Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cholelithiasis, Gallbladder polyp, Pain in extremity, Pyrexia, Ultrasound scan
Clinical narrative: Gallbladder stones; Gallbladder polyp; Feverish; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHOLELITHIASIS (Gallbladder stones), GALLBLADDER POLYP (Gallbladder polyp), PYREXIA (Feverish) and PAIN IN EXTREMITY (Pain in arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    There was no reported medical history.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second 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. In February 2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On an unknown date, the patient experienced CHOLELITHIASIS (Gallbladder stones) (seriousness criterion medically significant) and GALLBLADDER POLYP (Gallbladder polyp) (seriousness criterion medically significant). The patient was treated with Surgery for Cholelithiasis and Surgery for Gallbladder polyp. In 2021, PYREXIA (Feverish) and PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, CHOLELITHIASIS (Gallbladder stones) and GALLBLADDER POLYP (Gallbladder polyp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: polyps and stones in gall bladder.         No concomitant medications were reported.  The patient had surgery removal of gall bladder.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 reported by a consumer, concerns a 61 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of CHOLELITHIASIS (Gallbladder stones), GALLBLADDER POLYP, PYREXIA and PAIN IN EXTREMITY (Pain in arm) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient had previously received the 1 dose with Moderna vaccine about 1 month ago, with no adverse events reported. On an unknown date, Ultrasound scan showed polyps and stones in gall bladder and patient was treated with surgery for cholelithiasis and gall bladder polyp. On an unknown date, the patient had received ADALIMUMAB (Humira) for Ankylosing spondylitis. Age of the subject is a confounder for the events cholelithiasis and gall bladder polyps. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 61 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of CHOLELITHIASIS (Gallbladder stones), GALLBLADDER POLYP, PYREXIA and PAIN IN EXTREMITY (Pain in arm) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient had previously received the 1 dose with Moderna vaccine about 1 month ago, with no adverse events reported. On an unknown date, Ultrasound scan showed polyps and stones in gall bladder and patient was treated with surgery for cholelithiasis and gall bladder polyp. On an unknown date, the patient had received ADALIMUMAB (Humira) for Ankylosing spondylitis. Age of the subject is a confounder for the events cholelithiasis and gall bladder polyps. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.