Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | LK6650 | LA |
lump on injection site and very itchy; lump on injection site and very itchy; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; injection site redness and site swelling that spread on the arm including pain; flu symptoms; pain at the injection site; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 at 11:00 as dose 1, single (Lot number: LK6650) at the age of 60 years, in left arm for immunisation. The patient did not receive any other vaccines on the same date as the vaccine(s) for which the reporter is reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which the reporter is reporting. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SIMVASTATIN. The following information was reported: INFLUENZA (non-serious) with onset 25Jun2025, outcome "recovering", described as "flu symptoms"; VACCINATION SITE PAIN (non-serious) with onset 25Jun2025, outcome "recovering", described as "pain at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Jun2025, outcome "recovering" and all described as "injection site redness and site swelling that spread on the arm including pain"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Jun2025, outcome "recovering" and all described as "lump on injection site and very itchy". Therapeutic measures were not taken as a result of influenza, vaccination site pain, vaccination site erythema, vaccination site swelling, pain in extremity, erythema, peripheral swelling, vaccination site mass, vaccination site pruritus. Additional information: On 25Jun2025 (day 2), the patient had flu symptoms and pain at the injection site. By 26Jun2025 (day 3), injection site redness and site swelling that spread on the arm including pain. By 27Jun2025 (day 4), all before and lump on injection site and very itchy.
Medical History/Concurrent Conditions: Allergy
AMLODIPINE; SIMVASTATIN