Age: 27.0
Sex: F
Vaccine: FLU3, HEP, VARCEL
Symptoms: Injection site swelling, Laboratory test normal, Pain, Palpitations, Pyrexia
Clinical narrative: Initial report was received from a health care provider on 12 October 2010. A 27 year-old female with a past medical history of hyperthyroid, fibromyalgia, depression and anxiety, had received on 11 October 2010 an intramuscular right arm injection of FLUZONE, lot number UH184AB, an intradermal right forearm injection of TUBERSOL 5 TU, lot number C3506AB, a Varicella vaccine (Merck, lot number 0903Z, route and site of administration not reported), and a Hep B vaccine (GSK, lot number AHBVB834AA, route and site of administration not reported). On 11 October 2010 in the "afternoon" the patient experienced shortness of breath, a racing heart, body aches and a red swollen "FLUZONE" injection site reaction. The patient was referred to the emergency room (reported as ER) and was admitted for an overnight stay. Treatments provided to the patient were not reported. The patient was taking concomitant medications AVIANE and EFFEXOR. The patient has allergies to BENADRYL, penicillin (reported PCN) and tetanus. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up received from a health care professional via Merck (#WAES 1010USA01336) on 26 October 2010. The health care professional considered trouble breathing, heart racing, achy and fever of 104 degrees Fahrenheit (F) to be life threatening and other important medical events. The patient received a 0.5 milliliter (ml) subcutaneous injection of VARIVAX (Merck, lot number 668256/0903Z). The patient had also developed a fever of 104 degrees F on 11 October 2010. The patient was kept overnight for observation and was sent home on 12 October 2010. On 12 October 2010, the patient recovered from trouble breathing, heart racing, achy and fever of 104 degrees F. Follow-up information received from a health care professional on 28 October 2010 reported that the patient had no illness at the time of vaccination. The patient received the injection of Varicella vaccine in the left arm and the hepatitis B vaccine in the left deltoid. It was confirmed that the patient was admitted for 24 hour observation and released by the hospital. The outcome was reported as recovered. Follow-up information received from a health care professional via Merck (#WAES 1010USA01336) on 02 November 2010 reported the following verbatim: "Follow up information has been received from the register nurse, who reported that on an unspecified dated the patient underwent a chest x-ray test, urinalysis and D-Dimer test, which were all negative. The nurse reported that the patient continued to do well. A standard lot check investigation had been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The outcome remained recovered. Follow-up information was received 03 February 2011 from a health care professional. The event diagnosis was reported as "allergic reaction to vaccine - suspected concurrent illness with sore throat and dry cough". The patient had no illness at the time of vaccination. Diagnostic testing (not specified) was negative. Corrective treatment consisted of observation. According to the reporter, the patient totally recovered (date not reported). It was further noted that this patient experienced a red swollen arm after receiving an unspecified Tetanus vaccine (manufacturer, lot number, route, site and date of administration not reported). No further information was provided. This patient experienced another adverse event captured in case number 2011-00505. Documents held by sender: none.