Received Mar 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | RA |
My body is hot; Not able to breathe; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet; Ear was in pain; Toe was really like a dry; looks like I have shingles; This is a spontaneous report received from a Consumer or other non HCP. A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Medical history: Consumer stated, No, I do not have any other medical condition. The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (medically significant), outcome "unknown", described as "My body is hot"; DYSPNOEA (medically significant), outcome "unknown", described as "Not able to breathe"; RASH (medically significant), PAIN (medically significant), outcome "not recovered" and all described as "Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet"; ERYTHEMA (medically significant), PRURITUS (medically significant), outcome "unknown" and all described as "Rashes in my whole body; had itches all over in pain; it became worse; more redness all over; rash in my hands, in my feet"; EAR PAIN (non-serious), outcome "unknown", described as "Ear was in pain"; DRY SKIN (non-serious), outcome "unknown", described as "Toe was really like a dry"; HERPES ZOSTER (non-serious), outcome "unknown", described as "looks like I have shingles". Therapeutic measures were taken as a result of feeling hot, rash, pruritus, pain, dry skin. Additional information: The consumer stated, "I need to report side effect of the vaccine, the Pfizer vaccine I take the Prevnar 20. The consumer stated, After two hours I did take the Prevnar 20 and got severe like a rashes in my whole body. My body is hot and then I had itches all over in pain. So, I took like I needed to go to the hospital and they gave me some shot for steroids (Suspect captured as Unspecified Steroid shot) or whatever and that didn't mean not a little bit the side effects so I went to sleep after that and then I wake up my body was normal but the yesterday starting like a 07:30 PM. I start eat again and I have bed time it became worse because then it was more redness all over and then attack you know my ear was in pain and then my toe was really like a dry and I start like not able to breathe and I needed to rush to the emergency room. Now they gave me more like a medication they gave me Prednisolone and the guy told me that this should be okay to take and I was 5 until like around 2 PM today and I assume getting worse and worse. I need to go to the emergency room again because neither the shot neither the medication nothing is helping and I can't feel right now, my body is becoming rash in my hands, in my feet and I am in pain and it is not resolving my problem and I don't know at this point what to do? The consumer further stated, This is like, is that attacking me looks like I have shingles and nobody told me that these vaccines shot have sort of side effects because if they will tell me I will not take it and for now on I am not taking any Pfizer vaccine or any vaccine at all because I am done with vaccine because after these side effect I can not deal with it no more. It is very painful and I am comfortable costly you know I am not able to wanted that yesterday today and even to take off of what because I am in pain." 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: No, Comment: Other Medical history: Consumer stated, No, I do not have any other medical condition.