Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Follicular cystitis, Headache, Pericardial effusion, Red blood cell count, Red blood cell count decreased
Clinical narrative: Back pain; Crohn's disease flare up during covid-19 vaccination; Ear infection and though that it was due to allergies/Ear infection swollen outside of ear; Headache; Urinary tract infection four times after COVID-19 vaccination; Chronic follicular cystitis; Fluid on heart; Red blood cell decreased; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FOLLICULAR CYSTITIS (Chronic follicular cystitis), CROHN'S DISEASE (Crohn's disease flare up during covid-19 vaccination), PERICARDIAL EFFUSION (Fluid on heart) and URINARY TRACT INFECTION (Urinary tract infection four times after COVID-19 vaccination) in a 65-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.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 01-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection four times after COVID-19 vaccination) (seriousness criterion medically significant). On 01-Jun-2021, the patient experienced EAR INFECTION (Ear infection and though that it was due to allergies/Ear infection swollen outside of ear) and HEADACHE (Headache). In 2021, the patient experienced FOLLICULAR CYSTITIS (Chronic follicular cystitis) (seriousness criterion medically significant), PERICARDIAL EFFUSION (Fluid on heart) (seriousness criterion medically significant), RED BLOOD CELL COUNT DECREASED (Red blood cell decreased) and DIARRHOEA (Diarrhea). On 18-Nov-2021, the patient experienced CROHN'S DISEASE (Crohn's disease flare up during covid-19 vaccination) (seriousness criterion medically significant). On 20-Dec-2021, the patient experienced BACK PAIN (Back pain). In 2021, EAR INFECTION (Ear infection and though that it was due to allergies/Ear infection swollen outside of ear) and HEADACHE (Headache) had resolved. In November 2021, CROHN'S DISEASE (Crohn's disease flare up during covid-19 vaccination) had resolved. At the time of the report, FOLLICULAR CYSTITIS (Chronic follicular cystitis) was resolving, PERICARDIAL EFFUSION (Fluid on heart) and DIARRHOEA (Diarrhea) had not resolved and URINARY TRACT INFECTION (Urinary tract infection four times after COVID-19 vaccination), BACK PAIN (Back pain) and RED BLOOD CELL COUNT DECREASED (Red blood cell decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Colonoscopy: Result : Unknow. On an unknown date, Red blood cell count: Decreased.      Company comment : This spontaneous case concerns a 65-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of Chronic follicular cystitis, Pericardial effusion, and Crohn's disease aggravated in association with a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the events chronic follicular cystitis and pericardial effusion relative to vaccination cannot be determined with unknown events' onset dates. Event Crohn's disease aggravated occurred approximately 7 months after receiving a 2nd dose of mRNA-1273 vaccine. Patient had 4 episodes of urinary tract infection 29 days after vaccination. Event chronic follicular cystitis may have presented with urinary incontinence. Diagnostics reported were colonoscopy without results and a decreased red blood cell count. Outcome of the event pericardial effusion was reported as not resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Reportedly, an event of ear infection occurred after each dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's age and gender could predispose her to urinary tract infection and cystitis. Her underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Her ear infection was swollen outside of the ear, and she took antibiotics for it. She had a colonoscopy done for esophagus on 01-Jun-2021 and no results provided.  Primary reporter did not have the lot number information, because the packaging was discarded. Concomitant product provided as Magic mouthwash with unknown indication.   On 01 Sep 2021, she had a fall and broke her wrist and injured her back, last vertebrae L1 lower back compressed disc and bruised chin  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.     Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Significant follow-up appended(Seriousness criteria,1st dose date, event updated) On 02-Mar-2022: Significant follow-up: Event updated and Event deleted, Current condition added, Lab data added.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with a concurrent condition of Crohn's disease treated with adalimumab, who experienced the unexpected, medically significant events of Chronic follicular cystitis, Pericardial effusion, and Crohn's disease aggravated in association with a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the events chronic follicular cystitis and pericardial effusion relative to vaccination cannot be determined with unknown events' onset dates. Event Crohn's disease aggravated occurred approximately 7 months after receiving a 2nd dose of mRNA-1273 vaccine. Patient had 4 episodes of urinary tract infection 29 days after vaccination. Event chronic follicular cystitis may have presented with urinary incontinence. Diagnostics reported were colonoscopy without results and a decreased red blood cell count. Outcome of the event pericardial effusion was reported as not resolved. Vaccination history included a 2-dose primary series of mRNA-1273 vaccine, given 28 days apart. Reportedly, an event of ear infection occurred after each dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's age and gender could predispose her to urinary tract infection and cystitis. Her underlying Crohn's disease and treatment with adalimumab remain as confounders in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement.