Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Nasal congestion, Oropharyngeal swelling, Pharyngeal oedema, Pruritus generalised, Pyrexia
Clinical narrative: Information has been received from licensed practical nurse concerning a 35 year old white female pt and from the pt herself who has allergies to aspirin, codeine, vicodin, caffeine, yeast, molds, and dust, who on 13Oct2003 (also reported by licensed practical nurse as 16Oct2003) was vaccinated in the left upper outer arm with a first dose of varicella virus vaccine live. The pt reported she was not on any other prescription medications (also reported by the LPN that the pt takes cetirizine hydrochloride (Zyrtec) for allergies). The LPN reported that on 13Oct03, within several hours of the pt receiving a first dose of varicella virus vaccine live, she developed several hives, which the pt reported were in her throat, in one nostril, behind her knees, and on her forehead. The pt also reported "allergy like symptoms" started within an hour of administration of the vaccine, and were described as an itchy throat with swelling in her throat (also reported as scratchy throat), nasal congestion, and generalized itching (also reported by LPN as generalized pruritis), which was most severe the first four days. She also reported feeling "some SOB, racing heart, somewhat feverish off and on, and extreme fatigue". The pt sated that she did get some relief (minimal) of symptoms by taking cetirizine hydrochloride (Zyrtec) after the vaccine. It was noted that the allergy symptoms lasted for four days, but some symptoms lasted for almost a week. The pt reported the first four days were the worst and she felt better after four days. The LPN reported the pt recovered one week from the vaccine administration. No prescription drug was required. The pt reported neither her brothers or herself had ever had adverse reactions to prior vaccinations. No other information was available. There was no product quality complaint involved. No further information is expected.   Follow-up information was received from a published article, title as stated above that a 35-year-old female with an allergy to yeast was vaccinated with a dose of hepatitis B virus vaccine rHBsAG (yeast) (manufacturer unknown). One hour after vaccination, the patient experienced probable anaphylaxis with tachycardia, dyspnea, urticaria, pruritus, oropharyngeal edema, nasal congestion. A doctor and/or emergency room visit may have been required. Since no allergy testing was done in these subjects to confirm sensitivity to yeast, the role of other allergens in these vaccines cannot be ruled out. Allergic reactions due to gelatin in vaccines have been described previously. This could also possibly explain the reactions in patients that received the varicella virus vaccine live (Oka/Merck), since they also received vaccines that may contain gelatin. The evidence from passive surveillance for vaccine safety, as well as from the medical literature, suggests that recombinant yeast derived hepatitis B vaccine rHBsAg (yeast) (manufacturer unknown) pose minimal risk of allergic reactions in yeast sensitive individuals. The small number of reports to VAERS may be partly due to health care professionals observing current contraindications by no vaccinating yeast sensitive individuals. Nevertheless, yeast associated anaphylaxis in sensitized patients appears to be a rare event. If potential recipients of the hepatitis B vaccine indicate that they are "allergic" or "hypersensitive" to yeast, they should be further queried about the nature of their reactions ot yeast. Only for those who would rarely respond with a convincing history of a potentially mast cell-mediated reaction within minutes of inhalation or ingestion of yeast should the vaccine be withheld. The article also discussed the experience of 11 other patients while on therapy with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES numbers 0603USA01762, 0603USA02783 through 0603USA02791 and one patient while on therapy with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and measles virus vaccine live (Enders-Edmonton) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (WAES # 0603USA02461). A copy of the published article is attached as further documentation of the patient's experience.