Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram abdomen, Cough, Discomfort, Electrocardiogram, Hypersensitivity
Clinical narrative: Rupture spleen/Internal bleeding/Pain/Sickness/Gastrointestinal discomfort; Allergy; Discomfort; Cough; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC RUPTURE (Rupture spleen/Internal bleeding/Pain/Sickness/Gastrointestinal discomfort) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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.    The patient's past medical history included Neck injury in 2004, Hysterectomy in 2000 and Augmentation mammoplasty in April 2005. Previously administered products included for Drug use for unknown indication: VICODIN, TETRACYCLINE, MELOXICAM, TETRACYCLINE, MELOXICAM and TETRACYCLINE. Past adverse reactions to the above products included Blisters with TETRACYCLINE; Hives with MELOXICAM; Itch with TETRACYCLINE and VICODIN; Itching with MELOXICAM; and Ulcer with TETRACYCLINE. Concurrent medical conditions included Non-tobacco user, Rheumatoid arthritis, Acid reflux (oesophageal), Chronic obstructive pulmonary disease and Obesity (BMI of 45.732). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Chronic obstructive pulmonary disease, FOLIC ACID, SULFASALAZINE and METHOTREXATE for Rheumatoid arthritis.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 05-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced SPLENIC RUPTURE (Rupture spleen/Internal bleeding/Pain/Sickness/Gastrointestinal discomfort) (seriousness criteria hospitalization and medically significant). In May 2022, the patient experienced COUGH (Cough). On 13-Jul-2022, the patient experienced DISCOMFORT (Discomfort). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy). The patient was hospitalized from 10-Jun-2021 to 14-Jun-2021 due to SPLENIC RUPTURE. The patient was treated with BACLOFEN at an unspecified dose and frequency; CELECOXIB (CELEBREX) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, SPLENIC RUPTURE (Rupture spleen/Internal bleeding/Pain/Sickness/Gastrointestinal discomfort), DISCOMFORT (Discomfort) and HYPERSENSITIVITY (Allergy) outcome was unknown and COUGH (Cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2021, Computerised tomogram abdomen: Spleen ruptured. In June 2021, Electrocardiogram: Not provided.         Patient was non-alcoholic.  On unknown date, the patient experienced HUMIRA HELPED WITH ALLERGIES and ALLERGIES. On 09-Jun-2021, the patient experienced INTERNAL BLEEDING, PAIN, GOT SICK and DISCOMFORT IN DIGESTIVE SYSTEM. On 10-Jun-2021, the patient experienced RUPTURED SPLEEN. In May-2022, the patient experienced BAD COUGH. On 13 Jul 2022, the patient experienced DISCOMFORT. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  On 10 Jun 2021, midnight when patient felt excruciating pain which was relieved by self-medication. From 10-Jun-2021 to 14-Jun-2021, after the second dose of COVID vaccine patient went to emergency room and hospitalized for 5 days for ruptured spleen, and for internal bleeding. Patient did not undergo any surgery for the ruptured spleen. Patient was continuously monitoring blood and had an appointment with a cancer doctor. Patient was feeling a sick after had vaccine. Humira was related to the reported adverse events because it was discontinued. On 13-Jul-2022, patient had some discomfort as the weather was a little cloudy. On May-2022 patient thought she had COVID but it was something else and had bad cough which was about for 10 weeks. Since patient was on the HUMIRA, it helped her with allergies.  Company Comment This spontaneous case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (hospitalization and medically significant) event of Splenic rupture on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Following vaccination, patient felt sick and experienced abdominal pain and discomfort that became excruciating the next day prompting emergency room visit where an abdominal computed tomography scan revealed a ruptured spleen along with an electrocardiogram with undisclosed result.  Patient was admitted for 5 days and underwent non-surgical management of the ruptured spleen and internal bleeding by continuous monitoring of hematologic status and treatment with Ondansetron among other medications. An oncology consultation was done with no further details provided. Patient previously received mRNA-1273 vaccine as the first dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (hospitalization and medically significant) event of Splenic rupture on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Following vaccination, patient felt sick and experienced abdominal pain and discomfort that became excruciating the next day prompting emergency room visit where an abdominal computed tomography scan revealed a ruptured spleen along with an electrocardiogram with undisclosed result.  Patient was admitted for 5 days and underwent non-surgical management of the ruptured spleen and internal bleeding by continuous monitoring of hematologic status and treatment with Ondansetron among other medications. An oncology consultation was done with no further details provided. Patient previously received mRNA-1273 vaccine as the first dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.