Sex: F
Vaccine: COVID19, FLUC3, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Product use issue, Rubber sensitivity, Skin fissures
Clinical narrative: Autoimmune compromised; Arthritis issues; Cracking in fingers; Bad allergic reaction; Whole body has been very sensitive to everything, complete immune response; Dermatitis/Face was inflamed; Face was red; Face was sore; Positive through bloodwork for HLA-B27 gene variant; Hernia; Latex allergy; Freaking out all the time; Fingers chapped up; Carpal tunel surgery on hand, which was healing well and stopped healing/Things aren't healing well; Shingles; Having problems with eyesight; Non-radiographic ankylosing arthritis/Non-radiographic ankylosing spondylitis; Spondylitis; Endometritis was back; Had a cyst, one that exploded; The patient received Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine in the same day and in the same arm; Axial spondyloarthritis on middle finger; Could barely move/Couldn't move; Pain/Really sore/Excruciating pain; Whole back seized up; Couldn't walk; Left middle finger totally swelled up/ Fingers swelling/Hands swelling; Sore arm/Fingers painful/Can't use hands, painful, so painful couldn't use hands at all; This spontaneous case, initially received on 17-Jun-2024, was reported by a non health professional and concerns an adult female patient.  Past medical history included chicken pox, Hernia surgery, Carpal tunnel surgery, Partial hysterectomy, Endometriosis.  The patient's historical vaccines included: two Pfizer COVID-19 vaccines (tozinameran) 1st dose on 26-Mar-2021 and 2nd dose on 17-Apr-2021, three Moderna COVID-19 vaccines (elasomeran) 3rd dose on 15-Nov-2021, 4th dose on 29-Apr-2022 (when patient was 50 years old) and 5th dose on an unspecified date, all used for unknown indication; Varicella zoster vaccine (reported as 'shingles vaccine') three years ago (when patient turned 50)  after which the patient was a little sick; and influenza vaccines (brand not specified) for over 30 years and the patient had no problems, also reported as Flucelvax Quad, which patient has had forever with no issues. The patient was extremely fit, eats healthy, works out, always on go, was healthy, active.  Administration of company suspect drug(s): On 27-Sep-2023, the patient received Flucelvax Quadrivalent (influenza vaccine inact sag 4v) for Indication not reported. Dose and Route of administration: Not reported, Anatomical location: Left arm ('same arm'). Lot number: No batch number available.  Non-company suspect drugs: On 27-Sep-2023, the patient received a non-company co-suspect Pfizer BioNTech COVID-19 vaccine (Tozinameran), Indication reported as: New booster was out and patient takes care mother in law so wanted to protect mother in law, Dose and Route of administration: Not reported, Anatomical location: Left arm, Lot number: HG4628.   On an unspecified date, the patient received a non-company co-suspect varicella zoster vaccine (reported as 'normal shingles vaccine'; brand not specified) for shingles virus lives in lower spine, patient had slight case of chicken pox when little. Dose and Route of administration, Anatomical location: Not reported. Lot number: Not reported.   Adverse reactions/events and outcomes: On 27-Sep-2023, The patient received Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine in the same day and in the same arm (outcome: Not Reported, stop date: 27-Sep-2023).  On Sep-2023, within 9 hours of getting Flucelvax Quadrivalent and co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced Sore arm/Fingers painful/Can't use hands, painful, so painful couldn't use hands at all (outcome: Not Reported), Could barely move/Couldn't move (outcome: Not Reported), Pain/Really sore/Excruciating pain (outcome: Not Reported), Whole back seized up (outcome: Not Reported), Couldn't walk (outcome: Not Reported), Left middle finger totally swelled up/ Fingers swelling/Hands swelling (outcome: Not Reported). The first symptom was in Sep-2023 when left middle finger totally swelled up, and had not gone down. Started literally 9 hours after getting the booster. Patient couldn't move, whole back seized up, had pain, and couldn't walk. The patient had sore arm, but nothing to speak of. Slowly started having strange arthritis issues, all of the sudden after initial vaccines but would get really sore, went to see chiropractor, happened three times where patient could barely move, really sore.   On Oct-2023, the patient experienced Endometritis was back (Medically Significant, outcome: Not Reported), Had a cyst, one that exploded (Medically Significant, outcome: Not Reported). The patient had female issues, problems patient had 20 years ago. Patient had partial hysterectomy in 2014, then 10 days after booster was in excruciating pain, needed ultrasound, doctor said makes no sense, patient had a cyst, one that exploded, and endometriosis was back which made no sense because patient had those problems 20 years ago.   On Dec-2023, the patient was diagnosed with Spondylitis (outcome: Not Reported). When doctors determined the problem, the patient was told it would take three months for Sulfasalazine to work.  On 15-Dec-2024, the patient had a hernia surgery, the patient came out of surgery that was supposed to be 1.5 hours, surgery was two hours because she had complications.   On Jan-2024, the patient was diagnosed with Non-radiographic ankylosing arthritis/Non-radiographic ankylosing spondylitis (Medically Significant, outcome: Not Reported). Patient received a diagnosis of non-radiographic ankylosing arthritis in January, nonradiographic meaning it doesn't show up on x-rays.  Clarified it is called non-radiographic ankylosing spondylitis, which patient was diagnosed with in Jan-2024, which was a modification, in December knew patient had spondylitis, now rheumatology (RA) doctor said doesn't show up on x-ray. Bloodwork was the key thing that found it. The patient had a pelvic MRI, to confirm that it was also hips, buttocks, lower spine and knees, which the doctors were fairly certain based on the patient's symptoms, but wanted to confirm. The patient was like a grandma on a phone. The patient had to see an ophthalmologist annually because apparently this wears on eyesight and patient stated she was definitely having problems with eyesight, and had an appointment coming up on 22-Jan-2024.  