Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; a low grade fever; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Jan2025 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "Drug Allergy", notes: in the 1980's. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Jan2025 at 07:00, outcome "recovered" (07Feb2025) and all described as "Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "a low grade fever". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pain, vaccination site pruritus. Additional information: She took Prevnar 20 on 06Jan2025 at 10:00 AM. On 13Jan2025, she woke up with a horrible red rash on my left upper arm. It was painful and itching. As the day progressed the rash extended all around my left upper arm. She had the Prevnar vaccine on 06Jan2025 at the doctor's office. Benadryl and Advil relieved the symptoms some. She sent a message to the nurse practitioner and was instructed to monitor her arm, take the Benadryl and Papin relievers. Should she develop shortness of breath or other serious symptoms to go to an ER for treatment. The rash itched for approximately 2 weeks and the rash started fading after about a week. She continued taking the Benadryl and Advil for "203" weeks. The symptoms were reported to the doctor's office on the 13Jan2025 and an update reported through massaging on the 16Jan2025. She did develop a low-grade fever, and the itching continued over several weeks. It was reported that the patient did not receive any other vaccines on the same date as Prevnar 20. The patient was taking other medications within 2 weeks prior to the event onset date. The patient did not receive any other vaccines within 4 weeks prior to Prevnar 20. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None