Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy, Malaise, Myalgia, Nausea, Night sweats
Clinical narrative: This is a spontaneous report from a contactable physician. A 19-year-old male patient received TRUMENBA on an unspecified date at 0.5 ml single. The patient had to get 3 doses. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced lab abnormalities (elevated AST, ALT and total bilirubin), nausea immediately after vaccination, severe headache, severe generalized body aches, weakness, malaise, feverish mist/ fever(ishness), shaking chills, night sweats, anorexia, injection, local reactions with an hour after vaccination, non-gas exudative pharyngitis/ tonsillopharyngitis (13 days after immunization), cervical lymphadenopathy (13 days after immunization), myalgias. Except from nausea and local reactions, the other events developed within a week from the injection. Serologic testing (performed 5 days after immunization) yielded positive result for EBV, VCA, lgM (VCA lgG, EA and EBNA: negative). The reporting physician saw the patient 8 days after getting the vaccine. Due to this lab result and belated development of non-GAS exudative pharyngitis and cervical lymphadenopathy, the physician considered that EBV/IM was responsible for abnormal LFTs and perhaps some of the other events. The physician, upon learning of positive VCA lgM result, prescribed a 5-day course of steroids (on 8th post-immunization day: prior to onset of tonsillopharyngitis and cervical lymphadenopathy, which developed 1 day after completion of steroids. Fever, chills, night sweats, headache, myalgias resolved on days 9-11 post-immunization, after initiation of steroids, and had not recurred after completion of steroids. The outcome of the other reported events was unknown. Follow-up (16Aug2016): This is a Follow-up Spontaneous report from a contactable physician. This physician reported via reportum in response to HCP letter sent that included: Adverse Events: Suspect products: TRUMENBA. Adverse events: No new adverse event. Patient Details: Is the patient also the reporter? No. Reporter Details: Is it ok for us to contact you should we have further questions about this report? Yes. What Happened: No new adverse event. Products: Suspect products: TRUMENBA. Is this a Pfizer product? Yes. Additional Context: The Physician mentioned that he was responding to the mailing he got from the Pfizer asking him to fill out some fax regarding a safety issue for TRUMENBA about which he had called and inquire back in July, at that time he indicated to the Pfizer's agent that he used to file various reports, so in his understanding it was sufficient and he did not want to do all the reporting as the Primary Healthcare Physician already done that and he also did not have any direct involvement or responsibility with the administration of them. He received multiple page questionnaires. He provided the report# as #. The first letter identifies the patient by his initial and second one said unknown but all of his conversation was about the one patient so it was looking like they have generated the second report which was really the same. He wanted Pfizer to stop sending him the letters as it was either helpful or necessary because the pediatrician have administered the vaccine and had already reported all the information. Causality was not available over the call. This case is in cross linked with #. Follow-up (16Aug2016): This follow up report contains no new safety information. Follow up attempts completed. No further information expected.