Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | Z004034 | OT / LL |
reached a fever of 102 overnight from 10/1/2025 to 10/2/2025; sterile abscess; swelling at the injection site; pain at the injection site/he is still experiencing mild pain at the injection site; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's medical history included febrile seizures. The patient's concurrent conditions included allergy to cephalosporin. Concomitant therapies were not reported. On 30-Sep-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, 0.5 ml, lot #Z004034, expiration date: 19-Jan-2027, administered by intramuscular route in the left thigh (dose number was not provided), for prophylaxis. On the same date (reported as "that evening"), the patient became symptomatic and he experienced pain and swelling at the injection site. The patient reached a fever of 102 (unit not provided) overnight from 01-Oct-2025 to 02-Oct-2025. The patient's mother alternated paracetamol (TYLENOL) and ibuprofen (MOTRIN) for symptom relief and he was also provided with a cold compress which did not help the symptoms. The patient's mom brought him to his primary care physician (PCP) who advised him to be seen at an unspecified hospital where he was diagnosed with a "sterile abscess". The patient was not admitted and was sent home with instructions to continue paracetamol (TYLENOL) and ibuprofen (MOTRIN) as needed for pain and fever. On an unknown day in October, the patient's fever resolved however he was still experiencing mild pain at the injection site and was "still favoring the left leg." The outcome of swelling at injection site and sterile abscess was not provided. At the reporting time, the patient did not recover from pain at injection site. The action taken with the suspect vaccine regarding events was considered as not applicable. The causal relationship between events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided.
Allergy to antibiotic
Medical History/Concurrent Conditions: Febrile seizure
Test Date: 20251001; Test Name: fever of 102; Result Unstructured Data: fever of 102 (unit not provided)