Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis, Wrong product administered
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2022 as dose 4 (booster), single (Lot number: FR2583, Expiration Date: 30Jun2023) at the age of 32 years for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Moderna coviD-19 vaccine (Dose 3, First booster), administration date: 19Nov2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 2), administration date: 05Mar2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 1), administration date: 05Feb2021, for COVID-19 immunisation; flu vaccine, administration date: 19Oct2022, for immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2022, outcome "unknown", described as "Range of motion has significantly reduced"; ARTHRITIS REACTIVE (medically significant) with onset 2022, outcome "unknown", described as "for the 2nd booster it was supposed to be the Pfizer Bivalent but they gave him this monovalent dose and he developed a reactive arthritis"; JOINT SWELLING (non-serious) with onset 2022, outcome "not recovered", described as "swelling in elbow"; TENDONITIS (non-serious) with onset 2022, outcome "unknown", described as "tendinitis"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 23Nov2022, outcome "unknown", described as "He was told he went to get the bivalent vaccine, but was told by the pharmacy that it wasn't the bivalent vaccine"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2022, outcome "unknown"; ANXIETY (non-serious), outcome "unknown", described as "and is scared"; INFECTION (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown". The event "swelling in elbow" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Negative; Blood test: Test confirmed markers still high, notes: Has 2 blood tests, 3 weeks apart. Did not have lupus or anything like that; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of joint swelling.  Clinical Information: Reporter had a question about whether or not the vaccine given was in fact the Pfizer COVID vaccine. He was told he went to get the bivalent vaccine but was told by the pharmacy that it wasn't the bivalent vaccine. The patient wanted to confirm if it's the Pfizer COVID vaccine or if it was expired or anything, stemming from medical issues with that booster. There had been a question of whether or not he had gotten Pfizer bivalent booster in November and the pharmacy gave him a lot number on his patient card for this dose of GJ9733 and when he spoke with Pfizer Medical Information, he found out it was not a valid lot number so he called the pharmacy back and they said in their system the lot for this dose is FR2583 so customer service confirmed that is a Pfizer Covid vaccine for this lot number but it is a grey cap monovalent and is not the bivalent. The patient got for his primary series Moderna vaccine and for his first booster got Moderna and for the 2nd booster it was supposed to be the Pfizer Bivalent, but they gave him this monovalent dose and he developed a reactive arthritis. Patient has been having medical issues from last fall from the dose previously given. Started having swelling in the elbow, starting maybe a week or 2 after that injection. Thought it was tendinitis. Had MRIs and things like that the last 6 months. They think it might be reactive arthritis infection, or something related, based off the timeline. Swelling in elbow: Though he had tendinitis or something like that. Was thinking, it was in that same time frame. Lost range of motion 2 weeks, maybe a week after the injection. Did have some pain in elbow before the injection but had full range of motion and no swelling. Range of motion has significantly reduced and had taken months to figure this out. Clarified that swelling is in the right elbow. Outcome: Swelling is still there. Is now seeing rheumatologist, having to take medications. They are doing a procedure with a needle, the end of the month, to find out what the fluid is. They think it is arthritis, not conclusive of auto immune. It is hard to diagnose. They suspect it is reactive arthritis, to an infection of some sort. Started to notice this aligns with the vaccine. Has not seen any bug bites or anything. Outcome of event: Once it got into full swing of being swollen, it has been about the same. Treatment: Was trying to wait for his physical, saw orthopedist in Jan2023. They tried using Cortisone shot, nothing happened. It might have been in the wrong spot. Did Physical Therapy for about 6 or 7 weeks. Had MRI after that, physical therapy didn't work. After MRI, orthopedist said he needed to see a rheumatologist. Subsequently, they took a lot of blood tests at the rheumatologist. Test confirmed markers still high. Has 2 blood tests, 3 weeks apart. Did not have lupus or anything like that. Had antinucleus, ANA test, showing there is kind of some auto immune thing going on. All major auto immune diseases, he tested negative for. That is why the rheumatologist was thinking it might be reactive arthritis. On and off Vitamin D3. Is fairly fair skinned. No prescribed medications, other than doctor recommended Vitamin D boost. Test results: Had the MRIS, various physical therapies, various blood tests, Cortisone injection, that didn't hit the right area where the swelling occurred. No family history of rheumatoid arthritis or anything like that, that he is aware of. AE required visit to: No, just tests mentioned before, was not emergency. Still has some range of motion in arm, just not full range of motion. Clarified they thought this was related to Covid injection.  Description of Product Complaint: Description of complaint: Suspect product: follow up report with reference number #; There had been a question of whether or not he had gotten Pfizer bivalent booster in November and the pharmacy gave him a lot number on his patient card for this dose of GJ9733 and when he spoke with Pfizer Medical Information, he found out it was not a valid lot number so he called the pharmacy back and they said in their system the lot for this dose is FR2583 so customer service confirmed that is a Pfizer Covid vaccine for this lot number but it is a grey cap monovalent and is not the bivalent. He may not trust his pharmacy right now with the very different lot number provided initially and then them telling him what he has now received, and this information was changed after the fact and is something incorrect and he does not know what he was injected with.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (10May2023): This is a spontaneous follow-up report from a contactable consumer. This consumer (patient) reported that: Updated information: Reporter email captured. HCP information added in slide 2, Historical vaccine, vaccine lot number updated. Lab test coded, product details, Expiration date, concomitant, vaccine facility information and new events added.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.