Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9P329 | OT |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | C24B9 | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK042AA | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | X026330 | OT |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | HR3649 | OT |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y013348 | OT |
Measles PCR positive; presented with rash on 2/13/2025 described as hives subjectively; RESPIRATORY SYMPTOM; Flu A was negative; Flu B was negative; SARS-COV-2 TEST NEGATIVE; Diagnosed with RSV same day; RSV Rapid multiplex postivie; COUGH; VOMITING; UPPER-AIRWAY COUGH SYNDROME; congestion; PYREXIA; This spontaneous report was received from the Food and Drug Administration (FDA) regulatory authority (2828620-1) regarding a 1-year-old female patient. The patient had no documented medical history and no known allergies. The patient´s concomitant therapies were unknown and concurrent conditions were not reported. On 23-JAN-2025, the patient was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) administered by Intramuscular route in the right leg (RL) (lot number reported as HR3649 was invalid for Pneumococcal 15-valent Conjugate Vaccine [VAXNEUVANCE], expiration date was not reported); with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered by Subcutaneous route in the left leg (LL) (lot number X026330 has been verified to be valid for Measles, Mumps, and Rubella [Wistar RA 27-3] Virus Vaccine, Live [M-M-R II], expiration date not provided but upon internal validation established as 07-NOV-2025), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number was not provided); with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), administered by Subcutaneous route in the RL (lot number Y013348 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date not provided but upon internal validation established as 02-AUG-2026), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number was not provided); all of them were administered as prophylaxis. On that same date, she was also vaccinated with the fist dose of HIB vaccine conj (tet tox) (ACTHIB) administered by Intramuscular route in the RL (lot number reported as UK042AA, expiration date and indication were not reported); with the first dose of Hepatitis a vaccine inact (HAVRIX) administered by Intramuscular route in the LL (lot number reported as C24B9, indication and expiration date were not reported); and with Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), administered by Intramuscular route in the LL (lot number reported as 9P329, indication and expiration date were not reported) (dose, formulation and vaccination scheme frequency were not reported for any of mentioned vaccines). On 07-FEB-2025, the patient experienced congestion (Respiratory tract congestion), cough, vomiting, respiratory symptom, upper-airway cough syndrome, pyrexia, Respiratory syncytial virus (RSV) multiplex was positive (respiratory syncytial virus test positive) and was diagnosed with RSV virus infection (respiratory syncytial virus infection). That day, COVID test was negative (SARS-COV-2 test negative), flu A was negative (influenza A virus test negative) and flu B was negative (influenza B virus test negative). Symptoms resolved on an unspecified date. On 13-FEB-2025, the patient experienced rash described as hives subjectively (urticaria) per urgent case visit on 14-FEB-2025. She was treated with amoxicillin. On 15-FEB-2025, measles PCR test was positive (Morbillivirus test positive). On an unknown day, the patient recovered from all the events. The reporter considered the event of Morbillivirus test positive to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (reported as attributed to vaccine-strain) and sterile diluent (BAXTER STERILE DILUENT), while the causal relationship with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX), HIB vaccine conj (tet tox) (ACTHIB), Hepatitis a vaccine inact (HAVRIX) and sterile diluente (BAXTER STERILE DILUENT) was not reported. The causal relationship between the suspect vaccines and sterile diluent regarding the events of Respiratory tract congestion, cough, vomiting, respiratory symptom, upper-airway cough syndrome, pyrexia, respiratory syncytial virus test positive, respiratory syncytial virus infection, SARS-COV-2 test negative, influenza A virus test negative, influenza B virus test negative and urticaria was not provided.
Sterile diluent
Test Date: 20250215; Test Name: Measles PCR; Test Result: Positive ; Test Date: 20250207; Test Name: RSV Rapid MultiPlex; Test Result: Positive ; Test Date: 20250207; Test Name: COVID test; Test Result: Negative ; Test Date: 20250207; Test Name: Flu A; Test Result: Negative ; Test Date: 20250207; Test Name: Flu B; Test Result: Negative