Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Eyelid oedema, Face oedema, Immunisation reaction, Impaired driving ability
Clinical narrative: Her face swelled "looked like someone had beat her to death"; Can not drive due to the swelling on her face; Allergic reaction to the vaccine; Her eyes were swollen shut; Patient had dermatitis and also respiratory swelling which self resolved / had respiratory swelling; Patient had dermatitis and also respiratory swelling which self resolved; redness,; This spontaneous report was received from a consumer (patient's father) and a nurse, concerning a 21-year-old female patient. Her concurrent conditions included sulfa allergy, a cyst on her head (the nurse reported onset date unknown, but prior to of HPV rL1 6 11 16 18 VLP vaccine (yeast) dose), migraine headaches and anxiety. Historical drugs included sulfamethoxazole (+) trimethoprim (BACTRIM), sulfonamides and mesalamine. Concomitant medications included paroxetine, alprazolam (XANAX), rizatriptan benzoate (MAXALT), ethinylestradiol (+) levonorgestrel (SEASONALE), amoxicillin (+) clavulanate potassium (AUGMENTIN) and ibuprofen (manufacturer unknown).  On 08-JUL-2011, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot# 1560Z, expiry date: 28-APR-2013 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL), which was administered to the patient on the same day.  On 08-JUL-2011, also reported as "almost immediately", the patient began to swell up. Her face swelled to the point that she looked "like someone had beat her to death" (face oedema), and that her eyes were swollen shut (eyelid oedema). The reporter stated that she could not drive due to the swelling on her face. On the same day, the patient was prescribed with amoxicillin (+) clavulanate potassium (AUGMENTIN) and ibuprofen (manufacturer unknown). On 09-JUL-2011, an incision and drainage of the cyst was performed and acetaminophen (+) hydrocodone bitartrate (VICODIN) was prescribed as needed for the pain. On 11-JUL-2011, also reported as on Monday, the cyst on the patient's head was examined. The patient's father stated that he and the physician were questioning if the swelling might had been due to the cyst. However, the swelling continued to progress, and she returned to the physician again.  On 11-JUL-2011 (also reported as 12-JUL-2011), the patient received an injectable steroid, possibly betamethasone (CELESTONE), for facial swelling. On 12-JUL-2011, she received oral prednisone to ease the progression of what the physician diagnosed as an allergic reaction to the vaccine.  The nurse stated that she had not heard from the patient since 12-JUL-2011, "so assumed as not getting worse". At the time of the report, the patient had not recovered from the events. The patient sought medical attention.  The events face oedema, allergy to vaccine, eyelid oedema and impaired driving ability were considered to be disabling by the father of the patient.  The causality assessment between the events: face oedema, allergy to vaccine, eyelid oedema, impaired driving ability and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) were reported as related.  Follow-up information was received from a pharmacist (patient's husband) on 19-MAY-2022. The pharmacist reported the patient was allergic to sulfa, mesalamine and sulfamethoxazole (+) trimethoprim (BACTRIM). She received human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose description, anatomical location and route of administration were not provided) (discrepant information, also reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9]) and subsequently had a reaction. The patient had dermatitis and also respiratory swelling which self-resolved. The patient additionally had redness, and she did not need an epinephrine injection. She did not receive any further doses of human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) either. The outcome of the events dermatitis and respiratory swelling was reported as resolved, whereas for redness it was not provided.  The causality assessment between the events: dermatitis, respiratory swelling, redness, and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  This is one of two reports received from the same reporter.