Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| EBZR | EBOLA ZAIRE (ERVEBO) | MERCK & CO. INC. | 4 | LP4946 | IM / RL |
| EBZR | EBOLA ZAIRE (ERVEBO) | MERCK & CO. INC. | 4 | LP4946 | OT / RL |
INFLUENZA A VIRUS TEST NEGATIVE; INFLUENZA B VIRUS TEST NEGATIVE; INJECTION SITE SCAB; HYPOPHAGIA; RESPIRATORY SYNCYTIAL VIRUS TEST NEGATIVE; SARS-COV-2 TEST NEGATIVE; FEELING HOT; PYREXIA; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; IRRITABILITY; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency # 2844349-1) on 20-Aug-2025. This spontaneous report refers to a 1.25-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-Jun-2025, the patient was vaccinated with the forth dose of Ebola Zaire Vaccine (rVSV delta G-ZEBOV-GP, live) (ERVEBO), lot # "LP4946" is an invalid lot 3 for Ebola Zaire Vaccine, dose number 4, administered by Intramuscular route in Right Thigh (expiration date was not reported), administered as prophylaxis. Few hours after the vaccine was given on 04-Jun-2025, the patient's parents noted fussiness. The patient was fussy, he felt warm and had a temp 102-104 (units not provided) by temporal thermometer. Patient got a bath and ibuprofen (MOTRIN). His right thigh was red and swollen and tender the evening of 04-Jun-2025. On an unspecified date in June 2025, the patient was irritable. On 05-Jun-2025, the patient was seen in the office visit at approximately 3:30 pm and patient was walking, had decreased oral intake that day, no rash and seemed to be improving. Site coloration was bluish red; minimally tender over of 2cmx1cm on right lateral thigh with central 1-mm diameter scab. This overlies firm muscle of about 4x3cm. He has "FROM" and walked well, no bleeding, no other rash. Parent did take patient to the Emergency room (ER) on 05-Jun-2025 approximately at 9 pm for complaint of a fever. During the ER the patient received acetaminophen and patient responded and was discharged. On 05-Jun-2025, Influenza A virus test, Influenza B virus test, Respiratory Syncytial Virus (RSV) test and SARS-COV-2 TEST were performed and showed Negative results. At the reporting time, the outcome of influenza A virus test negative, influenza B virus test negative, injection site scab, injection site pain, hypophagia, respiratory syncytial virus test negative, pyrexia, injection site erythema, feeling hot, SARS-COV-2 test negative and irritability was unknown. The causal relationship between the events of influenza A virus test negative, influenza B virus test negative, injection site scab, injection site pain, hypophagia, respiratory syncytial virus test negative, pyrexia, injection site erythema, feeling hot, SARS-COV-2 test negative and irritability with Ebola Zaire Vaccine (rVSV delta G-ZEBOV-GP, live) (ERVEBO) was unknown not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-08-20 , number : , number : , number : , number : 2844349 , date : 2025-08-20 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
Test Date: 20250605; Test Name: Influenza A virus test; Test Result: Negative ; Test Date: 20250605; Test Name: Influenza B virus test; Test Result: Negative ; Test Date: 20250605; Test Name: RSV test; Test Result: Negative ; Test Date: 20250605; Test Name: SARS-COV-2 TEST; Test Result: Negative