Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y013565 | IM / LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT / LA |
She also reports that her daughter developed a headache; swelling in the left arm where she received the vaccine; eczema flare up; 1st dose received on 08-JUN-2024, 2nd dose on 01-JUL-2025, over 12 months apart; the consumer developed signs of an allergic reaction including red bumps on the inside of both arms, eczema flare up and swelling in the left arm where she received the vaccine; low white blood cell count at 3.9; Consumer's mother called to report an adverse event for GARDASIL-9. The caller reported that her daughter received the 1st dose of the GARDASIL-9 series on June 8th, 2024. She had a minor eczema flare up which her mother reported was typical followi; This spontaneous report was received from a Consumer (the patient's mother) and refers to a(n) 11-year-old female patient (also reported as 12 years old at the time of the report). The patient's medical history was not reported. The patient's concurrent conditions included eczema. Concomitant therapies were not reported. On 08-Jun-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, formulation, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2024, she had a minor eczema flare up which her mother reported was typical following any vaccine or shot. On 01-Jul-2025, the patient received the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) (dose, formulation, lot # and expiration date not provided) intramuscularly in Left Arm for prophylaxis (preventative Vaccine) (inappropriate schedule of product administration). On the same day, within a couple of hours or receiving the second dose of the suspect vaccine, the patient developed signs of an allergic reaction including red bumps on the inside of both arms, eczema flare up (assessed as different from the flare up after the 1st dose) and swelling in the left arm where she received the vaccine. On 02-Jul-2025, the patient developed a headache. The mother reported that the patient's left arm was still swollen and she continued to have the constant headache every day since 02-JUL-2025. She reported that her daughter has taken allergy medicine and Tylenol. The Tylenol worsened the headaches. She had an appointment with her Primary Care Provider on 14-JUL-2025, to discuss these symptoms and was recommended Magnesium and vitamin B2. The Magnesium and vitamin B2 have had no effect on the headaches. She also had a magnetic resonance imaging (MRI) performed on 24-JUL-2025. The caller has not received the results of the MRI at this time. On an unknown day in July 2025, blood work was also completed, showing everything within normal range, except low White Blood Cell count at 3.9 (unit not provided). The mother reported that they have an upcoming appointment with a neurologist. No additional information provided. A call was also received from a physician, who was looking to see if there was any data suggesting long term headaches via VAERS and if there were any recommendations for treatment. The physician requested for information to be sent via email. No additional questions. The outcome of eczema flare up (both episodes), low white blood cell count, and allergic reaction was not provided. At the reporting time, the patient had not recovered from headache and swelling in the left arm. The action taken with the suspect vaccine was not applicable. The causal relationship between the events and the suspect vaccine was not provided. Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02846065-02846064 , CLIC number : , ESTAR number : , IRMS number : 500UW00000h6fVzYAI|28072025230048|3348 , Central date : 2025-07-29 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02846065 , MNSC interaction number : 02846064 , Integration log UniqueID : 500UW00000h6fVzYAI|28072025230048|3348 , Service cloud CaseID : 500UW00000h6fVzYAI
Eczema
Test Date: 202507; Test Name: blood work; Result Unstructured Data: normal; Test Date: 202507; Test Name: white blood cell count; Result Unstructured Data: 3.9 (unit not provided)