Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | — | RA |
Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Arm started turning red; discoloration in the arm; White spots; Fever; Heart palpitations; Increased amount of joint pain; This is a spontaneous report received from a consumer. A 56-year-old female patient received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), in Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Arm started turning red; discoloration in the arm"; PYREXIA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Fever"; PALPITATIONS (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Heart palpitations"; ARTHRALGIA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Increased amount of joint pain"; EXTENSIVE SWELLING OF VACCINATED LIMB (medically significant), JOINT SWELLING (medically significant), BREAST SWELLING (medically significant) all with onset Jun2025, outcome "recovered" (2025) and all described as "Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip"; SKIN DEPIGMENTATION (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "White spots". The events "severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip", "arm started turning red; discoloration in the arm", "white spots", "fever", "heart palpitations" and "increased amount of joint pain" required physician office visit. Therapeutic measures were taken as a result of extensive swelling of vaccinated limb, joint swelling, breast swelling, erythema, skin depigmentation, pyrexia, palpitations, arthralgia. The patient had an adverse reaction to Prevnar 20. The patient was vaccinated in Jun2025 in the right shoulder and that night (of the same day) began to experience severe swelling, discoloration in the arm. The arm started turning red, these white spots, fever and also experienced heart palpitations and the swelling went from the shoulder down through the right side into the right breast down to the right hip, and increased amount of joint pain. All of this, the patient was not hospitalized, the patient was treated at home outpatient service, but these symptoms persisted for approximately roughly three months. The patient was not hospitalized. The patient had multiple doctor visits with her doctor, now she did not know what kind of treatment the doctor gave or prescribed to the patient. The information on the batch/lot number for Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) will be requested and submitted if and when received.