Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
feels like she is getting the flu; phlegm is coming up; feels like her throat is closing up; injection site was bruised; it was red, hot, and itchy; arm was swelling/arm was swelled up like a baseball; it was red, hot, and itchy; it was red, hot, and itchy; She has a lump in her arm; Feels like she is getting laryngitis; stretch marks on her skin; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A 77-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Oct2025 as dose number unknown, 0.5 ml single (Batch/Lot number: unknown) at the age of 77 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LARYNGITIS (non-serious) with onset 2025, outcome "unknown", described as "Feels like she is getting laryngitis"; VACCINATION SITE MASS (non-serious) with onset 2025, outcome "not recovered", described as "She has a lump in her arm"; SKIN STRIAE (non-serious) with onset 2025, outcome "unknown", described as "stretch marks on her skin"; PERIPHERAL SWELLING (non-serious) with onset 29Oct2025, outcome "recovering", described as "arm was swelling/arm was swelled up like a baseball"; VACCINATION SITE BRUISING (non-serious) with onset 29Oct2025, outcome "not recovered", described as "injection site was bruised"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 29Oct2025, outcome "recovering" and all described as "it was red, hot, and itchy"; THROAT TIGHTNESS (non-serious) with onset 01Nov2025, outcome "not recovered", described as "feels like her throat is closing up"; PRODUCTIVE COUGH (non-serious) with onset 03Nov2025, outcome "not recovered", described as "phlegm is coming up"; INFLUENZA LIKE ILLNESS (non-serious) with onset 04Nov2025, outcome "not recovered", described as "feels like she is getting the flu". The events "it was red, hot, and itchy" required emergency room visit. Therapeutic measures were taken as a result of vaccination site bruising, vaccination site warmth, throat tightness, productive cough, vaccination site mass, peripheral swelling, vaccination site erythema, vaccination site pruritus. 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. Additional information: Reporter stated that patient received Prevenar 20 as routine vaccination just because people her age were dying of Pneumonia. Patient's arm was swelling: (From: 29 Oct 2025 To: Ongoing), injection site was bruised: (From: 29 Oct 2025 To: Ongoing), it was red, hot, and itchy: (From: 29 Oct 2025 To: Ongoing), feels like her throat is closing up: (From: 1 Nov 2025 To: Ongoing) was reported as worsened, phlegm is coming up: (From: 3 Nov 2025 To: Ongoing) was reported as worsened, feels like she is getting the flu: (From: 4 Nov 2025 To: Ongoing). Caller was a consumer calling about the medication Prevnar 20. She does not know what was in it. She does not believes in vaccines because she had a reaction to one 10 years ago when her grandson was born. She got the Prevnar 20 vaccine and by Friday her arm was swelling. She got it a week ago Monday on 27Oct2025. Her arm was all swollen and the injection site was bruised. Her arm started getting worse and worse. By Sunday morning her arm was swelled up like a baseball, it looked like her thigh it was swelled up so bad. Her arm was red, hot, and itchy. She went to the emergency clinic and they said it was a allergic reaction to something in the vaccine. She took 60mg of Prednisone at the emergency center along with Benadryl. She was on 40mg of Prednisone for 5 days, and she was on day 3 of the Prednisone. She was 77 years old and she felt like her throat was closing up and phlegm was coming up. Stated that she felt like she was getting the flu. She hopes she does not get pneumonia from this because she was 77 years old. She sent the pictures to her doctor, her doctor was unable to examine her so she went to the emergency clinic. Her arm was itching like crazy and the swelling has gone down quite a bit. It swelled so bad she has stretch marks on her skin. She had a lump in her arm that was not painful like it was before. She thought the injector was not experienced with that kind of injection. Thought he jammed the needle in not in the right spot. There was a lot of vaccine and the person injecting her said that it was the recommended amount. She knew something was going to happen. She knew she was going to have a problem. Her arm started getting more and more swollen on the 30Oct2025, 31Oct2025, and 01Nov2025. 01Nov2025 was the worst day. She should've have gone to the emergency clinic on the 01Nov2025. The redness, hot, and itchiness was better now that she was on the prednisone. On 01Nov2025, she took a Benadryl and a antihistamine because she thought it was a allergic reaction. By Sunday, she had to go to the emergency clinic. She felt like a lump of phlegm was in her throat that won't come out even after coughing. Felt like she was getting laryngitis, was what it feels like. Stated that the Prevnar 20 was in red syringe and the medication looked like it was white. She knew she should not have gotten it, she knew it. The emergency clinic told her to go to the Emergency Room if she did not get better and they would draw her blood to see if she had a bacterial injection. She might have to have it done anyway she has scheduled on 06Nov2025 at 11:15 with Dr. Any AE require a visit to the Emergency Room: No. Any AE require a visit to a Physician's Office: Yes for arm was swelling, injection site was bruised, arm was swelled up like a baseball, it was red, hot, and itchy, feels like her throat was closing up, phlegm was coming up, feels like she was getting the flu. If the patient was hospitalized, please provide the following: N/A. Treatment received for the adverse event/incident: Prednisone and Benadryl. Allergic to any previous vaccination, medications, food or other products: Whooping cough vaccine had a reaction to it 10 years ago. Stated that the arm swelled up and got red and hot, but not as bad as with the Prevnar 20. Was treated with Prednisone at that time. She has not slept in 3 nights because of the prednisone. She is kind of touchy. Description of Product Complaint: Stated that the Prevnar 20 was in red syringe and the medication looked like it was white.