Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BRAIN NEOPLASM MALIGNANT (Brain neoplasm malignant/brain cancer/brain tumors), LUNG NEOPLASM MALIGNANT (Lung cancer) and HYPERTHYROIDISM (Hyperthyroidism/mild hyperthyroidism) in a 64-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 Rheumatoid arthritis. In 1980, colonoscopy was performed with unknown results. Patient had Mesh Urethral (Started 03 Nov 2010), nodes removed from throat and disc protrusion. The patient's past medical history included Degenerative disc disease on 18-Sep-2012, Sleep apnea in May 2013, Fibromyalgia, Plantar fasciitis, Overactive bladder, Tonsillectomy in 2006, Continuous positive airway pressure on 03-Nov-2010, Discectomy on 04-Oct-2012, Surgery (Lumber Spine Surgery) and Hysterectomy in 1985. Previously administered products included for Drug use for unknown indication: MURINE CLEAR and PREDNISONE. Past adverse reactions to the above products included No adverse event with MURINE CLEAR and PREDNISONE. Concurrent medical conditions included Rheumatoid arthritis since 05-Jan-2012, Hypertension since June 2022, Abstains from alcohol, Tobacco user, Dry eye syndrome, Osteoarthritis, Penicillin allergy, Drug allergy (Prednisone Allergy), Drug allergy (Murine Eye Drops Allergy) and Cervical cancer since 1985. Concomitant products included GABAPENTIN, MILNACIPRAN HYDROCHLORIDE (SAVELLA), METHYLPREDNISOLONE, FENOFIBRATE, OMEPRAZOLE, METHIMAZOLE, SALBUTAMOL SULFATE (VENTOLIN HFA), METOCLOPRAMIDE, DEXAMETHASONE, METOPROLOL SUCCINATE, FOLIC ACID, FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE WITH D3), PARACETAMOL (TYLENOL) and AIRBORNE for an unknown indication. On 18-Oct-2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg,1 in 2 wk. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine)  (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, received 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, 40MG/0.4ML. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, 40MG/0.4ML, Solution for injection in pre-filled pen. On 19-Jan-2022, the patient experienced HYPERTHYROIDISM (Hyperthyroidism/mild hyperthyroidism) (seriousness criterion medically significant). On 08-Feb-2022, the patient experienced BRAIN NEOPLASM MALIGNANT (Brain neoplasm malignant/brain cancer/brain tumors) (seriousness criterion medically significant) and LUNG NEOPLASM MALIGNANT (Lung cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (Sickness/she got very sick following the booster dose) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, BRAIN NEOPLASM MALIGNANT (Brain neoplasm malignant/brain cancer/brain tumors) and LUNG NEOPLASM MALIGNANT (Lung cancer) was resolving and HYPERTHYROIDISM (Hyperthyroidism/mild hyperthyroidism), ILLNESS (Sickness/she got very sick following the booster dose) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: 0.14 No unit. On, 03-Nov-2011, bronchoscopy was performed with unknown results. On an unknown date cytometry, stereotactic biopsy of breast, biopsy was performed with unknown results. On, 10 Feb 2022, ultrasound left lung biopsy, was performed with unknown results. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication details were 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 a female patient aged 64 years with relevant past medical history of multiple carcinomas, multiple allergies and tobacco user who experienced the unexpected, serious (medically significant) events of Brain neoplasm malignant, Lung neoplasm malignant and Hyperthyroidism (AESI) that occurred after third dose of mRNA-1273 vaccination. Brain neoplasm malignant, Lung neoplasm malignant occurred 20 days after with resolving outcome and Hyperthyroidism occurred on the same day of vaccination with outcome unknown. Patient had received initial two doses of same vaccine at an interval of 28 days and third dose approximately nine and half months later. Patient was diagnosed with brain and lung cancer. patient experienced Covid vaccine related issues flu like symptoms, she got very sick following the booster dose. On 19 Jan 2022, she experienced mild hyperthyroidism and it was low, was 0.14. Ultrasound left lung done as on 10-Feb-2022, reports not available. The Clinical course, other investigations, treatment details were not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-623772 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow-up appended- Information Update about suspect drug. On 12-Aug-2022: Follow-up appended-Added concomitant drug, medical history, lab data information, updated outcome for (Lung neoplasm malignant, Brain neoplasm malignant) and start date for event (brain neoplasm malignant, lung neoplasm malignant). Sender's Comments: This spontaneous case concerns a female patient aged 64 years with relevant past medical history of multiple carcinomas, multiple allergies and tobacco user who experienced the unexpected, serious (medically significant) events of Brain neoplasm malignant, Lung neoplasm malignant and Hyperthyroidism (AESI) that occurred after third dose of mRNA-1273 vaccination. Brain neoplasm malignant, Lung neoplasm malignant occurred 20 days after with resolving outcome and Hyperthyroidism occurred on the same day of vaccination with outcome unknown. Patient had received initial two doses of same vaccine at an interval of 28 days and third dose approximately nine and half months later. Patient was diagnosed with brain and lung cancer. patient experienced Covid vaccine related issues flu like symptoms, she got very sick following the booster dose. On 19 Jan 2022, she experienced mild hyperthyroidism and it was low, was 0.14. Ultrasound left lung done as on 10-Feb-2022, reports not available. The Clinical course, other investigations, treatment details were not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.