Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y013009 | OT / LA |
headache; Injection site erythema; Injection site pain; Injection site pruritus; Injection site inflammation; Injection site warmth; This spontaneous report was received from a Regulatory Authority and refers to a 65-year-old female patient. The patient's medical history was headache, injection site erythema, injection site inflammation, injection site pain, injection site pruritus and injection site warmth. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Jan-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (lot #Y013009, expiration date: 17-Nov-2025), dose number 1, administered by Intramuscular route in Left Arm for prophylaxis. On 16-Jan-2025, the patient experienced headache. On 16-Jan-2025, the patient experienced Injection site erythema. On 16-Jan-2025, the patient experienced Injection site pain. On 16-Jan-2025, the patient experienced Injection site pruritus. On 16-Jan-2025, the patient experienced Injection site inflammation. On 16-Jan-2025, the patient experienced Injection site warmth. At the reporting time, the patient had not recovered from headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site inflammation and Injection site warmth. The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of all adverse events and Pneumococcal 21-valent Conjugate Vaccine was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2821300-1 , Central date : 2025-03-26 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Medical History/Concurrent Conditions: Headache; Injection site erythema; Injection site inflammation; Injection site pain; Injection site pruritus; Injection site warmth