Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9547 | IM / RA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
painful golf ball size lumb; I end up with a lump right below my right shoulder about size of golf ball and it was very painful; I end up with a lump right below my right shoulder about size of golf ball and it was very painful and also radiate pain all the way down to my fingers; chills; The initial case was missing the following minimum criteria: ICH unspecified product. Upon receipt of follow-up information on (07Oct2025), this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 69-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: influenza vaccine (Flu shot.), administration date: 15Sep2025, when the patient was 69-year-old, for Immunization; Bnt162b2 (DOSE: 1), administration date: 2020, for COVID-19 Immunization; Bnt162b2 (DOSE: 2), administration date: 2020, for COVID-19 Immunization; Bnt162b2 (DOSE: 3), administration date: 2020, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Sep2025, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 19Sep2025, outcome "recovered" (Oct2025), described as "I end up with a lump right below my right shoulder about size of golf ball and it was very painful"; PAIN (non-serious) with onset 19Sep2025, outcome "recovered" (Oct2025), described as "I end up with a lump right below my right shoulder about size of golf ball and it was very painful and also radiate pain all the way down to my fingers"; VACCINATION SITE MASS (non-serious) with onset 19Sep2025, outcome "not recovered", described as "painful golf ball size lumb". The events "painful golf ball size lumb", "i end up with a lump right below my right shoulder about size of golf ball and it was very painful" and "i end up with a lump right below my right shoulder about size of golf ball and it was very painful and also radiate pain all the way down to my fingers" required emergency room visit. Therapeutic measures were taken as a result of vaccination site pain, pain. Additional information: Bad vaccination sight effects. Given this past monday. Painful golf ball size lump, pain radiating down to my fingers, & Chills. Got Pain pill & bandage on arm. Still in pain. Upon follow-up on 07Oct2025 Consumer stated, Today, he got a long form to fill out and he thought , he just about finished everything except emergency room records. He also send his primary, will follow-up his primary care physician tomorrow. he made several weeks ago. He went to his physician and got my Flu Shot (Unspecified Flu shot). Now, the nurse tried to tell patient that he could not get COVID shot because they tried to say that his insurance would not pay for it. When patient went to go get his diabetic medications at (withheld) pharmacy, they said, patient was covered. So, they proceed to go ahead and gave him a Pfizer COVID Shot. Now, it already says on page one here, they kept the results of that form that patient filled out online, patient end up with a lump right below his right shoulder about size of golf ball and it was very painful and also radiate pain all the way down to his fingers, it was that way for two whole weeks. Matter of fact, the lump golf ball size lump is still there. patient just not feeling any pain shooting down on his fingers anymore. In about seven hours after he got the injection, he had to go to ER, emergency room, the nearest emergency room he could, about 15 miles from where he lived. He went to emergency room and the only thing they gave him was a pain pill and a Lidocaine patch. When he found at the very next morning went to sleep in my car at the (withheld) and went into the pharmacy the very next day. Since that time the pharmacist not the one that gave patient the shot, the lady manager, pharmacist manager called him and followed up with him and patient have not spoke to the store manager yet, she had been busy. But they got a hold of some kind of national drug reporting, it's kind of like CBC but they did not call it CBC, they called it something else and they are going to file a claim for him. They were spoke Walmart pharmacy the bill, they were supposed to sent him an email to read but had not received that email yet." When paraphrased the concern, consumer stated, "Since, he actually filled out the online form on Pfizer.com, he actually filled out in detail everything that happened from the time he got his Flu Shot that Thursday and then the following Monday, he got the COVID Shot. They did not warn him because he had there COVID Shots back in 2020 and he did not have any problem with it. he had like a cold day and a hot day but then three Pfizer shots but this was terrible. This was awful. This vaccination was totally awful." Consumer was informed about the role of Pfizer Drug Safety and was requested to fill out the questionnaire and send it back to sender. Consumer was also informed that provided information would be mentioned in the report. Consumer stated, "This is all turned in to his and Medicare provider. he got withheld and he got notified, he got actually got a thing in the mail from withheld showing where they had got billed for the vaccination. he had to look around here because he more than getting mail from. he thought, had got it on email, could print it up. he think he can send it in to also. If he could not get all this forms filled out, he would take it to his physician tomorrow and give them to fill as much if it as he can too, also, got his physician. patient also going to take emergency room records with him to physician tomorrow also." Consumer was requested the consumer to fill out the questionnaire and send it back to sender. Consumer was also informed that provided information will be mentioned in the report. Consumer stated, "They said, it will go to, the prepaid, Pfizer incorporated Drug Safety Unit and anyways, it's got a number there go to withheld. Anyway, it going to be going to when they get it all filled out by most, patient going to take the form with him tomorrow, when patient went to see his primary care physician and to help got it filled out and like they said, the people. patient would look it the vaccination online when he filled out that form to send in to them and that's how he ended up getting this form in the mail. If a person read all the possible side effects on the Pfizer website, they would not have got the vaccination. There is a list of side-effects on there absolutely worse than what I have been through. But what I have been through has been bad enough. he got lump on his arm about the size of a golf ball where they put the syringe, stick the syringe in and then there for about two short weeks, he had pain radiate down his arm from there to his fingers. he have passed all the information on to emergency room physician and would pass all that on to his regular physician when patient saw her tomorrow because they request, they said they want patient to follow-up with his primary care physician so he was going to be seeing her tomorrow morning. Weight: Consumer stated, "he was about 250 pounds(Consumer was not sure hence not captured in tab)." Vaccination details: Date: Consumer stated, "19Sep2025 When probed to clarify that consumer got Vaccine at withheld, Flu shot details: Date: Consumer stated, "Go back exactly four days and when he got the flu shot at his physician office. All, patient know is, it shows the claim number and it says COMIRNATY (Suspect captured as provided), then it says 2025 or 2026 (12 Y UP 0.3 milliliters syringe). Probably had to find that out from the pharmacy. I got bunch of region code down here of #. Product details (Flu shot): LOT#, expiration date, NDC# and UPC#: Consumer stated, "he got, this says bill date (19Sep2025), Got the claim number, patient going to use the claim number because they do not need that. This says COMIRNATY 2025-26, then (12 Y UP then it says 0.3 ML syringe. That's all withheld has gotten printed on the summary." When probed if consumer got any vaccine on the same date, consumer stated, "No." When probed if consumer had other vaccinations four weeks prior, consumer stated, "No, no other vaccination other than flu shot a few days before." Event details: Still experiencing: Consumer stated, "he still have the golf ball size race place that's the bad information they already had on the form from Pfizer." Treatment: Consumer stated, "When he went to the emergency room, the only thing they gave him was a pain pill and they put a Lidocaine patch on that spot on his arm, that was it." Consumer stated, "he would just say, he would have his physician or the pharmacy and all that fill this. he will fill all this form out and get it back to guys as soon as possible. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.