Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2013US000590 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 470184) on 02 Jan 2013 and a follow-up information was received from Quality Assurance Department (reference number: 209097) on 14 May 2014. This report refers to a 65-year-old female patient. Concomitant medications included DEXILANT, SINGULAIR, sucralfate and folic acid. Her medical history included seasonal allergies and asthma. The patient was vaccinated with FLUVIRIN (batch number: 1203901) and PNEUMOVAX (batch number: H010515) on 08 Oct 2012. The patient and her husband received the flu vaccinations at the same time and on the same date. On 08 Oct 2012, after the vaccination, she experienced very mild serum sickness symptoms of temperature of 99 degrees, generalized muscle aches, and mild malaise. The second day after the vaccination, there was the onset of more severe muscle pain which was localized to the neck, shoulders, and upper trunk. The pain was present at rest but became much greater with motion, simulating the severe muscle cramps that occur with athletic endeavors. By the later afternoon, she was extremely uncomfortable with the muscle pains which had begun to limit any activity related to motion of the neck and arms. There was no headache, the temperature remained only slightly elevated, but the muscle pains continued to increase in severity. The patient's husband wanted her to start on a MEDROL dose pack in order to block the pain. She was also given ROBAXIN and VICODIN so that she could sleep. The third day after the vaccination, her muscle pain was worst. The "same muscle groups" were involved with constant but increasing pain at rest with very severe (crying out) pain with the slightest motion. Movement of only millimeters triggered intense muscle spasm that continued until the muscles were again released and placed at rest, with the pain not disappearing but returning to the "baseline". She remained as motionless as possible, out of bed only with great pain and a large amount of help for trips to the bathroom. Beginning with the fourth day, after vaccination, all of the symptoms began to subside to the point that she remained in a great deal of muscle pain, but could, with help move and show some very minimal improvement. The only significant change was that, as the pain improved in the upper part of the body and it began to involve the trunk, pelvis, and legs. In subsequent days, all of the symptoms had improved but, even on the tenth day after vaccination, she remains symptomatic with pain in the pelvis, legs, and strap muscles of the neck. The outcome of events was reported as condition unchanged as of 17 Oct 2012. The seriousness and causality of the events was not reported. Batch review report (reference number: 209097) received from quality assurance department on 14 May 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 1203901, expiry date: 31 May 2013) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 209097) on 14 May 2014: Updated batch review report, labeling and expiry date of vaccine.