Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Pain, Rotator cuff syndrome
Clinical narrative: Achy; Feeling tired; Painful shoulder; Shoulder rotator cuff surgery; Flu like symstom with Moderna booster vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Shoulder rotator cuff surgery) in a 59-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 ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-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) , Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to  Citrate free. In December 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symstom with Moderna booster vaccination). In January 2022, the patient experienced ROTATOR CUFF SYNDROME (Shoulder rotator cuff surgery) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Achy), FATIGUE (Feeling tired) and ARTHRALGIA (Painful shoulder). In December 2021, INFLUENZA LIKE ILLNESS (Flu like symstom with Moderna booster vaccination) had resolved. In 2022, ROTATOR CUFF SYNDROME (Shoulder rotator cuff surgery) had resolved. At the time of the report, PAIN (Achy), FATIGUE (Feeling tired) and ARTHRALGIA (Painful shoulder) had not resolved.            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.  No concomitant medication was reported.  In Jan-2022, patient had surgery for shoulder rotator cuff. She went off the Humira for a few weeks during that time in Jan-2022. She felt tired and achy, painful shoulder.  When she had booster dose of vaccination, she had flu like symptoms for three days.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of Shoulder rotator cuff surgery, feeling tired, achy, painful shoulder and flu like symstom with Moderna booster vaccination was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of shoulder rotator cuff surgery, feeling tired, achy, painful shoulder and flu like symstom with Moderna booster vaccination are related to Humira (adalimumab).  Company comment This spontaneous case reported by a consumer, concerns a 59 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of ROTATOR CUFF SYNDROME (Shoulder rotator cuff surgery) unknown days after receiving 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of pain, fatigue and Arthralgia. Patient previously received 2 doses of Moderna vaccines with the last dose given about 7 months prior to 3 dose without any adverse events reported. After the booster dose of vaccination, she had flu like symptoms for three days. It was reported that the Patient had also received on an unknown date, ADALIMUMAB (HUMIRA) injection for Crohn's disease and Rheumatoid arthritis, which could be considered as a confounder. The patient had surgery for shoulder rotator cuff syndrome. She went off the Humira for a few weeks during that time. She felt tired and achy, painful shoulder. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The event had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Significant follow up appended. Patient demographics, event information, suspect drug information and narrative description updated.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 59 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of ROTATOR CUFF SYNDROME (Shoulder rotator cuff surgery) unknown days after receiving 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of pain, fatigue and Arthralgia. Patient previously received 2 doses of Moderna vaccines with the last dose given about 7 months prior to 3 dose without any adverse events reported. After the booster dose of vaccination, she had flu like symptoms for three days. It was reported that the Patient had also received on an unknown date, ADALIMUMAB (HUMIRA) injection for Crohn's disease and Rheumatoid arthritis, which could be considered as a confounder. The patient had surgery for shoulder rotator cuff syndrome. She went off the Humira for a few weeks during that time. She felt tired and achy, painful shoulder. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. The event had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.