Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | X018884 | — |
swelling eye, face; swelling eye, face; Patient had rash toneck/face; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2227735. The previous case ID: 2501USA009410, and 2501USA009410. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report was received from a nurse via company representative and refers to a patient (age and gender were unknown). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient developed a rash on their face immediately after the vaccination. No additional details to report. At the time of reporting, the outcome of the event was not known. The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Lot # is being requested and will be submitted if received. This report is considered to be non-valid due to lack of patient's identifiers. Follow up information has been received from an unspecified health care professional on 19-FEB-2025, which reported that and refers to a(n) 14-year-old female patient with no illness at the time of vaccination. The patient's medical history was not reported. The patient's concurrent conditions included obesity. Historical drugs included Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid), and Menquadfi (Meningococcal vaccine A/C/Y/W conj (tet tox)). Concomitant medications included Lisdexamfetamine Mesilate(VYVANSE), Amfetamine aspartate;Amfetamine sulfate;Dexamfetamine saccharate;Dexamfetamine sulfate (ADDERALL), Clonidine hydrochloride (CLONIDINE). On 05-APR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Injection, prefilled syringe, (lot #X018884, expiration date: 23-APR-2025) for the treatment of Prophylaxis. On 05-APR-2024, reported as 3-4 hours after vaccination, the patient experienced rash in face and neck (rash) and swelling eye, face. No anaphylaxis was reported. No new medications, products, foods ingested this day. No treatment or medical care sought. The outcome of the events was reported as recovered on 06-APR-2024, reported as duration 1 day. The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02741444-02741430 , CLIC number : , ESTAR number : , IRMS number : 500UW00000S4bVWYAZ|19022025230027|1681 , Central date : 2025-02-20 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2501USA009410 , MNSC case number : 02741444 , MNSC interaction number : 02741430 , Integration log UniqueID : 500UW00000S4bVWYAZ|19022025230027|1681 , Service cloud CaseID : 500UW00000S4bVWYAZ
Obesity
Vyvanse; Adderall; clonidine