Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vaccination site bruising, Vaccination site pain
Clinical narrative: blood in stools; Injection site bruising; Chills; Pain in arm; Pain during injection; achy; groggy; tired; cramping; 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-163-4362390-00, 22K-163-4448347-00.  An 18-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159931) at unk citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "blood in stools"; VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "Injection site bruising"; CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain during injection"; PAIN (non-serious), outcome "unknown", described as "achy"; SOMNOLENCE (non-serious), outcome "unknown", described as "groggy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramping". The action taken for adalimumab was dosage increased.  Clinical course: patient with events of non-serious chills, sore arm, pain when injecting and bruising when injecting with humira (adalimumab). On unknown dates, the patient experienced chills, sore arm, pain when injecting and bruising when injecting. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for humira (adalimumab): the reporter(s) causality for the event(s) of chills, sore arm, pain when injecting and bruising when injecting was not provided. Causality for BNT162B2: the reporter(s) causality for the event(s) of chills, sore arm was possible and for pain when injecting and bruising when injecting was not provided.   The reporter's assessment of the causal relationship of "injection site bruising" and "pain during injection" 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 "chills" and "pain in arm" related to BNT162b2. The reporter's assessment of the causal relationship of Groggy (Somnolence), Tiredness (Fatigue)Blood in stool (Haematochezia), Pain (Pain), Cramps (Muscle spasms) with the suspect product(s) BNT162b2 was possible at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (29Jun2022): This is a solicited follow-up report based on the information received by Pfizer from MFR (Mfr Control No.: 22K-163-4448347-00). A contactable consumer reported for herself that: Updated Information included: New event achy, groggy, tired, blood in stools and cramping' added and additional information updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.