Received Aug 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 2 | LX2636 | OT / RA |
neck pain; done pale; vomiting 7 to 8 times/ Went home and then got vomited two hours later one time and then in the evening one time; bad headache/ severe headache; This is a spontaneous report received from a Physician and a Consumer or other non HCP from medical information team. A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 28Jul2025 as dose 2, 0.5 ml single (Lot number: LX2636, Expiration Date: 31Jan2027) intramuscular, in right deltoid for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Sulfur, reaction(s): "allergic to Sulfur". Vaccination history included: Trumenba (DOSE 1, SINGLE), administration date: 2024, for immunization. The following information was reported: HEADACHE (non-serious) with onset Jul2025, 1 hr after the suspect product(s) administration, outcome "recovered" (Jul2025), described as "bad headache/ severe headache"; PALLOR (non-serious) with onset Jul2025, 1 hr after the suspect product(s) administration, outcome "recovered" (Jul2025), described as "done pale"; NECK PAIN (non-serious) with onset Jul2025, 1 hr after the suspect product(s) administration, outcome "recovered" (Jul2025); VOMITING (non-serious) with onset Jul2025, 1 hr after the suspect product(s) administration, outcome "recovered" (Jul2025), described as "vomiting 7 to 8 times/ Went home and then got vomited two hours later one time and then in the evening one time". The events "neck pain", "done pale", "vomiting 7 to 8 times/ went home and then got vomited two hours later one time and then in the evening one time" and "bad headache/ severe headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, pallor, vomiting, headache. Additional information: It was reported that the patient experienced severe headache, neck hurting and he started vomiting about seven-eight times, he vomited, he turned pale, and he came back to the office for 45 minutes and his vitals were and reporter made him lay down and observed him for a half hour, monitored his pulse oximeter and his oxygen, everything, he was back to normal, so reporter let him go home, reporter checked on him, two hours later, he vomited one time and then one time in the evening. He did not vomited, he slept pretty good quite a bit day before reporting day afternoon his mom says but he was back to normal and this was the second episode. He was not on any other medications. He had not been sick or had not any other vaccination in one month prior. His mom gave him Tylenol when he returned home after leaving their office. Reporter thought that it was due to Trumenba vaccine. After 1 year of first vaccination. Within first 10 minutes of medical observation, there was no reaction. One hour later, patient experienced severe headache, vomiting 8 times at mall; 2 times at home, was pale. So, this was his second dose, and he was, we watched him 10-15 minutes in the office to make sure that he was okay before they go and he left, after one hour, he called and start having a neck pain, headache, severe headache, vomited about 7 to 8 times, became pale. They came to the office, they observed him, made him lie down, monitor the blood pressure everything, got better, went home. He was back to normal.
Test Date: 202507; Test Name: blood pressure; Result Unstructured Data: Test Result:everything, got better; Test Date: 202507; Test Name: pulse oximeter; Result Unstructured Data: Test Result:his oxygen, everything, he was back to normal; Test Date: 202507; Test Name: vitals; Result Unstructured Data: Test Result:unknown results