Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Fear, Flushing, Headache, Impaired work ability
Clinical narrative: This spontaneous report was received from a consumer, referring to a 39 year old female patient. The patient concomitant therapies included ZYRTEC, ALLEGRA, SINGULAIR, PEPCID, BENADRYL, prednisone and hydralazine. The patient drug reaction or allergies were not provided, because she stated that the list was too long to go through. On an unspecified date, the patient received an unspecified dose of M-M-R II during her childhood, before the "grade of kindergarten" or "before 6th grade" (dose, route, frequency, lot #, expiration date and indication were not reported for the vaccine and for the diluent used for reconstituting the vaccine). It was not confirmed if the patient had the pre-existing conditions before receiving her first dose of M-M-R II. On 09-JUN-2015, a titer test was performed to confirm immunity to measles, mumps, and rubella. The patient had full immunity to measles and mumps but showed a low immunity for rubella (rubella antibody negative). The patient was not informed until two years after the test was performed. On 26-JUL-2017, the patient received the second dose of M-M-R II intramuscularly, lot # M034857 and expiration date 27-JUL-2018, reconstituted with a sterile diluent lot # M034444 and expiration date 27-MAR-2019, for prophylaxis also reported as "for work indication" by the patient. The patient reported that she had to apply the M-M-R II because she could lose her job due to her low immunity of rubella based on the titer test, so she had no time to confirm if she would be able to receive a dose of M-M-R II due to her preexisting condition (systemic mastocytosis, urticaria pigmentosa and syncope). After vaccination, on an unspecified date in 2017, the patient developed the following adverse symptoms: fever, chills, joint pain, body pain "like flu", severe headache, hives, flushing and swollen lymph nodes all over her body. The patient stated that she became worst over a course of a week, when the first symptoms started and began to experience, also in 2017,  dizziness, syncope, rash, blisters on her skin, sore throat, fatigue, cellulitis and changes in her blood pressure. She also stated that since the M-M-R II she had become more sensitive to chemicals in the environment and had reactions that normally she did not; she clarified that reactions means that she would develop symptoms as reported or similar to anaphylaxis. The patient had to take the Family and Medical Leave Act (FMLA), so she was waiting for short term disability and was told that this would not be considered a claim for worker compensation. Referring to life threatening, the patient clarified that she was not in immediate danger, but she had become sensitive, so she was afraid. The patient also stated that this was a significant disability because she could not work for not being able to stay for long periods of time and also had the many symptoms reported before. Additionally she informed that she did not trust herself to be around other patients due to these symptoms (psychiatric symptom). On 15-AUG-2017, a second titer test was performed and confirmed that the patient had full immunity to measles, mumps, and rubella. The patient also had several unspecified tests for infectious disease performed on an unspecified date; all of them were reported as negative. An unspecified infectious disease doctor, stated to the patient that the M-M-R II had taken her preexisting condition (systemic mastocytosis, urticaria pigmentosa and syncope) from being stable to being unstable. The patient sought medical attention and several unspecified physician provided different treatments, like two rounds of an unspecified antibiotic, varies unspecified steroids, unspecified intravenous fluids, and unspecified topical steroid creams. There was no intervention to prevent serious criteria. The outcome of rubella antibody negative were reported as recovered on 15-AUG-2017. The outcomes of lymphadenopathy, cellulitis and fever were reported as recovering. The outcome of chills, joint pain, body pain, headache, hives, flushing, dizziness, syncope, rash, blisters on her skin, oropharyngeal pain, fatigue, blood pressure fluctuation, feeling abnormal, systemic mastocytosis, urticaria pigmentosa, dysstasia and psychiatric symptom were reported as unknown. At the time of reporting, the action taken with M-M-R II was not applicable. Additionally, the assessment causality between fever, lymphadenopathy, cellulitis, chills, joint pain, body pain, headache, hives, flushing, dizziness, rash, blisters on her skin, oropharyngeal pain, fatigue, blood pressure fluctuation, dysstasia and hypersensitivity with M-M-R II were not provided. The assessment causality between syncope, systemic mastocytosis and urticaria pigmentosa with M-M-R II were reported as related. The reporter considered feeling abnormal to be life threatening. Furthermore, she stated that all reported events were disabling. Upon internal review cellulitis, systemic mastocytosis reaction were determined to be medically significant.