Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
bile ducts Look totally inflamed.; 1 gall bladder attack; cough worsening; general malaise; nodules in the liver; fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGITIS (bile ducts Look totally inflamed.) and CHOLECYSTITIS ACUTE (1 gall bladder attack) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus (Lupus, diagnosed in 1989) since 1989, NASH (diagnosed 29 years ago) since 1996 and Cough (has always had cough). In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2024, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CHOLANGITIS (bile ducts Look totally inflamed.) (seriousness criterion medically significant), CHOLECYSTITIS ACUTE (1 gall bladder attack) (seriousness criterion medically significant), COUGH (cough worsening), MALAISE (general malaise), HEPATIC MASS (nodules in the liver) and PYREXIA (fever). At the time of the report, CHOLANGITIS (bile ducts Look totally inflamed.) and HEPATIC MASS (nodules in the liver) outcome was unknown, CHOLECYSTITIS ACUTE (1 gall bladder attack), COUGH (cough worsening) and COVID-19 (COVID-19) was resolving and MALAISE (general malaise) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2024, SARS-CoV-2 test: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication included as other monoclonal antibodies and antibody drug conjugates for lupus. Patient had gotten all Moderna Covid vaccines from 2020-2024. Had always had a cough. Since the vaccinations were offered in 2020, Patient had received all the vaccinations until last year. 2024 in the fall, doctor said, at this point it was probably October, get the flu shot now and got the RSV shot now, and then hold off on getting Covid. So held off and patient got the COVID, the disease. Patient received last Covid vaccine sometime in 2024, "it was 2024 And patient also got monoclonal antibodies besides getting the Moderna shot because patient have lupus. Patient contracted Covid in December 2024. It was reported to patient always had a cough. However, in December of 2024, went to urgent care (Medical Center) for the cough worsening and tested positive for Covid. It was reported that that cough lingered, lingered, lingered, lingered. It was still somewhat there, but patient always had a cough, so it was kind of hard to distinguish. Most of October patient has been feeling really well. also reported to always get sick following all Covid vaccines. "Patient did necessarily do really well with the vaccination. Patient usually sick for 2 or 3 days afterwards. Reported symptoms might be a fever. thought just general malaise, just all over. And then it went away, all those symptoms went away. Pre-existing NASH led to diagnosis of nodules in the liver. patient had an ongoing liver problem, and there were nodules on liver. It was also reported following 1 gall bladder attack, patient had an outpatient cholecystectomy in May 2025. Patient had to have gallbladder out, had one attack. So, patient saw the surgeon. Patient was told by the HCP, the gallbladder looks, diseased or whatever, but the bile ducts Looked totally inflamed. it was reported feeling fine from the gallbladder now. No specific treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790561 (E2B Linked Report). This case was linked to MOD-2025-790559 (Patient Link).; Reporter's Comments: Company comment: Causality for cholangitis, hepatic mass (liver nodule) and acute cholecystitis is assessed as not related considering patient's advanced age and underlying Lupus erythematosus and Metabolic dysfunction-associated steatohepatitis. Event of cough is assessed as not related as associated with COVID 19 infection. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790561:husband case
Cough (has always had cough); Lupus erythematosus (Lupus, diagnosed in 1989); NASH (diagnosed 29 years ago)
Test Date: 202412; Test Name: COVID; Test Result: Positive