Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 1 | Y015910 | SYR / AR |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y015995 | SYR / AR |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 4 | Y017360 | SYR / AR |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y015558 | SYR / AR |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 1 | Y015910 | OT / RA |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y015995 | OT / RA |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 4 | Y017360 | OT / RA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y015558 | OT / RA |
SCAB; SKIN DISCOLOURATION; URINE OUTPUT DECREASED; RHINORRHOEA; FOOD REFUSAL; COUGH; IRRITABILITY; LABORATORY TEST; Information has been received from FDA VAERS#2838411-1) on 19-MAY-2025, concerning to a 1-year-old male patient. The patient's medical history included atrial-septal heart defect (repaired via catheterization on 25-Mar-2025). The patient's concurrent conditions included Trisomy 21, club foot, plagiocephaly, torticollis, growth hormone deficiency, ketotic hypoglycemia and hypotonia. Concomitant therapies were not reported. On 15-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y015995 has been verified to be valid for this product (also reported as 4015995), expiration date confirmed as 24-Sep-2026), reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). As prophylaxis. On 22-Apr-2025 (approximately 1 week post vaccination), the patient experienced increased irritability (Irritability), runny nose (Rhinorrhoea), refused to eat foods that required chewing (Food refusal), mouth pain (Oral pain). On 25-Apr-2025, the experienced maculopapular rash "which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days." (Rash maculo-papular). It was reported that the rash was swabbed, result was pending The outcomes for the events were not provided. The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live was/were not provided. The causal relationship between the events and sterile diluent was/were not provided. Follow up information has been received from Regulatory Authority FDA on 16-Jun-2025 concerning to a 1-year-old male patient. No illness at the time of vaccination. Concomitant medications included Acetylsalicylic acid (ASPIRIN) and Colecalciferol (VITAMIN D) . On 15-Apr-2025, as private, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y015558, expiration date not reported but upon validation established as: 16-Sep-2026; with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot #Y015995, expiration date not reported but upon validation established as: 24-Sep-2026, reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported); with the fourth dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) lot #Y017360, expiration date not reported but upon validation established as: 28-May-2027; with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot #Y015910, expiration date not reported but upon validation established as: 06-Feb-2026. All vaccines were received in his right arm (route not provided) as prophylaxis. On 22-Apr-2025 (approximately 1 week post vaccination), the patient experienced increased irritability (irritability), refused to eat foods that required chewing (Food refusal) presumably due to mouth pain and cough. Patient also showed a runny nose (rhinorrhoea). On 25-APR-2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days (skin discolouration). Spots were raised and crusty and looked like chicken pox (scab). Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite and fewer wet diapers (urine output decreased). On 28-APR-2025, the patient was evaluated by pediatrician as it was necessary office visit. Swabs of spots were taken and results are pending (Laboratory test). The events required physician office visit. At the reporting time, the patient had not recovered from all adverse events. The causal relationship between all adverse events and suspect therapies were not provided. Additional information is not expected.
Clubfoot; Growth hormone deficiency; Heart septal defect atrial ((repaired via catheterization on 3/25/2025)); Hypotonia; Ketotic hypoglycemia; Plagiocephaly; Torticollis; Trisomy 21
aspirin; Vitamin D
Test Date: 20250428; Test Name: Investigation; Result Unstructured Data: Swabs of spots were taken and results were pending.