Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
it has started to itch; felt warm to touch, felt achy, just kind of like flu type symptoms; Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.; Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.; As far redness, seems to be getting a little better.; arm was hurting; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old female patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 21May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). Concomitant medication(s) included: TETANUS VACCINE. Vaccination history included: Pneumovax, for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22May2025, outcome "not recovered", described as "arm was hurting"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23May2025, outcome "unknown", described as "As far redness, seems to be getting a little better."; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 23May2025, outcome "unknown" and all described as "Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body."; INFLUENZA LIKE ILLNESS (non-serious) with onset 23May2025, outcome "unknown", described as "felt warm to touch, felt achy, just kind of like flu type symptoms"; VACCINATION SITE PRURITUS (non-serious) with onset 28May2025, outcome "unknown", described as "it has started to itch". Therapeutic measures were taken as a result of vaccination site pain. Additional information: Caller states, she called before about Prevnar 20, last week. Unfortunately, was driving, could not write down what agent was going to give her. They wanted to ask more questions. Wanted to speak to someone who could tell about reaction. Only had enough time to speak to one person, wanted to find out if she should go to hospital or not. When clarifying what day report was made with Pfizer, caller states, she got injection Wednesday. 99 percent sure she called Friday, 23May2025, was on the way to go watch her granddaughter. Arm hurt: When clarifying reaction caller referring to, that she experienced after Prevnar 20 injection, she states, was a pretty severe reaction. Had injection Wednesday morning, about noon, probably around noon. Then, Thursday, arm, did not pay attention by looking at it but, arm was hurting. Has had tetanus shots that hurt. But this, felt warm to touch, felt achy, just kind of like flu type symptoms. Did not think much of it, took some Advil. Arm swollen: Then, on Friday morning, woke up, arm was swollen, from like, shoulder to elbow. Had huge red, like bright red, probably 4 inches long, looked like someone had smashed her or something. Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body. Always gets shots in left because, she is right handed. Hurt to move it, even to get up off couch, was hurting extremely bad. Did not have difficulty breathing. Looked up what they considered to be severe, was not having anaphylactic shock. Thought, will be another day, thought the next day should be better. Woke up Friday morning, was not better, was worse. When she started getting panicky, called Pfizer, talked to girl, told her about this, gave all symptoms, as being described here. Wanted to talk to someone who could tell if this was normal and, if it should be getting worse after 48 hours. The agent could not help, she did not get the information, they were not helpful. Asked how many times they get reports of people saying 48 hours, still have this, getting worse, if they think it should get a little better. This is worse, redder, more swollen, hurts more. Agent was not helpful at all. This was Friday, kept wanting to go to Emergency Room. Then, Monday was holiday. On27May2025, contacted doctor office because, left message with assistant. Has not heard back from doctor. Always worries because, doctor does not have best medical assistant, not as thorough. On 28May2025, has been a week. Just today it has started to itch. A little itchy means, it is getting better. However, arm still in pain. Told them originally, where arm goes up into shoulder, at very top of shoulder, further than were shoulder meets arm, goes probably another 3 inches, that pain still there, that part has not gotten better. As far redness, seems to be getting a little better. Swelling sems to be going down a bit, now itchy and has been scratching. Clarified, 23May2025, Friday was the date she called, clarifying that the pain started that Thursday, 22May2025. Pain was not much but, all ready knew pain was there, was getting red. Friday, 23May2025, was looking really bad. All symptoms described, were getting bad, worse and took pictures every day, of arm, was sending to son, who is paramedic. Patient's son told her to go to Emergency room, did not want to sit in room with bunch of people. When she spoke with Pfizer, they did not talk like it was horrible. Wanted to report it still because, she is still having the pain in arm. Can still see slight redness, can tell is a little swollen but, the pain still there. That is concerning to her, why she is still having pain like this. Now, can move arm around but, it hurts, all the way from elbow, up all the way into above shoulder blade, where it connects to arm. When she moves arm, hurts all the way, about 3 inches up into shoulder. Wanted to make sure that was all on file. Did not know if there was something she can do. Clarified, the pain and swelling being referred to, where she received injection, in left arm. Not like she gets a lot of shots, did get original Covid, the 2 and the booster. That was years ago. Thinks she just got flu shot last year. In past, has had Pneumovax, all the ones they want people to have. Treatment: The only thing, other than Advil is, she has some muscle relaxers that she had, Tizanidine. If she has lower back pain, muscle spasms, can take Tizanidine, does not take it often. The pain so bad, as far as sleeping, did take Tizanidine Friday night, Saturday night, Sunday night. Can't drive if she takes those, so just took the 3 nights. Does not have pain medicine or anything, nothing like that. Causality for "arm was hurting", "was like, odd shape, was long, from under where she got shot, down. was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.", "as far redness, seems to be getting a little better.", "it has started to itch" and "felt warm to touch, felt achy, just kind of like flu type symptoms" was determined associated to device constituent of pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (malfunction). The information on the batch/lot number for pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Lupus erythematosus
TETANUS VACCINE