Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | UNK | K010215 | — |
Anaphylaxis; This spontaneous report was received from a physician and refers to a female patient of 21-years old by reporting time. The patient's medical history, concurrent conditions were not reported. The pt vaccination history included unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 07-JUL-2014, 26-JUL-2007, 23-NOV-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified immunoglobulin antihepatitis b (HEPATITIS B VACCINE) (reported as Hep B, adolescent or pediatric) (on 30-MAY-2003, 30-JUN-2003 and 05-MAR-2004) (captured in case 2262117); unspecified immunoglobulin antihepatitis a (HEPATITIS A VACCINE) (reported as Hep A, ped/adol, 2 dose) (on 02-MAY-2006 and 29-JUN-2005), unspecified hib vaccine (reported as HIB) (on 30-AUG-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 07-JUL-2014); unspecified polio vaccine (reported as IPV) (on 26-JUL-2007, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003); unspecified varicella zoster vaccine (reported as varicella) (on 26-JUL-2007 and 11-JUN-2004); unspecified measles vaccine, mumps vaccine, rubella vaccine (MMR) (on 26-JUL-2007 and 11-JUN-2004): unspecified pneumococcal vaccine (reported as pneumococcal conjugate PCV 7) (on 29-JUN-2005, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003), unspecified influenza vaccine (reported as Influenza, seasonal, injectable, presentative free) (on 22-OCT-2013), unspecified tuberculin PPD (reported as TST-PPD intradermal) (on 11-JUN-2013) and quadrivalent human papillomavirus (GARDASIL) (on 18-AUG-2015 On 18-AUG-2015, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) intramuscular injection (valid lot number K010215, expiration date: 05-MAY-2017 obtained per internal validation) (1 (units not provided) for prophylaxis. On an unknown date, the patient experienced anaphylaxis. The patient also was vaccinated with unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 02-MAR-2020), unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 02-MAR-2020). On 26-MAR-2021, the pt was vaccinated with the first dose of human papillomavirus, recombinant (GARDASIL 9) (captured in case 2221838) and with pertussis vaccine acellular, tetanus vaccine toxoid (DTAP VACCINE) (reported as Tdap). At the reporting time, the outcome of Anaphylaxis was not provided. The causal relationship between the event of anaphylaxis and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was not reported. Upon internal review, the event of anaphylaxis was determined to be medically significant.