Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Failure to thrive, Glucose tolerance test abnormal, Performance status decreased
Clinical narrative: Failure to thrive; Initial information received on 26-Jun-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 50 years old female patient who experienced failure to thrive, while she received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and BOOSTRIX.  The patient's past medical history included Bronchitis in JUN-1990, Sinus operation in JAN-1994, Hysterectomy in MAR-2005, Sleep apnoea syndrome from JUN-2009 to 04-NOV-2014, Cerebrovascular accident in 2014, Cellulitis from 22-OCT-2005 to 05-NOV-2015, Gastric bypass on 04-NOV-2014, Abdominal pain from JUN-2015 to JUN-2017, Blood zinc decreased from JUN-2017 to 12-JUN-2018, Bilateral great toe surgery in JUN-2017, Large intestine polyp in 2012, Anaemia from JUN-1988 to AUG-2018, Tonsillectomy in JUN-2009, Carpal tunnel decompression in MAY-2011, Ear pain on 23-SEP-2015, Oesophagogastroduodenoscopy on 15-MAR-2016, Oesophagogastroduodenoscopy on 07-DEC-2017, Colonoscopy in MAY-2018 and Knee arthroplasty on 22-AUG-2018. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rhinitis allergic in FEB-1973, Sickle cell trait in 1988, Tobacco abuse in 2001, Blood cholesterol increased in 2009, Gastric ulcer in 2009, Cognitive disorder in DEC-2014, Neuropathy peripheral in DEC-2014, Insomnia in JUN-2015, Malnutrition in AUG-2015, Anxiety in NOV-2015, Gastrooesophageal reflux disease in 2016, Arthritis in 2016, Schizophrenia in 2016, Dysarthria in JAN-2016, Pain in 2017, Hypoalbuminaemia in 2017, Dyspnoea in 2017, Asthenia in MAY-2017, Hypertension in JUN-2017, Chronic obstructive pulmonary disease on 14-AUG-2017, Emphysema on 14-AUG-2017, Bipolar disorder in NOV-2017, Oedema peripheral in JAN-2018, Depression in JUN-2018, Thrombocytopenia in AUG-2018, Dysstasia in AUG-2018, Hypoalbuminaemia in 2017, Depression in JUN-2018, Temporomandibular joint syndrome on 22-OCT-2018, Constipation on 16-NOV-2018, Fatigue in DEC-2018, Malaise in DEC-2018, Asthenia in DEC-2018, Hypotension on 26-FEB-2019, Major depression on 26-FEB-2019, Oedema peripheral and Neutropenia.  Concomitant medications included tralokinumab (tralokinumab) for dermatitis atopic; salbutamol sulfate (ventolin [salbutamol sulfate]) for chronic obstructive pulmonary disease; atorvastatin (atorvastatin) for blood cholesterol increased; folic acid, iron (cerovite) for nutritional supplementation; cetirizine hydrochloride (zyrtec [cetirizine hydrochloride]); vitamin d3 (vitamin d3); diazepam (diazepam) for anxiety; docusate (docusate) for constipation; iron (iron) for anaemia; ibuprofen (ibuprofen) for pain; imipramine hydrochloride (tofranil); melatonin (melatonin); paraffin, liquid, wool alcohols (hydrocerin) for dermatitis atopic; naloxone hydrochloride (narcan); omeprazole (omeprazole) for gastrooesophageal reflux disease; oxycodone hydrochloride, paracetamol (oxycodone and acetaminophen); macrogol 3350 (glycolax) for constipation; potassium chloride (klor-con) for oedema peripheral; quetiapine fumarate (seroquel) for schizophrenia and depression; tiotropium (tiotropium) for bronchitis, chronic obstructive pulmonary disease and emphysema; trifluoperazine (trifluoperazine) for schizophrenia, anxiety and bipolar disorder; vitamin c [ascorbic acid] (vitamin c [ascorbic acid]) for anaemia; zolpidem tartrate (ambien) for insomnia; furosemide (lasix [furosemide]) for hypertension; sucralfate (sucralfate) for ulcer; bismuth subsalicylate (peptobismol) for diarrhoea; diphenhydramine hydrochloride (benadryl [diphenhydramine hydrochloride]) for nasopharyngitis; cogentin tablets for depression and sea soft nasal mist for congestion.  On 07-Jun-2019, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) lot number not reported via intramuscular route in unknown administration site and the patient received a dose of suspect BOOSTRIX lot number not reported via intramuscular route in unknown administration site.  On 11-Jun-2019, the patient developed a serious failure to thrive four days following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL VACCINE. The patient was hospitalized on the same day this event occurred.  Relevant laboratory test results included: Blood alkaline phosphatase - On 07-Jun-2019: 379 U/L [range 32-123 u/l] Blood lactate dehydrogenase - On 07-Jun-2019: 472 U/L [range 53-234 u/l] Glucose tolerance test - On 07-Jun-2019: 324 U/L [range 4-49 u/l]  Final diagnosis was failure to thrive.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for failure to thrive.  The reporter assessed the causal relationship with suspect vaccine as possible.  Company Remarks: Failure to thrive is considered unexpected according to the Reference Safety Information for Tralokinumab Menactra, and Boostrix (Tdap).  This case concerns a 50-year-old female with an extensive list of medical history and several current medical conditions, including COPD, cardiovascular diseases, arthritis, pain syndromes, metabolic disorders (including malnutrition) and neurological conditions (psychiatric disorders including fatigue, weakness, malaise, insomnia, bipolar disorder, depression, anxiety, and schizophrenia). The subject had a gastric bypass in 2014. More than 20 concomitant medications were reported. The start of the event was 91 days after the first administration of the blinded IMP (Tralokinumab or placebo) and 4 days after the administration of the vaccination (Tdap and meningococcal vaccines). The investigator causality is reported as possible, the subject's primary care provider assessed it as not related. It is reported that the primary care provider have noted a continued weight loss and decreased overall performance in the subject over an unspecified time period. The sponsor assess the causal relationship between the event failure to thrive and the Tdap and meningococcal vaccine as not related, as a considerate weight loss is very unlikely in the time frame of 4 days. Based on the subject's medical history, the current medical conditions, and the many concomitant medications reported, the sponsor assess these factors to account better for the occurrence of this event than then blinded IMP, and therefore the causal relationship between the event failure to thrive and the blinded IMP is considered to be not related.  List of documents held by sender: none.; Sender's Comments: This case concerns a 50 years old female patient who experienced failure to thrive after vaccination with MENACTRA] and BOOSTRIX. The time to onset is compatible with the role of the vaccine. Past medical history and several current medical conditions, including COPD, cardiovascular diseases, arthritis, pain syndromes, metabolic disorders (including malnutrition) and neurological conditions (psychiatric disorders including fatigue, weakness, malaise, insomnia, bipolar disorder, depression, anxiety, and schizophrenia). The subject had a gastric bypass in 2014. More than 20 concomitant medications were reported. Moreover, considering the patient's medical condition at time of vaccination and lab test ruling out alternate etiologies the role of the suspect products cannot be individually assessed.