Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Depression, Diarrhoea, Ear discomfort, Hypoacusis
Clinical narrative: Urinary tract infection; Numbness in right hand; Weight loss; popping sound in ears; Swelling in arm due to COVID-19 vaccine; pain in left hip/issue with hip; Diarrhea; Difficulty hearing out of right ear; depression; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 74-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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to Severe Adult Crohn's Disease).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen, Citrate free. In March 2022, the patient experienced DEPRESSION (depression). On 13-Sep-2022, the patient experienced HYPOACUSIS (Difficulty hearing out of right ear). On 07-Mar-2023, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness in right hand), WEIGHT DECREASED (Weight loss), EAR DISCOMFORT (popping sound in ears), VACCINATION SITE SWELLING (Swelling in arm due to COVID-19 vaccine) and ARTHRALGIA (pain in left hip/issue with hip). The patient was hospitalized for 5 days due to URINARY TRACT INFECTION. The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, at an unspecified dose and frequency and Surgery (Right Hip replacement and Left Hip replacement) for Arthralgia. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), DEPRESSION (depression) and EAR DISCOMFORT (popping sound in ears) was resolving, HYPOAESTHESIA (Numbness in right hand) had not resolved and HYPOACUSIS (Difficulty hearing out of right ear), WEIGHT DECREASED (Weight loss), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling in arm due to COVID-19 vaccine) and ARTHRALGIA (pain in left hip/issue with hip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Lost 5 to 10 pounds and Lost 27 pounds. Concomitant medication of the patient was not reported.  MPID of Moderna COVID-19 vaccine was reported as 4782591.  The patient could not determine if HUMIRA was helpful as she had issues with her hip and that pain was in same area. On 24-Mar-2022, she had right hip replacement. She experienced pain in left hip and on September 2022, she underwent left hip replacement. She also had numbness in right hand and feeling was now returned since surgery ring and pinky finger still numb can felt them. For urinary tract infection, the patient was stayed in hospital for five days. She lost 27 pounds and again lost might be 5 to 10 pounds more since then, but she also had a lot of other conditions that could affect as well. She had diarrhea that she felt was due to something that she ate.  The reporter's causality for the event(s) of diarrhea, difficulty hearing out of right ear, numbness in right hand, popping sound in ears, swelling in arm due to COVID-19 vaccine, urinary tract infection, depression and pain in left hip/issue with hip with adalimumab solution for injection was not provided.  AbbVie's opinion was that the causality for the event(s) of urinary tract infection with adalimumab solution for injection was not assessable. AbbVie's opinion was that the causality for the event(s) of diarrhea, difficulty hearing out of right ear, numbness in right hand, popping sound in ears, swelling in arm due to COVID-19 vaccine, depression and pain in left hip/issue with hip with adalimumab solution for injection was no reasonable possibility.  Assessment Results for HUMIRA: Urinary tract infection: Market Authorization Holder (MAH), Global Introspection, Not assessable Urinary tract infection: Non-Health Care Professional, Global Introspection, Not Reported Depression: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Depression: Non-Health Care Professional, Global Introspection, Not Reported Diarrhea: Non-Health Care Professional, Global Introspection, Not Reported Diarrhea: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Ear popping sensation: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Ear popping sensation: Non-Health Care Professional, Global Introspection, Not Reported Hypoacusis unilateral: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Hypoacusis unilateral: Non-Health Care Professional, Global Introspection, Not Reported Numbness in hand: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Numbness in hand: Non-Health Care Professional, Global Introspection, Not Reported Pain in hip: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Pain in hip: Non-Health Care Professional, Global Introspection, Not Reported Vaccination site swelling: Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility Vaccination site swelling: Non-Health Care Professional, Global Introspection, Not Reported  Company Comment:  This is a Spontaneous case reported by a consumer, concerning a 74-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization) event of Urinary tract infection, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 74-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization) event of Urinary tract infection, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for Crohn´s disease. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.