Received Dec 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y019158 | OT / LA |
INJECTION SITE ERYTHEMA; TENDERNESS; INJECTION SITE PAIN; INJECTION SITE STREAKING; Information has been received from FDA (agency #US-009507513-2360631) on 10-DEC-2025. This Spontaneous report was received from Regulatory Authority and referred to a/an 71 -year-old Female patient. The patient's concurrent condition(s) included Thyroid and Allergies ampicillin. The patient's historical drugs included Ampicillin. The patient's concomitant medications included Levothyroxine and Ozempic. On 19-Aug-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) (Batch/Lot Number: Y019158) (Expiration date: 20-May-2026) via Intramuscular (Anatomical Site: Left Arm). The patient started therapy with PNC21 PNEUMO (CAPVAXIVE) for the treatment of Prophylaxis, On 20-Aug-2025, the patient experienced TENDERNESS. On 20-Aug-2025, the patient experienced INJECTION SITE PAIN. On 20-Aug-2025, the patient experienced INJECTION SITE STREAKING. On 20-Aug-2025, the patient experienced INJECTION SITE ERYTHEMA. At the time of reporting, the patient had not recovered from Injection site erythema . At the time of reporting, the patient had not recovered from Injection site pain . At the time of reporting, the patient had not recovered from Injection site streaking . At the time of reporting, the patient had not recovered from Tenderness . The causal relationship between the event of TENDERNESS and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided. The causal relationship between the event of INJECTION SITE PAIN and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided. The causal relationship between the event of INJECTION SITE STREAKING and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided. The causal relationship between the event of INJECTION SITE ERYTHEMA and Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPVAXIVE) was not provided.
Penicillin allergy; Thyroid disorder
Levothyroxine; Ozempic