Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Haemorrhage, Muscle spasms, Pain, Vaccination site pain
Clinical narrative: Bleeding; Pain; Cramps; Fatigue; Vaccination site pain; 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-163-4462288-00 (Agency).  A 64-year-old female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunization; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Route of administration: Intramuscular), administration date: 26Mar2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 06Mar2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "not recovered", described as "Bleeding"; PAIN (non-serious), outcome "not recovered"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "Cramps"; FATIGUE (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "bleeding", "pain", "cramps" and "fatigue" 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. The reporter considered "vaccination site pain" related to BNT162b2. Clinical course: Solicited report by a consumer of an adult female with events of non-serious fatigue, bleeding, sore arm after covid vaccine, pain and cramps with Humira (Adalimumab). There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Solution for injection in pre-filled pen) (Adalimumab): Fatigue: Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Probable, Dechallenge: N/A and for Bleeding, Vaccination site pain, Pain, Cramps it was reported as Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) with events Fatigue, Bleeding, Pain and Cramps was reported as Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A and for Vaccination site pain it was reported that Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.