Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Fatigue, Infectious mononucleosis, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tonsillitis pyogenic in a 16-year-old female patient who received MENVEO. Previously administered products included meningococcal vaccine (manufacturer unknown and well tolerated), flu vaccine with an associated reaction of pain in extremity, flu vaccine with an associated reaction of peripheral swelling (see case US2016GSK2162303) and ALLEGRA (had a sore throat about 3 weeks before reporting date). Concurrent medical conditions included acne and plantar warts (takes TAGAMET for the plantar warts). Concomitant products included TAGAMET. On 12th October 2016, the patient received MENVEO (intramuscular). On 12th October 2016, less than a day after receiving MENVEO, the patient experienced general body pain and fever. On 13th October 2016, the patient experienced injection site swelling and pain in arm. On 16th October 2016, the patient experienced chest tenderness, scapula pain and difficulty sleeping. On 17th October 2016, the patient experienced tonsillitis pyogenic (serious criteria GSK medically significant), cardiac enzymes increased (serious criteria GSK medically significant), tiredness, feeling unwell, electrocardiogram abnormal, raised liver function tests, spleen enlarged, tonsillar hypertrophy and throat pain. On 18th October 2016, the patient experienced mononucleosis heterophile test. The patient was treated with ADVIL, ibuprofen, medication unknown (Ice pack (NOS)) and acetaminophen. In October 2016, the outcome of the injection site swelling, general body pain and fever were recovered/resolved. On an unknown date, the outcome of the tonsillitis pyogenic, tiredness, feeling unwell, mononucleosis heterophile test, tonsillar hypertrophy, throat pain and difficulty sleeping were not recovered/not resolved and the outcome of the cardiac enzymes increased, raised liver function tests and spleen enlarged were unknown and the outcome of the pain in arm, chest tenderness and scapula pain were recovering/resolving and the outcome of the electrocardiogram abnormal was recovered/resolved. It was unknown if the reporter considered the tonsillitis pyogenic, cardiac enzymes increased, feeling unwell, chest tenderness, scapula pain, mononucleosis heterophile test, electrocardiogram abnormal, raised liver function tests, spleen enlarged, tonsillar hypertrophy, throat pain and difficulty sleeping to be related to MENVEO. The reporter considered the injection site swelling, general body pain and fever to be related to MENVEO. The reporter considered the pain in arm and tiredness to be possibly related to MENVEO. Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The mother noted her daughter was not sick nor had symptoms at the time of the vaccination. The patient had a sore throat about 3 weeks prior to vaccination and for that patient took an ALLEGRA and that helped. At 16:00 hours, the patient received the MENVEO. The patient experienced the injection site swelling and arm soreness 1 day after vaccination. The body aches resolved and the site swelling resolved with ice pack. The next day, things were normal as the patient returned to school, her both arms were aching. Five days after vaccination, in evening, the patient was tired and not feeling well and took acetaminophen but did not resolve. On 16th October 2016, 4 days after vaccination, the patient's chest was tender to touch and there was pain in her chest and scapula area of her back. The reporter contacted physician who recommended ADVIL for the chest pain. The physician did a mono test on the 5th day, but it was negative. At 6 am, on Monday, the mother presented to the emergency room due to the chest pain. An electrocardiogram was performed and found to be abnormal, so cardiac enzymes were drawn. The troponin was 17.3, blood creatine phosphokinase (CPK) was 894 and blood creatine phosphokinase MB (CKMB) was 109. Another set was drawn and they were higher with troponin 18.1. A cardiac consult was obtained, echocardiogram (ECHO) was normal and found the heart was fine. The patient was treated with ibuprofen (600mg) three times daily and was released from the emergency department home. The liver function tests were also drawn and a normal urinalysis was obtained. The following day, the mono test was performed at physician office and found to be negative, however two days later the blood work was positive for mononucleosis (origin unknown). The liver function tests came back high with SGOT of 101. The patient continued to follow up with the physician every other day to monitor the symptoms. The patient was tired, not feeling well and having difficulty sleeping which was previously due to the chest pain but now could be because of the prednisone (taken for the painful and swollen tonsils in her throat). The mother noted the tonsils was filled with pus. As per the patient's mother, the physician believed that the spleen was getting smaller at last examination. The throat pain and tonsils was continued to be an issue, the patient was not able to attend school and still had issues sleeping. The chest pain was resolving, but she remained tired. The cardiac troponin was to be repeated in about a week. The mother wondered if the vaccination caused the mononucleosis (origin unknown) or was the virus already present and the vaccine exacerbated it.