Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal hernia, Chills, Immunodeficiency, Infection, Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TUBERCULOSIS (Tuberculosis) and IMMUNODEFICIENCY (Immunocompromised) in a 55-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. The patient's past medical history included COVID-19 in June 2020, Vaccination adverse reaction on 15-Jul-2021, Hernia (got infected inside and outside that gave this hernia), Infection (got infected inside and outside that gave this hernia), Abdominal operation on 30-Dec-2020 and Hernia repair (Hernia surgery) in December 2020. Concurrent medical conditions included Plaque psoriasis. On 15-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Dec-2020, the patient experienced ABDOMINAL HERNIA (Abdominal hernia). In September 2021, the patient experienced PAIN (Generalized aching), PALPITATIONS (heart palpitation), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced TUBERCULOSIS (Tuberculosis) (seriousness criterion medically significant), IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant), POST PROCEDURAL INFECTION (Post procedural infection), INFECTION (Infection), MALAISE (ill feeling) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, TUBERCULOSIS (Tuberculosis), IMMUNODEFICIENCY (Immunocompromised), POST PROCEDURAL INFECTION (Post procedural infection) and MALAISE (ill feeling) had resolved, PAIN (Generalized aching), PALPITATIONS (heart palpitation), INFECTION (Infection), PYREXIA (Fever), CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and ABDOMINAL HERNIA (Abdominal hernia) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: (Positive) covid-19. The patient's immune system was compromised. In Sep-2021 on vaccination fever, chills, body aches was reported and also heart palpitation was reported for two months. 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 55-year-old female patient, with relevant medical conditions of plaque psoriasis, who experienced the unexpected and serious (due to medically significant) events of Tuberculosis and Immunodeficiency, which occurred related to mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Co-suspect products included non-company product Adalimumab for plaque psoriasis, and Pfizer vaccine against COVID-19. No information disclosed regarding diagnostic tests performed or treatments received. Underlying condition of plaque psoriasis remains a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Significant follow up appended: Event, dose, onset date updated. On 17-Dec-2021: Significant Live Follow-up appended: New events updated. On 08-Mar-2022: Significant Live follow up appended: history, event updated. Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 55-year-old female patient, with relevant medical conditions of plaque psoriasis, who experienced the unexpected and serious (due to medically significant) events of Tuberculosis and Immunodeficiency, which occurred related to mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Co-suspect products included non-company product Adalimumab for plaque psoriasis, and Pfizer vaccine against COVID-19. No information disclosed regarding diagnostic tests performed or treatments received. Underlying condition of plaque psoriasis remains a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.