Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
Venous Stasis Dermatitis; Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen; Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen; his feet were completely swollen; Sick; walking at like 25 percent of his capacity because of all the swelling and the rash; couldn't walk properly; Sleeping 12 hours everyday exhausted with a cough; Sleeping 12 hours everyday exhausted with a cough; did not feel well; Lethargic; Sick; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient's relevant medical history included: "pre-diabetic" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RASH (non-serious), SWELLING (non-serious) all with onset 09Feb2025, outcome "recovering" and all described as "Rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen"; STASIS DERMATITIS (medically significant) with onset 09Feb2025, outcome "recovering", described as "Venous Stasis Dermatitis"; PERIPHERAL SWELLING (non-serious) with onset 09Feb2025, outcome "recovering", described as "his feet were completely swollen"; INFECTION (medically significant) with onset Feb2025, outcome "recovering", described as "Sick; walking at like 25 percent of his capacity because of all the swelling and the rash"; GAIT INABILITY (non-serious) with onset Feb2025, outcome "recovering", described as "couldn't walk properly"; LETHARGY (non-serious) with onset 2025, outcome "recovering", described as "Lethargic"; ILLNESS (non-serious) with onset 2025, outcome "recovering", described as "Sick"; SOMNOLENCE (non-serious), COUGH (non-serious) all with onset 2025, outcome "recovering" and all described as "Sleeping 12 hours everyday exhausted with a cough"; MALAISE (non-serious) with onset 2025, outcome "recovering", described as "did not feel well". The events "lethargic", "sleeping 12 hours everyday exhausted with a cough", "rash from the inside of his calves around his shins of his leg with a swelling; his feet were completely swollen" and "his feet were completely swollen" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: (Feb2025) Unknown results; Blood gases: (Feb2025) Unknown results; (Feb2025) Unknown results; Blood glucose: (Feb2025) Unknown results; Blood test: (Feb2025) Unknown results; (Feb2025) Unknown results; Chest X-ray: (Feb2025) Unknown results; Computerised tomogram: (Feb2025) Unknown results; Fibrin D dimer: (Feb2025) Unknown results, notes: D-dimer you know to look it the blood clots for the information that she had; Full blood count: (Feb2025) Unknown results; electrolyte: (Feb2025) Unknown results; (Feb2025) Unknown results; Ultrasound scan: (Feb2025) Unknown results; Urine analysis: (Feb2025) Unknown results; White blood cell count: (Feb2025) 113. Therapeutic measures were taken as a result of stasis dermatitis, rash. Additional information: The reporter stated, "Well I am calling to complaint about Prevnar 20. My husband was given or he was stupidly took the pneumonia vaccine (Prevnar 20) on 24Jan2025 and he was never the same since then. He was sleeping 12 hours everyday exhausted with a cough, did not feel well, lethargic. We kept thinking that it was going to pass, we went away to a wedding and all he wanted to do is sleep and then he woke up this past Sunday with a rash from the inside of his calves around his shins of his leg with a swelling. We fly home by the time he got home off the plane his feet were completely swollen. The (Withheld) never ever had a problem. I took him to the ER on Monday, I did take him to a clinic on Sunday and he was diagnosed with Venous Stasis Dermatitis but I had to have him go through many test they said he definitely had an infection, his white blood cell count was 113, he was given a bag of fluid and Zosyn which is a broad spectrum antibiotic. He is currently on antibiotic, he had a chest X-ray." The reporter stated, "Right now he is on Amoxicillin 125 two times a day." The reporter stated, "It's poison, my husband is I had him checked for, I know he is going through all the test and your that company should be paying whatever I paid. I have good insurance I paid deductible at the hospital and I am sure we are going to get hit with some other like rather I am going to get him with some Gigantic bills, these are the test that we are done. His blood gas, Venous blood gas and the blood work that they did I am sure they did a regular CBC but they checked Venous blood gas, electrolyte. They also checked they did blood cultures, chest X-ray, ultrasound of the legs, D-dimer you know to look it the blood clots for the information that she had. He had, they were checking his blood sugar because he is, it's like a pre-diabetic, checking his blood sugar. They did a septic blood work, Urine test, CAT- Scan with contrast. I haven't checked for Lyme disease, mononucleosis. So, basically I just want you guys to know because I am upset and I am going to write letters everywhere so basically I am going to get a bill from the ER doctor. The neurologist, the hospitalist because my husband took a stupid vaccine they got him sick. He is better now, he couldn't walk properly, he is walking at like 25 percent of his capacity because of all the swelling and the rash. I had to buy antibiotics and ointment for his rash. Can I expect somebody to call me because I am going to go on everyone, every platform that I have and believe me I am a loud mouth on whatever you are going to call it. I am going to write a letter. I have a family member who works and I am going to everybody you know what because this and excuse my language all right so that my husband is 65 years old, he doesn't have an ounce of sad on his body doesn't get sick. He has medications that he takes because he took another vaccine and I am going to tell everybody and I expect to get somebody to call me back from Pfizer and left Pfizer pay all my medical bills that I just had to lay out. I didn't lay them out yet because I didn't get the bills because he took a vaccine and injured him temporarily this is all again of money and I also wanted to know how much my doctor, my PCP. I don't know how much money she gets to tell my husband to fix this poison pen."
Medical History/Concurrent Conditions: Pre-diabetic
Test Date: 202502; Test Name: blood cultures; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: blood gas; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: Venous blood gas; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: blood sugar; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: septic blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: CAT- Scan with contrast; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown results; Comments: D-dimer you know to look it the blood clots for the information that she had; Test Date: 202502; Test Name: CBC; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: electrolyte; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: test; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: ultrasound of the legs; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: Urine test; Result Unstructured Data: Test Result:Unknown results; Test Date: 202502; Test Name: white blood cell count; Result Unstructured Data: Test Result:113