Symptomtext
Fever with chills; Clenched teeth; Neck and back pain; Neck and back pain; shaking; psychosomatic versus allergic reaction; psychosomatic versus allergic reaction; This is a spontaneous report received from contactable reporter (Nurse) from medical information team. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 23Jun2022 as dose number unknown, 0.5 ml single (Lot number: ER2622, Expiration Date: 31Jan2024) at the age of 16 years, in right deltoid for immunization; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 23Jun2022 as dose number unknown, 0.5ml single (Lot number: U7299AC, Expiration Date: 04Aug2024), in left deltoid for immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRUXISM (medically significant) with onset 23Jun2022, outcome "recovering", described as "Clenched teeth"; PYREXIA (medically significant) with onset 23Jun2022, outcome "recovering", described as "Fever with chills"; NECK PAIN (medically significant), BACK PAIN (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "Neck and back pain"; SOMATIC SYMPTOM DISORDER (medically significant), HYPERSENSITIVITY (medically significant) all with onset 23Jun2022, outcome "recovering" and all described as "psychosomatic versus allergic reaction"; TREMOR (medically significant) with onset 23Jun2022, outcome "recovering", described as "shaking". The events "fever with chills", "clenched teeth", "neck and back pain", "shaking" and "psychosomatic versus allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of pyrexia, bruxism, neck pain, back pain, tremor, somatic symptom disorder, hypersensitivity which included Benadryl. They have a patient who was administered Trumenba and Menquadfi to yesterday. Two (2) and a half hours after receiving the vaccines the patient complained of severe neck and back pain, fever, clenched teeth and chills and shaking. So the patient went to the Emergency Room and was given Benadryl and all symptoms seem to resolve. She said the Emergency Room called this a psychosomatic versus allergic reaction.; Sender's Comments: There is a reasonable possibility that the events pyrexia and hypersensitivity were related to TRUMENBA based on known drug safety profile and close temporal relationship. Based on the close temporal relationship, the association between the other events 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.
