Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site haemorrhage
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4501919-00. A 32-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 28Jul2022 (ongoing) (Lot number: 1162694) at 80 mg (80 mg (1 in 2 wk)), subcutaneous for hidradenitis. The patient's relevant medical history included: "Laparoscopic surgery", start date: 2008, stop date: 2008, notes: Laparoscopic surgery (started 2008); "Endometriosis", start date: 2014 (unspecified if ongoing), notes: Endometriosis (started 2014); "Gall bladder removed", start date: 2015, stop date: 2015, notes: Gall bladder removed (started 2015); "Non-smoker" (unspecified if ongoing); "Alcohol use: occasional drinker, vodka soda" (unspecified if ongoing), notes: Alcohol use: occasional drinker, vodka soda; "Sulfa drugs allergy manifested by rash" (unspecified if ongoing), notes: Sulfa drugs allergy manifested by rash; "Penicillin allergy manifested by rash" (unspecified if ongoing), notes: Penicillin allergy manifested by rash; "Anxiety and Depression" (unspecified if ongoing), notes: Anxiety and Depression; "Anxiety and Depression" (unspecified if ongoing), notes: Anxiety and Depression; "Acid Reflux" (unspecified if ongoing), notes: Acid Reflux. Concomitant medication(s) included: LEXAPRO taken for anxiety, depression; WELLBUTRIN taken for anxiety, depression; DEXILANT taken for gastroesophageal reflux disease. Past drug history included: Cipro, reaction(s): "Cipro allergy manifested by burning and itchiness", notes: Cipro allergy manifested by burning and itchiness; Cipro, reaction(s): "Cipro allergy manifested by burning and itchiness", notes: Cipro allergy manifested by burning and itchiness. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 10Aug2022, outcome "recovered" (10Aug2022), described as "Vaccination site bleeding/More bleeding than the first time when patient did the injection with pfizer vaccine". The action taken for adalimumab was dosage not changed. Causality for Humira 80 MG/ 0.8 ML (Adalimumab): The reporter's causality for the event(s) of more bleeding than the first time when patient did the injection with Pfizer vaccine with Humira 80 mg/ 0.8 ml (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) Vaccination site bleeding (Vaccination site haemorrhage) was not related. Additional information: A female with events of non-serious more bleeding than the first time when patient did the injection with Pfizer vaccine, auto injector delayed delivery and needle bent with Humira 80 mg/ 0.8 ml (Adalimumab). On unknown dates, the patient experienced autoinjector delayed delivery and needle bent. On 10Aug2022, the patient experienced more bleeding than the first time when patient did the injection with Pfizer vaccine. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.