Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Immunisation reaction, Nasal pruritus, Renal pain
Clinical narrative: ulcerative colitis flare up; heightened sensitivity to heat; itchy nose; did not feel right; easily distracted; had lost all brain function/noticed could not concentrate; had lost all brainfunction/noticed could not concentrate; dizzy; kidney pain; Shaking; Vaccination adverse reaction; COVID; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4449823-00.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159929) at 40 mg (40 mg (citrate free,1 in 2 wk))), subcutaneous for colitis ulcerative; nirmatrelvir, ritonavir (PAXLOVID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Jun2022, outcome "not recovered", described as "COVID"; COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "ulcerative colitis flare up"; TEMPERATURE INTOLERANCE (non-serious), outcome "not recovered", described as "heightened sensitivity to heat"; NASAL PRURITUS (non-serious), outcome "not recovered", described as "itchy nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "did not feel right"; DISTRACTIBILITY (non-serious), outcome "not recovered", described as "easily distracted "; CEREBRAL DISORDER (non-serious), outcome "not recovered", described as "had lost all brain function/noticed could not concentrate"; DISTURBANCE IN ATTENTION (non-serious), outcome "not recovered", described as "had lost all brainfunction/noticed could not concentrate"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy"; RENAL PAIN (non-serious), outcome "unknown", described as "kidney pain"; TREMOR (non-serious), outcome "not recovered", described as "Shaking"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "Vaccination adverse reaction". The action taken for adalimumab and nirmatrelvir, ritonavir was unknown. Clinical course: report by a consumer of a 63 year old female with events of non-serious bad reaction to pfizer vaccination, on unknown dates, the patient experienced bad reaction to pfizer vaccination, heightened sensitivity to heat, itchy nose, did not feel right, had lost all brain function/noticed could not concentrate, easily distracted and shakes uncontrollably, dizzy, kidney pain and ulcerative colitis flare up. In Jun2022, the patient experienced COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter declined to be contacted. Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB).  Causality: 1) Vaccination adverse reaction (Immunisation reaction), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A. 2) Heat sensitivity (Temperature intolerance), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 3) Nasal itching (Nasal pruritus) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 4) Feeling abnormal(Feeling abnormal), Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A. 5) Distractibility(Distractibility), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 6) Concentration loss (Disturbance in attention) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 7) Dizzy (Dizziness), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 8) Shaking (Tremor) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A. 9)Kidney pain (Renal pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A.10)Colitis ulcerative aggravated (Colitis ulcerative), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A.11) covid-19 (covid-19), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A.  The reporter's assessment of the causal relationship of "ulcerative colitis flare up", "heightened sensitivity to heat", "itchy nose", "did not feel right", "easily distracted ", "had lost all brain function/noticed could not concentrate", "had lost all brainfunction/noticed could not concentrate", "dizzy", "kidney pain", "shaking" and "covid" 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 adverse reaction" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer drug 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.