Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Computerised tomogram head normal, Dizziness, Headache, Hyperhidrosis
Clinical narrative: fainted; sweating/Diaphoresis; have pain in the lower back of the head and back of his neck; have pain in the lower back of the head and back of his neck; generalized weakness; dizziness; shaking; blood pressure was a little low at 91/51; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 04Apr2022 as dose 1, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), on 04Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization) with onset 04Apr2022, outcome "recovering"; ASTHENIA (hospitalization) with onset 04Apr2022, outcome "recovering", described as "generalized weakness"; HEADACHE (hospitalization), NECK PAIN (hospitalization) all with onset 04Apr2022, outcome "recovering" and all described as "have pain in the lower back of the head and back of his neck"; TREMOR (hospitalization) with onset 04Apr2022, outcome "recovering", described as "shaking"; HYPERHIDROSIS (hospitalization) with onset 04Apr2022, outcome "recovering", described as "sweating/Diaphoresis"; SYNCOPE (hospitalization, medically significant), outcome "recovering", described as "fainted"; HYPOTENSION (medically significant), outcome "recovering", described as "blood pressure was a little low at 91/51". The events "sweating/diaphoresis", "have pain in the lower back of the head and back of his neck", "generalized weakness", "dizziness" and "shaking" required emergency room visit. Therapeutic measures were taken as a result of syncope, hyperhidrosis, headache, neck pain, asthenia, dizziness, tremor, hypotension. Clinical course: The patient received his first dose of Trumenba, as well as Menactra on 04Apr2022. Trumenba and Menactra are routinely given together. He had a well visit at 1pm and did not immediately have any issues and was fine when he left the office. His mother reported he had nothing to eat or drink prior to his 1pm appointment. Forty-five minutes later he went to withheld with a parent and he began to have pain in the lower back of the head and back of his neck, generalized weakness, dizziness, shaking, and sweating/diaphoresis. They called 911 and he had to go to the ER. There his blood pressure was a little low at 91/51. He was given two liters of normal saline and the IV medications administered were benadryl, toradol and reglan. He had a CT scan of the brain which came back normal. Then when he was getting up to leave he again got weak, experienced dizziness, and sweating and then fainted. He was admitted overnight for IV fluids. While admitted he had a cardiology and neurology consult. Overnight he continued to improve, he had a heart echo done, he had no symptoms and was discharged the next day.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event syncope and headache were related to TRUMENBA use based on known drug safety profile. Based on the close temporal relationship, the association between the events hyperhidrosis, neck pain, asthenia, dizziness, and tremor with TRUMENBA can not be fully excluded. The association between the event hypotension with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.