Age: 1.08
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Ear infection, Epstein-Barr virus test, Food allergy, Haemoglobin, Inappropriate schedule of product administration
Clinical narrative: stage 3 sarcoma; My son received his first dose of varivax on April 29, 2013/My son also received his first dose of MMR II on April 29, 2013; super bug; Huge haemorrhage; ear and chest infection; pneumonia like symptoms; ear and chest infection; problems peeing; constipated; had infections; nut allergy; allergy to certain soaps; This spontaneous report as received from a consumer refers to her son, a patient of approximately 7 years of age. The patient's medical history included eczema and the use of Penicillin. The patient also had a head to toe reaction to unspecified vaccinations as a child the time frame of which was not known. The patient had drug reaction/allergy to Penicillin. The patient's concomitant medication included cefdinir. On 29-APR-2013, the patient was vaccinated with first doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Strength, dose, route, lot # and expiry date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) (Strength, route, lot # and expiry date were not reported) in the left arm for prophylaxis as per physician's recommendations (Inappropriate schedule of product administration). On 01-FEB-2017, the patient was vaccinated with an another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) recombinant Human albumin (rHA) of lot #M034857, expiration date not reported, upon internal validation established as 27-JUL-2018. The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) was reconstituted with the sterile diluent of lot # N019616. On 26-SEP-2017, the patient was vaccinated with another dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) of lot # N017399, expiration date not reported, but upon internal validation established as 07-JUN-2019). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with the sterile diluent of lot # M034194. On an unknown date (also reported as "prior to the diagnosis with stage 3 sarcoma) after receiving varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II), the patient kept getting ear, chest infection and also had problems in "peeing". On 13-JUN-2018, the patient was then diagnosed with stage 3 sarcoma. On an unknown date, the patient experienced constipation and had infections as informed by the physician to the patient's mother. On an unknown date, the patient was hospitalized due to stage 3 sarcoma for a duration of 30 days for chemotherapy during his initial diagnosis. The patient was reportedly in and out of the hospital. The patient received 42 rounds of chemotherapy treatment for the event of sarcoma. On an unknown date, the patient developed a super bug and experienced a huge hemorrhage at the end of his treatment with chemotherapy. On unknown dates, the patient developed a nut allergy and an allergy to certain soaps. On an unknown date, the patient also experienced pneumonia like symptoms during his chemotherapy treatment. It was also reported that, the patient had no evidence of the disease in his body and the patient's mother did not know when her son had the reaction to vaccinations as a child and to which vaccinations. The patient sought medical attention by visiting the physician. The patient underwent hemoglobin studies, Epstein-barr virus test, treponema pallidium microhemoglobin, non-reactive regain antibodies, teardrop cells, platelet neuropathy and parvovirus B19 but the results of which were not provided. There was no product quality complaint associated with this report.  The outcome of all the events was reported to be recovered by the end of March 2019. The causality assessment was not provided.  Upon internal review, the events of sarcoma, pathogen resistance, lower respiratory tract infection, pneumonia and hemorrhage were determined to be medically significant.