Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | — | — |
he went to the gastro and he has holes/he had bacteria in his intestines; tinnitus/The ringing in his ears and the bells in his ears are getting worse; headaches are getting worse; he lost 30 pounds in 30 days. He states he continues to lose weight; he went to the gastro and he has holes/he had bacteria in his intestines; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cluster headache in 2006 and Traumatic brain injury in 1973. Concurrent medical conditions included Hypothyroidism (inactive thyroid) and Disability (Patient was a disabled). On 11-Aug-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines) (seriousness criterion medically significant), TINNITUS (tinnitus/The ringing in his ears and the bells in his ears are getting worse), HEADACHE (headaches are getting worse), WEIGHT DECREASED (he lost 30 pounds in 30 days. He states he continues to lose weight) and GASTROINTESTINAL BACTERIAL INFECTION (he went to the gastro and he has holes/he had bacteria in his intestines). At the time of the report, GASTROINTESTINAL PERFORATION (he went to the gastro and he has holes/he had bacteria in his intestines), TINNITUS (tinnitus/The ringing in his ears and the bells in his ears are getting worse), HEADACHE (headaches are getting worse) and WEIGHT DECREASED (he lost 30 pounds in 30 days. He states he continues to lose weight) had not resolved and GASTROINTESTINAL BACTERIAL INFECTION (he went to the gastro and he has holes/he had bacteria in his intestines) had resolved. No Concomitant medications provided by the reporter. Suspect product batch number was mentioned as: 017822A or 017B22A. Patient experienced symptom of tinnitus from last two and half year. It was reported that from last 4 months patient experienced worse headache. Patient stated that he was 148 pounds and then he lost 30 pounds in 30 days. He continued to lose weight. He went down to 104 pounds. He stated that he cannot get above 111-112 pounds. Patient went to a boot camp 129 pounds and came out with 165. Patient was stated that he should be the hulk by now, as he ate more carbs. He stated that he went to visit with gastroenterologist, and he had holes that he did not know he had. It was found that patient had bacteria in his intestines and patient took an unspecified treatment medication pill for the Gastrointestinal bacterial infection and the symptom was gone within 7 days. Patient was reported that the only time he did not hear it (ringing in his ears) and the only time he did not feel his headaches was when he went to sleep and when he wakes up, the symptom of ringing in his ears and headache was started for patient. Patient went through CTs, brain scans, MRI's, ultrasounds, thyroid infusion test, blood work, stool samples. But no lab data was available. Patient reported that his concern was related with body weight from last 2.5 years.; Reporter's Comments: Company comment. Etiology of the gastrointestinal perforation (probably based on Helico bacter pylori infection) and lack of information about the date of diagnosis did not confirm positive relationship between gastrointestinal perforation and gastrointestinal infection and vaccination thusevents are assessed as not related. Weight decrease is assessed as not related as it can be related to GI infection. The other events of headache, tinnitus are assessed as related. The benefit-risk relationship of product is not affected by this report.
Disability (Patient was a disabled); Hypothyroidism (inactive thyroid)
Medical History/Concurrent Conditions: Cluster headache; Traumatic brain injury