Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: dizziness; sweating; a drop in blood pressure to 90/70.; received the 2nd dose of Trumenba on 02Apr2022; first dose 02Jul2021; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on [04Apr2022], this case now contains serious adverse reaction and all safety information were processed together.   This is a spontaneous report received from a contactable reporter (Physician) from medical information team. A 16-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 02Apr2022 as dose 2, 0.5 ml, single (Lot number: AT1920, Expiration Date: May2022) at the age of 16 years intramuscular, in left deltoid for immunization. It was mentioned that the patient was very nervous before the administration of the meningococcal group b Rlp2086. He was asking a lot of questions. When the physician mentioned about side effects, he was really scared of the needle, asking if the needle could cause pain. Concomitant medication included: MENACTRA intramuscular taken for immunization, on 25Mar2022 as dose 2, 0.5 ml, single. It was mentioned that the patient had no reaction to this product.Vaccination history included: Menactra (dose 1, lot # not provided), administration date: 2016, for Immunization and TRUMENBA (dose 1, lot#: AT1920, exp: May2022), administration date: 02Jul2021, when the patient was 15-year-old, for Immunization. Then, received the 2nd dose on 02Apr2022 as inappropriate schedule of vaccine administered. About 5 minutes after that dose was administered, patient had onset of some dizziness, he was sweating, and his blood pressure dropped to 90/70. Treatment of these events only included observation in office by this physician for about 30 minutes. The physician was about to send the patient to the emergency room and contacting the patients parents, but the patient advised that he was going to walk home. She advised patient that if at anytime he felt anything or different, he must go to the emergency room. She has not heard anything from him since he left the office on 02Apr2022. After that he was not complaining as much. His blood pressure gradually went back up to 110/80 before he left the office. The patient supposed to have follow-up visit with the physician at the time of the report. Seriousness criteria of all of these events captured as medically significant. The physician explained that events were a little significant but not that serious, not life threatening, and patient was not hospitalized relative to these events. The patient recovered from the events of dizziness, sweating, and blood pressure dropped on 02Apr2022.; Sender's Comments: Based on the close temporal relationship, the association between the events dizziness, sweating, and blood pressure dropped 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.