Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Burning sensation, Muscle spasms, Pain in extremity, Sciatica
Clinical narrative: back spasms (mainly in his upper back between the shoulder blades); left sciatic pain; a burning pain down his left leg; He almost looks like he is hiccupping where he is getting spasms; He almost looks like he is hiccupping where he is getting spasms; burning sensation; This is a spontaneous report received from a Physician from medical information team.  A 16-year-old male patient received meningococcal group abcwy vaccine (PENBRAYA), on 31Oct2024 as dose number unknown (booster), 0.5 ml single (Lot number: LJ0077, Expiration Date: 28Feb2026) at the age of 16 years, in left deltoid for immunisation. The patient's relevant medical history included: "Nose bleeds" (unspecified if ongoing); "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HICCUPS (medically significant), MUSCLE SPASMS (medically significant) all with onset 31Oct2024, outcome "not recovered" and all described as "He almost looks like he is hiccupping where he is getting spasms"; PAIN IN EXTREMITY (medically significant) with onset 31Oct2024, outcome "not recovered", described as "a burning pain down his left leg"; MUSCLE SPASMS (medically significant) with onset 31Oct2024, outcome "not recovered", described as "back spasms (mainly in his upper back between the shoulder blades)"; BURNING SENSATION (medically significant) with onset 31Oct2024, outcome "not recovered"; SCIATICA (medically significant) with onset 31Oct2024, outcome "not recovered", described as "left sciatic pain". The pediatrician stated, "Patient was due for booster meningitis quadrivalent vaccine, to keep up with vaccine schedule. The patient was given an injection of Penbraya in the left deltoid muscle. When the patient got home, which was about half an hour later after the injection on the same day 31Oct2024, he developed back spasms (mainly in his upper back between the shoulder blades) and left sciatic pain, a burning pain down his left leg. He had a physical exam and the physician made him touch his toes; the reporter didn't know if he has a spasm from that.  The reporter physician just did a video visit with him and it's not like it is a specific spasm.  He almost looks like he was hiccupping where he was getting spasms.  The reporter personally didn't think it is a reaction to Penbraya but since it happened after he got it."  Clarified, caller was the primary provider, who prescribed this product to patient. The reporter would say it was pretty serious, was having a pretty hard time even associating it with the Pembraya, other than the fact that it occurred after he got it, it just does not make sense. Outcome of event: Clarified, patient still experiencing this because, he just had video appointment with patient about 40 minutes ago on 31Oct2024, he was sitting there, not having spasms but, does not know how to explain, his back, sitting there, was almost like a big hiccup not a hiccup, because of the pain, the spasms, between the shoulder blades, with intermittent burning sensation, going down his left leg. Test results: Patient had exam this morning, was completely normal. On video, did not get chance to examine patient's leg or anything like that because, it was by video. Patient could not get back to the office. Causality: Not convinced this was caused by the Pembraya, the reporter did not know. The patient underwent the following laboratory tests and procedures: Physical exam/exam: (31Oct2024) Normal, notes: He had a physical exam and physician made him touch his toes; physician didn't know if he has a spasm from that.; Sender's Comments: A possibly contributory role of PENBRAYA in triggering the onset of all reported events cannot be fully excluded, considering the close temporal relationship.  More investigations regarding the alternative etiologies are needed for fully medical assessment.  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.