Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood glucose, Feeling abnormal, Headache, Immunisation reaction
Clinical narrative: Type one diabetes; Tendon tear on finger of right hand; Felt horrible; Deadly sick after both injections of COVID vaccine; Left shoulder had torn or partially torn rotator cuff; Terrible headache; Feverish; Vomiting/could not keep food down; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TYPE 1 DIABETES MELLITUS (Type one diabetes) and TENDON RUPTURE (Tendon tear on finger of right hand) in an elderly 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 Rheumatoid arthritis.    Family history included Aneurysm. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced TYPE 1 DIABETES MELLITUS (Type one diabetes) (seriousness criterion medically significant), TENDON RUPTURE (Tendon tear on finger of right hand) (seriousness criterion medically significant), FEELING ABNORMAL (Felt horrible), IMMUNISATION REACTION (Deadly sick after both injections of COVID vaccine), ROTATOR CUFF SYNDROME (Left shoulder had torn or partially torn rotator cuff), HEADACHE (Terrible headache), PYREXIA (Feverish), VOMITING (Vomiting/could not keep food down) and ARTHRALGIA (Joint pain). At the time of the report, TYPE 1 DIABETES MELLITUS (Type one diabetes), TENDON RUPTURE (Tendon tear on finger of right hand) and IMMUNISATION REACTION (Deadly sick after both injections of COVID vaccine) was resolving and FEELING ABNORMAL (Felt horrible), ROTATOR CUFF SYNDROME (Left shoulder had torn or partially torn rotator cuff), HEADACHE (Terrible headache), PYREXIA (Feverish), VOMITING (Vomiting/could not keep food down) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Magnetic resonance imaging head: Normal. On an unknown date, Blood glucose: Up to 500 (Elevated).         No concomitant medication was reported.  The co-suspect Humira concentration was reported as 40 MG/0.4 ML and formulation was reported as solution for injection in pre-filled pen. Eye exam: Report was unknown. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the event of deadly sick after both injections of COVID vaccine, ill, left shoulder had torn or partially torn rotator cuff, type one diabetes, two bouts of blood sugar reaction shooting up of over 500 and vomiting/could not keep food down with co-suspect Humira was no reasonable possibility. The reporter causality for the events felt horrible, tendon tear on finger of right hand, terrible headache, feverish and joint pain with co-suspect Humira was not provided.  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 elderly female patient of an unknown age, with concurrent medical history rheumatoid arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) event of Type 1 diabetes mellitus and Tendon rupture after receiving a dose of mRNA-1273 vaccine. The onset dates of the events were not reported. Patient had tendon tear on finger of the right hand. Also reported non serious events of headache and vomiting which could be in association with the type 1 diabetes mellitus along with elevated blood sugar over 500 (units not reported). Clinical course and treatment details were not reported. The outcome of event was reported as resolving. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 28 days which is within the recommended dosing schedule. Rheumatoid arthritis could be a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2022: Followup includes new event (left shoulder had torn or partially torn rotator cuff, type one diabetes, felt horrible, tendon tear on finger of right hand, terrible headache and feverish) added. The event of sick was amended to deadly sick after both injections of COVID vaccine. On 31-Mar-2022: Follow up includes updated suspect information, event information, reporter causality and narrative description. On 27-Apr-2022: Follow up includes event information, lab data, narrative description updated. Event (stroke) removed. Sender's Comments: This spontaneous case concerns an elderly female patient of an unknown age, with concurrent medical history rheumatoid arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) event of Type 1 diabetes mellitus and Tendon rupture after receiving a dose of mRNA-1273 vaccine. The onset dates of the events were not reported. Patient had tendon tear on finger of the right hand. Also reported non serious events of headache and vomiting which could be in association with the type 1 diabetes mellitus along with elevated blood sugar over 500 (units not reported). Clinical course and treatment details were not reported. The outcome of event was reported as resolving. Patient received 2 doses of mRNA-1273 vaccine as primary series at an interval of 28 days which is within the recommended dosing schedule. Rheumatoid arthritis could be a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.