Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Eye irritation, Fatigue, Gingival pain, Malaise
Clinical narrative: Initial non-serious report received from a patient on 10 October 2007. A 44-year-old female with history of bat exposure developed gum sensitivity and eye irritation on an unspecified date following her second post-exposure dose of IMOVAX (lot number A0259-2), administered intramuscularly to the deltoid area on 21 September 2007. It was also reported that the patient had received a rabies vaccine (trade name, manufacturer, lot number and route/site of administration not reported) on 18 September 2007. At the time of the report, the patient had not recovered. No additional information was provided. Follow-up information received on 26 November 2007 from a health care facility. The reporter's name was not provided. A copy of the patient's rabies immunization flow sheet was provided. It was reported the patient had medical history of allergies to Sulfa, Biaxin, Niacin, and dyes used in Cat Scans; and was taking "Lovoxyl", Alavert, and Zyrtec at the time of the vaccination with IMOVAX Rabies vaccine on 21 September 2007. It was previously reported the patient had experienced eye irritation and gum sensitivity after the second dose of IMOVAX Rabies vaccine, but from the rabies immunization (low sheet, the patient experienced the events after receiving the sixth dose of IMOVAX Rabies vaccine (lot number A0259-2, expiration date 16 May 2009) in the right (not left as previously reported) deltoid on 21 September 2007. The reporter was not aware of the adverse events of eye irritation and gum sensitivity since these were not reported to them; therefore, the onset dates of these events were "unknown' to the reporter. There was "no treatment" received for these adverse events. Per the reporter, the patient had extreme anxiety regarding the rabies vaccinations prompting her to call the clinic several times a day. It is worth to note the patient received one dose of IMOGAM vaccine and the first five doses of the six dose series of the IMOVAX Rabies Vaccine, following bat exposure (date not provided) as follows: 26 May 2007: IMOGAM vaccine, dose one, lot number A0373-4, expiration date 26 April 2009, administered 1cc in the wound, and 6.9 cc's split between the right and left gluteal muscle. 26 May 2007: IMOVAX Rabies vaccine, dose one, lot number Z0877-2, expiration date 10 March 2008, in the right deltoid. 29 may 2007: IMOVAX Rabies vaccine, dose two, lot number Z0877-2 (reported as Z0877), expiration date 10 March 2008, in the left deltoid. 02 June 2007: IMOVAX Rabies vaccine, dose three, lot number Z0943-1, expiration date 03 October 2008, in the right deltoid (it was noted that the patient experienced an adverse event of slight malaise and fatigue on 05 June 2007, three days after this dose of IMOVAX Rabies vaccine that is reported in case number 2007-04075). 09 June 2007: IMOVAX Rabies vaccine, dose four, lot number A0017-2, expiration date 01 March 2009, in th left deltoid. 23 June 2007: IMOVAX Rabies vaccine, dose five, lot number A0017-2, 01 March 2009, in the right deltoid. From the rabies immunization flow sheet that was provided, the patient did not received a dose of IMOVAX Rabies vaccine on 16 September 2007 as previously reported. It was also noted on the flow sheet that the patient experienced slight nasal itching (onset date not reported) that required a dose of Zyrtec on 02 June 2007. It was unclear if this was an adverse event from the IMOVAX Rabies vaccine and/or IMOGAM vaccine so further information has been requested for clarification. At the time of this report, the recovery status of the patient was "unknown" regarding the eye irritation and gum sensitivity. Follow-up information received on 12 February via telephone contact to a health care professional who clarified all the above previously received information. The patient experienced a second exposure to a bat sometime prior to 18 September 2007 and as result, she received two booster doses of IMOVAX. The first intramuscular left deltoid booster dose of IMOVAX (lot number reported as 942320). This is not a valid Sanofi Pasteur lot number, expiration date May 16 2009) was administered on 18 September 2007. The patient received a second intramuscular right deltoid booster dose of IMOVAX (lot number A0259-2, expiration date 16 May 2009) on 21 September 2007, and at an unspecified amount of time after the second boost dose, the patient experienced eye irritation and gum sensitivity. The patient did not receive any treatment for he adverse events, and her recovery status was unknown. It was further clarified that the patient had experienced a first exposure to a bat come time prior to 26 May 2007, and received a first dose of IMOGAM Rabies HT, and a five dose series of IMOVAX. It was noted on the immunization record the patient had taken Zyrtec for slight nasal itching the same day as the third dose of IMOVAX vaccine the patient experienced slight malaise and fatigue. These events are reported in case 2007-04075.