Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Palpitations, Pustule, Vaccination site pain
Clinical narrative: hashimoto's thyroiditis; pustules on hand and right foot; developed large thryoid; racing heart; stomach got upset if ate something; raised and itchy about the size of a baseball; raised  about the size of a baseball; injection site got red; after second covid vaccine was ache and skin hurt; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (hashimoto's thyroiditis) in a 57-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) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (MODERATE TO SEVERE ULCERATIVE COLITIS).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-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) Daily dose CF. In 2021, the patient experienced VACCINATION SITE PAIN (after second covid vaccine was ache and skin hurt). On an unknown date, the patient experienced AUTOIMMUNE THYROIDITIS (hashimoto's thyroiditis) (seriousness criterion medically significant), PUSTULE (pustules on hand and right foot), GOITRE (developed large thryoid), PALPITATIONS (racing heart), ABDOMINAL DISCOMFORT (stomach got upset if ate something), INJECTION SITE PRURITUS (raised and itchy about the size of a baseball), INJECTION SITE PAPULE (raised  about the size of a baseball) and INJECTION SITE ERYTHEMA (injection site got red). The patient was treated with BETAMETHASONE DIPROPIONATE (DIPROLENE) at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE THYROIDITIS (hashimoto's thyroiditis), PUSTULE (pustules on hand and right foot), PALPITATIONS (racing heart), INJECTION SITE PRURITUS (raised and itchy about the size of a baseball), INJECTION SITE PAPULE (raised  about the size of a baseball) and INJECTION SITE ERYTHEMA (injection site got red) had resolved and GOITRE (developed large thryoid), ABDOMINAL DISCOMFORT (stomach got upset if ate something) and VACCINATION SITE PAIN (after second covid vaccine was ache and skin hurt) outcome was unknown.            No concomitant medications were reported.  In 2021, the patient experienced after second covid vaccine was achey and skin hurt.  The reporter causality for the events of pustules on hand and right foot, hashimotos thyroiditis, racing heart, injection site got red and raised and itchy about the size of a baseball unknown onset, injection site got red and raised and itchy about the size of a baseball unknown onset and injection site got red and raised and itchy about the size of a baseball unknown onset with Humira(adalimumab) was no reasonable possibility. The reporter causality for the events of after second covid vaccine was achey and skin hurt, developed large thyroid and stomach got upset if ate something that maybe should not had been not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial  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 is a spontaneous case, reported by a consumer, concerning a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Autoimmune thyroiditis, reported as hashimoto's thyroiditis, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine with given at an interval of 30 days which falls within the recommended vaccine dosing schedule. The patient also experienced palpitation, goiter, abdominal discomfort, pustule, injection site pruritus, pain and redness. The patient was treated with Diprolene. No further details about the clinical course and diagnostic procedures were provided.  It was reported that the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Autoimmune thyroiditis, reported as hashimoto's thyroiditis, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine with given at an interval of 30 days which falls within the recommended vaccine dosing schedule. The patient also experienced palpitation, goiter, abdominal discomfort, pustule, injection site pruritus, pain and redness. The patient was treated with Diprolene. No further details about the clinical course and diagnostic procedures were provided.  It was reported that the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.