Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Vaccination site bleeding/More bleeding than the first time when patient did the injection with pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. 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 ((80 mg, 1 in 2 wk))), subcutaneous for hidradenitis. The patient's relevant medical history included: "Laparoscopic surgery", start date: 2008 (unspecified if ongoing); "Endometriosis", start date: 2014 (unspecified if ongoing); "Gall bladder removed", start date: 2015 (unspecified if ongoing), notes: Gall bladder removed; "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); "Acid Reflux" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression; WELLBUTRIN taken for depression; DEXILANT taken for gastrooesophageal reflux disease. Past drug history included: Cipro, reaction(s): "Allergy_Cipro", notes: Cipro for Unknown Indication, Cipro allergy manifested by burning and itchiness. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", 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.  Additional information: It was reported that a female patient 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. On 10Aug2022, the more bleeding than the first time when patient did the injection with Pfizer vaccine resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Study no: FACILITATED COLLECT.   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 as per reporter (Drug/Vaccine): Not reported.  The reporter's causality for the event(s) of Auto injector delayed delivery and needle bent was not provided. Vaccination site bleeding (Vaccination site haemorrhage): Causality as per reporter (Drug/Vaccine): Not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.