Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | LK6655 | LA |
Extreme injection site pain and swelling; Extreme injection site pain and swelling; extreme itchiness; Unable to sleep at night because of the pain; This is a spontaneous report received from a Nurse from a sales representative. A 64-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 17Mar2025 at 11:45 as dose 1, single (Lot number: LK6655), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 20Mar2025, outcome "recovered" (26Mar2025) and all described as "Extreme injection site pain and swelling"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "Unable to sleep at night because of the pain"; VACCINATION SITE PRURITUS (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "extreme itchiness". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site pruritus, sleep disorder due to general medical condition, insomnia type. Additional information: Extreme injection site pain and swelling. Along with extreme itchiness. Unable to sleep at night because of the pain. The patient did not receive any other vaccines on the same date as the PREVNAR 20.