Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammatory marker increased, Intentional dose omission, Investigation, Stress cardiomyopathy, Uterine dilation and curettage
Clinical narrative: Cardiac arrest; Takotsubo syndrome; Burning sensation; Hot flushes; Sweating; Inflammatory marker increased; Intentional dose omission; booster; Fear; Dry eyes; Endometrial hyperplasia; Uterine dilation and curettage; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4188352-00 (Agency).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Nov2021 (Lot number: 3203bd) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2018 (Batch/Lot number: unknown) to 2021 at 40 mg (40 mg/ 0.4 ml (citrate free)) and second regimen subcutaneous from 2021 (Batch/Lot number: unknown) to 05Nov2021 at 40 mg (40 mg/ 0.4 ml (citrate free)) for rheumatoid arthritis. Relevant medical history included: "Auto immune condition" (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Left spondo branch block in the heart" (unspecified if ongoing); "Irritable bladder" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Mild lactose intolerant" (unspecified if ongoing); "Hair and nails" (unspecified if ongoing); "Hair and nails" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Stomach" (unspecified if ongoing); "swelling and vascular problem" (unspecified if ongoing); "swelling and vascular problem" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Non-Tobacco user" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "could not walk", start date: 2020 (unspecified if ongoing); "worsened pain in right groin", start date: 2020 (unspecified if ongoing); "Cartilage injury", start date: Nov2020 (unspecified if ongoing); "Bone spur", start date: Nov2020 (unspecified if ongoing); "pain aggravated", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: CELEBREX taken for pain; SYNTHROID taken for thyroid disorder; FUROSEMIDE taken for swelling, angiopathy; OMEPRAZOLE taken for abdominal pain upper; EFFEXOR taken for depression; FOLIC ACID; LAMOTRIGINE taken for depression; METOPROLOL taken for hypertension; SIMVASTATIN taken for blood cholesterol; TIMOLOL taken for glaucoma; LATANOPROST taken for glaucoma; REFRESH [CARBOMER] taken for dry eye; BIOTIN taken for hair disorder, nail disorder; VITAMIN D [COLECALCIFEROL]; MELATONIN taken for sleep disorder; VALERIANA [VALERIANA OFFICINALIS]; MAGNESIUM; ZINC; OMEX-3; FISH OIL. Past drug history included: Z-pak allergy, reaction(s): "Z-pak allergy"; Codeine allergy manifested with itch, reaction(s): "Codeine allergy manifested with itch"; Biaxin allergy, reaction(s): "Biaxin allergy". Vaccination history included: Bnt162b2 (Dose:1, single), administration date: 11Jan2021, when the patient was 61 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, single), administration date: 01Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Impaired driving ability", "Reading disorder", "Blurry vision"; Tuberculosis shot, reaction(s): "allergy manifested with severe itchiness", "allergy manifested with severe itchiness". The following information was reported: CARDIAC ARREST (hospitalization, medically significant) with onset Nov2021, outcome "recovered" (2021), described as "Cardiac arrest"; STRESS CARDIOMYOPATHY (hospitalization, medically significant) with onset Nov2021, outcome "recovered" (2021), described as "Takotsubo syndrome"; IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; INFLAMMATORY MARKER INCREASED (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Inflammatory marker increased"; FEAR (non-serious) with onset Nov2021, outcome "unknown", described as "Fear"; INTENTIONAL DOSE OMISSION (non-serious) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Intentional dose omission"; DRY EYE (non-serious) with onset Nov2021, outcome "recovered" (Dec2021), described as "Dry eyes"; HOT FLUSH (non-serious) with onset Dec2021, outcome "not recovered", described as "Hot flushes"; HYPERHIDROSIS (non-serious) with onset Dec2021, outcome "unknown", described as "Sweating"; ENDOMETRIAL HYPERPLASIA (non-serious) with onset 2021, outcome "not recovered", described as "Endometrial hyperplasia"; UTERINE DILATION AND CURETTAGE (non-serious) with onset 2021, outcome "unknown", described as "Uterine dilation and curettage"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation". The patient underwent the following laboratory tests and procedures: computerised tomogram: (Jun2021) lung nodule; eye inflammation: (2021) unknown results; investigation: (unspecified date) unknown results; (Nov2021) high inflammation levels. The action taken for adalimumab was dosage not changed. The causality of Endometrial hyperplasia, Uterine dilation and curettage, lung nodule, Unable to walk , reading disorder, fear, Impaired driving ability, Intentional dose omission, sweating, pain aggravated, cardiac arrest, Inflammatory marker increased, blurry visions, dry eyes, Hot flushes, cartilage injury, bone spur, burning sensation are not reported and Takotsubo syndrome was probable. Clinical course:  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of thick endometrium, takotsubo cardiomyopathy, dilation and curettage and heart stop pumping for a minute, inflammation levels were up/high inflammation levels, lung nodule, torn labrum, hip spur, could not walk, could not drive, could not read a lot, scared, skipped one dose of Humira with out health care professional advise, blurry vision/could not stay long in front of a computer, dry eyes, hot flushes, sweats and worsened, pain in right groin was not provided. The reporter's causality for the event(s) of  burning hot feeling in body with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for  the event(s) of TORN LABRUM and HIP SPUR with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. (Withheld) opinion is that there is no reasonable possibility that the events of  thick endometrium, takotsubo cardiomyopathy, dilation and curettage and heart stop pumping for a minute and non-serious inflammation levels were up/high inflammation levels, burning hot feeling in body, lung nodule, torn labrum, hip spur, could not walk, could not drive, could not read a lot, scared, skipped one dose of Humira with out health care professional advise, blurry vision/could not stay long in front of a computer, dry eyes, hot flushes, sweats and worsened pain in right groin are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). Agency's opinion is that the event of lung nodule is not assessable.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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