Sex: F
Vaccine: FLUX, HEPA, TDAP, UNK, UNK, UNK, UNK, VARCEL
Symptoms: Cytogenetic analysis abnormal, Demyelinating polyneuropathy, Electromyogram abnormal, Gene sequencing, Hereditary neuropathy with liability to pressure palsies
Clinical narrative: Hereditary neuropathy with liability to pressure palsy (HNPP); acute demyelinating polyneuropathy; diminished deep tendon reflexes; This case was reported in a literature article and described the occurrence of hereditary neuropathy with liability to pressure palsies in a 19-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, ADENOVIRUS VACCINE for prophylaxis, MEASLES MUMPS RUBELLA for prophylaxis, LIVE VARICELLA VIRUS VACCINE (VARICELLA VACCINE) for prophylaxis and POLIOMYELITIS VACCINE (IPV VACCINE) for prophylaxis.   The subject's past medical history included upper respiratory tract infection (prior to the onset of her neurologic symptoms).   On an unknown date, the patient received Hepatitis A vaccine at an unknown dose, Influenza vaccine at an unknown dose, Meningococcal ACWY Vaccine (potential Menveo) at an unknown dose, Tdap Vaccine at an unknown dose, ADENOVIRUS VACCINE at an unknown dose, MEASLES MUMPS RUBELLA at an unknown dose, VARICELLA VACCINE at an unknown dose and IPV VACCINE at an unknown dose. On an unknown date, 4 days after receiving Hepatitis A vaccine, Influenza vaccine, Meningococcal ACWY Vaccine (potential Menveo) and Tdap Vaccine, the patient experienced hereditary neuropathy with liability to pressure palsies (serious criteria hospitalization, GSK medically significant and other: as per reporter), demyelinating polyneuropathy (serious criteria hospitalization, GSK medically significant and other: as per reporter) and diminished reflexes (serious criteria hospitalization and other: as per reporter). The subject was treated with immunoglobulins nos (Intravenous Immunoglobulin). On an unknown date, the outcome of the hereditary neuropathy with liability to pressure palsies, demyelinating polyneuropathy and diminished reflexes were unknown.   The reporter considered the hereditary neuropathy with liability to pressure palsies, demyelinating polyneuropathy and diminished reflexes to be possibly related to Hepatitis A vaccine, Influenza 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 hereditary neuropathy with liability to pressure palsy (HNPP) in a 19 year old female patient who was vaccinated unspecified adenovirus vaccine; unspecified hepatitis A; unspecified inactivated influenza (IIV), unspecified inactivated poliovirus (IPV), unspecified meningococcal conjugate vaccine (MCV4), unspecified measles mumps and rubella vaccine (MMR), unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified varicella vaccine (manufacturer unknown for all vaccines) for prophylaxis.   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 reports among persons who received adenovirus vaccine during 1st October 2011 through 31st July 2018 including participants in a military observational study. [In this study, they identified those reports filled from 24th October 2011 to 5th October 2012, an FDA-mandated, post marketing military observational study was conducted using the Surveillance System 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 recent history of illness of upper respiratory tract infection (URTI) prior to the onset of her neurologic symptoms. No information on patient's family history or concomitant medication was provided.  On unspecified date, the patient had received unspecified adenovirus vaccine; unspecified hepatitis A; unspecified inactivated influenza (IIV), unspecified inactivated poliovirus (IPV), unspecified meningococcal conjugate vaccine (MCV4), unspecified measles mumps and rubella vaccine (MMR), unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified varicella 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 2016, 4 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 MedDRA 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]. This case has been considered as serious due to the hospitalization. [In this study, all patients were hospitalized. Reports are classified as serious based on the Code of Regulations if one of the following was reported as death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly. In this study, 2 serious reports of patients diagnosed with HNPP following adenovirus vaccine who required hospitalization]. The patient received treatment with intravenous immunoglobulin (IVIG) for presumed the GBS. 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 military population. The investigators of the earlier military 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 military 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 military 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).