status migrainosus; A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MENABCWY IN HEALTHY PARTICIPANTS 10 TO 26 YEARS OF AGE   This is a report from a Pfizer.  A 16-year-old female patient received first dose of blinded study vaccine (PF-06886992;RLP2086;PLACEBO) on 19Aug2020 at 10:55 via intramuscular route administered in left deltoid and in right deltoid, and second dose on 16Feb2021 at 10:08 via intramuscular route administered in left deltoid, as single doses for meningococcal disease. The patient also received suspect concomitant product tozinameran (BNT162B2) via intramuscular route, dose 1 on 16Apr2021 (lot no. EW0158, expiry date: 31Jul2021) and dose 2 on 06May2021 (lot no. EW0175, expiry date: 31Aug2021), both as single doses for COVID-19 immunization (reported as COVID-19 prevention). Ongoing medical history included migraine without aura from Jan2020, attention deficit disorder from 22Jul2020, and dyslexia from 2014. There was no family medical history relevant to the adverse event, concomitant vaccines, and prior vaccinations (within 4 weeks).  The patient experienced status migrainosus on 20Apr2021 which required emergency room visit, physician office and hospitalization for 2 days. The clinical course was as follows: Patient had a history of migraines without aura which started in Jan2020, prior to her enrollment in study. Patient indicated she was seen "2 or 3 times" at urgent care leading up to the hospitalization. Per mom, patient had migraines 1-2 per week. But the clinic only had record of her being seen on 22Apr2021. Patient recently discontinued prophylactic medication rizatriptan 10 mg po PRN, on 20Apr2021 switched from topiramate 100 mg po daily to zonisamide 100 mg po daily. Patient confirmed she was taking home meds in days leading up to hospitalization. Patient had recently switched birth control from medroxyprogesterone acetate (DEPO-PROVERA) (last given 21Apr2021) to OCP (ethinylestradiol/levonorgestrel (AVIANE) 0.1-20 mcg/mog po daily first dose 13May2021), also had her first period in a while due to the medroxyprogesterone acetate which started on 20Apr2021. She had onset of migraine 20Apr2021 that persisted despite multiple treatment attempts, so her neurologist recommended admission to inpatient unit on 23Apr2021. On arrival she rated her headache at 7-8 out of 10, stated it was behind her eyes and constant. Because she had taken oral rizatriptan in the evening of 23Apr2021, she was unable to start dihydroergotamine mesilate (DHE) so she received an infusion of Depakote with only minimal improvement. She received the following medications: Ketorolac 30 mg IM, promethazine 25 mg IM, Diphenhydramine HCl 25 mg IM. This was in addition to her routine home medications: Rizatriptan 10 mg po PRN and Zonisamide 100 mg po daily. She was started on dihydroergotamine mesilate on 24Apr2021 which relieved her headache, and she was discharged home on 25Apr2021. This event was reported to site on 31Aug2021 during the phone call required for Visit 5. The action taken in response to the event for the blinded study vaccine was not applicable. The outcome of event was recovered on 25Apr2021.   The investigator considered there was not a reasonable possibility that the event was related to blinded study vaccine or clinical trial procedure but related to concomitant product BNT162B2. PI felt she could not rule out relationship to COVID-19 vaccine due to the timing of when subject got injection and onset of headaches (within 4 days).    Follow-up (22Dec2021): This is a Pfizer follow-up report. Updated information: SAE term updated from chronic migraine without aura, with status migrainosus to status migrainosus, blinded study vaccine indication and suspect concomitant information.  Follow-up (01Apr2022): This is a Pfizer Sponsored follow-up report. Updated information: medications that patient taken (Ketorolac, promethazine, Diphenhydramine HCl).  Follow up (26Aug2022) The blind was broken by the Company at the end of the study. The patient was found to be treated with Meningococcal Group B RPL2086.; Sender's Comments: The company reasonably does not attribute the case to blinded study vaccine, concomitant vaccine or clinical trial procedure based on the known adverse event profile of the suspect product, on the lack of a plausible pathophysiological mechanism for the event and on the 2 months latency.