Sex: F
Vaccine: MENB
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Chest discomfort, Chest pain, Choking sensation
Clinical narrative: inflammation; lightheaded/dizzy; there was a double temperature excursion on the vaccine/patient recieved; there was a double temperature excursion on the vaccine/patient recieved; numbness in her arms, that progress to all 4 limbs; choking; severe pressure in chest/ intense pressure on the chest; fainted/required her rescue inhaler atleast twice during these episodes and that is when she fainted; intense sharp pain, at level 10/ her pain level is now at a 7; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported on behalf of another Other-HCP . A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot Number: X46476, Expiry date: 30Apr2020) intramuscular in right deltoid on 16Aug2019 at 0.5 ml single dose for immunization at a health fair for back to school. Medical history included asthma chronic prevention inhaler. Ongoing concomitant medications included mometasone furoate (ASMANEX) (started before 22Sep2016), fluticasone propionate (PROAIR) (noticed in 2016 already started). On 16Aug2019 a physical was did on her. The patient experienced severe pressure in chest, like she was choking, it was intense sharp pain, at level 10 on 16Aug2019. From what she read at the time, if the pressure was blood vessles constricting then this was angina. She required her rescue inhaler at least twice during these episodes and that was when she fainted on 16Aug2019. She had numbness in her arms on 17Aug2019, that progress to all 4 limbs on 03Sep2019. The biggest things with her complaint was the intense pressure on the chest, she has been in the office for the intense chest pressure for follow up. The patient did go to the Emergency Room but was not admitted into the hospital. If she kept having this then would refer her to cardiology for echocardiogram, they did do electrocardiogram (EKG) and it came out to normal and prescribed her prednisone to help with inflammation. It was also reported that there was a double temperature excursion on the vaccine, it went to highest point of 56.3 degrees Fahrenheit and above range for 7 hours, they were simultaneous, with another at 13 hours and 55mins at 32.7 degrees Fahrenheit. Her pain level was now at a 7. The patient still got lightheaded and dizzy as of 09Sep2019. All tests were done on 04Sep2019, EKG, C-reactive Protein, Creatinine Kinase, CBC/CMP, and red blood cell sedimentation rate all resulting in normal. The events "sharp pain at level 10", "numbness in her arms/progress to all 4 limbs" were considered serious as medically significant, the event "fainted/required an rescue inhaler" was considered serious as life threatening. The outcome of event "fainted" was recovered on 16Sep2019, outcome of "pain", "severe pressure in chest/ intense pressure on the chest" was recovering, outcome of "numbness in her arms, that progress to all 4 limbs" was not recovered, the outcome of rest events was unknown.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.