medical history of Psoriatic arthritis on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) events of Cyst (reported as surgery for cyst under right arm/underarm was sore), Back pain, and Arthralgia (reported as Pain in hip) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset dates of the events were not reported. A non-serious event of procedural pain was also reported in association with the cyst surgery. Information on any other doses of COVID-19 vaccination was not provided. The relevant medical history of Psoriatic arthritis could be considered a confounder for the event Arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with relevant medical history of Psoriatic arthritis on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) events of Cyst (reported as surgery for cyst under right arm/underarm was sore), Back pain (reported as Low back pain), and Arthralgia (reported as Pain in hip) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and onset dates of the events were not reported. A non-serious event of procedural pain was also reported in association with the cyst surgery. Information on any other doses of COVID-19 vaccination was not provided. The relevant medical history of Psoriatic arthritis could be considered a confounder for the event Arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.