Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | 2 | FL5302 | LA |
Dizziness while sitting; chest pain; shortness of breath; This is a spontaneous report received from a Physician. A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 23Apr2025 at 08:00 as dose 2, single (Lot number: FL5302) at the age of 17 years, in left arm for immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL (XR). Vaccination history included: Meningococcal vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Immunization. The following information was reported: DIZZINESS (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "Dizziness while sitting"; CHEST PAIN (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering"; DYSPNOEA (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "shortness of breath". Therapeutic measures were taken as a result of dizziness, chest pain, dyspnoea. Additional information: Vaccine was administered at Doctor's office/urgent care. Patient did not receive any other vaccines on the same date as the suspect vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the suspect vaccine. Patient was taking other medications within 2 weeks of the event starting. Dizziness while sitting, chest pain and shortness of breath 14 hours after having her well visit and Trumenba. Treatment received for the adverse event was IVF (intravenous fluid treatment) in the ER.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Dizziness, Dyspnoea, Chest pain and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Medical History/Concurrent Conditions: ADHD; Drug allergy
ADDERALL