Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Positron emission tomogram, Psoriasis, Skin exfoliation
Clinical narrative: Psoriasis; Skin exfoliation; Breast cancer female; Palpitation; Shortness of breath; Chest tightness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Provided). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Mar2021 (Lot number: EN6193) at the age of 69 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Jul2012 (Batch/Lot number: unknown) as 40 mg (1 in 2 wk) and administration date 01Feb2022 (ongoing) (Batch/Lot number: unknown) as 40 (1 in 2 wk) for psoriasis. Relevant medical history included: "Hysterectomy" (unspecified if ongoing); "Tonsillectomy" (unspecified if ongoing); "Abstains from Alcohol" (unspecified if ongoing); "Tomato Allergy Manifestated by red spots on skin" (unspecified if ongoing); "Tomato Allergy Manifestated by red spots on skin" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Diuretic" (unspecified if ongoing); "had surgery to remove all the breast cancer on right side in July or Aug2021" (unspecified if ongoing), notes: had surgery to remove all the breast cancer on right side in July or Aug2021. Family history included: "Patient had two aunts with breast cancer on maternal side" (unspecified if ongoing). Concomitant medication(s) included: FUROSEMIDE taken for polyuria; LISINOPRIL; SIMVASTATIN taken for blood cholesterol increased; ISOSORBIDE MONONITRATE; ATENOLOL taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, Route of Admin: Intra-muscular, Lot Number: EN6200), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 Immunization. The following information was reported: BREAST CANCER FEMALE (medically significant) with onset Jun2021, outcome "unknown", described as "Breast cancer female"; PSORIASIS (medically significant), outcome "unknown", described as "Psoriasis"; CHEST DISCOMFORT (medically significant) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "Chest tightness"; SKIN EXFOLIATION (non-serious) with onset 01Feb2022, outcome "recovered" (01Feb2022), described as "Skin exfoliation"; PALPITATIONS (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "Palpitation"; DYSPNOEA (non-serious) with onset 29Mar2021, outcome "recovered" (29Mar2021), described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: computerised tomogram: (Jun2021) breast cancer; mammogram: (Jun2021) breast cancer; positron emission tomogram: (Jun2021) breast cancer. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of breast cancer female. Clinical course: On an unknown date, the patient experienced top layer of skin fell on floor where psoriasis was/ psoriasis on 80 percent of body. On 29Mar2021, the patient experienced palpitation, shortness of breath and chest tightness. On 29Mar2021, the palpitation, shortness of breath and chest tightness resolved. In Jun2021, the patient experienced female breast cancer. On 01Feb2022, the patient experienced top layer of skin fell on floor where psoriasis was/ psoriasis on 80 percent of body. On 01Feb2022, the Top layer of skin fell on floor where psoriasis was/ psoriasis on 80 percent of body resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had no signs and symptoms of breast cancer. It was diagnosed in routine mammogram. She had radiation therapy and chemo therapy that started 01Dec2021. She had surgery to remove all the breast cancer on right side in July or Aug2021. She was admitted overnight. She had two aunts with breast cancer on her maternal side. She had psoriasis 80 percent of the body. The top layer of skin fell on floor where psoriasis was when she injected Humira. She did not have the expiry date of the Covid 19 vaccine because it was not written in the vaccination card. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with TAXOL.  Causality for Humira 40MG/0.4ML (Adalimumab)   The reporter's causality for the event(s) of female breast cancer, palpitation, shortness of breath and chest tightness with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of top layer of skin fell on floor where psoriasis was/ psoriasis on 80 percent of body onset 01Feb2022 and top layer of skin fell on floor where psoriasis was/ psoriasis on 80 percent of body unknown onset was not provided.  Causality to Humira:   1) Breast cancer female (Breast cancer female), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: UNK  2) Skin exfoliation (Skin exfoliation), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not assessable, Dechallenge: Yes 3) Palpitation (Palpitations), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: Yes  4) Shortness of breath (Dyspnoea), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: Yes 5) Chest tightness (Chest discomfort), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Dechallenge: Yes 6) Psoriasis (Psoriasis), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: UNK  Drug: Pfizer Biontech Covid-19 Vaccine   1) Breast cancer female (Breast cancer female), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A  2) Skin exfoliation (Skin exfoliation), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A 3) Palpitation (Palpitation), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A 4) Shortness of breath (Dyspnoea), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A 5) Chest tightness (Chest discomfort), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A 6) Psoriasis (Psoriasis), Action(s) taken with drug: Not Applicable, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A  No follow-up attempts are possible. No further information is expected.