Sex: M
Vaccine: ADEN, HEPAB, MNQ, TDAP
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy, Nerve conduction studies abnormal
Clinical narrative: Guillain Barré syndrome; diminished deep tendon reflexes; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a 18-year-old male patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and ADENOVIRUS VACCINE for prophylaxis.   The subject's past medical history included upper respiratory tract infection.   On an unknown date, the patient received Hepatitis A and Hepatitis B vaccine at an unknown dose, Meningococcal ACWY Vaccine (potential Menveo) at an unknown dose, Tdap Vaccine at an unknown dose and ADENOVIRUS VACCINE at an unknown dose. On an unknown date, 9 days after receiving Hepatitis A and Hepatitis B vaccine, Meningococcal ACWY Vaccine (potential Menveo) and Tdap Vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization, GSK medically significant and other: as per reporter) and diminished reflexes (serious criteria hospitalization). The subject was treated with prednisolone and immunoglobulins nos (Intravenous Immunoglobulin). On an unknown date, the outcome of the guillain barre syndrome and diminished reflexes were unknown.   The reporter considered the guillain barre syndrome and diminished reflexes to be possibly related to Hepatitis A and Hepatitis B vaccine, Meningococcal ACWY Vaccine (potential Menveo) and Tdap Vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of guillain barre syndrome (GBS) in a male patient 18 year old who was vaccinated with unspecified adenovirus vaccine; unspecified combined hepatitis A and B vaccine; unspecified meningococcal conjugate vaccine (MCV4) and Unspecified Tetanus, Diphtheria & Acellular Pertussis Vaccine (Tdap) Vaccine (manufacturer unknown for all vaccines) for prophylaxis. This case corresponds to table 4 (case No.4) reported in this literature article. The patient was the part of the observational study that aimed to investigate adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). They searched the VAERS database for reports among persons who received adenovirus vaccine during 1st October 2011 through 31st July 2018 including participants in an observational study. [In this study, they identified those reports filled from 24th October 2011 to 5th October 2012, an FDA-mandated, post marketing observational study was conducted using the agency database. This study compared 100,000 recruits exposed to the adenovirus vaccine with a historical unexposed cohort and identified statistical signals for psoriasis, anaphylaxis and other hypersensitivity reactions as emergent AEs possibly related to vaccination. During the study period, VAERS received a total of 100 reports following adenovirus vaccine; among all reports, the earliest vaccination date with the adenovirus vaccine we identified was November 9, 2011]. The patient was from the observational study. The patient had the history of the upper respiratory tract infection (URTI). No information on patient's family history or concomitant medication was provided.  On unspecified date, the patient received unspecified adenovirus vaccine; unspecified combined hepatitis A and B vaccine,; unspecified meningococcal conjugate vaccine (MCV4) and Unspecified Tetanus, Diphtheria & Acellular Pertussis Vaccine (Tdap) Vaccine (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided. On an unspecified date in 2012, 9 day after vaccination, the patient had diminished deep tendon reflexes (DTR). The cerebrospinal fluid (CSF) was not performed. The electromyogram (EMG) and nerve conduction (NCS) study was consistent with Guillain Barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP). The patient was diagnosed with GBS (level 2). [In this study, the main diagnosis for each report was categorized into a grouping. Reports suggestive of anaphylaxis or GBS were further classified using the criteria or a physician's diagnosis. Criterion for cytoalbuminologic dissociation was CSF protein elevation above laboratory normal value and CSF total wbc count less than 50 cells per ul.]. This case has been considered as serious due to the hospitalization and as per reporter. [In this study, all patients were hospitalized. Reports are classified as serious based on the Regulations if one of the following was reported as death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly]. The patient received treatment with intravenous immunoglobulin (IVIG) and prednisolone.  The outcome of event was not reported. [In this study, all patients were recovered, however, four required ICU admission and were intubated]. The author commented, "In addition, 95 percent of the adenovirus vaccine reports documented co-administration of other vaccines and 50 percent reported co-administration of penicillin G (or other antibiotic if allergic to penicillin) according to standard agency protocol in this population. The investigators of the earlier observational study also commented that concurrent vaccine exposures in the recruit population was an important limiting factor for attributing the statistical signaling outcomes including psoriasis, anaphylaxis and other hypersensitivity reactions as possibly related to the vaccine". The author concluded "The reporting rate for serious AEs was higher than with other vaccines administered in the comparison recruit population (39 percent vs 18 percent however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile". This is 1 of the 19 valid cases reported in this literature article.      Lab Comments: The electromyogram (EMG) and nerve conduction (NCS) study was consistent with Guillain Barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP). The patient was diagnosed with GBS (level 2).