Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Extra dose administered, Feeling abnormal, Illness
Clinical narrative: third dose of bnt162b2 on 28Aug2021 16:00; third dose of bnt162b2 on 28Aug2021 16:00; big, hot, red, bump on the site; feel kind of crummy a couple of days after third shot; thought it was an abscess or cellulitis, or staph, or strep; thought it was an abscess or cellulitis, or staph, or strep; thought it was an abscess or cellulitis, or staph, or strep; thought it was an abscess or cellulitis, or staph, or strep; feel very sick; fever of 101; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 44-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3183), via an unspecified route of administration, administered in Arm Right on 28Aug2021 16:00 (at age of 44 years old) as single dose for COVID-19 immunization; ocrelizumab (OCREVUS), route of administration, start and stop date, batch/lot number and dose were not reported for Multiple sclerosis. Medical history included auto immune vasculitis, Multiple sclerosis from 2007 (States 14 years before was diagnosed with multiple sclerosis), COVID -19 from Oct2020, trouble remembering things, cognitive issue. Concomitant medications included rituximab (RITUXAN) for vasculitis; cyclophosphamide (CYTOXAN) for vasculitis. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6204) on 10Mar2021 (at age of 44 years old) as single dose for COVID-19 immunization, and it was not as bad as the second one, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8732) on 01Apr2021 (at age of 44 years old) as single dose for COVID-19 immunization, it made her feel crummy. Caller wanting to report adverse events from having the third Covid shot because she is immunocompromised from a drug taken for Multiple sclerosis and a rare auto immune vasculitis. Got the third shot on 28Aug and a few days later, Aug2021, developed a really big, hot, red, bump on the site where she got it. Ended up at her doctor's office and the nurse (at the surgeon's) came in. They are good at noticing/seeing an infection. Asked her what was wrong with her arm. She thought it was normal and they thought it was an abscess or cellulitis, or staph, or strep (2021). They put her on 10 days of Keflex 500mg, 1 capsule by mouth four times daily for that and was told to report this to Pfizer. It made her feel very sick with fever of 101 (in 2021) and it was not good. Her arm was killing her and she is slow to heal due to being immunocompromised and it takes forever for her to develop antibodies. Clarifies she was immunocompromised and had Multiple sclerosis and a rare auto immune vasculitis prior to getting any Covid shots. States 14 years before (in 2007) was diagnosed with multiple sclerosis and having been on a number of medicines since then, immunosuppressant drugs. Unable to provide all immunosuppressant drugs by Genzyme, Sanofi, Biogem, but she has tried all the MS drugs, pysabri, Capaxone, Betaseron 1A shot. Provides spelling for products. Unable to provide product name, NDC, Lot, or expiry for drug taken that caused her to be immunocompromised in past. Then provides for the rare autoimmune vasculitis she takes 2 medicines at a time, Rituxan and Cytoxan. The Rituxan is every 6 months and Cytoxan was monthly, plus a truck load of IV corticosteroids, but she does not know how much, but it was a lot. Mentions she has cognitive issues, trouble remembering things and her husband helps her to make sure she says the right things. Mentions she had Covid back last October and she'd rather have the shot than the real Covid and she does not care if it gave her cellulitis. Says she had the third shot on a Saturday and on Sunday morning she woke up with the quarter sized bump on her arm and the websites says it could just be a site reaction, but it got worse and worse. On Wednesday, last week, 01Sep2021 she went to the doctor and it wasn't her primary care provider, but a pain specialist she sees for her Baclofen pump. She was there having that refilled when they happened to notice her arm since she was wearing a sleeveless shirt and they noticed it didn't look good. It was pretty big and softball sized.  Says it could be a perfect storm, because she is on a new drug for her multiple sclerosis called Ocrevus, it's a form of Rituxan, but it's like 4-6 times stronger than that. One of the warnings on the bottle is for skin infections and lower respiratory infections. That you are more at risk for skin infections, so it's a perfect storm. Like maybe a critter got in there and made her life miserable and caused this skin infection. This medication certainly makes you immunocompromised and her blood work recently showed she is low on immunoglobulins. Wonders if the skin infection could have come from this new medication or shot. Unable to provide NDC, Lot, or expiry for new medication, Ocrevus. Caller provides spelling of product. Mentions she is also taking 5 days a month of IVIG therapy, unable to provide NDC, Lot, or expiry. Says she got this third shot at CVS #1003 and the first 2 shots in #. She is an opera singer and had a concert that Saturday in # and no one had the third shot available and they were not gibing it out until the end of September/October. She is still masking up and all that stuff and didn't want to travel and they had it. Got the shot because she is immunocompromised and was called by # to get the third shot. Was worried she did not make enough antibodies because of COVID. They made a call to her to schedule the shot. Mentions again, it could be a combo of the Ocrevus due to skin infection warning and it could be the combination with getting a hole in the arm. Pfizer may have to provide a warning to watch out for skin infections because she know and she didn't know she had a fever, but she felt really bad and her arm was huge. It was pretty scary. AEs require a visit to: Physician Office visit. The action taken in response to the events for ocrelizumab was unknown. The outcome of the events was unknown.