Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Dizziness, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Crohn's aggravated; Headache; Dizziness; Vaccination site pain; sore arm  (pain in arm); This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4176286-00 (RA).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's aggravated"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; DIZZINESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Dizziness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm  (pain in arm)". The action taken for adalimumab was unknown. Additional information:  Causality for Humira  The reporter's causality for the event (s) of Crohns Worsened with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of headache, dizziness and sore arm after COVID 19 Vaccine with Humira was no reasonable possibility. Seq.No.: 1 Drug: Humira (Solution for injection in pre-filled pen) (Adalimumab) Causality: 1. Crohn's aggravated (Crohn's disease) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge: N/A 2. Headache (Headache) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine):  No reasonable possibility Dechallenge : N/A 3. Dizziness (Dizziness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A 4. Vaccination site pain (Vaccination site pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge:  N/A  Suspect drug(s) information: Suspect Drug(s) (include generic name): PFIZER BIONTECH Covid-19  Vaccine (Tozinameran) (Injection) (Tozinameran), Unknown, Unknown  Daily dose: (1 in 1 once) Indication for use: COVID-19 Vaccination Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown Daily Dose:  1. First Dose (1 in 1 Once) 2. Second Dose (1 in 1 Once) Causality Crohn's aggravated  (Crohn's disease) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 2. Headache (Headache) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine):  Not Related Dechallenge: N/A 3. Dizziness (Dizziness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A 4. Vaccination site pain (Vaccination site pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  The reporter's assessment of the causal relationship of the [Crohn's aggravated] with the suspect product was not provided and [Headache, Dizziness and Vaccination site pain] with the suspect product was not related 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.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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.