Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Autoimmune thyroiditis, Ear discomfort, Ear infection, Fatigue
Clinical narrative: Rheumatoid arthritis flare up/Certain foods caused inflammation; Hashimotos; Rheumatoid arthritis flare up/Certain foods caused inflammation; Ear feels clogged; Ear infection; Sinus infection; Weight gain; Stressed; Reaction/Covid-19 vaccines caused fatigue and headache; Reaction/Covid-19 vaccines caused fatigue and headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years and on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), since 15Dec2021 (ongoing) (Lot number: 1172499), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "Reaction/Covid-19 vaccines caused fatigue and headache"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", AUTOIMMUNE THYROIDITIS (medically significant), outcome "not recovered" and all described as "Hashimotos"; ADVERSE FOOD REACTION (non-serious), outcome "unknown", described as "Rheumatoid arthritis flare up/Certain foods caused inflammation"; EAR DISCOMFORT (non-serious), outcome "recovering", described as "Ear feels clogged"; EAR INFECTION (non-serious), outcome "recovering"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "Weight gain"; STRESS (non-serious), outcome "not recovered", described as "Stressed". The action taken for upadacitinib was unknown.  Clinical information: Solicited report by a consumer of a 62 years old female with events of and non-serious Weight gain, ears felt clogged, stressed, ear infection, reaction/covid-19 vaccines caused fatigue and headache, reaction/covid-19 vaccines caused fatigue and headache, sinus infection, rheumatoid arthritis flare up/certain foods caused inflammation, hashimotos, and rheumatoid arthritis flare up/certain foods caused inflammation with Upadacitinib modified-release tablet. Pfizer biontech covid-19 vaccine was also considered suspect. Patient had sinus infection. When she was off Rinvoq for an infection she started with increased pain in joint and stiffness, it got better when she came back on Rinvoq. Her ear felt clogged. She had ear infection. She had rheumatoid arthritis flare up. In 2021, Pfizer vaccines caused fatigue and headache for a week. She had condition like Hashimotos, stressed. She had hand stiffness, certain foods caused inflammation.  The reporter's causality for the event(s) of ears felt clogged and Rheumatoid arthritis flare up/certain foods caused inflammation with Upadacitinib modified-release tablet was not provided. The reporter's causality for the event(s) of Rheumatoid arthritis flare up/Certain foods caused inflammation and sinus infection with Upadacitinib modified-release tablet was reasonable possibility (probable). The reporter's causality for the event(s) of ear infection, hashimotos, reaction/covid-19 vaccines caused fatigue and headache, stressed, weight gain with upadacitinib modified-release Tablet was No Reasonable Possibility (not related).  Causality assessment: Pfizer biontech covid-19 vaccine with Hashimoto's disease, Stress, Weight gain, Ear infection, Ear feels clogged, Sinus infection, Rheumatoid arthritis flare up and Adverse food reaction was Not Reported. The reporter's causality for the event(s) of reaction/covid-19 vaccines caused fatigue and headache with pfizer biontech covid-19 vaccine (Tozinameran) was Reasonable Possibility; also reported as Pfizer biontech covid-19 vaccine with Fatigue and Headache was Possible.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up/certain foods caused inflammation", "hashimotos", "ear feels clogged", "ear infection", "sinus infection", "weight gain" and "stressed" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "reaction/covid-19 vaccines caused fatigue and headache" related to BNT162b2.  Agency's opinion was that the causality for the event(s) of ear infection, ears felt clogged, hashimotos, reaction/covid-19 vaccines caused fatigue and headache, rheumatoid arthritis flare up/certain foods caused inflammation unknown onset, sinus infection, stressed, weight gain with upadacitinib modified-release tablet was not provided.  Agency's opinion was that the causality for the event(s) of ear infection, ears felt clogged, hashimotos, reaction/covid-19 vaccines caused fatigue and headache, rheumatoid arthritis flare up/certain foods caused inflammation unknown onset, sinus infection, stressed, weight gain with pfizer biontech covid-19 vaccine (tozinameran) was not provided.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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.