Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Blood glucose fluctuation, Cataract, Fatigue, Glycosylated haemoglobin increased
Clinical narrative: Fatigue; Lack of motivation; body achiness; Hidradenitis suppurativa; Fever; Stress; blood sugar fluctuations/acid increased from six point eight to seven point three; blood sugar fluctuations/acid increased from six point eight to seven point three; Right cataract; Left cataract; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4411314-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159670) at citrate free, second regimen (Lot number: 1162439) at citrate free and third regimen (Lot number: 1163328) at citrate free, all subcutaneous for hidradenitis. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CATARACT (medically significant) with onset 31Mar2022, outcome "unknown", described as "Left cataract"; CATARACT (medically significant) with onset 05May2022, outcome "unknown", described as "Right cataract"; BLOOD GLUCOSE FLUCTUATION (non-serious), GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious) all with onset Aug2022, outcome "unknown" and all described as "blood sugar fluctuations/acid increased from six point eight to seven point three"; FATIGUE (non-serious), outcome "unknown"; APATHY (non-serious), outcome "unknown", described as "Lack of motivation"; PAIN (non-serious), outcome "unknown", described as "body achiness"; HIDRADENITIS (non-serious), outcome "not recovered", described as "Hidradenitis suppurativa"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; STRESS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood glucose fluctuation: (unspecified date) Unknown Results; Glycosylated haemoglobin increased: (Aug2022) increased from 6.8 to 7.3; Pyrexia: (unspecified date) Unknown result. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "left cataract", "right cataract", "fatigue", "lack of motivation", "body achiness", "hidradenitis suppurativa", "fever", "blood sugar fluctuations/acid increased from six point eight to seven point three" and "stress" 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.  Clinical information: Solicited report by a consumer of a 69 year old female with events of left cataract and right cataract and non-serious lack of motivation, blood sugar fluctuations/acid increased from six point eight to seven point three, stress, hidradenitis suppurativa outbreaks/flares/four draining spots and fever and achiness with Humira (Adalimumab). The patient had a relevant medical history of diabetes. On unknown dates, the patient experienced lack of motivation, stress, hidradenitis suppurativa outbreaks/flares/four draining spots and fever and achiness. On 31Mar2022, the patient experienced left cataract. On 05May2022, the patient experienced right cataract. In Aug2022, the patient experienced blood sugar fluctuations/acid increased from six point eight to seven point three. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. On 31Mar2022 she had left cataract surgery. On 05May2022 she had right cataract surgery. In Aug2022 her A1C increased from six point eight to seven point three. She had fatigue and lack of motivation for a day following injection. She had fever and body achiness and fatigue with the second vaccine. She occasionally had hidradenitis suppurativa flares four draining spots that she related to stress and blood sugar fluctuations. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for pfizer biontech covid-19 vaccine(tozinameran) for Fatigue (Fatigue), Lack of motivation (Apathy), Hidradenitis suppurativa (Hidradenitis), Fever (Pyrexia) were not reported, Pain (Pain): Possible. Causality for Humira(adalimumab as per reporter (Drug/Vaccine) for events Fatigue (Fatigue), Lack of motivation (Apathy), Pain (Pain), Hidradenitis suppurativa (Hidradenitis), Fever (Pyrexia) were Not Reported.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of left cataract, right cataract, lack of motivation, blood sugar fluctuations/acid increased from six point eight to seven point three onset in Aug2022, blood sugar fluctuations/acid increased from six point eight to seven point three onset in Aug2022, stress, hidradenitis suppurativa outbreaks/flares/four draining spots and fever and achiness was not provided.   Company's opinion is that there is no reasonable possibility that the events of left cataract, right cataract, lack of motivation, blood sugar fluctuations/acid increased from six point eight to seven point three onset in August 2022, blood sugar fluctuations/acid increased from six point eight to seven point three onset in Aug2022, stress, hidradenitis suppurativa outbreaks/flares/four draining spots and fever and achiness are related to Humira (Adalimumab)). Company's opinion is that the event of lack of motivation is not assessable.   Causality for Humira for event Left cataract (Cataract), Right cataract (Cataract), Blood sugar level fluctuation (Blood glucose fluctuation), Haemoglobin A1C increased (Glycosylated haemoglobin increased), Hidradenitis suppurativa (Hidradenitis), Fever (Pyrexia): Causality as per reporter (Drug/Vaccine), Stress (Stress): Not Reported. Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility, for event Lack of motivation (Apathy): Causality as per reporter (Drug/Vaccine) : Not Reported. Causality as per Mfr.(Drug/Vaccine) : Not assessable.  Causality for BNT162B2 for event Left cataract (Cataract), Right cataract (Cataract), Lack of motivation (Apathy), Blood sugar level fluctuation (Blood glucose fluctuation), Haemoglobin A1C increased (Glycosylated haemoglobin increased), Stress (Stress), Hidradenitis suppurativa (Hidradenitis): Causality as per reporter (Drug/Vaccine) : Not Reported and for Fever (Pyrexia): Causality as per reporter (Drug/Vaccine) : Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Aug2022): This is a solicited follow-up report from a Non-Interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer, MFR Control No. 22K-163-4411314-00). A contactable female consumer (patient) reported for herself that:  Updated information includes: For suspect BNT162B2 product indication updated. RMH diabetes added. Lab data added. Dose Description added for Humira and three lot number added. New events "Left cataract" and "Right cataract" were added. blood sugar fluctuations/acid increased from six point eight to seven point three added with onset date as Aug2022 and event stress added.; Sender's Comments: Based on the currently available information the possibility of causal association between the events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. 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.