Sex: M
Vaccine: FLUX, HEP, TDAP, TDAP, UNK, UNK
Symptoms: Cytogenetic analysis abnormal, Demyelinating polyneuropathy, Electromyogram abnormal, Extra dose administered, Hereditary neuropathy with liability to pressure palsies
Clinical narrative: Acute demyelinating polyneuropathy; Hereditary Neuropathy with liability to Pressure palsy (HNPP); diminished deep tendon reflexes; Overdose; This case was reported in a literature article and described the occurrence of demyelinating polyneuropathy in a 17-year-old male patient who received Hepatitis B vaccine for prophylaxis.    Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis and ADENOVIRUS VACCINE for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, Influenza vaccine at an unknown dose, Tdap Vaccine at an unknown dose, Tdap Vaccine at an unknown dose, Meningococcal ACWY Vaccine (potential Menveo) at an unknown dose and ADENOVIRUS VACCINE at an unknown dose. On an unknown date, 8 days after receiving Hepatitis B vaccine, Influenza vaccine, Tdap Vaccine, Tdap Vaccine and Meningococcal ACWY Vaccine (potential Menveo), the patient experienced demyelinating polyneuropathy (serious criteria GSK medically significant), hereditary neuropathy with liability to pressure palsies, diminished reflexes and overdose. The subject was treated with steroids nos (Steroids). On an unknown date, the outcome of the demyelinating polyneuropathy, hereditary neuropathy with liability to pressure palsies, diminished reflexes and overdose were unknown.   The reporter considered the demyelinating polyneuropathy, hereditary neuropathy with liability to pressure palsies and diminished reflexes to be possibly related to Hepatitis B vaccine, Influenza vaccine, Tdap Vaccine, Tdap Vaccine and Meningococcal ACWY Vaccine (potential Menveo).  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of hereditary neuropathy with liability to pressure palsy (HNPP) in a 17 year old male patient who was vaccinated with unspecified adenovirus vaccine; unspecified hepatitis B; unspecified inactivated influenza (IIV), unspecified meningococcal conjugate vaccine (MCV4), unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines (twice) (manufacturer unknown for all vaccines) for prophylaxis. This case corresponds to table 5 (case No.2) 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 a 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 Medical Surveillance System (MSS) 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 the study identified was November 9, 2011]. The patient had the no recent history of illness. No information on patient's family history or concomitant medication was provided.  On unspecified date, the patient had received unspecified adenovirus vaccine; unspecified hepatitis B; unspecified inactivated influenza (IIV), unspecified meningococcal conjugate vaccine (MCV4), unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines (twice) (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 2016, 8 day after vaccination, the patient had diminished deep tendon reflexes (DTR). The cerebrospinal fluid (CSF) was not done. The electromyogram (EMG) and nerve conduction (NCS) study showed Acute demyelinating polyneuropathy on nerve conduction study. The patient had an genetic testing which was Positive for PMP22 gene deletion. The patient was diagnosed with hereditary neuropathy with liability to pressure palsy (HNPP).[In this study, the main diagnosis for each report was categorized into a System Organ Class (SOC) grouping. Reports suggestive of anaphylaxis or GBS were further classified using the Brighton Collaboration criteria or a physician's diagnosis. All patients presented within 4-8 days following exposure to multiple vaccinations with a history of progressive muscle weakness, numbness and paresthesia, received a presumptive diagnosis of GBS. However, on clinical neurologic examination there was evidence of peripheral motor and sensory involvement, electromyogram/nerve conduction studies found slowing of multiple motor and sensory nerves consistent with a diagnosis of peripheral polyneuropathy, but no evidence of radiculopathy and myopathy on needle exam. In all these cases, genetic testing demonstrated deletion at chromosome 17p11.2-12, containing the peripheral myelin protein 22 (PMP22) gene, confirming the diagnosis of HNPP].The patient was classified as non-serious because the patient presented to the emergency department ED and subsequently was followed in the clinic. The patient received treatment with 6 day steroid course initially. The outcome of event was not reported.  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 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 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 cerebrospinal fluid (CSF) was not done. The electromyogram (EMG) and nerve conduction (NCS) study showed Acute demyelinating polyneuropathy on nerve conduction study. The patient had an genetic testing which was Positive for PMP22 gene deletion. The patient was diagnosed with hereditary neuropathy with liability to pressure palsy (HNPP).