Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Vaccination site pain, Vaccination site swelling
Clinical narrative: almost like a, looks like a pimple type of little cyst; She had continued swelling, kind of bubbling like a cyst, from a covid vaccine she got a couple months back; She got the injection except the pain was kind of dissipated. The pain was still there for they knew, maybe two months, it is just tender now,; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03May2024 as dose 1 (toppac), single (Lot number: HJ8939) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sarcoma" (unspecified if ongoing), notes: 20 year cancer survivor (primary bone cancer, a sarcoma); "immune problems" (ongoing), notes: present prior to getting the covid vaccine) so she sometimes has weird reactions; "Surgery" (unspecified if ongoing), notes: many years before; "nerve pain" (ongoing). Concomitant medication(s) included: LYRICA taken for neuralgia. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EP7533, left arm), administration date: 16Apr2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: ER8736, left arm), administration date: 07May2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: FF2593, left arm), administration date: 10Nov2021, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE,Lot: FK9894, left arm), administration date: 20Apr2022, for COVID-19 immunization; BNT162b2 (DOSE 5 (BOOSTER), SINGLE,LOT: GH9702, left arm), administration date: 21Sep2022, for COVID-19 immunization; rsv vaccine (LOT: 579F4), administration date: 15Nov2023, for immunization; Moderna vaccine (DOSE 6 (BOOSTER), SINGLE), administration date: Oct2023, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "not recovered", described as "She got the injection except the pain was kind of dissipated. The pain was still there for they knew, maybe two months, it is just tender now,"; VACCINATION SITE SWELLING (non-serious) with onset 2024, outcome "not recovered", described as "She had continued swelling, kind of bubbling like a cyst, from a covid vaccine she got a couple months back"; ACNE (non-serious) with onset 2024, outcome "not recovered", described as "almost like a, looks like a pimple type of little cyst". Additional information:The caller stated she occasionally had reactions to vaccines. She had, not a major problem, but a reaction to the Pfizer Covid Vaccine 2023-2024 formula for adults. She had continued swelling, kind of bubbling like a cyst, from a covid vaccine she got a couple months back. She stated, she thought it was her imagination. However, she knew where she got it on her body because she had them put different vaccines in different places. She was able to get the lot number- HJ8939. She knew from her experience, that sometimes there are additives added like antibiotics and that was where she usually has issues. She was a 20 year cancer survivor (primary bone cancer, a sarcoma) and has some immune problems (present prior to getting the covid vaccine) so she sometimes has weird reactions. This is not new territory. The caller stated she knew some come in large batches and some come in individual dose batches. Usually her doctor's office gets them in a different way than the pharmacies do, or that was at least what they traditionally used to do. She wanted to know what ingredients this particular batch/lot number had. It was reported that, she had a bubbling like cyst and swelling from the covid vaccine that she got a couple of months back. She was calling about the Pfizer Covid Vaccine (Comirnaty) 2023-2024 Formula. She reported that she had a reaction of swelling, a bubbling like cyst from the vaccine that she got a couple of months ago. So, she said she was swelling kind of, a bubbling like a cyst." When paraphrased the concern, consumer stated, "Yes and that there was still, that did not seem to be like any discharge, but it that area has swelling around it, it was still after four months, almost four months now, three months. She got this vaccine May, she thaught May 9th. So, after three months, She still had this and it is periodically has almost like a, looks like a pimple type of little cyst and if she tried to break it, it just keeps coming up over and over and the swelling was still there. It did not really hurt but it was still lumpy. She did have a LOT# of the that vaccine, She did not know, if that was something she need to reference. Height: Consumer stated, "5(Feet), 8 and half(inches). Vaccination facility details (redated). Date of vaccination, consumer stated, "She thaught it was the 9th. It was a May 3rd, 2024." Product details of Pfizer Covid Vaccine (Comirnaty) 2023-2024 Formula: Expiration date: Consumer stated that she did not knew it was right, you know, in the middle of when they were doing spring vaccine so, clinic might knew that information, She did not had that." When probed to clarify that consumer was not able to provide NDC#, UPC#: Consumer stated, "Correct, they just gave her the LOT#(Later consumer provided NDC#)." Dose of the vaccine, Patient