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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: abscess in the left groin; pain in the administration; pain at the administration site; abscess at the administration site; hordeolum in the right eyelid; face cellulite; self-limited diarrhea; refused solid food; This spontaneous report was received from a physician via Regulatory Authority (two-way agreement) concerning a 19-month-old male patient. The patient''s pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 10-APR-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 180170, intramuscularly (dose, frequency and the expiration date were not reported) for antiviral prophylaxis. Lot number 180170 is an invalid lot number for hepatitis a vaccine, inactivated. Other suspect therapies included varicella virus vaccine live (unspecified) lot # S50117091, subcutaneously (dose, frequency and the expiration date were not reported) for prophylaxis; measles virus vaccine live (enders-edmonston), mumps virus vaccine live (jeryl lynn), rubella virus vaccine live (wistar ra 27/3) lot# 187VVA057Z, intramuscularly (dose, frequency and the expiration date were not reported) and influenza virus vaccine (unspecified) Lot# S50117091 (also reported as 190042) intramuscularly (dose, frequency and the expiration date were not reported). On the same date, the patient experienced self-limited diarrhea (diarrhea) and refused solid food (eating disorder). On 11-APR-2019, the patient''s mother noticed an abscess in the left groin (groin abscess) and the patient complained of pain (injection site pain/ administration site pain), the mother made a compress with warm water, a purulent discharge came from the abscess (injection site abscess), the mother also noticed a hordeolum in the right eyelid (hordeolum) and face cellulite (peau d''orange). On 12-APR-2019, with the increase of the lesion, hardening and bleeding, the mother took the patient to the Emergency Department, there was also a report that the child regurgitated cow''s milk, but ingested solid foods. At the Emergency Department, the patient was evaluated by a doctor and treatment with amoxicillin + clavulanate was indicated, and he was hospitalized. On 13-APR-2019, the patient was medicated with the antibiotic and at 10:30 pm, the mother had the child asleep in her lap and noticed the pale child, called the local nurse, resuscitation maneuvers were performed, and the child did not respond to commands. On 13-APR-2019, the patient died. The cause of death was unknown (reported as the body was sent to "IML" and the agency file did not describe the cause of death). It was unknown whether an autopsy was performed. The outcome of groin abscess, injection site abscess, injection site pain and administration site pain were reported as fatal. The outcome of diarrhoea was reported as recovered on 10-APR-2019 and peau d''orange was reported as recovered on 13-APR-2019. The outcome of eating disorder and hordeolum was unknown. The relatedness between the suspect therapies and the events was not provided. Upon internal review, groin abscess was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death
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