Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Hypopnoea, Lethargy, Mental status changes, Mydriasis, Pallor
Clinical narrative: TACHYCARDIA; PUPILS DILATED; PUPILS SLUGGISH AND EQUAL; ALTERED MENTAL STATUS; LETHARGIC; CONFUSION; DECREASED LEVEL OF CONSCIOUSNESS; CAPILLARY REFILL DELAYED; SHALLOW BREATHING; VOMITING; DIARRHEA; DECREASED PO INTAKE / UNABLE TO ACCEPT FEEDINGS; SKIN PALE; SKIN DRY / MEMBRANES / TURGOR DRY; "END STAGE AID"; CARDIOPULMONARY ARREST; CONGENITAL HIV; DEHYDRATION; SEIZURES (TONIC / CLONIC); CHICKENPOX / DISSEMINATED VARICELLA; EAR ACHE; Information has been downloaded from Agency (US-1577272925-2009-05439).  This spontaneous report was received from a healthcare professional concerning a male patient of unknown age.  The patient's concurrent conditions included human immunodeficiency virus (hiv) test, end stage aids, mycobacterium avium complex infection, asplenia, drug hypersensitivity, sinusitis and rash. The patient's medical history included gastrostomy and the patient's concomitant medications included lamivudine (EPIVIR), zidovudine (RETROVIR), sulfamethoxazole (+) trimethoprim (BACTRIM), abacavir sulfate (ZIAGEN), lopinavir (+) ritonavir (KALETRA), didanosine, emtricitabine, fluconazole, calcium (unspecified), folic acid, cyclosporine, ethambutol, moxifloxacin, pyridoxine, vitamins (unspecified), nelfinavir, valganciclovir hydrochloride, famotidine (reported as FLAMOTADINE    ) and levocarnitine (reported as PEROCARNITINE).  On an unknown date, the patient started therapy with ferrous sulfate (strength, dose, frequency, route of administration, lot number, expiration date and indication were not provided).  On 20-AUG-2008, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), for immunization (route of administration was reported as unknown; lot number was reported as 0630X410, strength, dose, frequency and expiration date were not provided).    On 16-SEP-2008, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) for immunization (route of administration was reported as unknown and lot number was reported as C3355A; strength, dose, frequency and expiration date were not provided).    On an unknown date the patient experienced end stage aids, skin dry-membranes and turgor dry (dry skin), skin pale (pallor), decreased oral intake  unable to accept feedings (hypophagia), diarrhea, vomiting, shallow breathing (hypopnea), capillary refill delayed (capillary nail refill test abnormal), decreased level of consciousness (depressed level of consciousness), confusion (confusional state), letargic (lethargy), altered mental status (mental status changes), pupils dilated (mydriasis), pupils sluggish and equal (pupillary reflex impaired ), tachycardia, dehydration, congenital hiv infection and cardiopulmonary arrest (cardio-respiratory arrest).  On an unspecified date in 2008, the patient experienced ear ache (ear pain). On 22-OCT-2008 the patient experienced chicken ports and disseminated varicella (varicella).   On 28-NOV-2009 the patient experienced seizures tonic-clonic (generalised tonic-clonic seizure).  It was reported that the patient was hospitalized due to the events on an unspecified date.   The outcome of end stage aids, varicella, dehydration, congenital hiv infection and cardio-respiratory arrest was reported as fatal and the outcome of generalised tonic-clonic seizure, ear pain, dry skin, pallor, hypophagia, diarrhoea, vomiting, hypopnoea, capillary nail refill test abnormal, depressed level of consciousness, confusional state, lethargy, mental status changes, pupillary reflex impaired, mydriasis and tachycardia was unknown.   Therapy with varicella virus vaccine live (oka/merck)(VARIVAX) was restarted and pallor did not recur.   The patient died on 28-NOV-2009. The cause of death and if an autopsy was performed was not reported.   The causality assessment between the suspect drugs and the events occurrence was not provided.  Lot number 0630X410 is an invalid lot number for varicella virus vaccine live (oka/merck).