reported, "It was a May 3rd of 2024. No, She did not know." Other medical conditions and other medication: She did take Lyrica and she was a cancer survivor." Indication for Lyrica: Consumer stated, "Nerve pain due to my surgery, many years before, She had a surgery many years ago." Events details: Date: Consumer stated, "Probably, right when shehad the vaccine, She knew, she had the swelling and after she took the band-aid off, it was kind of looking that way and then just kind of kept staying that way. So, everything was being the same since She got the injection except the pain was kind of dissipated. The pain was still there for they knew, maybe two months, it is just tender now, it is now, did not hurt, it is just tender to push on the kind of swollen area." Still experiencing the events:Reported that, Yes, she was." Outcome of event: Consumer stated, "Well, it was only been a very slight improvement since She got the injection." Treatment: She went to doctor's visit to look at it and she just suggested a warm compress, she did not see any discharge that she was worried about. She just said to put warm compress on it but she thought she should report this because it was still been so swollen since she got it, no treatment, no just warm compresses." Vaccination details: Time of vaccination: Consumer stated, "Time of day, She thought it was morning, morning time. Her appointment was, it was 1 PM." When probed if there was any previous immunization with the Pfizer Covid vaccine: Consumer stated, "Any other, no, She got another Vaccination later for RSV but not, nothing at the same time. She needed to look on one more record here." When probed for product details for RSV Vaccine (LOT#, Expiration date#, NDC#, UPC#), consumer stated, "That one She got that at different pharmacy and they did send me some follow-up information, so, it was be here. May have been the Pneumonia, She was old so, she got a lot of vaccines, She was going to have them checked. She got really different, it was not RSV vaccine, She got the Pneumonia vaccine (Prevnar 20) on June 28th 2024 so, it was Prevnar 20. She did have the LOT# and then manufacturer for that, that was Pfizer." Product details for Prevnar 20 (Expiration date#, NDC#, UPC#): Consumer stated, "Unfortunately, that She did not have." Consumer further stated, "That Prevnar 20, She got after the COVID vaccine, the only other vaccine She got before then were in November of 2023." When probed if any vaccines administered on same date with the Pfizer COVID Vaccine, consumer stated, "No, there were no other vaccines that day." When probed if there was any other vaccinations within four weeks prior to the administration of Pfizer Covid Vaccine, consumer stated, "Yes, there were several in 2023 that I got in October and November. So, November of 2023, I got the RSV vaccine." When probed to clarify that consumer did not had any problem with other vaccine that she got in November 2023, consumer stated, "Right, She did not have any problem with that and the previous Covid vaccine She got in October of 2023 was Moderna Vaccine not Pfizer, She had no problem with that." Product details of Moderna Covid Vaccine (LOT#, Expiration date#, NDC#, UPC#): Consumer stated, She only had the LOT# for that one." When probed for (LOT#, Expiry date, NDC#, UPC#) for the previous Pfizer Covid vaccine that consumer took in 2023, consumer stated, She only had the LOT# for that matter and She did not have the UPC or any other information." When probed for the date of administration of first Covid vaccine, consumer stated, "The very first one She got was, she thought April 16th, 2021. She thought she got before that, She would have to go back to her mother record here. April 16, 2021, it looks like that was the first Covid Vaccine, that was Pfizer, she only got a Moderna recently, all the other ones she ever had were Pfizer and she did not know if she had LOT numbers on these and all. I do actually. I have every LOT number for all of the previous Pfizer's." Consumer stated, "The first one I got was April 16, 2021 and that was EP7533 and the second one I got and that's the only information I have for that is all in my left arm as far as I can tell. The second one she got was May 7,2021, that was LOT# ER8736. Then she got one, November 10, 2021, LOT# FF2593. She got one April 20, 2022. She did have two numbers for this. She got LOT# FK9894 and NDC# 59267- 1025-1 and it said dose was 3 milliliters. She got one September 21, 2022, LOT# GH9702, NDC# 59267- 0304-2, dose 3 milliliters." When confirmed the NDC# of the dose administered on May 3, 2024, consumer stated, "It also says Comirnaty, it's the product." When probed for the LOT#, Expiry date, NDC#, UPC# for the RSV vaccine, consumer stated, "That was November 15, 2023. The RSV number, She just had the LOT#, 579F4." Reassurance: Consumer stated, "No, that's good She always had good luck with Pfizer in the past and that was surprising to me but perhaps it's just all these vaccinations.The caller did not report any drug inefficacy.