On an unknown date, the patient experienced Hernia (outcome: not reported), Autoimmune compromised (Medically Significant, outcome: Unknown), Axial spondyloarthritis on middle finger (outcome: Unknown), Having problems with eyesight (outcome: Unknown), Positive through bloodwork for HLA-B27 gene variant (outcome: Unknown), Arthritis issues (outcome: Not Reported), Cracking in fingers (outcome: Not Reported), Latex allergy (outcome: Not Reported), Bad allergic reaction (outcome: Not Reported), Whole body has been very sensitive to everything, complete immune response (outcome: Not Reported), Freaking out all the time (outcome: Not Reported), Fingers chapped up (outcome: Not Reported), Dermatitis/Face was inflamed (outcome: Not Reported), Face was red (outcome: Not Reported), Face was sore (outcome: Not Reported), Carpal tunnel surgery on hand, which was healing well and stopped healing/Things aren't healing well (outcome: Not Reported), Shingles (outcome: Not Reported).   The patient has been meeting with arthritis doctor who did a ton of ultrasounds, magnetic resonance imagings (MRIs), x-rays, and a ton of bloodwork. The MRI the patient had on middle finger where this all initially started proved that patient had axial spondyloarthritis. Patient is now officially autoimmune compromised. The doctor sent the patient to get a pneumonia vaccine, wanted patient to get RSV vaccine but patient did not qualify because she is not old enough or pregnant. The patient could not work, basically lived at doctor offices. At first, the patient thought she was healing slowly. She has seen an arthritis doctor, family doctor, allergist, dermatologist, and an obstetrician (OB). The patient started treatment with sulfasalazine DR 500mg, 2 tablets every 12 hours, for a total of 4 tablets a day, Robaxin (methocarbamol) 750mg twice a day and the patient was hoping to go down to one a day, it was for before bed, to make patient comfortable, a muscle relaxer, and naproxen 500mg twice a day to help with swelling. One key thing they found is why this happened, stating the patient tested positive through bloodwork for HLA-B27 gene variant. The patient was told 8% of the population has this which is disturbing. Having this gene variant may make more likely to develop this type of arthritis, which is usually triggered by environmental factors. The patient was told for Sulfasalazine right at 3 month point they would know if it was working, but patient had bad allergic reaction. Ironically, patient's whole body since getting the booster has been very sensitive to everything, complete immune response, freaking out all the time. Patient's fingers, which is where issues started in September, all fingers were chapped up, swelling, and cracking, couldn't use hands, painful, so painful she couldn't  use hands at all. She was sent to dermatologist to confirm dermatitis, which was common with that medication, so RA doctor took the patient off of the Sulfasalazine, because said could go into anaphylaxis shock. Something was off, patient had no issues before. So patient was not on anything, dermatologist recommended to the patient to see an allergist to see about possible latex allergy. Patient was wearing gloves when cooking, cleaning, or painting, which she has done for 20 years, always wearing gloves. Turns out the gloves were latex, she has since gotten rid of those. The patient was told pretty sure she has a latex allergy because face was red, inflamed, and sore. Didn't think much of it, didn't think she used latex at all, then issue happened with hands. RA doctor said only medication the patient can take is Humira, and the patient read up on it, which said she can't take if she has a latex allergy, so allergist said don't take until knowing the results. She should have gotten those results on 06-May-2024 when she meets with allergist again. The doctor did not want the patient to start medication until she gets results. The patient had to be off the medication that stops spine from fusing and getting worse for 6 weeks, until patient gets an answer.   The patient had a carpal tunnel surgery on hand 15-Jul-2023, which was healing well and as soon as got the booster stopped healing. Originally dermatologist and family doctor said would be better in a couple of months, which hasn't gotten better. From everything patient has seen since booster, her body is like an immuno-response thing, things aren't healing well, everything that could go wrong, has gone wrong. During all of this with hands swelling, the week before saw allergist, at end of March patient came down with shingles and patient had the vaccine for shingles, patient unknown of the name of the vaccine patient had, but patient still came down with shingles. With medications now patient is auto compromised. Shingles virus lives in lower spine, patient had slight case of chicken pox when little, so that's why patient got shingles vaccine. When RA doctor did MRI to determine that it is arthritis that patient has, that is the area of patient's spine that is impacted the worst where the shingles virus lives. Family doctor mentioned that anything patient had a little bit of, like patient had a little arthritis but worked out, was active, but anything that was slightly there went insane when patient had booster. Everything patient had slightly has since gone wrong, insane. Patient got the vaccine because patient takes care of in-laws, in-laws are healthy, and now patient was not.  Non-drug treatment/Other action taken:  Flucelvax Quadrivalent action taken: Not Applicable Treatment medication: Naproxen 500 mg Twice a day, Robaxin 750 mg Twice a day, Sulfasalazine 2 DF Twice a day  Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Causality for the events of pain in extremity, gait disturbance, pain, decreased mobility, back muscle spasms, peripheral swelling, spondylitis, and ankylosing spondylitis is assessed as possibly related. Despite confounding by non-company co-suspect vaccine, compatible temporal relationship implies that suspect vaccine contributed to the potential occurrence of the reported events. Causality for the events of axial spondyloarthritis, visual impairment, arthritis, cracking in fingers, allergic reaction, non-specified hypersensitivity, dermatitis, face erythema, and facial pain is unassessable. The provided information is insufficient and the temporal relationship is unclear to make any assessment. For the rest of the events causality is assessed as not related, based on biological implausibility.