Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Autoimmune disorder, Rheumatoid arthritis, Tendonitis
Clinical narrative: autoimmune problems; arthritis, such as rheumatoid arthritis; thumb joint and tendons have inflammation; thumb joint and tendons have inflammation; The initial case was missing the following minimum criteria: Invalid as Other-Info not qualifying for AE reporting - Medical Information (as new event added). Upon receipt of follow-up information on (23Sep2022), this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (non-serious), outcome "unknown", described as "autoimmune problems"; RHEUMATOID ARTHRITIS (non-serious), outcome "unknown", described as "arthritis, such as rheumatoid arthritis"; INFLAMMATION (non-serious), outcome "unknown", described as "thumb joint and tendons have inflammation".  Additional Information: Characterization of drug role: SUSPECT. Proprietary medicinal product name: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine (Monovalent) and/or Biv. Active Drug substance names: COVID-19 Vaccine, mRNA (Monovalent and/or Bivalent). PQC Details: Request Name: REQ-929235. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. RN was calling to see if there was any relationship between the various Pfizer BioNTech Covid 19 vaccines and arthritis, particularly rheumatoid arthritis, inflammation or autoimmune problems a couple months after receiving the vaccine. Call dropped before transfer occurred. PQC Details: Request Name: REQ-929238. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine (Monovalent) and/or Bivalent. Calling about Pfizer COVID 19 Vaccine. The patient wanted to ask whether there was a relationship between the various vaccines that we have had such as Arthritis, RA, or any inflammation happening after getting the vaccine. Such as autoimmune problems. Safety would still file report due to caller not wanting to file a report or clarify further. The patient was asking because she was deciding if she want to get the new one. The patient had a weird thing that she didnt think of until today and she was just curious. She woke up 6 weeks after last vaccine with trigger-some, where thumb joint and tendons have inflammation. The patient was wondering if any of that, her husband's, family of docs and nurses talking about whether there has been any. She didnt do anything to injury herself. 6 weeks after last dose, all Pfizer vaccines. Have you heard of any autoimmune thing after covid vaccines. E-transmitting to DSU for duplicate AE reporting. Request Name: REQ-929247. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine (Monovalent) and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than 12 years - 15/15 mcg per dose. She heard about the Omicron-adapted vaccine or variant-adapted vaccine. Do you have any information on this variant with regards to Comirnaty/Pfizer-BioNTech COVID-19 Vaccine. The new vaccine, not tested on people, only tested on animals, how confident are they that they changes that are made will cause any safety issues. She had read the studies do not pertain to this specific cone. Maybe the one she read was wrong and watched a whole video was wrong. Pfizer put out press release but they didnt actually product studies. Moderna put out something with a study. Pfizer has not put anything out. so it was not possible to see what you are reading to her. Reaction/Event as Reported by the Primary Source for Translation: arthritis, such as rheumatoid arthritis, Inflammation, autoimmune problems. Outcome of reaction/events at the time of last observation was unknown. Submitted by Call Centre 1 Ref:333246, ININ: 11b07e33-9e8b-444b-b727-a5438b9e7a66. NDC number, Expiry Date of COVID-19 vaccine, Other Conditions, Investigations and Other Products were Not Provided. Caller was calling about the COVID vaccine to ask about whether there was a relationship with the various COVID vaccines caller received like arthritis, such as rheumatoid arthritis, or any inflammation happening a couple of months after getting the vaccines, or autoimmune problems occurring a couple of months after getting the vaccines. Caller wants to find out about whether certain things have been reported. COVID-19 vaccine: Upon attempting to clarify which COVID vaccine caller was calling about caller clarified caller was calling about the Pfizer COVID-19 vaccine. Declined to provide additional reporter details, declined to provide additional information, declined to complete a report, requested to get transferred to Agency. Event details: Unable to clarify with caller if caller was experiencing the adverse events that caller was calling about due to caller declining to provide additional information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events AUTOIMMUNE DISORDER and RHEUMATOID ARTHRITIS cannot be excluded for the suspect drug BNT162b2.  The follow-up information received does not alter the previous company clinical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.