Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Pain in extremity, Strangulated hernia
Clinical narrative: Hernia strangulated; Lethargic; Tiredness; Pain of extremities; Headache; This spontaneous case was reported by a consumer and describes the occurrence of STRANGULATED HERNIA (Hernia strangulated) in an 84-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) for Rheumatoid arthritis and TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    The patient's past medical history included Automobile accident in 2019, Alcohol use (occasional glass of wine/margarita twice a month), Appendicitis, Multiple fractures, Methicillin-resistant Staphylococcus aureus infection in 2019, Non-tobacco user, Gallbladder removal, Total knee replacement, Open reduction of fracture with internal fixation (Femur stabilization), Hysterectomy in 1965 and Oophorectomy in 1965. Concurrent medical conditions included Penicillin allergy (penicillin allergy manifestated by hives), Sulfonamide allergy (sulfa drugs allergy), Asthma, Incontinence, Rheumatoid arthritis, Atrial fibrillation, Nerve damage and Clostridium difficile infection in 2019. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM MUPS [ESOMEPRAZOLE MAGNESIUM]) and CIMETIDINE for Acid reflux (esophageal), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA [TIOTROPIUM BROMIDE MONOHYDRATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, RIVAROXABAN (XARELTO) and BIFIDOBACTERIUM ANIMALIS, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS BIFIDUS) for Atrial fibrillation, ETIZOLAM for Heart rate abnormal, MIRABEGRON (MYRBETRIQ) for Incontinence, CYCLOBENZAPRINE for Muscle relaxant, GABAPENTIN for Nerve damage, METHOTREXATE for Rheumatoid arthritis, PREDNISONE, IRON, CALCIUM and FOLIC ACID for an unknown indication.   In 2010, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 TOFACITINIB CITRATE (XELJANZ) (unknown route) at an unspecified dose. In May 2021, the patient experienced STRANGULATED HERNIA (Hernia strangulated) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LETHARGY (Lethargic), FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain of extremities) and HEADACHE (Headache). At the time of the report, STRANGULATED HERNIA (Hernia strangulated) was resolving and LETHARGY (Lethargic), FATIGUE (Tiredness), PAIN IN EXTREMITY (Pain of extremities) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Whole body scan: Confirmed that patient had strangulated Hernia and was in need of surgery stat..         Patient had other concomitants included multivitamins. No treatment medication reported by reporter.  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 concerning an 84-year-old female patient, with medical history of uterus and ovary removal, appendicitis and gallbladder removal, who was hospitalized due to the unexpected, serious (medically significant) event of Strangulated hernia, approximately 2 months after receiving the second dose of mRNA-1273 vaccine. Body scan confirmed that the patient had strangulated hernia and underwent emergency intestinal surgery. The patient was hospitalized for three to four days. Medical history of uterus and ovary removal, appendicitis and gallbladder removal remain as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 84-year-old female patient, with medical history of uterus and ovary removal, appendicitis and gallbladder removal, who was hospitalized due to the unexpected, serious (medically significant) event of Strangulated hernia, approximately 2 months after receiving the second dose of mRNA-1273 vaccine. Body scan confirmed that the patient had strangulated hernia and underwent emergency intestinal surgery. The patient was hospitalized for three to four days. Medical history of uterus and ovary removal, appendicitis and gallbladder removal remain as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.