Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 2 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 3 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 3 | — | — |
is experiencing light headedness; breathing issues; sharp pains in her stomach; She also feels anxious; her throat has been bothering her; she feels generally unwell; Consumer called to report that they received extra doses of HPV vaccine. Consumer stated that her HCP told her she had not been previously vaccinated for HPV and recommended GARDASIL 9. After receiving all 3 doses of GARDASIL 9, with the first dose; This spontaneous report was received from a 34-year-old non pregnant female patient reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 04-MAY-2007, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), then on unspecified dates in 2007, the patient received the other doses of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, dose, route, lot #, expiration date and anatomical location were not provided) for prophylaxis. On 25-JUN-2024, the patient received the first dose (Extra dose administered) of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 27-AUG-2024, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided), then on 17-DEC-2024, the patient received the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 ml (strength, route, lot#, expiration date and anatomical location were not provided). All doses for prophylaxis. It was mentioned that the patient's health care professional stated that she had not been previously vaccinated for any HPV vaccine and recommended Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), then she discovered she had previously received the full series of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (first dose administered on 04-MAY-2007); the prior administration of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was discovered while she was reviewing her immunization records. Her HCP stated that he did not see that in her history. After vaccination of 3 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) in December 2024, she experienced generally unwell, light headedness, breathing issues, sharp pain in her stomach, anxiety and her throat had been bothering her. On unspecified date the patient's flu and COVID tests were negative. The outcome of all adverse events was considered as not recovered as it was mentioned that they happened on and off. The causal relationship between all adverse events and both suspect therapies was not reported.
Test Name: Flu test; Test Result: Negative ; Test Name: Covid test; Test Result: Negative