Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Eye inflammation, Inflammation
Clinical narrative: stress out the autoimmune system; inflammation in my eyes; inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "celiac" (unspecified if ongoing), notes: I'm celiac person; "auto immune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 ("First on 11Mar2021 - Lot # EN6208), administration date: 11Mar2021, for Covid-19 immunization, reaction(s): "stress out the autoimmune system", "inflammation in my eyes", "inflammation"; BNT162b2 (Second dose 01Apr2021 - Lot# ER7734), administration date: 01Apr2021, for Covid-19 immunization, reaction(s): "auto-immune disease and was hoping to discuss if there was any correlation between the two", "I have had a side effect of increased inflammation numbers and it settled into my eyes/ had inflammation in my eyes/ second one my eyes were inflamed", "she was having an allergic reaction it is like seasonal reaction/ having allergic reaction (seasonal allergy)"; BNT162b2 (17Oct2021 - Booster - Lot# FF2590"), administration date: 17Oct2021, for Covid-19 immunization, reaction(s): "stress out the autoimmune system", "inflammation in my eyes", "inflammation". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "stress out the autoimmune system"; EYE INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in my eyes"; INFLAMMATION (non-serious), outcome "unknown".  Additional information: Reporter was a patient that states the following: Reporter reached out to Pfizer before, and we guys have sent some forms to fill out because of the COVID vaccine and some of the terminology she just don't know what it was. She really need to sit down to review it again. The reason she was reaching out this time was that she wanted to know if we guys have learned any more about how the COVID vaccine could stress out the autoimmune system and we can have some inflammation as a result of that. Patient had some inflammation in her eyes to come down. She was seeing a specialist. She needed information for both [Pfizer monovalent and bivalent vaccines] because her first reaction was from the initial vaccine and then she had reactions to the booster also. She do have an auto immune disorder already, she was a celiac person so we know she had other things go on but mainly the thing she can't seem to, she guess she was having a hard time figuring out was that inflammation and the only thing that can come down to is that it might be a reaction to the COVID vaccine. She was just curious about what we guys were finding out about that and if other people are having the same reaction and if they were going down and see if they can get it resolved, we know what she was saying, she was not upset about it, she was just trying to figure it out. Reporter confirmed above information and stated she received an additional booster dose. She got another booster this fall, would've been in Sep she does not have a date at this time, she can find that lather for us if we need it was the booster that had the ability to work with the new stuff there is, it was not the older one booster, is the new one. And she had that report still at home because she think she had to find documentation or something and she just haven't taken the time to do it and shame on her but, she just really want to see if there's any more information for we guys to share because she had a physician at [Facility name withheld] that deals with her celiac and he is an expert in his area, he's at [Facility name withheld] and he said that he has seen people in his office that had the COVID shot that have had this eye inflammation as she was just curious if we guys had documented or what we were seeing.  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.