Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y011819 | OT / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | PJ353 | OT |
CHILLS; INJECTION SITE WARMTH; PYREXIA; INJECTION SITE PAIN; PRURITUS; INJECTION SITE ERYTHEMA; This spontaneous report was received from FDA (agency# 2848498) and refers to a 60-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Influenza vaccine (Influenza vaccine). Concomitant therapies were not reported. On 27-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, which was confirmed to be a valid lot#, expiration date: 01-Oct-2025), dose number 1, administered by Intramuscular route in Right Arm for an unknown indication. On 27-Jun-2025, the patient was vaccinated with Shingrix (Varicella zoster vaccine rgE (CHO)) (lot #PJ353) dose 1, administered by Intramuscular route in the left arm (indication and expiration date were not reported). On 30-Jun-2025, the patient experienced injection site warmth, pyrexia, chills, injection site pain, pruritus, and injection site erythema. Patient had a reaction of redness around the injection site which seemed like spreading but slowly, tenderness with warm touch, fever, chills, and itchiness. Patient started to react around 3rd day of injection, and it has not healed after a week. Recommended patient to apply cold compresses and to take ibuprofen, Tylenol to help reach remission of fever and chills. Also, asked them to get medical attention but patient refused. At the reporting time, the outcome of the events was unknown. The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) and Shingrix (Varicella zoster vaccine rgE (CHO)) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (withheld) , Index date : 2025-09-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2848498 , Central date : 2025-09-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Comments: None
Test Date: 20250630; Test Name: body temperature; Result Unstructured Data: fever